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An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient comfort and pain relief

An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient comfort and pain relief
An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient comfort and pain relief

Background: Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery. Methods: We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes. Results: Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0–6 h, at 6–24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey. Conclusions: We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery. Systematic review protocol: Open Science Framework (10.17605/OSF.IO/DJQFE).

analgesia, clinical trials, Delphi, nausea, patient experience, patient-reported outcomes, postoperative pain, vomiting
0007-0912
1450-1459
Myles, Paul S.
33760c6d-ba95-4948-8d8f-43be43aad3f5
Wallace, Sophie
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Boney, Oliver
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Botti, Mari
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Chung, Frances
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Cyna, Allan M.
c31d9baf-b930-43d8-a9df-41439fa41cc2
Gan, Tong J.
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Grocott, Michael P.W.
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Jensen, Mark P.
97b2e180-d1bd-4506-807c-ed5acef4e744
Kehlet, Henrik
331009ae-8710-4ec1-8f6f-165090051a37
Kurz, Andrea
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Leger, Maxime
f5836a4c-9c51-43e5-b487-7fbe13f85cd1
Nilsson, Ulrica
2528afdb-90b4-4159-9383-0ffadb101600
Peyton, Phillip
193c3beb-ec68-4d9e-a28d-1fbe6eead047
Sessler, Daniel I.
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Tramèr, Martin R.
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Wu, Christopher L.
e8a469ae-74f8-4a4b-8260-cc49770a0dda
Myles, Paul S.
33760c6d-ba95-4948-8d8f-43be43aad3f5
Wallace, Sophie
9bd8dd85-bc6f-42c7-9f73-2a294af19585
Boney, Oliver
83b255f2-d5bc-4224-bde7-ed8aa11191b1
Botti, Mari
7bc6317f-b0cf-481b-a866-c5ab067c0d67
Chung, Frances
69b42167-498a-4d13-a064-afedeb084846
Cyna, Allan M.
c31d9baf-b930-43d8-a9df-41439fa41cc2
Gan, Tong J.
3e877034-bb19-43e2-8dba-1d26059de9ec
Grocott, Michael P.W.
1e87b741-513e-4a22-be13-0f7bb344e8c2
Jensen, Mark P.
97b2e180-d1bd-4506-807c-ed5acef4e744
Kehlet, Henrik
331009ae-8710-4ec1-8f6f-165090051a37
Kurz, Andrea
48b45843-6dc9-4884-b406-ee595cf5d506
Leger, Maxime
f5836a4c-9c51-43e5-b487-7fbe13f85cd1
Nilsson, Ulrica
2528afdb-90b4-4159-9383-0ffadb101600
Peyton, Phillip
193c3beb-ec68-4d9e-a28d-1fbe6eead047
Sessler, Daniel I.
35e08a9b-7012-4409-ba5a-68b8d1f59df0
Tramèr, Martin R.
1e42d6d2-4be2-4339-973a-aaccc11d7895
Wu, Christopher L.
e8a469ae-74f8-4a4b-8260-cc49770a0dda

Myles, Paul S., Wallace, Sophie, Boney, Oliver, Botti, Mari, Chung, Frances, Cyna, Allan M., Gan, Tong J., Grocott, Michael P.W., Jensen, Mark P., Kehlet, Henrik, Kurz, Andrea, Leger, Maxime, Nilsson, Ulrica, Peyton, Phillip, Sessler, Daniel I., Tramèr, Martin R. and Wu, Christopher L. (2025) An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient comfort and pain relief. British Journal of Anaesthesia, 134 (5), 1450-1459. (doi:10.1016/j.bja.2025.02.025).

Record type: Review

Abstract

Background: Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery. Methods: We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes. Results: Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0–6 h, at 6–24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey. Conclusions: We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery. Systematic review protocol: Open Science Framework (10.17605/OSF.IO/DJQFE).

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More information

Accepted/In Press date: 15 February 2025
e-pub ahead of print date: 24 March 2025
Published date: 20 April 2025
Additional Information: Copyright © 2025 British Journal of Anaesthesia. All rights reserved.
Keywords: analgesia, clinical trials, Delphi, nausea, patient experience, patient-reported outcomes, postoperative pain, vomiting

Identifiers

Local EPrints ID: 503043
URI: http://eprints.soton.ac.uk/id/eprint/503043
ISSN: 0007-0912
PURE UUID: 7206a4e6-6f1b-4cf4-81b3-2a5905fe67d5
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581

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Date deposited: 17 Jul 2025 16:50
Last modified: 18 Jul 2025 01:43

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Contributors

Author: Paul S. Myles
Author: Sophie Wallace
Author: Oliver Boney
Author: Mari Botti
Author: Frances Chung
Author: Allan M. Cyna
Author: Tong J. Gan
Author: Mark P. Jensen
Author: Henrik Kehlet
Author: Andrea Kurz
Author: Maxime Leger
Author: Ulrica Nilsson
Author: Phillip Peyton
Author: Daniel I. Sessler
Author: Martin R. Tramèr
Author: Christopher L. Wu

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