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BACKGROUND: Balance deficits and an increased fall risk are well documented in individuals
with COPD. Despite evidence that balance training programs can improve performance on
clinical balance tests, their minimal clinically important difference (MCID) is unknown. The
aim of this study was to determine the MCID of the Berg Balance Scale (BBS), Balance
Evaluation Systems Test (BESTest), and Activities-Specific Balance Confidence (ABC) scale
in patients with COPD undergoing pulmonary rehabilitation.
METHODS: We performed a secondary analysis of data from two studies of balance training in
COPD (n ¼ 55). The MCID for each balance measure was estimated using the following
anchor and distribution-based approaches: (1) mean change scores on a patient-reported
global change in balance scale, (2) optimal cut-point from receiver operating characteristic
curves (ROCs), and (3) the minimal detectable change with 95% confidence (MDC95).
RESULTS: Data from 55 patients with COPD (mean age, 71.2 7.1 y; mean FEV1,
39.2 15.8% predicted) were used in the analysis. The smallest estimate of MCID was from
the ROC method. Anchor-based estimates of the MCID ranged from 3.5 to 7.1 for the BBS,
10.2 to 17.4 for the BESTest, and 14.2 to 18.5 for the ABC scale; their MDC95 values were
5.0, 13.1, and 18.9, respectively.
CONCLUSIONS: Among patients with COPD undergoing pulmonary rehabilitation, a change
of 5 to 7 points for the BBS, 13 to 17 points for the BESTest, and 19 points for the ABC scale
is required to be both perceptible to patients and beyond measurement error.
CHEST 2016; 149(3):696-703
KEY WORDS: COPD; exercise; minimal clinically important difference; outcome measures;
physical therapy; pulmonary rehabilitation; responsiveness
ABBREVIATIONS: ABC = Activities-Specific Balance Confidence; An abstract of this work was presented at the 2015 American Thoracic
AUC = area under the curve; BBS = Berg Balance Test; BESTest = Society Conference in Denver, CO, May 15-20, 2015.
Balance Evaluation Systems Test; GRC = global rating of change scale; FUNDING/SUPPORT: Dr Beauchamp was supported by a fellowship
MCID = minimal clinically important difference; MDC95 = minimal from the Canadian Institutes of Health Research; Dr Goldstein is
detectable change with 95% confidence; PR = pulmonary rehabilita- supported by the University of Toronto, National Sanitarium Associ-
tion; RCT = randomized controlled trial; ROC = receiver operating ation Chair in Respiratory Rehabilitation Research; and Dr Brooks is
characteristic curve supported by a Canada Research Chair.
AFFILIATIONS: From the Department of Physical Medicine and CORRESPONDENCE TO: Marla K. Beauchamp, PhD, PT, School of
Rehabilitation (Dr Beauchamp), Harvard Medical School, Spaulding Rehabilitation Science, McMaster University, 1400 Main Street West,
Rehabilitation Hospital, Cambridge, MA; the Department of Respiratory Hamilton, ON, Canada L8S 1C7; e-mail: beaucm1@mcmaster.ca
Medicine (Drs Beauchamp, Harrison, Goldstein, and Brooks), West Park
Copyright Ó 2016 American College of Chest Physicians. Published by
Healthcare Centre, Toronto, ON, Canada; and the Department of
Elsevier Inc. All rights reserved.
Medicine (Dr Goldstein) and the Department of Physical Therapy
DOI: http://dx.doi.org/10.1378/chest.15-0717
(Dr Brooks), University of Toronto, Toronto, ON, Canada.
Dr Beauchamp is currently at the School of Rehabilitation Science,
McMaster University (Hamilton, ON, Canada).
