Minimal clinically important difference: terminology and estimated methods_Chinese Journal of Evidence-Based Medicine

Authors：

YANG Lihong ^1,2 , LIU Shaonan ^1,2 , WU Darong ¹ , GE Long ³ ,  GUO Xinfeng ¹

1. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P.R.China;
2. The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou 510405, P.R.China;
3. Evidence-Based Social Science Research Center, School of Public Health, Lanzhou University, Lanzhou 730000, P.R.China;

Corresponding author：

GUO Xinfeng, Email: guoxinfeng@gzucm.edu.cn

Keywords：

Minimal clinically important difference; MCID; Terminology; Estimated method

DOI：

10.7507/1672-2531.202007091

Video：

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Interpretation of results of clinical research should not only focus on statistical significance (P value less than 0.05) but also clinical significance. The minimal clinically significance difference (MCID) assists to answer the question with the results being clinically significant. In addition, MCID plays an important role in evidence assessment during clinical guideline development, sample size estimation for clinical trials, and clinical decision-making. This paper primarily introduces the terminology and definition of MCID and four common methods used to estimate MCID.

Citation： YANG Lihong, LIU Shaonan, WU Darong, GE Long, GUO Xinfeng. Minimal clinically important difference: terminology and estimated methods. Chinese Journal of Evidence-Based Medicine, 2020, 20(11): 1345-1352. doi: 10.7507/1672-2531.202007091 Copy

1.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Intern J Surg, 2012, 10(1): 28-55.
2.	Kay R. Statistical thinking for non-statisticians in drug regulation. New York: John Wiley, 2009.
3.	King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res, 2011, 11(2): 171-184.
4.	Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis, 1987, 40(2): 171-178.
5.	Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials, 1989, 10(4): 407-415.
6.	Guyatt GH, Osoba D, Wu AW, et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc, 2002, 77(4): 371-383.
7.	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(5): 582-592.
8.	Turner D, Schünemann HJ, Griffith LE, et al. The minimal detectable change cannot reliably replace the minimal important difference. J Clin Epidemiol, 2010, 63(1): 28-36.
9.	de Vet HC, Terwee CB. The minimal detectable change should not replace the minimal important difference. J Clin Epidemiol, 2010, 63(7): 804-805.
10.	Barrett B, Brown D, Mundt M, et al. Sufficiently important difference: expanding the framework of clinical significance. Med Decis Making, 2005, 25(3): 250-261.
11.	Sloan JA, Cella D, Frost M, et al. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc, 2002, 77(4): 367-370.
12.	Wyrwich KW, Bullinger M, Aaronson N, et al. Estimating clinically significant differences in quality of life outcomes. Qual Life Res, 2005, 14(2): 285-295.
13.	Lidwine BM, Caroline BT, Donald LP, et al. COSMIN checklist manual, 2012. Available at: http://facksuedusa/sites/default/files/cosmin_checklist_manual_v9pdf.
14.	de Vet HC, Beckerman H, Terwee CB, et al. Definition of clinical differences. J Rheumatol, 2006, 33(2): 434.
15.	Beaton DE, Bombardier C, Katz JN, et al. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol, 2001, 28(2): 400-405.
16.	de Vet HC, Terwee CB, Ostelo RW, et al. Minimal changes in health status questionnaires: Distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes, 2006, 4: 54.
17.	Beckerman H, Roebroeck ME, Lankhorst GJ, et al. Smallest real difference, a link between reproducibility and responsiveness. Qual Life Res, 2001, 10(7): 571-578.
18.	Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum, 2001, 45(4): 384-391.
19.	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(2): 102-109.
20.	Osoba DK. Interpreting QOL in individuals and groups: meaningful differences. In: Assessing Quality of Life in Clinical Trials: Methods and Practice. Oxford: Oxford University Press, 2005.
21.	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(2): 109-114.
