e14026 Background: Due to eligibility criteria, most, if not all, randomized controlled trials (RCTs) exclude patients at the outset, before randomization. Understanding which patients are excluded is important to evaluate the external validity of the results. The proportion of trials that report the entire flow diagram of patient enrollment, in accordance with the CONSORT 2010 statement, is unknown. Failure to do so makes it more difficult to discuss the generalizability of the trial findings. Methods: We performed the systematic retrieval and analysis of all phases II and III RCTs published in paper form between 2013 and 2015, in four high impact factor journals, in the field of clinical oncology. Our main objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We further aimed to identify the variables that affect this reporting as well as the reasons for patient exclusion, to calculate the recruitment fraction and the number needed to screen and to determine the proportion of trials that include a discussion on the generalizability of the trial findings. Results: 462 RCTs were reviewed. Among them, 426 (92.2%) included the flow diagram in the article and 224 (48.5%) reported the number of patients assessed for eligibility. This proportion varied significantly between the journals studied, but it did not increase over time. A total of 116 (25.1%) included a discussion of generalizability. Among the trials that reported the entire enrollment process, the reason for patient exclusion could not be found in 50 (22.3%). Conclusions: There is still room for improvement in the reporting of the determinants of external validity in clinical oncology RCTs. Increasing the reporting of the enrollment process could help clinicians and health policy makers establish to whom the results of a trial apply.
External Validity and Worksite Wellness: Lessons From China and Illinois
