Abstract
BackgroundUrinary tract infections (UTIs) are the second most common infection presenting in the community. Clinical guidelines and decision aids assist health practitioners to treat a UTI; however, treatment practices vary due to patient needs and context of presentation. Numerous trials have evaluated the effectiveness of treatment interventions for UTI; however, it is difficult to compare the results between trials due to inconsistencies between reported outcomes. Poor choice of outcome measures can lead to impairment of evidence synthesis due to the inability to compare outcomes between trials with similar aims. Transparency in selecting and reporting outcomes can be mitigated through the development of an agreed minimum set of outcomes that should be reported in clinical trials, referred to as a core outcome set (COS). This paper presents the protocol for the development of a COS for interventions in the treatment of uncomplicated UTI in adults.MethodsThis COS development consists of three phases. Phase 1 is a systematic review, which aims to identify the core outcomes that have been reported in trials and systematic reviews of interventions treating uncomplicated UTI in adults. Phase 2 consists of a three-round online Delphi survey with stakeholders in the area of treatment interventions for UTI. The aim of this online Delphi survey is to achieve consensus on the importance of the outcomes emerging from Phase 1 of this research. Phase 3 is a consensus meeting to finalise the COS that should be reported in trials evaluating the effectiveness of interventions for the treatment of UTI.DiscussionIt is hoped that the development of a COS for interventions for the treatment of uncomplicated UTI in adults will be adopted as a minimum set of outcomes that should be reported and measured within this context. If the findings from clinical trials related to treatment interventions for UTI are to impact on policy and practice, it is important that the findings from different treatment interventions are comparable across trials.
Highlights
Urinary tract infections (UTIs) are the second most common infection presenting in the community
Treatment of an uncomplicated UTI is often empirical, meaning that treatment decisions are based on symptoms which are unconfirmed by microbiological tests [7]
Aims and objectives This paper presents the protocol for the development of a core outcome set (COS) for interventions in the treatment of uncomplicated UTI in adults
Summary
This protocol has been developed using recommendations outlined in the Core Outcome Set Handbook [10], Core Outcome Set reporting guidelines [13], and guidance from a stakeholder advisory group made up of healthcare professionals (general practitioners, microbiologists, nephrologists, and epidemiologists), researchers in the field of UTI and trial methodology including COS development, and members of the public affected by UTI. The COS development will encompass three phases: Phase 1 is a systematic review identifying the core outcomes that have been reported in randomised trials and systematic reviews of randomised trials of interventions for the treatment of uncomplicated UTI in adults; Phase 2 is an online, three-round Delphi survey with stakeholders; and Phase 3 is a consensus meeting. Public representatives will be identified and invited to participate through established patient advocacy groups and social media activities This process will ensure that the list of emerging outcomes is relevant and important to all stakeholder groups. Participants in round 2 will be invited to consider if they are willing to attend a face-to-face consensus meeting to discuss the final set of outcomes. Any outcomes that do not meet either definition will be classified as no consensus and brought forward to the meeting [10, 23]
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