22.	Witt S, Krauss E, Barbero MAN, et al. Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis. Respir Res, 2019, 20(1): 47.
23.	Gupta S, Chandra D, Sciurba F. Minimal or maximal clinically important difference: using death to define MCID. Am J Respir Crit Care Med, 2013, 187(12): 1391-1392.
24.	Polkey MI, Spruit MA, Edwards LD, et al. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med, 2013, 187(4): 382-386.
25.	Polkey MI, Spruit MA, Wouters E, et al. Reply: minimal or maximal clinically important difference: using death to define MCID. Am J Respir Crit Care Med, 2013, 187(12): 1392.
26.	万崇华, 禹玉兰, 谭健烽, 等. 生命质量研究导论. 北京: 科学出版社, 2016.
27.	许传志, 陈莹. 基于量表得分的最小临床重要性差值(MCID)制定方法. 中国卫生统计, 2019, 36(3): 436-440.
28.	王家良. 临床流行病学—临床科研设计, 测量与评价(第三版). 上海: 上海科学技术出版社, 2009.
29.	Patrick DL, Gagnon DD, Zagari MJ, et al. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer, 2003, 39(3): 335-345.
30.	McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA, 2014, 312(13): 1342-1343.
31.	Speer DC, Greenbaum PE. Five methods for computing significant individual client change and improvement rates: support for an individual growth curve approach. J Consult Clin Psychol, 1995, 63(6): 1044-1048.
32.	Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol, 2003, 56(5): 395-407.
33.	Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods, 2002, 7(2): 147-177.
34.	Cohen J. Statistical power analysis for the behavioural sciences (2nd Edition). NJ: Lawrence Erlbaum Associates, 1988.
35.	Samsa G, Edelman D, Rothman ML, et al. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark Ⅱ. Pharmacoeconomics, 1999, 15(2): 141-155.
36.	Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care, 1989, 27(3 Suppl): S178-189.
37.	Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care, 1990, 28(7): 632-642.
38.	方积乾. 生存质量: 测定方法及应用. 北京: 北京大学医学出版社, 2006.
39.	Wyrwich KW, Nienaber NA, Tierney WM, et al. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care, 1999, 37(5): 469-478.
40.	Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol, 1999, 52(9): 861-873.
41.	Nolan CM, Delogu V, Maddocks M, et al. Validity, responsiveness and minimum clinically important difference of the incremental shuttle walk in idiopathic pulmonary fibrosis: a prospective study. Thorax, 2018, 73: 680-682.
42.	Shikiar R, Harding G, Leahy M, et al. Minimal important difference (MID) of the dermatology life quality index (DLQI): results from patients with chronic idiopathic urticaria. Health Qual Life Outcomes, 2005, 3: 36.
43.	Wells G, Beaton D, Shea B, et al. Minimal clinically important differences: review of methods. J Rheumatol, 2001, 28(2): 406-412.
44.	Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol, 1991, 59(1): 12-19.
45.	Beaton DE, Bombardier C, Katz JN, et al. A taxonomy for responsiveness. J Clin Epidemiol, 2001, 54(12): 1204-1217.
46.	FDA. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims, 2009. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims.
47.	van der Heijde D, Lassere M, Edmonds J, et al. Minimal clinically important difference in plain films in RA: group discussions, conclusions, and recommendations. OMERACT Imaging Task Force. J Rheumatol, 2001, 28(4): 914-917.
48.	N B. Musculoskeletal clinical metrology. Lancaster: Kluwer Academic Publishers, 1993.
49.	Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum, 1995, 38(6): 727-735.
50.	Oliveira A, Machado A, Marques A. Minimal important and detectable differences of respiratory measures in outpatients with AECOPD. COPD, 2018, 15(5): 479-488.
51.	Mahler DA, Ward J, Waterman LA, et al. Patient-reported dyspnea in COPD reliability and association with stage of disease. Chest, 2009, 136(6): 1473-1479.
52.	Oliveira A, Lage S, Rodrigues J, et al. Reliability, validity and minimal detectable change of computerized respiratory sounds in patients with chronic obstructive pulmonary disease. Clin Respir J, 2018, 12(5): 1838-1848.
53.	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(3): 195-203.
54.	Johnston BC, Ebrahim S, Carrasco-Labra A, et al. Minimally important difference estimates and methods: A protocol. BMJ Open, 2015, 5: e007953.

