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 EVIDENCE REPORT AND
EVIDENCE-BASED
RECOMMENDATIONS

Chronic Disease Self

Management for Diabetes,
Osteoarthritis, Post-Myocardial
Infarction Care, and
Hypertension
Southern California
Evidence-
Evidence-Based
Practice
Center

Santa
Santa Monica
Monica
Los
Los Angeles
Angeles
San
San Diego
Diego

PREPARED FOR: U.S. Department of Health and Human Services

Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

PREPARED BY: RAND

CONTRACT NUMBER: 500-98-0281

CONTRACT PERIOD: September 30, 1998 to September 29, 2003

 Project Staff

Principal Investigator Paul Shekelle, MD, PhD

Project Manager Margaret Maglione, MPP

Article Screening/Review Josh Chodosh, MD, MSHS

Walter Mojica, MD, MPH

Senior Statistician Sally C Morton, PhD

Senior Quantitative Analyst Marika J Suttorp, MS

Senior Programmer/Analyst Elizabeth A Roth, MA

Programmer Lara Jungvig, BA

Staff Assistant/ Database Manager Shannon Rhodes, MFA

Eileen McKinnon, BA

Cost Analyst Shin-Yi Wu, PhD

Principal Investigator Laurence Rubenstein, MD, MPH

Healthy Aging Project

CMS Project Officer Pauline Lapin, MHS

i
TABLE OF CONTENTS
EXECUTIVE SUMMARY ..................................................................................... V
INTRODUCTION ...............................................................................................1
METHODS ......................................................................................................5
Conceptual Model ...................................................................................................... 5
Identification of Literature Sources .......................................................................... 9
Evaluation of Potential Evidence ............................................................................ 17
Extraction of Study-Level Variables and Results .................................................. 19
Statistical Methods................................................................................................... 28
Cost Effectiveness ................................................................................................... 36
Expert Review Process and Post-Hoc Analyses ................................................... 36
RESULTS .....................................................................................................42
Identification of Evidence........................................................................................ 42
Selection of Studies for the Meta-Analysis............................................................ 44
Results of the Meta-Analyses ................................................................................. 56
LIMITATIONS...............................................................................................115
CONCLUSIONS ............................................................................................117
RECOMMENDATIONS ...................................................................................119
REFERENCES CITED ...................................................................................120
APPENDIX A. EXPERT PANELIST ..................................................................155
APPENDIX B. ACCEPTED ARTICLES .............................................................156
APPENDIX C. REJECTED ARTICLES ..............................................................162
EVIDENCE TABLES......................................................................................186

ii
Figures and Tables
Figure 1. Conceptual Model ...................................................................................................................... 7
Figure 2. Screening Form........................................................................................................................ 18
Figure 3. Quality Review Form ............................................................................................................... 20
Figure 4. Flow of Evidence...................................................................................................................... 43
Figure 5. Article Flow of References from Boston Group .................................................................... 46
Figure 6. Forest Plot of Diabetes Studies: Hemoglobin A1c ............................................................... 58
Figure 7. Funnel Plot of Diabetes Studies: Hemoglobin A1c .............................................................. 58
Figure 8. Forest Plot of Diabetes Studies: Weight ............................................................................... 59
Figure 9. Funnel Plot of Diabetes Studies: Weight............................................................................... 59
Figure 10. Forest Plot of Diabetes Studies: Fasting Blood Glucose .................................................. 60
Figure 11. Funnel Plot of Diabetes Studies: Fasting Blood Glucose ................................................. 60
Figure 12. Forest Plot of Osteoarthritis Studies: Pain ......................................................................... 63
Figure 13. Funnel Plot of Osteoarthritis Studies: Pain ........................................................................ 63
Figure 14. Forest Plot of Osteoarthritis Studies: Functioning ............................................................ 64
Figure 15. Funnel Plot of Osteoarthritis Studies: Functioning ........................................................... 64
Figure 16. Forest Plot of Post-Myocardial Infarction Care Studies: Mortality ................................... 67
Figure 17. Funnel Plot of Post-Myocardial Infarction Care Studies: Mortality .................................. 67
Figure 18. Forest Plot of Post-Myocardial Infarction Care Studies: Return to Work........................ 68
Figure 19. Funnel Plot of Post-Myocardial Infarction Care Studies: Return to Work ....................... 68
Figure 20. Forest Plot of Hypertension Studies: Systolic Blood Pressure........................................ 71
Figure 21. Funnel Plot of Hypertension Studies: Systolic Blood Pressure ....................................... 71
Figure 22. Forest Plot of Hypertension Studies: Diastolic Blood Pressure....................................... 72
Figure 23. Funnel Plot of Hypertension Studies: Diastolic Blood Pressure...................................... 72
Figure 24. Forest Plot of Pooled Studies............................................................................................... 74
Figure 25. Funnel Plot of Pooled Studies .............................................................................................. 75
Figure 26. Regression of Intermediate 2 on Intermediate 1................................................................. 91
Figure 27. Regression of Outcome on Intermediate 2 ......................................................................... 92

iii
Table 1. Review Articles .......................................................................................................................... 12
Table 2. Articles Rejected from Meta-analysis...................................................................................... 47
Table 3. Diabetes articles Contributing to Meta-analysis .................................................................... 53
Table 4. Osteoarthritis Articles Contributing to Meta-analysis ........................................................... 54
Table 5. Post-Myocardial Infarction Care Articles Contributing to Meta-analysis ............................ 54
Table 6. Hypertension Articles Contributing to Meta-analysis............................................................ 55
Table 7. Publication Bias for Diabetes Studies..................................................................................... 61
Table 8. Publication Bias for Osteoarthritis Studies ............................................................................ 65
Table 9. Publication Bias for Post-Myocardial Infarction Care Studies ............................................. 69
Table 10. Publication Bias for Hypertension Studies...........................................................................73
Table 11. Meta-Analysis Results for Diabetes ...................................................................................... 76
Table 12. Meta-Analysis Results for Osteoarthritis.............................................................................. 77
Table 13. Meta-Analysis Results for Post-Myocardial Infarction Care ............................................... 78
Table 14. Meta-Analysis Results for Hypertension .............................................................................. 79
Table 15. Meta-Analysis Results Pooled Across Conditions .............................................................. 80
Table 16. Meta-Analysis Results for Diabetes (RE-AIM Model)............................................................ 82
Table 17. Meta-Analysis Results for Osteoarthritis (RE-AIM Model) ................................................... 83
Table 18. Meta-Analysis Results for Post-Myocardial Infarction Care (RE-AIM Model) .................... 84
Table 19. Meta-Analysis Results for Hypertension (RE-AIM Model).................................................... 85
Table 20. Meta-Analysis Results Pooled Across Conditions (RE-AIM Model) ................................... 86
Table 21. Meta-analysis Results for Diabetes (Severity Model) ........................................................... 88
Table 22. Meta-analysis Results for Osteoarthritis (Severity Model) .................................................. 88
Table 23. Meta-analysis Results Pooled Across Conditions (“Essential Elements” Model) ........... 89

iv
EXECUTIVE SUMMARY

Introduction

Chronic diseases currently affect well over one hundred million Americans. Though

chronic diseases are not immediately life threatening, they pose a significant threat to the health,

economic status and quality of life for individuals, families and communities.1, 2 The greatest

burden of chronic disease is concentrated in the 65-year and older age group. In 1995, 79% of

noninstitutionalized persons who were 70 years and older reported having at least one of seven

of the most common chronic conditions: arthritis, hypertension, heart disease, diabetes,

respiratory diseases, stroke, and cancer.1 Demographic trends portend alarming increases in the

next 20 years.

There is a growing enthusiasm for self-management programs, either as stand alone

program or as integral components of chronic care models, in controlling and preventing chronic

disease complications.3-7 Despite this enthusiasm, there is no agreed definition of what

constitutes a “chronic disease self-management program” nor is there agreement on which

elements of self management programs are most responsible for any beneficial effects.

We therefore sought to use empirical data from the literature to address the following

research questions posed by the Centers for Medicare and Medicaid Services (CMS).

1. Do these programs work?

2. Are there features that are generalizable across all diseases?

3. Does this intervention belong in the medical care system?

4. Define chronic disease self-management and distinguish between it and disease management.

5. What is the role or potential of technology?

v
6. What is the impact of chronic disease self-management programs on quality of life, health

status, health outcomes, satisfaction, pain, independence, and mental health (e.g., depression,

emotional problems)?

7. To what extent does self-management educate a patient on how to care for himself/herself

(e.g., take medications appropriately, consult with a physician when necessary, etc.)?

8. What is the patient’s retention of self-management skills after the intervention? Is a follow-

up intervention needed at some point?

9. How does the approach for self-management differ for people with multiple chronic

diseases?

10. Is a generic self-management approach preferable to a disease-by-disease approach?

11. Should this intervention be targeted to a subset of the population or available to everyone?

Are there particular chronic conditions that should be addressed (e.g., diabetes, arthritis,

stroke, cancer, Parkinson’s, hypertension, dyslipidemia)?

12. What is the role of the physician? Can physicians be used to reinforce learning?

13. Cost effectiveness or cost savings—does the intervention appear to reduce health care costs

by reducing disease, physician office visits, hospitalizations, nursing home admissions, etc.?

14. Delivery mechanism: What do we know about whom (which provider type? trained lay

person?) should deliver this service? Do we know which care settings have proven effective

(e.g., physician’s office, senior center, other community or clinical settings)?

To address these questions, we focused on evaluating the effect of self-management

programs for the four chronic conditions most commonly studied in controlled trials of older

adults: osteoarthritis, diabetes mellitus, hypertension, and post myocardial infarction.

vi
Methods

Conceptual Model

In order to avoid the premature loss of potentially relevant studies, we broadly defined

"chronic disease self-management" as a systematic intervention that is targeted towards patients

with chronic disease to help them to actively participate in either or both of the following

activities: self-monitoring (of symptoms or of physiologic processes) or decision-making

(managing the disease or its impact based on self-monitoring). All interventions included in this

study attempt to modify patient behavior to reach specific goals of chronic disease self-

management.

We attempted to understand the characteristics particular to chronic disease self-

management programs that may be most responsible for their effectiveness. Based on the

literature and expert opinion, we postulated five hypotheses regarding effectiveness of chronic

disease self-management programs:

1 Patients who receive interventions tailored to their specific needs and circumstances are

likely to derive more benefit than those receiving interventions that are generic. (Tailored)

2 Patients are more likely to benefit from interventions received within a group setting that

includes others affected by the same condition than they are to benefit from an intervention

that was provided by other means. (Group Setting)

3 Patients who are engaged in a cycle of intervention followed by some form of individual

review with the provider of the intervention are more likely to derive benefit than from

interventions where no such review exists. (Feedback)

vii
4 Patients who engage in activities using a psychological intervention are more likely to derive

benefit than from interventions where there is no psychological emphasis. (Psychological)

5 Patients who receive interventions directly from their medical providers are more likely to

derive benefit than those who received interventions from non-medical providers. (Medical

Care)

Outcome measures

For the diabetes studies we used hemoglobin A1c, fasting blood glucose, and weight as

outcomes. For osteoarthritis, we used measures of pain and function. As would be expected, we

used systolic and diastolic blood pressure for hypertension. For post MI care, we used return to

work and mortality. For all conditions, we also collected intermediate outcomes such as

knowledge, feeling of self-efficacy, and health behaviors that are postulated to be related to

clinical outcomes. We separately assessed studies reporting costs.

Databases for Literature Search

To identify existing research and potentially relevant evidence for this report we searched

a variety of sources including the Cochrane Library (containing both a database of systematic

reviews and a controlled-trials register), the Assessment of Self-Care Manuals published by the

Oregon Health Sciences University (March 2000), and An Indexed Bibliography on Self-

Management for People with Chronic Disease 8 published by the Center for Advancement of

Health (CAH). In addition Medline, PsycInfo, and Nursing and Allied Health databases were

search.

Seventy-three other review articles on disease management were obtained; each review

discussed at least one intervention aimed at chronic disease self-management. We retrieved all

relevant documents referenced. We also contacted experts in the field and asked for any studies

viii
that were in press or undergoing review. Finally, we exchanged reference lists (but not analyses

or results) with a leading east coast university also performing a review of chronic disease self-

management programs, but not limited to older adults

Article Selection and Data Abstraction

Article selection, quality assessment, and data abstraction were done in standard fashion

by using two trained physician reviewers working independently; disagreements were resolved

by consensus or third-party adjudication.

Statistical Analyses

We answered many of the research questions through meta-analysis. We conducted

separate meta-analyses for each of the four medical conditions. We included all controlled trials

that assessed the effects of an intervention or interventions relative to either a group that received

usual care or a control group. The majority of our outcomes were continuous and we extracted

data to estimate effect sizes for these outcomes. For each pair of arms, an unbiased estimate9 of

Hedges’ g effect size10 and its standard deviation were calculated. A negative effect size

indicates that the intervention is associated with a decrease in the outcome at follow-up as

compared with the control or usual care group.

Because follow-up times across studies can lead to clinical heterogeneity, we excluded

from analysis any studies whose data were not collected within a specified follow-up interval

chosen based on clinical knowledge.

For each condition and outcome, we conducted the same analysis. We first estimated a

pooled random effects estimate11 of the treatment effect and a pooled effect size for continuous

outcomes across all studies and its associated 95% confidence interval. For each of the original

five hypotheses stated above, study arms either met the hypothesis (a “yes”) or did not (a “no”)

ix
and thus, no missing values exist. For each hypothesis, a simple stratified analysis would have

produced a pooled estimate of the treatment effect for all the “yes” study arms together, and a

pooled estimate for all the “no” study arms together. To facilitate testing the difference between

the two pooled estimates, we constructed these estimates using meta-regression in which the only

variables in the regression were a constant, and an indicator variable equal to one if the study

arm met the hypothesis and zero if the study arm did not. For some outcomes and hypotheses,

all study arms were either "yes" or "no." In this case, we could not fit a model.

As an overall test of the hypotheses, we combined the pain outcomes from osteoarthritis

studies, hemoglobin A1c outcomes from diabetes studies, and systolic blood pressure outcomes

from hypertension into one analysis using effect size and fit the five separate regressions as

above. We also fit a sixth regression that had a constant and all five-indicator variables for the

separate regressions included.

Sensitivity Analyses

Within each regression, and especially in the combined analysis, our primary analysis

ignored the fact that individual studies had multiple intervention arms and thus could contribute

more than one treatment effect to the analysis. The correlation between treatment effects within

the same study, due to the fact the each intervention arm was compared to the same control or

usual care arm, was ignored in this analysis. Our sensitivity analyses consisted of refitting the

meta-regression models using a two-level random effects model that contains a random effect at

the study level, as well as one at the arm level. This hierarchical approach controls for the

correlation within arms in the same study. None of these sensitivity analyses results differed

markedly from that of the primary analysis.

x
Post Hoc Analyses

We presented the results of the above analyses to a group of experts in chronic disease

self-management. Based on this presentation, members of this group suggested a series of

additional analyses exploring other possible mechanisms for an effect of self-management

programs. These included classifying the studies according to categories proposed in the RE-

AIM Model,12 classifying the studies according to potential “essential elements” proposed by

this group,13 assessing whether the effectiveness of self-management programs varied by severity

of illness, and assessing whether interventions more likely to improve the “intermediate

variables,” such as knowledge and perception of self-efficacy, were more likely to improve

health outcomes

Results

Question 1. Do these programs work?

Question 2. Are there features that are generalizable across all diseases?

Question 6. What is the impact of chronic disease self-management programs on

quality of life, health status, health outcomes, satisfaction, pain, independence,

mental health (e.g., depression, emotional problems)?

Question 10. Is a generic self-management approach preferable to a disease-by-

disease approach?

These questions are all related and were the focus of our meta-analysis. We first present

a disease-by-disease assessment of the evidence for efficacy, then our assessment of

generalizable or generic elements of a self-management program.

xi
Diabetes

There were 14 comparisons from 12 studies that reported hemoglobin A1c outcomes. In

an overall analysis of the effectiveness of chronic disease self-management programs, these

studies reported a statistically and clinically significant pooled effect size of -0.45 in favor of the

intervention (95% CI: (-0.26, -0.63)). The negative effect size indicates a lower hemoglobin A1c

in the treatment group as compared to the usual care or control group. An effect size of –0.45 is

equal to a reduction in hemoglobin A1c of about 1.0. For change in weight, there were 10

comparisons from 8 studies. There was no statistically significant difference between change in

weight in the intervention and control groups (effect size of -0.05; 95% CI:(-0.12, 0.23)). There

were 10 comparisons from 9 studies that reported fasting blood glucose outcomes. The pooled

effect size was -0.41 in favor of the intervention (95% CI: (-0.23, -0.60)). This effect size equates

to a drop in blood glucose of 1 mml/l.

Our assessment of publication bias revealed likely publication bias in studies reporting

hemoglobin A1c outcomes. Therefore, our results regarding efficacy of chronic disease self-

management programs for improving hemoglobin A1c must be interpreted with caution.

Osteoarthritis

For both pain and function outcomes there were 10 comparisons from 7 different studies.

The pooled results did not yield any statistically significant differences between intervention and

control groups (pooled effect sizes of -0.04 and -0.01 for pain and function respectively). Our

assessment of publication bias did not yield any evidence of publication bias.

Hypertension

For hypertension there were 23 comparisons from 14 studies that reported systolic and

diastolic blood pressure changes. The overall pooled result of the chronic disease self-

xii
management programs was a statistically and clinically significant reduction in systolic and

diastolic blood pressure (effect size for systolic blood pressure -0.32; 95% CI: (-0.50, -0.15);

effect size for diastolic blood pressure -0.59; 95% CI: (-0.81, -0.38)). An effect size of 0.32 is

equivalent to a change in blood pressure of 3.5 mm of mercury, the corresponding value for an

effect size of 0.59 is 6.5 mm of mercury. In our assessment of publication bias, there was

evidence of publication bias. Therefore our pooled result favoring chronic disease self-

management programs for hypertension must be viewed with caution.

Post Myocardial Infarction Care

There were 9 studies that reported mortality outcomes. There was no effect of chronic

disease self management programs on improving mortality (pooled relative risk 1.04; 95% CI:

(0.56, 1.95)). For return to work there were 10 comparisons from 8 studies. The pooled relative

risk did not show any difference between groups (relative risk 1.02; 95% CI: (0.97, 1.08)). Our

assessment of publication bias showed evidence of publication bias for the mortality outcome but

not the return to work outcome.

Tests of hypothesis of elements essential to chronic disease self-management efficacy

Other than an increased effectiveness seen in hypertension studies reporting systolic

blood pressure outcomes that used tailored interventions, there were no statistically significant

differences between interventions with or without the 5 features hypothesized to be related to

effectiveness (tailoring, use of group setting, feedback, psychological component, and medical

care). Indeed, many of the effects seen were inconsistent across outcomes within the same

condition. For example, in hypertension studies, for the hypothesis “use of a group setting,”

there was a greater than 50% increase in the effect size for improvement in systolic blood

xiii
pressure, but only a 5% increase in the effect size for improvement in diastolic blood pressure

(with neither result reaching statistical significance).

Our "across condition" analysis shows effect sizes that, in general, go in the direction of

supporting increased effectiveness associated with the use of these intervention features,

however none of the differences are statistically significant.

Post Hoc Analyses

Our “post hoc” tests of possible “essential elements” of chronic disease self-management

programs was unrevealing. The RE-AIM theory12 suggests that the following components: one-

on-one counseling interventions (individual), group sessions (group), telephone calls (telephone),

interactive computer-mediated interventions (computer), mail interventions (mail) and health

system policies (policy 1 and policy 2) led to positive outcomes. With few exceptions, there

were no results that were statistically significant. An exception is the result for the use of one-

on-one counseling sessions, which did show a statistically significant increased effect size when

used.

For the “Essential Elements of Self-management Interventions” evaluation, we did not

find as much variation among studies and components as is necessary for optimal power in the

analysis. Most of the studies scored positively for “problem identification and solving,” and did

not score positively for the “ensuring implementation component.” Given these data, we did not

find evidence to support either any one of these three broad “essential elements” as necessary,

nor some threshold (such as two out of three) in terms of efficacy. This was not an optimal test

of these hypotheses due to the lack of variation in the data.

xiv
 Our analysis of the effect of self-management intervention on “intermediate variables”

such as knowledge and self-efficacy did not produce consistent results supporting an effect in the

expected direction.

Lastly, it was suggested we stratify by baseline patient severity. Only the assessment of

hemoglobin A1c demonstrated an increased effect size in patients who had higher (worse) value

of hemoglobin A1c at baseline, and this difference did not quite reach statistical significance.

Question 3. Does this intervention belong in the medical care system?

Whether chronic disease self-management belongs in the medical care system or in the

community is a decision that needs to be made by policy makers, based on many factors. One of

the first hypotheses we tested was whether patients who receive interventions directly from their

medical providers are more likely to have better outcomes than those who received interventions

from non-medical providers; no effect was found. Of the controlled studies that made it into our

meta-analysis, no studies of osteoarthritis or hypertension used medical providers in their self-

management interventions. Regarding diabetes, one intervention used medical providers; the

results of this intervention were not significantly different than those using lay leaders. One

post-myocardial infarction intervention used medical providers; the effects on mortality and

return to work were not statistically different from those of the other interventions.

Question 4. Define chronic disease self-management and distinguish between it

and disease management.

For purposes of this review, we initially defined chronic disease self-management

broadly as a systematic intervention that is targeted towards patients with chronic disease to help

them to actively participate in either or both of the following activities: self monitoring (of

xv
symptoms or physiologic processes) or decision-making (managing the disease or its impact

based on self-monitoring). Our analytic attempts to “define” chronic disease self-management

by identifying the components most responsible for the success of the program were

unsuccessful.

The draft evidence report was presented to a group of experts in chronic disease self-

management at a meeting convened by the Robert Wood Johnson Foundation on December 14,

2001. The panel’s aim was to focus on interventions offered to patients who need a more intense

level and type of self-management support. They agreed that all self-management programs

should address the following three areas.

Disease, medication and health management. While patients need medical information

about their particular disease (diabetes, arthritis, asthma, etc.), the majority of the content in most

successful self-management programs emphasized generic lifestyle issues such as exercise,

nutrition, and coping skills. More disease-specific medication-specific information can be useful,

but such information rarely constitutes more than 20 percent of the content of programs.

Role management. Patients benefit from programs that help them maintain social

support, connection to work and family, and normal functions of daily life.

Emotional management. Programs should encompass managing depression and stress,

adaptation to change, and maintaining interpersonal relationships.

A monograph authored by Dr. Jesse Gruman (Center for the Advancement of Health,

2002) summarized the discussions from this meeting. The experts concluded that the essential

elements of self-management programs should include the following:

xvi
 1. Problem-solving training that encourages patients and providers to identify problems,

identify barriers and supports, generate solutions, form an individually tailored action

plan, monitor and assess progress toward goals, and adjust the action plan as needed.

2. Follow-up to maintain contact and continued problem-solving support, to identify

patients who are not doing well and assist them in modifying their plan, and to relate the

plan to the patient’s social/cultural environment.

3. Tracking and ensuring implementation by linking the program to the patient’s regular

source of medical care and by monitoring the effects of the program on the patient’s

health, satisfaction, quality of life, and health system quality measures.

The experts also recommended that any chronic disease self-management program be

composed of two tiers to accommodate the wide variety of patients with chronic conditions. The

first tier would include a low-intensity intervention designed to reach mass audiences and open

to anybody with a particular illness. The second tier would include a high-intensity intervention

targeted to people who require one-on-one support and case management. This program could

be offered to those who have not successfully managed their condition with the minimal support

of tier #1, those who have complicated conditions, and those whose life circumstances or

conditions change significantly.

Question 5. What is the role or potential of technology?

The advent of new technologies makes communication between patients, providers, and

others more convenient than ever. However, none of the randomized controlled studies on

chronic disease self-management for our study conditions in older patients used email or the

Internet. Thus, we were not able to quantitatively assess the impact of these technologies. A

xvii
recently reported study of back pain in middle aged adults reported modest improvements in

outcomes and costs for subjects randomized to a physician-moderated “email discussion group”

and educational material compared to a control group that received a magazine subscription. This

study suggests that incorporating these technologies into future randomized studies would be a

worthwhile endeavor.

Question 7. To what extent does self-management educate a patient on how to

care for himself/herself (e.g., take medications appropriately, consult with a

physician when necessary, etc.)?

Most CDSM studies that assess knowledge and self-efficacy reported beneficial

improvements. Most studies did NOT measure whether medications were taken appropriately or

“necessary” physician visits were made. The two studies that did assess compliance were

hypertension studies. One had a borderline beneficial overall result; the other reported a

significant beneficial result. One study was based on a conceptual model that specifically

considered that changing medication-taking behavior was going to be easier than changing diet

behavior or other such behaviors. This study did not actually measure compliance, but rather

measured “commitment to taking medications” and showed that this differed between

intervention and controls and that it was one of only three variables among those tested to be

associated with significant changes in blood pressure (the other two were “”belief in severity of

the disease” and “beliefs in efficacy of therapy”). Many studies assessed utilization, but none

assessed whether the utilization was necessary.

xviii
Question 8. What is the patient’s retention of self-management skills after the

intervention? Is a follow-up intervention needed at some point?

We were unable to find studies that actually included a “follow-up intervention” which

incorporated refresher skills on self-management. In light of this, we used a meta-regression

model to test whether self-management interventions that provide follow-up support led to better

results than those that did not. We classified interventions that maintained contact with the

patient through contracts, provider feedback, reminders, peer support, material incentives, or

home visits as including “follow-up support.” Of the interventions which could be included in

our meta-analyses, 19 had “follow-up support” while 28 did not. Pooled results were not

statistically different between the two groups.

Question 9. How does the approach for self-management differ for people with

multiple chronic diseases?

We found no evidence on this topic.

Question 11. Should this intervention be targeted to a subset of the population or

available to everyone? Are there particular chronic conditions that should be

addressed (e.g., diabetes, arthritis, stroke, cancer, Parkinson’s, hypertension,

dyslipidemia)?

We were able to quantitatively assess the effects of chronic disease self-management

programs on patients with diabetes, osteoarthritis, and hypertension. In addition, we were able to

pool results for post myocardial infarction programs. There were insufficient studies on stroke,

cancer, Parkinson’s and dyslipedemia to allow pooling.

xix
 In an attempt to assess whether chronic disease self-management programs were more

effective for more severe patients, we undertook a post-hoc quantitative analysis. Two clinicians

independently categorized each diabetes and osteoarthritis program as focusing on either more

severe or less severe patients. The clinicians were unable to categorize the hypertension and

post- MI programs in such a fashion, due to the lack of heterogeneity of the patients. In the

diabetes analysis, there was no statistical difference between the effectiveness of programs

targeted to more severe and less severe patients, in terms of change in hemoglobin A1c or

weight. For osteoarthritis studies, there was no statistical difference in change in pain or

functioning.

Question 12. What is the role of the physician? Can physicians be used to

reinforce learning?

Out meta-analysis did not reveal any statistically significant differences supporting the

role of physicians at enhancing the efficacy of chronic disease self-management programs.

Question 13. Cost effectiveness or cost savings—does the intervention appear to

reduce health care costs by reducing disease, physician office visits,

hospitalizations, nursing home admissions, etc.?

A total of 19 clinical trial studies were identified in this review of the economic impact of

Chronic Disease Self-Management (CDSM). These include 9 studies on diabetes, 4 studies on

osteoarthritis, one study on hypertension, two on post-myocardial infarction, and three non-

disease-specific programs for chronically ill patients. They represented only a subset of possible

strategies for CDSM. Thus our economic review has limited generalizability beyond the studied

interventions.

xx
 Costs of the intervention were rarely reported and health care costs as an outcome of the

intervention were rarely studied. Changes in health care utilization were seldom reported, and in

many cases only studied on a limited scale (not including all types of services). The follow-up

period was short, while many outcomes will not be evident for many years (e.g., rigid metabolic

control may result in delay or prevention of diabetic complications, but only after several years).

Among the four diseases reviewed, the programs to promote self-management with

osteoarthritis patients have the best economic information and most consistently report

reductions in health care utilization and costs, even to the point of cost-savings. Such findings

are compatible with observational studies.14-16 Programs for diabetic patients have mixed results,

and overall are weaker in the economic information they report. There is only one hypertension

program identified that include any economic information, and the information provided does

not allow us to adequately judge cost-effectiveness of the program. The two reviewed MI studies

both lacked a rigorous collection of economic data, but the limited evidence presented suggests

that home-based rehabilitation programs could potentially be a cost-effective alternative to group

rehabilitation or standard care. As for the three general, non-disease-specific programs, two

RCTs and two observational studies reported that low-cost, community-based CDSM programs

may potentially be cost-saving.

Limitations

Despite finding evidence that CDSM programs have a clinically and statistically

significant beneficial effect on some outcomes, we were unable to discern which elements of

CDSM programs are most associated with success. This may have been because we did not test

the right hypotheses regarding CDSM elements, or because key variables describing these

components were either not recorded adequately or not recorded at all in the published articles,

xxi
or that the individual components themselves each have relatively weak effects. We considered

contacting original authors for additional information regarding their interventions, but rejected

this due to time and resource constraints. Furthermore, our experience has been that any study

published more than a few years ago has a much lower likelihood for getting a favorable

response to such a request. In addition, we may have lacked the statistical power, due to the

small number of studies available, to discern the reasons for the relatively small amount of

heterogeneity in the study results. We note that the preceding challenges are common to all

studies of complex, multicomponent interventions, and these challenges did not prevent us from

detecting important differences in the effectiveness of interventions for prevention of falls17 or

increasing the use of cancer screening and immunizations.18

An additional primary limitation of this systematic review, common to all such reviews,

is the quantity and quality of the original studies. We made no attempt to give greater

importance to some studies based on "quality." The only validated assessment of study quality

includes criteria not possible in self-management (double-blinding). As there is a lack of

empirical evidence regarding other study characteristics and their relationship to bias, we did not

attempt to use other criteria.

As previously discussed, we did find evidence of publication bias in hemoglobin A1c,

mortality, and systolic and diastolic blood pressure outcomes in diabetes, post-myocardial

infarction care, and hypertension, respectively. Therefore, the beneficial results that we report in

our pooled analysis need to be considered in light of the possible existence of unpublished

studies reporting no benefit.

xxii
Conclusions

1. Chronic disease self-management programs probably have a beneficial effect on some, but

not all, physiologic outcomes. In particular, we found evidence of a statistically significant

and clinically important benefit on measures of blood glucose control and blood pressure

reduction for chronic disease self management programs for patients with diabetes and

hypertension, respectively. Our conclusions are tempered by our finding of possible

publication bias, favoring beneficial studies, in these two clinical areas. These was no

evidence of a beneficial effect on other physiologic outcomes such as pain, function, weight

loss, and return to work.

2. There is not enough evidence to support any of the proposed elements as being essential to

the efficacy of chronic disease self-management programs. More research is needed to try

and establish the optimum design of a chronic disease self-management program, and

whether or not this differs substantially depending on the particular chronic disease or

characteristics of the patient.

3. While no randomized studies of chronic disease self-management programs for older adults

assessed the use of email or the Internet, one recently reported randomized study of email use

in the self-management of middle aged adults with back pain was sufficiently promising to

warrant testing such interventions for chronic disease self-management in the Medicare

population.

4. There is no evidence to conclusively support or refute the role of physician providers in

chronic disease self-management programs for older adults.

5. The evidence is inconclusive but suggests that chronic disease self-management programs

may reduce health care use.

xxiii
INTRODUCTION
Chronic diseases are conditions that are usually incurable. Although often not

immediately life threatening, they pose significant burdens on the health, economic status, and

quality of life for individuals, families, and communities.1 In 1995, seventy-nine percent of

noninstitutionalized persons who were 70 years or older reported having at least one of seven of

the most common chronic conditions affecting this age group: arthritis, hypertension, heart

disease, diabetes, respiratory diseases, stroke, and cancer.1

Of these seven conditions, arthritis is most prevalent, affecting more than 47 percent of

individuals 65 years and older.19 Hypertension affects 41 percent of this population while 31

percent have some form of heart disease, of which ischemic heart disease and a history of

myocardial infarction are major components. Diabetes affects approximately 10% of persons 65

years and older and increases the risk for other chronic conditions, including ischemic heart

disease, renal disease, and visual impairment.19

Life-altering disability is a frequent consequence of chronic disease. Of the seven

conditions listed above, arthritis is the leading cause of disability.2 In 1995, 11 percent of

noninstitutionalized persons who were 70 years or older reported arthritis as a cause of limitation

in their activities of daily living. Heart disease was reported by four percent, while 1.5 percent

reported diabetes as a cause of functional limitation.2

The proportion of Americans who are 65 years or older is rising steadily. In 1997,

thirteen out of every 100 Americans were 65 years or older. Demographers predict this

proportion will increase to 20 out of 100 by the year 2030, or approximately 70 million people.

1
Within this age-group, 8.5 million people will be over 85 years old, more than double the 1997

estimates.20

Given these demographic projections, the prevalence of chronic disease and its related

costs will also increase dramatically. Therapies for conditions such as osteoarthritis, heart

disease, and diabetes have improved considerably over the past 20 years. For example, evidence

suggests that exercise programs improve symptoms and reduce disability in individuals with

osteoarthritis;21 modest blood pressure control reduces the incidence of myocardial infarction

and stroke;22 and improved control of blood glucose significantly reduces the incidence of

diabetes, complications including neuropathy, renal disease, and blindness.23, 24

There is a growing conviction that self-management will be an important component of

controlling and preventing illness complications. Studies of condition-specific self-management

interventions have been used to evaluate the benefits of particular interventions. However, one

difficulty in drawing conclusions from this literature is that the interventions being evaluated

often consist of more than one component, making it difficult to identify what caused the

intervention as a whole to succeed or fail.

This evidence report was commissioned by the Centers for Medicare and Medicaid

Services (CMS) to examine the evidence regarding the effectiveness of chronic disease self-

management programs and to assess which components may be most crucial to success. More

specifically, this report reviews evidence from controlled trials of chronic disease self-

management programs for four of the most common conditions of older adults: diabetes,

osteoarthritis; post-myocardial infarction care; and hypertension. Our charge was to report the

evidence regarding the following key questions specified by CMS:

2
1. Do these programs work?

2. Are there features that are generalizable across all diseases?

3. Does this intervention belong in the medical care system?

4. Define chronic disease self-management and distinguish between it and disease

management.

5. What is the role or potential of technology?

6. What is the impact of chronic disease self-management programs on quality of life,

health status, health outcomes, satisfaction, pain, independence, mental health (e.g.,

depression, emotional problems)?

7. To what extent does self-management educate a patient on how to care for

himself/herself (e.g., take medications appropriately, consult with a physician when

necessary, etc.)?

8. What is the patient’s retention of self-management skills after the intervention? Is a

follow-up intervention needed at some point?

9. How does the approach for self-management differ for people with multiple chronic

diseases?

10. Is a generic self-management approach preferable to a disease-by-disease approach?

11. Should this intervention be targeted to a subset of the population or available to

everyone? Are there particular chronic conditions that should be addressed (e.g.,

diabetes, arthritis, stroke, cancer, Parkinson’s, hypertension, dyslipidemia)?

12. What is the role of the physician? Can physicians be used to reinforce learning?

3
13. Cost effectiveness or cost savings—does the intervention appear to reduce health care

costs by reducing disease, physician office visits, hospitalizations, nursing home

admissions, etc.?

14. Delivery mechanism: What do we know about whom (which provider type? trained

lay person?) should deliver this service? Do we know which care settings have

proven effective (e.g., physician’s office, senior center, other community or clinical

settings)?

4
METHODS
We synthesize evidence from the scientific literature on effectiveness of chronic disease

self-management programs, using the evidence review and synthesis methods of the Southern

California Evidence-Based Practice Center, an Agency for Healthcare Research and Quality—a

designated center for the systematic review of literature on the evidence for benefits and harms

of health care interventions. Our literature review process consisted of the following steps:

x Develop a conceptual model (also sometimes called an evidence model or a causal

pathway).

x Identify sources of evidence (in this case, sources of scientific literature).

x Identify potential evidence.

x Evaluate potential evidence for methodological quality and relevance.

x Extract study-level variables and results from studies meeting methodological and

clinical criteria.

x Synthesize the results.

CONCEPTUAL MODEL
These is no standard definition of what constitutes a chronic disease self-management

program. Indeed, the second key question we were assigned seeks to define essential

components empirically. Still, we needed to start with some initial definition in order to target

our literature search. Therefore, for this review, we defined "chronic disease self-management"

broadly as a systematic intervention that is targeted towards patients with chronic disease to help

them actively participate in either or both of the following activities: self monitoring (of

5
symptoms or of physiologic processes) or decision-making (managing the disease or its impact

based on self-monitoring).

Figure 1 represents a simple conceptual model of how self-management influences

patient outcomes. Patient behavior describes all that patients do to self-manage their chronic

diseases. All interventions included in this study attempt to modify patient behavior to reach

specific goals of chronic disease self-management.

Traditional behavior-change intervention components

Education. Educational efforts can be directed toward an individual, group, or entire

community. Pamphlets and posters can raise awareness among older adults or staff members at

senior centers and nursing homes. More intense educational interventions include one-on-one

counseling.

Psychological. Psychological efforts include counseling, cognitive-behavioral therapy,

relaxation training, and emotional support groups.

Feedback & Incentives include clinical reviews with patients, contracts, provider

feedback, reminders, diaries, goal setting instruction, and material/ financial incentives.

Intervention components aimed at particular physiologic targets include:

Physical Activity includes non-physiotherapy activity, for example walking, cycling, and

aerobic movements. P.A. also includes training geared specifically towards balance, strength, or

gait, for example tai chi or tailored physical therapy.

Medical and Related Interventions include interventions such as medication therapy,

blood pressure monitoring, and dietary monitoring.

6
 Figure 1. Conceptual Model

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Intervention

 


Patient
Patient Behavior Clinical Practice
Characteristics

Chronic Disease
Self-Management

Chronic Disease
Clinical Outcomes

7
 Interventions may be modified to account for specific patient characteristics, which result

in individualized intervention programs. In this way, the relevance of interventions is enhanced

and patients have greater opportunity to be more personally engaged than with generalized

programs. Programs that utilize intervention components such as group programs, feedback, or

psychological approaches may have greater impact than those programs lacking such

components. Programs using approaches more likely to be engaging may therefore enhance the

level of patient commitment and effort. These programs are also likely to provide more

opportunity for emotional support, both formally and informally, which may address a critical

need of patients who struggle with chronic disease conditions. Interventions that work within the

context of a clinical practice or are delivered by physicians who are otherwise engaged in the

study participants’ care may be more relevant and require potentially a greater investment on the

part of patients, resulting in increased likelihood of behavior change.

Hypotheses

Of key importance to both CMS and providers is what the essential elements of chronic

disease self-management programs seem to be. In this analysis, we attempt to understand the

characteristics particular to chronic disease self-management programs that may be most

responsible for their effectiveness. This analysis was undertaken to help answer CMS’s

secondary question, “Are there features that are generalizable across all diseases?” We

developed five hypotheses regarding effectiveness (terms in parentheses relate to terms used in

evidence tables). These five hypotheses operate on the areas indicated in the conceptual model

with the corresponding number.

8
 1. Patients who receive interventions tailored to their specific needs and circumstances

are likely to derive more benefit than those receiving interventions that are generic.

(Tailored)

2. Patients are more likely to benefit from interventions received within a group setting

that includes others affected by the same condition than they are to benefit from an

intervention that was provided by other means. (Group Setting)

3. Patients whose intervention is followed by some form of individual review with the

provider of the intervention are more likely to derive benefit than patients whose

interventions involve no such review. (Feedback)

4. Patients are more likely to derive benefit from activities that use a psychological

intervention than from interventions where there is no psychological emphasis.

(Psychological)

5. Patients who receive interventions directly from their medical providers are more

likely to derive benefit than those who received interventions from non-medical

providers. (MD Care)

IDENTIFICATION OF LITERATURE SOURCES

We used the sources described below to identify existing research and potentially

relevant evidence for this report. We searched each source for articles specific to the four

conditions of interest: diabetes, osteoarthritis, myocardial infarction, hypertension. We chose

these conditions because each had a significant quantity of published literature and each is highly

prevalent in older adults. (Because of these criteria we did not search for literature on conditions

9
with an extensive body of chronic disease self-management literature, such as rheumatoid

arthritis or asthma, as both of these are of low frequency in older adults.)

Cochrane Collaboration

The Cochrane Collaboration is an international organization that helps people make well-

informed decisions about health care by preparing, maintaining, and promoting the accessibility

of systematic reviews on the effects of heath-care interventions. The Cochrane Library contains

both a database of systematic reviews and a controlled-trials registry. The library receives

additional material continually to ensure that reviews are maintained and updated through

identification and incorporation of new evidence. The Cochrane Library is available on CD-

ROM by subscription. The Cochrane Library contained 15 reports on chronic disease self-

management; we obtained all studies referenced therein.

Oregon Health Sciences University

The Evidence-based Practice Center (EPC) at the Oregon Health Sciences University

published the Assessment of Self-Care Manuals in March 2000. The Oregon EPC systematically

searched the scientific literature for evidence that self-care manuals produce changes in a variety

of outcomes for health care consumers. We scanned the reference list and ordered relevant

articles.

In addition, the Oregon EPC sent a brief description of the preliminary review process for

a projected titled “Diabetes Self-Management Programs: Medical Guidelines and Patient Self-

Monitoring.” This document included abstracts on over 20 studies and a list of 13 review articles

on diabetes self-management. We ordered all relevant publications.

