Rates of discontinuation and non-publication of upper and lower extremity fracture clinical trials

• Published in: Journal of orthopaedic surgery and research 2023-03, Vol.18 (1), p.256-256, Article 256
• Main Authors: Shepard, Samuel, Anderson, J Michael, Heigle, Benjamin, Thompson, Jay C, Detweiler, Byron, Hartwell, Micah, Vassar, Matt
• Format: Article
• Language: English
• Subjects: Clinical trials; Data Collection; Decision making; Discontinuation; Fracture; Fractures; Human subjects; Humans; Lower Extremity; Medical research; Medicine, Experimental; Non-publication; Orthopedics; Patient safety; Patient Selection; Upper extremity
• ISSN: 1749-799X; 1749-799X
• DOI: 10.1186/s13018-023-03698-5

To our knowledge, no study has quantified the rate of discontinuation and nonpublication of randomized controlled trials (RCTs) regarding upper and lower extremity fractures. We searched ClinicalTrials.gov on September 9th, 2020, for phase 3 and 4 RCTs pertaining to upper and lower extremity fractures. Trial completion status was determined using records available on ClinicalTrials.gov. Publication status was determined using records on ClinicalTrials.gov and by searching PubMed (MEDLINE), Embase, and Google Scholar. We queried corresponding authors on trial status if a peer-reviewed publication was not identified. Our final analysis included 142 RCTs, of which 57 (40.1%) were discontinued and 71 (50%) were unpublished. Thirty-six (of 57, 63.2%) discontinued trials failed to provide a reason for discontinuation, the most commonly identified reason for discontinuation was due to inadequate recruitment (13/21, 61.9%). Completed trials were more likely to reach publication (59/85; 69.4%; X  = 32.92; P ≤ 0.001) than discontinued trials. Trials with more than 80 participants were less likely not to reach publication (AOR: 0.12; 95% CI 0.15-0.66). Our analysis of 142 upper and lower extremity fracture RCTs demonstrated one-half failed to reach publication and two-fifths were discontinued prior to trial completion. These findings indicate the need for increased guidance in developing, completing, and publishing RCTs in upper and lower extremity fractures. Discontinuation and nonpublication of orthopaedic RCTs hinder the public's access to collected data and negate the valued contribution from study participants. Discontinuation and non-publication of clinical trials may subject participants to potentially harmful interventions, limit the advancement of clinical research, and contribute to research waste. III.