Patient and public involvement in contemporary large intensive care trials: A meta-epidemiological study

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Background: Patient and public involvement in randomised clinical trials has received increased focus, including in intensive care trials, but the frequency, method and extent is unknown. This meta-epidemiological study investigated patient and public involvement in contemporary, large ICU trials. Methods: We systematically searched PubMed for large (≥225 randomised patients), contemporary trials (published between 1 January 2019 and 31 January 2022) assessing interventions in adult patients in ICU settings. Abstracts and full-text articles were assessed independently and in duplicate. Data were extracted using a pre-defined, pilot-tested data extraction form with details on trials, patient and public involvement including categories and numbers of individuals involved, methods of involvement, and trial stage(s) with involvement. Trials authors were contacted as necessary. Results: We included 100 trials, with 18 using patient and public involvement; these were larger and conducted in more centres than trials without patient and public involvement. Among trials with patient and public involvement, patients (in 14/18 trials), clinicians (13 trials), and family members (12 trials) were primarily involved, mainly in the development of research design (15 trials) and development of research focus (13 trials) stages and mostly by discussion (12 trials) and solo interviews (10 trials). A median of 65 individuals (range 1–6894) were involved. Conclusions: We found patient and public involvement in a fifth of large, contemporary ICU trials. Primarily patients, families, and clinicians were included, particularly in the trial planning stages and mostly through interviews and discussions. Increased patient and public involvement in ICU trials is warranted.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Issue number3
Pages (from-to)256-263
Number of pages8
Publication statusPublished - 2023

Bibliographical note

Funding Information:
The Department of Anaesthesia and Intensive Care at Aalborg University Hospital has received funding for other research projects from the Novo Nordisk Foundation and conducts contract research for AM‐Pharma.

Funding Information:
The Department of Intensive Care at Rigshospitalet–Copenhagen University Hospital has received funding for other projects from The Novo Nordisk Foundation, Pfizer, Fresenius Kabi, and the Lundbeck Foundation, and conducts contract research for AM‐Pharma.

Funding Information:
This study was conducted as part of the Intensive Care Platform Trial (INCEPT) research programme ( ), which has received funding by Sygeforsikringen “danmark”, Ehrenreich's Foundation and Dagmar Marshalls Fond. The funders had no influence on any aspects of this study, which received no specific funding.

Publisher Copyright:
© 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.

    Research areas

  • clinical trial, community participation, critical care, patient participation, randomised controlled trial

ID: 362388157