背景：神经源性膀胱（NGB）是一种慢性和致残性疾病，患病率很高，给患者及其家庭造成经济负担,降低患者的生活质量。研究人员对不同干预措施治疗NGB的有效性和安全性进行了大量临床试验。已发表的NGB临床试验通常存在结果指标报告不一致和不规则的问题。为了促进NGB的未来研究，需要核心结果集(COS)，这有助于将结果转化为高质量的证据。
方法：这个混合方法项目分为四个阶段：在第1阶段，对文献进行范围审查，以确定临床试验中报告的结果，并对干预措施的临床试验进行系统评价NGB；在第2阶段，使用访谈获取NGB患者观点的定性组成部分，家庭,和他们的照顾者；在第3阶段，在利益相关者中进行德尔菲调查，以优先考虑核心成果；在第4阶段，进行面对面的共识会议，讨论并商定最终的NBGCOS。
结论：我们将开发一种COS，该COS将在未来的NGB临床试验中报告。
背景：有效性试验中的核心成果措施（COMET）倡议数据库注册：http://www.comet-initiative.org/studies/details/1985。2022年1月02日注册。INPLASYINPLASY202210007。
BACKGROUND: Neurogenic bladder (NGB) is a chronic and disabling condition with a high prevalence rate, which can cause economic burden on patients and their families and reduce the quality of life of patients. Researchers have carried out a large number of clinical trials on the effectiveness and safety of different interventions for the treatment of NGB. The published clinical trials of NGB generally suffered from inconsistent and irregular reporting of outcome indicators. To facilitate future research studies of NGB, a core outcome set (COS) is required, which helps translate the results into high-quality evidence.
METHODS: This mixed-method project has four phases instrument: in phase 1, a scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for NGB; in phase 2, a qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers; in phase 3, Delphi survey among stakeholders to prioritize the core outcomes; and in phase 4, a face-to-face consensus meeting to discuss and agree on the final NBG COS.
CONCLUSIONS: We will develop a COS that should be reported in future clinical trials of NGB.
BACKGROUND: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: http://www.comet-initiative.org/studies/details/1985 . Registered on 02 January 2022. INPLASY INPLASY202210007.
