TY  - BOOK
AU  - Imbergamo, Casey 
AU  - Means, Kenneth R Jr
AU  - Sequeira, Sean 
AU  - Stein, Jason A
TI  - The statistical fragility of studies on rotator cuff repair with graft augmentation
SN  - 1058-2746
KW  - *Rotator Cuff
KW  - *Rotator Cuff Injuries
KW  - Arthroplasty
KW  - Humans
KW  - Neurosurgical Procedures
KW  - Research Design
KW  - Rotator Cuff Injuries/su [Surgery]
KW  - Rotator Cuff/su [Surgery]
KW  - Automated
KW  - MedStar Union Memorial Hospital
KW  - Curtis National Hand Center
KW  - Orthopaedic Surgery
KW  - Orthopaedic Surgery Residency
KW  - Journal Article
N2  - BACKGROUND: Clinical decision-making often relies on evidence-based medicine. Our purpose was to determine the fragility index (FI) and fragility quotient (FQ) for studies evaluating rotator cuff repair (RCR) with graft augmentation. A lost to follow-up (LTF) value greater than the FI indicates statistical instability for the reported outcomes and conclusions; CONCLUSION: Studies of RCR with graft augmentation lack statistical stability, with few altered outcome events required to reverse statistical significance. Larger comparative studies with better follow-up will strengthen the statistical stability of the evidence for RCR with graft augmentation. For future investigations and reports, we recommend including FI and FQ along with traditional statistical significance analyses to provide better context on the strength of conclusions. Copyright � 2023. Published by Elsevier Inc; METHODS: We performed a systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines by searching PubMed, the Cochrane library, and Embase in June 2022 to identify studies of RCR with graft augmentation. Comparative studies with at least one statistically analyzed dichotomous outcome were included. Seventeen studies published in seven peer-reviewed journals from 2003 to 2019 were subsequently evaluated. The FI was determined by changing each reported outcome event within 2 x 2 contingency tables until statistical significance or non-significance was reversed. The associated FQ was determined by dividing the FI by the sample size. LTF values were also extracted from each included study; RESULTS: The included studies had a total of 1,098 patients with 36 dichotomous outcomes. The associated median FI was 4 (IQR 2-5), indicating that the reversal of 4 patients' outcomes would have reversed the finding of significant difference. The median FQ was 0.08 (IQR 0.04-0.15), indicating that in a sample of 100 patients, reversal of 8 patients' outcomes would reverse statistical significance. The median number of patients lost to follow-up was 3 (range 0-25), with 56% of reported outcomes having LTF greater than their respective FI
UR  - https://dx.doi.org/10.1016/j.jse.2022.12.017
ER  -