Analysis of Terminated Hand and Wrist-Related Clinical Trials.

Purpose: While clinical trials provide high-quality evidence guiding medical decision-making, early trial termination can result in both lost time and resources. Our purpose was to investigate the rate of and reasons for clinical trial termination for hand and wrist-related conditions and identify study characteristics associated with early trial termination. Methods: The ClinicalTrials.gov database was queried for all hand and wrist-related clinical trials. All terminated and completed trials were reviewed, with characteristics and reasons for termination recorded. Study characteristics included type, purpose, intervention assessed, enrollment, group allocation, blinding, trial phase, sponsor type, and geographic region. Chi-square test was used to identify associations between trial characteristics and terminated versus completed status. Results: A total of 793 hand and wrist-related clinical trials were identified, with 77 trials (10%) terminated prior to completion. The most common reason for termination was "recruitment/retention difficulty," reported in 37 (48%) terminated trials. In comparing competed versus terminated trials, primary purpose (nonobservational studies), enrollment (<50 patients), and geographic region (North America) were all significantly more likely to be terminated. Terminated trials were more likely to have an intervention type investigating a specific device or drug. Conclusions: Early trial termination for hand and wrist-related conditions is common (10%), with patient recruitment and retention identified as the leading cause of termination. Trials involving potential commercial incentives (those investigating a device or drug) were associated with an increased rate of trial termination. Clinical relevance: An emphasis on patient enrollment during study design may aid in mitigating the most common cause of early clinical trial termination.

Race and Ethnicity Reporting in Randomized Controlled Trials Published in Upper-Extremity Journals.

PURPOSE: Hand surgery remains one of the least racially and ethnically diverse subspecialties in all of medicine, and minority patients demonstrate overall worse health care outcomes compared with White patients. Our purpose was to determine the frequency of race and ethnicity reporting in randomized controlled trials (RCTs) published in journals with an upper-extremity (UE) focus. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines by searching EMBASE and MEDLINE for RCTs contained in peer-reviewed journals with an UE focus. All articles from 2000 to 2021 were included. Information such as article sample size, center type, funding, and location was recorded. We assessed each article to determine whether demographic information, including race and ethnicity, was reported for study participants. RESULTS: A total of 481 RCTs in 9 UE journals were included. For UE RCTs, 96% of studies reported age, 90% reported sex, and 5% reported either race or ethnicity. Demographic information about economic status, insurance status, mental health, educational level, and marital status were each reported in <10% of RCTs. Racial representation was highest for White participants (80%) and lowest among American Indian participants. Of studies conducted within the United States, all racial groups except for White patients were underrepresented compared with census data. CONCLUSIONS: Demographic data related to race and ethnicity for patients involved in UE RCTs are infrequently reported. When reported, the racial demographics of UE RCT patients do not match the demographics of the patients in United States. Black patients remain underrepresented in RCTs. CLINICAL RELEVANCE: Academic journals mandating the reporting of demographic data related to race may aid in improved reporting and allow for subsequent aggregation within systematic reviews to assess outcomes for racial minorities.