10
Center for Advancement of Health

The Center for Advancement of Health (CAH) in association with the Group Health

Cooperative of Puget Sound, recently published An Indexed Bibliography on Self-Management

for People with Chronic Disease. The role of the Center is to promote widespread acceptance

and application of an expanded view of health that recognizes psychological and behavioral

factors. The bibliography contained abstracts from over 400 journal articles, from 1980 to the

present, covering 18 chronic diseases and conditions. We ordered all relevant publications.

Library Search

In addition to obtaining references and materials from the above sources we conducted a

library search for all studies published (subsequent to) the CAH bibliography,8 using the search

terms listed below.

Medline, PsycInfo and Nursing and Allied Health databases were the primary sources of

citation information. Searches covered 1980 to 1995, although relevant articles from earlier

dates were included. The major search strategy consisted of keyword searches using a

combination of descriptors to focus the search on pertinent topical areas. Terms representing

each of the chronic diseases included in the bibliography were combined with a set of other

keyword terms that were likely to identify the types of articles that met inclusion criteria. The

following diseases were searched: Arthritis, Chronic Illness, Diabetes, Heart Disease, and

Hypertension. Keywords used in combination with disease names included Anxiety, Behavior,

Compliance, Coping , Depression , Disability, Exercise, Family, Isolation, Modeling, Nutrition,

Patient Education, Patient Satisfaction, Problem-Solving, Relaxation, Self-care ,and Social

Support.

11
 Related topics of interest were also searched by keyword, such as interactive video,

computer interventions, telephone intervention, media, practice redesign, case management,

patient provider interaction and illness model. Articles covering a number of different illnesses

or behaviors were sometimes identified by one particular keyword in a database. For instance,

many types of pertinent self-care behaviors would be included within the keyword “compliance,”

but not all articles retrieved under “compliance” would be relevant to chronic illness. Thus of

articles retrieved with such a search were reviewed for the subset of articles pertinent to chronic

illness management.

Previous Systematic Reviews

Sources using the aforementioned, we identified 73 previously completed reviews

relevant to this project (see Table 1). Each review discusses at least one intervention aimed at

chronic disease self-management. We retrieved all relevant documents referenced in these

publications.

Table 1. Review Articles

Review: Self-management education for adults with asthma improves health outcomes. Evidence-
Based Medicine. 1999;4:15. Rec #: 740
ACP Journal Club. Review: Several interventions reduce complications in type 2 diabetes mellitus.
ACP J Club. 1998;128:30. Rec #: 2577
Anderson BJ, Auslander WF. Research on diabetes management and the family: A critique. Diabetes
Care. 1980;3:696-702. Rec #: 2220
Assal JP, Muhlauser I, Pernot A, Gfeller R, Jorgens V, Berger M. Patient education as the basis for
diabetes care in clinical practice and research. Diabetologia. 1985;28:602-613. Rec #: 2104
Blumenthal J A, Thyrum E T, Gullette E D, Sherwood A, Waugh R . Do exercise and weight loss
reduce blood pressure in patients with mild hypertension? N C Med J. 1995;56(2):92-5. Rec #:
753
Broderick J E. Mind-body medicine in rheumatological disease. Rheumatic Disease Clinics of North
America. 1999. Rec #: 609
Brown S A . Meta-analysis of diabetes patient education research: variations in intervention effects
across studies. Res Nurs Health. 1992;15(6):409-19. Rec #: 759
Brown S A . Studies of educational interventions and outcomes in diabetic adults: a meta-analysis
revisited. Patient Educ Couns. 1990;16(3):189-215. Rec #: 760

12
 Table 1. Review Articles
Brown SA. Effects of educational interventions in diabetes care: a meta-analysis of findings. Nurs Res.
1988;37:223-230. Rec #: 2090
Brownell KD, Kramer FM. Behavioral management of obesity. Medical Clinics of North America.
1989;73:185-201. Rec #: 2642
Cassem NH, Hacket TP. Psychological rehabilitation of myocardial infarction patients in the acute
phase. Heart Lung. 1973;2:382-38. Rec #: 2409
Clark N M . Asthma self-management education. Research and implications for clinical practice.
Chest. 1989;95(5):1110-3. Rec #: 763
Clark N M, Becker M H, Janz N K, Lorig K, Rakowski W, Anderson L. Self-management of chronic
disease by older adults: A review and questions for research. J Aging Health. 1991;3:3-27.
Rec #: 904
Clark NM, Evans D, Zimmerman BJ, Levison MJ, Mellins RB . Patient and family management of
asthma: theory-based techniques for the clinician. J Asthma. 1994;31(6):427-35. Rec #: 764
Clement S . Diabetes self-management education. Diabetes Care. 1995;18(8):1204-14. Rec #: 769
Cox DJ, Gonder-Frederick L. Major developments in behavioral diabetes research. Journal of
Consulting and Clinical Psychology. 1992;60(4):628-638. Rec #: 2441
Dubbert PM, Rappaport NB, Martin JE. Exercise in cardiovascular disease. Behavior Modification.
1987;11:329-347. Rec #: 2643
Dunn S M . Rethinking the models and modes of diabetes education. Patient Educ Couns.
1990;16(3):281-6. Rec #: 778
Epstein LH, Cluss PA. A Behavioral Medicine perspective on adherence to long-term medical
regimens. Journal of Consulting and Clinical Psychology. 1988;6:77-87. Rec #: 2238
Fawzy F I, Fawzy N W, Arndt L A, Pasnau R O . Critical review of psychosocial interventions in cancer
care. Arch Gen Psychiatry. 1995;52(2):100-13. Rec #: 786
Freemantle N, Harvey EL, Wolf F, et al. Printed educational materials to improve the behavior of health
care professionals and patient outcomes. In: Cochrane Database of Systematic Reviews,
Issue 3, 1998. Rec #: 2618
Giloth B E . Promoting patient involvement: educational, organizational, and environmental strategies.
Patient Educ Couns. 1990;15(1):29-38. Rec #: 796
Glanz K. Patient and public education for cholesterol reduction: A review of strategies and issues.
Patient Education and Counseling. 1988;12:235-257. Rec #: 2644
Glasgow R E, Toobert D J, Hampson S E, Wilson W. Behavioral research on diabetes at the Oregon
Research Institute. Ann Behav Med. 1995;17:32-40. Rec #: 905
Glasgow RE, Osteen VL. Evaluating diabetes education: Are we measuring the most important
outcome? Diabetes Care. 1992;15:1423-1432. Rec #: 2177
Goodall T A, Halford W K . Self-management of diabetes mellitus: A critical review [published erratum
appears in Health Psychol 1992;11(1):77]. Health Psychol. 1991;10(1):1-8. Rec #: 802
Griffin S, Kinmonth AL. Diabetes care: the effectiveness of systems for routine surveillance for people
with diabetes (Cochrane Review). In: The Cochrane Library, Issue 4, 1998. Oxford: Update
Software. Rec #: 2620
Hackett TP. The use of groups in the rehabilitation of the postcoronary patient. Adv Cardiol.
1978;24:127-135. Rec #: 2411
Haynes RB, McKibbon KA, Kanani R, et al. Interventions to assist patients to follow prescriptions for
medications (Cochrane Review). In: The Cochrane Library, Issue 4, 1998. Oxford: Update
Software. Rec #: 2621

13
 Table 1. Review Articles
Hill D R, Kelleher K, Shumaker S A . Psychosocial interventions in adult patients with coronary heart
disease and cancer. A literature review. Gen Hosp Psychiatry. 1992;14(6 Suppl):28S-42S.
Rec #: 811
Hirano P C, Laurent D D, Lorig K . Arthritis patient education studies, 1987-1991: a review of the
literature [see comments]. Patient Educ Couns. 1994;24(1):9-54. Rec #: 813
Jacob RG, Wing R, Shapiro AP. The behavioral treatment of hypertension: long-term effects. Behav
Therapy. 1987;18:325-352. Rec #: 2471
Jacobson AM, Leibovich JB. Psychological issues in diabetes mellitus. Psychosomatic Illness Review.
1984;25:7-13. Rec #: 2255
Johnston DW. Behavioral treatment in the reduction of coronary risk factors Type A behavior and blood
pressure. Br J Clin Psychol. 1982;21:281-294. Rec #: 2364
Johnston DW. Stress managements in the treatment of mild primary hypertension. Hypertension.
1991;17(Suppl 3):63-68. Rec #: 2470
Kaplan RM, Davis WK. Evaluating costs and benefits of outpatients diabetes education and nutrition
counseling. Diabetes Care. 1986;9:81-86. Rec #: 2379
Kaplan S H, Greenfield S, Ware J E. Assessing the effects of physician-patient interactions on the
outcomes of chronic disease [published erratum appears in Med Care 1989 Jul;27(7):679].
Med Care. 1989;27(3 Suppl):S110-27. Rec #: 820
Keefe F J, Dunsmore J, Burnett R . Behavioral and cognitive-behavioral approaches to chronic pain:
recent advances and future directions. J Consult Clin Psychol. 1992;60(4):528-36. Rec #: 822
Keefe FJ, Gil KM, Rose SC. Behavioral approaches in the multidisciplinary management of chronic
pain: Programs and issues. Clinical Psychology Review. 1986;6:87-113. Rec #: 2292
Keefe FJ, Williams DA. New Directions in pain assessment and treatment. Clinical Psychology
Review. 1989;9:549-568. Rec #: 2293
Kemper D W, Lorig K, Mettler M . The effectiveness of medical self-care interventions: a focus on self-
initiated responses to symptoms. Patient Educ Couns. 1993;21(1-2):29-39. Rec #: 823
Linden W, Chambers L. Clinical effectiveness of non-drug treatment for hypertension: A meta-analysis.
Ann Behav Med. 1994;16:35-45. Rec #: 910
Lorig K. Self-management of chronic illness: A model for the future. Generations. 1993:11-14. Rec #:
911
Lorig K, Holman H . Arthritis self-management studies: a twelve-year review. Health Educ Q.
1993;20(1):17-28. Rec #: 831
Lorig K, Laurin J . Some notions about assumptions underlying health education. Health Educ Q.
1985;12(3):231-43. Rec #: 834
Mazzuca S A . Does patient education in chronic disease have therapeutic value? J Chronic Dis.
1982;35(7):521-9. Rec #: 843
Mazzuca S A . Education and behavioral and social research in rheumatology. Curr Opin Rheumatol.
1994;6(2):147-52. Rec #: 844
Meyer T J, Mark M M . Effects of psychosocial interventions with adult cancer patients: a meta-analysis
of randomized experiments [see comments]. Health Psychol. 1995;14(2):101-8. Rec #: 848
Mullen P D, Laville E A, Biddle A K, Lorig K . Efficacy of psychoeducational interventions on pain,
depression, and disability in people with arthritis: a meta-analysis. J Rheumatol. 1987;14
Suppl 15:33-9. Rec #: 850
Mullen PD, Green LW, Persinger GS. Clinical trials of patient education for chronic conditions: a
comparative meta-analysis of intervention types. Prev Med. 1985;14:753-781. Rec #: 2350

14
 Table 1. Review Articles
Mumford E, Schlesinger H J, Glass G V . The effect of psychological intervention on recovery from
surgery and heart attacks: an analysis of the literature. Am J Public Health. 1982;72(2):141-
51. Rec #: 852
Norris SL, Engelgau MM, Narayan KMV. Effectiveness of self-management training in Type 2
Diabetes. Diabetes Care. 2001;24:561-587.
Nunes E V, Frank K A, Kornfeld D S . Psychologic treatment for the type A behavior pattern and for
coronary heart disease: a meta-analysis of the literature. Psychosom Med. 1987;49(2):159-
73. Rec #: 854
O'Connor GT, Collins R, Burning JE et al. Rehabilitation with exercise after myocardial infarction.
Circulation. 1989;80(2):234-244. Rec #: 2692
Padgett D, Mumford E, Hynes M, Carter R . Meta-analysis of the effects of educational and
psychosocial interventions on management of diabetes mellitus. J Clin Epidemiol.
1988;41(10):1007-30. Rec #: 857
Razin A M . Psychosocial intervention in coronary artery disease: a review. Psychosom Med.
1982;44(4):363-87. Rec #: 864
Rosenstock IM. Understanding and enhancing patient compliance with diabetic regimens. Diabetes
Care. 1985;8:610-616. Rec #: 2268
Rosenstock J, Raskin P. Diabetes and its complications: Blood glucose control vs. genetic
susceptibility. Diabetes/Metabolism Reviews. 1988;4:417-435. Rec #: 2269
Schlundt DG, McDonel EC, Langford HG. Compliance in dietary management of hypertension.
Comprehensive Therapy. 1985;11:59-66. Rec #: 2645
Sobel D S . Rethinking medicine: improving health outcomes with cost-effective psychosocial
interventions. Psychosom Med. 1995;57(3):234-44. Rec #: 876
Spiegel D . Health caring. Psychosocial support for patients with cancer. Cancer. 1994;74(4
Suppl):1453-7. Rec #: 878
Strecher V J, DeVellis B M, Becker M H, Rosenstock I M . The role of self-efficacy in achieving health
behavior change. Health Educ Q. 1986;13(1):73-92. Rec #: 882
Sunin RM. Intervention with Type A behaviors. J Consult Clin Psychol. 1982;50:933-949. Rec #: 2365
Tattersall RB, McCulloch DK, Aveline M. Group therapy in the treatment of diabetes. Diabetes Care.
1985;8:180-188. Rec #: 2196
Tobin D L, Reynolds R V C, Holroyd K A, Creer T L. Self-management and social learning theory. In:
Holroyd KA, Creer TL. (Eds.) Self-Management of Chronic Disease: Handbook of Clinical
Interventions and Research. Orlando, FL: Academic Press, 1986. Rec #: 914
Toobert DJ and Glasgow RE. Assessing diabetes self-management: The summary of diabetes self-
care activities questionnaire. Berkshire, England: Hardwood Academic. 1994. Rec #: 2446
Turk D, Meichenbaum D. A Cognitive-behavioral approach to pain management. In: Wall P, Melzack
R. Textbook of Paid . London: Churchill Livingstone, 1994. pgs. 1337. Rec #: 2085
Vickery DM. Medical self-care: a review of the concept and program models. Am J Health Promotion.
1986;Summer:23-28. Rec #: 2301
Vijan S Stevens DL Herman et al. Screening, prevention, counseling, and treatment for the
complications of type II diabetes mellitus. Putting evidence into practice. Journal of General
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Wagner E H, Austin B T, Von Korff M . Organizing care for patients with chronic illness. Milbank Q.
1996;74(4):511-44. Rec #: 894
Watts FN. Behavioral aspects of the management of diabetes mellitus: Education, self-care and
metabolic control. Behavior Research and Therapy. 1980;18:171-180. Rec #: 2278

15
 Table 1. Review Articles
Wing RR. Behavioral strategies for weight reduction in obese Type II diabetic patients. Diabetes Care.
1989;12:139-144. Rec #: 2641
Wing RR, Epstein LH, Nowalk MP, Lamparski D. Behavioral self-regulation in the treatment of patients
with diabetes mellitus. Psychological Bulletin. 1986;99:78-89. Rec #: 2282

Health Care Quality Improvement Projects (HCQIP)

Each U.S. state and territory is associated with a Medicare Peer Review Organization

(PRO) that conducts various research projects. Centers for Medicare and Medicaid Services

(CMS), maintains a database with a narrative description of each research project, called a

Narrative Project Document (NPD). An NPD includes the aims, background, quality indicators,

collaborators, sampling methods, interventions, measurement, and results of a project. Our

search of the NPD database for studies on chronic disease self-management found none.

Experts

We contacted several experts in the field and asked for any studies which were in press or

undergoing review or that we had missed in our published literature.

Other Ongoing Reviews of Chronic Disease Self-management

During our review process we became aware of another group in Boston reviewing the

evidence on chronic disease self-management. While their focus was somewhat different than

ours, both groups were reviewing evidence on some illnesses in common. The two groups

therefore agreed to exchange reference lists (but no analytic strategies or results). The list of

studies included by the other group was provided by Daniel Solomon, MD.

16
EVALUATION OF POTENTIAL EVIDENCE
We reviewed the articles retrieved from the literature sources against exclusion criteria to

determine whether to include them in the evidence synthesis. A one-page screening review form

that contains a series of yes/no questions was created for this purpose (Figure 2). Two

physicians, each trained in the critical analysis of scientific literature, independently reviewed

each study, abstracted data, and resolved disagreements by consensus. Dr. Shekelle resolved any

disagreements that remained unresolved after discussions between the reviewers. Project staff

entered data from the checklists into an electronic database that was used to track all studies

through the screening process.

While we were searching primarily for data relevant to the Medicare population, we

included studies that contained data on populations under age 65 to avoid loss of potentially

useful data. To be accepted, a study had to be a controlled clinical trial. We further classified

controlled clinical trials as randomized or not, based on the following definitions:

Randomized controlled trial (RCT). A trial in which the participants (or other units) are

definitely assigned prospectively to one of two (or more) alternative forms of health care, using a

process of random allocation (e.g., random number generation, coin flips).

Controlled clinical trial (CCT). A trial in which participants (or other units) are either

(a) definitely assigned prospectively to one of two (or more) alternative forms of health care

using a quasi-random allocation method (e.g., alternation, date of birth, patient identifier), or

(b) possibly assigned prospectively to one of two (or more) alternative forms of health care using

a process of random or quasi-random allocation.

17
 Figure 2. Screening Form
1. Article ID: 7. Conditions studied: (Check all that apply):
† Heart disease
† Emphysema
2. First Author: † Heart failure
† Asthma
(Last name of first author) † Angina pectoris
† COPD
3. Reviewer: † Other heart conditions
† Back disorders
† Hypertension
4. Subject of article: † Osteoarthritis
Circle one † Diabetes
Chronic disease self-management................... 1 † Rheumatoid arthritis
Other ............................................................... 9 (STOP) † Other (sp:___________) † Other (sp:__________)
If other, then STOP † Other (sp:___________) † Unsure

8.Ages of study participants: Circle one

5. Do interventions studied satisfy OUR definition of chronic Excludes over 65............................................. 1
disease self-management? Check all that apply Includes over 65.............................................. 2 (Answer #9)
Studies a systematic intervention ................. † Unsure............................................................. 9
…targeted towards patients.......................... †
…with chronic disease................................. † 9. If study includes persons 65 and older, are the results
…to help them to actively participate ......... † reported separately for this group? Circle one
…in the following activities: ........................ † Yes .................................................................. 1
self-monitoring (of symptoms or of No ................................................................... 2
illness on quality of life), OR Not applicable ................................................. 8
decision-making (managing disease or Unsure............................................................. 9
its impacts based on self-monitoring)
If ANY are unchecked, then STOP Notes:

6. Study design: Circle one

Descriptive (editorial etc. Do not pull) .......... 0 (STOP)
Review/meta-analysis (pull article)................. 1 (STOP)
Randomized Clinical Trial .............................. 2
Controlled Clinical Trial ................................. 3
Controlled Before and After............................ 4
Interrupted Time Series................................... 5
Simple Pre-Post............................................... 6
Cohort ............................................................. 7
Other ............................................................... 8
Unsure............................................................. 9
If descriptive or review article, then STOP

18
EXTRACTION OF STUDY-LEVEL VARIABLES AND RESULTS
Using a specialized Quality Review Form (QRF - see Figure 3) we abstracted data from

the articles that passed our screening criteria. The form contains questions about the study

design; the number and characteristics of the patients; the setting, location, and target of the

intervention; the intensity of the intervention; the types of outcome measures and the time from

intervention until outcome measurement. We selected the variables for abstraction with input

from the project’s technical experts. Two physicians, working independently, extracted data in

duplicate and resolved disagreements by consensus. A senior physician resolved any

disagreements not resolved by consensus.

To evaluate the quality of the study, we collected information on the study design (with

the hierarchy of internal validity being RCT, CCT, CBA, and ITS), withdrawal/dropout rate,

agreement between the unit of randomization and the unit of analysis, blinding and concealment

of allocation.25

19
 Figure 3. Quality Review Form

6. If reported, was the method of double blinding appropriate? (circle one)

Article ID: Reviewer: Yes ........................................................................................1
No .........................................................................................2
First Author: Double blinding not described ..............................................8
(Last Name Only) Not applicable (not double blinded)......................................9
Study Number: of Date of Publication:
(Enter ‘1of 1’ if only one) 7. If study was randomized, did the method of randomization provide for concealment
of allocation? (circle one)
Description (if more than one study): Yes ........................................................................................1
No .........................................................................................2
Concealment not described ...................................................8
Study Quality Not applicable (not randomized)...........................................9
1. Design: (circle one)
RCT ......................................................................................1 8. Are numbers and reasons for withdrawals and dropouts described?
CCT ......................................................................................2 (circle one)
If not RCT or CCT, then STOP. Yes ........................................................................................1
No .........................................................................................2
2. Does the study present data on people age 50 and up? (circle one)
Yes........................................................................................1 9. What is the geographic setting of the study? (circle one)
No .........................................................................................2 Rural .....................................................................................1
If not, reject --STOP. Urban/Suburban ....................................................................2
Mixed....................................................................................4
3. Is the study described as randomized? (circle one) Other (specify: ) .......5
Yes........................................................................................1 Not specified .........................................................................8
No .........................................................................................2
10. What is the setting of study? (circle one)
4. If the study was randomized, was the method of randomization Academic ..............................................................................1
appropriate? (circle one) Non-academic .......................................................................2
Yes........................................................................................1 Both academic and non-academic.........................................3
No .........................................................................................2 Not specified .........................................................................8
Method not described............................................................8
Not applicable (not randomized)...........................................9 11. In what country was the study conducted? (circle one)
US .........................................................................................1
5. Is the study described as: (circle one) Great Britain .........................................................................2
Double blind .........................................................................1 France ...................................................................................3
Single blind, patient ..............................................................2 Germany ...............................................................................4
Single blind, outcome assessment ........................................3 Other (specify:___________________________)................5
Open .....................................................................................4 Not specified .........................................................................8
Blinding not described ..........................................................8
 Figure 3. Quality Review Forms (con't)
12. What is the refusal rate?
___ ___ %
(Enter NR if not reported)
13. Which best describes the reimbursement system in which
the study occurred: (check all that apply)
FFS ................................................................................... ‰
HMO................................................................................. ‰
MCO (not HMO) ............................................................. ‰
Mixed................................................................................ ‰
Other (specify: ) ....... ‰
Not sure............................................................................. ‰
14. Are data stratified by any of these groups or does a group
make up t 2/3 of the subjects? (check all that apply)
85 and older ...................................................................... ‰
African-American ............................................................ ‰
Hispanic ........................................................................... ‰
Other minority ................................................................. ‰
Low income ..................................................................... ‰
Nursing home ................................................................... ‰
Veterans ............................................................................ ‰
Other (specify: ) ....... ‰
None of the above ............................................................. ‰
15. Comorbid conditions (check all that apply)
Heart disease (not hypertension)....................................... ‰
Hypertension..................................................................... ‰
Kidney (renal) disease....................................................... ‰
Chronic respiratory disease............................................... ‰
PVD .................................................................................. ‰
Neuropathy ....................................................................... ‰
Obesity.............................................................................. ‰
DM.................................................................................... ‰
Arthritis............................................................................. ‰
CHF .................................................................................. ‰
Tobacco Abuse ................................................................. ‰
Angina .............................................................................. ‰
Other (specify: ) ....... ‰
None specified .................................................................. ‰
 ECG .................................................................................. ‰
21
DIABETES STUDIES ONLY:
16. Type of diabetes: (circle one)
Type I DM (IDDM) ............................................................1
Type II DM (NIDDM) ........................................................2
Both types ...........................................................................3
Not specified .......................................................................8

17. Which baseline diagnostic criteria were used? (check all that apply)
Fasting blood sugar ........................................................... ‰
Urine glucose .................................................................... ‰
HgbA1c............................................................................. ‰
Other (specify: ) ....... ‰
Diagnostic criteria not specified................................... .‰
OA/RA STUDIES ONLY:
18. Type of disease: (circle one)
RA only...............................................................................1
OA only ..............................................................................2
OA and RA .........................................................................3
Arthritis NOS......................................................................4
19. Which baseline diagnostic criteria were used? (check all that apply)
X-ray ................................................................................. ‰
Physical Exam................................................................... ‰
MD diagnosis w/o other detail .......................................... ‰
Other (specify:__________________________).............. ‰
Diagnostic criteria not specified........................................ ‰
MI STUDIES ONLY:
20. Type of disease: (check all that apply)
Uncomplicated .................................................................. ‰
Complicated ...................................................................... ‰
First Occurrence................................................................ ‰
Recurrence ........................................................................ ‰
Angina w/o infarction ....................................................... ‰
Angina w/ infarction ......................................................... ‰
Unsure/ unspecified .......................................................... ‰
21. Which baseline diagnostic criteria were used? (check all that apply)
CPK-MB elevation............................................................ ‰
Cardiac troponins .............................................................. ‰
Diagnostic criteria not specified........................................ ‰
Other (specify:__________________________).............. ‰
 Figure 3. Quality Review Forms (con't)
If study has a control group, then enter data for that group here. Otherwise, Use these abbreviations for interval:
enter data for each group in order of first mention. Complete one page for each arm MI minute WK week ND not described
Arm ____ of ____ Description: HR hour MO month NA not applicable
DY day YR year
22. Intervention:
Intervention Delivery Provider Duration of session/ Total # of
component Target Content by/during type Setting Frequency per interval units sessions Total duration / units Grouped With
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.

23. What was the sample size in this intervention arm? 26. What was the length of the intervention period?
___ ___ ___ , ___ ___ ___ ___ ___ ___ , ___ ___ ___ _________ _________
Entering Completing Number Units
(Enter 999,999 if not reported.) Enter MI, HR, DY, WK, MO, YR as defined above
IF “usual care” then SKIP to next page

24. Was there a protocol for the intervention? (circle one) 27. Were the intervention providers’ qualifications appropriate? (circle one)
Yes......................................................................................1 Yes ......................................................................................1
No .......................................................................................2 No .......................................................................................2
Protocol not mentioned .......................................................8 Qualifications not described................................................8

25. Was the intervention tailored to the individual? (circle one) 28. Were the providers homogeneous? (circle one)
Yes......................................................................................1 Yes ......................................................................................1
No .......................................................................................2 No .......................................................................................2
Qualifications not described................................................8 Therapists not described......................................................8

22
 Figure 3. Quality Review Forms (con't)

Outcomes, Evaluation, and Statistics

29. Type of outcomes measured: 30. When, relative to the start of the intervention, were outcomes measured?
Enter the code for each outcome measured. Circle at least Patient, assessor, or
one of the letters “P”, “A”, and “L” for each outcome laboratory rated? Enter the number of weeks in the appropriate box. Enter ‘999’ if not applicable.
measured. If rating method is not described, circle ONLY (ND=not described) use the following
“ND”.
Number Unit abbreviations for units:
N
P A L D 1st follow-up MI minute
N HR hour
P A L D 2nd follow-up DY day
N WK week
P A L D 3rd follow-up MO month
N YR year
P A L D 4th follow-up
N
P A L D 5th follow-up
N
P A L D
31. What was the unit of allocation? (circle one)
N
P A L Patient .................................................................................1
D
N Provider...............................................................................3
P A L D Organization (practice, hospital, HMO, community)..........4
N Other (specify: ) .....6
P A L D Not reported ........................................................................8
N
P A L D 32. What was the unit of analysis? (circle one)
N Patient .................................................................................1
P A L D Provider...............................................................................3
N Organization (practice, hospital, HMO, community)..........4
P A L D
Other (specify: ) .....6
N
P A L D
Not reported ........................................................................8
N
P A L D 33. If the unit of allocation is not the same as the unit of analysis, was any
N statistical correction made for clustering? (circle one)
P A L D Yes ......................................................................................1
N No .......................................................................................2
P A L D Not sure...............................................................................8
N Not Applicable....................................................................9
P A L D
N 34. Was any cost information provided? (circle one)
P A L D
Yes ......................................................................................1
N
P A L D No .......................................................................................2
N
P A L D

23
 Figure 3. Quality Review Forms (con't)
Hypertension Only Studies
Article ID: Reviewer:
First Author:
Description:
35. Types of hypertension (circle one)
Essential ................................................. 1
Secondary............................................... 2
Both........................................................ 3
Not specified .......................................... 8
Not applicable ........................................ 9
36. Types of hypertension (circle one)
Systolic................................................... 1
Diastolic ................................................. 2
Both........................................................ 3
Not specified .......................................... 8
Not applicable ........................................ 9
24
37. Types of hypertension (circle one)
Treated ................................................... 1
Untreated................................................ 2
Both........................................................ 3
Not specified .......................................... 8
Not applicable ........................................ 9
38. Which baseline diagnostic criteria
were used? (check all that apply)
One blood pressure recording ...............‰
More than 1 recording...........................‰
MD diagnosis ........................................‰
Other (specify:_________________) ...‰
Diagnostic criteria not specified ...........‰

39. Medication Treatment? (circle one)
Yes ......................................................... 1
No........................................................... 2
Other: (specify:_________________) ... 3
Not specified .......................................... 8
Not applicable ........................................ 9
 Figure 3. Quality Review Forms (con't)

Code Sheet

Intervention components 32. Exercise testing 20. Hospitals

1. Control 33. Exercise monitoring 21. Clinics
2. Usual Care 34. Patient directed discussion group 22. Practices
3. Advocacy training (how to ask MDs) 35. Compensation for participation 23. Other organizations, not specified
4. ASMP (Arthritis self-management) 36. Practice diagnostic skills 24. Group facilitator
5. Clinical reviews w/ patient 37. Blood pressure monitoring 25. Podiatrist
6. Cognitive-behavioral (including 38. Self monitoring 26. Pharmacist
relaxation training) 39. Medication therapy 27. Exercise leader
7. Consultation with specialists 40. Blood pressure lowering medication 28. Medical student
8. Contracts 99. Component not specified 29. Exercise therapist
9. Counseling/Therapy 30. Social worker
10. Dietary monitoring Targets, provider types 31. Physician assistant
11. Education 1. Patients 32. Therapist/counselor
12. Feedback 2. Physicians 33. _
13. Financial incentives 3. Psychologists 34. _
14. Mass media 4. Psychiatrists 35. Psychologists and nurses
15. Nontraditional therapies (massage, 5. Nurses
acupuncture, biofeedback, etc.) 6. Nurse practitioners
16. Practice methods 7. Other/non-specified medical
17. Psychological assessment/care professionals
18. Emotional support 8. Educators
19. Reminders/reinforcement 9. Nutritional Expert
20. Material incentive 10. Office Staff
21. Referrals 11. Non-medical personnel not staff
22. Unstructured group time 12. Lay leaders
23. Exercise program 13. Lay (affected) leaders/role models
24. Competition between groups 14. Family members
25. Exercise diary 15. Research assistants
26. Follow up 16. Qualified researchers
27. Social/peer support 17. Researchers, qualifications not
28. Cholesterol lowering medication specified
29. Placebo medication 18. Physical/Occupational Therapists
30. Practice self care skills 19. Health care organizations (e.g.,
31. Goal setting HMOs)

25
 Figure 3. Quality Review Forms (con't)

Code Sheet

Specific Content 34. Metabolic control 13. Video/Audio tapes

1. Behavioral assessment/strategies 35. Educational methods 14. Other mechanisms
2. Diet 36. Rehabilitation 15. One on one NOS
3. Disease information 37. Blood pressure 16. Protocols
4. Exercise 38. Psychotherapy 17. Detailed reading materials NOS
5. Foot care 39. Exercise capacity 18. Self-delivery
6. Medication information/compliance 40. Pain 19. Prescription
7. Pain coping skills 41. CPR 99. Mechanism not specified
8. Physical activity 42. Cardiac function
9. Prevention NOS 43. Work Settings
10. Smoking cessation 44. Psychosocial issues 1. Hospital
11. Stress management 45. Medication administration 2. Home
12. Weight management 46. Physical exam 3. In office
13. Sleep/fatigue management 47. Alcohol 4.
14. Symptom management 48. Peer support 5. Other setting specified (write in)
15. Use of community resources 49. Symptoms NOS 6. Nursing home
16. Communication skills 50. Depression 7. Day center
17. Problem solving/decision making 99. Content not specified 8. Community Center
18. Goal setting 99. Setting not specified
19. Empowerment Content Delivered By/During
20. Communicating with professionals 1. Group meeting Frequency Per Interval
21. Treatment information 2. Office visit 98. Variable frequency
22. Adherence/compliance 3.
23. Self-help 4. Hospitalization
24. BG(Blood Glucose) machine use 5. Home visit
25. Sexual activity/dysfunction 6. Telephone
26. Complementary therapy 7. Mail (postcards, letters)
27. Cognitive assessments/strategies 8. Detailed reading materials mailed
28. Self-monitor (pamphlets, newsletters)
29. Blood glucose monitor 9. Detailed reading materials (hand-
30. Joint preservation outs)
31. Relaxation methods 10. Instructional manuals
32. Emotional symptoms 11. Computer program
33. Urine monitor 12. Email/Internet

26
 Figure 3. Quality Review Forms (con't)

Code Sheet

Outcomes 69. Ischemic heart disease 114. Self rated health

DIABETES 70. CHF 115. ER visits
1. Diabetic complications 71. Cardiac symptoms 116. Functional status
2. Foot care activity 72. Angioplasty (PTCA) 117. Medication compliance
3. Foot lesions 73. Chest pain 118. Medication use
4. FSBG 74. ECG 119. Work activity
5. HgbA1c 75. Exercise tolerant test 120. Sexual activity (same as 63)
6. Hypoglycemic episodes (ETT)/Treadmill 121. Physical activity
7. Self monitoring frequency (BG) 122. BMI (Body Mass Index)
8. Diabetic symptoms OTHER/COMMON 123. Self care
9. Postpandrial blood glucose 90. MD visits 124. Physician-patient interactions
10. C-peptide 91. Nurse visits 125. Cardiac procedures
11. Urine glucose 92. Behavioral measures 126. Compliance/adherence
12. Self-monitoring accuracy 93. Blood pressure 127. Marital Adjustment
13. Plasma insulin 94. Coping strategies 128. Aerobic capacity (VO2Max)
14. Creatinine 95. Depression assessment 129. Anaerobic threshold
15. Self-monitoring frequency(UG) 96. Dietary measures 130. Skin fold thickness
97. Disability, physical 131. Problem solving
OA 98. Disease duration 132. Anxiety
30. Pain measurement 99. Emotional well-being 133. Exercise capacity (METS)
31. Physical performance 100. Exercise frequency 134. Alcohol use
32. Mobility 101. Health service utilization NOS 135. Heart rate
33. Stiffness 102. Hospitalization 136. Symptoms
103. Hospitalizations (Days) 137. Catecholamines
MI 104. Interpersonal support 138. Urinary sodium
60. “Rose” questionnaire 105. Mortality 139. Physiologic measures
61. Cholesterol 106. Patient knowledge 140. Renin
62. Occurrence/Reoccurrence of MI 107. Patient Satisfaction 141. Cognitive measures
63. Sexual activity (same as 112) 108. Provider Satisfaction 142. BUN (plasma urea)
64. Tobacco use 109. Psychological measures 999. Not specified
65. Hypertension 110. Quality of life scales
66. Angina 111. Self-efficacy (helplessness)
67. Arrhythmia 112. Social assessment
68. CABG 113. Weight control

27
STATISTICAL METHODS
In the analysis, we sought to answer the questions specified by CMS that can be found at

the beginning of the Methods Section.

Our summary of the evidence is both qualitative and quantitative. We first assessed the

distribution of studies based on the classification of interventions as specified in our data

abstraction form (Figure 3). For many of the fourteen specific questions listed above, the

evidence was too sparse and/or heterogeneous to support statistical pooling. In these cases, our

summary of evidence is qualitative.

To help answer Question 2 posed by CMS, we proposed five overall hypotheses that

encompassed the questions concerning intervention components. These hypotheses were listed

in the introduction. We denote these as the “original” hypotheses to distinguish them from post-

hoc hypotheses we tested subsequently. We recoded each intervention arm in each study into

“yes” (met hypothesis) or “no” (did not meet hypothesis), and conducted analyses to test these

hypotheses as described below.

Meta-Analysis

We conducted separate meta-analyses for each of the four conditions: diabetes,

osteoarthritis, post-myocardial infarction care, and hypertension. Though separate, these

analyses were sufficiently similar that we will discuss our general analytic approach, inserting

comments about specific outcomes or conditions as needed.

We first identified the most commonly reported clinically relevant outcome or outcomes

for each condition. These outcomes were:

28
 x for diabetes

– fasting blood glucose

– hemoglobin A1c

– weight

x osteoarthritis

– pain

– functioning

x post-myocardial infarction care

– mortality

– return to work

x hypertension

– systolic blood pressure

– diastolic blood pressure

We considered only studies that assessed the effects of an intervention or interventions

relative to either a group that received usual care or a control group and that provided outcome

data.

The majority of our outcomes were continuous. For these outcomes we extracted data to

estimate effect sizes. The effect size for the study’s comparison between a particular

intervention arm and usual care or control arm is the difference between the intervention group

and usual care or control group divided by its standard deviation, and is therefore a unitless

29
measure convenient for comparing studies measuring outcomes in the same domain but using

different measures. For the two dichotomous outcomes (mortality and return to work for post-

myocardial infarction care), we estimated risk ratios. We will discuss each of these general types

of outcomes in turn.

Because follow-up times across studies can lead to clinical heterogeneity, we excluded

from analysis any studies whose data were not collected within a specified follow-up interval.

These intervals were chosen based on clinical knowledge. For diabetes, studies that had a

follow-up time between three and twelve months were included. Four studies were excluded

because their follow-up time fell outside this interval. For osteoarthritis, all studies retrieved

included a follow-up time between four and six months. One study had multiple follow-up times

between four and six months, and we included the measurement that was closest to six months.

For post-myocardial infarction care, studies that had a follow-up time between six and twelve

months were included, and no studies were excluded due to follow-up time. For hypertension,

all studies were included; a follow-up time between two and six months was used. Four studies

had multiple follow-up times but had only one data point in between two and six months, and we

included this measurement in our analysis.

Some studies had more than one intervention arm of interest. For these “multi-arm”

studies, we estimated one effect size or one risk ratio (depending on the outcome) for each

comparison between an intervention arm and the control or usual care group. The possibility that

a single study might contribute multiple treatment effects to a meta-analysis was addressed via a

sensitivity analysis discussed below.

Data extraction and basic calculations were performed in the statistical package SAS26

and the spreadsheet package Excel.27 The majority of the modeling was performed in the

30
statistical package Stata,28 with some special modeling implemented in StatXact29 for the

mortality outcome, and sensitivity analyses conducted in statistical software package SAS26 as

described below.

Continuous Effect Sizes

For each study, we estimated an effect size for each comparison that was considered

relevant, that is for each intervention arm of interest as compared with the usual care or control

arm. The follow-up mean and standard deviation of each outcome for each relevant arm were

extracted if available. If a study did not report a follow-up mean, or a follow-up mean could not

be calculated from the given data, the study was excluded from the meta-analysis.

For studies that did not report a standard deviation or for which a standard deviation

could not be calculated from the given data, we imputed the standard deviation by using those

studies and arms that did report a standard deviation and weighting all arms equally, or we

assumed that the standard deviation was 0.25 of the theoretical range for the specific measure in

the study. For example, if a study measured pain on a 0-100 scale, we assumed the standard

deviation was 25.

No imputation was required for the diabetes outcomes. For osteoarthritis outcomes, we

used the range approach to impute the standard deviations for pain and functioning for five

studies. For hypertension outcomes, we used five of the studies to impute the standard deviations

for both blood pressure outcomes for the remaining six studies. The post-myocardial infarction

care outcomes were dichotomous and required no imputation, as discussed below.

For each comparison of interest, an unbiased estimate9 of Hedges’ g effect size10 and its

standard deviation were calculated. A negative effect size indicates that the intervention is

31
associated with a decrease in the outcome at follow-up as compared with the control or usual

care group. For example, in the osteoarthritis meta-analysis, the outcome was pain, so a negative

effect size indicated that the intervention was associated with a decrease in pain at follow-up as

compared with the control group.

Risk Ratio Calculations for Dichotomous Outcomes

For the return-to-work outcome for post-myocardial infarction care, we estimated log risk

ratios and standard deviations. We conducted the analysis on the logarithmic scale for variance-

stabilization reasons.30 We then back-transformed to the risk ratio scale for interpretability.

A risk ratio greater than one indicates that the risk of the outcome in the intervention arm

is larger than that in the control or usual care arm. For example, if the risk ratio is 1.10, then

patients in the intervention group are 1.10 times as likely to return to work as those in the control

or usual care arm.

One study reported that all patients in a particular arm returned to work. For this study,

we performed a continuity correction by adding 0.5 to all cells in the two-by-two table of arm by

outcome. This continuity correction is necessary in order for the risk ratio and its standard

deviation to be estimated.

Mortality was a rare event and the asymptotic method used for the return-to-work

outcome would have required continuity corrections for many studies, not just one as in the

return-to-work situation. We were concerned that many corrections would bias our results.

Thus, we employed exact calculations to estimate the risk ratios using statistical software

package StatXact.29 This approach uses exact nonparametric inference and, in particular, does

not require continuity corrections to be performed for zero cells. For mortality, a risk ratio less

32
than one indicates that the risk of mortality in the intervention arm is smaller than that in the

control or usual care arm.

Analysis

For each condition and outcome except for mortality, we conducted the same analysis.

