Introduction: There is little consensus and high heterogeneity on the optimal set of relevant clinical outcomes in research studies regarding extubation in neurocritical care patients with brain injury undergoing mechanical ventilation. The aims of this study are to: (1) develop a core outcome set (COS) and (2) reach consensus on a hierarchical composite endpoint for such studies.
Methods and analysis The study will include a broadly representative, international panel of stakeholders with research and clinical expertise in this field and will involve four stages: (1) a scoping review to generate an initial list of outcomes represented in the literature, (2) an
investigator meeting to review the outcomes for inclusion in the Delphi surveys, (3) four rounds of online Delphi consensus-building surveys and (4) online consensus meetings to finalise the COS and hierarchical composite
endpoint.
Ethics and dissemination: This study received ethical approval from the French Society of Anesthesia and Critical Care Medicine Institutional Review Board (SFAR CERAR-IRB 00010254-2023-029). The study results will be disseminated through communication to stakeholders, publication in a peer-reviewed journal, and presentations at conferences.
Trial registration number: This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative
Our goal is to develop a standard set of outcomes for research studies on mechanically ventilated neurocritical care patients undergoing extubation. The primary aim of this study is to achieve international consensus on a COS, including definitions of outcomes and timing of measurements. The secondary aim is to reach consensus on a hierarchical composite endpoint for future research.
ContributorsJean Digitale, Gregory Burns, Nicholas Fong , Julian Boesel, Chiara Robba, Robert D Stevens, Raphaël Cinotti, Romain Pirracchio
Disease Category: Neurology
Disease Name: Brain injury (traumatic), Traumatic and non-traumatic acute brain injury patients
Age Range: 18
Sex: Either
Nature of Intervention: Mechanical ventilation
- Clinical experts
- Patient/ support group representatives
- Researchers
- COS (Other)
- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review
The study will include a broadly representative, international panel of stakeholders as described below. It will involve four stages: (1) a scoping literature review to generate an initial list of outcomes, (2) an investigator meeting to review the outcomes for inclusion in the Delphi surveys, (3) four rounds of online Delphi consensus-building surveys and (4) online consensus meetings to finalise the COS and hierarchical composite endpoint. The study will be overseen by an expert in methodology and biostatistics. The study is planned to
start in September 2023 and to be concluded approximately 18 months after it begins.