Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys

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 efectiveness and safety of diferent interventions for the treatment of NGB. The published clinical trials of NGB generally sufered 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 and analysis: 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 fnal NBG COS.
Conclusions: We will develop a COS that should be reported in future clinical trials of NGB.

Aim

The aim of our study is to develop a COS for NGB clinical trials. If necessary, we will develop a domain of COS according to the type of intervention.

Contributors

Yan Zhang, Yamin Chen, Mingming Niu, Yuanyuan Li, Jiaoyan Zhang, Li Zhang, Fangfang Wu
Qingyun Chen, Huijin Yu and Jinhui Tian

Publication

Journal: BMC
Volume: 23
Issue: 1
Pages: 485 -
Year: 2022
DOI: 10.1186/s13063-022-06419-1

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This study has been funded by Talent Innovation and Entrepreneurship Project of Lanzhou City (grant number: 2020-RC-63), Natural Science Foundation of Department of Science and Technology in Gansu province (grant number: 20JR10RA350), and Gansu Provincial Health Industry Research Fund Project (grant number: GSWSKY2020-67)

Health Area

Disease Category: Urology

Disease Name: Neurogenic bladder

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

Phase 1: A scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of interventions for NGB
Phase 2: A qualitative component using interviews to obtain the views of NGB patients, families, and their caregivers
Phase 3: Delphi survey among stakeholders to prioritize the core outcomes
Phase 4: A consensus meeting to discuss and agree on the fnal NBG COS.

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