Materials and Methods Balance Evaluation Systems Test: The BESTest is a 36-item
comprehensive balance measure that evaluates six underlying postural
We performed a secondary analysis of data from 55 subjects who control systems: biomechanics, stability limits/verticality, anticipatory
participated in either a randomized controlled trial (RCT) of balance control during postural transitions, reactive control strategies,
training (n ¼ 36) (NCT01424098)16 or a study of knowledge translation weighting of sensory information, and stability during gait.23 Total
of balance training into PR (n ¼ 19) (NCT02080442).19 Both studies scores range from 0% to 100%, with higher scores indicating greater
were conducted at the same center and used identical procedures for balance ability. Evidence supports the BESTest’s construct validity in
screening and assessing patients. Details of the balance training, study COPD5,17 and sensitivity to change, test-retest reliability, and
methods, and outcomes used have been previously published.16 Briefly, concurrent validity in adults with and without balance disorders.23,24
the studies both involved individuals with COPD, enrolled in PR, who
met one or more of three criteria: (1) a self-reported problem with their ABC Scale: Patients are asked to rate their confidence in maintaining
balance, (2) a history of one or more falls in the last 5 years, or (3) a their balance during 16 specific activities requiring progressively
report of a recent trip or loss of balance that resulted in a near fall. Those increased balance control on an 11-point scale.25 Examples of tasks
with comorbid conditions that might affect communication, balance, or include standing on a chair and walking on an icy sidewalk. Overall
safety were excluded. Patients assigned to the intervention group in the scores range from 0% to 100%, with higher scores indicating greater
RCT and those in the knowledge translation study underwent 30 min of balance confidence. The ABC scale has good test-retest reliability
balance training three times a week for 6 weeks in conjunction with PR. and predicts falls in older adults residing in the community.22,25 In
Individuals assigned to the control arm of the RCT received only PR. All patients with COPD, the ABC scale has demonstrated construct
the outcome measures were collected prior to and on completing validity as well as criterion validity for falls.4,17
rehabilitation by the same rater, and all assessments were conducted by
Global Rating of Change Scale: The global rating of change scale
physiotherapists experienced in administering the balance tests. All
(GRC) was administered only at 6 weeks; participants were asked to
subjects gave written informed consent, and the studies were approved
rate the amount of change they experienced in their balance over the
by the West Park Healthcare Centre and Bridgepoint Health joint
6-week period on a 5-point Likert scale with the following options:
research ethics board (13-011-WP).
much better, a little better, no change, a little worse, or much worse.
We selected a 5-point GRC to facilitate discrimination between
Balance Measures categories of change and to be consistent with the number of
Berg Balance Scale: The 14-item BBS20 is a commonly used measure of categories (five to seven) previously recommended for such scales.26
balance in older adults. Discrete physical tasks, such as changes in body
position, reaching, stair tapping, and standing on one leg, are evaluated Analysis
on a scale from 0 (unable/unsafe) to 4 (independent/safe). Total scores on To optimally determine increments of meaningful change, a
the BBS range from 0 to 56, with higher scores for better balance control. combination of distribution (ie, statistical distributions of change and
Evidence supports the BBS’s construct validity17 and sensitivity to reliability) and anchor-based approaches (ie, external criterion that
change21 following PR in individuals with COPD. Test-retest reliability reflects a patient’s perspective) are recommended.18,27 The following
and predictive validity for fall risk has been demonstrated in community- methods were used to calculate meaningful change estimates for
dwelling older adults.22 each balance measure:
journal.publications.chestnet.org 697
1. The mean change scores on the balance measures were calculated and (2) including those with a large improvement (GRC: much
for each answer on the GRC. better) vs those with small or no improvement (GRC: little better,
2. The minimal detectable change with 95% confidence (MDC95) re- no change). The data point closest to the upper left corner of the
fers to the smallest amount of change that falls outside of mea- curve (ie, cut-point that optimizes both sensitivity and specificity)
surement error and was calculated as 1.96 sqrt2 SEM.27 The was chosen as the optimal threshold for detection of a change,
SEM was calculated as with the area under the curve (AUC) of the ROC reflecting the
measure’s accuracy. An AUC > 0.7 was considered sufficient for
pffiffiffiffiffiffiffiffiffiffiffiffiffiffi
Sb ð1 rÞ discrimination.29
Given that those with lower starting scores on the balance tests have
where Sb is the SD of our sample at baseline, and r is the test-retest
higher change potential than those with scores near the ceiling, we
reliability coefficient. As there are no reliability studies of the balance
also conducted a sensitivity analysis to examine the effect of the
measures specifically in COPD, we used test-retest reliability co-
baseline score on the MCID. Among those with a self-reported
efficients derived from other clinical populations with similar
improvement on the GRC, we compared the change scores of
baseline balance ability and age as our sample.24,25,28
patients with low starting balance scores (lowest tertile) with change
3. The optimal cut-point from a receiver operating characteristic curve scores of patients with higher baseline scores (highest tertile).
(ROC) was used to determine the MCID using the balance measures Spearman correlation coefficients were computed to examine the
as diagnostic tests for discriminating between improved and association between GRC score and change in the balance measures.
unchanged patients based on the GRC. We performed this analysis Data were analyzed using SPSS 22.0 for Windows (IBM
twice: (1) including those with any improvement (GRC: much Corporation). A sample size $ 50 was deemed adequate for
better, little better) vs those who were unchanged (GRC: no change), determining the MCID based on recommended guidelines.29
Data are mean change SD. ABC ¼ Activities-Specific Balance Confidence; BBS ¼ Berg Balance Scale; BESTest ¼ Balance Evaluation Systems Test.