For this analysis, we first calculated a pooled random effects estimate11 of the treatment effect, a

pooled effect size for continuous outcomes, or a pooled log risk ratio for the dichotomous

outcome of return to work, as appropriate, across all studies and their associated 95% confidence

interval. We then back-transformed to the risk ratio scale for return to work. We used exact

calculations to estimate the pooled risk ratio of mortality directly. We assessed the between-

study heterogeneity for each outcome using a chi-squared test of heterogeneity p-value.9

For each of the original five hypotheses, study arms either meet the criteria (a “yes”) or

do not (a “no”), thus no missing values exist. For each hypothesis, a simple stratified analysis

would have produced a pooled estimate of the treatment effect for all the “yes” study arms

together and a pooled estimate for all the “no” study arms together. To facilitate testing the

difference between the two pooled estimates, we constructed these estimates using a meta-

regression model in which the only variables in the regression were a constant, and an indicator

variable equal to one if the study arm met the hypothesis and zero if the study arm did not. For

some outcomes and hypotheses, all study arms were either "yes" or "no". In this case, we could

not fit a model, and we labeled those situations as “not estimable (NE)” in our Results tables.

A random effects meta-regression31 allows a straightforward statistical test of the

coefficient for the indicator variable, which is equivalent to testing whether the “yes” pooled

treatment effect and the “no” pooled treatment effect are equal, i.e., whether there is evidence

33
against the hypothesis. In addition, we estimated 95% confidence intervals for each treatment

effect ("yes" and "no"). If the confidence interval does not contain the null value of zero (for a

continuous outcome) or one (for a risk ratio outcome), the treatment effect is probably

statistically significant. For each outcome, we fit five separate regressions, corresponding to the

five original hypotheses. We estimated these models in the statistical package Stata28 using the

“metareg” command with the restricted maximum likelihood estimation option.32

For the mortality outcome, we used exact calculations to conduct the stratified analyses

separately and observed whether the resulting confidence intervals overlapped in order to

determine if there was evidence against each hypothesis. For this outcome, we did not allow

multiple intervention arms per study to contribute to a single stratified analysis. To eliminate

this occurrence, we collapsed the data over multiple intervention arms within a single study

within each stratified analysis. By collapsing the data, we mean we aggregated the numbers of

patients and deaths across all intervention arms in a single study into a combined single

intervention arm.

As an overall test of all the hypotheses, we combined the pain outcomes from

osteoarthritis studies, hemoglobin A1c outcomes from diabetes studies, and systolic blood

pressure outcomes from hypertension studies into one analysis and fit the five separate

regressions as above. These outcomes were chosen because we judged them to be the most

clinically relevant continuous outcomes for each condition. We also fit a sixth regression that

had a constant and all five indicator variables for the separate hypotheses included. Post-

myocardial infarction care studies did not have a continuous outcome, so we could not include it

in our overall test of the hypotheses.

34
Sensitivity Analyses

Within each regression, and especially in the combined analysis, our primary analyses

ignored the fact that some studies had multiple intervention arms and thus could contribute more

than one treatment effect to the analysis. The correlation between treatment effects within the

same study, due to the fact the each intervention arm was compared to the same control or usual

care arm, was ignored in this analysis. Among diabetes studies, two studies had two intervention

arms each; among osteoarthritis studies, three studies had two intervention arms; and among

hypertension studies, four studies had two intervention arms, and two studies had three

intervention arms. In post-myocardial infarction care, we collapsed across intervention arms in

the same study as done in the primary mortality analysis. For this outcome, two studies had two

intervention arms and one study had five intervention arms.

Our sensitivity analyses consisted of refitting the meta-regression models using a two-

level random effects model that contains a random effect at the study level, as well as one at the

arm level. This hierarchical approach controls for the potential correlation within arms in the

same study. We estimated these models in the statistical software package SAS26 using PROC

MIXED.

For the mortality outcome, no sensitivity analysis of the possible effect of multiple

intervention arms was needed as we collapsed prior to analysis as described above. None of these

sensitivity analyses results differed markedly from that of the primary analysis we present in this

report.

35
Assessment of publication bias

We assessed the possibility of publication bias by evaluating funnel plots of effect sizes

or log risk ratios for asymmetry, which results from the non-publication of small, negative

studies. Because graphical evaluation can be subjective, we also conducted an adjusted rank

correlation test33 and a regression asymmetry test34 as formal statistical tests for publication bias.

We conducted these tests at the intervention arm level, and also at the study level by choosing

only the most statistically significant treatment effect for multi-arm studies as a sensitivity

analysis. We conducted all analyses and constructed all graphs using the statistical package

Stata.28

COST EFFECTIVENESS
To assess the cost-effectiveness of the interventions, we first determined whether the

studies included cost data. We chose to summarize these studies qualitatively because of

heterogeneity.

EXPERT REVIEW PROCESS AND POST-HOC ANALYSES

The draft evidence report was presented to a group of experts in chronic disease self-

management at a meeting convened by the Robert Wood Johnson Foundation and held in Seattle

on December 14, 2001. The list of experts attending is present in Appendix A. At this meeting,

the draft evidence report, which had been mailed to each panelist several weeks in advance, was

presented and discussed. As a result of this discussion several additional hypotheses and

analyses were proposed, which we term “post-hoc” hypotheses and analyses since they were

generated after seeing the results of the original five hypotheses analyses. These “post-hoc”

hypotheses and analyses were:

36
 x Assessing the effectiveness of intervention components as defined by the RE-AIM

model of Glasgow.

x Assessing the effectiveness of CDSM programs stratified by severity of illness at

baseline.

x Assessing the effectiveness of CDSM program components as classified by the

“Essential Elements of Self-management Interventions,” which was the result of the

group discussion at the Seattle meeting.

x Assessing the effectiveness of CDSM program that assessed and demonstrated

improvement in “intermediate” variables according to the following conceptual

model:

InterventionÆ knowledge, self-efficacy, Æ dietary measures Æ hemoglobin A1c

attitudes physical activity pain
behavior blood pressure

With regard to the first suggested analysis, components of CDSM were classified in RE-

AIM as including:12

x one-on-one counseling interventions,

x group sessions,

x interactive computer-mediated interventions,

x telephone calls,

x mail interventions, and

x health system policies.

37
 We coded each of our included articles as having each component present or not, and

then conducted meta-analysis and meta-regression analyses for each hypothesis using the method

described previously for our original hypotheses. “Health system policies” was particularly

difficult to define, so we developed both a “strict” and a “broad” definitions, and tested each.

With regard to stratifying by severity at presentation, we assessed those studies that

presented baseline information on blood pressure, hemoglobin A1c, weight, glucose control,

pain, and function, and stratified these into two categories: “more severe” and “less severe.” We

were not able to stratify the hypertension studies or diabetes studies reporting fasting blood

glucose outcomes as the distributions of baseline values in these studies did not support a

“threshold” value. We were able to stratify by severity for hemoglobin A1c, weight, pain, and

functioning. Effect sizes were then compared between studies of “more severe” and “less

severe” patients at baseline.

With regard to the “Essential Elements of Self-management Interventions,” these were

defined by the Seattle Expert Panel to be:13

1. problem-solving training that encourages patients and providers

ƒidentify problems

ƒidentify barriers and supports

ƒgeneral solutions

ƒform an individually tailored action plan, including:

à long and short-term goals

à goals that are measurable and achievable

38
 ƒmonitor and assess progress toward goals, including feedback

ƒadjust the action plan as needed, reinforcing positive outcomes

à repeat problem-solving process, enhancing the person’s

– confidence or self-efficacy (“I can do it.”)

– skill mastery (“Here’s how.”)

– modeling (“I am not alone.”)

– Social persuasion (“I can be a role model for others.”)

– Ability to re-interpret symptoms (“I know what different symptoms

mean.”)

2. follow-up

ƒmaintain contact and continued problem-solving support via one of many

available modalities (e.g., telephone, e-mail, mail, etc)

ƒidentify patients who are not doing well and assist them in modifying their plan

and actions to ensure optimal outcomes

ƒrelate plan to patient’s social/ cultural environment

à teach patients how to connect with resources and support in their own

community because the need for these links changes over time

3. tracking and ensuring implementation

ƒprograms should be linked to the individual’s regular source of medical care

39
 à communication among the patient, the self-management delivery staff, and the

patient’s usual provider of medical care is likely to improve results

ƒprograms should monitor their effects on patients’ health, satisfaction, quality of

life, and the health-system quality measures in order to help make improvements

over time and to help decision-makers evaluate the benefits

For our purposes, the studies available were not characterized in detail sufficient to

perform an analysis except at the coarsest level of aggregation:

x problem-solving training

x follow-up

x tracking and ensuring implementation

Each of our included studies was characterized as having these features as present or

absent, and then we performed meta-analysis and meta-regression analyses for each hypothesis

using the method previously described. We ran a meta-regression controlling for each of the

three components separately. We then ran a meta-regression controlling for all three components

simultaneously and calculated an adjusted effect size for each component.

Lastly, to assess the effectiveness of CDSM programs according to their effect on

intermediate variables, we identified those studies that assessed intermediate variables and with

the help of Russ Glasgow, MD, we classified these into the previously presented model. We

then assessed the effectiveness of the CDSM programs by regressing the effect size of

“intermediate 2 variables” (such as dietary measures, physical activity, behavioral measures) on

“intermediate 1 variables” (such as self-efficacy, patient knowledge, psychological measures)

and regressing the effect size of “outcome variables” (such as hemoglobin A1c, pain, systolic

40
blood pressure) on “intermediate 2 variables.” The conceptual model for these analyses is that

studies with interventions that promote improvements in self-efficacy, patient knowledge, and

psychosocial measures should be more likely to result in improvements in dietary measures,

physical activity, and behavioral measures, which in turn should lead to improvements in

outcomes measures such as hemoglobin A1c, pain, and blood pressure. Therefore, studies that

measured these “intermediate variables” can be assessed to see if their evidence support this

conceptual model.

41
RESULTS

IDENTIFICATION OF EVIDENCE
Figure 4 describes the flow of evidence from the original sources to final acceptance for

our review. The Cochrane Database provided 15 relevant citations. From the Center for

Advancement of Health publication, An Indexed Bibliography on Self-management for People

with Chronic Disease, we ordered 168 articles based on a review of included abstracts. 549

additional articles were ordered upon review of the reference lists from these articles. A library

search yielded an additional seven articles and four additional articles not previously noted were

obtained from experts. From the Boston group, we received a reference list of 62 articles

included in their analysis that were not in our dataset. Of these, however, only nineteen were

considered for screening after title review. Articles were rejected at title review because their

focus was on conditions not included in our analysis (such as studies of asthma, rheumatoid

arthritis, or fibromyalgia), or concerned children or young adults (Figure 5). In total, the above

sources yielded 762 articles. We were unable to obtain 23 of these. This left 739 articles for the

screening process.

42
 Figure 4. Flow of Evidence

Cochrane Center for Reference Library Identified Boston

Review Advancement Lists Search by Expert Group
(n = 15) of Health (n = 549) (n = 7) (n = 4) (n = 19)
(n = 168)

762 Articles Requested

n = 15 n = 168 n = 526 n=7 n=4 n = 19

23 Not Found

739 Articles Screened

n=0 n = 26 n = 80 n=3 n=2 n = 10

618 Rejected
79 Subject
121 Articles Passed on to Quality Review 13 Age
77 CDSM Definition
319 Study Design
122 Condition
8 Duplicate Article

79 Articles Passed on to Consideration for Meta-Analysis 42 Rejected:

14 not RCT study design
28 no usual care or comparable control group

44 Articles Contribute Data to Meta-Analysis 35 Rejected:

9 Myocardial Infarction 20 insufficient statistics
14 Diabetes 5 follow-up time outside 3-12 months
14 Hypertension 6 no relevant outcomes
7 Osteoarthritis 4 duplicate data or study population

43
 Of the 739 articles screened, 79 did not assess chronic disease self-management. Three

hundred nineteen were rejected because they were not randomized controlled trials (RCTs) or

controlled clinical trials (CCTs), 13 because they did not satisfy the age criteria (not adults), and

122 did not discuss one the conditions of interest (osteoarthritis, diabetes, hypertension, or post-

myocardial infarction care). Another 8 articles were duplicates of articles already on file.

Seventy-seven others did not meet our chronic disease self-management definition. This left 121

articles for further review.

SELECTION OF STUDIES FOR THE META-ANALYSIS

Studies that met the inclusion criteria listed above were reviewed in more detail for

potential inclusion in the meta-analysis. At the first stage of this review, a study needed to be an

RCT and compare a chronic disease self-management program to a control or usual care group.

Of the 121 studies accepted for quality review, 79 went on to be considered for meta-analysis

because they were randomized controlled trials with a usual care or comparable control group.

These studies were then reviewed in more detail regarding their reported outcomes and follow-

up times. Based on the distribution of these outcomes and follow-up times, and using our

clinical judgment, we accepted into the next stage diabetes studies that reported any of the

following outcomes: hemoglobin A1c, weight, and/or fasting blood glucose, with a follow-up

time between 3 - 12 months. If there was more than one follow-up time, the time closest to 12

months was selected for inclusion in the final analysis. For osteoarthritis, we accepted studies

that reported a pain outcome or a function outcome. For post-myocardial infarction care, we

used studies with return to work and mortality outcomes. For hypertension, studies that reported

mean systolic and diastolic blood pressure outcomes, with follow-up time of between 8 weeks to

44
6 months were selected for inclusion. If more than one follow-up time was reported, the time

closest to 6 months was selected.

Of the 79 studies considered for meta-analysis, 35 studies were excluded because of

insufficient statistics and/or follow-up times, no relevant outcomes, duplicate data (data

presented in another included study), or duplicate study populations. From the 19 articles

received from the Boston group only two meet the eligibility criteria for our meta-analysis, the

remainder being rejected due to not being a controlled trial, not having a usual care or

comparable control group, or not having sufficient statistical data for meta-analysis (Figure 5).

Therefore, forty-four studies contributed data to the meta-analysis (14 diabetes studies, 7

osteoarthritis studies, 9 post-myocardial infarction care studies, and 14 hypertension studies; see

Tables 2-5).

45
 Figure 5. Article Flow of References from Boston Group

Boston List (n = 70)

8 Rejected: Duplicate of article in database

43 Rejected at title review

19 Passed Title Review

on to Article Screening

5 Rejected: Not condition of interest

4 Rejected: Study design not RCT or CCT

10 Articles Accepted after Screening

on to QRF

3 Rejected: No usual care or comparable control group

1 Rejected: Age

6 Articles Accepted after QRF

on to Data Extraction

4 Rejected: Insufficient statistics

2 Articles Accepted into meta-analysis

46
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Diabetes Articles
Integrated care for diabetes: clinical, psychosocial, and economic evaluation. no usual care or comparable
Diabetes Integrated Care Evaluation Team. BMJ. 1994;308(6938):1208- control group
1212. Rec #: 2614
Allen BT, DeLong ER, Feussner JR. Impact of glucose self-monitoring on non- no usual care or comparable
insulin-treated patients with type II diabetes mellitus. Diabetes Care. control group
1990;13:1044-1050. Rec #: 2201
Anderson R M, Funnell M M, Butler P M, Arnold M S, Fitzgerald J T, Feste C C . not RCT
Patient empowerment. Results of a randomized controlled trial. Diabetes
Care. 1995;18(7):943-9. Rec #: 747
Arseneau D L, Mason A C, Wood O B, Schwab E, Green D . A comparison of no usual care or comparable
learning activity packages and classroom instruction for diet management of control group
patients with non-insulin-dependent diabetes mellitus. Diabetes Educ.
1994;20(6):509-14. Rec #: 749
Aubert RE Herman WH Waters J et al. Nurse case management to improve no usual care or comparable
glycemic control in diabetic patients in a health maintenance organization. control group
A randomized, control trial (see comments). Annals of Internal Medicine.
1998;129(8):605. Rec #: 2581
Bethea DC, Stallings SF, Wolman PG, Ingram RC. Comparison of conventional not RCT
and videotaped diabetic exchange lists instruction. Journal of the American
Dietetic Association. 1989;89:405-406. Rec #: 2105
Bloomgarden ZT, Karmally W, Metzger J, Borhters M, Nechemias C, Bookman follow-up time not 3-12 months
J, et al. Randomized, controlled trial of diabetic education: improved
knowledge without improved metabolic status. Diabetes Care.
1987;10:263-272. Rec #: 2172
Boehm S, Schlenk E A, Raleigh E, Ronis D . Behavioral analysis and insufficient statistics
behavioral strategies to improve self- management of type II diabetes. Clin
Nurs Res. 1993;2(3):327-44. Rec #: 754
Campbell EM Redman S Moffitt PS et al. The relative effectiveness of insufficient statistics
educational and behavioral instruction programs for patients with NIDDM: a
randomized trial. Diabetes Educator. 1996;22(4):379. Rec #: 2586
de Bont AJ, Baker IA, St Leger AS, Sweetman PM, Wragg KG, Stephens SM, et no usual care or comparable
al. A randomized controlled trial of the effect of low fat diet advice on control group
dietary response in insulin independent diabetic women. Diabetologia.
1981;21(6):529. Rec #: 2210
Emori KH. The Use of a Programmed Textbook in Diabetic Patient Education. follow-up time not 3-12 months
Loma Linda, CA: Loma Linda University; 1964. [Dissertation]. Rec #: 2118
Glasgow RE/Toobert DJ, Mitchell DL, Donnely JE, Calder D. Nutrition insufficient statistics
education and social learning interventions for type II diabetes . Diabetes
Care. 1989;12:150-152. Rec #: 2209
Glasgow R E, Toobert D J, Hampson S E . Effects of a brief office-based insufficient statistics
intervention to facilitate diabetes dietary self-management. Diabetes Care.
1996;19(8):835-42. Rec #: 799
Glasgow RE, La Chance PA, Toobert DJ, Brown J, Hampson SE, Riddle MC. insufficient statistics
Long-term effects and costs of brief behavioural dietary intervention for
patients with diabetes delivered from the medical office. Patient Educ Couns
1997;32(3):175-84. Rec #: 3433

47
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Hanefield M Fischer S Schmechel H et al. Diabetes Intervention Study. Multi- no usual care or comparable
intervention trial in newly diagnosed NIDDM. Diabetes Care. control group
1991;14(4):308. Rec #: 2595
Hassell J, Medved E. Group/audiovisual instruction for patients with diabetes. no glucose or weight outcomes
Journal of the American Dietetic Association. 1975;5:465-470. Rec #: 2121 reported
Hoskins PL Fowler PM Constantino M et al. Sharing the care of diabetic no usual care or comparable
patients between hospital and general practitioners: does it work? Diabetic control group
Medicine. 1993;10(1):81. Rec #: 2597
Kaplan, Wilson, Hartwell/Merino, Wallace. Prospective evaluation of HDL insufficient statistics
changes after diet and physical conditioning programs for patients with Type
II diabetes mellitus. Diabetes Care. 1985;8:343-48. Rec #: 2817
Kaplan RM, Hartwell SL, Wilson KD, Wallace JP. Effects of diet and exercise insufficient statistics
interventions on control and quality of life in non-insulin dependent diabetes
mellitus. J Gen Intern Med. 1987;2:220-227. Rec #: 2175
Kendall PA, Jansen GR. Educating patients with diabetes: comparison of no usual care or comparable
nutrient-based and exchanged group methods. J Am Diet Assoc. control group
1990;90:238-243. Rec #: 2207
Kinmonth AL Woodcock A Griffin S et al. Randomised controlled trial of patient no usual care or comparable
centred care of diabetes in general practice: impact on current wellbeing control group
and future disease risk. The Diabetes Care From Diagnosis Research
Team. British Medical Journal. 1998;317(7167):1202. Rec #: 2599
Kumana CR/Ma JT, Kung A, Kou M, Lauder I. An assessment of drug no glucose or weight outcomes
information sheets for diabetic patients: Only active involvement by patients reported
is helpful. Diabetes Research and Clinical Practice. 1988;5:225-231. Rec
#: 2130
Litzelman D K, Slemenda C W, Langefeld C D, Hays L M, Welch M A, Bild D E, no glucose or weight outcomes
et al. Reduction of lower extremity clinical abnormalities in patients with reported
non-insulin-dependent diabetes mellitus. A randomized, controlled trial.
Ann Intern Med. 1993;119(1):36-41. Rec #: 828
Mazzuca SA, Moorman NH, Wheeler ML, Norton JA, Fineberg NS, Vinicor F, et duplicate data (Vinicor, 1987)
al. The diabetes education study: A controlled trial of the effects of
diabetes patient education. Diabetes Care. 1986;9:1-10. Rec #: 2132
Mulrow C, Bailey S, Sonksen PH, Slavin B. Evaluation of an audiovisual no usual care or comparable
diabetes education program: Negative results of a randomized trial of control group
patients with non-insulin dependent diabetes mellitus. Journal of General
Medicine. 1987;2:215-219. Rec #: 2266
Pratt C, Wilson W, Leklem J, Kingsley L. Peer support and nutrition education follow-up time not 3-12 months
for older adults with diabetes. Journal of Nutrition for the Elderly.
1987;6:37-43. Rec #: 2139
Rabkin SW, Boyko E, Wilson A, Sreja DA. A randomized clinical trial comparing no usual care or comparable
behavior modification and individual counseling in the nutritional therapy of control group
non-insulin-dependent diabetes mellitus: comparison of the effect on blood
sugar, body weight, and serum lipids. Diabetes Care. 1983;6:50-56. Rec #:
2195
Rainwater N, Ayllon T, Frederiksen LW, Moore EJ, Bonar JR. Teaching self- no usual care or comparable
management skills to increase diet compliance in diabetics. In: Stewart RB control group
(Ed.). Adherence, Compliance and Generalization in Behavioral Medicine.
New York: Brunner/Mazel, 1982. pgs. 304-328. Rec #: 2140

48
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Rettig BA, Shrauger DG, Recker RP, Gallagher TF, Wiltse H. A randomised no glucose or weight outcomes
study of the effects of a home diabetes education program. Diabetes Care. reported
1986;9:173-178. Rec #: 2270
Sadur C N, Moline N, Costa M, Michalik D, Mendlowitz D, Roller S, et al. not RCT
Diabetes management in a health maintenance organization. Efficacy of
care management using cluster visits [In Process Citation]. Diabetes Care.
1999;22(12):2011-7. Rec #: 1668
Stevens J, Burgess MB, Kaiser Dl, Sheppa CM. Outpatient management of no usual care or comparable
diabetes mellitus with patient education to increase carbohydrate and fiber. control group
Diabetes Care. 1985;8:359-366. Rec #: 2208
Vinicor F, Cohen S J, Mazzuca S A, Moorman N, Wheeler M, Kuebler T, et al. follow-up time not 3-12 months
DIABETES: a randomized trial of the effects of physician and/or patient
education on diabetes patient outcomes. J Chronic Dis. 1987;40(4):345-
56. Rec #: 892
Ward WK, Haas LB, Beard JC. A randomized, controlled comparison of no usual care or comparable
instruction by a diabetes educator versus self-instruction in self-monitoring control group
of blood glucose. Diabetes Care. 1985;8:284-286. Rec #: 2152
Werdier JD, Jesdinsky HJ, Helmich P. A randomized controlled study on the not RCT
effect of diabetes counseling in the offices on 12 general practitioners. Rev
Epidemiol Med Sante Publique . 1984;32:225-229. Rec #: 2401
Wheeler LA, Wheeler ML, Ours P, Swider C. Evaluation of computer-based diet follow-up time not 3-12 months
education in persons with diabetes mellitus and limited educational
background. Diabetes Care 1985;8(6):537-44. Rec #: 3442
Wilson W, Pratt C . The impact of diabetes education and peer support upon duplicate data (Pratt, 1987)
weight and glycemic control of elderly persons with non-insulin dependent
diabetes mellitus (NIDDM). Am J Public Health. 1987;77(5):634-5. Rec #:
900
Wing RR, Epstein LH, Nowalk MP, Koeske R, Hagg S. Behavior change, no usual care or comparable
weight loss and physiological improvements in Type II diabetic patients. control group
Journal of Consulting and Clinical Psychology. 1985;53:11-122. Rec #:
2156
Wing RR, Epstein LH, Nowalk MP, Scott N, Koeske R, Hagg S. Does self- no usual care or comparable
monitoring of blood glucose levels improve dietary compliance for obese control group
patients with Type II diabetes? the American Journal of Medicine.
1986;81:830-836. Rec #: 2158
Wing RR, Epstein LH, Nowalk MP, Scott N, Koeski R. Self-regulation in the no usual care or comparable
treatment of Type II diabetes. Behavior Therapy. 1988;19:11-23. Rec #: control group
2283
Wise PH, Dowlatshahi DC, Farrant S, Fromson SS/Meadows KA. Effect of not RCT
computer-based learning on diabetes knowledge and control. Diabetes
Care. 1986;9:504-508. Rec #: 2205
Wood ER. Evaluation of a hospital-based education program for patients with not RCT
diabetes. Journal of the American Dietetic Association. 1989;89:354-358.
Rec #: 2159
Worth R, Home PD, Johston DG, Anderson J, Ashworth L, Burrin JM, et al. no usual care or comparable
Intensive attention improves glycemic control in insulin-dependent diabetes control group
without further advantage from home glucose monitoring: results of a
controlled trial. BMJ. 1982;285:1233-1240. Rec #: 2198

49
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Osteoarthritis
Cohen J L, Sauter S V, deVellis R F, deVellis B M . Evaluation of arthritis self- insufficient statistics
management courses led by laypersons and by professionals. Arthritis
Rheum. 1986;29(3):388-93. Rec #: 770
Doyle TH, Granada JL. Influence of two management approaches on the health no usual care or comparable
status of women with osteoarthritis. Arthritis and Rheumatism. control group
1982;25:S56. Rec #: 2427
Keefe F, Caldwell D, Baucom D, et al. Spouse-assisted coping skills training in no usual care or comparable
the management of osteoarthritis knee pain. Arthritis Care and Research. control group
1996;9:279. Rec #: 2082
Keefe F J, Caldwell D S, Williams D A, Gil K M, et al. Pain coping skills training duplicate populations (Keefe,
in the management of osteoarthritic knee pain: A comparative study. 1990a)
Behavior Therapy. 1990b;21:49-62. Rec #: 908
Laborde JM, Powers MJ. Evaluation of education interventions for insufficient statistics
osteoarthritics. Multiple Linear Reg Viewpoints. 1983;12:12-37. Rec #:
2355
Weinberger M, Tierney W M, Booher P, Katz B P . Can the provision of duplicate data (Weinberger,
information to patients with osteoarthritis improve functional status? A 1991)
randomized, controlled trial. Arthritis Rheum. 1989;32(12):1577-83. Rec #:
430
Weinberger M, Tierney W M, Booher P, Katz B P . The impact of increased insufficient statistics
contact on psychosocial outcomes in patients with osteoarthritis: a
randomized, controlled trial. J Rheumatol. 1991;18(6):849-54. Rec #: 898

50
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Post-Myocardial Infarction Care Articles
DeBusk RF, Miller NH, Superko HR, Dennis CA, Thomas RJ, Lew HT, et al. A no usual care or comparable
case-management system for coronary risk factor modification after acute control group
myocardial infarction [see comments]. Ann Intern Med. 1994;120(9):721-9.
Rec #: 775
Frasure-Smith N, Prince R . The ischemic heart disease life stress monitoring not RCT
program: impact on mortality. Psychosom Med. 1985;47(5):431-45. Rec #:
790
Frasure-Smith N, Prince R. Long-term follow-up of the ischemic heart disease not RCT
life stress monitoring program. Psychosom Med. 1989;51:485-513. Rec #:
2218
Friedman M, Thoresen C, Gill JJ, Ulmer DK. Feasibility of altering Type A not RCT
behavior pattern after myocardial infarction: Recurrent coronary prevention
project study: Methods, baseline results and preliminary findings.
Circulation. 1982;66:83-92. Rec #: 2367
Friedman M, Thoresen CE, Gill JJ, et al. Alteration of Type A behavior and no usual care or comparable
reduction in cardiac recurrences in postmyocardial infarction patients. Am control group
Heart J. 1984;108:237-248. Rec #: 2362
Gruen W. Effects of brief psychotherapy during the hospitalization period on the not RCT
recovery process in heart attacks. J Consulting Clinical Psychology.
1975;43:223-232. Rec #: 2360
Lewin B, Robertson I H, Cay E L, Irving J B, Campbell M . Effects of self-help insufficient statistics
post-myocardial-infarction rehabilitation on psychological adjustment and
use of health services. Lancet. 1992;339(8800):1036-40. Rec #: 827
Miller NH, Haskell WL, Berra K et al. Home versus group exercise training for insufficient statistics
increasing functional capacity after myocardial infarction. Circulation.
1984;4:645-649. Rec #: 2670
Oldenburg B, Allan R, Fastier G. The role of behavioral and educational insufficient statistics
interventions in the secondary prevention of coronary heart disease. In P.F.
Lovibond & P.H. Wilson (Eds), Clinical and Abnormal Psychology
Proceedings of the XXIV International Congress of Psychology of the
International Union of Psychological Science. 1989:429-438. Rec #: 2698
Oldenburg B, Perkins RJ, Andrews G. Controlled trial of psychological not RCT
intervention in myocardial infarction. Journal of Consulting and Clinical
Psychology. 1985;53:852-859. Rec #: 2699
Ott CR, Sivarajan ES, Newton KM et al. A controlled randomized study of early insufficient statistics
cardiac rehabilitation: the Sickness Impact Profile as an assessment tool.
Heart Lung. 1983;12:162-170. Rec #: 2657
Payne T J, Johnson C A, Penzien D B, Porzelius J, Eldridge G, Parisi S, et al. not RCT
Chest pain self-management training for patients with coronary artery
disease. J Psychosom Res. 1994;38(5):409-18. Rec #: 859
Powell LH, Friedman M, Thoresen CE, Gill JJ, Ulmer DK. Can the Type A no usual care or comparable
behavior pattern be altered after myocardial infarction? A second year control group
report from the Recurrent Coronary Prevention Project. Psychosom Med.
1984;46(4):293-313. Rec #: 2361
Schulte MB, Pluym B, Van Schendel G. Reintegration with duos: A self-care not RCT
program following myocardial infarction. Patients Education and
Counseling. 1986;8:233-244. Rec #: 2438

51
 Table 2. Articles Rejected from Meta-analysis
Reason for Exclusion
Sivarajan ES, Bruce RA, Lindskog BD, et al. Treadmill test responses to an duplicate population (Froelicher,
early exercise program after myocardial infarction: a randomized study. 1994)
Circulation. 1982;65:1420. Rec #: 3248
Sivarajan ES, Newton KM, Almes MJ, et al. Limited effects of outpatient insufficient statistics
teaching and counseling after myocardial infarction: A controlled study.
Heart and Lung. 1983;12:65-73. Rec #: 2439
Turner L, Linden W, van der Wal R, Schamberger W . Stress management for no mortality or return to work
patients with heart disease: a pilot study. Heart Lung. 1995;24(2):145-53. outcomes reported
Rec #: 887
Hypertension Articles
Irvine MJ, Johnson DW, Jenner DA, et al. Relaxation and stress management no usual care or comparable
in the treatment of essential hypertension. J of Psychosomatic Res. control group
1986;30:437-450. Rec #: 2458
Leveille SG, Wagner EH, Davis C, Grothaus L, Wallace J, LoGerfo M, et al. insufficient statistics
Preventing disability and managing chronic illness in frail older adults: A
randomized trial of a community-based partnership with primary care.
JAGS. 1998;46(10):1-9. Rec #: 1175
Levine DM, Green LW, Deeds SG, Chwalow J, Russell RP, Finlay J. Health insufficient statistics
education for hypertensive patients. JAMA 1979;241:1700-1703. Rec #:
3453
Martinez-Amenos A, Ferre LF, Vidal CM, Rocasalbas JA. Evaluation of two insufficient statistics
educative models in a primary care hypertension programme. Journal of
Human Hypertension 1990;4:362-4. Rec #: 3457
Morisky DE, Levine DM, Green LW, Russell RP, Smith C, Benson P, et al. The insufficient statistics
relative impact of health education for low- and high-risk patients with
hypertension. Prev Med 1980;9(4):550-8. Rec #: 3461
Morisky DE, Levine DM, Green LW, et al. Five-year blood pressure control and insufficient statistics
mortality following health education for hypertensive patients. Am J Public
Health. 1983;73(2):153-162. Rec #: 2304

52
 Hemoglobin

Glucose
Weight

Blood
Table 3. Diabetes articles Contributing to Meta-analysis

A1c
D'Eramo-Melkus GA, Wylie-Rosett J, Hagan JA. Metabolic impact of education in NIDDM .
X X X
Diabetes Care. 1992;18:864-869. Rec #: 2202
Falkenberg MG, Elwing BE, Goransson AM, Hellstrand BE, Riis UM. Problem oriented
participatory education in the guidance of adults with non-insulin-treated type II diabetes X
mellitus. Scand J Prim Health Care. 1986;4:157-164. Rec #: 2190
Frost G, Wilding J, Beecham J . Dietary advice based on the glycemic index improves
dietary profile and metabolic control in type 2 diabetic patients. Diabet Med. X X
1994;11(4):397-401. Rec #: 791
Glasgow RE, Toobert DJ, Hampson SE, Brown JE, Lewinsohn PM, Donnelly J. Improving
self-care among older patients with type II diabetes: the "sixty something...." study. X X
Patient Educ Couns. 1992;19:61-74. Rec #: 2212
Greenfield S, Kaplan S H, Ware J E, Yano E M, Frank H J . Patients' participation in medical
care: effects on blood sugar control and quality of life in diabetes. J Gen Intern Med. X
1988;3(5):448-57. Rec #: 803
Jaber LA Halapy H Fernet M et al. Evaluation of a pharmaceutical care model on diabetes
X X
management. Annals of Pharmacotherapy. 1996;30(3):238. Rec #: 2598
Jennings PE, Morgan HC, Barnett AH. Improved diabetes control and knowledge during a
X
diabetic self-help group. The Diabetes Educator. 1987;13:390-393. Rec #: 2126
Korhonen T, Huttnen JK, Aro A, Hentinen M, Ihalainen O, Majander H, et al. A controlled trial
of the effects of patient education in the treatment of insulin dependent diabetes. X
Diabetes Care. 1983;6:256-261. Rec #: 2259
Laitinen JH, Ahola IE, Sarkkinen ES, Winberg RL, Harmaakorpi-Ilvonen PA, Usitupa MI.
Impact of intensified dietary therapy on energy and nutrient intakes and fatty acid
X X X
composition of serum lipids in patients with recently diagnosed non-insulin-dependent
diabetes mellitus. J Am Diet Assoc. 1993;93:276-283. Rec #: 2176
McCulloch DK, Mitchell RD, Ambler J, Tattersall RB. Influence of imaginative teaching of diet
on compliance and metabolic control in insulin dependent diabetes. British Medical X X
Journal. 1983;28:1858-1861. Rec #: 2264
Raz I, Soskolne V, Stein P. Influence of small-group education sessions on glucose
X X X
homeostasis in NIDDM. Diabetes Care. 1988;11:67-71. Rec #: 2141
Vanninen E, Uuspitupa M, Siitonen O, Laitinen J, Lansimies E. Habitual physical activity,
aerobic capacity and metabolic control in patients with newly-diagnosed type 2 (non-
X X X
insulin-dependent) diabetes mellitus: effect of 1-year diet and exercise intervention.
Diabetologia. 1992;35:340-346. Rec #: 2174
Weinberger M, Kirkman M S, Samsa G P, Shortliffe E A, Landsman P B, Cowper P A, et al.
A nurse-coordinated intervention for primary care patients with non- insulin-dependent
X X
diabetes mellitus: impact on glycemic control and health-related quality of life [see
comments]. J Gen Intern Med. 1995;10(2):59-66. Rec #: 896
White N, Carnahan J, Nugent CA, Iwaoka T, Dodsono MA. Management of obese patients
with diabetes mellitus: comparison of advice education with group management. X X X
Diabetes Care. 1986;9:490-496. Rec #: 2154
Total number of studies 8 12 9

53
Table 4. Osteoarthritis Articles Contributing to Meta-analysis

Barlow JH, Turner AP, Wright CC. A randomized controlled study of the Arthritis Self-Management Programme in
the UK. Health Educ Res. 2000;15(6):665-80. Rec #: 3274
Goeppinger J, Arthur M W, Baglioni A J, Brunk S E, Brunner C M . A reexamination of the effectiveness of self-care
education for persons with arthritis. Arthritis Rheum. 1989;32(6):706-16. Rec #: 801
Keefe F J, Caldwell D S, Williams D A, Gil K M, et al. Pain coping skills training in the management of osteoarthritic
knee pain-II: Follow-up results. Behavior Therapy. 1990a;21:435-447. Rec #: 907
Lorig K, Feigenbaum P, Regan C, Ung E, Chastain R L, Holman H R . A comparison of lay-taught and
professional-taught arthritis self- management courses. J Rheumatol. 1986;13(4):763-7. Rec #: 830
Lorig K, Lubeck D, Kraines R G, Seleznick M, Holman H R . Outcomes of self-help education for patients with
arthritis. Arthritis Rheum. 1985;28(6):680-5. Rec #: 835
Lorig K, Seleznick M, Lubeck D, Ung E, Chastain R L, Holman H R . The beneficial outcomes of the arthritis self-
management course are not adequately explained by behavior change. Arthritis Rheum. 1989;32(1):91-5. Rec
#: 837
Lorig K R, Sobel D S, Stewart A L, Brown Jr B W, Bandura A, Ritter P, et al. Evidence suggesting that a chronic
disease self-management program can improve health status while reducing hospitalization: A randomized trial.
Medical Care. 1999;37(1):5-14. Rec #: 608
All articles contributed both pain and function outcomes.

Return to
Table 5. Post-Myocardial Infarction Care Articles Contributing to

Death

Work
Meta-analysis

Burgess AW, Lerner DJ D'Agostino RB, Vokonas PS, Hartman CR, Gaccione P. A randomized
X X
control trial of cardiac rehabilitation. Soc Sci Med. 1987;24:359-370. Rec #: 2652
DeBusk F, Haskell WL, Miller NN et al. Medically directed at-home rehabilitation soon after clinically
uncomplicated acute myocardial infarction: a new mode for patient care. Am J Cardio. X
1985;85:251-257. (in MA for mortality only) Rec #: 2669
Dennis C, Houston-Miller N, Schwartz RG et al. Early return to work after uncomplicated myocardial
X X
infarction. JAMA. 1988;260:214-220. Rec #: 2656
Froelicher E S, Kee L L, Newton K M, Lindskog B, Livingston M . Return to work, sexual activity,
and other activities after acute myocardial infarction. Heart Lung. 1994;23(5):423-35. Rec #: X X
792
Heller R F, Knapp J C, Valenti L A, Dobson A J . Secondary prevention after acute myocardial
X X
infarction. Am J Cardiol. 1993;72(11):759-62. Rec #: 809
Horlick L, Cameron R, Firor W, et al . The effects of education and group discussion in the
X X
postmyocardial infarction patient. J Psychosom Res. 1984;28:485-492. Rec #: 2219
Oldridge N, Guyatt G, Jones N. Effects of quality of life with comprehensive rehabilitation after
X X
acute myocardial infarction. Am J Cardiol. 1991;67:1084-1089. Rec #: 2653
Rahe RM, Ward HW, Hayes V. Brief group therapy in myocardial infarction rehabilitation: Three to
X X
four year follow-up of a controlled trial . Psychosom Med. 1979;41:229-242. Rec #: 2406
Stern MJ, Gorman PA, Kaslow . The group counseling vs. exercise therapy study: A controlled
intervention with subjects following myocardial infarction. Arch Intern Med. 1983;143:1719- X X
1725. Rec #: 2377
Total number of studies 9 8

54
Table 6. Hypertension Articles Contributing to Meta-analysis

Blumenthal JA, Siegel WC, Appelbaum M . Failure of exercise to reduce blood pressure in patients with mild
hypertension. Results of a randomized controlled trial [see comments]. JAMA. 1991;266(15):2098-104. Rec
#: 752
Given C, Given B, Coyle B. The effects of patient characteristics and beliefs on responses to behavioral
interventions for control of chronic diseases. Pat Ed Counsel. 1984;6(3):131-140. Rec #: 2309
Goldstein IB, Shapiro D, et al. Comparison of drug and behavioral treatments of essential hypertension. Health
Psychology. 1982;1:7-26. Rec #: 2466
Gonzalez-Fernandez RA, Rivera M, Torres D, Quiles J, Jackson A. Usefulness of a systemic hypertension in-
hospital program. The American Journal of Cardiology 1990;65:1384-1386. Rec #: 3451
Hafner RJ. Psychological treatment of essential hypertension: A controlled comparison of meditation and
medication plus biofeedback. Biofeedback and Self-Regulation. 1982;7:305-315. Rec #: 2467
Hoelscher TJ, Lichstein KL, Fischer S, et al. Home relaxation practice in hypertension treatment: Objective
assessment and compliance induction. J of Consulting and Clinical Psychology. 1986;54:217-221. Rec #:
2457
Jacob RG, Fortmann SP, Kraemer HC, et al. Combining behavioral treatments to reduce blood pressure: A
controlled outcome study. Behavior Modification. 1985;9:32-45. Rec #: 2459
Jorgensen RS, Houston BK, Zurawski RM. Anxiety management training in the treatment of essential hypertension.
Behavior Research and Therapy. 1981;19:467-474. Rec #: 2452
Kostis JB, Rosen RC, Brondolo E, et al. Superiority of nonpharmacologic therapy compared to propranolol and
placebo in men with mild hypertension: A randomised prospective trial. American Heart Journal.
1992;123:466-474. Rec #: 2472
Lagrone R, Jeffrey TB, Ferguson CL. Effects of education and relaxation training with essential hypertension
patients. J of Clinical Psychology. 1988;44:271-276. Rec #: 2460
Muhlhauser I, Sawicki PT, Didjurgeit U, Jorgens V, Trampisch HJ, Berger M. Evaluation of a structured treatment
and teaching programme on hypertension in general practice. Clin Exp Hypertens 1993;15(1):125-42. Rec #:
3467
Southam MA, Agras WS, Taylor CB, et al. Relaxation training: Blood pressure lowering during the working day.
Archives of General Psychiatry. 1982;39:715-717. Rec #: 2453
Taylor CB, Farquhar JW, Nelson E, et al. Relaxation therapy and high blood pressure. Arch General Psychiatry.
1977;34:339-342. Rec #: 2464
Watkins CJ, Papacosta AO, Chinn S, Martin J. A randomized controlled trial of an information booklet for
hypertensive patients in general practice. J R Coll Gen Pract 1987;37(305):548-50. Rec #: 3469
All studies contributed to both systolic and diastolic blood pressure analyses.

