Determine what to measure and how to measure in clinical trials of neurogenic bladder: A study protocol for a core outcome set for neurogenic bladder

Neurogenic bladder is one of the common complications in patients with neuropathy such as stroke, spinal cord injury, peripheral nerve injury. Although many studies have been conducted on interventions to prevent, treat, and care for neurogenic bladder to minimize the consequences, there is significant heterogeneity in the results measured and reported in existing studies, which prevents meaningful comparisons. This makes the universality of clinical practice challenging. This study will propose a research plan to develop a core outcome set (COS) for research on neurogenic bladder. The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search nine databases and two registry platforms to identify currently reported NB treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct semi-structured interviews with clinicians, nurses, and adult NB patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to reach final COS and recommend measurement instruments for each outcome.

Contributors

Yamin Chen Evidence-based Nursing Center, School of Nursing,Lanzhou University, China
Jinhui Tian Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, China
Mingming Niu Evidence-based Nursing Center, School of Nursing,Lanzhou University, China
Yuanyuan Li Evidence-based Nursing Center, School of Nursing,Lanzhou University, China
Jiaoyan Zhang Evidence-based Nursing Center, School of Nursing,Lanzhou University, China

Further Study Information

Current Stage: Ongoing
Date: December 2021 - December 2022
Funding source(s): None


Health Area

Disease Category: Urology

Disease Name: Neurogenic bladder

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review

The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. This study will include a systematic review of the literature to identify outcomes that have been reported in prior studies in this area. Semi-structured interviews with clinicians, nurses, and NB patients will be conducted to collect their opinions on important outcomes. Key stakeholders shall then prioritize these outcomes using a Delphi study. A face-to-face consensus meeting shall be held with stakeholders to determine the list of outcomes included in the final COS.

Linked Studies

    No related studies


Related Links

    No related links