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

OBJECTIVE: To evaluate the progression, quality, and challenges associated with conducting and publishing randomized controlled trials (RCTs) in sports medicine.

DESIGN: Systematic review and survey.

SETTING: 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.

PARTICIPANTS: Where the systematic search revealed no corresponding published definitive trial, authors of the published pilots were surveyed.

INTERVENTIONS: Survey assessing limitations to definitive trials.

MAIN OUTCOME MEASURES: Protocol/method articles, pilot articles, and relevant clinical trial registry records with corresponding definitive trials were pooled.

RESULTS: 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 Of the 176 authors surveyed, 59 (33.5%) responded; 24.6% (14/57) stated that they completed an unpublished definitive trial, while 52.6% (30/57) reported having one underway.

CONCLUSIONS: 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.