The statistical fragility of studies on rotator cuff repair with graft augmentation.
The statistical fragility of studies on rotator cuff repair with graft augmentation.
- 2023
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.
English
1058-2746
10.1016/j.jse.2022.12.017 [doi] S1058-2746(23)00026-5 [pii]
*Rotator Cuff
*Rotator Cuff Injuries
Arthroplasty
Humans
Neurosurgical Procedures
Research Design
Rotator Cuff Injuries/su [Surgery]
Rotator Cuff/su [Surgery]--Automated
MedStar Union Memorial Hospital
Curtis National Hand Center
Orthopaedic Surgery
Orthopaedic Surgery Residency
Journal Article
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.
English
1058-2746
10.1016/j.jse.2022.12.017 [doi] S1058-2746(23)00026-5 [pii]
*Rotator Cuff
*Rotator Cuff Injuries
Arthroplasty
Humans
Neurosurgical Procedures
Research Design
Rotator Cuff Injuries/su [Surgery]
Rotator Cuff/su [Surgery]--Automated
MedStar Union Memorial Hospital
Curtis National Hand Center
Orthopaedic Surgery
Orthopaedic Surgery Residency
Journal Article