Interpretation of the credibility evaluation instrument for minimal important differences and the optimal value selection approach_Chinese Journal of Evidence-Based Medicine

Authors：

YU Yan ¹ , CHEN Xueyin ² , HUANG Qian ² , LIU Shaonan ^2,3 , GUO Xinfeng ^2,3 ,  YANG Lihong ²

1. Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;
2. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
3. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, P. R. China;

Corresponding author：

YANG Lihong, Email: lihongyang@gzucm.edu.cn

Keywords：

Minimal important difference (MID); Patient reported outcome measure (PROM); Credibility evaluation; Reporting quality

DOI：

10.7507/1672-2531.202503019

Video：

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Patient reported outcome measures (PROM) are widely used in clinical research and practice. To aid the interpretation of PROM, researchers have proposed the minimal important difference (MID), the smallest change or difference that patients perceive as important. However, the estimation methods of MID are numerous and inconsistent, which brings difficulties to selecting the optimal MID estimate to interpret PROM results. To address this issue, a research team from McMaster University in Canada has proposed an approach for selecting the optimal MID. This method includes three core steps: evaluating the credibility of MID estimates, assessing the consistency among credible MID estimates, and selecting the optimal value based on contextual factors. The credibility evaluation instrument for anchor-based MID examines five core criteria, including the data sources of PROM and anchor, the interpretability of anchor, the correlation between anchor and PROM, the precision of MID estimates, and the judgment of anchor thresholds. When there are multiple credible MID estimates, the optimal MID estimate is selected by evaluating the consistency among the estimates and considering contextual factors that affect the variability among the estimates, such as the type of intervention, follow-up time, and disease severity. In addition, the team provided recommendations to improve the reporting quality of MID studies. This article provides a detailed introduction and interpretation of these developments, aiming to enhance researchers' and clinicians' understanding and application of MID, thereby supporting clinical research and healthcare decision-making.

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2.	Kluzek S, Dean B, Wartolowska KA. Patient-reported outcome measures (PROMs) as proof of treatment efficacy. BMJ Evid Based Med, 2022, 27(3): 153-155.
3.	Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials, 1989, 10(4): 407-415.
4.	路桃影, 吴大嵘. 最小重要差值及其在中医临床研究中的应用展望. 中国中西医结合杂志, 2013, 33(4): 544-548,558.
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6.	杨丽虹, 肖晶旻, 刘少南, 等. 最小临床意义差值的确定和应用. 广州中医药大学学报, 2022, 39(04): 959-965.
7.	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.
8.	McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA, 2014, 312(13): 1342-1343.
9.	Draak THP, de Greef BTA, Faber CG, et al. The minimum clinically important difference: which direction to take. Eur J Neurol, 2019, 26(6): 850-855.
10.	Tubach F, Giraudeau B, Ravaud P. The variability in minimal clinically important difference and patient acceptable symptomatic state values did not have an impact on treatment effect estimates. J Clin Epidemiol, 2009, 62(7): 725-728.
11.	Leidy NK, Wyrwich KW. Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD, 2005, 2(1): 157-165.
12.	Devji T, Carrasco-Labra A, Qasim A, et al. Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study. BMJ, 2020, 369: m1714.
13.	Wang Y, Devji T, Carrasco-Labra A, et al. A step-by-step approach for selecting an optimal minimal important difference. BMJ, 2023, 381: e073822.
14.	Carrasco-Labra A, Devji T, Qasim A, et al. Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement. J Clin Epidemiol, 2022, 25-32.
15.	Carrasco-Labra A, Devji T, Qasim A, et al. Minimal important difference estimates for patient-reported outcomes: a systematic survey. J Clin Epidemiol, 2021, 133: 61-71.
16.	Escobar A, García Pérez L, Herrera-Espiñeira C, et al. Total knee replacement; minimal clinically important differences and responders. Osteoarthritis Cartilage, 2013, 21(12): 2006-2012.
17.	Dechartres A, Trinquart L, Atal I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study. BMJ, 2017, 357: j2490.
18.	Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
19.	Schünemann HJ, Guyatt GH. Commentary--goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res, 2005, 40(2): 593-597.
20.	Weinfurt KP, Reeve BB. Patient-reported outcome measures in clinical research. JAMA, 2022, 328(5): 472-473.
21.	Devji T, Guyatt GH, Lytvyn L, et al. Application of minimal important differences in degenerative knee disease outcomes: a systematic review and case study to inform BMJ rapid recommendations. BMJ Open, 2017, 7(5): e015587.
22.	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(5): 71-77.
23.	Riepe C, Osada N, Reich A, et al. Minimal clinically important difference in chronic pruritus appears to be dependent on baseline itch severity. Acta Derm Venereol, 2019, 99(13): 1288-1290.
24.	Rodrigues JN, Mabvuure NT, Nikkhah D, et al. Minimal important changes and differences in elective hand surgery. J Hand Surg Eur Vol, 2015, 40(9): 900-912.