55
RESULTS OF THE META-ANALYSES
Of the 14 questions posed by CMS, the following four could be most directly addressed

via meta-analyses. Theses four questions are related and their results are presented together.

Question 1. Do these programs work?

Question 2. Are there features that are generalizable across all diseases?

Question 6. What is the impact of chronic disease self-management programs on

quality of life, health status, health outcomes, satisfaction, pain, independence,

mental health (e.g., depression, emotional problems)?

Question 10. Is a generic self-management approach preferable to a disease-by-

disease approach?

The responses to these questions are presented in this section, by condition, (Diabetes,

Osteoarthritis, Post-Myocardial Infarction Care and Hypertension). We then by report the results

as they address our five hypotheses, both within condition and across conditions.

Diabetes

There were 14 comparisons from 12 studies that reported hemoglobin A1c outcomes. In

an overall analysis of the effectiveness of chronic disease self-management programs, these

studies reported a statistically and clinically significant pooled effect size of -0.45 in favor of the

intervention (95% CI: (-0.26, -0.63); see Figure 6). The negative effect size indicates a lower

hemoglobin A1c in the treatment group as compared to the usual care or control group. An

effect size of –0.45 is equal to a reduction in hemoglobin A1c of about 1.0. For change in

weight, there were 10 comparisons from 8 studies. There was no statistically significant

56
difference between change in weight in the intervention and control groups (effect size of -0.05;

95% CI:(-0.12, 0.23); see Figure 8). There were 10 comparisons from 9 studies that reported

fasting blood glucose outcomes. The pooled effect size was -0.41 in favor of the intervention

(95% CI: (-0.23, -0.60); see Figure 10). This effect size equates to a drop in blood glucose of

1 mml/l.

Our assessment of publication bias (graphically depicted in funnel plots in Figures 7, 9,

and 11 and also presented in Table 7) revealed likely publication bias in studies reporting

hemoglobin A1c outcomes. Therefore, our results regarding efficacy of chronic disease self-

management programs for improving hemoglobin A1c must be interpreted with caution.

57
 Figure 6. Forest Plot of Diabetes Studies: Hemoglobin A1c

D'Eramo-Melk(2202)

D'Eramo-Melk(2202)

Falkenberg(2190)

Glasgow(2212)

Greenfield(803)

Jaber(2598)

Jennings(2126)

Laitinen(2176)

McCulloch(2264)

McCulloch(2264)

Raz(2141)

Vanninen(2174)

Weinberger(896)

White(2154)

Combined

-2 -0.45 0 1
Effect Size
Favors Treatment Favors Control

Figure 7. Funnel Plot of Diabetes Studies: Hemoglobin A1c

0.5

0
Effect Size

-0.5

-1

-1.5
0.00 0.20 0.40
Standard Error of Effect Size

58
 Figure 8. Forest Plot of Diabetes Studies: Weight

D'Eramo-Melk(2202)

D'Eramo-Melk(2202)

Frost(791)

Glasgow(2212)

Laitinen(2176)

McCulloch(2264)

McCulloch(2264)

Raz(2141)

Vanninen(2174)

White(2154)

Combined

-1 - 0.05 1
Effect Size
Favors Treatment Favors Control

Figure 9. Funnel Plot of Diabetes Studies: Weight

0.5
Effect Size

-0.5

-1
0.00 0.10 0.20 0.30 0.40
Standard Error of Effect Size

59
 Figure 10. Forest Plot of Diabetes Studies: Fasting Blood Glucose

D'Eramo-Melk(2202)

D'Eramo-Melk(2202)

Frost(791)

Jaber(2598)

Korhonen(2259)

Laitinen(2176)

Raz(2141)

Vanninen(2174)

Weinberger(896)

White(2154)

Combined

-1.5 -0.41 0 0.5

Effect Size
Favors Treatment Favors Control

Figure 11. Funnel Plot of Diabetes Studies: Fasting Blood Glucose

0.5

0
Effect Size

-0.5

-1

0.00 0.10 0.20 0.30 0.40

Standard Error of Effect Size

60
 Table 7. Publication Bias for Diabetes Studies

Correlation Asymmetry Correlation Asymmetry

Condition/ Test Test Test Test
Outcome # arms (p-value) (p-value) # studies (p-value) (p-value)
Hemoglobin 14 0.016 0.006 12 0.011 0.008
Weight 10 0.210 0.079 8 0.108 0.090
Blood Glucose 10 0.210 0.136 9 0.118 0.177

61
Osteoarthritis

For both pain and function outcomes there were 10 comparisons from 7 different studies.

The pooled results of these chronic disease self-management programs did not yield any

statistically significant differences between intervention and control groups (pooled effect sizes

of -0.04 and -0.01 for pain and function respectively; see Figures 12 and 14).

Our assessment of publication bias depicted graphically in Figures 13 and 15 and Table 8

did not yield any evidence of publication bias.

62
 Figure 12. Forest Plot of Osteoarthritis Studies: Pain

Barlow(3274)

Goeppinger(801)

Goeppinger(801)

Keefe(907)

Keefe(907)

Lorig(608)

Lorig(830)

Lorig(830)

Lorig(835)

Lorig(837)

Combined

-1 -0.04 1
Effect Size
Favors Treatment Favors Control

Figure 13. Funnel Plot of Osteoarthritis Studies: Pain

0.5

0
Effect Size

-0.5

-1
0.00 0.10 0.20 0.30

Standard Error of Effect Size

63
 Figure 14. Forest Plot of Osteoarthritis Studies: Functioning

Barlow(3274)

Goeppinger(801)

Goeppinger(801)

Keefe(907)

Keefe(907)

Lorig(608)

Lorig(830)

Lorig(830)

Lorig(835)

Lorig(837)

Combined

-1 -.01 1
Effect Size
Favors Treatment Favors Control

Figure 15. Funnel Plot of Osteoarthritis Studies: Functioning

0.5

0
Effect Size

-0.5

0.00 0.10 0.20 0.30

Standard Error of Effect Size

64
 Table 8. Publication Bias for Osteoarthritis Studies

Correlation Asymmetry Correlation Asymmetry

Condition/ Test Test Test Test
Outcome # arms (p-value) (p-value) # studies (p-value) (p-value)
Pain 10 0.592 0.724 7 0.548 0.831
Functioning 10 0.788 0.230 7 0.764 0.337

65
Post Myocardial Infarction Care

There were 9 studies that reported mortality outcomes. There was no effect of chronic

disease self-management programs on improving mortality (pooled relative risk 1.04; 95% CI:

(0.56, 1.95); see Figure 16). For return to work there were 10 comparisons from 8 studies. The

pooled relative risk did not show any difference between groups (relative risk 1.02; 95% CI:

(0.97, 1.08); see Figure 18).

Our assessment of publication bias (Funnel Plots 17 and 19, and Table 9) showed

evidence of publication bias for the mortality outcome but not the return to work outcome.

66
Figure 16. Forest Plot of Post-Myocardial Infarction Care Studies: Mortality

Burgess {2652}

Debusk {2669}

Dennis {2656}

Heller {809}

Horlick {2219}

Oldridge {2653}

Rahe {2406}

Sivarajan-Fr {792}

Stern {2377}

Combined

0.01 1.04 21
Risk Ratio - log scale

Figure 17. Funnel Plot of Post-Myocardial Infarction Care Studies: Mortality

2
Effect Size

-2

-4
0.0 0.5 1.0 1.5
Standard Error of Effect Size

67
Figure 18. Forest Plot of Post-Myocardial Infarction Care Studies: Return to Work

Burgess {2652}

Dennis {2656}

Heller {809}

Horlick {2219}

Oldridge {2653}

Rahe {2406}

Sivarajan-Fr {792}

Sivarajan-Fr {792}

Stern {2377}

Stern {2377}

Combined

0.01 1.02 100

Risk Ratio - log scale

Figure 19. Funnel Plot of Post-Myocardial Infarction Care Studies: Return to

Work

2
log Risk Ratio
Ri k R ti

-2

-4
0 0.5 1 1.5

Standard Error of log Risk Ratio

68
 Table 9. Publication Bias for Post-Myocardial Infarction Care Studies

Correlation Asymmetry Correlation Asymmetry

Condition/ Test Test Test Test
Outcome # arms (p-value) (p-value) # studies (p-value) (p-value)
Mortality 15 0.012 0.005 9 0.076 0.087
Return to Work 10 1.000 0.450 8 0.902 0.641

69
Hypertension

For hypertension there were 23 comparisons from 14 studies that reported systolic and

diastolic blood pressure changes. The overall pooled result of the chronic disease self-

management programs was a statistically and clinically significant reduction in systolic and

diastolic blood pressure (effect size for systolic blood pressure -0.32; 95% CI: (-0.50, -0.15);

effect size for diastolic blood pressure -0.59; 95% CI: (-0.81, -0.38); see Figures 20 and 22). An

effect size of 0.32 is equivalent to a change in blood pressure of 3.5 mm of mercury, the

corresponding value for an effect size of 0.59 is 6.5 mm of mercury.

In our assessment of publication bias, (presented in Funnel Plots 21 and 23 and

Table 10), there was evidence of publication bias. Therefore our pooled result favoring chronic

disease self-management programs for hypertension must be viewed with caution.

70
 Figure 20. Forest Plot of Hypertension Studies: Systolic Blood Pressure

Blumenthal {752}
Blumenthal {752}
Given {2309}
Goldstein {2466}
Goldstein {2466}
Goldstein {2466}
Gonzalez-Fer {3451}
Hafner {2467}
Hafner {2467}
Hoelscher {2457}
Hoelscher {2457}
Hoelscher {2457}
Jacob {2459}
Jorgensen {2452}
Kostis {2472}
Kostis {2472}
Lagrone {2460}
Lagrone {2460}
Muhlhauser {3467}
Southam {2453}
Taylor {2464}
Taylor {2464}
Watkins {3469}

Combined

-3.5 -0.32 0 1.5

Effect Size

Figure 21. Funnel Plot of Hypertension Studies: Systolic Blood Pressure

0
Effect Size

-1

-2
0.00 0.20 0.40 0.60 0.80
Standard Error of Effect Size

71
 Figure 22. Forest Plot of Hypertension Studies: Diastolic Blood Pressure

Blumenthal {752}
Blumenthal {752}
Given {2309}
Goldstein {2466}
Goldstein {2466}
Goldstein {2466}
Gonzalez-Fer {3451}
Hafner {2467}
Hafner {2467}
Hoelscher {2457}
Hoelscher {2457}
Hoelscher {2457}
Jacob {2459}
Jorgensen {2452}
Kostis {2472}
Kostis {2472}
Lagrone {2460}
Lagrone {2460}
Muhlhauser {3467}
Southam {2453}
Taylor {2464}
Taylor {2464}
Watkins {3469}

Combined

-3.5 -0.59 0 1.5

Effect Size

Figure 23. Funnel Plot of Hypertension Studies: Diastolic Blood Pressure

0
Effect Size

-1

-2
0.00 0.20 0.40 0.60 0.80
Standard Error of Effect Size

72
 Table 10. Publication Bias for Hypertension Studies

Correlation Asymmetry Correlation Asymmetry

Condition/ Test Test Test Test
Outcome # arms (p-value) (p-value) # studies (p-value) (p-value)
Systolic BP 20 0.074 0.077 11 0.008 0.021
Diastolic BP 20 0.074 0.045 11 0.043 0.017

73
Overall Analysis

For the three conditions that reported continuous outcomes (diabetes, osteoarthritis and

hypertension) we chose the one outcome from each study that we judged most clinically relevant

(hemoglobin A1c, pain, and systolic blood pressure, respectively) and used this to perform an

overall analysis of the efficacy of chronic disease self-management programs across conditions.

This analysis is shown in Figure 24, which contains 47 comparisons from 33 studies. The

overall pooled result is a statistically and clinically significant effect size favoring chronic

disease self-management programs of -0.26; 95% CI: (-0.36, -0.15).

Figure 24. Forest Plot of Pooled Studies

Barlow {3274}
Blumenthal {752}
Blumenthal {752}
D'Eramo-Melk {2202}
D'Eramo-Melk {2202}
Falkenberg {2190}
Given {2309}
Glasgow {2212}
Goeppinger {801}
Goeppinger {801}
Goldstein {2466}
Goldstein {2466}
Goldstein {2466}
Gonzalez-Fer {3451}
Greenfield {803}
Hafner {2467}
Hafner {2467}
Hoelscher {2457}
Hoelscher {2457}
Hoelscher {2457}
Jaber {2598}
Jacob {2459}
Jennings {2126}
Jorgensen {2452}
Keefe {907}
Keefe {907}
Kostis {2472}
Kostis {2472}
Lagrone {2460}
Lagrone {2460}
Laitinen {2176}
Lorig {608}
Lorig {830}
Lorig {830}
Lorig {835}
Lorig {837}
McCulloch {2264}
McCulloch {2264}
Muhlhauser {3467}
Raz {2141}
Southam {2453}
Taylor {2464}
Taylor {2464}
Vanninen {2174}
Watkins {3469}
Weinberger {896}
White {2154}

Combined

-3.5 -0.26 0 1.5

Effect Size

74
 Figure 25. Funnel Plot of Pooled Studies

0
Effect Size

-1

-2
0.00 0.20 0.40 0.60 0.80
Standard Error of Effect Size

Tests of hypothesis of elements essential to chronic disease self-management efficacy

Tables 11 through 14 present the results of our analysis looking at the five hypotheses

regarding the elements contributing to the effectiveness of chronic disease self-management

programs. Other than the increased effectiveness seen in hypertension studies reporting systolic

blood pressure outcomes that used tailored interventions, there were no statistically significant

differences between interventions with or without the 5 features hypothesized to be related to

effectiveness (tailoring, use of group setting, feedback, psychological component, and MD care).

Indeed, many of the effects seen are inconsistent across outcomes within the same condition.

For example, in hypertension studies, for hypothesis 2 (use of a group setting), there is a greater

than 50% increase in the effect size for improvement in systolic blood pressure, but only a 5%

increase in the effect size for improvement in diastolic blood pressure (note that neither result is

75
 statistically significant). In other situations, the effect actually goes the opposite way (for

example, hypothesis 4, the use of a psychological component, shows opposite effects in studies

of diabetes depending on whether hemoglobin A1c or fasting blood glucose is used as the

outcome).

Our "across condition" analysis, presented in Table 15 shows effect sizes that, in general,

go in the direction of supporting increased effectiveness associated with the use of these

intervention features, however none of the differences are statistically significant.

Table 11. Meta-Analysis Results for Diabetes

Hemoglobin A1c Weight Fasting blood glucose
Outcome
(N = 12) (N = 8) (N = 9)
effect size effect size effect size
# comparisons (95% CI) # comparisons (95% CI) # comparisons (95% CI)
Overall 14 -0.45 10 -0.05 10 -0.41
(-0.63, -0.26) (-0.23, 0.12) (-0.60, -0.23)
Tailored No 1 -0.32 1 0.0 1 -0.81
(-1.05, 0.41) (-0.56, 0.56) (-1.42, -0.20)
Yes 13 -0.46 9 -0.06 9 -0.37
(-0.66, -0.26) (-0.24, 0.12) (-0.55, -0.19)
Group Setting No 4 -0.50 2 -0.05 4 -0.38
(-0.83, -0.18) (-0.39, 0.30) (-0.68, -0.09)
Yes 10 -0.42 8 -0.05 6 -0.46
(-0.66, -0.18) (-0.25, 0.15) (-0.74, -0.18)
Feedback No 4 -0.26 3 0.10 2 -0.42
(-0.58, 0.07) (-0.18, 0.38) (-0.90, 0.06)
Yes 10 -0.52 7 -0.15 8 -0.42
(-0.73, -0.30) (-0.38, 0.07) (-0.65, -0.20)
Psychological No 8 -0.48 5 -0.09 5 -0.37
(-0.74, -0.22) (-0.36, 0.18) (-0.63, -0.11)
Yes 6 -0.42 5 -0.02 5 -0.49
(-0.71, -0.12) (-0.25, 0.20) (-0.80, -0.18)
MD Care No 13 -0.45 9 -0.04 8 -0.48
(-0.66, -0.25) (-0.22, 0.15) (-0.70, -0.27)
Yes 1 -0.43 1 -0.14 2 -0.20
(-1.08, 0.21) (-0.59, 0.30) (-0.58, 0.18)
Overall Chi-squared p-value 0.081 0.942 0.195
N = number of studies contributing data; CI = confidence interval; NE = not estimable

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 Table 12. Meta-Analysis Results for Osteoarthritis
Pain Functioning
Outcome
(N = 7) (N = 7)
effect size effect size
# comparisons (95% CI) # comparisons (95% CI)
-0.04 -0.01
Overall 10 10
(-0.11, 0.04) (-0.09, 0.07)
Tailored No 0 NE 0 NE
Yes 10 NE 10 NE
0.10 0.17
Group Setting No 1 1
(-0.14, 0.34) (-0.06, 0.41)
-0.05 -0.03
Yes 9 9
(-0.13, 0.02) (-0.11, 0.04)
-0.04 0.01
Feedback No 4 4
(-0.17, 0.10) (-0.13, 0.16)
-0.04 -0.01
Yes 6 6
( -0.12, 0.05) ( -0.11, 0.08)
0.04 0.10
Psychological No 3 3
(-0.13, 0.20) (-0.07, 0.26)
-0.05 -0.04
Yes 7 7
( -0.14, 0.03) (-0.12, 0.04)
MD Care No 10 NE 10 NE
Yes 0 NE 0 NE
Overall Chi-squared p-value 0.243 0.532
N = number of studies contributing data; CI = confidence interval; NE = not estimable

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Table 13. Meta-Analysis Results for Post-Myocardial Infarction Care
Mortality Return to Work
Outcome
(N = 9) (N = 8)
risk ratio risk ratio
# comparisons (95% CI) # comparisons (95% CI)
Overall 9 1.04 10 1.02
(0.56, 1.95) (0.97, 1.08)
Tailored No 0 NE 0 NE
Yes 9 NE 10 NE
Group Setting No 5 1.22 4 1.02
(0.54, 2.79) (0.95, 1.11)
Yes 6 0.81 6 1.01
(0.32, 2.05) (0.92, 1.11)
Feedback No 4 1.01 4 0.91
(0.34, 3.20) (0.81, 1.02)
Yes 6 1.03 6 1.05*
(0.48, 2.23) (1.00, 1.11)
Psychological No 4 1.81 4 0.97
(0.68, 5.35) (0.88, 1.07)
Yes 7 0.69 6 1.05
(0.31, 1.54) (0.98, 1.13)
MD Care No 8 1.09 9 1.01
(0.57, 2.10) (0.95, 1.08)
Yes 1 0.52 1 1.07
(0.01, 9.90) (0.94, 1.22)
Overall Chi-squared p-value 0.30 0.035
N = number of studies contributing data; CI = confidence interval; NE = not estimable
* "yes" is statistically significant as compared to "no" (p<0.05)

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 Table 14. Meta-Analysis Results for Hypertension
Systolic BP Diastolic BP
Outcome
(N = 14) (N = 14)
effect size effect size
# comparisons (95% CI) # comparisons (95% CI)
Overall 23 -0.32 23 -0.59
(-0.50, -0.15) (-0.81, -0.38)
Tailored No 6 -0.08 6 -0.41
(-0.33, 0.16) (-0.78, -0.03)
Yes 17 -0.41* 17 -0.67
(-0.59, -0.22) (-0.92, -0.42)
Group Setting No 10 -0.20 10 -0.54
(-0.46, 0.06) (-0.87, -0.21)
Yes 13 -0.41 13 -0.64
(-0.65, -0.18) (-0.94, -0.35)
Feedback No 13 -0.26 13 -0.56
(-0.49, -0.02) (-0.85, -0.26)
Yes 10 -0.40 10 -0.65
(-0.67, -0.14) (-0.98, -0.32)
Psychological No 8 -0.25 8 -0.44
(-0.50, 0.00) (-0.76, -0.12)
Yes 15 -0.38 15 -0.70
(-0.62, -0.14) (-0.98, -0.42)
MD Care No 23 NE 23 NE
Yes 0 NE 0 NE
Overall Chi-squared p-value 0.008 0.000
N = number of studies contributing data; CI = confidence interval; NE = not estimable
* "yes" is statistically significant as compared to "no" (p<0.05)

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Table 15. Meta-Analysis Results Pooled Across Conditions
Pain, Hemoglobin A1c, Systolic
Outcome
(N = 30) Adjusted
effect size effect size
# comparisons (95% CI) (95% CI)
Overall 47 -0.26
NA
(-0.36, -0.15)
Tailored No 7 -0.14
NA
(-0.42, 0.13)
Yes 40 -0.28 -0.21
(-0.39, -0.16) (-0.53, 0.12)
Group Setting No 15 -0.26
NA
(-0.46, -0.07)
Yes 32 -0.26 -0.16
(-0.38, -0.13) (-0.45, 0.14)
Feedback No 21 -0.16
NA
(-0.32, 0.00)
Yes 26 -0.32 -0.27
(-0.46, -0.18) (-0.69, 0.15)
Psychological No 19 -0.27
NA
(-0.43, -0.11)
Yes 28 -0.25 -0.08
(-0.39, -0.11) (-0.51, 0.34)
MD Care No 46 -0.25
NA
(-0.36, -0.15)
Yes 1 -0.43 -0.23
(-1.09, 0.22) (-0.99, 0.54)
Overall Chi-squared p-value 0.000 NA
N = number of studies contributing data; CI = confidence interval; NE = not estimable
Adjusted effect size is adjusted for all components simultaneously

80
Post Hoc Analyses

Components of CDSM according to RE-AIM

The components of CDSM can be classified using RE-AIM as:

x one-on-one counseling interventions (individual)

x group sessions (group)

x telephone calls (telephone)

x interactive computer-mediated interventions (computer)

x mail interventions (mail)

x health system policies (policy 1 and policy 2)

The results of the meta-regression analyses are presented in Tables 16-20. With few

exceptions, there were no results that were statistically significant. An exception is the result for

the use of one-on-one counseling sessions, which did show a statistically significant increased

effect size when used. “Policy 1” is the variable we constructed using a strict definition of health

system policies, while “Policy 2” uses a broad definition of health system policies.

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 Table 16. Meta-Analysis Results for Diabetes (RE-AIM Model)

Hemoglobin Weight Blood Glucose

Outcome
(N = 12) (N = 8) (N = 9)
effect size effect size effect size
# comparisons (95% CI) # comparisons (95% CI) # comparisons (95% CI)
-0.45 -0.05 -0.41
Overall 14 10 10
(-0.63, -0.26) (-0.23, 0.12) (-0.60, -0.23)
-0.23 0.0 -0.55
Individual No 6 3 3
(-0.44, -0.02) (-0.29, 0.29) (-0.89, -0.20)
-0.60* -0.08 -0.36
Yes 8 7 7
(-0.83, -0.38) (-0.30, 0.13) (-0.60, -0.11)
-0.54 -0.05 -0.38
Group No 6 3 4
(-0.82, -0.27) (-0.36, 0.27) (-0.68, -0.09)
-0.36 -0.05 -0.46
Yes 8 7 6
(-0.62, -0.10) (-0.26, 0.15) (-0.74, -0.18)
-0.48 -0.44
Telephone No 13 10 NE 9
(-0.68, -0.28) (-0.67, -0.22)
-0.23 -0.32
Yes 1 0 NE 1
(-0.74, 0.29) (-0.78, 0.13)
Computer No 14 NE 10 NE 10 NE
Yes 0 NE 0 NE 0 NE
Mail No 14 NE 10 NE 10 NE
Yes 0 NE 0 NE 0 NE
-0.48 -0.44
Policy 1 No 13 10 NE 9
(-0.68, -0.28) (-0.67, -0.22)
-0.23 -0.32
Yes 1 0 NE 1
(-0.74, 0.29) (-0.78, 0.13)
-0.48 -0.44
Policy 2 No 13 10 NE 9
(-0.68, -0.28) (-0.67, -0.22)
-0.23 -0.32
Yes 1 0 NE 1
(-0.74, 0.29) (-0.78, 0.13)
0.081 0.942 0.195
N = number of studies contributing data; CI = confidence interval; NE = not estimable
* "yes" is statistically significant as compared to "no" (p<0.05)

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Table 17. Meta-Analysis Results for Osteoarthritis (RE-AIM Model)

Pain Functioning
Outcome
(N = 7) (N = 7)
effect size effect size
# comparisons (95% CI) # comparisons (95% CI)
-0.04 -0.01
Overall 10 10
(-0.11, 0.04) (-0.09, 0.07)
Individual No 10 NE 10 NE
Yes 0 NE 0 NE
-0.67 0.06
Group No 1 1
(-1.20, -0.14) (-0.46, 0.59)
-0.02* -0.01
Yes 9 9
( -0.10, 0.05) (-0.09, 0.08)
-0.03 -0.01
Telephone No 8 8
(-0.10, 0.05) (-0.10, 0.07)
-0.32 0.17
Yes 2 2
( -0.68, 0.05) ( -0.20, 0.53)
Computer No 10 NE 10 NE
Yes 0 NE 0 NE
-0.05 -0.03
Mail No 9 9
(-0.13, 0.02) (-0.11, 0.04)
0.10 0.17
Yes 1 1
( -0.14, 0.34) (-0.06, 0.41)
-0.03 0.03
Policy 1 No 9 9
(-0.12, 0.06) (-0.05, 0.12)
-0.06 -0.12*
Yes 1 1
( -0.19, 0.07) (-0.25, 0.01)
-0.03 0.03
Policy 2 No 9 9
(-0.12, 0.06) (-0.05, 0.12)
-0.06 -0.12*
Yes 1 1
( -0.19, 0.07) (-0.25, 0.01)
Chi-squared p-value 0.243 0.532
N = number of studies contributing data; CI = confidence interval; NE = not estimable
* "yes" is statistically significant as compared to "no" (p<0.05)

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Table 18. Meta-Analysis Results for Post-Myocardial Infarction Care
(RE-AIM Model)

Return to Work
Outcome
(N = 8)
risk ratio
# comparisons (95% CI)
1.02
Overall 10
(0.97, 1.08)
0.97
Individual No 5
(0.89, 1.06)
1.05
Yes 5
(1.00, 1.11)
1.03
Group No 5
(0.95, 1.11)
1.01
Yes 5
(0.92, 1.11)
1.00
Telephone No 9
(0.95, 1.08)
1.07
Yes 1
(0.94, 1.22)
Computer No 10 NE
Yes 0 NE
1.03
Mail No 7
(0.95, 1.11)
1.01
Yes 3
(0.92, 1.11)
Policy 1 No 10 NE
Yes 0 NE
Policy 2 No 10 NE
Yes 0 NE
Chi-squared p-value 0.035
N = number of studies contributing data; CI = confidence interval; NE = not estimable
NA = not applicable
Note: it was not possible to perform this analysis for the outcome “mortality”.

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 Table 19. Meta-Analysis Results for Hypertension (RE-AIM Model)

Systolic BP Diastolic BP
Outcome
(N = 14) (N = 14)
effect size effect size
# comparisons (95% CI) # comparisons (95% CI)
-0.32 -0.59
Overall 23 23
(-0.50, -0.15) (-0.81, -0.38)
-0.32 -0.64
Individual No 17 17
(-0.53, -0.12) (-0.79, -0.30)
-0.33 -0.75
Yes 6 6
(-0.70, 0.05) (-1.19, -0.31)
-0.21 -0.51
Group No 15 15
(-0.42, -0.01) (-0.78, -0.24)
-0.48 -0.75
Yes 8 8
(-0.76, -0.21) (-1.12, -0.38)
-0.32 -0.57
Telephone No 22 22
(-0.50, -0.14) (-0.79, -0.35)
-0.42 -1.24
Yes 1 1
(-1.39, 0.54) (-2.38, -0.10)
Computer No 23 NE 23 NE
Yes 0 NE 0 NE
Mail No 23 NE 23 NE
Yes 0 NE 0 NE
-0.40 -0.63
Policy 1 No 20 20
(-0.55, -0.17) (-0.86, -0.39)
-0.06 -0.38
Yes 3 3
(-0.57, 0.46) (-0.99, 0.24)
-0.40 -0.63
Policy 2 No 20 20
(-0.55, -0.17) (-0.86, -0.39)
-0.06 -0.38
Yes 3 3
(-0.57, 0.46) (-0.99, 0.24)
Chi-squared p-value 0.008 0.006
N = number of studies contributing data; CI = confidence interval; NE = not estimable

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Table 20. Meta-Analysis Results Pooled Across Conditions (RE-AIM Model)

Pain, Hemoglobin A1c, Systolic

Outcome
(N = 30) Adjusted
# comparisons effect size effect size
-0.26
Overall 47 NE
(-0.36, -0.15)
-0.14
Individual No 33 NE
(-0.23, -0.05)
-0.51* -0.54*
Yes 14
(-0.70, -0.32) (-0.75, -0.34)
-0.35
Group No 22 NE
(-0.51, -0.19)
-0.18 -0.15
Yes 25
(-0.31, -0.05) (-0.26, -0.03)
-0.25
Telephone No 43 NE
(-0.37, -0.14)
-0.30 -0.34
Yes 4
(-0.65, 0.04) (-0.65, -0.04)
Computer No 47 NE NE
Yes 0 NE NE
-0.27
Mail No 46 NE
(-0.37, -0.16)
0.10 0.03
Yes 1
(-0.41, 0.61) (-0.39, 0.45)
-0.28
Policy 1 No 42 NE
(-0.39, -0.17)
-0.10 -0.07
Yes 5
(-0.40, 0.20) (-0.35, 0.20)
-0.28
Policy 2 No 42
(-0.39, -0.17) excluded from
-0.10 model
Yes 5
(-0.40, 0.20)
Chi-squared p-value 0.000
N = number of studies contributing data; CI = confidence interval; NE = not estimable
* "yes" is statistically significant as compared to "no" (p<0.05)
Adjusted effect size is adjusted for all components simultaneously

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Effectiveness of CDSM According to Baseline Severity

We were able to perform the meta-analysis according to baseline severity for

hemoglobin A1c and weight outcomes in diabetes, and pain and function for osteoarthritis. For

hemoglobin A1c, a study’s sample was considered more severe if the mean baseline hemoglobin

value was greater than or equal to 10%. Seven out of the 12 studies were considered more

severe, which provided 9 comparisons. For weight, severity was assigned to studies with a mean

baseline weight of greater than 185 lbs or 84.1 kgs, or BMI greater than 30 kg/m2. Six of the 8

weight studies were categorized as “more severe” which provided seven comparisons. For the

pain outcome, a study had a more severe patient sample if the mean baseline pain value was

greater than 5 on a 0-10 or 0-15 Visual Analogue Scale or on the AIMs pain scale. Four of the

six pain studies were rated as “more severe” which provided 6 comparisons. A sample was

considered more severe for the functioning outcome if the baseline mean was greater than one on

the HAQ (0-3). One of the six studies was considered “more severe” which provided one

comparison. Effect sizes were then compared between studies of “more severe” and “less

severe” patients at baseline. Only the assessment of hemoglobin A1c demonstrated an increased

effect size in patients who were more severely effected, and this difference did not quite reach

conventional levels of statistical significance.

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 Table 21. Meta-analysis Results for Diabetes (Severity Model)

Hemoglobin A1c Weight

(N = 12) (N = 8)
effect size effect size
Level # comparisons (95% CI) # comparisons (95% CI)
-0.55 -0.04
More Severe 9 7
(-0.79, -0.31) (-0.42, 0.35)
-0.29 -0.06
Less Severe 5 3
(-0.57, -0.01) (-0.25, 0.14)
N = number of studies contributing data; CI = confidence interval; NE = not estimable

Table 22. Meta-analysis Results for Osteoarthritis (Severity Model)

Pain Functioning
(N = 6) (N = 6)
effect size effect size
Level # comparisons (95% CI) # comparisons (95% CI)
-0.04 -0.02
More Severe 6 1
(-0.14, 0.05) (-0.11, 0.08)
-0.03 0
Less Severe 4 9
(-0.14, 0.08) (-0.20, 0.20)
N = number of studies contributing data; CI = confidence interval

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Effectiveness of CDSM Program Components According to the “Essential Elements of Self-

management Interventions”

For the “Essential Elements of Self-management Interventions” evaluation, we did not

find as much variation among studies and components as is necessary for optimal power in the

analysis. Most of the studies scored positively for “problem identification and solving,” and did

not score positively for the “ensuring implementation component.” Given these data, we did not

find evidence to support either any one of these three broad “essential elements” as necessary,

nor some threshold (such as two out of three) in terms of efficacy. This was not an optimal test

of these hypotheses due to the lack of variation in the data.

Table 23. Meta-analysis Results Pooled Across Conditions

(“Essential Elements” Model)

Pain, Hemoglobin A1c, Systolic

Outcome
(N = 30) Adjusted
# comparisons effect size effect size
-0.24
Problem No 8 NE
(-0.47, 0)
-0.26 -0.27
Yes 39
(-0.38, -0.14) (-0.46, -0.09)
-0.27
Support No 28 NE
(-0.41, -0.13)
-0.24 -0.20
Yes 19
(-0.41, -0.08) (-0.54, 0.14)
-0.25
Track No 44 NE
(-0.35, -0.14)
-0.38 -0.35
Yes 3
(-0.76, 0.01) (-0.84, 0.13)
N = number of studies contributing data; CI = confidence interval; NE = not estimable
Adjusted effect size is adjusted for all three components simultaneously

89
Effectiveness According to Intermediate Variables

Figures 26 and 27 present graphical representations of the correlation between

“intermediate” variable 1 and variable 2, and between variable 2 and outcome. Figure 26 shows

that the correlation between intermediate variables 1 and 2 is strongly effected by outliers.

Including two outlier values actually produces a negative correlation, meaning that

improvements in intermediate variable 1 (such as self-efficacy, patient knowledge, and

psychological measures) actually is associated with worsening values for intermediate 2

variables (such as dietary measures, physical activity, and behavioral measures). Ignoring the

two outlier values yields a correlation in the expected direction. Figure 27 shows that the

correlation of intermediate 2 on outcome is weak but in the expected direction.

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Figure 26. Regression of Intermediate 2 on Intermediate 1

91
Figure 27. Regression of Outcome on Intermediate 2

92
Question 3. Does this intervention belong in the medical care system?

Whether chronic disease self-management belongs in the medical care system or in the

community is a decision that needs to be made by policy makers, based on many factors. That

being said, one of the first hypotheses we tested was whether patients who receive interventions

directly from their medical providers are more likely to have better outcomes than those who

received interventions from non-medical providers. Of the controlled studies that made it into

our meta-analysis, no studies of osteoarthritis or hypertension used medical providers in their

self-management interventions. Regarding diabetes, one intervention used medical providers; the

results of this intervention were not significantly different than those using lay leaders (see

Table 11). One post-myocardial infarction intervention used medical providers; the effects on

mortality and return to work were not statistically different from those of the other interventions.

Question 4. Define chronic disease self-management and distinguish between it

and disease management.

There is no standard definition of chronic disease self-management. For purposes of this

review, we initially defined chronic disease self-management broadly as a systematic

intervention that is targeted towards patients with chronic disease to help them to actively

participate in either or both of the following activities: self monitoring (of symptoms or

physiologic processes) or decision-making (managing the disease or its impact based on self-

monitoring). Our analytic attempts to “define” chronic disease self-management by identifying

the components most responsible for the success of the program were unsuccessful.

The draft evidence report was presented to a group of experts in chronic disease self-

management at a meeting convened by the Robert Wood Johnson Foundation and held in Seattle

93
on December 14, 2001. The list of experts attending is present in Appendix A. The panel’s aim

was to focus on interventions offered to patients who need a more intense level and type of self-

management support. They agreed that all self-management programs should address the

following three areas.

Disease, medication and health management. While patients need medical information

about their particular disease (diabetes, arthritis, asthmas, etc.), the majority of the content in

most successful self-management programs emphasized generic lifestyle issues such as exercise,

nutrition, and coping skills. More disease-specific medication-specific information can be useful,

but such information rarely constitutes more than 20 percent of the content of programs.

Role management. Patients benefit from programs that help them maintain social

support, connection to work and family, and normal functions of daily life.

Emotional management. Programs should encompass managing depression and stress,

adaptation to change, and maintaining interpersonal relationships.

A monograph authored by Dr. Jesse Gruman (Center for the Advancement of Health,

2002) summarized the discussions from the meeting of December 14, 2001. The experts

concluded that the essential elements of self-management programs should include the

following:

1. Problem-solving training that encourages patients and providers to identify problems,

identify barriers and supports, generate solutions, form an individually tailored action

plan, monitor and assess progress toward goals, and adjust the action plan as needed.

94
 2. Follow-up to maintain contact and continued problem-solving support, to identify

patients who are not doing well and assist them in modifying their plan, and to relate

the plan to the patient’s social/ cultural environment.

3. Tracking and ensuring implementation by linking the program to the patient’s regular

source of medical care and by monitoring the effects of the program on the patient’s

health, satisfaction, quality of life, and health system quality measures.

The experts also recommended that any chronic disease self-management program be

composed of two tiers to accommodate the wide variety of patients with chronic conditions. The

first tier would include a low-intensity intervention designed to reach mass audiences and open

to anybody with a particular illness. The second tier would include a high-intensity intervention

targeted to people who require one-on-one support and case management. This program could

be offered to those who have not successfully managed their condition with the minimal support

of tier #1, those who have complicated conditions, and those whose life circumstances or

conditions change significantly.

Question 5. What is the role or potential of technology?

The advent of new technologies makes communication between patients, providers, and

others more convenient than ever. However, none of the randomized controlled studies on

chronic disease self-management used email or the Internet. Thus, we were not able to

quantitatively assess the impact of these technologies. Still, incorporating these technologies into

future randomized studies would be a worthwhile endeavor.

None of the randomized controlled trials of programs for arthritis, hypertension, or post-

myocardial infarction involved patient use of computer programs. However, diabetes self-

95
management programs have utilized computer programs since the late 1970s. Randomized

controlled trials are discussed below.

The DIABEDS study, conducted from 1978 to 1982 at University of Indiana, used

computers to generate diet menus and physician reminders.35, 36 Over 500 patients were assigned

to either routine care, patient education, physician education, or both physician and patient

education. At two-year follow-up, the combination of patient plus physician education resulted in

the greatest improvements in fasting plasma glucose, hemoglobin A1C, body weight, and

diastolic blood pressure. A small substudy was conducted at the university on computer-based

techniques for diet education and meal planning.37 Sixteen inner city, low SES patients received

computer-assisted instruction combined with an interactive videodisc system. They also received

face-to-face education from a dietitian. The computer –assisted instruction was operated entirely

by the patient, who answered questions by pressing on of three color-coded keys on the

keyboard. At four-week follow-up the group had lost an average of 4.6 pounds (p<0.005) and

reduced their reported fat intake (p<0.05).

Scientists in the U.K. also designed and evaluated two interactive computer based

diabetes education tools in the early 1980s.38 One was a teaching program with animated

graphics, while the other was a multiple choice knowledge assessment with optional prescriptive

feedback. Each program used questioning after each provision of fact, followed by optional or

compulsory rerun of the fact sequence if inadequate performance was recorded. Patients could

progress through the programs at their own rate. In a controlled trial, the programs led to an

increase in knowledge and a decrease in Hemoglobin A1c levels.

More recently, Glasgow and colleagues developed a single session MD office-based

intervention for diabetics using a brief touchscreen computer assessment that provided

96
individualized feedback to both providers and patients.39 The feedback took the form of a report

on key barriers to dietary self-management, along with goal setting and problem-solving

counseling. At three-month follow-up, intervention patients had lowered mean serum

cholesterol from 216 to 207, while patients in the usual care group actually increased total

cholesterol from 223 to 231 (p<0.001). In addition, intervention patients had larger decreases in

percent of calories from fat (p<0.008). Differences remained significant at twelve months.40

Recently, Lorig and colleagues reported the results of an “email discussion group” for

patients with back pain.41 While not one of our conditions of interest, and also not assessing

older individuals (mean age of study subjects was 45 years), the results are the first we have

found to assess the use of internet technology in patient management of a chronic illness. The

“email discussion group” participants received an educational book and videotape about back

pain, and had access to an email listserve where subjects could post questions or comments about

their illness. The “email discussion group” was moderated by content experts who answered

(non-participant specific) questions about back pain. The authors report that at one year subjects

in the “email discussion group” had, compared to controls that received a magazine subscription,

modest improvements in measures of self-efficacy, self-care orientation, pain interference, and

health related quality of life, and about one less physician visit for back pain over the past year.

This study suggests that email and the Internet may be a promising method for delivering self-

care interventions.

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Question 7. To what extent does self-management educate a patient on how to

care for himself/herself (e.g., take medications appropriately, consult with a

physician when necessary, etc.)?

