Statistical Fragility of Single-Row Versus Double-Row Anchoring for Rotator Cuff Repair: A Systematic Review of Comparative Studies.

Autor:	Fackler NP; Department of Orthopaedic Surgery, University of California, Irvine, Irvine, California, USA.; Georgetown University School of Medicine, Washington, DC, USA., Ehlers CB; Department of Orthopaedic Surgery, University of California, San Diego, San Diego, California, USA., Callan KT; Department of Orthopaedic Surgery, University of California, Irvine, Irvine, California, USA., Amirhekmat A; Department of Orthopaedic Surgery, University of California, Irvine, Irvine, California, USA., Smith EJ; Department of Orthopaedic Surgery, University of California, Irvine, Irvine, California, USA., Parisien RL; Department of Orthopaedic Surgery, Mount Sinai, New York, New York, USA., Wang D; Department of Orthopaedic Surgery, University of California, Irvine, Irvine, California, USA.
Jazyk:	angličtina
Zdroj:	Orthopaedic journal of sports medicine [Orthop J Sports Med] 2022 May 10; Vol. 10 (5), pp. 23259671221093391. Date of Electronic Publication: 2022 May 10 (Print Publication: 2022).
DOI:	10.1177/23259671221093391
Abstrakt:	Background: Comparative studies and randomized controlled trials (RCTs) often use the P (probability) value to convey the statistical significance of their findings. P values are an imperfect measure, however, and are vulnerable to a small number of outcome reversals to alter statistical significance. The inclusion of a fragility index (FI) and fragility quotient (FQ) may aid in the interpretation of a study's statistical strength. Purpose/hypothesis: The purpose of this study was to examine the statistical stability of studies comparing single-row to double-row rotator cuff repair. It was hypothesized that the findings of these studies would be vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. Study Design: Systematic review; Level of evidence, 3. Methods: We analyzed comparative studies and RCTs on primary single-row versus double-row rotator cuff repair that were published between 2000 and 2021 in 10 leading orthopaedic journals. Statistical significance was defined as a P < .05. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. Results: Of 4896 studies screened, 22 comparative studies, 10 of which were RCTs, were ultimately included for analysis. A total of 74 outcomes were examined. Overall, the median FI was 2 (interquartile range [IQR], 1-3), and the median FQ was 0.035 (IQR, 0.020-0.057). The mean FI was 2.55 ± 1.29, and the mean FQ was 0.043 ± 0.027. In 64% of outcomes, the FI was less than the number of patients lost to follow-up.) Additionally, 81% of significant outcomes needed just a single outcome reversal to lose their significance. Conclusion: Over half of the studies currently used to guide clinical practice have a number of patients lost to follow-up greater than their FI. The results of these studies should be interpreted within the context of these limitations. Future analyses may benefit from the inclusion of the FI and the FQ in their statistical analyses. Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: R.L.P. has received grant support and education payments from Arthrex. D.W. has received education payments from Arthrex and Smith & Nephew; consulting fees from Newclip, Ipsen Biosciences, DePuy/Medical Device Business Services, and Vericel; and hospitality payments from Linvatec and Stryker. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. (© The Author(s) 2022.)
Databáze:	MEDLINE
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