COPD.4-11 In fact, the updated American Thoracic scope of outcomes assessment in COPD to include
Society/European Respiratory Society statement on balance.30 To our knowledge, this is the first study to
pulmonary rehabilitation recommended expanding the identify clinically important increments of change for
measures of balance in people with COPD. We present a
range of MCID values for three recommended balance
TABLE 3 ] MCID Values for the Three Balance Measures
Assessed Using Three Different Approaches: measures that can be used to enhance the interpretability
Mean Change, MDC95, and ROC Curve Cutoff of balance assessment in this population.
Value
The choice of MCID value hinges on its definition.
Measure Approach MCID
When a global rating scale of self-reported change is
BBS MDC95 5.0
used as an anchor, some authors define minimal as a
ROC curve A little or 3.5
“small” or “slight” change on the anchor, whereas others
much better
use categories corresponding to “much” or a “good deal”
Much better 4.5
of improvement.31 This highlights a critical issue in
Mean change A little better 4.8
defining what constitutes a minimally important
Much better 7.1
improvement when using anchor-based approaches.
Overall range 3.5-7.1
Should the MCID be based on the magnitude of change
BESTest MDC95 13.1
or on its importance? Given this problem and the often-
ROC curve A little or 10.2
cited limitation of using an unvalidated patient reported
much better
scale as a gold standard, we propose that the optimal
Much better 11.1
MCID should be one that is both perceptible and
Mean change A little better 12.6
detectable. Therefore, we favor also using a distribution-
Much better 17.4
based approach, such as the MDC95, as a complementary
Overall range 10.2-17.4
method for determining the MCID. The MDC95
ABC MDC95 18.9
corresponds to a threshold for improvement that can be
scale
considered true change beyond measurement error.27
ROC curve N/Aa
Triangulating the estimates from the anchor- and
Mean change A little better 14.2
distribution-based methods in our study suggests that
Much better 18.5
the MCID should be at least 5 points for the BBS,
Overall range 14.2-18.9
13 points for the BESTest, and 19 points for the ABC
Data are mean change SD unless otherwise indicated. MCID ¼ minimal scale. Nonetheless, selection of the optimal MCID
clinically important difference; MDC95 ¼ minimal detectable change with will depend on the specific clinical context. Based on
95% confidence; N/A ¼ not applicable; ROC ¼ receiver operating char-
acteristic curve. See Table 2 legend for expansion of other abbreviations. the results of our sensitivity analysis, a smaller MCID
a
Area under the curve was not significant. value (ie, a change that is perceptible to patients but
journal.publications.chestnet.org 699
A B
1.0 1.0
0.8 0.8
0.6 0.6
Sensitivity
Sensitivity
0.4 0.4
0.2 0.2
AUC = 0.74 (95% CI, 0.60-0.87) AUC = 0.76 (95% CI, 0.62-0.89)
0.0 0.0
0.0 0.2 0.4 0.6 0.8 1.0 0.0 0.2 0.4 0.6 0.8 1.0
1 - Specificity 1 - Specificity
Figure 1 – A, B, ROC for (A) the Berg Balance Scale and (B) the Balance Evaluation Systems Test for discriminating between those with a
large perceived improvement and those with little or no change. The data point closest to the upper left corner of the curve, which maximizes both
sensitivity and specificity, was chosen as the optimal threshold. The AUC of the ROC reflects the measure’s accuracy. AUC ¼ area under the curve;
ROC ¼ receiver operating characteristic curve.
not necessarily above measurement noise) might be case for the ABC scale in this study. Another challenge is
chosen for individuals with high baseline balance to decide whether any perceived improvement should be
scores. For those with relatively good balance, a “large” considered as the diagnostic standard or whether this
improvement may not be realistic, and a small should be restricted to only a large improvement. To
improvement could still be considered important. address this issue we included the ROC curve MCID
estimates for both categories of improvement (Table 3).
