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The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting regulations complicate the situation further. The proposal is currently being discussed and will be applicable at the earliest in the second half of 2024, providing time for further adjustments and clarification. [ABSTRACT FROM AUTHOR]

Objective: To assess the panel composition of the 2 most important guideline developers in urology as equity and acceptability, important domains in clinical guideline development, require broad stakeholder representation., Methods: Following a predefined protocol, we identified all current AUA and EAU guideline documents. Two authors independently abstracted data including guideline topic, number and roles of panel members, voting status, and academic rank. We determined panel member's gender (woman, man, or nonbinary) and racialization (White or non-White) status based on name, internet picture, pronouns used, bios available, and gender listed on their profile., Results: We identified 31 AUA and 20 EAU guidelines for inclusion. Median panel size was 19 (interquartile range [IQR]: 17; 21) with 12 (IQR: 10; 14) voting members. The average composition of voting panels was predominantly male (81.8%) and White (86.8%). Eleven guideline panels (21.6%) did not include any women, and 9 (17.6%) panels had no representation of individuals from non-White groups. While gender distribution was similar among guidelines of the 2 organizations, the AUA included more voting members from non-White groups (14.3% vs 8.0%; P = .010). Analysis of the AUA panel composition over time revealed stable proportions of female and non-White individuals., Conclusion: Both AUA and EAU guidelines exhibit insufficient representation of females and non-White individuals, with no evident improvement observed over time. Implementing more transparent processes that advocate for diverse panel representation may enhance the incorporation of stakeholder values and preferences, thereby improving the dissemination and adoption of guidelines., Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interest., (Published by Elsevier Inc.)

Purpose: We evaluate the reporting of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to rating the certainty of evidence in systematic reviews published in the urological literature., Materials and Methods: Based on a predefined protocol, we identified all systematic reviews published in 5 major urological journals from 1998 to 2021 that reported the use of GRADE. Two authors performed study selection and data abstraction independently to assess reporting in accordance with established criteria for applying GRADE., Results: We included 68 of 522 (13.0%) systematic reviews that reported the use of GRADE; the first was published in 2009. Approximately half were published between 2009-2018 (n=36) and the other half between 2019-2021 (n=32). Oncology (24; 35.3%) was the most common clinical topic, and the authors were mostly based in Europe (34; 50%). In their abstract, less than half of all systematic reviews (32; 47.1%) provided any certainty of evidence rating. Only 41 (60.3%) included a tabular result summary in the format of a summary of findings table (24; 35.3%) or evidence profile (17; 25.0%). Few (35.3%) addressed the GRADE certainty of evidence rating in the discussion section. Reporting did not improve over time when comparing the 2 time periods., Conclusions: Whereas GRADE is increasingly being applied for rating the certainty of evidence, systematic reviews published in the urological literature frequently have not followed established criteria for applying or using GRADE. There is a need for better training of authors and editors, as well as for a GRADE reporting checklist for systematic review authors.

Purpose: We determined the rate of duplicate research presentations at recent American Urological Association and European Urological Association annual meetings., Materials and Methods: We cross-referenced all clinical research presentations related to prostate cancer presented at the 2006 American Urological Association and European Urological Association annual meetings with those presented at the corresponding annual meetings in 2005, 2006 and 2007 using a defined search strategy based on author names, abstract titles, study design and objectives. All data abstraction was performed in duplicate by 2 independent reviewers to ensure accuracy., Results: We identified 282 and 312 abstracts on prostate cancer clinical research at the 2006 European Urological Association and American Urological Association annual meetings, respectively. The overall duplication rate of American Urological Association abstracts was 19.2% (60 of 312). Of duplicated abstracts 80.0% (48 of 60) were presented at the European Urological Association annual meeting the same year. Duplication of European Urological Association abstracts was identified in 20.9% (59 of 282). Authors who presented the same research (71 duplicate abstracts) at the 2 meetings altered the presentations in various ways, including a different study title in 40.8%, a different first and senior author in 14.1% and 18.3%, and increased or decreased sample size in 8.5% and 14.1%, respectively., Conclusions: Approximately a fifth of clinical research abstracts on prostate cancer presented at the American Urological Association annual meeting were also presented at the European Urological Association meeting and vice versa. Inconsistencies between duplicate abstracts raise concerns about the integrity of the underlying studies. Stricter submission guidelines and improved dissemination of research findings from the 2 meetings may help limit this practice.

Purpose: The concept of levels of evidence is one of the guiding principles of evidence based clinical practice. It is based on the understanding that certain study designs are more likely to be affected by bias than others. We provide an assessment of the type and levels of evidence found in the urological literature., Materials and Methods: Three reviewers rated a random sample of 600 articles published in 4 major urology journals, including 300 each in 2000 and 2005. The level of evidence rating system was adapted from the Center of Evidence Based Medicine. Sample size was estimated to detect a relative increase in the proportion of studies that provided a high level of evidence (I and II combined) from 0.2 to 0.3 with 80% power., Results: Of the 600 studies reviewed 60.3% addressed questions of therapy or prevention, 11.5% addressed etiology/harm, 11.3% addressed prognosis and 9.2% addressed diagnosis. The levels of evidence provided by these studies from I to IV were 5.3%, 10.3%, 9.8% and 74.5%, respectively. A high level of evidence was provided by 16.0% of studies in 2000 and by 15.3% in 2005 (p = 0.911)., Conclusions: This study suggests that a majority of studies in the urological literature provide low levels of evidence that may not be well suited to guide clinical decision making. We propose that editors of leading urology journals should promote awareness for this guiding principle of evidence based clinical practice by providing a level of evidence designation with each published study.