1. Valderas JM, Kotzeva A, Espallargues M, et al. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res, 2008, 17(2): 179-193.
2. Kluzek S, Dean B, Wartolowska KA. Patient-reported outcome measures (PROMs) as proof of treatment efficacy. BMJ Evid Based Med, 2022, 27(3): 153-155.
3. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials, 1989, 10(4): 407-415.
4. 路桃影, 吴大嵘. 最小重要差值及其在中医临床研究中的应用展望. 中国中西医结合杂志, 2013, 33(4): 544-548,558.
5. 杨丽虹, 刘少南, 吴大嵘, 等. 最小临床意义差值的概念及其估算方法. 中国循证医学杂志, 2020, 20(11): 1345-1352.
6. 杨丽虹, 肖晶旻, 刘少南, 等. 最小临床意义差值的确定和应用. 广州中医药大学学报, 2022, 39(04): 959-965.
7. 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.
8. McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA, 2014, 312(13): 1342-1343.
9. Draak THP, de Greef BTA, Faber CG, et al. The minimum clinically important difference: which direction to take. Eur J Neurol, 2019, 26(6): 850-855.
10. Tubach F, Giraudeau B, Ravaud P. The variability in minimal clinically important difference and patient acceptable symptomatic state values did not have an impact on treatment effect estimates. J Clin Epidemiol, 2009, 62(7): 725-728.
11. Leidy NK, Wyrwich KW. Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD, 2005, 2(1): 157-165.
12. Devji T, Carrasco-Labra A, Qasim A, et al. Evaluating the credibility of anchor based estimates of minimal important differences for patient reported outcomes: instrument development and reliability study. BMJ, 2020, 369: m1714.
13. Wang Y, Devji T, Carrasco-Labra A, et al. A step-by-step approach for selecting an optimal minimal important difference. BMJ, 2023, 381: e073822.
14. Carrasco-Labra A, Devji T, Qasim A, et al. Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement. J Clin Epidemiol, 2022, 25-32.
15. Carrasco-Labra A, Devji T, Qasim A, et al. Minimal important difference estimates for patient-reported outcomes: a systematic survey. J Clin Epidemiol, 2021, 133: 61-71.
16. Escobar A, García Pérez L, Herrera-Espiñeira C, et al. Total knee replacement; minimal clinically important differences and responders. Osteoarthritis Cartilage, 2013, 21(12): 2006-2012.
17. Dechartres A, Trinquart L, Atal I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study. BMJ, 2017, 357: j2490.
18. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
19. Schünemann HJ, Guyatt GH. Commentary--goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res, 2005, 40(2): 593-597.
20. Weinfurt KP, Reeve BB. Patient-reported outcome measures in clinical research. JAMA, 2022, 328(5): 472-473.
21. Devji T, Guyatt GH, Lytvyn L, et al. Application of minimal important differences in degenerative knee disease outcomes: a systematic review and case study to inform BMJ rapid recommendations. BMJ Open, 2017, 7(5): e015587.
22. 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(5): 71-77.
23. Riepe C, Osada N, Reich A, et al. Minimal clinically important difference in chronic pruritus appears to be dependent on baseline itch severity. Acta Derm Venereol, 2019, 99(13): 1288-1290.
24. Rodrigues JN, Mabvuure NT, Nikkhah D, et al. Minimal important changes and differences in elective hand surgery. J Hand Surg Eur Vol, 2015, 40(9): 900-912.

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