Similar to other research,32,33 the ROC method yielded
It is reassuring that for the BBS and BESTest, the MCID
the smallest MCID estimates in this study. An advantage
estimate based on the ROC for “much improved”
of the ROC method is that the cutoff point is based on
aligned well with the MDC95 and the mean change in
both unchanged and improved patients and thus uses all
balance corresponding to a rating of “a little better.”
possible data.32 However, use of this approach can result
in small MCID estimates that may not be beyond Previous reports on responsiveness of the BBS, BESTest,
measurement noise. This is particularly true if data are and ABC scale in other clinical populations have focused
not normally distributed, resulting in curves that are not on distribution-based approaches such as the MDC95.
smooth and potentially erratic cut-points,33 as was the The values we report are generally within the range of
those previously reported for older adults and
TABLE 4 ] Influence of Baseline Balance Score on the individuals with neurologic conditions (3-7 points for
MCID Based on the Global Rating of Change the BBS, 9-16 for the BESTest, and 13 for the
Scale
ABC).23,24,34,35 For the BBS, it is well accepted that the
Mean change SD for MDC95 varies across the scale, with higher values of
Measure Baseline Score Improved Patients, (n)
change being required for lower baseline starting
BBS Low 9.7 7.1, (18)
scores.35 We note a similar trend when using the GRC,
High 2.2 2.7, (12)
in which individuals with baseline balance in the lowest
BESTest Low 21.4 10.2, (17)
tertile required larger amounts of change to be
High 9.4 4.8, (10) perceptible (Table 4). This trend was apparent for all
ABC scale Low 32.5 20.4, (19) three balance measures, but most pronounced for the
High 1.8 4.2, (11) BBS and ABC scale, possibly because of a ceiling effect,
Data are presented for change scores based on lowest and highest tertiles which has been well documented for the ABC and BBS
of baseline scores. See Table 2 legend for expansion of abbreviations. in the gerontology literature.35,36 Although the patients
journal.publications.chestnet.org 701
Acknowledgments people with COPD: an observational study. 22. Finch E, Brooks D, Stratford P, Mayo N.
Physiother Can. 2011;63(4):423-431. Physical Rehabilitation Outcome
Author contributions: M. K. B. had full Measures: A Guide to Enhanced Clinical-
access to all the data in the study and takes 11. Smith MD, Chang AT, Seale HE,
Decision-Making. 2nd ed. Hamilton,
responsibility for the integrity of the data and Walsh JR, Hodges PW. Balance is
Ontario: Canadian Physiotherapy
the accuracy of the data analysis, including and impaired in people with chronic
Association; 2002.
obstructive pulmonary disease. Gait
especially any adverse effects. All authors 23. Horak FB, Wrisley DM, Frank J. The
Posture. 2010;31(4):456-460.
contributed to the design, interpretation of balance evaluation systems test (BESTest)
data, and critical revision of manuscript; 12. Beauchamp MK, Brooks D, Goldstein RS. to differentiate balance deficits. Phys Ther.
M. K. B. and S. L. H. contributed to the Deficits in postural control in individuals 2009;89(5):484-498.
acquisition of data; M. K. B. conceived the idea, with COPD - emerging evidence for an
important secondary impairment. 24. Leddy AL, Crowner BE, Earhart GM.
performed the analysis, and drafted the paper.
Multidiscip Respir Med. 2010;5(6):417-421. Utility of the Mini-BESTest, BESTest, and
Financial/nonfinancial disclosures: None BESTest sections for balance assessments
declared. 13. Lawlor DA, Patel R, Ebrahim S. in individuals with Parkinson disease.
Association between falls in elderly J Neurol Phys Ther. 2011;35(2):90-97.
Role of sponsors: The sponsor had no role in women and chronic diseases and drug use:
cross sectional study. BMJ. 25. Powell LE, Myers AM. The activities-
the design of the study, the collection and
2003;327(7417):712-717. specific balance confidence (ABC) scale.
analysis of the data, or the preparation of the J Gerontol A Biol Sci Med Sci. 1995;
manuscript. 14. Roig M, Eng JJ, MacIntyre DL, et al. Falls 50A(1):M28-M34.
in people with chronic obstructive
26. Streiner D, Norman GR. Health
References pulmonary disease: an observational
Measurement Scales. A Practical Guide to
cohort study. Respir Med. 2011;105(3):
1. Tinetti ME, Speechley M, Ginter SF. Risk Their Development and Use. 2nd ed. New
461-469.
factors for falls among elderly persons York, NY: Oxford University Press; 1995.
living in the community. N Engl J Med. 15. Sibley KM, Voth J, Munce SE, Straus SE, 27. Haley SM, Fragala-Pinkham MA.
1988;319(26):1701-1707. Jaglal SB. Chronic disease and falls in Interpreting change scores of tests and
community-dwelling Canadians over 65 measures used in physical therapy. Phys
2. Scuffham P, Chaplin S, Legood R. years old: a population-based study
Incidence and costs of unintentional falls Ther. 2006;86(5):735-743.
exploring associations with number and
in older people in the United Kingdom. pattern of chronic conditions. BMC 28. Berg K, Wood-Dauphinee S, Williams JI.