Most CDSM studies that assess knowledge and self-efficacy reported beneficial

improvements. Most studies did NOT measure whether medications were taken appropriately or

“necessary” physician visits were made. The two studies that did assess compliance were

hypertension studies. One had a borderline beneficial overall result; the other reported a

significant beneficial result. One study was based on a conceptual model that specifically

considered that changing medication-taking behavior was going to be easier than changing diet

behavior or other such behaviors. This study did not actually measure compliance, but rather

measured “commitment to taking medications” and showed that this differed between

intervention and controls and that it was one of only three variables among those tested to be

associated with significant changes in blood pressure (the other two were “”belief in severity of

the disease” and “beliefs in efficacy of therapy”). Many studies assessed utilization, but none

assessed whether the utilization was necessary.

Question 8. What is the patient’s retention of self-management skills after the

intervention? Is a follow-up intervention needed at some point?

The best way to answer this question would be to review clinical trials where one arm

receives a “follow-up intervention” and another does not. No such studies were found. Failing

this, we could compare the results of studies that included a “follow-up intervention” with

studies that did not. Again, we were unable to find studies that actually included a “follow-up

intervention” which incorporated refresher skills on self-management. In light of this, we used a

meta-regression model to test whether self-management interventions that provide follow-up

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support led to better results than those that did not. We classified interventions that maintained

contact with the patient through contracts, provider feedback, reminders, peer support, material

incentives, or home visits as including “follow-up support.” Of the interventions which could be

included in our meta-analyses, 19 had “follow-up support” while 28 did not. Pooled results were

not statistically different between the two groups.

Question 9. How does the approach for self-management differ for people with

multiple chronic diseases?

We found no evidence on this topic.

Question 11. Should this intervention be targeted to a subset of the population or

available to everyone? Are there particular chronic conditions that should be

addressed (e.g., diabetes, arthritis, stroke, cancer, Parkinson’s, hypertension,

dyslipidemia)?

We were able to quantitatively assess the effects of chronic disease self-management

programs on patients with diabetes, osteoarthritis, and hypertension. In addition, we were able to

pool results for post myocardial infarction programs. There were insufficient studies on stroke,

cancer, Parkinson’s and dyslipedemia to allow pooling. As reported above, self-management

programs for hypertension had a significant beneficial effect on systolic and diastolic blood

pressure when compared to usual care. Programs for diabetics showed a beneficial effect on

hemoglobin A1c and blood glucose, but not on weight. There was insufficient evidence to

support a beneficial effect on the health outcomes for pain and function for programs targeting

patients with osteoarthritis or the health outcomes of death or return-to-work for heart attack

patients.

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 In an attempt to assess whether chronic disease self-management programs were more

effective for more severe patients, we undertook a post-hoc quantitative analysis. Two clinicians

independently categorized each diabetes and osteoarthritis program as focusing on either more

severe or less severe patients. The clinicians were unable to categorize the hypertension and

post- MI programs in such a fashion, due to the lack of heterogeneity of the patients. In the

diabetes analysis, there was no statistical difference between the effectiveness of programs

targeted to more severe and less severe patients, in terms of change in hemoglobin A1c or

weight. For osteoarthritis studies, there was no statistical difference in change in pain or

functioning.

Question 12. What is the role of the physician? Can physicians be used to

reinforce learning?

Out meta-analysis did not reveal any statistically significant differences supporting the

role of physicians at enhancing the efficacy of chronic disease self-management programs.

Question 13. Cost effectiveness or cost savings—does the intervention appear to

reduce health care costs by reducing disease, physician office visits,

hospitalizations, nursing home admissions, etc.?

A total of 19 clinical trial studies were identified in this review of the economic impact of

Chronic Disease Self-Management (CDSM). These include 9 studies on diabetes, 4 studies on

osteoarthritis, one study on hypertension, two on post-myocardial infarction, and three non-

disease-specific programs for chronically ill patients.

The 19 articles were located by four search methods: 1) previously described Quality

Review Form (QRF) with the key words “cost” or “utilization,” 2) references listed in relevant

100
articles or review articles (e.g., Clement,42 Norris,43 Klonoff44), 3) key word “health care

use/costs” search in “An Indexed Bibliography on Self-Management for People with Chronic

Disease,” and 4) a PubMed search with key words “diabetes,” “osteoarthritis,” “hypertension,”

“self-care,” and “cost,” “cost-effectiveness” or “economics.” Then we did title and abstract

screening to choose the literature. Finally, after careful assessment of study quality and relevance

for CDSM and economic analysis, 19 studies representing 19 programs were selected for review

(Evidence Table 5). All studies were randomized clinical trials if not otherwise indicated.

Diabetes

The type of articles included in our economic review of diabetic self-management

programs discuss:

1. Providing patient education programs,45-47

2. Comparing relative effectiveness of various intensity of educational programs,48, 49

3. Providing behavioral-based interventions,50

4. Providing dietary-specific interventions,40 and

5. Providing CDSM education and support as part of changes in the healthcare delivery

system.51, 52

Two of the three educational programs45, 47 failed to demonstrate effectiveness for the

measured outcomes. Thus these interventions cannot be cost-effective. The hospital education

program in de Weerdt47 incurred program costs – direct and indirect – at US $144 (1990 dollars,

101
about $240 in 2002 dollars*) per participant. The home visitation education program in Rettig45

was more expensive with an estimated program cost at $175 per participant (1983 dollars, about

$470 in 2002 dollars). Authors of both studies attribute the ineffectiveness of the interventions

partially to lack of supportive changes in the healthcare delivery system.

Wood46 reported that hospitalized patients who received an inpatient group education

program, which stressed both knowledge and self-help behaviors, experienced a significantly

lower emergency room (ER) visitation rate over the next four months (p <0.005). Based on self-

report, the 40 control patients reported 20 ER visits, and the 53 intervention patients reported

only two ER visits. Moreover, the control patients reported 18 hospital readmissions, whereas the

intervention patients reported only eight hospital readmissions. Although program cost was not

reported, the dramatic results in healthcare utilization outcomes would likely offset the program

cost and result in cost savings.

Klonoff and Schwartz44 conducted an economic analysis of interventions for diabetes,

including a section on self-management programs. Of the six self-care education programs they

analyzed, two were overlapped with the current review45, 47 and were discussed above. These

were the only two that did not report favorable cost-benefit results. The other four programs

reported in six studies had a benefit-cost ratio ranging from $0.43 to $8.76 for each dollar

spent.53-58 However, all these programs were conducted in or before 1985.

Two studies compared the relative effectiveness of various intensities of educational

programs.48, 49 Arsennau48 compared individualized learning activity packages (LAP) with

*
The inflation to 2002 dollars is derived from the percentage increase from 1990 to 2002 in the Consumer Price Indexes of Total
Medical Care Prices (From Statistical Abstract of United States, 2001). The indexes give 1990 = 162.8 given 1982-1984 = 100.

102
classroom instruction. LAP could provide a cheaper means of education for individuals by

saving $108.50 (1994 dollars, about $140 in 2002 dollars) in instructional fees. However, the

study reported LAP was less effective in lowering blood glucose levels than classroom

education, and thus was likely not to save healthcare costs. Campbell49 compared four programs

ranging from minimal instruction to an intensive educational and behavioral program. They

found that programs that were more intensive in terms of patient time and resources may be more

effective, but became less cost-effective. Their results showed that the four programs of differing

intensity had no difference in results in healthcare utilization and many outcome measures,

except for that the most intensive program (behavioral program) did have greater reduction in

diastolic blood pressure and cholesterol risk ratio along with higher patient satisfaction.

Kaplan and colleagues investigated behavioral-based interventions.50 The authors

reported direct costs for a program combining diet and exercise to be $1,000 (1986 dollars, about

$2190 in 2002 dollars) per participant, and this program could result in 0.092 incremental years

of well-being for each participant. The authors calculated the cost/utility equal to $10,870 (about

$23,800 in 2002 value) per “well-year” by the combined program. A cost/utility ratio less than

$50,000 is often considered cost-effective. Moreover, had the authors subtracted the cost of the

control program (10 weeks of group education) from the cost of the intervention program

($1,000), the cost/utility ratio would have been even more favorable than the one they reported.

Glasgow40 reported on a personalized, medical office-based intervention focused on

behavioral issues related to dietary self-management. This intervention used touchscreen

computer assessments to provide immediate feedback on key issues to patients and providers just

We assume the same rate of increase to estimate the index for 2002 to be 270. This method of inflation to 2002 dollars is applied
to the rest of the cost data in this section of the report.

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prior to a visit, and provided goal setting and problem-solving assistance to patients following

the visit with a physician. Follow-up components included phone calls and videotape or

interactive video instruction depending on patient self-efficacy level. Incremental costs for the

delivery of this intervention totaled $14,755 (1995 dollars, about $18065 in 2002 dollars), or

$137 ($168 in 2002 dollars) per participant. At 12 month follow-up, this study resulted in $62

($76 in 2002 dollars) per reduction of each percent in dietary fat, $105 ($129 in 2002 dollars) per

percent reduction in saturated fat, and $8 ($10 in 2002 dollars) per mg/dl reduction in serum

cholesterol. The authors reported these costs are quite low compared to other studies of

pharmacological interventions to reduce cholesterol, which can cost from $350 ($430 in 2002

dollars) to $1,400 ($1715 in 2002 dollars) per patient per year. There were also significant

differences favoring the intervention as measured by patient satisfaction (p < 0.02). However,

there were no significant differences between groups to either hemoglobin A1c or on Body Mass

Index.

There are many ways to provide CDSM education and support as part of changes in the

healthcare delivery system. We were only able to review the economic impact of this type of

intervention based on two studies.51, 52 Sadur51 reported that, for patients who had poor diabetic

management, providing intensive multidisciplinary outpatient diabetes care management may be

cost neutral in the short term. This could be achieved by significant improvement in glycemic

control, which led to an early reduction in health care utilization, which would offset costs of the

intervention promptly. However, it is too early to conclude if improved glycemic control really

reduces health care utilization. Moreover, although the study reported the resources in terms of

providers’ time used for the program, the authors did not report the dollar figure that how much

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the program costs. A cost-effectiveness study and replication of this intervention should be

conducted.

Litzelman52 investigated a multifaceted intervention that included patient education and a

behavioral contract about foot-care, and provided patient reinforcement reminders. Other

components of the intervention involved health care system support of identifiers on patient

folders to prompt providers for foot-care, and giving providers practice guidelines and

informational flow sheets on foot-related risk factors for amputation. This intervention resulted

in improved foot-care outcomes and process measures. The authors reported this intervention

would only cost $5,000 (1993 dollars, about $6700 in 2002 dollars) for study materials if it could

be implemented with the existing staff of a healthcare organization.

Osteoarthritis

The four OA studies include three types of articles:

1. Comparing relative effectiveness of lay-taught and professional-taught educational

programs,59

2. Providing patient education programs,60, 61 and

3. Providing social support and education interventions.62

The study that compared lay-taught and professional-taught self-management courses

reported that lay leaders could teach arthritis courses with results similar to those achieved by

professionals.59 Cost then became an issue of concern to patients and providers. The authors

assumed that lay leaders would either volunteer their time or would be paid a maximum of $100

(1985 dollars, about $245 in 2002 dollars) for leading the course. Thus, the arthritis course that

needed two lay-leaders would cost $0 to $200. On the other hand, a profession-led course would

105
cost $240 to $600. The authors reported, with similar effects, a lay-led course could result in

savings of $40 to $600 per course over the same courses taught by health professionals. This cost

savings, however, did not take into account any costs required for training and support of the lay

leaders (such as a center to answer lay-leaders’ questions). When compared with the no

intervention group at four-month follow-up, we also note that this study failed to show any

benefit in reducing the number of physician visits by either lay- or professional-led self-

management courses.

A similar self-help education program for arthritis patients60 was taught solely by lay

persons in a four-month RCT with a 20-month follow-up.† At four months, arthritis patients who

received the self-management course significantly exceeded control patients (who received no

CDSM course) in knowledge, recommended behaviors, and in decreased pain. The number of

visits to physicians was reduced without reaching statistical significance. The 20-month

longitudinal data showed the number of physician visits reduced from baseline to four-month

follow-up, and from four-months to eight-months, and remained about the same from eight-

month to 20-months. However, none of the differences reached statistical significance.

In contrast to the previous two community-based educational programs, a more recent

study,61 a nonrandomized clinical trial, tested the effects of a limited self-care intervention for

patients with knee OA that was delivered by an arthritis nurse specialist as an adjunct to primary

care. This intervention emphasized nonpharmacologic management of joint pain and

preservation of function by problem solving and by practicing behavioral principles of joint

protection. Telephone follow-up at one week and one month after initial instruction was designed

106
as part of the intervention, and a full written report of patient teaching and outcomes as well as

any needs or questions was placed in patient’s clinic record for any action deemed necessary by

the primary care physician. The results showed fewer physician visits by intervention subjects

(median visits five) compared to attention-control subjects (median visits six)(p <0.05) at 1-year

follow-up. Fewer visits translated directly into reduced clinic costs in the intervention group

(median costs at 1996 dollars = $229/patient, about $270/patient in 2002 dollars), compared to

controls (median costs = $305/patient, about $360/patient in 2002 dollars)(p <0.05). However,

the intervention had no significant effects on utilization and costs of outpatient pharmacy,

laboratory, or radiology services at the one-year follow-up. The authors reported 80% of the cost

of delivering the intervention ($58.70 per participant at 1996 dollars, about $70 in 2002 dollars)

was offset within one year by the reduced frequency and costs of primary care visits in this

study.

Groessl and Cronan62 in a recent study demonstrated that the monetary savings of a

community-based social support and education intervention greatly outweighed the cost of

conducting the intervention. In this study, 363 members of a health maintenance organization

(HMO), 60 years of age and older with osteoarthritis were randomly assigned to one of three

intervention groups (social support, education, or a combination of both) or to a control group.

These intervention programs were adapted from existing efficacy programs.61, 63-68 The total

costs to deliver the intervention were $9,450 for social support group (1992 dollars, about

$13,530 in 2002 dollars), $18,675 ($26,740 in 2002 dollars) for education group, and $14,175

($20,300 in 2002 dollars) for combination group, totaling $42,300 ($60,580 in 2002 dollars).

†
The 20-month follow-up after the four months RCT was a longitudinal study design. In other words, only intervention subjects
were followed up to 20 months whereas the control subjects were only followed up to 4 months.

107
After determining that there were no significant differences among the four groups when

analyzed separately, the authors examined a planned comparison of differential changes in health

care costs for the three intervention groups combined, in contrast to the control group. Assessed

by patients’ medical records, the results showed health care costs (all costs except for mental

health services) increased less in the intervention groups than in the control group over the three

year follow-up period. Health care cost savings were $1,156/participant (between $1,550 to

$1,655 per participant in 2002 value) for year one and two, and $1,279/participant

($1,635/particpant in 2002 value) for year three. With 273 patients who remained in the study

and completed the assessment, the one-year cost savings was $315, 588 ($451,955 in 2002

dollars), and resulted in a cost-benefit ratio of $315,588/$42,300 = $7.46:1. After discounting the

savings at a rate of 5% per year, the total three-year cost-benefit ratio was calculated as $315,588

+ $300,560 + $316,705 = $932,853/$42,300 = $22.05:1. The authors conducted sensitivity

analysis and reported the cost-savings were quite robust.

There are three concerns in this study by Groessl and Cronan.62 First is attrition. The

authors found that the mean annual health care costs of participants who dropped out ($4,793 in

1992 dollars, about $6,865 in 2002 dollars) were significantly higher than those of participants

who continued ($1,802 in 1992 dollars, about $2,580 in 2002 dollars). Secondly, health care

costs did not vary as a function of attendance at the meetings. The authors argued that many of

the study participants may have already been well educated about osteoarthritis and self-

management principles and/or had strong support networks. This suggests that a shorter

intervention, less than 20 meetings, might be just as effective. The last issue is about

generalizability of the study to minority population; the sample was largely Caucasian (92.3%)

with a mean age of 70 years old at entry into the study.

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 Among the four OA self-management studies reviewed, two of them reported significant

reduction in healthcare utilization and costs.61, 62 Of these two, one was an RCT62 and the other

design was non-randomized attention-control.61 One RCT followed with a longitudinal study60

reported a reduction in number of visits to physician, but did not reach statistical significance at

D = 0.05 level. The other study did not find reduction in number of physician visits, but showed a

cheaper alternative – led by lay leaders – to deliver patient education with same effectiveness as

a professional-led course.

Hypertension

For hypertension self-management, we identified only one study with economic

information.69, 70 This study was intended to investigate methods to enhance patient compliance

with assigned relaxation practice and to understand the impact of accomplished relaxation on

elevated blood pressure. Although all interventions were found to have significant effects on

reducing blood pressure, the authors reported that group relaxation alone was the most cost-

effective strategy as compared to individual training and group plus contingency contracting.

This is because it achieved higher relaxation practice compliance and greater reductions in blood

pressure while using the least time of the therapist. The authors did not provide the actual costs

for therapist time; nor did they attempt to measure impact on healthcare costs or utilization. Thus

we cannot judge if such a relaxation practice is cost saving.

Post-Myocardial Infarction

We identified two studies of post-myocardial infarction programs containing economic

information.71, 72 Both programs assessed home-based rehabilitation as an alternative to

traditional rehabilitation programs.

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 The study of DeBusk71 compared the medically directed at-home rehabilitation training

with a group rehabilitation and two no-training intervention arms (one with exercise testing but

not subsequent exercise training, and one with neither testing nor training). Their targeted

population was male patients aged 70 or younger with a clinically uncomplicated acute

myocardial infarction (AMI). Compared to group rehabilitation, patients assigned to the

medically directed at-home rehabilitation had about equally high adherence to individually

prescribed exercise, increase in functional capacity, and equally low nonfatal reinfarction and

dropout rates. Compared to the no-training groups, the patients randomized to the two training

groups achieved significantly greater increases in functional capacity, but there was no

difference in cardiac events. The cost for the three months of at-home rehabilitation in this study

was estimated to be approximately $328 per patient (1983 dollars, about $885 in 2002 dollars).

In contrast, the group rehabilitation program was approximately $720 ($1,945 in 2002 dollars).

Thus the authors claimed that, compared to group rehabilitation, medically directed at-home

rehabilitation has the potential to increase the availability and to decrease the cost of

rehabilitating low-risk survivors of AMI.

The study by Lewin72 examined whether a comprehensive home-based program reduced

psychological distress and use of health services. Subjects randomized into the self-help

rehabilitation program were given a heart manual that included education, a home-based exercise

program, and a tape-based relaxation and stress management program. Also included were

specific self-help treatments for commonly experienced psychological problems among post –MI

patients. Spouses were given materials to support and encourage compliance by patients. A

treatment facilitator provided follow-up and feedback to potentiate self-help treatments. In the

control group, subjects received standard care plus a placebo package of information and

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informal counseling. Besides finding better psychological adjustment in the rehabilitation group

than the control, the authors reported significant differences in the use of health services. The

rehabilitation group made significantly less GP consultations in the one-year follow-up (a mean

of 1.8 less visits than did the control group in the first 6 months, and a mean of 0.9 less visits in

the subsequent 6 months). In addition, significantly more control patients than rehabilitation

group patients were admitted to the hospital in the first 6 months (18 vs. 6) but not significant at

the second 6 months (18 vs. 9).

Costs of the intervention were not assessed rigorously, but the authors estimated it to be

£30 - £50 (roughly $100 to $165 in 2002 dollars). The authors claimed that the modest costs of

the self-help program might well be balanced by the reduction in GP consultations and hospital

admissions. The caveat of this result is that the use of health services was based on patients’

general practitioners self-report, so the reliability and validity is uncertain. In addition, as an

alternative to hospital-based program, the cost-effectiveness of the home-based program should

be compared with that of a hospital-based program.

Non-disease-specific Programs

Three RCTs provided self-management programs to general chronically ill patients were

identified to include economic evaluation.73-75 One intervention setting was within healthcare

organization,74 another was community-based,75 and the other was collaboration between

primary care providers and community center.73 The latter two showed significant reductions in

hospital use (including number of hospitalized patients, number of hospitalizations, and inpatient

hospital days). From a societal perspective, such reduced hospital use may result in the two

CDSM programs being cost-saving interventions (i.e., the savings in hospital utilization offsets

111
the cost to provide interventions). Nevertheless, rigorous cost-benefit or cost-effectiveness

analyses were not done.

The primary care-based intervention, called “Chronic Care Clinics” for frail older adults,

did not find significant differences in healthcare costs or utilization between intervention and

control groups.74 Besides methodological reasons to explain these findings, the authors attributed

these results to a hindrance in implementation of this intervention due to major changes in the

delivery system under study. These changes resulted in a lack of continuity and support of

clinical and administrative staff and thus undoubtedly influenced the ability of the study to

demonstrate more positive effects on patient outcomes and utilizations.

A geriatric nurse-led “care manager” model that involved collaboration between primary

care providers and a community center reported beneficial reductions in hospital use, and should

be further examined.73 The utilization differences were of borderline statistical significance (see

Appendix evidence table). The study did not report beneficial findings on two outcome measures

– physical performance and overall health profile (as measured by SF-36). Additional studies

seeking to replicate or explain these findings are warranted.

The other program, the community-based Chronic Disease Self-Management Program

(CDSMP), was an extensive educational course with skills training, feedback, and group support.

It was designed for people who had lung disease, heart disease, stroke, arthritis, or diabetes. The

program approach did not differ by disease type. This program reported decreases in healthcare

utilization in the randomized clinical trial,75 and in two additional observational studies. One

study used a before-after cohort design,76 and the other study was a longitudinal design intended

to follow-up patients enrolled in the randomized trial.77 According to the authors, all three

studies were likely to be cost-saving from a societal perspective. However, this conclusion is

112
tempered as none of the studies performed a rigorous cost-benefit analysis. In addition, the

studies differed in what aspect of utilization was reduced. The randomized clinical trial75

significantly decreased the number of hospitalizations and length of hospital stays. The before-

after cohort study found the study participants had fewer visits to the emergency department.76

The longitudinal study reported a reduction in combined ER/outpatient visits.77 Compared to the

other two RCTs,73, 74 the CDSMP was provided to younger populations. The mean age of the

study participants was about 65 years old, while the mean age was about 77 years old in the other

two RCTs.

Critiques and Conclusions

These reviewed interventions from clinical trials represent only a subset of possible

strategies for CDSM. This economic review has limited generalizability beyond the studied

interventions. Critiques about the economic aspect of CDSM literature include:

1. Costs of the intervention are rarely reported and, when reported, was sometimes not

rigorously performed (e.g., by author’s best approximation; perspective of costing

was inconsistent; time costs to patients and providers were not fully accounted);

2. Health care costs as an outcome of the intervention were rarely studied;

3. Changes in health care utilization were seldom studied, and in many cases only

studied on a limited scale (not including all types of services);

4. The follow-up period is short, while many outcomes will not be evident for many

years (e.g., rigid metabolic control may result in a delay or prevention of diabetic

complications, but only after several years).

113
 Among the four diseases reviewed, the programs to promote self-management with

osteoarthritis patients have the best economic information and are most consistently reporting

reductions in health care utilization and costs, even to the point of cost-savings. Such findings

are compatible with observational studies.14-16 Programs for diabetic patients have mixed results,

and overall are weaker in the economic information they report. There is only one hypertension

program identified that include any economic information, and the information provided does

not allow us to adequately judge cost-effectiveness of the program. The two reviewed MI studies

both lacked a rigorous collection of economic data, but the limited evidence presented suggests

that home-based rehabilitation programs could potentially be a cost-effective alternative to group

rehabilitation or standard care. As for the three general, non-disease-specific programs, two

RCTs and two observational studies reported that low-cost, community-based CDSM programs

may potentially be cost-saving.

Question 14. Delivery mechanism: What do we know about whom (which

provider type? trained lay person?) should deliver this service? Do we know

which care settings have proven effective (e.g., physician’s office, senior center,

other community or clinical settings)?

Successful CDSM programs have been delivered by both medically-trained providers and

by training lay people, and have been performed in (list the settings that have positive studies).

However, we were unable to find evidence to support generalizing the finding of these individual

studies to policy.

114
LIMITATIONS
Despite finding evidence that CDSM programs have a clinically and statistically

significant beneficial effect on some outcomes, we were unable to discern which elements of

CDSM programs are most associated with success. This may have been because we did not test

the right hypotheses regarding CDSM elements, or because key variables describing these

components were either not recorded adequately or not recorded at all in the published articles,

or that the individual components themselves each have relatively weak effects. We considered

contacting original authors for additional information regarding their interventions, but rejected

this due to time and resource constraints. Furthermore, our experience has been that any study

published more than a few years ago has a much lower likelihood for getting a favorable

response to such a request, and 524 of our studies were published more than 10 years ago. In

addition, we may have lacked the statistical power, due to the small number of studies available,

to discern the reasons for the relatively small amount of heterogeneity in the study results. We

note that the preceding challenges are common to all studies of complex, multicomponent

interventions, and these challenges did not prevent us from detecting important differences in the

effectiveness of interventions for prevention of falls17 or increasing the use of cancer screening

and immunizations.18

An additional primary limitation of this systematic review, common to all such reviews,

is the quantity and quality of the original studies. We made no attempt to give greater

importance to some studies based on "quality." The only validated assessment of study quality

includes criteria not possible in self-management (double-blinding). As there is a lack of

empirical evidence regarding other study characteristics and their relationship to bias, we did not

attempt to use other criteria.

115
 As previously discussed, we did find evidence of publication bias in hemoglobin A1c,

mortality, and systolic and diastolic blood pressure outcomes in diabetes, post-myocardial

infarction care, and hypertension, respectively. Therefore, the beneficial results that we report in

our pooled analysis need to be considered in light of the possible existence of unpublished

studies reporting no benefit.

116
CONCLUSIONS
6. Chronic disease self-management programs probably have a beneficial effect on some, but

not all, physiologic outcomes. In particular, we found evidence of a statistically significant

and clinically important benefit on measures of blood glucose control and blood pressure

reduction for chronic disease self management programs for patients with diabetes and

hypertension, respectively. Our conclusions are tempered by our finding of possible

publication bias, favoring beneficial studies, in these two clinical areas. These was no

evidence of a beneficial effect on other physiologic outcomes such as pain, function, weight

loss, and return to work.

7. There is not enough evidence to support any of the proposed elements as being essential to

the efficacy of chronic disease self-management programs. More research is needed to try

and establish the optimum design of a chronic disease self-management program, and

whether or not this differs substantially depending on the particular chronic disease or

characteristics of the patient.

8. While no randomized studies of chronic disease self-management programs for older adults

assessed the use of email or the Internet, one recently reported randomized study of email use

in the self-management of middle aged adults with back pain was sufficiently promising to

warrant testing such interventions for chronic disease self-management in the Medicare

population.

9. There is no evidence to conclusively support or refute the role of physician providers in

chronic disease self-management programs for older adults.

117
10. The evidence is inconclusive but suggests that chronic disease self-management programs

may reduce health care use.

118
RECOMMENDATIONS
1. There is sufficient evidence to warrant a policy initiative promoting chronic disease self-

management programs for older adults.

2. However, before implementing such a policy, additional work is needed to optimally define

the essential elements of such programs, and whether they vary by condition or patient

characteristic.

119
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APPENDIX A. EXPERT PANELIST

Terry L. Bazzarre, PhD Albert Martin, MD

The Robert Wood Johnson Foundation Consultant

Linda A. Bergthold, PhD Robin Mockenhaupt, PhD

Health Care Consultant and Researcher The Robert Wood Johnson Foundation

Noreen Clark, PhD C. Tracy Orleans, PhD

University of Michigan School of Public
Health
James Cooper, MD
George Washington University
Medical Center, Geriatrics Division
Fran Ferrara
The Robert Wood Johnson Foundation
Russell E. Glasgow, PhD
AMC Caner Research Center
Catherine Gordon, RN, MBA
Center for Medicare and Medicaid Services
The Robert Wood Johnson Foundation
Suzanne Smith, MD
National Center for Chronic Disease
Prevention and Health Promotion
Paul Tarini
The Robert Wood Johnson Foundation
Sara Their, MPH
The Robert Wood Johnson Foundation
Michael VonKorff, Sc.D
Center for Health Care Studies,
Group Health Cooperative of Puget Sound

Jessie Gruman, PhD Ed Wagner, MD, MPH

Center for the Advancement of Health McCall Institute for Healthcare Innovations
Group Health Cooperative of Puget Sound
Kate Lorig, RN, DrPH
Stanford University

155
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Evidence Table 1: Diabetes
Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Allen BT, 1990 Diabetes (Type II) 1 Dietary monitoring (Office visit) Tailored: Yes Excluded from meta-analysis as no usual care
(#2201) Education (Office visit) Group Setting: No or comparable control group.
RCT Education (One-on-one) Feedback: Yes
Education (Reading material) Psychological: No Patients who self monitored diabetes using
Jadad Score: 3 Exercise diary (Office visit) Primary MD: n/a urine testing (arm 1) had similar statistically
Feedback (Office visit) significant reductions in fasting blood glucose,
Diagnostic criteria: Practice methods (Protocols) glycosylated hemoglobin, and weight as did
FBS patients utilizing serum glucose testing (arm 2).
n Entered: n/a No appreciable differences between groups
Comorbidities: n Analyzed: 27 were noted.
Obesity and
cholesterol 2 Dietary monitoring (Office visit) Tailored: Yes Follow-up times: 1 MO, 2 MO, 3 MO, 4 MO, 5
Education (Office visit) Group Setting: No MO, 6 MO
Education (One-on-one) Feedback: Yes
Education (Reading material) Psychological: No
Exercise diary (Office visit) Primary MD: n/a
Feedback (Office visit)
Practice methods (Protocols)

n Entered: n/a
n Analyzed: 27

Anderson R M, 1995 Diabetes (n/a) 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#747) Group Setting: n/a randomized.
CCT n Entered: n/a Feedback: n/a
n Analyzed: 23 Psychological: n/a Patients receiving a patient empowerment
Jadad Score: 0 Primary MD: n/a education program (arm 2) had reductions in
glycosylated hemoglobin that were greater than
Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes controls and were statistically significant
n/a Education (Video/audio tapes) Group Setting: Yes (p=0.05). Intervention subjects also improved in
Feedback (Group meeting) Feedback: Yes all self-efficacy sub-scales, which were
Comorbidities: Psychological: No sustained at 12-week follow-up.
n/a n Entered: n/a Primary MD: n/a
n Analyzed: 22 Follow-up times: 6 WK, 12 WK

N/A = Not Available or Not Applicable

NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.

186
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Anon, DICET, 1994 Diabetes 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2614) (Types I and II) Reminders (Mail) Group Setting: n/a or comparable control group.
Feedback: n/a
RCT n Entered: 135 Psychological: n/a Patients randomized to intervention (arm 2) had
n Analyzed: 111 Primary MD: n/a a greater number of MD evaluations but no
Jadad Score: 2 difference in diabetes related hospitalizations
compared with controls (arm 1). BMI trends
Diagnostic criteria: 2 Practice methods (Reading material) Tailored: Yes were higher in intervention patients compared
Reminders (Computer program) Group Setting: No
n/a with controls, but there were no treatment
Reminders (Mail) Feedback: Yes differences in glycosylated hemoglobin, systolic
Comorbidities: Psychological: No or diastolic blood pressure. There were also no
Hypertension, n Entered: 139 Primary MD: n/a significant differences in diabetes knowledge,
neuropathy, and n Analyzed: 124 anxiety, depression, satisfaction with treatment
cholesterol or self reported well-being.

Follow-up times: 2 YR
Arseneau D L, 1994 Diabetes (Type II) 1 Education (Group meeting) Tailored: No Excluded from meta-analysis as no usual care
(#749) Education (Instructional manuals) Group Setting: Yes or comparable control group.
RCT Feedback: No
n Entered: 20 Psychological: No Though knowledge and% ideal body weight
Jadad Score: 1 n Analyzed: n/a Primary MD: n/a significantly improved for Learning Activity
Packages (arm 1) at 5 months and HgbA1c and
Diagnostic criteria: 2 Education (Group meeting) Tailored: No behavior improved for diabetes class arm, only
n/a Education (Office visit) Group Setting: Yes knowledge scores were significantly higher at 5
Feedback: No months for the LAP arm.
Comorbidities: n Entered: 20 Psychological: No
n/a n Analyzed: n/a Primary MD: n/a Follow-up times: 2 MO, 5 MO

187
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Aubert RE, 1998 Diabetes 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2581) (Types I and II) Advocacy training (One-on-one) Group Setting: n/a or comparable control group.
Counseling/therapy (One-on-one) Feedback: n/a
RCT Education (Group meeting) Psychological: n/a Intervention subjects (arm 2) had greater
Follow up (One-on-one) Primary MD: n/a decreases in HbA1c levels than those receiving
Jadad Score: 1 usual care (arm 1) (1.7% versus 0.6% p<0.01).
n Entered: 67 Fasting serum glucose was lower in intervention
Diagnostic criteria: n Analyzed: n/a subjects by a mean of 48 mg/dl versus 15 mg/dl
MD (p=0.003). Self-rated health also improved in
2 Advocacy training (One-on-one) Tailored: Yes the intervention group (p=0.02).
Comorbidities: Consultation w/specialists (Protocols) Group Setting: Yes
Obesity, DM, Counseling/therapy (One-on-one) Feedback: Yes Follow-up times: 6 MO, 12 MO
tobacco abuse, and Counseling/therapy (Telephone) Psychological: Yes
cholesterol Education (Group meeting) Primary MD: n/a
Education (One-on-one)
Follow up (One-on-one)

n Entered: 71
n Analyzed: n/a

Bethea DC, 1989 Diabetes 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2105) (Types I and II) Education (One-on-one) Group Setting: n/a randomized.
Education (Reading material) Feedback: n/a
CCT Psychological: n/a Use of videotape instruction (arm 2) resulted in
n Entered: 12 Primary MD: n/a similar diabetes knowledge levels compared
Jadad Score: 0 n Analyzed: 12 with conventional instruction in hospitalized
patients (arm 1).
Diagnostic criteria:
2 Education (One-on-one) Tailored: Yes
n/a Education (Reading material) Group Setting: No Follow-up times: 45 MI
Education (Video/audio tapes) Feedback: No
Comorbidities:
Psychological: No
n/a
n Entered: 12 Primary MD: n/a
n Analyzed: 12

188
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Bloomgarden ZT, Diabetes 1 Usual Care (n/a) Tailored: n/a Follow-up time not in 3 - 12 months.
1987 (Types I and II) Group Setting: n/a
(#2172) n Entered: 180 Feedback: n/a Though subjects randomized to an education
RCT n Analyzed: 139 Psychological: n/a intervention (arm 2) demonstrated increased
Primary MD: n/a knowledge compared with usual care group
Jadad Score: 2 (arm 1) (p=0.007) and had significant reductions
2 Education (Group meeting) Tailored: Yes in HbA1c and fasting blood glucose, these
Diagnostic criteria: Education (Other mechanisms) Group Setting: Yes reductions in biochemical markers were not
n/a Education (Video/audio tapes) Feedback: No significantly greater than in the usual care
Psychological: No group. There were also no changes in
Comorbidities: n Entered: 165 Primary MD: No cholesterol, blood pressure, or foot lesions and
Heart disease, n Analyzed: 127 health service utilization was unaffected.
hypertension, kidney
disease, tobacco Follow-up times: 18 MO
abuse, cholesterol
and retinopathy

189
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Boehm S, 1993 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#754) Group Setting: n/a
RCT n Entered: 41 Feedback: n/a Behavioral strategy interventions (arms 2, 3 and
n Analyzed: 41 Psychological: n/a 4) resulted in no differences in glycosylated
Jadad Score: 1 Primary MD: n/a hemoglobin and weight loss between
intervention and control groups.
Diagnostic criteria: 2 Cognitive-behavioral (Office visit) Tailored: Yes
n/a Contracts (Office visit) Group Setting: No Follow-up times: n/a
Material incentive (Other mechanisms) Feedback: Yes
Comorbidities: Psychological: Yes
n/a n Entered: 32 Primary MD: No
n Analyzed: 32
3 Cognitive-behavioral (Office visit) Tailored: Yes
Contracts (Office visit) Group Setting: No
Feedback (Office visit) Feedback: Yes
Material incentive (Other mechanisms) Psychological: Yes
Primary MD: No
n Entered: 42
n Analyzed: 42

4 Cognitive-behavioral (Office visit) Tailored: Yes

Contracts (Office visit) Group Setting: Yes
Education (Group meeting) Feedback: Yes
Education (Instructional manuals) Psychological: Yes
Feedback (Office visit) Primary MD: No
Material incentive (Other mechanisms)

n Entered: 41
n Analyzed: 41

190
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Campbell EM, 1996 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2586) Education (One-on-one) Group Setting: n/a
RCT Feedback: n/a Control (arm 1) were more likely to have an
n Entered: 59 Psychological: n/a increase in intensity of diabetes treatment at 6-
Jadad Score: 1 n Analyzed: 59 Primary MD: n/a month follow-up (p=0.04) than intervention
subjects (arms 2, 3, and 4). Behavior program
2 Education (Group meeting) Tailored: Yes
Diagnostic criteria: (arm 4) and group education (arm 2) patients
Education (One-on-one) Group Setting: Yes
n/a had greater improvement in knowledge scores
Feedback: No
at 6-month follow-up, but differences were not
n Entered: 66 Psychological: No
Comorbidities: sustained at 12 months. Greater reductions in
n Analyzed: 38 Primary MD: No
Hypertension and diastolic blood pressure were seen for those
tobacco abuse attending behavioral interventions (p=0.02). No
3 Education (Group meeting) Tailored: Yes
difference in change between groups occurred
Education (One-on-one) Group Setting: Yes
for HbA1c, BMI, total cholesterol, or systolic
Feedback: No
blood pressure.
n Entered: 57 Psychological: No
n Analyzed: 34 Primary MD: No
Follow-up times: 3 MO, 6 MO, 12 MO
4 Cognitive-behavioral (Home visit) Tailored: Yes
Cognitive-behavioral (One-on-one) Group Setting: No
Cognitive-behavioral (Telephone) Feedback: Yes
Contracts (One-on-one) Psychological: Yes
Education (One-on-one) Primary MD: No
Feedback (One-on-one)
Social support (n/a)

n Entered: 56
n Analyzed: 51

191
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
D'Eramo-Melkus GA, Diabetes (Type II) 1 Control (n/a) Tailored: n/a Fasting blood glucose (mM) at 6 months:
1992 Education (n/a) Group Setting: n/a Arm 1 = 12.2 (5.5)
(#2202) RCT Feedback: n/a Arm 2 = 9.5 (3.6)
n Entered: 28 Psychological: n/a Arm 3 = 9.0 (3.0)
Jadad Score: 2 n Analyzed: 19 Primary MD: n/a
HbA1 (%) at 6 months:
Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes Arm 1 = 10.5 (3.2)
HgbA1C and GTT Education (One-on-one) Group Setting: Yes Arm 2 = 9.2 (3.3)
Education (n/a) Feedback: Yes Arm 3 = 8.3 (2.7)
Comorbidities: Goal setting (Group meeting) Psychological: No
Obesity Primary MD: No Weight (lbs) at 6 months:
n Entered: 28 Arm 1 = 205.1 (25.6)
n Analyzed: 19 Arm 2 = 200.7 (30.4)
Arm 3 = 191.8 (31.7)
3 Counseling/therapy (One-on-one) Tailored: Yes
Education (Group meeting) Group Setting: Yes Follow-up times: 3 MO, 6 MO
Education (One-on-one) Feedback: Yes
Education (n/a) Psychological: Yes
Goal setting (Group meeting) Primary MD: No

n Entered: 26
n Analyzed: 19

de Bont AJ, 1981 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2210) Counseling/therapy (Home visit) Group Setting: n/a or comparable control group.
RCT Counseling/therapy (n/a) Feedback: n/a
Psychological: n/a Patients in both intervention group (arm 2) and
Jadad Score: 2 n Entered: n/a Primary MD: n/a control group (arm 1) lost weight. Though
n Analyzed: 65 cholesterol levels fell significantly in the low fat
Diagnostic criteria: group (arm 2) (p<0.001), mean plasma glucose
n/a 2 Counseling/therapy (Home visit) Tailored: Yes and HbA1c remained unchanged.
Counseling/therapy (n/a) Group Setting: No
Comorbidities: Feedback: No Follow-up times: 6 MO
Obesity and tobacco n Entered: n/a Psychological: Yes
abuse n Analyzed: 65 Primary MD: n/a

192
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Emori KH, 1964 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Follow-up time not in 3 - 12 months.
(#2118) Group Setting: n/a
RCT n Entered: 13 Feedback: n/a Intervention subjects (arm 2) had greater
n Analyzed: 13 Psychological: n/a knowledge (p<0.005) and lower glycosylated
Jadad Score: 2 Primary MD: n/a levels (10.4% versus 11.8%, p<0.05) than usual
care group (arm 1) did at 4-6 weeks after the
Diagnostic criteria: 2 Education (One-on-one) Tailored: Yes program concluded. Change in body weight was
MD Education (Reading material) Group Setting: No not different between groups.
Education (Video/audio tapes) Feedback: No
Comorbidities: Psychological: No Follow-up times: 5 DY, 4 WK
Obesity n Entered: 13 Primary MD: No
n Analyzed: 13

Falkenberg MG, 1986 Diabetes (Type II) 1 Control (n/a) Tailored: n/a HbA1 (%) at 6 months:
(#2190) Education (Group meeting) Group Setting: n/a Arm 1 = 8.1 (1.0)
RCT Feedback: n/a Arm 2 = 7.2 (0.9)
n Entered: 18 Psychological: n/a
Jadad Score: 2 n Analyzed: 22 Primary MD: n/a Follow-up times: 3 MO, 9 MO

Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes

n/a Education (Instructional manuals) Group Setting: Yes
Feedback: No
Comorbidities: n Entered: 27 Psychological: No
Obesity n Analyzed: 22 Primary MD: No

