TY - JOUR
T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative
T2 - infection and sepsis
AU - Barnes, Jonathan
AU - Hunter, Jennifer
AU - Harris, Steve
AU - Shankar-Hari, Manu
AU - Diouf, Elisabeth
AU - Jammer, Ib
AU - Kalkman, Cor
AU - Klein, Andrew A.
AU - Corcoran, Tomas
AU - Dieleman, Stefan
AU - Grocott, Michael P.W.
AU - Mythen, Michael G.
AU - Myles, Paul
AU - Gan, Tang Joon
AU - Kurz, Andrea
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 - Boney, Oliver
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 - 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 - van Klei, Wilton
N1 - Funding Information:
The Standardized Endpoints for Perioperative Medicine (StEP) Collaborative has been supported by an unrestricted grant from the British Journal of Anaesthesia as well as administrative support from the National Institute of Academic Anaesthesia Health Services Research Centre and the Department of Anaesthesia and Perioperative Medicine, Monash University. M.P.W.G. is a National Institute of Health Research Senior Investigator. M.S.H. is supported by the National Institute for Health Research Clinician Scientist Award (NIHR-CS-2016-16-011). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research or the Department of Health.
Publisher Copyright:
© 2019 British Journal of Anaesthesia
PY - 2019/4
Y1 - 2019/4
N2 - Background: Perioperative infection and sepsis are of fundamental concern to perioperative clinicians. However, standardised endpoints are either poorly defined or not routinely implemented. The Standardised Endpoints in Perioperative Medicine (StEP) 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 infection and sepsis used in the perioperative literature. A multi-round Delphi consensus process that included more than 60 clinician researchers was then used to refine a recommended list of outcome measures. Results: A literature search yielded 1857 titles of which 255 met inclusion criteria for endpoint extraction. A long list of endpoints, with definitions and timescales, was generated and those potentially relevant to infection and sepsis circulated to the theme subgroup and then the wider StEP-COMPAC working group, undergoing a three-stage Delphi process. The response rates for Delphi rounds 1, 3, and 3 were 89% (n=8), 67% (n=62), and 80% (n=8), respectively. A set of 13 endpoints including fever, surgical site, and organ-specific infections as defined by the US Centres for Disease Control and Sepsis-3 are proposed for future use. Conclusions: We defined a consensus list of standardised endpoints related to infection and sepsis for perioperative trials using an established and rigorous approach. Each endpoint was evaluated with respect to validity, reliability, feasibility, and patient centredness. One or more of these should be considered for inclusion in future perioperative clinical trials assessing infection, sepsis, or both, thereby permitting synthesis and comparison of future results.
AB - Background: Perioperative infection and sepsis are of fundamental concern to perioperative clinicians. However, standardised endpoints are either poorly defined or not routinely implemented. The Standardised Endpoints in Perioperative Medicine (StEP) 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 infection and sepsis used in the perioperative literature. A multi-round Delphi consensus process that included more than 60 clinician researchers was then used to refine a recommended list of outcome measures. Results: A literature search yielded 1857 titles of which 255 met inclusion criteria for endpoint extraction. A long list of endpoints, with definitions and timescales, was generated and those potentially relevant to infection and sepsis circulated to the theme subgroup and then the wider StEP-COMPAC working group, undergoing a three-stage Delphi process. The response rates for Delphi rounds 1, 3, and 3 were 89% (n=8), 67% (n=62), and 80% (n=8), respectively. A set of 13 endpoints including fever, surgical site, and organ-specific infections as defined by the US Centres for Disease Control and Sepsis-3 are proposed for future use. Conclusions: We defined a consensus list of standardised endpoints related to infection and sepsis for perioperative trials using an established and rigorous approach. Each endpoint was evaluated with respect to validity, reliability, feasibility, and patient centredness. One or more of these should be considered for inclusion in future perioperative clinical trials assessing infection, sepsis, or both, thereby permitting synthesis and comparison of future results.
KW - anaesthesia
KW - core outcome measures
KW - infection
KW - perioperative medicine
KW - postoperative outcome
KW - sepsis
KW - standardised endpoints
KW - surgical site infection
UR - https://www.scopus.com/pages/publications/85061359801
U2 - 10.1016/j.bja.2019.01.009
DO - 10.1016/j.bja.2019.01.009
M3 - Review article
AN - SCOPUS:85061359801
SN - 0007-0912
VL - 122
SP - 500
EP - 508
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 4
ER -