• J Shoulder Elbow Surg · Dec 2019

    The fragility of findings of randomized controlled trials in shoulder and elbow surgery.

    • Joseph J Ruzbarsky, Ryan C Rauck, Joseph Manzi, Sariah Khormaee, Bridget Jivanelli, and Russell F Warren.
    • Department of Orthopaedics, Hospital for Special Surgery, New York, NY, USA. Electronic address: ruzbarskyj@hss.edu.
    • J Shoulder Elbow Surg. 2019 Dec 1; 28 (12): 2409-2417.

    BackgroundConsidered the gold standard of study designs, randomized controlled trials' (RCTs) results shape clinical practice, effect policy, and influence reimbursement. The fragility index (FI) can be used to quantitate the relative robustness of RCT results, with higher scores indicating more stout results. Unfortunately, most RCTs in surgery have fragile results. The aim of this study was to report on the FI in addition to a qualitative assessment of recent RCTs within the field of shoulder and elbow surgery.MethodsA systematic review was performed identifying recently published shoulder/elbow RCTs that included 1:1 allocated parallel study arms, dichotomous primary outcome variables, and statistical significance. The FI was calculated by sequentially modifying outcome groups by exchanging a nonevent in one group to an event until the P value for the outcome comparison, as calculated by the Fisher exact test, was increased above the .05 threshold.ResultsThirty RCTs were included. The median FI was 4. Sixty percent trials had a FI of 2 or less. Fifty-three percent studies reported that participants were lost to follow-up. In 87.5% of these studies, the losses to follow-up exceeded their respective FIs. Only 53% of studies defined a primary outcome variable and 60% studies performed a prestudy power analysis.ConclusionsThe median FI reported in the recent shoulder/elbow literature is 4; however, a high proportion of included RCTs display significant methodological concerns. The FI is a useful adjunct to analyze RCT results, but careful analysis of trial methods should be employed in each circumstance before drawing conclusions.Copyright © 2019 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

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