193
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Frost G, 1994 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Fasting blood glucose (mmol/L) at 12 weeks:
(#791) Group Setting: n/a Arm 1 = 9.8 (3.1)
RCT n Entered: 30 Feedback: n/a Arm 2 = 9.6 (3.0)
n Analyzed: 25 Psychological: n/a
Jadad Score: 3 Primary MD: n/a Weight (kg) at 12 weeks:
Arm 1 = 82.9 (14.8)
Diagnostic criteria: 2 Counseling/therapy (Instructional Tailored: Yes Arm 2 = 84.8 (23.5)
n/a manuals) Group Setting: No
Counseling/therapy (Reading material) Feedback: No Follow-up times: 4 WK, 12 WK
Comorbidities: Dietary monitoring (Instructional manuals) Psychological: Yes
n/a Dietary monitoring (Office visit) Primary MD: No

n Entered: 30
n Analyzed: 25

Glasgow RE/Toobert Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
DJ, 1989 Group Setting: n/a
(#2209) RCT n Entered: 22 Feedback: n/a Individuals participating in 2 nutrition groups
n Analyzed: 18 Psychological: n/a (arms 2 and 3) demonstrated decreased caloric
Jadad Score: 1 Primary MD: n/a intake compared with usual care group (arm 1).
The addition of a social learning program (arm
Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes 3) had a significant decrease in weight at 2-
HgbA1C and MD Group Setting: Yes month follow-up. Intervention conditions
n Entered: 20 Feedback: No produced a marginal improvement in fasting
Comorbidities: n Analyzed: 20 Psychological: No blood glucose (p<0.08).
n/a Primary MD: No
Follow-up times: 2 MO, 2 MO
3 Dietary monitoring (Group meeting) Tailored: Yes
Education (Group meeting) Group Setting: Yes
Feedback: No
n Entered: 23 Psychological: No
n Analyzed: 23 Primary MD: No

194
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Glasgow RE, 1992 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Glycosolated hemoglobin (%) at 6 months:
(#2212) Group Setting: n/a Arm 1 = 6.4 (1.4)
RCT n Entered: 50 Feedback: n/a Arm 2 = 6.7 (1.7)
n Analyzed: 52 Psychological: n/a
Jadad Score: 1 Primary MD: n/a Weight (lbs) at 6 months:
Arm 1 = 181.0 (34.7)
Diagnostic criteria: 2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 186.1 (32.6)
Welborn Education (Group meeting) Group Setting: Yes
Exercise program (Group meeting) Feedback: No Follow-up times: 10 WK
Comorbidities: Psychological: Yes
Heart disease and n Entered: 52 Primary MD: No
arthritis n Analyzed: 52

Glasgow R E, 1996 Diabetes 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#799) (Types I and II) Group Setting: n/a
n Entered: n/a Feedback: n/a Patients who received a brief intervention (arm
RCT n Analyzed: n/a Psychological: n/a 2) had no improvement in HbA1C at 3-month
Primary MD: n/a follow-up when compared with usual care group
Jadad Score: 2 (arm 1). However serum cholesterol was
2 Clinical reviews w/patient (Telephone) Tailored: Yes significantly lower (p<0.001) in the intervention
Diagnostic criteria: Consultation w/specialists (Office visit) Group Setting: No group as were 4 dietary behavioral measures.
MD Education (Reading material) Feedback: Yes Though patient satisfaction was improved,
Education (Video/audio tapes) Psychological: No quality of life was not.
Comorbidities: Feedback (Computer program) Primary MD: Yes
n/a Reminders (Telephone) Follow-up times: 3 MO

n Entered: n/a
n Analyzed: n/a

195
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Greenfield S, 1988 Diabetes (n/a) 1 Control (n/a) Tailored: n/a HbA (%) at 12 weeks:
(#803) Clinical reviews w/patient (One-on-one) Group Setting: n/a Arm 1 = 10.6 (2.2)
RCT Education (Office visit) Feedback: n/a Arm 2 = 9.1 (1.9)
Education (Reading material) Psychological: n/a
Jadad Score: 1 Primary MD: n/a Follow-up times: 12 WK
n Entered: 34
Diagnostic criteria: n Analyzed: 33
n/a
2 Advocacy training (Office visit) Tailored: Yes
Comorbidities: Clinical reviews w/patient (Office visit) Group Setting: No
n/a Education (Reading material) Feedback: Yes
Psychological: Yes
n Entered: 39 Primary MD: No
n Analyzed: 33

196
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Hanefield M, 1991 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2595) Counseling/therapy (Office visit) Group Setting: n/a or comparable control group.
RCT Reminders (Office visit) Feedback: n/a
Psychological: n/a Intervention subjects (arms 2 and 3) reported
Jadad Score: 2 n Entered: 378 Primary MD: n/a greater physical activity than controls (arm 1) at
n Analyzed: 346 5-year follow-up (p<0.01). Intervention subjects
Diagnostic criteria: also had better control of glucose and lower
FBS and GTT systolic blood pressure (143 versus 154 mmHg,
p<0.01) and required fewer antidiabetic drugs.
Comorbidities: Though no differences between groups were
Hypertension, noted for myocardial infarction incidence,
obesity, tobacco cumulative incidence mortality rates suggested
abuse, and a benefit from intervention.
hyperlipoproteinemia
2 Clinical reviews w/patient (One-on-one) Tailored: Yes
Follow-up times: 2 YR, 5 YR
Counseling/therapy (Office visit) Group Setting: Yes
Education (Group meeting) Feedback: Yes
Education (Reading material) Psychological: Yes
Placebo medication (n/a) Primary MD: n/a
Reminders (Office visit)

n Entered: 382
n Analyzed: 328

3 Cholesterol lowering medication (n/a) Tailored: Yes

Clinical reviews w/patient (One-on-one) Group Setting: Yes
Counseling/therapy (Office visit) Feedback: Yes
Education (Group meeting) Psychological: Yes
Education (Reading material) Primary MD: n/a
Reminders (Office visit)

n Entered: 379
n Analyzed: 334

197
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Hassell J, 1975 Diabetes (n/a) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
(#2121) Education (One-on-one) Group Setting: n/a outcomes.
RCT Feedback: n/a
n Entered: 24 Psychological: n/a Classroom teaching methods (arm 2) resulted in
Jadad Score: 2 n Analyzed: 22 Primary MD: n/a greater diabetes knowledge compared with
traditional bedside teaching methods (arm 1)
Diagnostic criteria: 2 Education (Group meeting) Tailored: No (77% post-test scores compared with 56%).
n/a Group Setting: Yes
n Entered: 21 Feedback: No Follow-up times: n/a
Comorbidities: n Analyzed: 19 Psychological: No
n/a Primary MD: No
Hoskins PL, 1993 Diabetes 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2597) (Types I and II) Education (n/a) Group Setting: n/a or comparable control group.
Feedback: n/a
RCT n Entered: 65 Psychological: n/a Subjects who participated in a system of care
n Analyzed: 65 Primary MD: n/a shared between specialist and generalist (arm
Jadad Score: 1 2) had significantly greater visit compliance than
2 Education (n/a) Tailored: Yes those with generalists alone (arm 3) (72%
Diagnostic criteria: Practice methods (Protocols) Group Setting: No versus 35%, p<0.04). HbA1c improved
MD Reminders (n/a) Feedback: Yes significantly in all 3 groups but no differences
(Care provided by specialists and Psychological: No between groups were noted. Nor were there
Comorbidities: generalists) Primary MD: n/a blood pressure differences between groups and
Hypertension and weight decreased marginally in all 3 groups
obesity n Entered: 69 though this was statistically significant only in
n Analyzed: 69 the shared care group (arm 2) (p<0.04).

3 Education (n/a) Tailored: Yes Follow-up times: 1 YR

Practice methods (Protocols) Group Setting: No
(Care provided by generalists alone) Feedback: No
Psychological: No
n Entered: 72 Primary MD: n/a
n Analyzed: 72

198
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Jaber LA, 1996 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Fasting blood glucose (mmol/L) at 4 months:
(#2598) Group Setting: n/a Arm 1 = 11.0 (3.9)
RCT n Entered: 22 Feedback: n/a Arm 2 = 8.5 (2.3)
n Analyzed: 17 Psychological: n/a
Jadad Score: 2 Primary MD: n/a Glycated hemoglobin (%) at 4 months:
Arm 1 = 12.1 (3.7)
Diagnostic criteria: 2 Consultation w/specialists (One-on-one) Tailored: Yes Arm 2 = 9.2 (2.1)
n/a Counseling/therapy (One-on-one) Group Setting: No
Education (One-on-one) Feedback: Yes Follow-up times: 4 MO
Comorbidities: Education (Reading material) Psychological: Yes
Hypertension, Feedback (One-on-one) Primary MD: No
obesity, and
hyperlipedemia n Entered: 23
n Analyzed: 17

Jennings PE, 1987 Diabetes (Type I) 1 Usual Care (n/a) Tailored: n/a HbA1 level (%) at 12 months:
(#2126) Group Setting: n/a Arm 1 = 10.9 (2.3)
RCT n Entered: 30 Feedback: n/a Arm 2 = 9.9 (2.3)
n Analyzed: 30 Psychological: n/a
Jadad Score: 1 Primary MD: n/a Follow-up times: 6 MO, 12 MO
2 Patient directed discussion group (Group Tailored: Yes
Diagnostic criteria: meeting) Group Setting: Yes
n/a Feedback: No
n Entered: 30 Psychological: No
Comorbidities: n Analyzed: 30 Primary MD: No
n/a

199
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Kaplan, 1985 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2817) Education (Group meeting) Group Setting: n/a
RCT Feedback: n/a Those participating in the diet intervention (arm
n Entered: n/a Psychological: n/a 2) lost more weight than the other 3 groups
Jadad Score: 1 n Analyzed: 15 Primary MD: n/a (arms 1, 3, and 4) (p<0.05). HDL cholesterol
was also significantly higher in this group
Diagnostic criteria: 2 Cognitive-behavioral (Group meeting) Tailored: Yes (p<0.01). No differences in glycosylated
FBS and MD Dietary monitoring (Self-delivery) Group Setting: Yes hemoglobin between groups were noted.
Education (Group meeting) Feedback: No
Comorbidities: Psychological: Yes Follow-up times: 3 MO
Obesity n Entered: n/a Primary MD: No
n Analyzed: 16

3 Cognitive-behavioral (Group meeting) Tailored: Yes

Contracts (Group meeting) Group Setting: Yes
Exercise diary (Self-delivery) Feedback: Yes
Exercise program (Group meeting) Psychological: Yes
Primary MD: No
n Entered: n/a
n Analyzed: 18

4 Cognitive-behavioral (Group meeting) Tailored: Yes

Contracts (Group meeting) Group Setting: Yes
Dietary monitoring (Self-delivery) Feedback: Yes
Education (Group meeting) Psychological: Yes
Exercise diary (Self-delivery) Primary MD: No
Exercise program (Group meeting)

n Entered: .
n Analyzed: 16

200
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Kaplan RM, 1987 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2175) Education (Group meeting) Group Setting: n/a
RCT Education (n/a) Feedback: n/a At 18-months follow-up diabetic patients
Financial incentives (Group meeting) Psychological: n/a receiving behavioral interventions in a combined
Jadad Score: 2 Primary MD: n/a diet and exercise program (arms 2, 3, and 4)
n Entered: n/a achieved greater reductions in glycosylated
Diagnostic criteria: n Analyzed: n/a hemoglobin than those receiving only diet,
FBS and MD exercise, or control interventions (arm 1)
2 Cognitive-behavioral (Group meeting) Tailored: Yes (p<0.05). Changes between other interventions
Comorbidities: Dietary monitoring (Other mechanisms) Group Setting: Yes were not significant. Improvements in quality of
Obesity Education (n/a) Feedback: Yes life measures were also greatest in the
Exercise program (Group meeting) Psychological: Yes combined group (arm 2) (p<0.05).
Feedback (Group meeting) Primary MD: No
Financial incentives (Group meeting) Follow-up times: 3 MO, 6 MO, 12 MO, 18 MO

n Entered: n/a
n Analyzed: n/a

3 Cognitive-behavioral (Group meeting) Tailored: Yes

Contracts (Group meeting) Group Setting: Yes
Education (Group meeting) Feedback: Yes
Exercise program (Group meeting) Psychological: Yes
Feedback (Group meeting) Primary MD: No
Financial incentives (Group meeting)

n Entered: n/a
n Analyzed: n/a

201
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
4 Cognitive-behavioral (Group meeting) Tailored: Yes
Dietary monitoring (Group meeting) Group Setting: Yes
Education (n/a) Feedback: Yes
Exercise program (Group meeting) Psychological: Yes
Financial incentives (Group meeting) Primary MD: No

n Entered: n/a
n Analyzed: n/a

Kendall PA, 1990 Diabetes (Type II) 1 Education (Group meeting) Tailored: Yes Excluded from meta-analysis as no usual care
(#2207) Education (Instructional manuals) Group Setting: Yes or comparable control group.
RCT Education (Video/audio tapes) Feedback: No
Psychological: No Both diet guide (arm 1) and exchange lists
Jadad Score: 1 n Entered: n/a Primary MD: n/a treatment group (arm 2) demonstrated
n Analyzed: 41 significantly higher levels of self-efficacy
Diagnostic criteria: compared with their pre-workshop scores
n/a 2 Education (Group meeting) Tailored: Yes (p<0.05). Knowledge scores were also
Education (Reading material) Group Setting: Yes significantly higher in both groups (p<0.01).
Comorbidities: Education (Video/audio tapes) Feedback: No Applied nutrition knowledge scores were
n/a Psychological: No however greater for the diet guide group
n Entered: n/a Primary MD: n/a (p<0.01).
n Analyzed: 42
Follow-up times: 3 MO, 6 MO
Kinmonth AL, 1998 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2599) Education (Group meeting) Group Setting: n/a or comparable control group.
RCT Feedback: n/a
n Entered: 161 Psychological: n/a The intervention group (arm 2) reported better
Jadad Score: 1 n Analyzed: 108 Primary MD: n/a communication with doctors, greater treatment
satisfaction and sense of well-being. BMI and

202
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Diagnostic criteria: 2 Advocacy training (Reading material) Tailored: Yes triglyceride concentrations were, however, lower
MD Education (Group meeting) Group Setting: Yes in the intervention group (arm 2) then in the
Education (Instructional manuals) Feedback: No control group (arm 1).
Comorbidities: Practice methods (Group meeting) Psychological: Yes
Heart disease, Primary MD: n/a Follow-up times: 1 YR
hypertension, n Entered: 199
obesity, and tobacco n Analyzed: 142
abuse
Korhonen T, 1983 Diabetes (n/a) 1 Control (n/a) Tailored: n/a Fasting blood glucose (mmol/L) at 6 months:
(#2259) Clinical reviews w/patient (Office visit) Group Setting: n/a Arm 1 = 7.9 (3.6)
RCT Education (One-on-one) Feedback: n/a Arm 2 = 8.3 (3.6)
Education (Reading material) Psychological: n/a
Jadad Score: 1 Primary MD: n/a Follow-up times: 1 MO, 3 MO, 6 MO, 9 MO, 12
n Entered: 38 MO, 15 MO, 18 MO
Diagnostic criteria: n Analyzed: 37
n/a
2 Clinical reviews w/patient (Office visit) Tailored: Yes
Comorbidities: Education (Group meeting) Group Setting: Yes
n/a Education (One-on-one) Feedback: Yes
Psychological: No
n Entered: 39 Primary MD: Yes
n Analyzed: 37

Kumana CR/Ma JT, Diabetes (n/a) 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
1988 Group Setting: n/a outcome.
(#2130) RCT n Entered: n/a Feedback: n/a
n Analyzed: 51 Psychological: n/a Of diabetic patients receiving drug information
Jadad Score: 1 Primary MD: n/a sheets (arm 2), those who recalled receipt had
the greatest improvement in follow-up test
Diagnostic criteria: 2 Education (Reading material) Tailored: No scores (4.53 to 6.16, p<0.001) but follow-up test
n/a Group Setting: No scores were significantly higher (p<0.001) in
n Entered: n/a Feedback: No both intervention group (arm 2) and usual care
Comorbidities: n Analyzed: 56 Psychological: No group (arm 1).
n/a Primary MD: No
Follow-up times: 2 MO

203
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Laitinen JH/Ahola Diabetes (Type II) 1 Control (n/a) Tailored: n/a Fasting blood glucose (mmol/L) at 3 months:
IE/Sarkkinen Counseling/therapy (Office visit) Group Setting: n/a Arm 1 = 7.5 (2.9)
ES/Winberg RL, 1993 RCT Education (Office visit) Feedback: n/a Arm 2 = 6.6 (1.9)
(#2176) Psychological: n/a
Jadad Score: 1 n Entered: 46 Primary MD: n/a Glycated hemoglobin A (%) at 3 months:
n Analyzed: 38 Arm 1 = 7.8 (2.0)
Diagnostic criteria: Arm 2 = 7.1 (1.8)
FBS and WHO 2 Goal setting (Group meeting) Tailored: Yes
Group Setting: Yes Weight (kg) at 3 months:
Comorbidities: n Entered: 40 Feedback: Yes Arm 1 = 88.8 (14.0)
Heart disease, n Analyzed: 38 Psychological: Yes Arm 2 = 88.3 (14.1)
hypertension, Primary MD: No
obesity, CHF, and Follow-up times: 3 MO, 15 MO
stroke

204
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Litzelman D K, 1993 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#828) Group Setting: n/a
RCT n Entered: 205 Feedback: n/a Foot care education, behavioral contracts, and
n Analyzed: n/a Psychological: n/a reinforcement (arm 2) resulted in 0.41 times
Jadad Score: 2 Primary MD: n/a fewer serious foot lesions and more appropriate
foot care behavior (p=0.0001). Intervention
Diagnostic criteria: 2 Counseling/therapy (Office visit) Tailored: Yes subjects (arm 2) were also more likely to have
FBS, HgbA1C, and Dietary monitoring (Group meeting) Group Setting: No foot examinations than were those in the usual
NDDG Dietary monitoring (Self-delivery) Feedback: Yes care group (arm 1) (68% vs. 28%, p<0.001).
Education (Group meeting) Psychological: No
Comorbidities: Education (Office visit) Primary MD: No Follow-up times: 12 MO
n/a Clinical reviews w/patient (Other
mechanisms)
Contracts (Reading material)
Education (Reading material)
Education (Video/audio tapes)
Practice methods (Other mechanisms)
Reminders (Mail)
Reminders (Other mechanisms)

n Entered: 191
n Analyzed: n/a

205
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
McCulloch DK, 1983 Diabetes (Type I) 1 Control (n/a) Tailored: n/a BMI (kg/m2) at 6 months:
(#2264) Education (One-on-one) Group Setting: n/a Arm 1 = 23.9 (2.3)
RCT Education (Reading material) Feedback: n/a Arm 2 = 23.7 (1.7)
Education (n/a) Psychological: n/a Arm 3 = 23.8 (2.0)
Jadad Score: 2 Feedback (n/a) Primary MD: n/a
HbA1 (%) at 6 months:
Diagnostic criteria: n Entered: 15 Arm 1 = 11.6 (0.9)
HgbA1C n Analyzed: 13 Arm 2 = 10.6 (2.1)
Arm 3 = 9.6 (2.3)
Comorbidities:
Obesity 2 Education (One-on-one) Tailored: Yes Follow-up times: 6 MO, 9 MO
Education (Reading material) Group Setting: Yes
Education (n/a) Feedback: Yes
Feedback (Group meeting) Psychological: No
Feedback (n/a) Primary MD: No
Practice self care skills (Group meeting)

n Entered: 14
n Analyzed: 13

3 Education (One-on-one) Tailored: Yes

Education (Reading material) Group Setting: No
Education (Video/audio tapes) Feedback: Yes
Education (n/a) Psychological: No
Feedback (n/a) Primary MD: No

n Entered: 15
n Analyzed: 13

206
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Mulrow C, 1987 Diabetes (Type II) 1 Education (Group meeting) Tailored: Yes Excluded from meta-analysis as no usual care
(#2266) Education (Reading material) Group Setting: Yes or comparable control group.
RCT Education (Video/audio tapes) Feedback: Yes
Feedback (Group meeting) Psychological: No Patient education utilizing videotapes (arm 1)
Jadad Score: 2 Primary MD: n/a had significant weight loss at 7 months
n Entered: 40 compared to education without videotapes
Diagnostic criteria: n Analyzed: 34 (arms 2 and 3), but changes were not sustained
MD at 11 months. There were no significant
2 Education (Group meeting) Tailored: Yes changes in HbA1c.
Comorbidities: Feedback (Group meeting) Group Setting: Yes
Obesity Unstructured group time (Group meeting) Feedback: Yes Follow-up times: 7 MO, 11 MO
Psychological: No
n Entered: 40 Primary MD: n/a
n Analyzed: 35

3 Education (Group meeting) Tailored: No

Group Setting: Yes
n Entered: 40 Feedback: No
n Analyzed: 35 Psychological: No
Primary MD: n/a

207
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Pratt C, 1987 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Follow-up time not in 3 - 12 months.
(#2139) Group Setting: n/a
RCT n Entered: 28 Feedback: n/a No differences in weight or glycosylated
n Analyzed: n/a Psychological: n/a hemoglobin were noted between intervention
Jadad Score: 1 Primary MD: n/a groups (arms 2 and 3) and usual care group
(arm 1) at 8- or 16-week follow-up.
Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes
n/a Education (Reading material) Group Setting: Yes Follow-up times: 8 WK
Feedback: No
Comorbidities: n Entered: 19 Psychological: No
n/a n Analyzed: n/a Primary MD: No

3 Cognitive-behavioral (Group meeting) Tailored: Yes

Education (Group meeting) Group Setting: Yes
Education (Reading material) Feedback: Yes
Feedback (Group meeting) Psychological: Yes
Goal setting (Group meeting) Primary MD: No
Social support (Group meeting)

n Entered: 32
n Analyzed: n/a

208
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Rabkin SW, 1983 Diabetes (Type II) 1 Counseling/therapy (One-on-one) Tailored: Yes Excluded from meta-analysis as no usual care
(#2195) Dietary monitoring (One-on-one) Group Setting: No or comparable control group.
RCT Education (One-on-one) Feedback: No
Education (Reading material) Psychological: Yes Patients attending a behavior modification group
Jadad Score: 2 Primary MD: n/a (arm 2) had greater weight loss than those in
n Entered: 20 individual counseling (arm 1) at 12 weeks
Diagnostic criteria: n Analyzed: 18 follow-up (p<0.05) but had higher triglyceride
n/a levels (p<0.10). Fasting serum glucose was not
2 Cognitive-behavioral (Group meeting) Tailored: Yes appreciably different between groups.
Comorbidities: Dietary monitoring (Group meeting) Group Setting: Yes
Neuropathy and Education (Group meeting) Feedback: No Follow-up times: 6 WK, 12 WK
cholesterol and Psychological: Yes
retinopathy n Entered: 20 Primary MD: n/a
n Analyzed: 20

Rainwater N, 1982 Diabetes (Type II) 1 Counseling/therapy (Office visit) Tailored: Yes Excluded from meta-analysis as no usual care
(#2140) Education (Hospitalization) Group Setting: No or comparable control group.
RCT Feedback (Office visit) Feedback: Yes
Psychological: Yes Self-management participants (arm 2) had
Jadad Score: 2 n Entered: 11 Primary MD: n/a continued weight loss at 2, 3 and 6-month
n Analyzed: 10 follow-up, compared to those receiving
Diagnostic criteria: conventional treatment (arm 1), who, on
MD average, gained weight. Fasting blood glucose
2 Cognitive-behavioral (Group meeting) Tailored: Yes
significantly decreased for both groups over
Counseling/therapy (Office visit) Group Setting: Yes
Comorbidities: time but was not significantly different between
Education (Group meeting) Feedback: Yes
Hypertension and groups. Systolic and diastolic blood pressures
Feedback (Office visit) Psychological: Yes
obesity increased in both groups over time but less so
Primary MD: n/a
for self-management subjects. Satisfaction
n Entered: 12
measures showed no differences.
n Analyzed: 10
Follow-up times: 1 MO, 2 MO, 3 MO, 6 MO

209
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Raz I, 1988 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Fasting glucose (mg/dl) at 12 months:
(#2141) Group Setting: n/a Arm 1 = 201.0 (45.9)
RCT n Entered: 26 Feedback: n/a Arm 2 = 157.5 (59.9)
n Analyzed: 23 Psychological: n/a
Jadad Score: 2 Primary MD: n/a HbA1c (%) at 12 months:
Arm 1 = 9.6 (4.6)
Diagnostic criteria: 2 Education (Group meeting) Tailored: No Arm 2 = 8.0 (5.3)
FBS, HgbA1C, and Group Setting: Yes
PPBS n Entered: 25 Feedback: No Weight (kg) at 12 months:
n Analyzed: 23 Psychological: No Arm 1 = 73.4 (25.0)
Comorbidities: Primary MD: No Arm 2 = 73.4 (22.1)
n/a
Follow-up times: 4 MO, 8 MO, 12 MO
Rettig BA, 1986 Diabetes 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
(#2270) (Types I and II) Group Setting: n/a outcome.
n Entered: 243 Feedback: n/a
RCT n Analyzed: 193 Psychological: n/a Intervention subjects (arm 2) had no significant
Primary MD: n/a differences compared to usual care group (arm
Jadad Score: 2 1) with respect to diabetes-related
2 Education (Group meeting) Tailored: Yes hospitalizations over a 12-month period.
Diagnostic criteria: Education (Home visit) Group Setting: Yes Similarly, length of hospitalization, emergency
n/a Feedback: No room visits, and physician visits were no
n Entered: 228 Psychological: No different between groups despite significant
Comorbidities: n Analyzed: 180 Primary MD: No gains for intervention subjects in self-care
n/a knowledge and skills in individual subject areas
as well as in aggregate (p<0.001).

Follow-up times: 6 MO, 1 YR

210
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Sadur C N, 1999 Diabetes 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#1668) (Types I and II) Group Setting: n/a randomized.
n Entered: 88 Feedback: n/a
CCT n Analyzed: 74 Psychological: n/a At 6 months, HbA1c levels decreased 1.3% for
Primary MD: n/a intervention subjects (arm 2) as compared to
Jadad Score: 0 0.22% for usual care group (arm 1). Intervention
2 Clinical reviews w/patient (Telephone) Tailored: Yes levels persisted at 12 months but control levels
Diagnostic criteria: Cognitive-behavioral (One-on-one) Group Setting: Yes had fallen to similar levels by then as well. Self-
HgbA1C and Consultation w/specialists (Group Feedback: Yes care practices, self-efficacy, and satisfaction
Registry meeting) Psychological: Yes with diabetes care were also greater for
Counseling/therapy (One-on-one) Primary MD: n/a intervention subjects compared with usual care
Comorbidities: Education (Group meeting) group.
n/a Referrals (Group meeting)
Follow-up times: 6 MO, 18 MO
n Entered: 97
n Analyzed: 82

211
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Stevens J, 1985 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2208) Counseling/therapy (n/a) Group Setting: n/a or comparable control group.
RCT Feedback: n/a
n Entered: n/a Psychological: n/a Patients in all groups were consulted by a
Jadad Score: 1 n Analyzed: 12 Primary MD: n/a nutritionist. Three intervention groups (arms 2,
3, and 4) received dietary plans that differed in
Diagnostic criteria: recommendations for fiber and oat bran intake.
FBS 2 Counseling/therapy (n/a) Tailored: Yes These groups demonstrated decreased body
Group Setting: No weight at 6-week follow-up for the oat bran
Comorbidities: n Entered: n/a Feedback: No group (arm 4) compared to controls (arm 1)
Obesity n Analyzed: 15 Psychological: Yes (p<0.05). Glycosylated hemoglobin decreased
Primary MD: n/a in all 3 dietary groups but only in the increased
3 Counseling/therapy (n/a) Tailored: Yes fiber group (arm 3) was this difference
Group Setting: No statistically significant compared with controls
n Entered: n/a Feedback: No (p<0.05).
n Analyzed: 12 Psychological: Yes
Primary MD: n/a Follow-up times: 2 WK, 6 WK
4 Counseling/therapy (n/a) Tailored: Yes
Group Setting: No
n Entered: n/a Feedback: No
n Analyzed: 13 Psychological: Yes
Primary MD: n/a

212
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Vanninen E, 1992 Diabetes (Type II) 1 Control (n/a) Tailored: n/a BMI (kg/m2) at 12 months:
(#2174) Education (n/a) Group Setting: n/a Arm 1 = 32.1 (4.5)
RCT Feedback: n/a Arm 2 = 31.4 (5.1)
n Entered: 40 Psychological: n/a
Jadad Score: 2 n Analyzed: 38 Primary MD: n/a Fasting blood glucose (mmol/L) at 12 months:
Arm 1 = 7.3 (2.1)
Diagnostic criteria: 2 Education (Office visit) Tailored: Yes Arm 2 = 6.3 (1.8)
FBS Education (One-on-one) Group Setting: No
Education (Reading material) Feedback: Yes HbA (%) at 12 months:
Comorbidities: Exercise program (Self-delivery) Psychological: No Arm 1 = 7.3 (1.6)
Heart disease, Feedback (One-on-one) Primary MD: Yes Arm 2 = 6.6 (1.6)
hypertension,
obesity, tobacco n Entered: 38 Follow-up times: 12 MO
abuse, and n Analyzed: 38
cholesterol
Vinicor F, 1987 Diabetes 1 Usual Care (n/a) Tailored: n/a Follow-up time not in 3 - 12 months.
(#892) (Types I and II) Group Setting: n/a
n Entered: 129 Feedback: n/a Significant improvements for patients receiving
RCT n Analyzed: 68 Psychological: n/a education (arm 2) were noted in HbA1c, fasting
Primary MD: n/a plasma glucose, weight and blood pressure, but
Jadad Score: 2 greatest improvements were noted in the group
2 Contracts (One-on-one) Tailored: Yes receiving both patient and physician education
Diagnostic criteria: Education (Computer program) Group Setting: No (arm 4).
FBS and PPBS Education (Home visit) Feedback: Yes
Education (One-on-one) Psychological: No Follow-up times: 26 MO
Comorbidities: Reminders (Telephone) Primary MD: No
Heart disease,
hypertension, kidney n Entered: 117
disease, neuropathy, n Analyzed: 69
obesity, CHF, and

213
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
cholesterol 3 Consultation w/specialists (Telephone) Tailored: Yes
Education (Detailed reading material) Group Setting: Yes
Education (Group meeting) Feedback: Yes
Education (Protocols) Psychological: No
Feedback (Group meeting) Primary MD: Yes
Practice methods (Group meeting)
Reminders (Computer program)

n Entered: 130
n Analyzed: 62

4 Consultation w/specialists (Telephone) Tailored: Yes

Contracts (One-on-one) Group Setting: Yes
Education (Computer program) Feedback: Yes
Education (Detailed reading material) Psychological: No
Education (Group meeting) Primary MD: Yes
Education (Home visit)
Education (One-on-one)
Education (Protocols)
Feedback (Group meeting)
Practice methods (Group meeting)
Reminders (Computer program)
Reminders (Telephone)

n Entered: 133
n Analyzed: 58

214
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Ward WK, 1985 Diabetes 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2152) (Types I and II) Education (Group meeting) Group Setting: n/a or comparable control group.
Education (Reading material) Feedback: n/a
RCT Psychological: n/a Thirty minutes of professional instruction for
n Entered: 14 Primary MD: n/a self-monitoring blood glucose with Chem-strip
Jadad Score: 1 n Analyzed: 14 bG (arm 2) compared with reading package
instructions and practice (arm 1) resulted only in
Diagnostic criteria: 2 Education (Group meeting) Tailored: Yes a lower percent error in blood glucose
FBS Education (Reading material) Group Setting: Yes estimation (p<0.02).
Feedback (Group meeting) Feedback: Yes
Comorbidities: Psychological: No Follow-up times: n/a
n/a n Entered: 16 Primary MD: n/a
n Analyzed: 16

Weinberger M, 1995 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Fasting blood glucose (mg/dl) at 12 months:
(#896) Group Setting: n/a Arm 1 = 193.1 (57.9)
RCT n Entered: 71 Feedback: n/a Arm 2 = 174.1 (59.0)
n Analyzed: 188 Psychological: n/a
Jadad Score: 2 Primary MD: n/a Glycohemoglobin (%) at 12 months:
Arm 1 = 11.1 (2.4)
Diagnostic criteria: 2 Clinical reviews w/patient (Telephone) Tailored: Yes Arm 2 = 10.5 (2.7)
n/a Education (Telephone) Group Setting: No
Feedback (Telephone) Feedback: Yes Follow-up times: 1 YR
Comorbidities: Practice methods (Detailed reading Psychological: No
n/a material) Primary MD: No
Practice methods (Telephone)
Referrals (Telephone)

n Entered: 204
n Analyzed: 188

215
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Werdier JD, 1984 Diabetes (Type II) 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2401) Group Setting: n/a randomized.
CCT n Entered: n/a Feedback: n/a
n Analyzed: 82 Psychological: n/a Subjects receiving diabetes counseling (arm 2)
Jadad Score: 0 Primary MD: n/a had significant reductions in post-prandial blood
glucose compared with usual care group (arm
Diagnostic criteria: 2 Counseling/therapy (One-on-one) Tailored: Yes 1) (p=0.009) at 6-month evaluation.
n/a Group Setting: No
n Entered: n/a Feedback: No Follow-up times: 6 MO
Comorbidities: n Analyzed: 81 Psychological: Yes
n/a Primary MD: n/a
White N, 1986 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Glycohemoglobin (%) at 6 months:
(#2154) Counseling/therapy (One-on-one) Group Setting: n/a Arm 1 = 10.1 (3.0)
RCT Education (Group meeting) Feedback: n/a Arm 2 = 9.2 (2.0)
Psychological: n/a
Jadad Score: 2 n Entered: 21 Primary MD: n/a Overweight (%) at 6 months:
n Analyzed: 16 Arm 1 = 45.0 (16.0)
Diagnostic criteria: Arm 2 = 34.0 (28.0)
FBS and PPBS 2 Emotional support (Group meeting) Tailored: Yes
Feedback (Group meeting) Group Setting: Yes Serum glucose (mg/dl) at 6 months:
Comorbidities: Feedback: Yes Arm 1 = 243.0 (120.0)
Obesity n Entered: 20 Psychological: Yes Arm 2 = 161.0 (48.0)
n Analyzed: 16 Primary MD: No
Follow-up times: 3 MO, 6 MO

216
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Wing RR/Epstein LH, Diabetes (Type II) 1 Contracts (Group meeting) Tailored: No Excluded from meta-analysis as no usual care
1985 Education (Group meeting) Group Setting: Yes or comparable control group.
(#2156) RCT Financial incentives (Group meeting) Feedback: Yes
Psychological: No Patients randomized to a behavior modification
Jadad Score: 1 n Entered: n/a Primary MD: n/a group (arm 2) lost more weight than nutrition
n Analyzed: n/a education (arm 3) or standard care (arm 1)
Diagnostic criteria: groups during a 4-month treatment period
FBS and GTT (p<0.01). However, 16 months later, differences
2 Cognitive-behavioral (Group meeting) Tailored: Yes in weight loss across these 3 groups were not
Comorbidities: Contracts (Group meeting) Group Setting: Yes significant.
Hypertension and Dietary monitoring (Group meeting) Feedback: Yes
obesity Education (Group meeting) Psychological: Yes Follow-up times: 4 MO, 10 MO, 16 MO
Exercise program (Group meeting) Primary MD: n/a
Financial incentives (Group meeting)
Group Competition (Other mechanisms)

n Entered: n/a
n Analyzed: n/a

3 Contracts (Group meeting) Tailored: No

Education (Group meeting) Group Setting: Yes
Education (Reading material) Feedback: Yes
Financial incentives (Group meeting) Psychological: No
Primary MD: n/a
n Entered: n/a
n Analyzed: n/a

217
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Wing RR/Epstein LH, Diabetes (Type II) 1 Cognitive-behavioral (Group meeting) Tailored: Yes Excluded from meta-analysis as no usual care
1986 Dietary monitoring (Group meeting) Group Setting: Yes or comparable control group.
(#2158) RCT Financial incentives (Group meeting) Feedback: Yes
Psychological: Yes Two groups of randomized patients: a standard
Jadad Score: 2 n Entered: 25 Primary MD: n/a behavioral weight control program (arm 1) and a
n Analyzed: 22 weight control program that included self-
Diagnostic criteria: monitoring of blood glucose and instruction in
MD 2 Cognitive-behavioral (Group meeting) Tailored: Yes the relationship between weight and glucose
Dietary monitoring (Group meeting) Group Setting: Yes levels (arm 2), both demonstrated significant
Comorbidities: Education (Group meeting) Feedback: Yes weight loss (mean of 6.3 +/- 4.0 kg) at 12 weeks
Obesity Financial incentives (Group meeting) Psychological: Yes but with no difference between groups.
Primary MD: n/a Significance was not maintained at one year.
n Entered: 25 Nor were there any differences between groups
n Analyzed: 23 for glycosylated hemoglobin, fasting blood
glucose, total cholesterol, blood pressure,
medication use, or depression scores.

Follow-up times: 12 WK, 62 WK

218
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Wing RR, 1988 Diabetes (Type II) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2283) Dietary monitoring (Group meeting) Group Setting: n/a or comparable control group.
RCT Education (Group meeting) Feedback: n/a
Financial incentives (Group meeting) Psychological: n/a After a 16-week treatment program, both self-
Jadad Score: 2 Follow up (Group meeting) Primary MD: n/a regulation group (arm 2) and monitoring only
Goal setting (Group meeting) group (arm 1) significantly improved in
Diagnostic criteria: Material incentive (Group meeting) biochemical and weight measures but with no
NDDG Practice self care skills (Group meeting) differences between arms. Though weight loss
was significant for both arms at one-year follow-
Comorbidities: n Entered: 10 up, lack of difference between arms remained.
Obesity n Analyzed: 9 HgbA1c values were unchanged in both arms
compared to pretreatment values.
2 Cognitive-behavioral (Group meeting) Tailored: Yes Follow-up times: 16 WK, 1 YR
Contracts (Group meeting) Group Setting: Yes
Dietary monitoring (Group meeting) Feedback: Yes
Education (Group meeting) Psychological: Yes
Feedback (Group meeting) Primary MD: n/a
Financial incentives (Group meeting)
Follow up (Group meeting)
Goal setting (n/a)
Material incentive (Group meeting)
Practice self care skills (Group meeting)
Reminders (Group meeting)

n Entered: 10
n Analyzed: 8

219
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Wise PH, 1986 Diabetes 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2205) (Types I and II) Group Setting: n/a randomized.
n Entered: n/a Feedback: n/a
CCT n Analyzed: 41 Psychological: n/a Significant decreases in HbA1c levels were
Primary MD: n/a seen for individuals participating in computer-
Jadad Score: 1 2 Education (Computer program) Tailored: Yes based interactive teaching programs with
Group Setting: No feedback (arm 2) compared with usual care
Diagnostic criteria: n Entered: n/a Feedback: No group (arm 1) (p<0.05). Knowledge increased in
n/a n Analyzed: 46 Psychological: No these groups as well.
Primary MD: n/a
Comorbidities: 3 Education (Computer program) Tailored: Yes Follow-up times: 5 MO
n/a Feedback (Computer program) Group Setting: No
Feedback: Yes
n Entered: n/a Psychological: No
n Analyzed: 46 Primary MD: n/a

4 Education (Computer program) Tailored: Yes

Education (Self-delivery) Group Setting: No
Feedback (Computer program) Feedback: Yes
Psychological: No
n Entered: n/a Primary MD: n/a
n Analyzed: 41

220
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Wood ER, 1989 Diabetes (n/a) 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2159) Education (Hospitalization) Group Setting: n/a randomized.
CCT Feedback: n/a
n Entered: n/a Psychological: n/a Hospitalized patients receiving a comprehensive
Jadad Score: 1 n Analyzed: 40 Primary MD: n/a inpatient diabetes education program (arm 2)
had better compliance compared with control
Diagnostic criteria: group (arm 1) at 4-month follow-up with regard
MD 2 Education (Group meeting) Tailored: Yes to self-care behaviors including exercise, insulin
Education (Hospitalization) Group Setting: Yes administration and diet, however only exercise
Comorbidities: Feedback (Group meeting) Feedback: Yes reached statistical significance (p=0.05). Blood
n/a Practice self care skills (Group meeting) Psychological: No glucose was also lower (p=0.10) as was the
Primary MD: n/a number of emergency room visits (20 for
n Entered: n/a controls versus 2 in experimental program,
n Analyzed: 53 p=0.005).

