DEPRESSION

AND

ANXIETY 27 : 977981 (2010)

Research Article
VALIDITY OF A SIMPLER DEFINITION OF MAJOR DEPRESSIVE DISORDER
Mark Zimmerman, M.D., Janine N. Galione, B.S., Iwona Chelminski, Ph.D., Diane Young, Ph.D., Kristy Dalrymple, Ph.D., and Caren Francione Witt, Ph.D.

Background: In previous reports from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we developed a briefer definition of major depressive disorder (MDD), and found high levels of agreement between the simplified and DSM-IV definitions of MDD. The goal of the present study was to examine the validity of the simpler definition of MDD. We hypothesized that compared to patients with adjustment disorder, patients with MDD would be more severely depressed, have poorer psychosocial functioning, have greater suicidal ideation at the time of the intake evaluation, and have an increased morbid risk for depression in their first-degree family members. Methods: We compared 1,486 patients who met the symptom criteria for current MDD according to either DSM-IV or the simpler definition to 145 patients with a current diagnosis of adjustment disorder with depressed mood or depressed and anxious mood. Results: The patients with MDD were more severely depressed, more likely to have missed time from work due to psychiatric reasons, reported higher levels of suicidal ideation, and had a significantly higher morbid risk for depression in their first-degree family members. Both definitions of MDD were valid. Conclusions: The simpler definition of MDD was as valid as the DSM-IV definition. This new definition offers two advantages over the DSM-IV definitionit is briefer and therefore more likely to be recalled and applied in clinical practice, and it is free of somatic symptoms thereby making it easier to apply with medically ill patients. Depression and Anxiety 27:977981, 2010.
r 2010 Wiley-Liss, Inc.

Key words: major depressive disorder; diagnostic criteria; validity; depression

The DSM-IV criteria for major depressive disorder

INTRODUCTION

physicians are unable to recall most of the MDD symptom criteria.[26]

The Department of Psychiatry and Human Behavior, Rhode Island Hospital, Brown Medical School, Providence, Rhode Island
Correspondence to: Mark Zimmerman, Bayside Medical Building,

(MDD) require the presence of at least five symptoms from a list of nine, one of which must be either low mood or loss of interest or pleasure in all, or almost all, usual activities. While the symptom inclusion criteria for MDD have remained essentially the same for the past 35 years, there are problems with their use. In a survey of physicians reported use of the DSM-IV MDD criteria, Zimmerman and Galione[1] found that approximately one-quarter of experienced psychiatrists often do not determine if the MDD criteria are met when diagnosing depression, and that the majority of primary care physicians usually do not determine whether the MDD criteria are met when diagnosing depression. The results of this survey were consistent with studies which found that most nonpsychiatrist

235 Plain Street, Providence, RI 02905. E-mail: mzimmerman@lifespan.org The authors report they have no financial relationships within the past 3 years to disclose. Received for publication 23 March 2010; Revised 8 April 2010; Accepted 15 April 2010 DOI 10.1002/da.20710 Published online 28 June 2010 in Wiley Online Library (wiley onlinelibrary.com).

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These findings raised concerns about the clinical utility of the MDD criteria. We therefore developed a simpler definition of MDD consisting of only five criteria, at least three of which need to be present (including low mood or loss of interest) in order to diagnose MDD.[7] As shown in Table 1, a high level of agreement between the simpler definition and the DSM-IV definition has been found in each of six samples.[79] The mean level of agreement between the two definitions across the studies was 94.6%. No previous report examined the validity of the simpler definition.[7,8] We argued that improved clinical utility was sufficient to consider revising the diagnostic criteria. Nonetheless, improving the clinical utility of the definition of MDD while sacrificing validity would argue against changing the diagnostic criteria. Accordingly, in the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we turned to the issue of the validity of the simpler definition of MDD. To test the validity of the simpler and DSM-IV definitions of MDD, we compared the patients diagnosed with MDD according to each algorithm to patients with adjustment disorder with depressed mood or depressed and anxious mood. Because patients with adjustment disorder with depressed mood also have a disturbance in mood, they are a particularly appropriate comparison group for a study of the validity of definitions of MDD. We hypothesized that compared to patients with adjustment disorder, patients with MDD would be more severely depressed, have poorer psychosocial functioning, have greater suicidal ideation at the time of the intake evaluation, and have an increased morbid risk for depression in their firstdegree family members. We predicted that both the simpler and DSM-IV definitions of MDD would be valid.

