ABSTRACT
Background: Previous reports found that 40% of randomized controlled trials (RCTs) published in The Journal of Bone & Joint Surgery (JBJS) from 1988 to 2000 and 47% of those published from 2001 to 2013 were of high quality. The purpose of this study was to assess the quality of RCTs published from 2014 to 2022 in JBJS and to compare these findings with those of prior analyses in order to identify trends over time and areas for continued improvement. Methods: PubMed was searched for the term "randomized controlled trial" to identify studies published in JBJS from 2014 to 2022. Each included RCT was evaluated with use of the Detsky score and a risk-of-bias assessment modified from the Cochrane tool. These evaluations were then compared with previous evaluations of RCTs from the 1988 to 2000 and 2001 to 2013 periods with use of independent-sample t tests. A transformed Detsky score of >75% and a modified risk-of-bias score of ≥8 were defined as being indicative of high quality. Results: A total of 218 RCTs were published in JBJS from 2014 to 2022. An a priori sample size was calculated in 183 studies (83.9%). A total of 152 (83.1%) of the 183 studies enrolled the calculated number of patients, of which 126 (82.9%) maintained an adequate number at the time of final follow-up. Most RCTs were conducted at a single center (146 of 218; 67%), evaluated a surgical intervention (162 of 218; 74%), and reported positive results (142 of 218; 65%). The mean transformed Detsky score was 85% ± 10% (95% confidence interval, 83.7% to 86.3%), with 82% of trials (179 of 218) scored as high quality. The mean transformed Detsky score from 2014 to 2022 was higher than that from 1988 to 2000 and that from 2001 to 2013 (85% versus 76% and 68%, respectively; p < 0.001). The mean modified risk-of-bias score was 7 ± 1, with 42% of trials (92 of 218) scored as high quality. RCTs published from 2014 to 2022 had a higher mean modified risk-of-bias score than those published from 2001 to 2013 (7 ± 1 versus 6 ± 1; p < 0.001). Compared with the 2001 to 2013 and 2014 to 2022 periods, the 1988 to 2000 period had a greater proportion of trials that reported positive results (51% and 65% versus 82%, respectively; p < 0.001) and that included data from multiple centers (31% and 33% versus 67%; p < 0.001). Conclusions: The quality of RCTs published in JBJS from 2014 to 2022 has improved from that reported previously, as demonstrated by the increases in the modified risk-of-bias score and transformed Detsky score from prior periods. This may be the result of journal policies such as the requirements of CONSORT adherence and prospective trial registration. Investigators should focus on improving the clarity of reporting, limiting attrition bias, and making efforts to blind support staff in order to increase the quality of future RCTs. Clinical Relevance: Improving the quality of RCTs is crucial given their potential to influence current clinical practice.
ABSTRACT
BACKGROUND: Prospective trial registration has become an important means of improving the transparency and reproducibility of randomized controlled trials (RCTs) and is recommended by the Journal of Shoulder and Elbow Surgery (JSES) per the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Herein, we performed a cross-sectional evaluation of RCTs published in JSES from 2010 to present to determine the prevalence of trial registration and consistency of outcome reporting. METHODS: The electronic database PubMed was searched to identify all RCTs on total shoulder arthroplasty (TSA) published in JSES from 2010 to 2022 using the search terms "randomized controlled trial" AND "shoulder" AND "arthroplasty OR replacement." RCTs were considered to be registered if they provided a registration number. For articles that were registered, authors also extracted the registry name, registration date, date of first enrollment, date of last enrollment, and if the primary outcomes reported in the registry were either (1) omitted, (2) newly introduced in the publication, (3) reported as a secondary outcome or vice versa, or (4) varied in timing of assessment compared to the publication. "Early" RCTs were considered those published from 2010 to 2016, whereas "later" RCTs were from 2017 to 2022. RESULTS: Fifty-eight RCTs met inclusion criteria. There were 16 early RCTs and 42 later RCTs. Twenty-three of the 58 (39.7%) studies were registered, with 9 of 22 with an available registry (40.9%) of those being enrolled prior to patient enrollment. Nineteen of the registered studies (82.6%) provided the name of the registry and a registration number. The proportion of later RCTs that were registered was not significantly different from the early RCTs (45.2% vs. 25.0%, P = .232). Seven RCTs (31.8%) had at least 1 inconsistency compared with the registry. The most common discrepancy was the timing of the assessment (ie, follow-up period) reported in the publication vs. the registry. DISCUSSION: Although JSES recommends prospective trial registration, less than half of shoulder arthroplasty RCTs are registered and more than 30% registered trials have at least 1 inconsistency with their registry record. More rigorous review of trial registration and accuracy is necessary to limit bias in published shoulder arthroplasty RCTs.
