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Purpose <p>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.</p> Methods <p>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 with a preliminary registration form, consisting of a list of 25 suggested definitions for adverse events relevant in the context of intensive care and severe acute brain injury. Based on feedback from the Delphi panel, we revised the tool and sent the revised registration form as a questionnaire in the second Delphi round.</p> Results <p>The Delphi panel consisted of 10 specialist physicians with experience in intensive care, neurosurgery or neurology. Consensus on the definition of an adverse event (defined as ≥ 70% agreement) was achieved for 27 out of the resulting 28 adverse events; for one adverse event, delirium, the level of agreement did not reach consensus in the second Delphi round; however, following revision, it was retained in the registration tool. The final version of the registration tool consisted of 28 adverse events for patients with severe acute brain injury.</p> Conclusion <p>A new tool for registration of adverse events and reactions in trial participants with severe acute brain injury was reviewed and refined by a Delphi panel of 10 Nordic neurocritical-care experts. The intention is to enhance the transparency, accuracy and consistency of reporting harms in clinical trials. Through thorough and standardized recording, the tool has the potential to improve the overall quality of clinical trials.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月22日

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  • Trine Hjorslev Andreasen,
  • Christian Gunge Riberholt,
  • Anne-Sophie Worm Fenger,
  • Anton Lund,
  • Alexandra Vassilieva,
  • Markus Harboe Olsen,
  • Kirsten Møller

摘要

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 with a preliminary registration form, consisting of a list of 25 suggested definitions for adverse events relevant in the context of intensive care and severe acute brain injury. Based on feedback from the Delphi panel, we revised the tool and sent the revised registration form as a questionnaire in the second Delphi round.

Results

The Delphi panel consisted of 10 specialist physicians with experience in intensive care, neurosurgery or neurology. Consensus on the definition of an adverse event (defined as ≥ 70% agreement) was achieved for 27 out of the resulting 28 adverse events; for one adverse event, delirium, the level of agreement did not reach consensus in the second Delphi round; however, following revision, it was retained in the registration tool. The final version of the registration tool consisted of 28 adverse events for patients with severe acute brain injury.

Conclusion

A new tool for registration of adverse events and reactions in trial participants with severe acute brain injury was reviewed and refined by a Delphi panel of 10 Nordic neurocritical-care experts. The intention is to enhance the transparency, accuracy and consistency of reporting harms in clinical trials. Through thorough and standardized recording, the tool has the potential to improve the overall quality of clinical trials.