Clinically relevant differences in COPD health status: Systematic review and triangulation

European Respiratory Journal

Volumn 52, Issue 3, 2018, Pages

  Alma, Harma ^a   De Jong, Corina ^a   Tsiligianni, Ioanna ^a,b   Sanderman, Robbert ^a,c   Kocks, Janwillem ^a   van der Molen, Thys ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b UNIVERSITY OF CRETE   (Greece)

^c UNIVERSITY OF TWENTE   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHRONIC OBSTRUCTIVE LUNG DISEASE; CHRONIC OBSTRUCTIVE PULMONARY DISEASE ASSESSMENT TEST; CLINICAL CHRONIC OBSTRUCTIVE PULMONARY DISEASE QUESTIONNAIRE; CLINICAL PRACTICE; DATA ANALYSIS; DISEASE EXACERBATION; HEALTH STATUS; HUMAN; MEDICAL RESEARCH; PRIORITY JOURNAL; QUALITY CONTROL; QUALITY OF LIFE ASSESSMENT; RESPIRATORY TRACT DISEASE ASSESSMENT; SHORT FORM 36; ST. GEORGE RESPIRATORY QUESTIONNAIRE; SYSTEMATIC ERROR; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TRIANGULATION; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; PATHOPHYSIOLOGY; QUALITY OF LIFE; QUESTIONNAIRE;

HEALTH STATUS; HUMANS; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUALITY OF LIFE; SURVEYS AND QUESTIONNAIRES;

EID: 85052935254     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.00412-2018     Document Type: Article

References (100)

1. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79.
2. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003; 56: 395–407.
3. Jones PW. Health status measurement in chronic obstructive pulmonary disease. Thorax 2001; 56: 880–887.
4. Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol 2002; 14: 109–114.
5. Jones PW. Health status: what does it mean for payers and patients? Proc Am Thorac Soc 2006; 3: 222–226.
6. Jones PW, Rennard S, Tabberer M, et al. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion. Int J COPD 2016; 11: 3069–3078.
7. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407–415.
8. Jones PW, Beeh KM, Chapman KR, et al. Minimal clinically important differences in pharmacological trials. Am J Respir Crit Care Med 2014; 189: 250–255.
9. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993; 118: 622–629.
10. Curtis JR, Patrick DL. The assessment of health status among patients with COPD. Eur Respir J 2003; 21: Suppl. 41, 36–45.
11. Jones PW. Issues concerning health-related quality of life in COPD. Chest 1995; 107: Suppl., 187S–193S.
12. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD (2017 Report). 2017. www.goldcopd.org/gold-2017-global-strategy-diagnosis-managementprevention-copd/ Date last accessed: 17 November 2017.
13. Westwood M, Bourbeau J, Jones PW, et al. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: a systematic review. Respir Res 2011; 12: 40-9921-12-40.
14. Tsiligianni I, Kocks J, Tzanakis N, et al. Factors that influence disease-specific quality of life or health status in patients with COPD: a review and meta-analysis of Pearson correlations. Prim Care Respir J 2011; 20: 257–268.
15. Martin AL, Marvel J, Fahrbach K, et al. The association of lung function and St. George’s Respiratory Questionnaire with exacerbations in COPD: a systematic literature review and regression analysis. Respir Res 2016; 17: 40.
16. Jones P, Miravitlles M, Van der Molen T, et al. Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement. Int J COPD 2012; 7: 697–670.
17. Farquhar M. Definitions of quality of life: a taxonomy. J Adv Nurs 1995; 22: 502–508.
18. Reardon JZ, Lareau SC, ZuWallack R. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006; 119: Suppl. 1, 32–37.
19. Bergner M, Rothman ML. Health status measures: an overview and guide for selection. Annu Rev Public Health 1987; 8: 191–210.
20. Bergner M. Quality of life, health status, and clinical research. Med Care 1989; 27: Suppl., S148–S156.
21. Jones PW, Lareau S, Mahler DA. Measuring the effects of COPD on the patient. Respir Med 2005; 99: Suppl. B, S11–S18.
22. Fitzpatrick R, Davey C, Buxton MJ, et al. Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess 1998; 2: i-iv,1–74.
23. Davidson M, Keating J. Patient-reported outcome measures (PROMs): how should I interpret reports of measurement properties? A practical guide for clinicians and researchers who are not biostatisticians. Br J Sports Med 2014; 48: 792–796.
24. Angst F, Aeschlimann A, Angst J. The minimal clinically important difference (MCID) raised the significance of outcome effects above the statistical level, with methodological implications for future studies. J Clin Epidemiol 2017; 82: 128–136.
25. Copay AG, Subach BR, Glassman SD, et al. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 2007; 7: 541–546.
26. Hays RD, Farivar SS, Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD 2005; 2: 63–67.
27. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008; 9: 105–121.
28. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J 2002; 19: 398–404.
29. Make B. How can we assess outcomes of clinical trials: the MCID approach. COPD 2007; 4: 191–194.
30. Norman GR. The relation between the minimally important difference and patient benefit. COPD 2005; 2: 69–73.
31. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 2008; 33: 90–94.
32. Revicki DA, Cella D, Hays RD, et al. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes 2006; 4: 70.
33. Revicki D, Hays RD, Cella D, et al. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 2008; 61: 102–109.
34. Sloan JA. Assessing the minimally clinically significant difference: scientific considerations, challenges and solutions. COPD 2005; 2: 57–62.
35. Turner D, Schünemann HJ, Griffith LE, et al. The minimal detectable change cannot reliably replace the minimal important difference. J Clin Epidemiol 2010; 63: 28–36.
36. Wyrwich KW, Wolinsky FD. Identifying meaningful intra-individual change standards for health-related quality of life measures. J Eval Clin Pract 2000; 6: 39–49.
37. Wells G, Beaton D, Shea B, et al. Minimal clinically important differences: review of methods. J Rheumatol 2001; 28: 406–412.
38. Make B, Casaburi R, Leidy NK. Interpreting results from clinical trials: understanding minimal clinically important differences in COPD outcomes. COPD 2005; 2: 1–5.
