Advertisement
Review Article| Volume 150, P25-32, October 2022

Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement

      Abstract

      Background and Objectives

      To evaluate reporting of minimal important difference (MID) estimates using anchor-based methods for patient-reported outcome measures (PROMs), and the association with reporting deficiencies on their credibility.

      Methods

      Systematic survey of primary studies empirically estimating MIDs. We searched Medline, EMBASE, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database until October 2018. We evaluated study reporting, focusing on participants’ demographics, intervention(s), characteristics of PROMs and anchors, and MID estimation method(s). We assessed the impact of reporting issues on credibility of MID estimates.

      Results

      In 585 studies reporting on 5,324 MID estimates for 526 distinct PROMs, authors frequently failed to adequately report key characteristics of PROMs and MIDs, including minimum and maximum values of PROM scale, measure of variability accompanying the MID estimate and number of participants included in the MID calculation. Across MID estimates (n = 5,324), the most serious reporting issues impacting credibility included infrequent reporting of the correlation between the anchor and PROM (66%), inadequate details to judge precision of MID point estimate (13%), and insufficient information about the threshold used to ascertain MIDs (16%).

      Conclusion

      Serious issues of incomplete reporting in the MID literature threaten the optimal use of MID estimates to inform the magnitude of effects of interventions on PROMs.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Epidemiology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Glasziou P.
        • Altman D.G.
        • Bossuyt P.
        • Boutron I.
        • Clarke M.
        • Julious S.
        • et al.
        Reducing waste from incomplete or unusable reports of biomedical research.
        Lancet. 2014; 383: 267-276
        • Chalmers I.
        • Glasziou P.
        Avoidable waste in the production and reporting of research evidence.
        Lancet. 2009; 374: 86-89
        • Jaeschke R.
        • Singer J.
        • Guyatt G.H.
        Measurement of health status. Ascertaining the minimal clinically important difference.
        Control Clin Trials. 1989; 10: 407-415
        • Simera I.
        • Altman D.G.
        Writing a research article that is "fit for purpose": EQUATOR network and reporting guidelines.
        Evid Based Med. 2009; 14: 132-134
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
        Obstet Gynecol. 2010; 115: 1063-1070
        • Dechartres A.
        • Trinquart L.
        • Atal I.
        • Moher D.
        • Dickersin K.
        • Boutron 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
        • Calvert M.
        • Blazeby J.
        • Altman D.G.
        • Revicki D.A.
        • Moher D.
        • Brundage M.D.
        Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
        JAMA. 2013; 309: 814-822
        • Johnston B.C.
        • Ebrahim S.
        • Carrasco-Labra A.
        • Furukawa T.A.
        • Patrick D.L.
        • Crawford M.W.
        • et al.
        Minimally important difference estimates and methods: a protocol.
        BMJ Open. 2015; 5: e007953
        • Carrasco-Labra A.
        • Devji T.
        • Qasim A.
        • Phillips M.R.
        • Wang Y.
        • Johnston B.C.
        • et al.
        Minimal important difference estimates for patient-reported outcomes: a systematic survey.
        J Clin Epidemiol. 2020; 133: 61-71
        • Devji T.
        • Carrasco-Labra A.
        • Qasim A.
        • Phillips M.
        • Johnston B.C.
        • Devasenapathy N.
        • 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
        • Pinotti R.
        PROQOLID.
        J Med Libr Assoc. 2016; 104: 91-92
        • Devji T.
        • Guyatt G.H.
        • Lytvyn L.
        • Brignardello-Petersen R.
        • Foroutan F.
        • Sadeghirad B.
        • 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: e015587
        • Calvert M.
        • Kyte D.
        • Price G.
        • Valderas J.M.
        • Hjollund N.H.
        Maximising the impact of patient reported outcome assessment for patients and society.
        BMJ. 2019; 364: k5267
        • Cella D.
        • Hahn E.A.
        • Dineen K.
        Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening.
        Qual Life Res. 2002; 11: 207-221
        • Guyatt G.H.
        • Norman G.R.
        • Juniper E.F.
        • Griffith L.E.
        A critical look at transition ratings.
        J Clin Epidemiol. 2002; 55: 900-908
        • de Vet H.C.
        • Terluin B.
        • Knol D.L.
        • Roorda L.D.
        • Mokkink L.B.
        • Ostelo R.W.
        • et al.
        Three ways to quantify uncertainty in individually applied "minimally important change" values.
        J Clin Epidemiol. 2010; 63: 37-45