Background: Uncomplicated urinary tract infections (UTIs) are among the most common presentations of bacterial infections in the outpatient setting. The variation of outcomes reported in trials to assess the most effective treatment interventions for uncomplicated UTIs has meant that comparing and synthesising the outcomes across trials is challenging and limits the reliability of evidence which would otherwise inform healthcare decisions. Objective: Develop a Core Outcome Set (COS) for interventions for the treatment of uncomplicated UTIs in otherwise healthy adults. Methods: The COS development consisted of three phases: (1) A systematic review to identify outcomes reported in randomised trials and systematic reviews of randomised trials comparing the effectiveness of any interventions for the treatment of uncomplicated UTI in otherwise healthy adults; (2) Outcomes identified in the systematic review were prioritised in an online 3-round modified Delphi survey with healthcare practitioners (n = 68), researchers (n = 5), and people who have experienced or cared for someone experiencing a UTI (n = 180); (3) An online consensus meeting to determine the final COS with healthcare practitioners and policymakers (n = 9), researchers (n = 4), and people who have experienced or cared for someone experiencing a UTI (n = 7). Results: We identified a large number of outcomes. Through the use of robust consensus methods, those outcomes were reduced to a core set of six outcomes that should, at a minimum, be measured and reported in randomised trials and systematic reviews of interventions treating uncomplicated UTIs in adults.
AimNumerous trials have evaluated the effectiveness of treatment interventions for Urinary Tract Infections (UTIs) in adult patients. However, inconsistency in the choice of outcomes reported have resulted in substantial challenges in synthesising evidence, ultimately limiting the capability to influence practice and policy.
The development of a core outcome set (COS), as a minimum set of agreed standardised outcomes to be reported in all trials, will address this problem. The development of a COS for interventions in the treatment of uncomplicated UTIs in adult patients would minimise the heterogeneity of outcome measures, allowing the efficient comparison and synthesis of trials in addition to encouraging a more complete reporting of outcomes which ultimately limits reporting bias.
Claire Beecher, Sinead Duane, Akke Vellinga, Andrew W Murphy, Martin Cormican, Andrew Smyth, Patricia Healy, Michael Moore, Paul Little, Carmel Geoghegan, Declan Devane
Disease Category: Urology
Disease Name: Urinary Tract Infection
Age Range: 18 - 100
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
A three step approach will be used to concurrently develop the COS.
1. A systematic review to identify primary outcomes previously reported in clinical trials evaluating the interventions in the treatment of UTI’s;
2. Refinement of outcomes by an iterative process using a Delphi study.
3. A consensus development meeting with stakeholders will be held and the COS agreed upon prior to disseminating to stakeholders.