Inadequate Reporting of Complications in Randomized Controlled Trials Cited as Supporting Evidence Underpinning AAOS CPG Recommendations for Hip and Knee Osteoarthritis: Application of the CONSORT Harms Checklist.
CONSORT harms
adverse events
clinical trials
harms reporting
reporting
Journal
The Journal of arthroplasty
ISSN: 1532-8406
Titre abrégé: J Arthroplasty
Pays: United States
ID NLM: 8703515
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
received:
18
04
2022
revised:
05
06
2022
accepted:
07
06
2022
pubmed:
17
6
2022
medline:
24
11
2022
entrez:
16
6
2022
Statut:
ppublish
Résumé
Randomized controlled trials (RCTs) have been shown to influence clinical decision-making and health policy. Therefore, it is essential that trial outcomes-including harms-are completely reported. We included all RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee, Osteoarthritis of the Knee, and Osteoarthritis of theHip Clinical Practice Guideline recommendations. Manuscripts were analyzed for compliance with the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms items. We determined the Extension for Harms' influence on harms reporting by comparing RCTs published before and after the extension's release. One hundred and seventy-three RCTs were included, of which 81 (47%) adequately reported ≥50% of the checklist and 75 (43%) reported ≤33% of the checklist items. The mean number of checklist items reported was 8 items (of 18; 45%). Our interrupted time-series analysis suggests the implementation of the CONSORT Extension for Harms did not have a statistically significant effect on the completeness of harms reporting (P = .35; 95% Confidence interval = -0.0041 to 0.0014). Harms-related data are poorly reported within RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons management for hip and knee OA Clinical Practice Guideline. Our time series analysis illustrates the failure of the CONSORT Extension for Harms on improving the reporting of harms-related data. Future efforts to improve the quality of harms reporting is crucial for patients, clinicians, and policy makers to perform thorough risk-benefit appraisals as RCT results directly influence clinical decision-making in orthopaedic surgery.
Sections du résumé
BACKGROUND
Randomized controlled trials (RCTs) have been shown to influence clinical decision-making and health policy. Therefore, it is essential that trial outcomes-including harms-are completely reported.
METHODS
We included all RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee, Osteoarthritis of the Knee, and Osteoarthritis of theHip Clinical Practice Guideline recommendations. Manuscripts were analyzed for compliance with the Consolidated Standards of Reporting Trials (CONSORT) Extension for Harms items. We determined the Extension for Harms' influence on harms reporting by comparing RCTs published before and after the extension's release.
RESULTS
One hundred and seventy-three RCTs were included, of which 81 (47%) adequately reported ≥50% of the checklist and 75 (43%) reported ≤33% of the checklist items. The mean number of checklist items reported was 8 items (of 18; 45%). Our interrupted time-series analysis suggests the implementation of the CONSORT Extension for Harms did not have a statistically significant effect on the completeness of harms reporting (P = .35; 95% Confidence interval = -0.0041 to 0.0014).
CONCLUSION
Harms-related data are poorly reported within RCTs cited as supporting evidence for the American Academy of Orthopaedic Surgeons management for hip and knee OA Clinical Practice Guideline. Our time series analysis illustrates the failure of the CONSORT Extension for Harms on improving the reporting of harms-related data. Future efforts to improve the quality of harms reporting is crucial for patients, clinicians, and policy makers to perform thorough risk-benefit appraisals as RCT results directly influence clinical decision-making in orthopaedic surgery.
Identifiants
pubmed: 35709908
pii: S0883-5403(22)00622-2
doi: 10.1016/j.arth.2022.06.004
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2466-2472.e2Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.