Randomized controlled trials on erectile dysfunction: quality assessment and relevant clinical impact (2007-2018)

Area of Science:

• Medical Research Methodology
• Clinical Trials
• Urology

Background:

• Assessing the quality of randomized controlled trials (RCTs) is crucial for reliable evidence in erectile dysfunction (ED) research.
• The period from 2007 to 2018 saw numerous RCTs published on ED, necessitating an evaluation of their methodological rigor.

Purpose of the Study:

• To assess the quality of RCTs on ED published between 2007 and 2018.
• To investigate the impact of factors like funding, institutional review board (IRB) approval, and intervention description on RCT quality.

Main Methods:

• A systematic search of PubMed, Embase, and Cochrane Library for ED RCTs (2007-2018).
• Quality assessment using Jadad scale, van Tulder scale, and Cochrane Risk of Bias Tool.
• Analysis of trends and correlations between study characteristics (funding, IRB, intervention details) and quality scores.

Main Results:

• Blinding and allocation concealment were inconsistently reported, with some fluctuations over time.
• Inclusion of funding statements (60.3%), IRB statements (78.3%), and detailed intervention descriptions (96.4%) generally increased.
• RCTs with funding statements demonstrated significantly higher quality scores (Jadad and van Tulder) compared to unfunded studies.
• Overall quality, measured by Jadad scores, showed improvement from 2007-2012 and 2017-2018, associated with increased funding and detailed reporting.

Conclusions:

• RCT quality in ED research has shown improvements, particularly linked to financial backing and comprehensive reporting of methods.
• Ensuring adequate funding, IRB approval, and clear intervention descriptions are key factors for enhancing the reliability of ED clinical trials.
• Continued focus on methodological rigor, including blinding and allocation concealment, remains important for advancing ED research.