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. 2021 Jan 20;103(2):185-190.
doi: 10.2106/JBJS.20.00474.

Interpreting Patient-Reported Outcome Measures in Orthopaedic Surgery: A Systematic Review

Shgufta Docter  1 , Zina Fathalla  2 , Michael J Lukacs  1 , Michaela C M Khan  1 , Morgan Jennings  1 , Shu-Hsuan Liu  2 , Susan Dong  2 , Alan Getgood  1 , Dianne M Bryant  1   2
Affiliations

Interpreting Patient-Reported Outcome Measures in Orthopaedic Surgery: A Systematic Review

Shgufta Docter et al. J Bone Joint Surg Am. .

Abstract

Background: The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value.

Methods: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs.

Results: A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019.

Conclusions: The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.

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Conflict of interest statement

Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work (http://links.lww.com/JBJS/G116).

References

    1. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):834-40. Epub 2010 Mar 25.
    1. Nagendran M, Harding D, Teo W, Camm C, Maruthappu M, McCulloch P, Hopewell S. Poor adherence of randomised trials in surgery to CONSORT guidelines for non-pharmacological treatments (NPT): a cross-sectional study. BMJ Open. 2013 Dec 18;3(12):e003898.
    1. Gardner MJ, Altman DG. Confidence intervals rather than p values: estimation rather than hypothesis testing. Br Med J (Clin Res Ed). 1986 Mar 15;292(6522):746-50.
    1. Harris JD, Brand JC, Cote MP, Faucett SC, Dhawan A. Research pearls: the significance of statistics and perils of pooling. Part 1: clinical versus statistical significance. Arthroscopy. 2017 Jun;33(6):1102-12. Epub 2017 Apr 25.
    1. Sullivan GM, Feinn R. Using effect size-or why the p value is not enough. J Grad Med Educ. 2012 Sep;4(3):279-82.

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