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, Oliver
AU - Botti, M.
AU - Cyna, A. M.
AU - Gan, T. J.
AU - Jensen, M. P.
AU - Kehlet, H.
AU - Kurz, Andrea
AU - De Oliveira, G. S.
AU - Peyton, P.
AU - Sessler, D. I.
AU - Tramèr, M. R.
AU - Wu, C. L.
AU - the StEP-COMPAC Group
PY - 2018/4/1
Y1 - 2018/4/1
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 - anaesthesia
KW - clinical trials
KW - patient-reported outcomes
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85045912280&partnerID=8YFLogxK
U2 - 10.1016/j.bja.2017.12.037
DO - 10.1016/j.bja.2017.12.037
M3 - Review Article
AN - SCOPUS:85045912280
SN - 0007-0912
VL - 120
SP - 705
EP - 711
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 4
ER -