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

Stine Estrup; Emily Barot; Camilla Bekker Mortensen; Carl Thomas Anthon; Elena Crescioli; Maj-Brit Nørregaard Kjaer; Gitte Kingo Vesterlund; Camilla Rahbek Lysholm Bruun; Marie Oxenbøll Collet; Bodil Steen Rasmussen; Praleene Sivapalan; Lone Musaeus Poulsen; Morten Hylander Møller; Anders Perner; Anders Granholm

doi:10.1111/aas.14183

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

Stine Estrup, Emily Barot, Camilla Bekker Mortensen, Carl Thomas Anthon, Elena Crescioli, Maj-Brit Nørregaard Kjaer, Gitte Kingo Vesterlund, Camilla Rahbek Lysholm Bruun, Marie Oxenbøll Collet, Bodil Steen Rasmussen, Praleene Sivapalan, Lone Musaeus Poulsen, Morten Hylander Møller, Anders Perner, Anders Granholm^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

2 Citations (Scopus)

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Abstract

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 language	English
Journal	Acta Anaesthesiologica Scandinavica
Volume	67
Issue number	3
Pages (from-to)	256-263
Number of pages	8
ISSN	0001-5172
DOIs	https://doi.org/10.1111/aas.14183
Publication status	Published - Mar 2023

Bibliographical note

Keywords

clinical trial
community participation
critical care
patient participation
randomised controlled trial

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10.1111/aas.14183Licence: CC BY 4.0

Estrup et al (2023) Patient and public involvement in contemporary large intensive care trialsFinal published version, 772 KBLicence: CC BY 4.0

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Estrup, S., Barot, E., Mortensen, C. B., Anthon, C. T., Crescioli, E., Kjaer, M-B. N., Vesterlund, G. K., Bruun, C. R. L., Collet, M. O., Rasmussen, B. S., Sivapalan, P., Poulsen, L. M., Møller, M. H., Perner, A., & Granholm, A. (2023). Patient and public involvement in contemporary large intensive care trials: A meta-epidemiological study. Acta Anaesthesiologica Scandinavica, 67(3), 256-263. Advance online publication. https://doi.org/10.1111/aas.14183

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

abstract = "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.",

keywords = "clinical trial, community participation, critical care, patient participation, randomised controlled trial",

author = "Stine Estrup and Emily Barot and Mortensen, {Camilla Bekker} and Anthon, {Carl Thomas} and Elena Crescioli and Kjaer, {Maj-Brit N{\o}rregaard} and Vesterlund, {Gitte Kingo} and Bruun, {Camilla Rahbek Lysholm} and Collet, {Marie Oxenb{\o}ll} and Rasmussen, {Bodil Steen} and Praleene Sivapalan and Poulsen, {Lone Musaeus} and M{\o}ller, {Morten Hylander} and Anders Perner and Anders Granholm",

note = "{\textcopyright} 2022 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.",

year = "2023",

month = mar,

doi = "10.1111/aas.14183",

language = "English",

volume = "67",

pages = "256--263",

journal = "Acta Anaesthesiologica Scandinavica",

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Estrup, S, Barot, E, Mortensen, CB, Anthon, CT, Crescioli, E, Kjaer, M-BN, Vesterlund, GK, Bruun, CRL, Collet, MO, Rasmussen, BS, Sivapalan, P, Poulsen, LM, Møller, MH, Perner, A & Granholm, A 2023, 'Patient and public involvement in contemporary large intensive care trials: A meta-epidemiological study', Acta Anaesthesiologica Scandinavica, vol. 67, no. 3, pp. 256-263. https://doi.org/10.1111/aas.14183

TY - JOUR

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

T2 - A meta-epidemiological study

AU - Estrup, Stine

AU - Barot, Emily

AU - Mortensen, Camilla Bekker

AU - Anthon, Carl Thomas

AU - Crescioli, Elena

AU - Kjaer, Maj-Brit Nørregaard

AU - Vesterlund, Gitte Kingo

AU - Bruun, Camilla Rahbek Lysholm

AU - Collet, Marie Oxenbøll

AU - Rasmussen, Bodil Steen

AU - Sivapalan, Praleene

AU - Poulsen, Lone Musaeus

AU - Møller, Morten Hylander

AU - Perner, Anders

AU - Granholm, Anders

PY - 2023/3

Y1 - 2023/3

N2 - 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.

AB - 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.

KW - clinical trial

KW - community participation

KW - critical care

KW - patient participation

KW - randomised controlled trial

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U2 - 10.1111/aas.14183

DO - 10.1111/aas.14183

M3 - Review article

C2 - 36537664

SN - 0001-5172

VL - 67

SP - 256

EP - 263

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 3

ER -

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

Abstract

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