Adverse events registration in clinical trial participants with severe acute brain injury: a Delphi consensus study.

ABSTRACT:

Purpose

Understanding the adverse effects of an intervention is important for evaluating its overall effect. Clinical trials mainly focus on the benefits of interventions with a risk of overlooking potential harms. Additionally, patients with severe acute brain injury frequently experience adverse events from other causes, which complicates the recording of harms in trials involving such participants. In this study, we developed a standardized registration form for recording adverse events in trial participants with severe acute brain injury using a structured Delphi process.

Methods

After developing the tool, we employed a Delphi process comprising two rounds of feedback from clinical experts in Nordic countries. In the first round, the Delphi panel received a questionnaire

SUBMITTER: Andreasen TH 

PROVIDER: S-EPMC12722466 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature