Background Well-designed randomized controlled trials (RCTs) have the potential to provide high-quality evidence to inform questions of therapy and prevention, but this potential is contingent on the use of appropriate methods and transparent reporting. Objective To systematically assess the quality of urology RCT reporting and identify trends over time. Design, setting, and participants All RCTs published in four leading urology journals in 2013 were identified and compared to a prior analysis of studies from 1996 and 2004. Two reviewers abstracted data based on the Consolidated Standards of Reporting Trials (CONSORT) checklist. Outcome measurements and statistical analysis A summary reporting score (range: 0–22) for each study was determined. Mean overall scores for 1996, 2004, and 2013 were compared using analysis of variance. We used χ2 to compare the reporting frequency of individual criteria. Results and limitations Mean CONSORT scores for RCTs were 15.6 ± 2.0 in 2013 (n = 82), 12.0 ± 0.3 in 2004 (n = 87), and 10.2 ± 0.3 in 1996 (n = 65); p < 0.01. Key deficiencies remain in reporting methods of allocation concealment and group assignment (selection bias), and blinding of participants, personnel, and outcome assessors (performance and detection bias). Study limitations are potential reviewer bias resulting from lack of journal deidentification and the relatively low number of studies reviewed. Conclusions There has been a substantial improvement in reporting quality of RCTs in urology since CONSORT. Some methodological criteria remain underreported, and increased efforts are necessary to further this improvement. Patient summary Treatment decisions are often based on data from randomized controlled trials. We looked at whether these trials in urology are transparent in reporting their design and conduct using a framework known as the CONSORT criteria and found significant improvements over time. Some areas of deficiency remain, and our paper aimed to highlight these drawbacks to promote continued high-quality research.
Bibliographical noteFunding Information:
Our study demonstrates that significant improvements in transparent RCT reporting have been achieved in the urology literature over the past decade. Despite evidence of higher reporting standards across urology journals, there remains room for improvement in many domains, such as reporting of allocation concealment and details of blinding. We encourage universal endorsement of the CONSORT reporting guidelines as well as their enforcement by urology journals to enhance transparency and ultimately provide for more effective and safer patient care. Author contributions: Vikram M. Narayan had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Narayan, Cone, Dahm, Scales. Acquisition of data: Narayan, Cone, Smith. Analysis and interpretation of data: Narayan, Cone, Dahm, Scales. Drafting of the manuscript: Narayan, Cone, Dahm, Scales. Critical revision of the manuscript for important intellectual content: Narayan, Cone, Dahm, Scales. Statistical analysis: Narayan, Cone, Dahm, Scales. Obtaining funding: Dahm, Scales. Administrative, technical, or material support: Dahm, Scales. Supervision: Dahm, Scales. Other (specify): None. Financial disclosures: Vikram M. Narayan certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/ affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: None. Funding/Support and role of the sponsor: This study received institutional support from the University of Minnesota, Minneapolis VA Health Care System, and Duke University/Duke Clinical Research Institute.
- CONSORT criteria
- Randomized controlled trials
- Reporting quality
- Systematic bias in research