Follow-up times: 1 MO, 4 MO

221
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 1: Diabetes (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Worth R, 1982 Diabetes (Type I) 1 Clinical reviews w/patient (Office visit) Tailored: Yes Excluded from meta-analysis as no usual care
(#2198) Education (Office visit) Group Setting: No or comparable control group.
RCT Self monitoring (Self-delivery) Feedback: Yes
Psychological: No The method of monitoring diabetic control had
Jadad Score: 2 n Entered: 13 Primary MD: n/a no effect on glycosylated hemoglobin,
n Analyzed: n/a postprandial blood glucose, serum cholesterol,
Diagnostic criteria: or body weight.
Insulin by regular
2 Clinical reviews w/patient (Office visit) Tailored: Yes
urine test Follow-up times: 3 MO
Education (Office visit) Group Setting: No
Self monitoring (Self-delivery) Feedback: Yes
Comorbidities:
Psychological: No
n/a
n Entered: 13 Primary MD: n/a
n Analyzed: n/a

3 Clinical reviews w/patient (Office visit) Tailored: Yes

Education (Office visit) Group Setting: No
Self monitoring (Self-delivery) Feedback: Yes
Psychological: No
n Entered: 12 Primary MD: n/a
n Analyzed: n/a

222
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis
Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Barlow JH, 2000 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Functioning (modified Health Assessment
(#3274) (OA and RA) Group Setting: n/a Questionnaire (0-3)) at 4 months:
n Entered: 258 Feedback: n/a Arm 1 = 1.4 (1.0)
RCT n Analyzed: 311 Psychological: n/a Arm 2 = 1.4 (1.0)
Primary MD: n/a
Jadad Score: 2 2 Cognitive-behavioral (Group meeting) Tailored: Yes Pain (VAS (0-10)) at 4 months:
Education (Group meeting) Group Setting: Yes Arm 1 = 6.4 (2.5)
Diagnostic criteria: Education (Instructional manuals) Feedback: Yes Arm 2 = 6.4 (2.5)
MD Follow up (Group meeting) Psychological: Yes
Goal setting (Group meeting) Primary MD: No Follow-up times: 4 MO, 12 MO
Comorbidities: Practice self care skills (Group meeting)
n/a
n Entered: 344
n Analyzed: 311

N/A = Not Available or Not Applicable

NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.

223
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Cohen J L, 1986 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#770) (OA, RA and other, Group Setting: n/a
NOS) n Entered: 36 Feedback: n/a Though knowledge of arthritis and use of
n Analyzed: 34 Psychological: n/a exercise increased for both intervention groups
RCT Primary MD: n/a compared with no intervention, delivery by
professional compared with layperson resulted
Jadad Score: 2 2 Advocacy training (Group meeting) Tailored: Yes in no differences with respect to pain,
Arthritis self-management (Group Group Setting: Yes depression, physical function, social support or
Diagnostic criteria: meeting) Feedback: No non-exercise behaviors.
MD Arthritis self-management (Instructional Psychological: Yes
manuals) Primary MD: No Follow-up times: 6 WK, 14 WK
Comorbidities: Arthritis self-management (Office visit)
n/a
n Entered: 32
n Analyzed: 28

3 Education (Group meeting) Tailored: No

Education (Instructional manuals) Group Setting: Yes
Feedback: No
n Entered: 28 Psychological: No
n Analyzed: 24 Primary MD: No

Doyle TH, 1982 Osteoarthritis (OA only) 1 Clinical reviews w/patient (One-on-one) Tailored: Yes Excluded from meta-analysis as no usual care
(#2427) Group Setting: No or comparable control group.
RCT n Entered: n/a Feedback: Yes
n Analyzed: n/a Psychological: No After 20 weeks of treatment, improvement was
Jadad Score: 1 Primary MD: n/a seen for pain and range of motion in both arms
with no difference seen between groups.
Diagnostic criteria: 2 Clinical reviews w/patient (Group meeting) Tailored: No
n/a Group Setting: Yes Follow-up times: 20 WK
n Entered: n/a Feedback: Yes
Comorbidities: n Analyzed: n/a Psychological: No
n/a Primary MD: n/a

224
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Goeppinger J, 1989 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Functioning (Health Assessment Questionnaire
(#801) (OA and RA) Group Setting: n/a disability score (0-3)) at 4 months:
n Entered: n/a Feedback: n/a Arm 1 = 1.0 (0.6)
RCT n Analyzed: 121 Psychological: n/a Arm 2 = 1.0 (0.6)
Primary MD: n/a Arm 3 = 1.1 (0.6)
Jadad Score: 1
2 Contracts (Group meeting) Tailored: Yes Pain (Pain Index) at 4 months:
Diagnostic criteria: Education (Group meeting) Group Setting: Yes Arm 1 = 25.7 (8.7)
n/a Feedback: Yes Arm 2 = 25.4 (8.7)
n Entered: n/a Psychological: No Arm 3 = 26.6 (8.7)
Comorbidities: n Analyzed: 121 Primary MD: No
n/a Follow-up times: 4 MO
3 Contracts (Group meeting) Tailored: Yes
Education (Group meeting) Group Setting: Yes
Education (Reading material) Feedback: Yes
Education (Video/audio tapes) Psychological: No
Primary MD: No
n Entered: n/a
n Analyzed: 121

Keefe F, 1996 Osteoarthritis (OA only) 1 Cognitive-behavioral (Group meeting) Tailored: Yes Excluded from meta-analysis as no usual care
(#2082) Education (Reading material) Group Setting: Yes or comparable control group.
RCT Feedback: No
n Entered: n/a Psychological: Yes Patients receiving spouse-assisted coping skills
Jadad Score: 1 n Analyzed: n/a Primary MD: n/a training (arm 2) had lower levels of pain and
psychological disability and higher self-efficacy
Diagnostic criteria: 2 Cognitive-behavioral (Group meeting) Tailored: Yes and more frequent use of pain-coping strategies
n/a Counseling/therapy (Group meeting) Group Setting: Yes after 10 weeks of treatment than did those
Education (Reading material) Feedback: No receiving the cognitive-behavioral intervention
Comorbidities: Psychological: Yes (arm 1). Subjects in the pain-coping skills
n/a n Entered: n/a Primary MD: n/a training without spouse assistance (arm 3) had
n Analyzed: n/a higher self-efficacy, coping, and marital
adjustment and lower pain and psychological

225
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
3 Education (Group meeting) Tailored: Yes disability as compared to the cognitive-
Education (Reading material) Group Setting: Yes behavioral group.
Feedback: No
n Entered: n/a Psychological: No Follow-up times: 10 WK
n Analyzed: n/a Primary MD: n/a

Keefe F J, 1990a Osteoarthritis (OA only) 1 Usual Care (n/a) Tailored: n/a Functioning (AIMS physical disability scale) at 6
(#907) Group Setting: n/a months:
RCT n Entered: 31 Feedback: n/a Arm 1 = 2.0 (1.3)
n Analyzed: 35 Psychological: n/a Arm 2 = 2.1 (1.3)
Jadad Score: 1 Primary MD: n/a Arm 3 = 2.3 (1.3)

Diagnostic criteria: 2 Cognitive-behavioral (Group meeting) Tailored: Yes Pain (AIMS pain scale) at 6 months:
X-ray and MD Cognitive-behavioral (Video/audio tapes) Group Setting: Yes Arm 1 = 5.7 (1.6)
Consultation w/specialists (Group Feedback: No Arm 2 = 5.7 (1.7)
Comorbidities: meeting) Psychological: Yes Arm 3 = 4.6 (1.7)
Obesity Counseling/therapy (Telephone) Primary MD: No
Follow-up times: 6 MO, 12 MO
n Entered: 32
n Analyzed: 35

3 Counseling/therapy (Telephone) Tailored: No

Education (Group meeting) Group Setting: Yes
Feedback: No
n Entered: 36 Psychological: Yes
n Analyzed: 35 Primary MD: No

226
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Keefe F J, 1990b Osteoarthritis (OA only) 1 Usual Care (n/a) Tailored: n/a Duplicate population Keefe F J, 1990b
(#908) Group Setting: n/a
RCT n Entered: 31 Feedback: n/a Patients who received pain coping skills training
n Analyzed: 28 Psychological: n/a (arm 2) had significantly lower levels of pain
Jadad Score: 1 Primary MD: n/a (p<0.01) and psychological disability (p<0.001)
than those who received arthritis education (arm
Diagnostic criteria: 2 Cognitive-behavioral (Group meeting) Tailored: Yes 3) or usual care (arm 1). Physical disability was
X-ray and MD Cognitive-behavioral (Video/audio tapes) Group Setting: Yes no different between groups after treatment.
Consultation w/specialists (Group Feedback: No
Comorbidities: meeting) Psychological: Yes Follow-up times: 10 WK
Obesity Primary MD: No
n Entered: 32
n Analyzed: 31

3 Education (Group meeting) Tailored: No

Group Setting: Yes
n Entered: 36 Feedback: No
n Analyzed: 35 Psychological: No
Primary MD: No

227
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Laborde JM, 1983 Osteoarthritis (OA only) 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2355) Group Setting: n/a
RCT n Entered: 20 Feedback: n/a Subjects receiving relaxation procedures (arm
n Analyzed: 20 Psychological: n/a 4) had significantly less pain than those
Jadad Score: 1 Primary MD: n/a receiving other interventions or those in the
control group (p<0.05). No differences were
Diagnostic criteria: 2 Education (Reading material) Tailored: No noted with respect to stiffness, mobility,
Chart review and Group Setting: No medication taking behavior, or knowledge.
self report n Entered: 35 Feedback: No
n Analyzed: 35 Psychological: No Follow-up times: 2 WK
Comorbidities: Primary MD: No
n/a
3 Education (Group meeting) Tailored: Yes
Education (Reading material) Group Setting: Yes
Feedback: No
n Entered: 35 Psychological: No
n Analyzed: 35 Primary MD: No

4 Education (Group meeting) Tailored: Yes

Education (Reading material) Group Setting: Yes
Feedback: No
n Entered: 35 Psychological: No
n Analyzed: 35 Primary MD: No

5 Education (Group meeting) Tailored: Yes

Education (Reading material) Group Setting: Yes
Feedback: No
n Entered: 35 Psychological: No
n Analyzed: 35 Primary MD: No

228
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Lorig K, 1985 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Functioning (Disability (0-3)) at 4 months:
(#835) (OA and RA) Group Setting: n/a Arm 1 = 0.5 (1.0)
n Entered: 65 Feedback: n/a Arm 2 = 0.6 (1.0)
RCT n Analyzed: 129 Psychological: n/a
Primary MD: n/a Pain (VAS (0-10)) at 4 months:
Jadad Score: 1 Arm 1 = 3.2 (2.5)
2 Arthritis self-management (Group Tailored: Yes Arm 2 = 3.4 (2.5)
Diagnostic criteria: meeting) Group Setting: Yes
MD Feedback: No Follow-up times: 4 MO
n Entered: 134 Psychological: No
Comorbidities: n Analyzed: 129 Primary MD: No
n/a
Lorig K, 1986 Osteoarthritis (OA and 1 Usual Care (n/a) Tailored: n/a Functioning (Health Assessment Questionnaire
(#830) RA) Group Setting: n/a (0-3)) at 4 months:
n Entered: 32 Feedback: n/a Arm 1 = 0.9 (1.0)
RCT n Analyzed: 29 Psychological: n/a Arm 2 = 0.8 (1.0)
Primary MD: n/a Arm 3 = 0.7 (1.0)
Jadad Score: 2 2 Arthritis self-management (Group Tailored: Yes
meeting) Group Setting: Yes Pain (Double anchored VAS (0-15)) at 4
Diagnostic criteria: Feedback: No months:
MD n Entered: 34 Psychological: No Arm 1 = 7.3 (3.8)
n Analyzed: 29 Primary MD: No Arm 2 = 8.9 (3.8)
Comorbidities: Arm 3 = 7.4 (3.8)
n/a 3 Arthritis self-management (Group Tailored: Yes
meeting) Group Setting: Yes Follow-up times: 4 MO
Feedback: No
n Entered: 34 Psychological: No
n Analyzed: 29 Primary MD: No

229
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Lorig K, 1989 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Functioning (Stanford Health Assessment
(#837) (OA and RA) Group Setting: n/a Questionnaire (0-3)) at 4 months:
n Entered: n/a Feedback: n/a Arm 1 = 0.7 (1.0)
RCT n Analyzed: 501 Psychological: n/a Arm 2 = 0.7 (1.0)
Primary MD: n/a
Jadad Score: 1 Pain (Double anchored VAS (0-10)) at 4
2 Arthritis self-management (Group Tailored: Yes months:
Diagnostic criteria: meeting) Group Setting: Yes Arm 1 = 4.5 (2.5)
MD Feedback: No Arm 2 = 4.2 (2.5)
n Entered: n/a Psychological: No
Comorbidities: n Analyzed: 501 Primary MD: No Follow-up times: 4 MO
n/a
Lorig K R, 1999 Osteoarthritis 1 Usual Care (n/a) Tailored: n/a Functioning (modified Health Assessment
(#608) (Arthritis, NOS) Group Setting: n/a Questionnaire disability score (0-3)) at 6
n Entered: 476 Feedback: n/a months:
RCT n Analyzed: 561 Psychological: n/a Arm 1 = 0.9 (1.0)
Primary MD: n/a Arm 2 = 0.8 (1.0)
Jadad Score: 2
2 Cognitive-behavioral (Group meeting) Tailored: Yes Pain (adaptation of Medical Outcomes Study
Diagnostic criteria: Education (Group meeting) Group Setting: Yes pain scale (0-100)) at 6 months:
MD Feedback (Group meeting) Feedback: Yes Arm 1 = 56.8 (25.0)
Practice methods (Group meeting) Psychological: Yes Arm 2 = 55.4 (25.0)
Comorbidities: Primary MD: No
Heart disease, n Entered: 664 Follow-up times: 6 MO
chronic respiratory n Analyzed: 561
disease, CHF, and
stroke

230
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 2: Osteoarthritis (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Weinberger M, 1989 Osteoarthritis (OA only) 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#430) Group Setting: n/a
RCT n Entered: 112 Feedback: n/a Education delivered by telephone (arms 2 and
n Analyzed: 103 Psychological: n/a 4) compared with no telephone (arms 1 and 3)
Jadad Score: 2 Primary MD: n/a resulted in improved physical health and
reduced pain (p=0.02) with trends suggesting
Diagnostic criteria: 2 Advocacy training (Telephone) Tailored: Yes improved psychological health (p=0.10).
X-ray and MD Clinical reviews w/patient (Telephone) Group Setting: No
Reminders (Telephone) Feedback: Yes Follow-up times: 11 MO
Comorbidities: Psychological: Yes
n/a n Entered: 109 Primary MD: No
n Analyzed: 95

3 Advocacy training (Office visit) Tailored: Yes

Clinical reviews w/patient (Office visit) Group Setting: No
Feedback: Yes
n Entered: 109 Psychological: Yes
n Analyzed: 99 Primary MD: No

4 Advocacy training (Office visit) Tailored: Yes

Advocacy training (Telephone) Group Setting: No
Clinical reviews w/patient (Office visit) Feedback: Yes
Clinical reviews w/patient (Telephone) Psychological: Yes
Reminders (Telephone) Primary MD: No

n Entered: 109
n Analyzed: 97

231
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care
Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Burgess AW, 1987 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 13 months:
(#2652) (Uncomplicated and Group Setting: n/a Arm 1 = 5 deaths
complicated) n Entered: 91 Feedback: n/a Arm 2 = 5 deaths
n Analyzed: 77 Psychological: n/a
RCT Primary MD: n/a Return to work (% return to same or new job) at
13 months:
Jadad Score: 2 2 Cognitive-behavioral (One-on-one) Tailored: Yes Arm 1 = 88% of 76 eligible subjects
Follow up (Mail) Group Setting: No Arm 2 = 88% of 77 eligible subjects
Diagnostic criteria: Social support (One-on-one) Feedback: Yes
CPK-MB elevation, Psychological: Yes Follow-up times: 3 MO, 13 MO
ECG, Symptoms n Entered: 89 Primary MD: No
n Analyzed: 77
Comorbidities:
CHF
DeBusk F, 1985 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
(#2669) (First occurrence Group Setting: n/a outcome.
and reoccurrence) n Entered: 37 Feedback: n/a
n Analyzed: n/a Psychological: n/a The average increase in functional capacity
RCT Primary MD: n/a (i.e., peak treadmill workload on METS)
between 3 and 26 weeks was significantly
Jadad Score: 2 2 Control (n/a) Tailored: n/a greater (p<0.05) in training groups (arms
Counseling/therapy (One-on-one) Group Setting: n/a 2,3,4,5, and 6) than in the usual care group
Diagnostic criteria: Exercise testing (n/a) Feedback: n/a (arm 1) (1.8 vs. 1.2 METs, respectively).
CPK-MB elevation, Psychological: n/a
ECG, SGOT, n Entered: 34 Primary MD: n/a Follow-up times: 3 WK, 11 WK, 26 WK
Symptoms n Analyzed: n/a

N/A = Not Available or Not Applicable

NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.

232
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Comorbidities: 3 Counseling/therapy (One-on-one) Tailored: Yes
n/a Exercise diary (Self-delivery) Group Setting: No
Exercise monitoring (Telephone) Feedback: Yes
Exercise program (One-on-one) Psychological: Yes
Exercise program (Reading material) Primary MD: No
Exercise testing (n/a)
Follow up (Telephone)

n Entered: 33
n Analyzed: n/a

4 Counseling/therapy (One-on-one) Tailored: Yes

Exercise diary (Self-delivery) Group Setting: No
Exercise monitoring (Telephone) Feedback: Yes
Exercise program (One-on-one) Psychological: Yes
Exercise program (Reading material) Primary MD: No
Exercise testing (n/a)
Follow up (Telephone)

n Entered: 33
n Analyzed: n/a

5 Counseling/therapy (One-on-one) Tailored: Yes

Exercise monitoring (Group meeting) Group Setting: Yes
Exercise program (Group meeting) Feedback: No
Exercise testing (n/a) Psychological: Yes
Primary MD: No
n Entered: 30
n Analyzed: n/a

233
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
6 Counseling/therapy (One-on-one) Tailored: Yes
Exercise monitoring (Group meeting) Group Setting: Yes
Exercise program (Group meeting) Feedback: No
Exercise testing (n/a) Psychological: Yes
Primary MD: No
n Entered: 31
n Analyzed: n/a

DeBusk RF, 1994 Myocardial infarction 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#775) (Angina with Counseling/therapy (Hospitalization) Group Setting: n/a or comparable control group.
infarction) Feedback: n/a
n Entered: 292 Psychological: n/a At 12 months, 4.1% had died in the intervention
RCT n Analyzed: 244 Primary MD: n/a arm (arm 2), compared to 3.4% in the control
group (arm 1). LDL and total cholesterol
Jadad Score: 3 decreased more in the intervention arm
2 Counseling/therapy (Computer program) Tailored: Yes (p <0.001). Smoking cessation at 12 months
Diagnostic criteria: Counseling/therapy (Hospitalization) Group Setting: No increased significantly for the case management
CPK-MB elevation, Counseling/therapy (Office visit) Feedback: Yes arm versus usual care (70% vs. 53%, p=0.03).
ECG, Chest pain, Counseling/therapy (Reading material) Psychological: Yes Functional capacity was higher in the
SGOT Counseling/therapy (Telephone) Primary MD: n/a intervention arm at 6 months 9.3 METS vs. 8.4
Counseling/therapy (Video/audio tapes) METS. The% consuming a low fat diet
Comorbidities: Education (Hospitalization) increased from 31% to 88% at 90 days in the
Tobacco abuse, Education (Office visit) intervention arm but was similar to usual care
substance abuse, Education (Telephone) arm.
and psychiatric Feedback (Mail)
problems Follow-up times: 3 MO, 6 MO, 12 MO
n Entered: 293
n Analyzed: 243

234
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Dennis C, 1988 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 6 months:
(#2656) (Uncomplicated MI) Group Setting: n/a Arm 1 = 2 deaths
n Entered: 102 Feedback: n/a Arm 2 = 1 death
RCT n Analyzed: 99 Psychological: n/a
Primary MD: n/a Return to work (% working part- or full-time) at 6
Jadad Score: 3 months:
2 Clinical reviews w/patient (Telephone) Tailored: Yes Arm 1 = 86% of 102 eligible subjects
Diagnostic criteria: Consultation w/specialists (Mail) Group Setting: No Arm 2 = 92% of 99 eligible subjects
CPK-MB elevation, Consultation w/specialists (Telephone) Feedback: Yes
ECG, MD Counseling/therapy (One-on-one) Psychological: Yes Follow-up times: 1 MO, 3 MO, 6 MO
Exercise testing (One-on-one) Primary MD: Yes
Comorbidities:
n/a n Entered: 99
n Analyzed: 99

Frasure-Smith N, Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
1985 (Uncomplicated, Group Setting: n/a randomized.
(#790) complicated, first n Entered: 231 Feedback: n/a
and reoccurrence, n Analyzed: 224 Psychological: n/a Nurse-delivered stress monitoring and stress
angina with infarction Primary MD: n/a reduction interventions resulted in lower stress
and unspecified) levels and fewer cardiac deaths (70% decrease)
2 Consultation w/specialists (Group Tailored: Yes for intervention patients (arm 2) compared with
CCT meeting) Group Setting: Yes usual care group (arm 1) but not reinfarction
Education (Home visit) Feedback: No rates. Differences between groups with respect
Jadad Score: 0 Psychological assessment/care (Home Psychological: Yes to SES may be responsible for these
visit) Primary MD: n/a differences.
Diagnostic criteria: Psychological assessment/care
n/a (Telephone) Follow-up times: 1 YR

Comorbidities: n Entered: 230

Hypertension, n Analyzed: 229
obesity, DM, CHF,
tobacco abuse, and
angina

235
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Frasure-Smith N, Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
1989 (Uncomplicated, Group Setting: n/a randomized.
(#2218) complicated, first n Entered: 233 Feedback: n/a
and reoccurrence) n Analyzed: 179 Psychological: n/a Subjects receiving home-based nursing
Primary MD: n/a interventions aimed at reducing stress (arm 2)
CCT had significantly fewer MI recurrences than
2 Consultation w/specialists (Group Tailored: Yes usual care subjects (arm 1) over a 4-year follow-
Jadad Score: 1 meeting) Group Setting: Yes up period (p=0.04). The difference in mortality
Education (Home visit) Feedback: No was maximal at 18 months post-MI, but during
Diagnostic criteria: Psychological assessment/care (Home Psychological: Yes the remaining years mortality between groups
MD visit) Primary MD: n/a was equivalent. No difference in hospitalization
Psychological assessment/care readmission rates was noted.
Comorbidities: (Telephone)
Hypertension, Follow-up times: 2 YR, 5 YR, 64 MO
obesity, DM, tobacco n Entered: 232
abuse, and n Analyzed: 176
cholesterol
Friedman M, 1982 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2367) (First occurrence Group Setting: n/a randomized.
and reoccurrence) n Entered: 151 Feedback: n/a
n Analyzed: 125 Psychological: n/a Subjects receiving interventions of both
CCT Primary MD: n/a cardiologic and behavioral counseling (arms 2
2 Counseling/therapy (Group meeting) Tailored: Yes and 3) had lower 1-yr rates of reinfarction
Jadad Score: 0 Group Setting: Yes (p<0.01) and death (p<0.05) than usual care
n Entered: 270 Feedback: No subjects (arm 1). Behavioral counseling (arm 3)
Diagnostic criteria: n Analyzed: 213 Psychological: Yes resulted in fewer reinfarctions (1.1% versus
CPK-MB elevation, Primary MD: n/a 3.3% p<0.05) than cardiologic counseling alone
ECG, Patient History 3 Cognitive-behavioral (Group meeting) Tailored: Yes (arm 2).
Counseling/therapy (Group meeting) Group Setting: Yes
Comorbidities: Feedback: No Follow-up times: 1 YR
Heart disease, n Entered: 614 Psychological: Yes
hypertension, CHF, n Analyzed: 514 Primary MD: n/a
tobacco abuse, and
cholesterol

236
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Friedman M, 1984 Myocardial infarction 1 Counseling/therapy (Group meeting) Tailored: Yes Excluded from meta-analysis as no usual care
(#2362) (First occurrence Psychological assessment/care (Group Group Setting: Yes or comparable control group.
and reoccurrence) meeting) Feedback: No
Psychological: Yes Patients receiving Type A behavioral counseling
RCT n Entered: 270 Primary MD: n/a (arm 2) had a 7.2% 3-year cumulative cardiac
n Analyzed: 164 recurrence rate compared with 13% for
Jadad Score: 1 individuals receiving only cardiologic counseling
2 Cognitive-behavioral (Group meeting) Tailored: Yes (arm 1) (p<0.005). Three-year survival without
Diagnostic criteria: Counseling/therapy (Group meeting) Group Setting: Yes cardiac recurrence was also higher for the
CPK-MB elevation, Feedback: No behavioral counseling group (p<0.01) but no
ECG, Clinical history n Entered: 592 Psychological: Yes differences were noted for arrhythmias or
n Analyzed: 381 Primary MD: n/a hypertension.
Comorbidities:
Heart disease, Follow-up times: 3 YR
hypertension, CHF,
and tobacco abuse
Froelicher E S, 1994 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 24 weeks:
(#792) (Uncomplicated MI) Group Setting: n/a Arm 1 = 2 deaths
n Entered: 84 Feedback: n/a Arm 2 = 3 deaths
RCT n Analyzed: 52 Psychological: n/a Arm 3 = 3 deaths
Primary MD: n/a
Jadad Score: 2 Return to work (% return to same job) at 24
2 Exercise program (Hospitalization) Tailored: Yes weeks:
Diagnostic criteria: Feedback (Office visit) Group Setting: No Arm 1 = 90% of 62 eligible subjects
MD Feedback: Yes Arm 2 = 95% of 63 eligible subjects
n Entered: 88 Psychological: No Arm 3 = 98% of 52 eligible subjects
Comorbidities: n Analyzed: 52 Primary MD: No
n/a Follow-up times: 3 MO, 6 MO
3 Counseling/therapy (Group meeting) Tailored: Yes
Education (Group meeting) Group Setting: Yes
Exercise program (Hospitalization) Feedback: Yes
Feedback (Office visit) Psychological: Yes
Primary MD: No
n Entered: 86
n Analyzed: 52

237
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Gruen W, 1975 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2360) (Uncomplicated, Group Setting: n/a randomized.
complicated, first n Entered: n/a Feedback: n/a
occurrence, and n Analyzed: 37 Psychological: n/a Intervention subjects (arm 2) had 2.5 fewer
unspecified) Primary MD: n/a hospital days (p<0.05), less observed weakness
and depression (p<0.05), decreased anxiety
CCT 2 Advocacy training (One-on-one) Tailored: Yes (p<0.001), and fewer supraventricular
Psychological assessment/care (One-on- Group Setting: No arrhythmias (p<0.05) compared with usual care
Jadad Score: 0 one) Feedback: No patients (arm 1). No differences in chest pain
Psychological: Yes occurrence were noted.
Diagnostic criteria: n Entered: 38 Primary MD: n/a
n/a n Analyzed: n/a Follow-up times: 4 MO

Comorbidities:
CHF, anxiety and
depression
Heller R F, 1993 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 6 months:
(#809) (Uncomplicated, first Group Setting: n/a Arm 1 = 3 deaths
and reoccurrence, n Entered: 237 Feedback: n/a Arm 2 = 6 deaths
angina with and n Analyzed: 61 Psychological: n/a
without infarction, Primary MD: n/a Return to work (% return to same job) at 6
and unspecified) months:
2 Contracts (Reading material) Tailored: Yes Arm 1 = 76% of 66 eligible subjects
RCT Education (Mail) Group Setting: No Arm 2 = 66% of 61 eligible subjects
Education (Reading material) Feedback: Yes
Jadad Score: 1 Feedback (Reading material) Psychological: No Follow-up times: 6 MO
Reminders (Other mechanisms) Primary MD: No
Diagnostic criteria:
n/a n Entered: 213
n Analyzed: 61
Comorbidities:
Heart disease,
hypertension,
obesity, tobacco
abuse, angina, and
cholesterol

238
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Horlick L, 1984 Myocardial infarction 1 Control (n/a) Tailored: n/a Death at 6 months:
(#2219) (Uncomplicated, Education (Video/audio tapes) Group Setting: n/a Arm 1 = 1 death
complicated, first Feedback: n/a Arm 2 = 6 deaths
and reoccurrence, n Entered: 33 Psychological: n/a
and unspecified) n Analyzed: 65 Primary MD: n/a Return to work (% working part- or full-time) at
6 months:
RCT Arm 1 = 92.8% of 29 eligible subjects
2 Education (Group meeting) Tailored: Yes Arm 2 = 80.6% of 65 eligible subjects
Jadad Score: 1 Education (One-on-one) Group Setting: Yes
Education (Video/audio tapes) Feedback: No Follow-up times: 3 MO, 6 MO
Diagnostic criteria: Unstructured group time (Group meeting) Psychological: No
n/a Primary MD: No
n Entered: 83
Comorbidities: n Analyzed: 65
CHF, anxiety and
depression
Lewin B, 1992 Myocardial infarction 1 Control (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#827) (First occurrence Counseling/therapy (Home visit) Group Setting: n/a
and reoccurrence) Counseling/therapy (Office visit) Feedback: n/a Anxiety and general emotional disturbance
Counseling/therapy (Telephone) Psychological: n/a scores for intervention subjects (arm 2) were
RCT Education (Reading material) Primary MD: n/a half that of controls (arm 1) at 1-year follow-up.
In the first 6 months of study, 18 control
Jadad Score: 4 n Entered: 88 compared with 6 intervention patients had
n Analyzed: 60 hospital admissions (p=0.02).
Diagnostic criteria:
WHO 2 Counseling/therapy (Home visit) Tailored: Yes Follow-up times: 6 WK, 6 MO, 12 MO
Counseling/therapy (Office visit) Group Setting: No
Comorbidities: Counseling/therapy (Telephone) Feedback: No
Tobacco abuse Education (Instructional manuals) Psychological: Yes
Education (Video/audio tapes) Primary MD: No

n Entered: 88
n Analyzed: 50

239
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Miller NH, 1984 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
(#2670) (First occurrence Group Setting: n/a outcome.
and reoccurrence) n Entered: 37 Feedback: n/a
n Analyzed: n/a Psychological: n/a Though functional capacity improved in patients
RCT Primary MD: n/a randomized to either home (arms 3 and 4) or
group (arms 5 and 6) exercise training
Jadad Score: 2 2 Control (n/a) Tailored: n/a compared with controls (arms 1 and 2), no
Counseling/therapy (One-on-one) Group Setting: n/a differences were seen between home and group
Diagnostic criteria: Exercise testing (n/a) Feedback: n/a training. Frequency of exercise induced angina
CPK-MB elevation, Psychological: n/a or ischemic ST-segment depression was no
ECG, SGOT, n Entered: 34 Primary MD: n/a different between groups when measured at 26
Symptoms n Analyzed: n/a weeks.

Comorbidities: 3 Counseling/therapy (One-on-one) Tailored: Yes Follow-up times: 3 WK, 11 WK, 26 WK

n/a Exercise diary (Self-delivery) Group Setting: No
Exercise monitoring (Telephone) Feedback: Yes
Exercise program (One-on-one) Psychological: Yes
Exercise program (Reading material) Primary MD: n/a
Exercise testing (n/a)
Follow up (Telephone)

n Entered: 33
n Analyzed: n/a

4 Counseling/therapy (One-on-one) Tailored: Yes

Exercise diary (Self-delivery) Group Setting: No
Exercise monitoring (Telephone) Feedback: Yes
Exercise program (One-on-one) Psychological: Yes
Exercise program (Reading material) Primary MD: n/a
Exercise testing (n/a)
Follow up (Telephone)

n Entered: 33
n Analyzed: n/a

240
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
5 Counseling/therapy (One-on-one) Tailored: Yes
Exercise monitoring (Group meeting) Group Setting: Yes
Exercise program (Group meeting) Feedback: No
Exercise testing (n/a) Psychological: Yes
Primary MD: n/a
n Entered: 30
n Analyzed: n/a

6 Counseling/therapy (One-on-one) Tailored: Yes

Exercise monitoring (Group meeting) Group Setting: Yes
Exercise program (Group meeting) Feedback: No
Exercise testing (n/a) Psychological: Yes
Primary MD: n/a
n Entered: 31
n Analyzed: n/a

Oldenburg B, 1985 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2699) (First occurrence) Group Setting: n/a randomized.
n Entered: 14 Feedback: n/a
CCT n Analyzed: 14 Psychological: n/a Both intervention groups (arms 2 and 3) had
Primary MD: n/a improved psychological measures related to
Jadad Score: 1 2 Cognitive-behavioral (Video/audio tapes) Tailored: No anxiety, distress, and Type A behavior,
Education (Video/audio tapes) Group Setting: No compared with the usual care group (arm 1)
Diagnostic criteria: Feedback: No (p<0.05). The counseling group (arm 3)
MD n Entered: 16 Psychological: Yes demonstrated sustained significant reductions in
n Analyzed: 14 Primary MD: n/a alcohol and tobacco consumption at 12-month
Comorbidities: follow-up. A higher proportion of counseling
Heart disease subjects reported returning to work by 12
3 Cognitive-behavioral (Video/audio tapes) Tailored: Yes months and a trend towards less chest pain and
Counseling/therapy (One-on-one) Group Setting: No related hospital admissions was also seen.
Education (Video/audio tapes) Feedback: No
Psychological: Yes Follow-up times: 3 MO, 6 MO, 12 MO
n Entered: 16 Primary MD: n/a
n Analyzed: 15

241
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Oldenburg B, 1989 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2698) (First occurrence Group Setting: n/a
and reoccurrence n Entered: n/a Feedback: n/a Subjects attending a behavioral group (arm 3)
and unspecified) n Analyzed: n/a Psychological: n/a had statistically significantly less anxiety and
Primary MD: n/a depression over 12-month follow-up than the
RCT usual care subjects (arm 1) (p<0.05). Type A
2 Education (One-on-one) Tailored: No behavior was also reduced to a greater degree
Jadad Score: 1 Education (Video/audio tapes) Group Setting: No than usual care or education intervention
Feedback: No subjects (p<0.01). Smoking decreased in all
Diagnostic criteria: n Entered: n/a Psychological: No groups but relapse rate for behavioral group
n/a n Analyzed: n/a Primary MD: No was almost half that of the other 2 groups
(p<0.05). The behavioral group also had fewer
Comorbidities: 3 Cognitive-behavioral (Group meeting) Tailored: Yes physical symptoms and greater exercise
Heart disease and Contracts (Group meeting) Group Setting: Yes capacity (p<0.05).
hypertension Education (One-on-one) Feedback: Yes
Education (Video/audio tapes) Psychological: Yes Follow-up times: 4 MO, 8 MO, 12 MO
Exercise program (Group meeting) Primary MD: No

n Entered: n/a
n Analyzed: n/a

Oldridge N, 1991 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 12 months:
(#2653) (First occurrence Group Setting: n/a Arm 1 = 4 deaths
and reoccurrence) n Entered: 102 Feedback: n/a Arm 2 = 3 deaths
n Analyzed: 54 Psychological: n/a
RCT Primary MD: n/a Return to work (% return to work) at 12 months:
Arm 1 = 83.6% of 61 eligible subjects
Jadad Score: 1 2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 79.3% of 54 eligible subjects
Education (Group meeting) Group Setting: Yes
Diagnostic criteria: Exercise program (Group meeting) Feedback: No Follow-up times: 8 WK, 4 MO, 8 MO, 12 MO
CPK-MB elevation, Psychological: Yes
ECG, Symptoms n Entered: 99 Primary MD: No
n Analyzed: 54
Comorbidities:
n/a

242
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Ott CR, 1983 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2657) (Uncomplicated, Group Setting: n/a
complicated, first n Entered: 84 Feedback: n/a Same study population as Sivarajan, et al.,
and reoccurrence) n Analyzed: 59 Psychological: n/a 1983. Using the Sickness Impact Profile survey
Primary MD: n/a instrument, researchers found improved
RCT physical and psychosocial function for those
2 Education (Hospitalization) Tailored: Yes receiving an exercise program coupled with
Jadad Score: 1 Exercise program (Hospitalization) Group Setting: No counseling about cardiac risk factors and
Exercise program (Office visit) Feedback: Yes emotional adjustment after myocardial infarction
Diagnostic criteria: Exercise program (Self-delivery) Psychological: No (arm 3). Differences between groups exceeded
CPK-MB elevation, Feedback (Office visit) Primary MD: n/a any changes noted for those receiving an
ECG, Clinical history exercise-only intervention and were significant
n Entered: 88 at a .01 to .05 level dependent upon specific
Comorbidities: n Analyzed: 68 measured categories.
Obesity and tobacco
abuse 3 Counseling/therapy (One-on-one) Tailored: Yes Follow-up times: 3 MO, 6 MO
Education (Group meeting) Group Setting: Yes
Education (Hospitalization) Feedback: Yes
Education (Reading material) Psychological: Yes
Education (Self-delivery) Primary MD: n/a
Education (Video/audio tapes)
Exercise program (Hospitalization)
Exercise program (Office visit)
Feedback (Office visit)

n Entered: 86
n Analyzed: 62

243
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Payne T J, 1994 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#859) (First occurrence Group Setting: n/a randomized.
and reoccurrence) n Entered: 26 Feedback: n/a
n Analyzed: 26 Psychological: n/a Chest pain frequency and depression scores
CCT Primary MD: n/a were significantly lower for intervention subjects
(arm 2) at 1-month follow-up but no differences
Jadad Score: 1 2 Cognitive-behavioral (Group meeting) Tailored: Yes between intervention and usual care (arm 1)
Education (Group meeting) Group Setting: Yes subjects were noted at 6-months.
Diagnostic criteria: Practice self care skills (Self-delivery) Feedback: No
MD, Stress test Psychological: Yes Follow-up times: 1 MO, 6 MO
n Entered: 60 Primary MD: n/a
Comorbidities: n Analyzed: 26
Heart disease and
anxiety and
depression
Powell LH, 1984 Myocardial infarction 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2361) (First and Counseling/therapy (Group meeting) Group Setting: n/a or comparable control group.
reoccurrence, angina Feedback: n/a
with infarction and n Entered: 270 Psychological: n/a Behavioral counseling (arm 2) targeted to “Type
unspecified) n Analyzed: 259 Primary MD: n/a A” life style resulted in greater reductions in
Type A behavior compared with standard
RCT 2 Cognitive-behavioral (Group meeting) Tailored: Yes counseling (arm 1). Cardiovascular recurrence
Cognitive-behavioral (Reading material) Group Setting: Yes rates were no different between counseling
Jadad Score: 2 Counseling/therapy (Group meeting) Feedback: No groups but behavioral counseling subjects had
Psychological: Yes lower 2-year cardiovascular recurrences than
Diagnostic criteria: n Entered: 592 Primary MD: n/a controls (2.76 versus 6.00
n/a n Analyzed: 564 p<0.05) Total cholesterol and blood pressure
were similar between groups.
Comorbidities:
Heart disease, Follow-up times: 2 YR
hypertension, and
hypercholeterelemia

244
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Rahe RM, 1979 Myocardial infarction 1 Control (n/a) Tailored: n/a Death at 12 months:
(#2406) (First occurrence Dietary monitoring (Office visit) Group Setting: n/a Arm 1 = 2 deaths
and unspecified) Education (Reading material) Feedback: n/a Arm 2 = 0 deaths
Psychological: n/a
RCT n Entered: 22 Primary MD: n/a Return to work (% who worked full-time before
n Analyzed: 17 MI who returned to work) at 12 months:
Jadad Score: 1 Arm 1 = 41.7% of 12 eligible subjects
2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 94.1% of 17 eligible subjects
Diagnostic criteria: Contracts (Group meeting) Group Setting: Yes
n/a Counseling/therapy (Group meeting) Feedback: Yes Follow-up times: 18 MO, 42 MO
Dietary monitoring (Office visit) Psychological: Yes
Comorbidities: Education (Group meeting) Primary MD: No
Heart disease, Education (Reading material)
hypertension,
obesity, DM, CHF, n Entered: 22
and tobacco abuse n Analyzed: 17

Schulte MB, 1986 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as not
(#2438) (First occurrence and Group Setting: n/a randomized.
unspecified) n Entered: 16 Feedback: n/a
n Analyzed: 16 Psychological: n/a Intervention subjects (arm 2) demonstrated
CCT Primary MD: n/a decreased anxiety (p<0.05) and increased self
care cardiac skills (p<0.01) compared with usual
Jadad Score: 0 2 Education (Group meeting) Tailored: Yes care subjects (arm 1).
Practice methods (Group meeting) Group Setting: Yes
Diagnostic criteria: Practice methods (Video/audio tapes) Feedback: No Follow-up times: 10 WK
n/a Practice self care skills (Group meeting) Psychological: No
Primary MD: n/a
Comorbidities: n Entered: 29
n/a n Analyzed: 29

245
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Sivarajan ES, 1983 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2439) (Uncomplicated, Group Setting: n/a
complicated, first n Entered: 84 Feedback: n/a Same study population as Ott, et al., 1983.
and reoccurrence) n Analyzed: 63 Psychological: n/a Though modest changes in diet were noted for
Primary MD: n/a intervention subjects (arms 2 and 3), no
RCT changes occurred between groups with respect
2 Education (Hospitalization) Tailored: Yes to weight or smoking.
Jadad Score: 1 Exercise program (Hospitalization) Group Setting: No
Exercise program (Office visit) Feedback: Yes Follow-up times: 3 MO, 6 MO
Diagnostic criteria: Exercise program (Self-delivery) Psychological: No
CPK-MB elevation, Feedback (Office visit) Primary MD: n/a
ECG, Clinical history
n Entered: 88
Comorbidities: n Analyzed: 68
Obesity and tobacco
abuse 3 Counseling/therapy (One-on-one) Tailored: Yes
Education (Group meeting) Group Setting: Yes
Education (Hospitalization) Feedback: Yes
Education (Reading material) Psychological: Yes
Education (Self-delivery) Primary MD: n/a
Education (Video/audio tapes)
Exercise program (Hospitalization)
Exercise program (Office visit)
Feedback (Office visit)

n Entered: 86
n Analyzed: 62

246
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 3: Post-Myocardial Infarction Care (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Stern MJ, 1983 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Death at 12 months:
(#2377) (Unspecified) Group Setting: n/a Arm 1 = 1 death
n Entered: 29 Feedback: n/a Arm 2 = 0 deaths
RCT n Analyzed: 9 Psychological: n/a Arm 3 = 0 deaths
Primary MD: n/a
Jadad Score: 1 Return to work (% who returned who hadn't
2 Exercise program (Group meeting) Tailored: Yes returned by baseline) at 12 months:
Diagnostic criteria: Group Setting: Yes Arm 1 = 0% of 5 eligible subjects
n/a n Entered: 42 Feedback: No Arm 2 = 60% of 5 eligible subjects
n Analyzed: 9 Psychological: No Arm 3 = 33.3% of 9 eligible subjects
Comorbidities: Primary MD: No
Hypertension and Follow-up times: 3 MO, 6 MO, 1 YR
tobacco abuse 3 Counseling/therapy (Group meeting) Tailored: Yes
Group Setting: Yes
n Entered: 35 Feedback: No
n Analyzed: 9 Psychological: Yes
Primary MD: No
Turner L, 1995 Myocardial infarction 1 Usual Care (n/a) Tailored: n/a Excluded from meta-analysis as no relevant
(#887) (Unspecified) Group Setting: n/a outcome.
n Entered: 15 Feedback: n/a
RCT n Analyzed: 6 Psychological: n/a Subjective distress decreased in the stress
Primary MD: n/a management group (arm 2) as compared to the
Jadad Score: 1 usual care group (arm 1). This study lacked
2 Cognitive-behavioral (Group meeting) Tailored: No significant statistical power to detect potentially
Diagnostic criteria: Reminders (Group meeting) Group Setting: Yes meaningful between-group differences.
MD Feedback: Yes
n Entered: 30 Psychological: Yes Follow-up times: n/a
Comorbidities: n Analyzed: 18 Primary MD: No
Hypertension,
tobacco abuse, and
CABG and high
cholesterol

247
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension
Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Blumenthal JA, 1991 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 16 weeks:
(#752) (Essential, Systolic Group Setting: n/a Arm 1 = 90 (6.2)
and Diastolic, n Entered: 23 Feedback: n/a Arm 2 = 89 (6.8)
Treated and n Analyzed: 31 Psychological: n/a Arm 3 = 89 (6.4)
Untreated) Primary MD: n/a
Systolic BP (mmHg) at 16 weeks:
RCT 2 Dietary monitoring (Self-delivery) Tailored: No Arm 1 = 133 (8.6)
Exercise program (Group meeting) Group Setting: Yes Arm 2 = 133 (10.4)
Jadad Score: 1 Feedback: No Arm 3 = 136 (11.6)
n Entered: 41 Psychological: No
Diagnostic criteria: n Analyzed: 31 Primary MD: No Follow-up times: 16 WK
MD and blood
pressure recordings 3 Dietary monitoring (Self-delivery) Tailored: No
Exercise program (Group meeting) Group Setting: Yes
Comorbidities: Feedback: No
n/a n Entered: 35 Psychological: No
n Analyzed: 31 Primary MD: No

Given C, 1984 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 24 weeks:
(#2309) (Systolic and Group Setting: n/a Arm 1 = 91.4 (5.6)
diastolic, Treated, n Entered: n/a Feedback: n/a Arm 2 = 87.1 (7.1)
and Medication n Analyzed: 62 Psychological: n/a
treatment) Primary MD: n/a Systolic BP (mmHg) at 24 weeks:
Arm 1 = 138.0 (8.9)
RCT 2 Cognitive-behavioral (One-on-one) Tailored: Yes Arm 2 = 135.1 (12.9)
Cognitive-behavioral (Prescription) Group Setting: No
Jadad Score: 1 Education (Instructional manuals) Feedback: Yes Follow-up times: 6 MO
Education (One-on-one) Psychological: Yes
Diagnostic criteria: Feedback (One-on-one) Primary MD: No
MD and blood
pressure recordings n Entered: n/a
n Analyzed: 62
Comorbidities:
n/a

N/A = Not Available or Not Applicable

NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.

