From Protocol to Definitive Study-The State of Randomized Controlled Trial Evidence in Sports Medicine Research: A Systematic Review and Survey Study.

Abstract

To evaluate the progression, quality, and challenges associated with conducting and publishing randomized controlled trials (RCTs) in sports medicine. Systematic review and survey. MEDLINE and Embase were searched for all publications before September 17, 2021. A targeted search of clinicaltrials.gov , BMC Musculoskeletal Disorders, PubMed, and Google Scholar were also conducted. The survey was administered to authors using REDCap. Where the systematic search revealed no corresponding published definitive trial, authors of the published pilots were surveyed. Survey assessing limitations to definitive trials. Protocol/method articles, pilot articles, and relevant clinical trial registry records with corresponding definitive trials were pooled. Our literature search yielded 27 006 studies; of which, we included 208 studies (60 (28.8%) pilot RCTs, 84 (40.4%) protocol/method articles, and 64 (30.8%) trial registry records). From these, 44 corresponding definitive RCTs were identified. Pilot study and definitive RCT methodological quality increased on average most significantly during the duration of this review (30.6% and 8.2%). Of the 176 authors surveyed, 59 (33.5%) responded; 24.6% (14/57) stated that they completed an unpublished definitive trial, while 52.6% (30/57) reported having one underway. The quality and number of RCT publications within the field of sports medicine has been increasing since 1999. The number of sports medicine-related protocol and pilot articles preceding a definitive trial publication showed a sharp increase over the past 10 years, although only 5 pilot studies have progressed to a definitive RCT.