TY - JOUR
T1 - Systematic reviews and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative
T2 - mortality, morbidity, and organ failure
AU - Jackson, Alexander I.R.
AU - Boney, Oliver
AU - Pearse, Rupert M.
AU - Kurz, Andrea
AU - Cooper, D. James
AU - van Klei, Wilton
AU - Cabrini, Luca
AU - Miller, Timothy E.
AU - Moonesinghe, S. Ramani
AU - Myles, Paul
AU - Grocott, Michael P.W.
AU - Myles, Paul
AU - Gan, T. J.
AU - Peyton, Phil
AU - Sessler, Dan
AU - Tramèr, Martin
AU - Cyna, Alan
AU - De Oliveira, Gildasio S.
AU - Wu, Christopher
AU - Jensen, Mark
AU - Kehlet, Henrik
AU - Botti, Mari
AU - Haller, Guy
AU - Grocott, Mike
AU - Cook, Tim
AU - Fleisher, Lee
AU - Neuman, Mark
AU - Story, David
AU - Gruen, Russell
AU - Bampoe, Sam
AU - Evered, Lis
AU - Scott, David
AU - Silbert, Brendan
AU - van Dijk, Diederik
AU - Kalkman, Cor
AU - Chan, Matthew
AU - Grocott, Hilary
AU - Eckenhoff, Rod
AU - Rasmussen, Lars
AU - Eriksson, Lars
AU - Beattie, Scott
AU - Wijeysundera, Duminda
AU - Landoni, Giovanni
AU - Leslie, Kate
AU - Biccard, Bruce
AU - Howell, Simon
AU - Nagele, Peter
AU - Richards, Toby
AU - Dieleman, Stefan
AU - van Klei, Wilton
N1 - Funding Information:
AIRJ was supported by the University of Southampton National Institute of Health Research Academic Clinical Fellowship . SRM is supported by the University College London Hospitals National Institute for Health Research (NIHR) Biomedical Research Centre . This manuscript represents the views of the authors and not of the NIHR or Department of Health and Social Care. MG is in part funded by NIHR Southampton Biomedical Research Centre and as an NIHR Senior Investigator.
Funding Information:
RP holds research grants, honoraria, or both from Edwards Lifesciences , Intersurgical and GlaxoSmithkline . MPWG is an elected council member of the Royal College of Anaesthetists, board member of the British Journal of Anaesthesia, board chair of the National Institute of Academic Anaesthesia, and deputy chair of the UK National Centre for Perioperative Care. MG has received unrestricted research funding from Edwards Lifesciences Ltd, Pharmacosmos Ltd and Sphere Medical Ltd. He has served on the medical advisory board of Sphere Medical Ltd and Edwards Lifesciences Ltd. RMP and PSM are editors of the British Journal of Anaesthesia.
Publisher Copyright:
© 2023 British Journal of Anaesthesia
PY - 2023/4
Y1 - 2023/4
N2 - Background: Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials. Methods: Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process. Results: A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien–Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien–Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus. Conclusions: Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien–Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
AB - Background: Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials. Methods: Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process. Results: A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien–Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien–Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus. Conclusions: Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien–Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
KW - anaesthesia
KW - consensus
KW - morbidity
KW - mortality
KW - organ failure
KW - perioperative outcomes
KW - postoperative morbidity
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85146666825&partnerID=8YFLogxK
U2 - 10.1016/j.bja.2022.12.012
DO - 10.1016/j.bja.2022.12.012
M3 - Article
C2 - 36697275
AN - SCOPUS:85146666825
SN - 0007-0912
VL - 130
SP - 404
EP - 411
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 4
ER -