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JU INSIGHT Reporting of Harms in Randomized Controlled Trials Published in Urology Journals: An Updated Analysis
By: Reece M. Anderson, MPH, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa; Andriana Peña, BS, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa; Trevor Magee, BS, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa; Del Perkins, BA, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa; Bradley S. Johnson, DO, Sparrow Hospital, Lansing, Michigan, Michigan State Urology, Michigan State University, East Lansing; Rodney H. Breau, MD, MSc, The Ottawa Hospital Research Institute, University of Ottawa, Ontario; Matt Vassar, PhD, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa Oklahoma State University Center for Health Sciences, Tulsa | Posted on: 19 Jan 2024
Anderson RM, Peña A, Magee T, et al. Reporting of harms in randomized controlled trials published in urology journals: an updated analysis. J Urol. 2024;211(1):48-54.
Study Need and Importance
A 2010 study by Breau et al found disparities in Consolidated Standards of Reporting Trials (CONSORT)–Harms adherence by randomized controlled trials (RCTs) cited in several key urology journals. We chose to reassess the state of adverse event reporting and extrapolate whether harms reporting has improved in the last decade.
What We Found
RCTs published in 4 key urology journals demonstrated greater adherence to and reporting of CONSORT-Harms checklist items as compared to those reviewed by Breau et al. This finding indicates an overall more robust reporting of harms and adverse events within writeups of clinical trials. Studies published in 2020 adequately reported 80% of checklist items—a substantial improvement compared to 58% in 2012 and 36% in 2004. Studies investigating trauma/reconstruction reported the greatest number of CONSORT-Harms criteria (91%) while studies focused on oncology reported the least (47%).
Limitations
This study evaluated RCTs published in only 4 urology journals from 2 years—2012 and 2020. While the authors of the present study sought to replicate the data extraction methods from the 2010 study by Breau et al, we recognize the limitations in drawing direct statistical comparisons between the 2 sets of comparable data. We cannot generalize these findings to RCTs cited in other urological journals.
Interpretation for Patient Care
Adequate reporting of adverse events in RCTs is imperative to high-quality and holistic patient care as it allows physicians to provide patients with more complete information about treatment options. This study provides evidence of improvements in adverse event reporting in urology. Although there is room for improvement in the reporting of adverse events—particularly for oncology RCTs—physicians should be reassured that the reporting of RCTs published by these key journals has improved considerably in the last decade.
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