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The reporting of CONSORT items and key feasibility elements in pilot and feasibility studies in hip and knee
Zinnia Chung1, Leigh-Ann Grant1, Lawrence Mbuagbaw2,3,4,5,6,7
1Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Background:
As the global demand for hip and knee arthroplasty procedures grow, advancements in orthopedic research are vital for progress. Pilot and feasibility trials play a critical role in optimising research efficiency, highlighting methodological gaps, and maximising study insights. However, the completeness of reporting in hip and knee arthroplasty pilot and feasibility trials remains unclear.
Objectives:
The primary objective was to evaluate reporting completeness, assessed using the CONSORT checklist extension to pilot and feasibility trials. Secondary objectives included evaluating the reporting of key feasibility items and exploring factors associated with reporting completeness.
Setting And Methods:
This methodological survey analysed pilot and feasibility trials in hip and knee arthroplasty. A PubMed search identified relevant manuscripts published between January 1, 2017, and December 31, 2023. A minimum acceptable sample size of 147 (of 278 eligible) was identified, based on a calculation involving an estimated reporting completeness of 25% of the CONSORT checklist, a 95% confidence interval, and a 5% margin of error. Descriptive statistics were reported, and a multivariable linear regression with robust (HC1) standard errors was completed.
Results:
Of 278 eligible publications identified from PubMed, a random sample of 147 studies was included. Reporting completeness was low, with studies accounting for a mean of 54.98% (16.95) of applicable CONSORT extension items. Notably, pilot-specific objectives and future study implications were often underreported. Similarly, manuscripts missed approximately 71.35% (10/14) of key feasibility elements. Studies that referenced reporting guidelines in the manuscript text were associated with better reporting, while those that failed to disclose their funding sources and lacked more key feasibility items demonstrated weaker reporting completeness.
Conclusion:
Hip and knee arthroplasty pilot and feasibility trials exhibit suboptimal reporting completeness with several missing feasibility elements. Improved adherence to CONSORT guidelines and enhanced transparency are needed.
