Patient-reported outcomes (PROs) in randomized controlled trials pertaining to inflammatory bowel disease are important in identifying patients’ perspective of treatment. Incompletely reported PROs within trials could misrepresent information for clinicians and may contribute to treatment which lacks accommodation of patient input. Our study evaluates completeness of reporting of PROs and risk of bias (RoB) to identify how well trialists are adhering to known resources for trials. We used MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify eligible trials from 2006 to 2020 with at least 1 PRO measure related to inflammatory bowel disease. The trials were screened in duplicate using Rayyan. We then compared trial completion of reporting to the Consolidated Standards of Reporting Trials (CONSORT)-PRO adaptation, and assessed RoB using the Cochrane Collaboration RoB 2.0 tool. To measure trial and reporting characteristics, we performed bivariate regression analyses. Among a sample of 29 trials, the mean completion percentage for CONSORT-PRO was 46.77%. We found PROs as a secondary outcome had significantly lower CONSORT-PRO reporting (p<0.05). In addition, per cent completeness of reporting was significantly higher with both a ‘therapy’ intervention, and trials published following the development of CONSORT-PRO (p<0.05). Incomplete PRO reporting is common in trials focused on inflammatory bowel disease. This suboptimal reporting indicates the need for adherence to reporting guidelines. Trialists should use the CONSORT-PRO checklist, as endorsed by Patient-Reported Outcomes Tools: Engaging Users and Stakeholders, to assess their studies in order to enhance reporting adherence.
Background: Authors' conflicts of interest and industry sponsorship have been shown to influence study outcomes. Objective: We aimed to determine whether author conflicts of interest and industry sponsorship influenced the nature of results and conclusions of systematic reviews focusing on treatment interventions for erectile dysfunction. Materials and methods: We searched PubMed and Embase for systematic reviews and meta-analyses focusing on erectile dysfunction treatments published between September 1, 2016, and June 2, 2020. Authors' conflicts of interest were collected from the systematic reviews' disclosure statements. These disclosures were verified using the information provided by the Open Payments, Dollars for Profs, Google Patents, and US Patent and Trademark Office databases and from previously published disclosure statements.Results: Our study included 24 systematic reviews authored by 138 authors. Nineteen authors (13.8%) were found to have conflicts of interest (disclosed, undisclosed, or both). No authors completely disclosed all conflicts. Nine reviews (37.5%) contained at least one author with conflicts of interest; of which eight reported narrative results favoring the treatment group, and seven reported conclusions favoring the treatment group. Of the 15 (62.5%) reviews without a conflicted author, 11 reported results favoring the treatment group, and 12 reported conclusions favoring the treatment group.
Discussion:The results and conclusions of systematic reviews for erectile dysfunction treatments did not appear to be influenced by authors who reported conflicts of interest. However, our search algorithm relied on the US-based Open Payments database and a large percentage of reviews in our study were produced by authors with international affiliations. Our study results underscore the difficulties in conducting such analyses.
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