ArticleBMC urology2026
Evaluation of safety reporting in interventional trials of benign prostatic hyperplasia: a registry-publication comparison study.
Article in BMC urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the concordance of adverse event reporting between clinical trial registries and their corresponding publications for interventions treating benign prostatic hyperplasia. MATERIALS AND
methodsWe conducted a registry-to-publication comparison study to evaluate the completeness and concordance of adverse event reporting in benign prostatic hyperplasia. Studies were identified via searches of ClinicalTrials.gov studies with results posted from September 2009 to December 2024. We identified corresponding publications via ClinicalTrials.gov, PubMed, Google Scholar, pharmaceutical company portals, and Cochrane reviews. Data extraction was performed independently and in duplicate by masked reviewers. A quantitative analysis used descriptive statistics, Bland-Altman plots, funnel plots, and regression to assess concordance and identify predictors of incomplete reporting. Due to the study's focus on concordance, traditional risk of bias assessment was not conducted, however robust systematic review methods were employed.
resultsOf 36 included benign prostatic hyperplasia trials, registry reporting of adverse events was more complete than in publications. Post-Final Rule, overall adverse events and death reporting improved in registries but declined or remained inconsistent in manuscripts. Over 70% of trials showed discrepancies in serious adverse events counts, with most publications underreporting events compared to ClinicalTrials.gov.
conclusionsIn benign prostatic hyperplasia trials, adverse event data were more complete in ClinicalTrials.gov than in corresponding publications. Serious harm reporting was inconsistent, and post-Final Rule improvements in registry data were not mirrored in print. These gaps risk distorting clinical interpretation and highlight the need for aligned reporting standards to ensure transparent, patient-relevant safety communication.
trial registrationRegistered on the Open Science Framework.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.