2,258
Views
425
CrossRef citations to date
0
Altmetric
Review

A point of minimal important difference (MID): a critique of terminology and methods

Pages 171-184 | Published online: 09 Jan 2014

References

  • Guyatt GH, Osaba D, Wu AW et al. Methods to explain the clinical significance of health status measures. Mayo Clin. Proc.77(4), 371–383 (2002).
  • Hays RD, Farivar SS, Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD2(1), 63–67 (2005).
  • Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J. Clin. Epidemiol.61(2), 102–109 (2008).
  • Wyrwich KW, Bullinger M, Aaronson N et al. Estimating clinically significant differences in quality of life outcomes. Qual. Life Res.14(2), 285–295 (2005).
  • Guyatt GH, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J. Chronic Dis.40(2), 171–178 (1987).
  • Jaeschke R, Singer J, Guyatt GH. Measurement of health status: ascertaining the minimal clinically important difference. Control. Clin. Trials10, 407–415 (1989).
  • Lydick E, Epstein RS. Interpretation of quality of life changes. Qual. Life Res.2, 221–226 (1993).
  • Norman GR, Sloan JA, Wyrwich WK. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med. Care41(5), 582–592 (2003).
  • Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J. Clin. Oncol.16(1), 139–144 (1998).
  • Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of EORTC QLQ-C30 data in randomised controlled trials. Eur. J. Cancer44, 1793–1798 (2008).
  • Schünemann HJ, Guyatt GH. Goodbye (M)CID! Hello MID, where do you come from? (Commentary). Health Serv. Res.40(2), 593–597 (2005).
  • Ringash J, Bezjak A, O’Sullivan B, Redelmeier DA. Interpreting differences in quality of life: the FACT-H&N in laryngeal cancer patients. Qual. Life Res.13(4), 725–733 (2004).
  • Ringash J, O’Sullivan B, Bezjak A, Redelmeier DA. Interpreting clinically significant changes in patient-reported outcomes. Cancer110(1), 196–202 (2007).
  • 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.28(2), 400–405 (2001).
  • de Vet HC, Terwee CB, Ostelo RW, Beckerman H, Knol DL, Bouter LM. Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change. Health Qual. Life Outcomes4, 54 (2006).
  • de Vet HC, Ostelo RW, Terwee CB et al. Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach. Qual. Life Res.16(1), 131–142 (2007).
  • Snyder C, Aaronson N. Use of patient-reported outcomes in clinical practice. Lancet374(9687), 369–370 (2009).
  • Fayers PM, Machin D. Quality of Life: Assessment, Analysis and Interpretation (1st Edition). John Wiley & Sons Ltd, NY, USA (2000).
  • Guyatt G, Schunemann H. How can quality of life researchers make their work more useful to health workers and their patients? Qual. Life Res.16, 1097–1105 (2007).
  • Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J; Quality of Life Committee of the NCIC CTG. Analysis and interpretation of health-related quality of life data from clinical trials: basic approach of the National Cancer Institute of Canada Clinical Trials Group. Eur. J. Cancer41, 280–287 (2005).
  • Yost KJ, Cella D, Chawla A et al. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J. Clin. Epidemiol.58(12), 1241–1251 (2005).
  • Norman G. Hi! How are you? Response shift, implicit theories and differing epistemologies. Qual. Life Res.12(3), 239–249 (2003).
  • Schwartz CE, Sprangers MA. Adaptation to Changing Health: Response Shift in Quality-of-Life Research (1st Edition). American Psychological Association, Washington, DC, USA (2000).
  • Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System (4th Edition). Evanston Northwestern Healthcare & Northwestern University, IL, USA (1997).
  • Ware JE Jr. SF-36 Health Survey: Manual and Interpretation Guide. The Health Institute, Boston, MA, USA (1993).
  • King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual. Life Res.5, 555–567 (1996).
  • Knox S, King MT. Validation and calibration of the SF-36 health transition question against an external criterion of clinical change in health status. Qual. Life Res.18(5), 637–645 (2009).
  • Osoba D, King M. Interpreting QOL in individuals and groups: meaningful differences. In: Assessing Quality of Life in Clinical Trials: Methods and Practice. Fayers P, Hays R (Eds). Oxford University Press, Oxford, UK, 243–257 (2005).
  • 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.45(4), 384–391 (2001).
  • Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J. Pain Symptom Manage.24(6), 547–561 (2002).
  • Maringwa JT, Quinten C, King M et al. Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials. Support. Care Cancer DOI: 10.1007/s00520–010–1016–1015 (2010) (Epub ahead of print).
  • Ross M. Relation of implicit theories to the construction of personal histories. Psychological Rev.96(2), 341–357 (1989).
  • Norman GR, Stratford P, Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J. Clin. Epidemiol.50(8), 869–879 (1997).
  • Wyrwich K, Tardino V. Understanding global transition assessments. Qual. Life Res.15(6), 995–1004 (2006).
  • Metz SM, Wyrwich KW, Babu AN, Kroenke K, Tierney WM, Wolinsky FD. A comparison of traditional and Rasch cut points for assessing clinically important change in health-related quality of life among patients with asthma. Qual. Life Res.15(10), 1639–1649 (2006).
  • de Vet HC, Terluin B, Knol DL et al. Three ways to quantify uncertainty in individually applied ‘minimally important change’ values. J. Clin. Epidemiol.63(1), 37–45 (2010).
  • McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual. Life Res.4(4), 293–307 (1995).