J Epidemiol Community Health. Geriatr. 2014;14:22. The Balance Scale: reliability assessment
2003;57(9):740-744. with elderly residents and patients with an
16. Beauchamp MK, Janaudis-Ferreira T, acute stroke. Scand J Rehabil Med.
3. Gillespie LD, Robertson MC, Gillespie WJ, Parreira V, et al. A randomized controlled
et al. Interventions for preventing falls in 1995;27(1):27-36.
trial of balance training during pulmonary
older people living in the community. rehabilitation for individuals with COPD. 29. Terwee CB, Bot SD, de Boer MR, et al.
Cochrane Database Syst Rev. 2009;(2): Chest. 2013;144(6):1803-1810. Quality criteria were proposed for
CD007146. measurement properties of health status
17. Oliveira CC, Lee A, Granger CL, Miller KJ, questionnaires. J Clin Epidemiol.
4. Beauchamp MK, Hill K, Goldstein RS, Irving LB, Denehy L. Postural control and
Janaudis-Ferreira T, Brooks D. 2007;60(1):34-42.
fear of falling assessment in people with
Impairments in balance discriminate chronic obstructive pulmonary disease: a 30. Spruit MA, Singh SJ, Garvey C, et al. ATS/
fallers from non-fallers in COPD. Respir systematic review of instruments, ERS Task Force on Pulmonary
Med. 2009;103(12):1885-1891. international classification of functioning, Rehabilitation. An official American
5. Beauchamp MK, Sibley KM, Lakhani B, disability and health linkage, and Thoracic Society/European Respiratory
et al. Impairments in systems underlying measurement properties. Arch Phys Med Society statement: key concepts and
control of balance in COPD. Chest. Rehabil. 2013;94(9):1784-1799.e7. advances in pulmonary rehabilitation. Am
2012;141(6):1496-1503. J Respir Crit Care Med. 2013;188(8):
18. Revicki D, Hays RD, Cella D, Sloan J. e13-e64.
6. Butcher SJ, Meshke JM, Sheppard MS. Recommended methods for determining
31. de Vet HC, Terwee CB, Ostelo RW,
Reductions in functional balance, responsiveness and minimally important
coordination, and mobility measures Beckerman H, Knol DL, Bouter LM.
differences for patient-reported outcomes.
Minimal changes in health status
among patients with stable chronic J Clin Epidemiol. 2008;61(2):102-109.
questionnaires: distinction between
obstructive pulmonary disease.
J Cardiopulm Rehabil. 2004;24(4):274-280. 19. Harrison SL, Beauchamp MK, Sibley KM, minimally detectable change and
et al. Minimizing the evidence-practice minimally important change. Health Qual
7. Janssens L, Brumagne S, McConnell AK, gap - a prospective cohort study Life Outcomes. 2006;4:54.
et al. Impaired postural control reduces incorporating balance training into 32. Turner D, Schünemann HJ, Griffith LE,
sit-to-stand-to-sit performance in pulmonary rehabilitation for individuals et al. Using the entire cohort in the
individuals with chronic obstructive with chronic obstructive pulmonary receiver operating characteristic analysis
pulmonary disease. PLoS One. 2014;9(2): disease. BMC Pulm Med. 2015;15:73. maximizes precision of the minimal
e88247.
20. Berg KO, Maki BE, Williams JI, important difference. J Clin Epidemiol.
8. Eisner MD, Blanc PD, Yelin EH, et al. Holliday PJ, Wood-Dauphinee SL. 2009;62(4):374-379.
COPD as a systemic disease: impact on Clinical and laboratory measures of 33. van der Roer N, Ostelo RW,
physical functional limitations. Am J Med. postural balance in an elderly population. Bekkering GE, van Tulder MW,
2008;121(9):789-796. Arch Phys Med Rehabil. 1992;73(11): de Vet HC. Minimal clinically important
9. Janssens L, Brumagne S, McConnell AK, 1073-1080. change for pain intensity, functional
et al. Proprioceptive changes impair 21. Beauchamp MK, O’Hoski S, Goldstein RS, status, and general health status in
balance control in individuals with Brooks D. Effect of pulmonary patients with nonspecific low back pain.
chronic obstructive pulmonary disease. rehabilitation on balance in persons with Spine. 2006;31(5):578-582.
PLoS One. 2013;8(3):e57949. chronic obstructive pulmonary disease. 34. Steffen T, Seney M. Test-retest reliability
10. Roig M, Eng JJ, Macintyre DL, Road JD, Arch Phys Med Rehabil. 2010;91(9): and minimal detectable change on balance
Reid WD. Postural control is impaired in 1460-1465. and ambulation tests, the 36-item short-
journal.publications.chestnet.org 703