diagnostic interview in the Rhode Island Hospital Department of Psychiatry outpatient practice. In the present report, we focus on the 1,486 patients who met the symptom criteria for current major depression according to either DSM-IV or the simpler definition. In addition, as a comparison group to establish the validity of the two definitions of major depression, we included 152 patients with a current diagnosis of adjustment disorder with depressed mood or depressed and anxious mood. Seven patients who met the criteria for both adjustment disorder and the simpler definition of MDD were included in the MDD group because this is consistent with the DSM-IV hierarchical relationship between MDD and adjustment disorder. This left 145 patients in the adjustment disorder group. Thus, the present sample consisted of a total of 1,631 psychiatric outpatients with MDD or adjustment disorder. The data in Table 2 show that the majority of the patients were white (85.9%), female (64.9%), married (42.2%) or single (27.7%), and graduated high school (64.4%). All patients were interviewed by a diagnostic rater who administered the Structured Clinical Interview for DSM-IV (SCID).[13] Because we were interested in the psychometric performance of the

TABLE 2. Demographic characteristics of 1,631 psychiatric outpatients with major depressive disorder or adjustment disorder with depressed mood
Characteristic Gender Female Male Education Less than high school Graduated high school Graduated college or greater Marital status Married Living with someone Widowed Separated Divorced Never married Race White Black Hispanic Asian Other Age (years) n 1,059 572 167 1,050 414 688 93 32 103 263 452 1,401 83 56 10 81 M 5 39.3 % 64.9 35.1 10.2 64.4 25.4 42.2 5.7 2.0 6.3 16.1 27.7 85.9 5.1 3.4 0.6 5.0 SD 5 12.4

METHODS
The Rhode Island MIDAS project represents an integration of research methodology into a community-based outpatient practice affiliated with an academic medical center.[1012] To date, 2,900 psychiatric outpatients have been evaluated with a semi-structured

TABLE 1. Concordance between a simpler definition of major depressive disorder with the DSM-IV symptom criteria for major depression in six samples
Samples Zimmerman et al. Derivation sample Cross-validation sample Andrews et al.[9] General population Zimmerman et al.[8] Psychiatric outpatients Pathological Gamblers Candidates for bariatric surgery Depression and Anxiety
[7]

N 805 789 10,641 1,100 210 1,200

No. of patients meeting DSM-IV symptom criteria 436 466 339 476 59 31

Sensitivity 92.7 92.3 92.9 89.1 89.8 80.6

Specificity 94.8 96.6 99.8 93.9 96.0 99.6

Overall agreement 93.7 94.0 94.6 91.8 94.3 99.1

Kappa 0.87 0.88 0.93 0.83 0.86 0.82

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DSM-IV symptom criteria for MDD, we modified the SCID and eliminated the skip-out that curtails the depression module for patients who did not report either depressed mood or loss of interest or pleasure. Thus, we inquired about all of the symptoms of depression for all patients. The Rhode Island Hospital institutional review committee approved the research protocol, and all patients provided informed, written consent. As an ongoing part of the MIDAS project, joint-interview diagnostic reliability information was collected on 48 participants. The reliability coefficients of the symptoms of depression ranged from .54 to .94 (mean k 5 .80). The interview also included items from the Schedule for Affective Disorders and Schizophrenia on the level of social functioning during the past 5 years, and the amount of time missing work due to psychiatric reasons during the past 5 years. Family history diagnoses were based on information provided by the patient. The interview followed the guide provided in the Family History Research Diagnostic Criteria[14] and assessed the presence or absence of problems for a variety of psychiatric disorders, although in the present report we focused on depression in the patients firstdegree family members. Morbid risks were calculated using agecorrected denominators or bezugsiffers based on Weinbergs shorter method.[15] Thus, relatives over the age of risk for the particular illness were given a value of 1; those within the age for risk were given a value of 0.5, and those below it were given a value of 0. Limits for the ages of risk for depression were 25 to 44 years based on the distribution of ages of onset in our probands. Morbid risks were compared using the w2 statistic.

92.6 to 95.4%). In a replication and extension study, we examined the simplest of these definitions: at least three of the following five symptoms are present (low mood, loss of interest, guilt or worthlessness, impaired concentration or indecisiveness, and death wishes or suicidal thoughts), one of which is low mood or loss of interest.[8] For both definitions of MDD, we compared the groups to the patients with adjustment disorder. Categorical variables were compared by the w2 statistic, or by Fishers Exact Test if the expected value in any cell of a 2 2 table was less than 5. Continuous variables were compared by t-test.

