TY - JOUR

T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative

T2 - patient comfort

AU - Myles, P S

AU - Boney, O

AU - Botti, M

AU - Cyna, A M

AU - Gan, T J

AU - Jensen, M P

AU - Kehlet, H

AU - Kurz, A

AU - De Oliveira, G S

AU - Peyton, P

AU - Sessler, D I

AU - Tramèr, M R

AU - Wu, C L

AU - Myles, Paul

AU - Grocott, Michael

AU - Biccard, Bruce

AU - Blazeby, Jane

AU - Boney, Oliver

AU - Chan, Matthew

AU - Diouf, Elisabeth

AU - Fleisher, Lee

AU - Kalkman, Cor

AU - Kurz, Andrea

AU - Moonesinghe, Ramani

AU - Wijeysundera, Duminda

AU - StEP–COMPAC Group

N1 - Copyright © 2018 British Journal of Anaesthesia. All rights reserved.

PY - 2018

Y1 - 2018

N2 - BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures.RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality.CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

AB - BACKGROUND: Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.METHODS: We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures.RESULTS: We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality.CONCLUSIONS: As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

KW - Consensus

KW - Delphi Technique

KW - Humans

KW - Patient Comfort/methods

KW - Perioperative Care/methods

KW - Practice Guidelines as Topic

KW - Research Design

U2 - 10.1016/j.bja.2017.12.037

DO - 10.1016/j.bja.2017.12.037

M3 - Review

C2 - 29576111

VL - 120

SP - 705

EP - 711

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 4

ER -