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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis
Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis

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.

core outcome measures, infection, perioperative medicine, postoperative outcome, sepsis, standardised endpoints, surgical site infection
0007-0912
500-508
Barnes, Jonathan
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Hunter, Jennifer
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Harris, Steve
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Shankar-Hari, Manu
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Diouf, Elisabeth
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Jammer, Ib
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Kalkman, Cor
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Klein, Andrew A.
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Corcoran, Tomas
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Dieleman, Stefan
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Grocott, Michael P.W.
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Mythen, Michael G.
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Myles, Paul
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Gan, Tang Joon
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Kurz, Andrea
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Peyton, Phil
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Sessler, Dan
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Tramèr, Martin
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Cyna, Alan
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De Oliveira, Gildasio S.
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Wu, Christopher
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Jensen, Mark
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Kehlet, Henrik
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Botti, Mari
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Boney, Oliver
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Haller, Guy
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Grocott, Michael P.W.
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Cook, Tim
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Fleisher, Lee
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Neuman, Mark
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Story, David
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Gruen, Russell
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Bampoe, Sam
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Evered, Lis
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Scott, David
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Silbert, Brendan
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van Dijk, Diederik
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Chan, Matthew
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Grocott, Hilary
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Eckenhoff, Rod
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Rasmussen, Lars
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Eriksson, Lars
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Beattie, Scott
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Wijeysundera, Duminda
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Landoni, Giovanni
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Leslie, Kate
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Biccard, Bruce
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Cooper, David James
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Shaw, Andrew
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Johnson, Mark
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the StEP-COMPAC Group
Barnes, Jonathan
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Hunter, Jennifer
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Harris, Steve
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Shankar-Hari, Manu
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Diouf, Elisabeth
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Jammer, Ib
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Kalkman, Cor
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Klein, Andrew A.
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Corcoran, Tomas
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Dieleman, Stefan
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Grocott, Michael P.W.
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Mythen, Michael G.
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Myles, Paul
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Gan, Tang Joon
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Kurz, Andrea
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Peyton, Phil
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Sessler, Dan
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Tramèr, Martin
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Cyna, Alan
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De Oliveira, Gildasio S.
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Wu, Christopher
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Jensen, Mark
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Kehlet, Henrik
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Botti, Mari
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Boney, Oliver
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Haller, Guy
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Grocott, Michael P.W.
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Cook, Tim
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Fleisher, Lee
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Neuman, Mark
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Story, David
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Gruen, Russell
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Bampoe, Sam
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Evered, Lis
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Scott, David
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Silbert, Brendan
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van Dijk, Diederik
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Chan, Matthew
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Grocott, Hilary
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Eckenhoff, Rod
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Rasmussen, Lars
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Eriksson, Lars
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Beattie, Scott
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Wijeysundera, Duminda
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Landoni, Giovanni
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Leslie, Kate
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Biccard, Bruce
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Cooper, David James
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Shaw, Andrew
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Johnson, Mark
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Barnes, Jonathan, Hunter, Jennifer, Harris, Steve, Shankar-Hari, Manu, Diouf, Elisabeth, Jammer, Ib, Kalkman, Cor, Klein, Andrew A., Corcoran, Tomas, Dieleman, Stefan, Grocott, Michael P.W., Mythen, Michael G., Myles, Paul, Gan, Tang Joon, Kurz, Andrea, Peyton, Phil, Sessler, Dan, Tramèr, Martin, Cyna, Alan, De Oliveira, Gildasio S., Wu, Christopher, Jensen, Mark, Kehlet, Henrik, Botti, Mari, Boney, Oliver, Haller, Guy, Grocott, Michael P.W., Cook, Tim, Fleisher, Lee, Neuman, Mark, Story, David, Gruen, Russell, Bampoe, Sam, Evered, Lis, Scott, David, Silbert, Brendan, van Dijk, Diederik, Chan, Matthew, Grocott, Hilary, Eckenhoff, Rod, Rasmussen, Lars, Eriksson, Lars, Beattie, Scott, Wijeysundera, Duminda, Landoni, Giovanni, Leslie, Kate, Biccard, Bruce, Cooper, David James, Shaw, Andrew and Johnson, Mark , the StEP-COMPAC Group (2019) Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis. British Journal of Anaesthesia, 122 (4), 500-508. (doi:10.1016/j.bja.2019.01.009).

Record type: Review

Abstract

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.

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More information

Accepted/In Press date: 8 January 2019
e-pub ahead of print date: 14 February 2019
Published date: 1 April 2019
Keywords: core outcome measures, infection, perioperative medicine, postoperative outcome, sepsis, standardised endpoints, surgical site infection

Identifiers

Local EPrints ID: 429290
URI: https://eprints.soton.ac.uk/id/eprint/429290
ISSN: 0007-0912
PURE UUID: 0eb7934a-6b60-4163-8942-3cc3ed43b767

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Date deposited: 26 Mar 2019 17:30
Last modified: 26 Mar 2019 17:30

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Contributors

Author: Jonathan Barnes
Author: Jennifer Hunter
Author: Steve Harris
Author: Manu Shankar-Hari
Author: Elisabeth Diouf
Author: Ib Jammer
Author: Cor Kalkman
Author: Andrew A. Klein
Author: Tomas Corcoran
Author: Stefan Dieleman
Author: Michael G. Mythen
Author: Paul Myles
Author: Tang Joon Gan
Author: Andrea Kurz
Author: Phil Peyton
Author: Dan Sessler
Author: Martin Tramèr
Author: Alan Cyna
Author: Gildasio S. De Oliveira
Author: Christopher Wu
Author: Mark Jensen
Author: Henrik Kehlet
Author: Mari Botti
Author: Oliver Boney
Author: Guy Haller
Author: Tim Cook
Author: Lee Fleisher
Author: Mark Neuman
Author: David Story
Author: Russell Gruen
Author: Sam Bampoe
Author: Lis Evered
Author: David Scott
Author: Brendan Silbert
Author: Diederik van Dijk
Author: Matthew Chan
Author: Hilary Grocott
Author: Rod Eckenhoff
Author: Lars Rasmussen
Author: Lars Eriksson
Author: Scott Beattie
Author: Duminda Wijeysundera
Author: Giovanni Landoni
Author: Kate Leslie
Author: Bruce Biccard
Author: David James Cooper
Author: Andrew Shaw
Author: Mark Johnson

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