Endorsement of reporting guidelines and clinical trial registration across urological medical journals: a cross-sectional study

Introduction

Over the years, funding for urologic diseases in the United States has witnessed a steady rise, reaching $587 million in 2020 from $541 million USD in 2018 (American Urological Association, 2024). In parallel, there has been a notable increase in the total number of urology journals from 2011 to 2018 (AlRyalat et al., 2021). This surge in research funding and journal publications calls for urologists to effectively navigate through a vast body of evidence to make the best evidence-based clinical decisions. However, optimal research production is not attained if its individual components are not sufficiently reported (Butcher et al., 2022). Therefore, journals are encouraged to advertise reporting guidelines to encourage high quality reporting, enabling urologists to critically appraise the research evidence based on transparently reported methodological decisions.

Although reporting guidelines can serve as checklists for authors to improve research quality, foster transparency, and mitigate poor methodological conduct that may lead to bias, they encompass much more by providing important conceptual explanations that enhance understanding of proper reporting (Turner et al., 2012; Chan et al., 2014). The Enhancing the QUAlity of Transparency Of health Research (EQUATOR) Network is an international collaboration that is dedicated to the progress of reporting health research studies (EQUATOR Network, 2024). The EQUATOR Network has compiled over 500 reporting guidelines for various research designs. Among the most frequently used guidelines this library hosts are the Consolidated Standards of Reporting Trials (CONSORT) guideline for randomized controlled trials, the Preferred reporting Items for Systematic Reviews (PRISMA) guideline for systematic reviews (Page et al., 2021), and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for observational studies (Von Elm et al., 2007). Using reporting guidelines to guide research practices helps facilitate the generation of evidence-based research, making it particularly valuable in the context of clinical trials.

Clinical trial registration offers another effective approach to mitigating reporting bias in the medical literature (Won et al., 2019). Lindsley et al. (2022) analyzed systematic reviews of clinical trials from 2015 to 2019 and found that clinical trial registration was linked with a low risk of bias for five of the six evaluated domains. Given the benefits of clinical trial registration, the International Committee of Medical Journal Editors (ICMJE) mandates that all journals published under its umbrella will consider clinical trials for publication only if they were registered before the first patient was enrolled (ICMJE, 2024a). While non-ICMJE member journals that mention the committee in their instructions for authors page are encouraged to follow its guidelines, it is not a requirement.

To date, only one study in urology has assessed journal publication policies concerning reporting guideline recommendations. In the 2012 study, Kunath et al. (2012) examined 55 urology journals to assess the endorsement of 11 reporting guidelines in the “instructions for authors” of these journals. Building upon the insights from this study, our study aims to expand the scope by including a broader range of reporting guidelines and also examining clinical trial registration policies of the top urology journals. We also assessed journal policies regarding clinical trial registration.

Methods

Results

Journal characteristics

Our initial search identified 99 urology journals for screening. We ultimately extracted data from 92 journals in our final sample (Fig. 1). Journals that did not accept specific study designs were excluded from our analysis of the total 92 journals.

Discussion

Our findings demonstrate a notable deficiency in the extent to which urology journals mention reporting guidelines and clinical trial registration policies in their “instructions for authors” webpages. Nearly one-fifth of our sample failed to refer to a single reporting guideline and approximately one-third of our sample failed to provide a statement regarding clinical trial registration policies. Further, we found that fourteen journals referenced QUOROM, which has largely been superseded by PRISMA, giving concern that some “instructions for authors” may be outdated (Moher et al., 2009). In 2012, a similar study was conducted by Kunath et al. (2012) finding that urology journals had suboptimal endorsement of reporting guidelines. However, our findings showed a marginal improvement in guideline reporting usage in comparison over a decade (Kunath et al., 2012). Additionally, in the previous study, only one journal mentioned the EQUATOR Network whereas ours acknowledged it in over a quarter of the included journals. Given our results, it is evident that there has been some advancement in the endorsement and awareness of guideline tools over the last decade. This may be attributable to the EQUATOR Network’s efforts towards improving familiarity with reporting guidelines by researchers and journal editors alike (Simera et al., 2010; Altman & Simera, 2016).

