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

Trials, 2022 · DOI: https://doi.org/10.1186/s13063-022-06419-1 · Published: May 20, 2022

Simple Explanation

Neurogenic bladder (NGB) is a chronic condition with a high prevalence, causing economic burden and reduced quality of life. Clinical trials for NGB treatments often have inconsistent outcome reporting, hindering reliable conclusions. This study aims to develop a core outcome set (COS) for NGB trials to standardize outcome reporting and improve evidence quality.

Study Duration

Not specified

Participants

Patients with NGB aged 18 and above, caregivers, healthcare professionals, and researchers

Evidence Level

Not specified

Key Findings

1
The study will identify outcomes reported in NGB clinical trials and systematic reviews through a scoping review.
2
Qualitative interviews will gather perspectives from NGB patients, families, and caregivers.
3
A Delphi survey will prioritize core outcomes among stakeholders, followed by a consensus meeting to finalize the NBG COS.

Research Summary

This study aims to develop a core outcome set (COS) for neurogenic bladder (NGB) clinical trials using a mixed-methods approach. The COS development involves a scoping review, qualitative interviews, Delphi surveys, and a consensus meeting to identify and prioritize relevant outcomes. The resulting COS is expected to standardize outcome reporting in NGB trials, improve evidence quality, and facilitate treatment comparisons.

Practical Implications

Standardized Outcome Reporting

The COS will promote consistent reporting of outcomes in NGB clinical trials.

Improved Evidence Quality

The COS will enhance the quality and comparability of evidence from different studies.

Enhanced Clinical Decision-Making

The COS will facilitate evidence-based clinical guidelines and treatment decisions.

Study Limitations

1
The study is limited by the potential for sampling bias in patient interviews.
2
The Delphi survey sample size may not be optimal.
3
The consensus meeting may face challenges in achieving complete agreement among diverse stakeholders.

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