248
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Goldstein IB, 1982 Hypertension 1 Control (n/a) Tailored: n/a Diastolic BP (mmHg) at 8 weeks:
(#2466) (Essential, Systolic Blood pressure monitoring (Self-delivery) Group Setting: n/a Arm 1 = 98.8 (6.7)
and Diastolic, Self monitoring (Self-delivery) Feedback: n/a Arm 2 = 92.6 (6.7)
Treated and Psychological: n/a Arm 3 = 100.6 (6.7)
Untreated) n Entered: 9 Primary MD: n/a Arm 4 = 92.9 (6.7)
n Analyzed: 9
RCT Systolic BP (mmHg) at 8 weeks:
Arm 1 = 144.7 (12.4)
Jadad Score: 1 2 Blood pressure monitoring (Self-delivery) Tailored: Yes Arm 2 = 129.4 (12.4)
Medication therapy (n/a) Group Setting: No Arm 3 = 152.3 (12.4)
Diagnostic criteria: Self monitoring (Self-delivery) Feedback: No Arm 4 = 145 (12.4)
Blood pressure Psychological: No
recordings n Entered: 9 Primary MD: No Follow-up times: 2 WK, 4 WK, 6 WK, 8 WK, 3
n Analyzed: 9 MO, 4 MO, 5 MO
Comorbidities:
Tobacco abuse
3 Blood pressure monitoring (Self-delivery) Tailored: No
Cognitive-behavioral (n/a) Group Setting: No
Self monitoring (Self-delivery) Feedback: No
Psychological: Yes
n Entered: 9 Primary MD: No
n Analyzed: 9

4 Blood pressure monitoring (Self-delivery) Tailored: Yes

Nontraditional therapies (One-on-one) Group Setting: No
Self monitoring (Self-delivery) Feedback: No
Psychological: No
n Entered: 9 Primary MD: No
n Analyzed: 9

249
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Hafner RJ, 1982 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 20 weeks:
(#2467) (Essential, Systolic Group Setting: n/a Arm 1 = 96.3 (6.7)
and Diastolic, n Entered: 8 Feedback: n/a Arm 2 = 88.2 (6.7)
Treated) n Analyzed: 7 Psychological: n/a Arm 3 = 91.9 (6.7)
Primary MD: n/a
RCT Systolic BP (mmHg) at 20 weeks:
Arm 1 = 150.5 (12.4)
Jadad Score: 1 2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 132.9 (12.4)
Cognitive-behavioral (Self-delivery) Group Setting: Yes Arm 3 = 139.2 (12.4)
Diagnostic criteria: Feedback: No
MD n Entered: 8 Psychological: Yes Follow-up times: 8 WK, 3 MO, 5 MO
n Analyzed: 7 Primary MD: No
Comorbidities:
n/a
3 Cognitive-behavioral (Group meeting) Tailored: Yes
Cognitive-behavioral (Self-delivery) Group Setting: Yes
Nontraditional therapies (Group meeting) Feedback: No
Psychological: Yes
n Entered: 8 Primary MD: No
n Analyzed: 7

250
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Hoelscher TJ, 1986 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 9-10 week:
(#2457) (Essential, Systolic Group Setting: n/a Arm 1 = 95.6 (6.7)
and Diastolic, n Entered: 14 Feedback: n/a Arm 2 = 91.6 (9.0)
Treated and n Analyzed: 12 Psychological: n/a Arm 3 = 89.5 (6.9)
Untreated) Primary MD: n/a Arm 4 = 87.5 (5.9)

RCT 2 Cognitive-behavioral (One-on-one) Tailored: Yes Systolic BP (mmHg) at 9-10 week:

Feedback (One-on-one) Group Setting: No Arm 1 = 146.9 (18.4)
Jadad Score: 1 Practice self care skills (Self-delivery) Feedback: Yes Arm 2 = 138.1 (13.6)
Psychological assessment/care (One-on- Psychological: Yes Arm 3 = 135.7 (9.4)
Diagnostic criteria: one) Primary MD: No Arm 4 = 140.3 (10.6)
Blood pressure
recordings n Entered: 12 Follow-up times: 6 WK, 9 WK
n Analyzed: 12
Comorbidities:
n/a 3 Feedback (One-on-one) Tailored: Yes
Practice self care skills (Self-delivery) Group Setting: Yes
Psychological assessment/care (Group Feedback: Yes
meeting) Psychological: Yes
Primary MD: No
n Entered: 12
n Analyzed: 12

4 Contracts (Group meeting) Tailored: Yes

Contracts (Telephone) Group Setting: Yes
Feedback (One-on-one) Feedback: Yes
Practice self care skills (Self-delivery) Psychological: Yes
Psychological assessment/care (Group Primary MD: No
meeting)

n Entered: 12
n Analyzed: 12

251
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Irvine MJ, 1986 Hypertension 1 Control (n/a) Tailored: n/a Excluded from meta-analysis as no usual care
(#2458) (Diastolic, Treated Education (One-on-one) Group Setting: n/a or comparable control group.
and untreated, Exercise program (One-on-one) Feedback: n/a
Medication Nontraditional therapies (One-on-one) Psychological: n/a At 6-month follow up, significantly greater
treatment) Primary MD: n/a decreases were seen for both systolic BP and
n Entered: 16 diastolic BP in the relaxation arm (arm 2)
RCT n Analyzed: n/a compared with control arm (arm 1) (p<0.01,
p<0.05, respectively).
Jadad Score: 1 2 Cognitive-behavioral (One-on-one) Tailored: Yes
Education (One-on-one) Group Setting: No Follow-up times: 10 WK, 22 WK
Diagnostic criteria: Nontraditional therapies (One-on-one) Feedback: No
Blood pressure Psychological: Yes
recordings n Entered: 16 Primary MD: n/a
n Analyzed: n/a
Comorbidities:
n/a
Jacob RG, 1985 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 24 weeks:
(#2459) (Systolic and Group Setting: n/a Arm 1 = 85.5 (6.7)
diastolic, Untreated, n Entered: 28 Feedback: n/a Arm 2 = 85.6 (6.7)
No medication n Analyzed: 30 Psychological: n/a
treatment) Primary MD: n/a Systolic BP (mmHg) at 24 weeks:
Arm 1 = 138.4 (12.4)
RCT 2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 137.4 (12.4)
Cognitive-behavioral (Video/audio tapes) Group Setting: Yes
Jadad Score: 1 Dietary monitoring (Self-delivery) Feedback: Yes Follow-up times: 2 MO, 6 MO, 7 MO, 1 YR
Education (Group meeting) Psychological: Yes
Diagnostic criteria: Financial incentives (Group meeting) Primary MD: No
Blood pressure Practice self care skills (Self-delivery)
recordings Reminders (Group meeting)

Comorbidities: n Entered: 29
Obesity and n Analyzed: 30
cholesterol

252
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Jorgensen RS, 1981 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 12 weeks:
(#2452) (Essential, Treated, Group Setting: n/a Arm 1 = 85.4 (6.7)
and Medication n Entered: 8 Feedback: n/a Arm 2 = 69.5 (6.7)
treatment) n Analyzed: 8 Psychological: n/a
Primary MD: n/a Systolic BP (mmHg) at 12 weeks:
RCT Arm 1 = 137.8 (12.4)
2 Cognitive-behavioral (Group meeting) Tailored: Yes Arm 2 = 110.8 (12.4)
Jadad Score: 1 Cognitive-behavioral (Video/audio tapes) Group Setting: Yes
Feedback (Group meeting) Feedback: Yes Follow-up times: 6 WK
Diagnostic criteria: Follow up (Group meeting) Psychological: Yes
MD Practice self care skills (Group meeting) Primary MD: No

Comorbidities: n Entered: 10
n/a n Analyzed: 8

253
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Kostis JB, 1992 Hypertension 1 Control (n/a) Tailored: n/a Diastolic BP (mmHg) at 12 weeks:
(#2472) (Essential, Systolic Placebo medication (n/a) Group Setting: n/a Arm 1 = 100.9 (6.7)
and Diastolic, Feedback: n/a Arm 2 = 90.7 (6.7)
Treated and n Entered: 26 Psychological: n/a Arm 3 = 92.7 (6.7)
Untreated) n Analyzed: 33 Primary MD: n/a
Systolic BP (mmHg) at 12 weeks:
RCT Arm 1 = 162.1 (12.4)
2 Blood pressure lowering medication (n/a) Tailored: Yes Arm 2 = 152.6 (12.4)
Jadad Score: 2 Group Setting: No Arm 3 = 149.9 (12.4)
n Entered: 28 Feedback: No
Diagnostic criteria: n Analyzed: 33 Psychological: No Follow-up times: 3 MO
Blood pressure Primary MD: No
recordings
3 Cognitive-behavioral (Group meeting) Tailored: Yes
Comorbidities: Dietary monitoring (Self-delivery) Group Setting: Yes
n/a Education (Group meeting) Feedback: Yes
Exercise program (Self-delivery) Psychological: Yes
Goal setting (Group meeting) Primary MD: No
Social support (Group meeting)

n Entered: 38
n Analyzed: 33

254
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Lagrone R, 1988 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 8 weeks:
(#2460) (Essential, Systolic Group Setting: n/a Arm 1 = 94.6 (6.7)
and Diastolic, n Entered: n/a Feedback: n/a Arm 2 = 84.9 (6.7)
Treated) n Analyzed: 10 Psychological: n/a Arm 3 = 86.9 (6.7)
Primary MD: n/a
RCT Systolic BP (mmHg) at 8 weeks:
2 Dietary monitoring (Self-delivery) Tailored: No Arm 1 = 136.1 (12.4)
Jadad Score: 1 Education (Group meeting) Group Setting: Yes Arm 2 = 126.1 (12.4)
Exercise program (Self-delivery) Feedback: No Arm 3 = 134.5 (12.4)
Diagnostic criteria: Psychological: No
Blood pressure n Entered: n/a Primary MD: No Follow-up times: 2 WK, 10 WK
recordings n Analyzed: 10

Comorbidities: 3 Cognitive-behavioral (Group meeting) Tailored: No

Obesity Dietary monitoring (Self-delivery) Group Setting: Yes
Education (Group meeting) Feedback: No
Exercise program (Self-delivery) Psychological: Yes
Primary MD: No
n Entered: n/a
n Analyzed: 10

Leveille SG, 1998 Hypertension 1 Usual Care (n/a) Tailored: n/a The intervention group (arm 2) had fewer
(#1175) (Not specified) Group Setting: n/a disability days and less self-reported functional
n Entered: 100 Feedback: n/a decline but there were no differences based on
RCT n Analyzed: 93 Psychological: n/a physical performance tests when compared with
Primary MD: n/a the usual care group (arm 1). The number of
Jadad Score: 2 2 Education (Group meeting) Tailored: Yes inpatient days was significantly less for
Education (Instructional manuals) Group Setting: Yes intervention subjects (33 days versus 116 days
Diagnostic criteria: Education (Reading material) Feedback: Yes for usual care group, p=0.049). Intervention
n/a Follow up (One-on-one) Psychological: No subjects also had greater physical activity
Follow up (Telephone) Primary MD: No (p=0.03) and less psychoactive medication use
Comorbidities: Goal setting (One-on-one) (p=0.04) than usual care group.
Heart disease, DM,
arthritis, tobacco n Entered: 101
abuse, and cancer n Analyzed: 95
and stroke

255
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Morisky DE, 1983 Hypertension 1 Usual Care (n/a) Tailored: n/a Insufficient statistics for meta-analysis.
(#2304) (Systolic and Group Setting: n/a
diastolic) n Entered: 50 Feedback: n/a Study subjects assigned to any of the
n Analyzed: 30 Psychological: n/a experimental groups had a 30% improvement in
RCT Primary MD: n/a blood pressure control at 2 years and a 70%
improvement at 5 years compared to 22% for
Jadad Score: 1 2 Counseling/therapy (One-on-one) Tailored: Yes the usual care group with no difference in
Group Setting: No weight control or compliance in appointments.
Diagnostic criteria: n Entered: 50 Feedback: No There was a 57% reduction in the 5-year all-
MD and blood n Analyzed: 35 Psychological: Yes cause mortality for intervention subjects
pressure recordings Primary MD: No compared to those receiving usual care
(p<0.05).
Comorbidities: 3 Education (One-on-one) Tailored: Yes
Heart disease, Group Setting: No Follow-up times: 2 YR, 5 YR
kidney disease, DM, n Entered: 50 Feedback: No
and CHF n Analyzed: 36 Psychological: No
Primary MD: No

4 Cognitive-behavioral (Group meeting) Tailored: Yes

Group Setting: Yes
n Entered: 50 Feedback: No
n Analyzed: 32 Psychological: Yes
Primary MD: No

5 Counseling/therapy (One-on-one) Tailored: Yes

Education (One-on-one) Group Setting: No
Feedback: No
n Entered: 50 Psychological: Yes
n Analyzed: 43 Primary MD: No

6 Cognitive-behavioral (Group meeting) Tailored: Yes

Counseling/therapy (One-on-one) Group Setting: Yes
Feedback: No
n Entered: 50 Psychological: Yes
n Analyzed: 36 Primary MD: No

256
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Morisky DE, 1983 7 Cognitive-behavioral (Group meeting) Tailored: Yes
(#2304) Education (One-on-one) Group Setting: Yes
continued Feedback: No
n Entered: 50 Psychological: Yes
n Analyzed: 36 Primary MD: No

8 Cognitive-behavioral (Group meeting) Tailored: Yes

Counseling/therapy (One-on-one) Group Setting: Yes
Education (One-on-one) Feedback: No
Psychological: Yes
n Entered: 50 Primary MD: No
n Analyzed: 42

Southam MA, 1982 Hypertension 1 Usual Care (n/a) Tailored: n/a Diastolic BP (mmHg) at 24 weeks:
(#2453) (Essential, Systolic Group Setting: n/a Arm 1 = 90.8 (6.7)
and Diastolic, n Entered: 23 Feedback: n/a Arm 2 = 85.8 (6.7)
Treated) n Analyzed: 16 Psychological: n/a
Primary MD: n/a Systolic BP (mmHg) at 24 weeks:
RCT Arm 1 = 141.3 (12.4)
2 Cognitive-behavioral (One-on-one) Tailored: Yes Arm 2 = 137.0 (12.4)
Jadad Score: 2 Cognitive-behavioral (Video/audio tapes) Group Setting: No
Feedback: No Follow-up times: 9 WK, 6 MO
Diagnostic criteria: n Entered: 19 Psychological: Yes
MD and blood n Analyzed: 16 Primary MD: No
pressure recordings

Comorbidities:
Tobacco abuse

257
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 4: Hypertension (con't)

Condition (Type)
Study Design
First Author Quality
Year Population Intervention Intervention Meta-Analysis Data* or Outcomes
(ID) Characteristics Arm Sample Size Characteristics Follow-up Time(s)
Taylor CB, 1977 Hypertension 1 Control (n/a) Tailored: n/a Diastolic BP (mmHg) at 24 weeks:
(#2464) (Essential, Systolic Practice methods (Protocols) Group Setting: n/a Arm 1 = 94.5 (6.7)
and Diastolic, Feedback: n/a Arm 2 = 88.5 (6.7)
Treated) n Entered: 14 Psychological: n/a Arm 3 = 90.0 (6.7)
n Analyzed: 10 Primary MD: n/a
RCT Systolic BP (mmHg) at 24 weeks:
Arm 1 = 138.0 (12.4)
Jadad Score: 2 2 Counseling/therapy (One-on-one) Tailored: Yes Arm 2 = 137.0 (12.4)
Feedback (One-on-one) Group Setting: No Arm 3 = 137.8 (12.4)
Diagnostic criteria: Practice methods (Protocols) Feedback: Yes
Blood pressure Psychological: Yes Follow-up times: 8 WK, 6 MO
recordings and n Entered: 13 Primary MD: No
Routine n Analyzed: 10
hypertension workup
3 Cognitive-behavioral (One-on-one) Tailored: Yes
Comorbidities: Cognitive-behavioral (Video/audio tapes) Group Setting: No
n/a Feedback (One-on-one) Feedback: Yes
Practice methods (Protocols) Psychological: Yes
Primary MD: No
n Entered: 13
n Analyzed: 10

258
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5. Cost Articles

Article Author/ Subjects (S), Follow- Interventions Costs of Effectiveness Health care costs or C/E Ratings
numb Year up period (F/U), intervention utilizations
er Research design (D)
and settings (ST)
Diabetes
2270 Rettig et S : 393 type1 and type I: Needs assessment Not reported, but At 6 months, intervention At 6 and 12 months, no Not cost-
al., 2 diabetic patients and tailored individual involving 4-day subjects showed difference was found effective.
1986 recruited from among instruction at patient intensive course in significantly greater self-care between control and
diabetic inpatients home by a trained RN diabetes self-care for knowledge and skills than intervention subjects in
(mean = 52, 67% or LPN from home participating nurses, control, although the actual terms of diabetes-related
female) health nursing and several home differences in self-care skills hospitalizations, length of
F/U: 6 and 12 months agencies. visits (no more than were probably too small to hospital stay, foot
D: RCT C: Usual care 12 for each have any practical meaning. problems, emergency
ST: Patient home individual). No differences between the room and physician visits,
groups were noted after 12 and sick days.
mo of F/U.
2159 Wood, S: 93 hospitalized I: Inpatient group Not reported, but Based on self-report. At 4 The intervention group Likely to be
1989 patients with type 1 or education program each patient attended month f/u, all respondents experienced a significantly cost-savings.
2 diabetes, age 20 to which stressed both two days of 2-hour reported a decline in lower emergency room
75 years old (mean 60, knowledge and self- education program, performing self-care visitation rate (p <.005): At
53% female). help behaviors. with an average behaviors in comparison 4 months, the 40 control
F/U: 1 mo, and 4 C: Usual care attendance of four to with the 1-month f/u. patients reported 20 ER
st
months. six patients. The 1 Compliance was lower for visits, and the 53
D: RCT session was taught the control group. intervention patients
ST: Hospital by a nurse educator, Intervention group showed reported 2 ER visits. The
nd
and the 2 by a significantly better control patients reported
registered dietitian compliance than control in 18 hospital readmission,
and a community regards to exercise, diet, and the intervention
health nurse. administering insulin, and patients reported 8
better outcome measures hospital readmission.
relating to improved
metabolic control and
significant reduction in blood
sugar levels.
2589 de S : 558 insulin-treated I: 1) Collaborative Direct costs of the No significant effect of No significant effect of Not cost-
Weerdt diabetic patients age group education led by education program education program on education program on effective.
et al., 18-65 years old (mean health-care worker (including the costs of metabolic control or quality costs of using health Possible
1991 = 45) (HCW), 2) Same employing the of life. services (although the reasons
F/U : 6 months education led by fellow educators) and experimental groups include the
D: RCT patients indirect costs (costs showed a trend to a quality of the
ST: 15 hospitals in C: Usual care of the hours spent by decrease in the length of education

N/A = Not Available or Not Applicable

NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.

259
Evidence Table 5: Cost Articles (con't)

Netherlands (5 for the participants in hospitalization, but it was program, and

control) attending the not significant). Almost the lack of
education) together equal changes in the supportive
equal to US$100 per number of visits to the changes in
patient (1990 dollar). physician and GP were standard
Adding the cost of found. No significant therapy and
developing difference in the daily follow-up of the
educational materials insulin dosage and education
make the per-patient number of injections were given.
cost to US$144 (1990 found between groups.
dollar). No difference Compared with the control
between I1 and I2. group, frequency of self-
blood glucose monitoring
increased significantly in
both experimental groups.
No significant effect of
education on the number
of sick days was found.
2175 Kaplan S : 76 volunteer adults I: Behavioral-based Direct cost for diet 70/76 completed follow-up N/A. Authors
et al., with type 2 diabetes group intervention. and exercise study. At 18 months, the reported
1987 (44 women), mean age Each participant was combined program is combination diet-and- cost/utility =
= 55. assigned to one of the estimated to be exercise group had achieved $10870/well
F/U: 3, 6, 12, and 18 three 10-week $1000 (1986 dollar) the greatest reductions in year. However,
months. programs: 1) diet, 2) per participant glycosylated hemoglobin cost is not
D: RCT exercise, 3) diet plus (including charges for measures. In addition, this calculated
ST: Community exercise. history and physical, group showed significant incrementally
C: 10-week programs lab work, sessions, improvements on a general (if so, the C/U
of group education. and medical quality of life measure, equal rate would be
consultations). This is to 0.092 incremental years more
non-incremental cost. of well-being for each favorable).
participant compared to
control.
0749 Arsenna S : 40 patients (mean I : Individualized Instruction at the At the 5-month f/u, the LAP Not studied. LAPs could
u et al., = 59) attending learning activity hospital costs $31 per group scored significantly provide a
1994 diabetes education packages (LAP) hour (1995 dollar), higher on knowledge cheaper
program C: Classroom The three LAPs were assessment and decreased means of edu.,
F/U: 2 and 5 months instruction developed to require percent of ideal body weight. but less
D: RCT 3.5 hours of Patients who received effectiveness
ST : Hospital instructional time. classroom instruction in lowering
Thus using LAPs exhibited significantly blood glucose
could save individuals decreased glycosylated levels than

260
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

$108.50 in hemoglobin levels. classroom edu.

instructional fees.
2586 Campbe S : 238 type 2 DM I: Comparing relative Not reported, but Individual and group There were no differences Programs that
ll et al., patients, 80 years or effectiveness of the involving 1) two 1- education programs had between groups over are more
1996 younger (mean = 58, following programs: 1) hour sessions, 2) two higher attrition rates (40%) three time periods in intensive in
51% female) without minimal instruction initial sessions, and than the behavioral and proportion of patients terms of
previous formal program, 2) education 30 minuets monthly minimal programs (10%). No consulting an patient time
instruction in diabetes program of individual session for 1 year, 3) different outcomes were ophthapmologist. The and resources
care. visits, 3) education at least two individual found between groups in behavioral program may not be
F/U: 3, 6, and 12 program incorporating sessions and a 3-day terms of physiological patients were more likely more effective,
months a group education small group education measures and BMI, except to have visited a podiatrist and thus be
D: RCT course, 4) behavioral course, as well as for behavioral program after 6 months. The less cost-
ST: Patients were program. (Note: 2) and two-hour group produced a greater groups did not differ in effective.
referred to a Diabetes 3) are standard care.) follow-ups at 3 & 9 reduction in diastolic blood terms of a mean number
Education Service for months, 4) 6 or more pressure over 12 mos and a of visits they had made to
education programs. individual visits from a greater reduction in the a general practitioner , in
Behavioral program nurse educator cholesterol risk ratio over 3 hospital admissions, or in
was conducted in mos. The behavioral the proportion who had
patient home. program patients reported changed the intensity of
higher satisfaction. their blood pressure
treatment.
3433 Glasgo S : 206 diabetic I: Individualized, From the perspective The intervention produced Not studied. $7-$8 per
w et al., patients 40 years and medical office-based of a health care significantly greater mg/dl
1997 older (mean age = 62, intervention focused organization, the improvement than usual reduction in
62% female) on dietary self- incremental cost for care on multiple measures cholesterol
F/U: 12 months management, involved the delivery of the of change in dietary compare well
D: RCT touch screen intervention totaled behavior (e.g., covariate to estimates of
ST: Outpatient clinics computer-assisted $14,755, or $137 per adjusted difference of 2.2% alternative
assessment that participant (1995 of calories from fat; p intervention
provided feedback on dollars). =0.023) and on serum including
key barriers to dietary cholesterol levels (covariate cholesterol
self-management, goal adjusted difference of lowering
setting and problem- 15mg/dl; p = 0.002) at 12- medications,
solving counseling. month follow-up. There which can cost
Follow-up components were also signicicant from $350 to
included phone calls differences favoring $1400 per
and videotape intervention on patient patient year.
intervention relevant to satisfaction (p < 0.02). No
each participant. significant improvement on
C: Usual care either HbA1c or on BMI.
1668 Sadur et S : 185 patients of a I: Multidisciplinary Not reported, but may After the intervention, HbA1c Intervention group For patients

261
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

al., HMO aged 16-75 outpatient diabetes not be more costly levels declined significantly patients had somewhat who had poor
1999 (mean = 56, 43% care management than usual care since in the intervention subjects higher ambulatory care diabetic
female) and had either delivered by a diabetes 3 providers saw 12- compared to control utilization and more management,
poor glycemic control nurse educator, a 18 patients for a 2- subjects. Several self-care intensive pharmaceutical providing this
or no HbA1c test psychologist, a hour session monthly practices and several management than control intensive
performed during the nutritionist, and a (somewhat higher measures of self-efficacy subjects during the 6- management
previous year pharmacist in cluster number of patients improved significantly in the month intervention. This program may
F/U : 6 and 12 months visit settings of 10-18 than these same intervention group. excess utilization was be cost neutral
after randomization patients/month for 6 providers would see Satisfaction with the offset by fewer hospital in the short
D: RCT months. in one-on-one program was high. admissions after the term (< 2
ST: Outpatient clinic C: Usual care sessions during the Limitation: Failure to obtain intervention. Both hospital years).
same 2 hour), and follow-up HbA1c levels and and outpatient utilization
modestly reduced questionnaires on 16% and were significantly lower for
physician visits. 25% of subjects intervention subjects after
respectively. the end of the program.
0828 Litzelma S : 395 patients with I: Multifaceted, The study materials, Patients receiving the At the end of the Indicative cost-
n et al., type 2 DM who including 1) patient including folders, foot intervention were less likely intervention, four effective.
1993 underwent the initial education and decals, postage, than control patients to have amputations had been Insufficient
patient risk behavioral contract printing, and serious foot lesions (odds done in the control group information
assessment (352 about foot-care, and educational materials, ratio 0.41, p = 0.05) and compared with one in the about cost
completed the study) also reinforcement cost less than $5000. other dermatological intervention group. saving.
(mean age = 60, 81% reminders, 2) health The major expense of abnormalities. Also they (Incidence rate is too
female, most subjects care system support of the study was the were more likely to report small to test statistical
are poorly educated identifiers on patient salary support for the appropriate self-foot-care significance). Physicians
and indigent black folders to prompt nurse-clinicians who behaviors, to have foot assigned to intervention
women) providers, 3) given did the assessments examinations during office patients were more likely
F/U : Completion of providers practice and for the research visits (68% vs. 28%, p < than physicians assigned
intervention (12 month guidelines and assistant who 0.001), and to receive foot- to control patients to refer
from initial informational flow processed the charts. care education from health patients to the podiatry
assessment) sheets on foot-related care providers (42% vs. clinic, but no difference in
D: RCT risk factors for 18%, p < 0.001). Physicians the pattern of patient
ST: Academic amputation. assigned to intervention referral to orthopedics and
outpatient clinic C: Usual care patients were more likely vascular surgery clinics.
than physicians assigned to
control patients to examine
patients’ feet.
Osteoarthritis
0830 Lorig et S : 100 subjects with I1 = An Arthritis Self- The 12-hour course Professional-taught groups No significant difference in Lay-taught
al., arthritis. 85 completed Management course taught by 2 lay- demonstrated greater number of visits to ASM course
1986 study. Mean age = 64. (ASM) group taught by leaders would cost knowledge gain while lay- physician at 4 months could be as
73% female. 73% had a male rheumatologist from $0.00 taught groups had greater follow-up between groups effective as

262
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

OA. and a female physical (volunteer) to $200 changes in relaxation than or change from baseline. professional-
F/U: 4 months therapist. (1985 dollars). By one the other two groups. The taught yet
D: RCT I2 = An ASM course health professional, subjects who received ASM cheaper.
ST: Community sites group taught by 2 the course would cost course were more likely to However, both
female lay-leaders. from $240 ($20/h) to exercise, and a tendency failed to
C: No intervention. $600 ($50/h). The toward less disability than demonstrate
costs of training and control subjects. reduction in
support for lay- number of
leaders were not physician
accounted. visits.
0835 Lorig et S : 190 subjects with I: An Arthritis Self- $15 to $20 per At 4 months, experimental At 4 months, there was a Indicative cost-
al., arthritis. Mean age = Management course participant. (1983 subjects significantly tendency of decline in effective.
1985 67. 83% female. 77% (ASM) given in 6 dollars). exceeded control subjects in visits to physicians by the Insufficient
had OA. sessions by lay knowledge, recommended intervention group, but did information
F/U: 4 months RCT persons, based on a behaviors, and in lessened not reach statistical about cost
and 20 months standardized pain. These changes significance at .05 level. saving.
longitudinal study. educational protocol remained significant at 20 The 20 months
D: RCT + longitudinal emphasizing group months. longitudinal study showed
study discussion, practice, the number of physician
ST: Community sites the use of contracts visits reduced from
and diaries to improve baseline to 4-month f/u,
compliance, and and from 4 months to 8-
weekly feedback. No months, and remained
subsequent about the same from 8
reinforcement. (129 months to 20 months.
subjects) These changes did not
C: Delayed reach statistical
intervention for 4 signiciance.
months. (61 subjects)

Mazzuc S : 211 patients with I : Self-care education: The cost of See health care costs or The 94 subjects remaining For more than
a et al., knee OA from the Individualized deliverying the self- utilizations. in intervention group 50% of
1999 general medicine clnic instruction and follow- care education made 528 primary care patients
of a municipal hospital up emphasizing intervention to 105 visits during the follow-up receiving the
(Of which 25 lost to nonpharmacologic subjects was $6,163 year, while the 92 intervention,
f/u). Mean age = 63. management of joint (in 1996 dollars), or controlled patients made the reduced
85% female. pain equivalently, $58.70 616 visits. The average outpatient
F/U: 1 year C: A standard public per patient. subject in intervention visits and costs
D: CT (Nonrandomized education presentation group generated $262 in offset the
Attention-controlled and attention- clinic costs, compared intervention
clinical trial) controlling follow-up. with $322 for the average costs. 80% of

263
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

ST: Outpatient clinic subject in control group. the

The frequencies and costs intervention
associated with charges costs was
for drugs, radiography, offset within
and laboratory tests were one year due
similar between groups. to reduced
outpatient
visits.
Groessl S : 363 members of a I1: Social support $9450 for social Feelings of helplessness Health care costs Cost effective
& HMO, 60 years of age I2: Education support group, decreased in the increased less in the and cost
Cronan, and older with OA. I3: A combination of $18675 for education intervention groups but not intervention groups than in saving. The
2000 Mean age = 70. social support and group, and $14175 in the control group. All the control group. Based one-year cost-
F/U: 3 years education for combination groups showed increases in on the HMO data, health benefit ratio
D: RCT C: Usual care group, totaling self-efficacy and overall care cost savings were was $7.29:1.
ST: Community $42300 (all in 1992 health status. $1,156/participant for year The three-year
dollars). one and two, and cost-benefit
$1,279/participant for year ratio was
three (1992 dollars). $22.05:1.
Hypertension
2457 Hoelsch S: 50 (24 female) adult I: 1) individualized Measured by Measured by percent Not measured. GR was
er et al., average 51.1 years of relaxation (IR), 2) therapist time reductions in systolic and significantly
1986 age with essential group relaxation (GR), diastolic blood pressure, and more cost
hypertension recruited 3) group relaxation by eliciting home relaxation effective than
via media plus contingency practice IR for systolic,
announcements. contracting for home whereas both
Secondary practice (GRCC) GR and GRCC
hypertension or with C: Waiting list control were more
mean baseline blood cost effective
pressures greater than than IR for
180 mm Hg systolic or diastolic blood
120 mm Hg diastolic pressure. For
were excluded. amount of
F/U: 6 weeks relaxation
D: RCT practice, GR >
ST: Patient home GRCC > IR.

Post Myocardial Infarction Care

2669 DeBusk S: 198 men 70 years I1A: Medically directed Three months of at- Compared to the group Not studied. Medically
et al., or younger, had had at-home rehabilitation home rehabilitation rehabilitation, medically directed at-
1985 clinically training for 23 weeks was estimated to be directed at-home home
uncomplicated AMI, I1B: Medically directed approximately $328 rehabilitation had about rehabilitation

264
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

mean age 52 ± 9 at-home training for 8 per patient (1982 or equally high adherence to has the
years. weeks 1983 dollar). The individually prescribed potential to
F/U: 26 weeks I2A: Supervised group group rehabilitation exercise, increase in decrease the
D: RCT training in a program was functional capacity, and low cost of
ST: Patient home or gymnasium for 23 approximately $720. nonfatal reinfarction and rehabilitating
community gymnasium weeks dropout rates. Compared to low-risk
I2A: Supervised group the no-training and control survivors of
training in a groups, the training groups AMI.
gymnasium for 8 were significantly greater in
weeks functional capacity, but not
I3: Exercise testing different in cardiac events.
without subsequent
exercise training
C: Neither testing nor
training
0827 Lewin et S: 176 male and I: A comprehensive The authors Psychological adjustment The two groups Based on
al., female patients with an self-help rehabilitation estimated the cost of was better in the significantly differed in the physician self-
1992 AMI and age less than programme based on treatment per patient rehabilitation group at 1 number of GP report data for
80 years (mean age = a heart manual to be £30 - £50 (1990 year. The improvement was consultations at six use of health
55.8 ± 10.6 years) Spouses were given dollar). greatest among patients months and after the services.
F/U: 1 year materials to support who were clinically anxious second six months; the Indicative cost-
D: RCT and encourage or depressed at discharge control group made a saving.
ST: Patient home compliance by from hospital. mean of 1.8 more visits
patients. Included than did the rehabilitation
follow-up and group in the first 6
feedback. months, and a mean of
C: Standard care plus 0.9 more visits in the
a placebo package of subsequent 6 months. In
information and addition, significantly more
informal counseling. control patients than
rehabilitation group
patients were admitted to
hospital in the first 6
months (18 vs. 6) but not
at 12 months (18 vs. 9).
Significantly fewer
rehabilitation group
patients were readmitted
to hospital in the first 6
months (8% vs. 24%).
Non-disease-specific Programs

265
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

1175 Leveille S: 201 chronically ill I: A geriatric nurse The authors The intervention group The number of Indicative cost
et al., seniors aged 70 and practitioner (GNP) led estimated the showed less decline in hospitalized participants saving, due to
1998 older (mean age = multi-component program cost function, as measured by increased by 69% (from less hospital
77.1 years) with heart program including risk (primarily the salaries disability days and lower 13 to 22) among the use.
disease, high blood factor and health for the GNP and the scores on the Health controls and decreased by
pressure, arthritis, assessment, feedback social worker) to be Assessment Questionnaire. 38% (from 21 to 13) in
cancer, stroke, or to PCPs, follow-up approximately $300 However, the measures by the intervention group (p =
diabetes. More % of visits and phone (1997 dollar) annually SF-36 and a battery of .083). The total number of
female in intervention contacts, physical per participant. physical performance tests inpatient hospital days
than in control (63.4% activity for disability did not show difference by during the study year
vs. 48.0%) prevention, and intervention. The decreased by 72% in the
F/U: 1 year individual counseling intervention led to intervention group but
D: RCT about disease self- significantly higher levels of increased by 21% in the
ST: A large senior management as well physical activity and senior control group
center, in collaboration as group classes. center participation. (p = .049). The 83 less
with primary care C: Access to all senior hospital days in the
providers of MCOs. center activities, but no intervention group yielded
GNP. a savings of
approximately $1200 per
participant. Outpatient
visits did not change in the
intervention group but
slightly increased in the
control group. There were
two less ER visits in the
intervention group but 8
less ER visits in the
control group.
1510 Colema S: 169 patients aged I: Chronic Care Clinics Not available. After 24 months, no At baseline, intervention Insufficient
n et 65 and older (mean = attempted to significant improvements in patients were more likely information
al./1999 77) with the highest reorganize the delivery frequency of incontinence, to be hospitalized. During (implied not
risk for being of primary care proportion with falls, the 24-month follow-up, cost saving).
hospitalized or services to better meet depression scores, physical costs of medical care
experiencing functional the needs of older function scores, or including frequency of
decline persons with chronic prescriptions of high risk hospitalization, hospital
F/U: 2 years illness, including medications were days, emergency and
D: RCT disease management demonstrated. A higher ambulatory visit, and total
ST: Nine primary care planning, medication proportion of intervention costs of care were not
physician offices in a review, patient self- patients rated the overall significantly different
large staff-model HMO management/support quality of their medical care between intervention and
group) as excellent compared with control groups.

266
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.
Evidence Table 5: Cost Articles (con't)

C: Usual care control patients (40% vs.

25%, p = 0.1)
0608 Lorig et S: 952 patients 40 I: Subjects received The authors At 6 months, treatment Based on patient self- Cost-effective
al., years and older (mean the Chronic Disease estimated the subjects demonstrated report, the treatment and indicative
1999 = 65) with heart Self-Management program cost to be improvements in weekly group reduced their cost-saving
disease, lung disease, Program (CDSMP), a approximately $70 minutes of exercise, physician visits slightly (approximately
stroke, or arthritis. community-based (1998 dollar) per frequency of cognitive more, but not significantly, a saving of
F/U: 6 months patient self- intervention symptom management, than did the control group. $750 per
D: RCT management participant. This communication with However, the decrease in participant,
ST: Community-based education course. The includes $26 for physicians, self-reported the number of according to
sites (churches, senior content and training leaders, $14 health, health distress, hospitalizations and in the author
and community methodology of the for volunteer leader fatigue, disability, and length of hospital stays estimates
centers, public CDSMP were based stipend, $15 for social/role activities were significant at p <.05. based on
libraries, & health care on needs course materials, and limitations, compared with Assuming a cost of $1000 patient self-
facilities) assessments. The $15 administrative control subjects. Program per day of hospitalization, reported
process of teaching costs. This analysis effects were similar across the 6-month health care utilization
the course is based on does not take into all four diagnostic costs for each control data).
Self-Efficacy Theory. account the cost of subgroups. participant in this study
The course was taught space or indirect were $820 greater than for
by a pair of trained, costs. each treatment subjects.
volunteer lay leaders.
C: Waiting list control

267
N/A = Not Available or Not Applicable
NOS = Not Otherwise Specified
* Unless otherwise specified, Mean (Standard Deviation) reported.