39. Chapman KR, Bergeron C, Bhutani M, et al. Do we know the minimal clinically important difference (MCID) for COPD exacerbations? COPD 2013; 10: 243–249.
40. Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics 2000; 18: 419–423.
41. Middel B, van Sonderen E. Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research. Int J Integr Care 2002; 2: e15.
42. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003; 41: 582–592.
43. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991; 59: 12–19.
44. Cook CE. Clinimetrics corner: the minimal clinically important change score (MCID): a necessary pretense. J Man Manip Ther 2008; 16: E82–E83.
45. Leidy NK, Wyrwich KW. Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD 2005; 2: 157–165.
46. Cazzola M, Hanania NA, MacNee W, et al. A review of the most common patient-reported outcomes in COPD – revisiting current knowledge and estimating future challenges. Int J COPD 2015; 10: 725–738.
47. Haughney J, Gruffydd-Jones K. Patient-centred outcomes in primary care management of COPD – what do recent clinical trial data tell us? Prim Care Respir J 2004; 13: 185–197.
48. Jayadevappa R, Cook R, Chhatre S. Important difference to infer changes in health related quality of life-a systematic review. J Clin Epidemiol 2017; 89: 188–198.
49. Kocks JWH, Asijeec GM, Tsiligianni IG, et al. Functional status measurement in COPD: a review of available methods and their feasibility in primary care. Prim Care Respir J 2011; 20: 269–275.
50. Ekström M, Currow DC, Johnson MJ. Outcome measurement of refractory breathlessness: endpoints and important differences. Curr Opin Support Palliat Care 2015; 9: 238–243.
51. Weldam SW, Schuurmans MJ, Liu R, et al. Evaluation of quality of life instruments for use in COPD care and research: a systematic review. Int J Nurs Stud 2013; 50: 688–707.
52. Kocks JWH, Seys SF, van Duin TS, et al. Assessing patient-reported outcomes in asthma and COPD patients: which can be recommended in clinical practice? Curr Opin Pulm Med 2018; 24: 18–23.
53. Jones PW. St. George’s Respiratory Questionnaire: MCID. COPD 2005; 2: 75–79.
54. Mahler DA, Witek TJ Jr. The MCID of the Transition Dyspnea Index is a total score of one unit. COPD 2005; 2: 99–103.
55. Donohue JF. Minimal clinically important differences in COPD lung function. COPD 2005; 2: 111–124.
56. Zhou Z, Zhou A, Zhao Y, et al. Evaluating the Clinical COPD Questionnaire: a systematic review. Respirology 2017; 22: 251–262.
57. Gupta N, Pinto LM, Morogan A, et al. The COPD Assessment Test: a systematic review. Eur Respir J 2014; 44: 873–884.
58. Bohannon RW, Glenney SS. Minimal clinically important difference for change in comfortable gait speed of adults with pathology: a systematic review. J Eval Clin Pract 2014; 20: 295–300.
59. Bohannon RW, Crouch PT. Minimal clinically important difference for change in 6-minute walk test distance in adults with pathology: a systematic review. J Eval Clin Pract 2017; 23: 377–381.
60. Binenbaum Y, Amit M, Billan S, et al. Minimal clinically important differences in quality of life scores of oral cavity and oropharynx cancer patients. Ann Surg Oncol 2014; 21: 2773–2781.
61. Keurentjes JC, Van Tol FR, Fiocco M, et al. Minimal clinically important differences in health-related quality of life after total hip or knee replacement: a systematic review. Bone Joint Res 2012; 1: 71–77.
62. Schrover R, Evans K, Giugliani R, et al. Minimal clinically important difference for the 6-min walk test: literature review and application to Morquio A syndrome. Orphanet J Rare Dis 2017; 12: 78.
63. Doganay Erdogan B, Leung YY, Pohl C, et al. Minimal clinically important difference as applied in rheumatology: an OMERACT Rasch Working Group systematic review and critique. J Rheumatol 2016; 43: 194–202.
64. Maltenfort M, Diaz-Ledezma C. Statistics in brief: minimum clinically important difference – availability of reliable estimates. Clin Orthop Relat Res 2017; 475: 933–946.
65. Moher D, Liberati A, Tetzlaff J, et al. The PRISMA Group Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. PLoS Med 2009; 6: e1000097.
66. Alma H, de Jong C, Tsiligianni I, et al. Measuring clinically relevant change in health status for patients with COPD: a systematic review and meta-analysis. PROSPERO 2015: CRD42015023221. www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42015023221 Date last accessed: October 2017.
67. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration, 2011. http://handbook-5-1.cochrane.org/ Date last updated: March 2011.
68. Terwee CB, Mokkink LB, Knol DL, et al. Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist. Qual Life Res 2012; 21: 651–657.
69. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther 2009; 17: 163–170.
70. Alma H, de Jong C, Jelusic D, et al. Health status instruments for patients with COPD in pulmonary rehabilitation: defining a minimal clinically important difference. NPJ Prim Care Respir Med 2016; 26: 16041.
