12/16/2023 0 Comments Data dredging biasTrial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). ![]() The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. Meta-information of 176,620 RCTs published between 19 was extracted. ![]() We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting.
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