TY - JOUR

T1 - Patient and public involvement in contemporary large intensive care trials

T2 - Protocol for a meta-epidemiological study

AU - Barot, Emily

AU - Kjær, Maj Brit Nørregaard

AU - Collet, Marie

AU - Crescioli, Elena

AU - Rasmussen, Bodil Steen

AU - Estrup, Stine

AU - Mortensen, Camilla Bekker

AU - Vesterlund, Gitte Kingo

AU - Sivapalan, Praleene

AU - Anthon, Carl Thomas

AU - Bruun, Camilla Rahbek Lysholm

AU - Poulsen, Lone Musaeus

AU - Møller, Morten Hylander

AU - Perner, Anders

AU - Granholm, Anders

N1 - Publisher Copyright: © 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd

PY - 2021

Y1 - 2021

N2 - Background: Patient and public involvement (PPI) in randomized clinical trials (RCTs) has increased in recent years but remains the exception rather than the rule. We aim to assess the frequency and extent of PPI in large, contemporary RCTs conducted in an intensive care setting. Methods and design: We will conduct a meta-epidemiological study of RCTs conducted in intensive care settings published since 2019 and assess their use of PPI. We will extract trial characteristics and verify the use of PPI with trial authors unless specifically stated in the published paper. The primary outcome will be the proportion of trials that use PPI. Secondary outcomes will explore which groups are consulted, at which stage of the trial process this occurs, and by what means these opinions are collected and implemented. Discussion: This meta-epidemiological study will provide an important insight into the use of PPI in large, contemporary intensive care trials. We wish to reveal ways in which patient involvement could be incorporated more broadly and purposefully here and help to empower clinicians, researchers and patients to collaborate further on future research processes and goals.

AB - Background: Patient and public involvement (PPI) in randomized clinical trials (RCTs) has increased in recent years but remains the exception rather than the rule. We aim to assess the frequency and extent of PPI in large, contemporary RCTs conducted in an intensive care setting. Methods and design: We will conduct a meta-epidemiological study of RCTs conducted in intensive care settings published since 2019 and assess their use of PPI. We will extract trial characteristics and verify the use of PPI with trial authors unless specifically stated in the published paper. The primary outcome will be the proportion of trials that use PPI. Secondary outcomes will explore which groups are consulted, at which stage of the trial process this occurs, and by what means these opinions are collected and implemented. Discussion: This meta-epidemiological study will provide an important insight into the use of PPI in large, contemporary intensive care trials. We wish to reveal ways in which patient involvement could be incorporated more broadly and purposefully here and help to empower clinicians, researchers and patients to collaborate further on future research processes and goals.

U2 - 10.1111/aas.13953

DO - 10.1111/aas.13953

M3 - Review

C2 - 34273181

AN - SCOPUS:85112325872

VL - 65

SP - 1351

EP - 1354

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 9

ER -