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Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia

Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia
Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia

Background: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. Methods: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. Results: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). Conclusions: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.

anaesthesia, core outcome, patient-centred outcome, perioperative medicine, standardised endpoints, surgery
0007-0912
174-185
Boney, Oliver
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Moonesinghe, S. Ramani
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Myles, Paul S.
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Bartoszko, J.
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Beattie, W. S.
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Canet, J.
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Cooper, D. J.
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Corcoran, T.
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Kavanagh, B.
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Klein, A.
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Leslie, K.
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McIlroy, D. R.
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Mazer, D.
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Moller, A.
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Mythen, M.
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Neuman, M.
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Pearse, R.
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Peyton, P.
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Prowle, J.
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Richards, T.
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Scott, D. A.
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Sessler, D.
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Shaw, A.
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Short, T.
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Shulman, M.
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Singer, M.
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Sneyd, J. R.
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Story, D.
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van Dijk, D.
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van Klei, W.
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the StEP-COMPAC Group
Boney, Oliver
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Moonesinghe, S. Ramani
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Myles, Paul S.
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Grocott, Michael P.W.
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Bartoszko, J.
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Beattie, W. S.
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Bellomo, R.
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Buggy, D.
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Cabrini, L.
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Canet, J.
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Cook, T.
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Cooper, D. J.
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Corcoran, T.
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Devereaux, P. J.
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Evered, L.
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Gin, T.
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Grocott, H.
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Haller, G.
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Howell, S.
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Jayarajah, M.
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Kalkman, C.
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Karkouti, K.
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Kavanagh, B.
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Klein, A.
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Landoni, G.
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Leslie, K.
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McIlroy, D. R.
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Mazer, D.
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Moller, A.
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Mythen, M.
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Neuman, M.
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Pearse, R.
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Peyton, P.
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Prowle, J.
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Richards, T.
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Scott, D. A.
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Sessler, D.
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Shaw, A.
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Short, T.
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Shulman, M.
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Silbert, B.
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Singer, M.
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Sneyd, J. R.
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Story, D.
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van Dijk, D.
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van Klei, W.
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Boney, Oliver, Moonesinghe, S. Ramani, Myles, Paul S., Grocott, Michael P.W., Bartoszko, J. and Beattie, W. S. , the StEP-COMPAC Group (2022) Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia. British Journal of Anaesthesia, 128 (1), 174-185. (doi:10.1016/j.bja.2021.09.027).

Record type: Article

Abstract

Background: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. Methods: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. Results: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). Conclusions: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.

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More information

Accepted/In Press date: 13 September 2021
e-pub ahead of print date: 2 November 2021
Published date: January 2022
Additional Information: Funding Information: The Standardized Endpoints for Perioperative Medicine (StEP) Collaborative has been supported by an unrestricted grant from the British Journal of Anaesthesia and administrative support from the National Institute of Academic Anaesthesia Health Services Research Centre and the Department of Anaesthesia and Perioperative Medicine, Monash University. The P-COMMaS study was supported by an Association of Anaesthetists small grant. MPWG is a National Institute of Health Research Senior Investigator. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health. Funding Information: The Standardized Endpoints for Perioperative Medicine (StEP) Collaborative has been supported by an unrestricted grant from the British Journal of Anaesthesia and administrative support from the National Institute of Academic Anaesthesia Health Services Research Centre and the Department of Anaesthesia and Perioperative Medicine, Monash University . The P-COMMaS study was supported by an Association of Anaesthetists small grant. MPWG is a National Institute of Health Research Senior Investigator. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, or the Department of Health. Publisher Copyright: © 2021 British Journal of Anaesthesia Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: anaesthesia, core outcome, patient-centred outcome, perioperative medicine, standardised endpoints, surgery

Identifiers

Local EPrints ID: 453047
URI: http://eprints.soton.ac.uk/id/eprint/453047
ISSN: 0007-0912
PURE UUID: 49e2e350-2c28-44ca-a9a7-9504d5c282b5
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581
ORCID for D. A. Scott: ORCID iD orcid.org/0000-0001-6475-8046

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Date deposited: 07 Jan 2022 17:47
Last modified: 18 Mar 2024 03:57

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Contributors

Author: Oliver Boney
Author: S. Ramani Moonesinghe
Author: Paul S. Myles
Author: J. Bartoszko
Author: W. S. Beattie
Author: R. Bellomo
Author: D. Buggy
Author: L. Cabrini
Author: J. Canet
Author: T. Cook
Author: D. J. Cooper
Author: T. Corcoran
Author: P. J. Devereaux
Author: R. Eckenhoff
Author: L. Evered
Author: T. J. Gan
Author: T. Gin
Author: H. Grocott
Author: G. Haller
Author: S. Howell
Author: M. Jayarajah
Author: C. Kalkman
Author: K. Karkouti
Author: B. Kavanagh
Author: A. Klein
Author: G. Landoni
Author: K. Leslie
Author: D. R. McIlroy
Author: D. Mazer
Author: A. Moller
Author: M. Mythen
Author: M. Neuman
Author: R. Pearse
Author: P. Peyton
Author: J. Prowle
Author: T. Richards
Author: D. A. Scott ORCID iD
Author: D. Sessler
Author: A. Shaw
Author: T. Short
Author: M. Shulman
Author: B. Silbert
Author: M. Singer
Author: J. R. Sneyd
Author: D. Story
Author: D. van Dijk
Author: W. van Klei
Corporate Author: the StEP-COMPAC Group

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