RESULTS
For the entire group of 2,900 patients, the prevalence of current MDD was 48.5% based on the DSM-IV criteria and 46.9% based on the simpler definition. The overall level of agreement between the simplified and DSM-IV definition of MDD was 92.9% (k 5 0.86). The prevalence of adjustment disorder with depressed mood or depressed and anxious mood was 5.0% (n 5 145). We compared the patients who met each definition of MDD to the patients with adjustment disorder. There were no differences in the demographic characteristics between the two groups. The data in Table 3 show that compared to the patients with adjustment disorder the patients with MDD according to each definition were more likely to have missed a month or more of work due to psychiatric reasons during the previous 5 years, more severely depressed at the time of the evaluation, reported higher levels of suicidal ideation, poorer social support, and had a significantly higher morbid risk for depression in their first-degree family members.

DATA ANALYSIS
Previously, we developed a simpler definition of MDD exclusive of somatic symptoms with the goal of maximizing concordance with the current DSM-IV definition.[7] (Technically, our previous and the current research have focused on the symptom criteria of a major depressive episode. For stylistic simplicity we refer to this as a simpler definition of MDD.) We approached the development of a new definition in six ways, each of which yielded comparable results (agreement rates with the original DSM-IV definition ranged from

TABLE 3. Clinical characteristics of psychiatric outpatients with adjustment disorder and patients meeting criteria for a simpler definition of MDD and the DSM-IV MDD criteria
Adjustment disorder (n 5 145) Clinical global impression of depression severity, mean (SD) Severity of suicidal ideation, mean (SD)c Global assessment of functioning, mean (SD) Best social functioning past 5 years, N (%)c Good or excellent Fair or worse Time out of work past 5 years, N (%)d Virtually no time One month or more Family history of depression, N (morbid risk)e 1.8 (0.7) 0.5 (1.0) 59.8 (8.2) 120 (82.8) 25 (17.2) 88 (71.0) 36 (29.0) 61 (7.8) MDD-simpler definition (n 5 1,360)a 3.1 (0.6) 1.5 (1.3) 49.2 (8.3) 843 (62.0) 516 (38.0) 348 (28.3) 882 (71.7) 916 (12.4) MDDDSM-IV definition (n 5 1,406)b 3.2 (0.6) 1.4 (1.3) 49.3 (8.3) 885 (63.0) 519 (37.0) 355 (27.9) 916 (72.1) 952 (12.4)

MDD, major depressive disorder. a MDD-Simpler definition versus adjustment disorder, Po.001. b MDD-DSM-IV definition versus adjustment disorder, Po.001. c Rating of 06 from Schedule of Affective Disorders and Schizophrenia. d Patients who were not expected to work (e.g. because they were students, physically ill) were not included. e The number of relatives at risk for the morbid risk calculations were 778.5 for adjustment disorder, 7,402.5 for simpler definition, and 7,657.5 for DSM-IV definition. Depression and Anxiety