1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Intern J Surg, 2012, 10(1): 28-55.
2. Kay R. Statistical thinking for non-statisticians in drug regulation. New York: John Wiley, 2009.
3. King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res, 2011, 11(2): 171-184.
4. Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis, 1987, 40(2): 171-178.
5. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials, 1989, 10(4): 407-415.
6. Guyatt GH, Osoba D, Wu AW, et al. Methods to explain the clinical significance of health status measures. Mayo Clin Proc, 2002, 77(4): 371-383.
7. 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(5): 582-592.
8. Turner D, Schünemann HJ, Griffith LE, et al. The minimal detectable change cannot reliably replace the minimal important difference. J Clin Epidemiol, 2010, 63(1): 28-36.
9. de Vet HC, Terwee CB. The minimal detectable change should not replace the minimal important difference. J Clin Epidemiol, 2010, 63(7): 804-805.
10. Barrett B, Brown D, Mundt M, et al. Sufficiently important difference: expanding the framework of clinical significance. Med Decis Making, 2005, 25(3): 250-261.
11. Sloan JA, Cella D, Frost M, et al. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin Proc, 2002, 77(4): 367-370.
12. Wyrwich KW, Bullinger M, Aaronson N, et al. Estimating clinically significant differences in quality of life outcomes. Qual Life Res, 2005, 14(2): 285-295.
13. Lidwine BM, Caroline BT, Donald LP, et al. COSMIN checklist manual, 2012. Available at: http://facksuedusa/sites/default/files/cosmin_checklist_manual_v9pdf.
14. de Vet HC, Beckerman H, Terwee CB, et al. Definition of clinical differences. J Rheumatol, 2006, 33(2): 434.
15. Beaton DE, Bombardier C, Katz JN, et al. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol, 2001, 28(2): 400-405.
16. de Vet HC, Terwee CB, Ostelo RW, et al. Minimal changes in health status questionnaires: Distinction between minimally detectable change and minimally important change. Health Qual Life Outcomes, 2006, 4: 54.
17. Beckerman H, Roebroeck ME, Lankhorst GJ, et al. Smallest real difference, a link between reproducibility and responsiveness. Qual Life Res, 2001, 10(7): 571-578.
18. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum, 2001, 45(4): 384-391.
19. 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(2): 102-109.
20. Osoba DK. Interpreting QOL in individuals and groups: meaningful differences. In: Assessing Quality of Life in Clinical Trials: Methods and Practice. Oxford: Oxford University Press, 2005.
21. 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(2): 109-114.
22. Witt S, Krauss E, Barbero MAN, et al. Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis. Respir Res, 2019, 20(1): 47.
23. Gupta S, Chandra D, Sciurba F. Minimal or maximal clinically important difference: using death to define MCID. Am J Respir Crit Care Med, 2013, 187(12): 1391-1392.
24. Polkey MI, Spruit MA, Edwards LD, et al. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med, 2013, 187(4): 382-386.
25. Polkey MI, Spruit MA, Wouters E, et al. Reply: minimal or maximal clinically important difference: using death to define MCID. Am J Respir Crit Care Med, 2013, 187(12): 1392.
26. 万崇华, 禹玉兰, 谭健烽, 等. 生命质量研究导论. 北京: 科学出版社, 2016.
27. 许传志, 陈莹. 基于量表得分的最小临床重要性差值(MCID)制定方法. 中国卫生统计, 2019, 36(3): 436-440.
28. 王家良. 临床流行病学—临床科研设计, 测量与评价(第三版). 上海: 上海科学技术出版社, 2009.
29. Patrick DL, Gagnon DD, Zagari MJ, et al. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer, 2003, 39(3): 335-345.
30. McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA, 2014, 312(13): 1342-1343.
31. Speer DC, Greenbaum PE. Five methods for computing significant individual client change and improvement rates: support for an individual growth curve approach. J Consult Clin Psychol, 1995, 63(6): 1044-1048.
32. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol, 2003, 56(5): 395-407.
33. Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods, 2002, 7(2): 147-177.
34. Cohen J. Statistical power analysis for the behavioural sciences (2nd Edition). NJ: Lawrence Erlbaum Associates, 1988.
35. Samsa G, Edelman D, Rothman ML, et al. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark Ⅱ. Pharmacoeconomics, 1999, 15(2): 141-155.
36. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care, 1989, 27(3 Suppl): S178-189.
37. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care, 1990, 28(7): 632-642.
38. 方积乾. 生存质量: 测定方法及应用. 北京: 北京大学医学出版社, 2006.
39. Wyrwich KW, Nienaber NA, Tierney WM, et al. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care, 1999, 37(5): 469-478.
40. Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol, 1999, 52(9): 861-873.
41. Nolan CM, Delogu V, Maddocks M, et al. Validity, responsiveness and minimum clinically important difference of the incremental shuttle walk in idiopathic pulmonary fibrosis: a prospective study. Thorax, 2018, 73: 680-682.
42. Shikiar R, Harding G, Leahy M, et al. Minimal important difference (MID) of the dermatology life quality index (DLQI): results from patients with chronic idiopathic urticaria. Health Qual Life Outcomes, 2005, 3: 36.
43. Wells G, Beaton D, Shea B, et al. Minimal clinically important differences: review of methods. J Rheumatol, 2001, 28(2): 406-412.
44. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol, 1991, 59(1): 12-19.
45. Beaton DE, Bombardier C, Katz JN, et al. A taxonomy for responsiveness. J Clin Epidemiol, 2001, 54(12): 1204-1217.
46. FDA. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims, 2009. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims.
47. van der Heijde D, Lassere M, Edmonds J, et al. Minimal clinically important difference in plain films in RA: group discussions, conclusions, and recommendations. OMERACT Imaging Task Force. J Rheumatol, 2001, 28(4): 914-917.
48. N B. Musculoskeletal clinical metrology. Lancaster: Kluwer Academic Publishers, 1993.
49. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum, 1995, 38(6): 727-735.
50. Oliveira A, Machado A, Marques A. Minimal important and detectable differences of respiratory measures in outpatients with AECOPD. COPD, 2018, 15(5): 479-488.
51. Mahler DA, Ward J, Waterman LA, et al. Patient-reported dyspnea in COPD reliability and association with stage of disease. Chest, 2009, 136(6): 1473-1479.
52. Oliveira A, Lage S, Rodrigues J, et al. Reliability, validity and minimal detectable change of computerized respiratory sounds in patients with chronic obstructive pulmonary disease. Clin Respir J, 2018, 12(5): 1838-1848.
53. 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(3): 195-203.
54. Johnston BC, Ebrahim S, Carrasco-Labra A, et al. Minimally important difference estimates and methods: A protocol. BMJ Open, 2015, 5: e007953.

Chinese Journal of Evidence-Based Medicine

Minimal clinically important difference: terminology and estimated methods

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