While our study demonstrates improved advocacy of reporting guidelines in urology journals recently, it remains uncertain how effectively these guidelines are being embraced and endorsed by journals. This potential disconnect between journal and author expectations for publication could hinder the production of high-quality and reproducible studies. For instance, Koch et al. (2016a, 2016b) reported that the explicit mention of reporting guidelines in urogynecology is relatively low, although there has been some improvement in randomized controlled trials; nonetheless, adherence remains notably insufficient. Similarly, Cook et al. (2018) observed that less than half of dermatology clinical trials published in journals mandating CONSORT adherence included a CONSORT flow diagram, a crucial component of the guideline, alongside their manuscripts. This variability in both journal advocacy and researcher adherence across different medical fields raises concerns about the adequacy of reported research, influencing clinical practice guidelines and clinical decision-making. To address this issue, improving the publication policies of academic journals is crucial. Some authors suggest implementing regular audits to update policies in line with current practices and expectations (De Kleijn & Van Leeuwen, 2018). If adopted, journals could ensure their “instructions for authors” are explicitly guided by evidence-supported reporting guidelines, such as CONSORT and PRISMA. These journals might also mandate prospective authors to submit a thoroughly completed checklist relevant to their study design along with their manuscript for consideration of publication. Such measures would help promote transparent and high-quality reporting of research, enhancing the overall reliability and influence of clinical research in urology and other medical fields.

Many academic journals now require the pre-registration of clinical trials as a prerequisite for publication, aiming to uphold ethical standards in research involving human subjects and ensuring high-quality outcomes (Harvey, 2017). The International Committee of Medical Journal Editors (ICMJE) goes a step further, considering clinical trial registration an ethical obligation for researchers, viewed as the “single most valuable tool we have to ensure unbiased reporting” (ICMJE, 2024b; Wallach & Krumholz, 2019; Weber, Merino & Loder, 2015). Despite this strong endorsement by the ICMJE, our study revealed a concerning gap in clinical trial registration policies among urology journals. While approximately three-quarters of the sampled journals mention the ICMJE in their “instructions for authors,” less than half of them actually require clinical trial registration. Additionally, only a quarter of the journals merely recommend this practice. It appears, however, this deficiency is not unique to urology. For example, Hooft et al. (2014) found in a survey of 757 ICMJE supporting journals, approximately half of their sample explicitly advocated for prospective clinical trial registration in their “instructions for authors”. Further, upon contacting the editorial teams of these journals, they uncovered that only 18% actually cross-checked manuscript submissions against public registries and that nearly 70% of journals would accept retrospectively registered trials (Hooft et al., 2014). Such practices raise concerns about potential selective reporting biases that could influence research outcomes (Zhou et al., 2022).

The editorial team of a journal plays a pivotal role as the gatekeeper of well-designed and published research, holding the power to influence how authors conduct and report their findings. As such, it is essential for journals to provide clear and explicit instructions for authors and establish easy channels for communication to address any ambiguities. In our study, we found journal homepages to be frequently difficult to navigate and composed of vague language which made data extraction a challenging process. To add to this, less than half of our sample followed up to our email correspondence by the time of this study’s conclusion. Not only does this pose a threat to our study’s accuracy regarding journal publication policies, but also interferes with the publication process for prospective authors who may misinterpret a journal’s requirements and recommendations, effectively reducing transparency and reproducibility of published works (Rauh et al., 2022). In 2020 an article was published describing four ways journals can aid reproducibility of research by using structure, transparency, accessibility, and reporting (S.T.A.R.) as a method which allows journals to enforce and introduce important policies for authors and editors (Elsevier, 2021). We recommend, therefore, that journals take action to improve the clarity of their webpages and offer reliable methods of contact to reduce strain between expectations and fulfilled requirements by authors.

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