71. Tsai CL, Hodder RV, Page JH, et al. The short-form chronic respiratory disease questionnaire was a valid, reliable, and responsive quality-of-life instrument in acute exacerbations of chronic obstructive pulmonary disease. J Clin Epidemiol 2008; 61: 489–497.
72. Dodd JW, Hogg L, Nolan J, et al. The COPD Assessment Test (CAT): response to pulmonary rehabilitation. A multicentre, prospective study. Thorax 2011; 66: 425–429.
73. Jones PW, Harding G, Wiklund I, et al. Tests of the responsiveness of the COPD Assessment Test following acute exacerbation and pulmonary rehabilitation. Chest 2012; 142: 134–140.
74. Kocks JW, Tuinenga MG, Uil SM, et al. Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire. Respir Res 2006; 7: 62.
75. Kon SS, Canavan JL, Jones SE, et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med 2014; 2: 195–203.
76. Kon SS, Dilaver D, Mittal M, et al. The Clinical COPD Questionnaire: response to pulmonary rehabilitation and minimal clinically important difference. Thorax 2014; 69: 793–798.
77. Kulich K, Keininger DL, Tiplady B, et al. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis 2015; 10: 79–94.
78. Nolan CM, Longworth L, Lord J, et al. The EQ-5D-5L health status questionnaire in COPD: validity, responsiveness and minimum important difference. Thorax 2016; 71: 493–500.
79. Perez T, Arnould B, Grosbois JM, et al. Validity, reliability, and responsiveness of a new short Visual Simplified Respiratory Questionnaire (VSRQ) for health-related quality of life assessment in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 2009; 4: 9–18.
80. Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol 1996; 49: 1215–1219.
81. Schünemann HJ, Griffith L, Jaeschke R, et al. Evaluation of the minimal important difference for the feeling thermometer and the St. George’s Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol 2003; 56: 1170–1176.
82. Smid DE, Franssen FM, Houben-Wilke S, et al. Responsiveness and MCID estimates for CAT, CCQ, and HADS in patients with COPD undergoing pulmonary rehabilitation: a prospective analysis. J Am Med Dir Assoc 2017; 18: 53–58.
83. Tsiligianni IG, van der Molen T, Moraitaki D, et al. Assessing health status in COPD. A head-to-head comparison between the COPD assessment test (CAT) and the clinical COPD questionnaire (CCQ). BMC Pulm Med 2012; 12: 20.
84. Van Stel HF, Maillé AR, Colland VT, et al. Interpretation of change and longitudinal validity of the quality of life for respiratory illness questionnaire (QoLRIQ) in inpatient pulmonary rehabilitation. Qual Life Res 2003; 12: 133–145.
85. Walters SJ, Brazier JE. What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health Qual Life Outcomes 2003; 1: 4.
86. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005; 14: 1523–1532.
87. Welling JB, Hartman JE, Ten Hacken NH, et al. The minimal important difference for the St George’s Respiratory Questionnaire in patients with severe COPD. Eur Respir J 2015; 46: 1598–1604.
88. Wyrwich KW, Metz SM, Kroenke K, et al. Measuring patient and clinician perspectives to evaluate change in health related quality of life among patients with chronic obstructive pulmonary disease. J Gen Intern Med 2007; 22: 161–170.
89. Zanini A, Aiello M, Adamo D, et al. Estimation of minimal clinically important difference in EQ-5D visual analog scale score after pulmonary rehabilitation in subjects with COPD. Respir Care 2015; 60: 88–95.
90. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test. Eur Respir J 2009; 34: 648–654.
91. Van der Molen T, Willemse BW, Schokker S, et al. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes 2003; 1: 13.
92. Guyatt GH, Berman LB, Townsend M, et al. A measure of quality of life for clinical trials in chronic lung disease. Thorax 1987; 42: 773–778.
93. EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199–208.
94. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011; 20: 1727–1736.
95. Ware J, Kosinski M, Dewey J. How to Score Version Two of the SF-36 Health Survey. Lincoln, RI, QualityMetric Inc., 2000.
96. Jones PW, Quirk FH, Baveystock CM. The St. George’s Respiratory Questionnaire. Respir Med 1991; 85: 25–31.
97. Cave AJ, Atkinson L, Tsiligianni IG, et al. Assessment of COPD wellness tools for use in primary care: an IPCRG initiative. Int J Chron Obstruct Pulmon Dis 2012; 7: 447–456.
98. Alma H, de Jong C, Jelusic D, et al. Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of COPD health status tools. Health Qual Life Outcomes 2018; 16: 130.
99. Yoo JY, Kim YS, Kim SS, et al. Factors affecting the trajectory of health-related quality of life in COPD patients. Int J Tuberc Lung Dis 2016; 20: 738–746.
100. Sundh J, Montgomery S, Hasselgren M, et al. Change in health status in COPD: a seven-year follow-up cohort study. NPJ Prim Care Respir Med 2016; 26: 16073.