The reporting of CONSORT items and key feasibility elements in pilot and feasibility studies in hip and knee arthroplasty is suboptimal: a methodological survey.
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Abstract
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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