Department of Spinal Cord Injury Rehabilitation, Gansu Province Hospital Rehabilitation Center, 53 Dingxi Road, Chengguan District, Lanzhou, 730000, Gansu, China.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, No.199, Donggang West Road, Lanzhou City, 730000, Gansu Province, China.
Trials. 2022 Jun 13;23(1):485. doi: 10.1186/s13063-022-06419-1.
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.
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.
We will develop a COS that should be reported in future clinical trials of NGB.
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.
神经源性膀胱（NGB）是一种具有高患病率的慢性和致残性疾病，会给患者及其家庭带来经济负担，并降低患者的生活质量。研究人员已经对治疗 NGB 的不同干预措施的有效性和安全性进行了大量的临床试验。已发表的 NGB 临床试验通常在报告结局指标方面存在不一致和不规范的问题。为了促进未来对 NGB 的研究，需要制定一个核心结局集（COS），这有助于将研究结果转化为高质量的证据。
这是一个混合方法项目，有四个阶段的工具：第 1 阶段，对文献进行范围综述，以确定已在 NGB 干预的临床试验和系统评价中报告的结局；第 2 阶段，采用访谈的定性部分，以获取 NGB 患者、家属及其照顾者的意见；第 3 阶段，利益相关者德尔菲调查，以确定核心结局的优先级；第 4 阶段，面对面共识会议，讨论并商定最终的 NBG COS。
我们将制定一个应在未来 NGB 的临床试验中报告的 COS。
有效性试验核心结局测量（COMET）倡议数据库注册：http://www.comet-initiative.org/studies/details/1985。于 2022 年 1 月 2 日注册。INPLASY INPLASY202210007。
