Statistical Fragility of Randomized Controlled Trials Evaluating Rehabilitation After Arthroscopic Rotator Cuff Repair. [Review]

MedStar author(s):
Citation: Orthopaedic Journal of Sports Medicine. 11(7):23259671231184946, 2023 Jul.PMID: 37533502Institution: MedStar Union Memorial Hospital | MedStar Union Memorial Hospital | MedStar Union Memorial HospitalDepartment: Orthopaedic Surgery | Orthopaedic Surgery Residency | OrthopedicsForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewYear: 2023ISSN:
  • 2325-9671
Name of journal: Orthopaedic journal of sports medicineAbstract: Background: Clinical decision-making often relies on evidence-based medicine, derived from objective data with conventional and rigorous statistical tests to evaluate significance. The literature surrounding rehabilitation after rotator cuff repair (RCR) is conflicting, with no defined standard of practice.Conclusion: The results of RCT studies of RCR rehabilitation protocols are moderately fragile, something clinicians should be aware of when implementing study results into practice. We recommend the inclusion of FI and FQ in addition to standard P values when reporting statistical results in future RCTs with dichotomous outcome variables on this topic. Copyright © The Author(s) 2023.Methods: A systematic review was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines by searching the PubMed, Cochrane Library, and Embase databases for RCTs evaluating rehabilitation protocols after arthroscopic RCRs from 2000 to June 1, 2022. The FI was determined by manipulating the dichotomous outcome events from each article until a reversal of significance with 2 x 2 contingency tables was achieved. The FQ was determined by dividing the FI by the sample size.Purpose: To determine the fragility index (FI) and the fragility quotient (FQ) of randomized controlled trials (RCTs) evaluating rehabilitation protocols after RCR.Results: Fourteen RCTs with 48 dichotomous outcomes were ultimately included for analysis. The mean FI for the included dichotomous outcomes was 4 (interquartile range, 3-6), suggesting that the reversal of 4 events is required to change study significance. The mean FQ was 0.048. Of the RCTs that reported data regarding loss to follow-up, most studies (58.5%) indicated that >4 patients had been lost to follow-up.Study Design: Systematic review.All authors: Murthi AM, Sequeira SB, Wright MAFiscal year: FY2024Digital Object Identifier: Date added to catalog: 2023-10-04
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Journal Article MedStar Authors Catalog Article 37533502 Available 37533502

Background: Clinical decision-making often relies on evidence-based medicine, derived from objective data with conventional and rigorous statistical tests to evaluate significance. The literature surrounding rehabilitation after rotator cuff repair (RCR) is conflicting, with no defined standard of practice.

Conclusion: The results of RCT studies of RCR rehabilitation protocols are moderately fragile, something clinicians should be aware of when implementing study results into practice. We recommend the inclusion of FI and FQ in addition to standard P values when reporting statistical results in future RCTs with dichotomous outcome variables on this topic. Copyright © The Author(s) 2023.

Methods: A systematic review was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines by searching the PubMed, Cochrane Library, and Embase databases for RCTs evaluating rehabilitation protocols after arthroscopic RCRs from 2000 to June 1, 2022. The FI was determined by manipulating the dichotomous outcome events from each article until a reversal of significance with 2 x 2 contingency tables was achieved. The FQ was determined by dividing the FI by the sample size.

Purpose: To determine the fragility index (FI) and the fragility quotient (FQ) of randomized controlled trials (RCTs) evaluating rehabilitation protocols after RCR.

Results: Fourteen RCTs with 48 dichotomous outcomes were ultimately included for analysis. The mean FI for the included dichotomous outcomes was 4 (interquartile range, 3-6), suggesting that the reversal of 4 events is required to change study significance. The mean FQ was 0.048. Of the RCTs that reported data regarding loss to follow-up, most studies (58.5%) indicated that >4 patients had been lost to follow-up.

Study Design: Systematic review.

English

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