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DISCUSSION
The present findings are important for two reasons. First, they demonstrate that a simpler definition of MDD can be developed that is as valid as the DSM-IV definition. Second, the findings highlight the validity of distinguishing between MDD and adjustment disorder. After eliminating the four somatic criteria from the DSM-IV definition of MDD leaving the five mood and cognitive features, a high level of concordance was found between this simpler definition of MDD with the original DSM-IV classification. This new definition offers two advantages over the DSM-IV definitionit is briefer and therefore more likely to be recalled and applied in clinical practice, and it is free of somatic symptoms thereby making it easier to apply with medically ill patients. As shown in Table 1, a high level of concordance between the simpler and DSM-IV definitions of MDD has been found in six samplesthree psychiatric outpatient samples, a general population community sample, a sample of gamblers who often were depressed but did not present with depression as their primary complaint, and a sample of obese subjects who often had medical comorbidity. None of the prior studies, however, examined the validity of the simpler definition of MDD. The present results indicate that MDD diagnosed according to either of the two definitions was distinguishable from adjustment disorder. In our previous reports on the correspondence between the simpler and DSM-IV definitions of MDD, we discussed whether the current MDD criteria should be changed in the absence of improved validity. The present findings do not provide evidence that the simpler definition is more valid than the DSM-IV definition. However, the clinical utility of the simpler definition is likely to be greater than the DSM-IV definition, and this might improve validity in the clinical setting. Although a simpler definition of MDD will not enhance validity in research studies using careful and thorough assessment procedures based on semi-structured diagnostic interviews, we believe that in clinical practice a simpler set of criteria for diagnosing MDD might improve validity because we suspect that MDD is sometimes underdiagnosed in medically ill patients due to the uncertainty as to whether or not to count the somatic criteria, and sometimes overdiagnosed when clinicians, particularly nonpsychiatrist physicians, do not fully evaluate the diagnostic criteria and diagnose MDD when fewer than the minimum number of features are present. The results of the present study supported the validity of the distinction between MDD and subthreshold variants of depression such as adjustment disorder. If this distinction is not made in clinical practice because the criteria are too long or complex to apply, then no matter how valid the DSM-IV criteria may be in research settings their validity in clinical settings will be
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compromised by failing to follow the DSM-IV diagnostic algorithm. The validity of clinical diagnosis is likely to be improved if a briefer, more clinically useful, albeit equally valid, set of criteria is adopted. In deciding how to proceed in the next versions of the DSM and ICD, the conceptual and practical advantages of a briefer set of criteria that is easier to apply to all patients, particularly medically ill patients and patients seen in primary care, needs to be weighted against the disadvantages of deviating from tradition and the risk of overlooking symptoms that are important to assess in depressed patients even though they are no longer diagnostic criteria. Is a potential gain in clinical utility and clinical validity, in the context of data demonstrating equal, though not superior, validity when using research assessment procedures, sufficient to warrant criteria modification? Both psychiatrists and primary care clinicians report that they often do not use the DSM-IV criteria when diagnosing depression.[1] There are likely multiple reasons why clinicians, particularly primary care clinicians, do not use the DSM-IV criteria for MDD when diagnosing depression, with the length and complexity of the criteria being only one reason. It is possible that even with an abbreviated set of diagnostic criteria clinicians still will not formally apply them but instead will continue to make noncriteria-based gestalt judgments regarding the presence or absence of depression. Perhaps, then, a change in diagnostic criteria based on clinical utility grounds should require a demonstration of improved clinical utility. To date, no study has examined whether a simpler definition of MDD would, in fact, improve the validity of diagnosis in clinical practice. Also, it is possible that with the increased use of self-administered depression screening scales to assist with diagnostic evaluations that the DSM-IV criteria will be applied more faithfully, and a simpler definition will not enhance validity. A limitation of the present study is that it was conducted in a single outpatient practice in which the majority of the patients were white, female, and had health insurance. Replication of the results in samples with different demographic characteristics is warranted. Also, replication in a sample of medically ill patients is important because the elimination of the somatic criteria might have its greatest influence in these patients. Depressed patients seen in the specialty health care sector may be more severely ill than patients seen in primary care, therefore replication in a primary care setting, where the level of severity may not be as great, is warranted.

REFERENCES
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2. Krupinski J, Tiller J. The identification and treatment of depression by general practitioners. Aust N Z J Psychiatry 2001;35:827832. 3. Medow M, Borowsky S, Dysken S, et al. Internal medical residents ability to diagnose and characterize major depression. West J Med 1999;170:3540. 4. Gerrity M, Cole S, Dietrich A, Barrett J. Improving the recognition and management of depression: is there a role for physician education? J Fam Pract 1999;48:949957. 5. Learman L, Gerrity M, Field D, et al. Effects of a depression education program on residents knowledge, attitudes, and clinical skills. Obstet Gynecol 2003;101:167174. 6. Rapp S, Davis K. Geriatric depression: physicians knowledge, perceptions, and diagnostic practices. Gerontologist 1989;29: 252257. 7. Zimmerman M, Chelminski I, McGlinchey JB, Young D. Diagnosing major depressive disorder X: can the utility of the DSM-IV symptom criteria be improved? J Nerv Ment Dis 2006;194:893897. 8. Zimmerman M, Galione JN, Chelminski I, et al. A simpler definition of major depressive disorder. Psychol Med 2010;40:451457. 9. Andrews G, Slade T, Sunderland M, Anderson T. Issues for DSM-V: simplifying DSM-IV to enhance utility: the case of major depressive disorder. Am J Psychiatry 2007;164:17841785.

10. Zimmerman M. Integrating the assessment methods of researchers in routine clinical practice: the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project. In: First M, editor. Standardized Evaluation in Clinical Practice. Washington, DC: American Psychiatric Publishing, Inc.; 2003: 2974. 11. Posternak MA, Zimmerman M, Solomon DA. Integrating outcomes research into clinical practice: a pilot study. Psychiatr Serv 2002;53:335336. 12. Zimmerman M, Mattia JI, Posternak MA. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice. Am J Psychiatry 2002;159:469473. 13. First MB, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV Axis I DisordersPatient Edition (SCID-I/P, version 2.0). New York: Biometrics Research Department, New York State Psychiatric Institute; 1995. 14. Endicott J, Andreasen N, Spitzer RL. Family History Research Diagnostic Criteria. 3rd ed. New York: Biometrics Research, New York State Psychiatric Institute; 1978. 15. Stromgren E. Statistical and genetic population studies within psychiatry: methods and principal results. Actualities Scientifiques et Industrelles. 1101 Congres International de Psychiatrie 1950;6:155157.

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