  • 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.52(9), 861–873 (1999).
  • Wyrwich K. Minimal important difference thresholds and the standard error of measurement: is there a connection? J. Biopharm. Stat.14(1), 97–110 (2004).
  • Wyrwich KW, Tierney WM, Wolinsky FD. Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Qual. Life Res.11(1), 1–7 (2002).
  • Turner D, Schünemann HJ, Griffith LE et al. The minimal detectable change cannot reliably replace the minimal important difference. J. Clin. Epidemiol.63(1), 28–36 (2010).
  • Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med. Care27(3 Suppl.), S178–S189 (1989).
  • Cohen J. Statistical Power Analysis for the Behavioural Sciences (2nd Edition). Lawrence Erlbaum Associates, NJ, USA (1988).
  • Farivar SS, Liu H, Hays RD. Half standard deviation estimate of the minimally important difference in HRQOL scores? Expert Rev. Pharmacoeconomics Outcomes Res.4(5), 515–523 (2004).
  • Beaton DE. Simple as possible? Or too simple? Possible limits to the universality of the one half standard deviation. Med. Care41(5), 593–596 (2003).
  • Wright JG. Interpreting health-related quality of life scores: the simple rule of seven may not be so simple. Med. Care41(5), 597–598 (2003).
  • King MT, Stockler MR, Cella DF et al. Meta-analysis provides evidence-based effect sizes for a cancer-specific quality of life questionnaire, the FACT-G. J. Clin. Epidemiol.63(3), 270–281 (2010).
  • Cocks K, King MT, Velikova G, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer quality of life questionnaire core 30 (EORTC QLQ-C30). J. Clin. Oncol.29(1), 89–96 (2011).
  • Aaronson NK, Cull A, Kaasa S et al. The European Organisation for Research and Treatment of Cancer (EORTC) modular approach to quality of life assessment in oncology: an update. In: Quality of Life and Pharmacoeconomics in Clinical Trials. Spilker B (Ed.). Lippincott-Raven Publishers, PA, USA, 179–189 (1996).
  • Yost KJ, Eton DT. Combining distribution- and anchor-based approaches to determine minimally important differences: the FACIT experience. Eval. Health Prof.28(2), 172–191 (2005).
  • Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in symptoms: a comparison of two techniques [see comments]. J. Clin. Epidemiol.49(11), 1215–1219 (1996).
  • Deyo RA, Inui TS, Leininger J, Overman S. Physical and psychosocial function in rheumatoid arthritis. Clinical use of a self-administered health status instrument. Arch. Intern. Med.142(5), 879–882 (1982).
  • Kvam AK, Fayers P, Wisloff F. What changes in health-related quality of life matter to multiple myeloma patients? A prospective study. Eur. J. Haematol.84(4), 345–353 (2010).
  • Wyrwich KW, Metz SM, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. Interpreting quality-of-life data: methods for community consensus in asthma. Ann. Allergy Asthma Immunol.96(6), 826–833 (2006).
  • Wyrwich KW, Metz SM, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. Triangulating patient and clinician perspectives on clinically important differences in health-related quality of life among patients with heart disease. Health Serv. Res.42(6 Pt 1), 2257–2274; discussion 2294–2323 (2007).
  • Wyrwich KW, Metz SM, Kroenke K, Tierney WM, Babu AN, Wolinsky FD. 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.22(2), 161–170 (2007).
  • King MT, Cella D, Osoba D et al. Meta-analysis provides evidence-based interpretation guidelines for the clinical significance of mean differences for the FACT-G, a cancer-specific quality of life questionnaire. Patient Reported Outcome Measures2010(1), 119–126 (2010).
  • Fayers PM, Machin D. Sample sizes. In: Quality Of Life: The Assessment, Analysis And Interpretation Of Patient-Reported Outcomes. Wiley, Chichester, UK, 247–270 (2007).
  • Food and Drug Administration. Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Federal Register74(235), 65132–65133 (2009).
  • Dworkin RH, Turk DC, McDermott MP et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J. Pain Symptom Manage.9(2), 105–121 (2008).
  • Ware JE, Keller SD. Interpreting general health measures. In: Quality of Life and Pharmacoeconomics in Clinical Trials. Spilker B (Ed.). Lippincott-Raven, NY, USA, 445–460 (1996).
  • Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR; Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clin. Proc.77(4), 371–383 (2002).
  • Beaton D, Boers M, Wells G. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr. Opin. Rheumatol.14(2), 109–114 (2002).
  • Hays R, Woolley J. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics18, 419–423 (2000).
  • Wyrwich KW, Spratt DI, Gass M, Yu H, Bobula JD. Identifying meaningful differences in vasomotor symptoms among menopausal women. Menopause15(4 Pt 1), 698–705 (2008).
  • Sloan JA, Cella D, Frost M, Guyatt GH, Sprangers M, Symonds T; Clinical Significance Consensus Meeting Group. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms. Mayo Clin. Proc.77(4), 367–370 (2002).
  • de Vet HC, Beckerman H, Terwee CB, Terluin B, Bouter LM. Definition of clinical differences. J. Rheumatol.33(2), 434; author reply 435 (2006).
  • Beckerman H, Roebroeck ME, Lankhorst GJ, Becher JG, Bezemer PD, Verbeek AL. Smallest real difference, a link between reproducibility and responsiveness. Qual. Life Res.10(7), 571–578 (2001).
  • Oken MM, Creech, RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am. J. Clin. Oncol.5, 649–655 (1982).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.