Duane Sinead, Vellinga Akke, Murphy Andrew W, Cormican Martin, Smyth Andrew, Healy Patricia, Moore Michael, Little Paul, Devane Declan
HRB Trials Methodology Research Network, College of Medicine, Nursing & Health Sciences, National University of Ireland, Galway, Ireland.
Discipline of General Practice, School of Medicine, National University of Ireland, Galway, Ireland.
Trials. 2019 Feb 7;20(1):106. doi: 10.1186/s13063-019-3194-x.
Urinary 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.
This 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.
It 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.
尿路感染（UTIs）是社区中第二常见的感染。临床指南和决策辅助工具可帮助医疗从业者治疗尿路感染；然而，由于患者需求和就诊背景的不同，治疗方法也存在差异。许多试验评估了治疗尿路感染干预措施的有效性；然而，由于报告结果不一致，很难在不同试验之间比较结果。由于无法在具有相似目标的试验之间比较结果，结局指标选择不当可能会导致证据综合出现障碍。通过制定一套商定的、在临床试验中应报告的最低限度结局指标（称为核心结局集，COS），可以提高结局指标选择和报告的透明度。本文介绍了针对成人单纯性尿路感染治疗干预措施制定核心结局集的方案。
本核心结局集的制定包括三个阶段。第一阶段是系统评价，旨在确定在治疗成人单纯性尿路感染的试验和系统评价中报告的核心结局。第二阶段包括对尿路感染治疗干预领域的利益相关者进行三轮在线德尔菲调查。本次在线德尔菲调查的目的是就本研究第一阶段出现的结局的重要性达成共识。第三阶段是一次共识会议，以最终确定在评估尿路感染治疗干预措施有效性的试验中应报告的核心结局集。
希望针对成人单纯性尿路感染治疗干预措施制定的核心结局集将被采纳为在此背景下应报告和测量的最低限度结局指标集。如果与尿路感染治疗干预措施相关的临床试验结果要对政策和实践产生影响，那么不同治疗干预措施的结果在不同试验之间具有可比性就很重要。
