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

infection and sepsis

Jonathan Barnes, Jennifer Hunter, Steve Harris, Manu Shankar-Hari, Elisabeth Diouf, Ib Jammer, Cor Kalkman, Andrew A. Klein, Tomas Corcoran, Stefan Dieleman, Michael P.W. Grocott, Michael G. Mythen, the StEP-COMPAC Group

Research output: Contribution to journalReview ArticleResearchpeer-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.

Original languageEnglish
Pages (from-to)500–508
Number of pages9
JournalBritish Journal of Anaesthesia
Volume122
Issue number4
DOIs
Publication statusPublished - 1 Apr 2019

Keywords

  • anaesthesia
  • core outcome measures
  • infection
  • perioperative medicine
  • postoperative outcome
  • sepsis
  • standardised endpoints
  • surgical site infection

Cite this

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. ; the StEP-COMPAC Group. / Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative : infection and sepsis. In: British Journal of Anaesthesia. 2019 ; Vol. 122, No. 4. pp. 500–508.
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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.",
keywords = "anaesthesia, core outcome measures, infection, perioperative medicine, postoperative outcome, sepsis, standardised endpoints, surgical site infection",
author = "Jonathan Barnes and Jennifer Hunter and Steve Harris and Manu Shankar-Hari and Elisabeth Diouf and Ib Jammer and Cor Kalkman and Klein, {Andrew A.} and Tomas Corcoran and Stefan Dieleman and Grocott, {Michael P.W.} and Mythen, {Michael G.} and {the StEP-COMPAC Group} and Paul Myles and Gan, {Tang Joon} and Andrea Kurz and Phil Peyton and Dan Sessler and Martin Tram{\`e}r and Alan Cyna and {De Oliveira}, {Gildasio S.} and Christopher Wu and Mark Jensen and Henrik Kehlet and Mari Botti and Oliver Boney and Guy Haller and Mike Grocott and Tim Cook and Lee Fleisher and Mark Neuman and David Story and Russell Gruen and Sam Bampoe and Lis Evered and David Scott and Brendan Silbert and {van Dijk}, Diederik and Matthew Chan and Hilary Grocott and Rod Eckenhoff and Lars Rasmussen and Lars Eriksson and Scott Beattie and Duminda Wijeysundera and Giovanni Landoni and Kate Leslie and Bruce Biccard and Simon Howell and Peter Nagele and Toby Richards and Andre Lamy and Manoj Lalu and Rupert Pearse and Monty Mythen and Jaume Canet and Ann Moller and Tony Gin and Marcus Schultz and Paolo Pelosi and Marcelo Gabreu and Emmanuel Futier and Ben Creagh-Brown and Alexander Fowler and Tom Abbott and Andy Klein and David McIlroy and Rinaldo Bellomo and Andrew Shaw and John Prowle and Keyvan Karkouti and Josh Billings and David Mazer and Mohindas Jayarajah and Michael Murphy and Justyna Bartoszko and Rob Sneyd and Steve Morris and Ron George and Ramani Moonesinghe and Mark Shulman and Meghan Lane-Fall and Ulrica Nilsson and Nathalie Stevenson and {van Klei}, Wilton and Luca Cabrini and Tim Miller and Nathan Pace and Sandy Jackson and Donal Buggy and Tim Short and Bernhard Riedel and Vijay Gottumukkala and Bilal Alkhaffaf and Mark Johnson",
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Barnes, J, Hunter, J, Harris, S, Shankar-Hari, M, Diouf, E, Jammer, I, Kalkman, C, Klein, AA, Corcoran, T, Dieleman, S, Grocott, MPW, Mythen, MG & 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, vol. 122, no. 4, pp. 500–508. https://doi.org/10.1016/j.bja.2019.01.009

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative : infection and sepsis. / 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.; the StEP-COMPAC Group.

In: British Journal of Anaesthesia, Vol. 122, No. 4, 01.04.2019, p. 500–508.

Research output: Contribution to journalReview ArticleResearchpeer-review

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 - the StEP-COMPAC Group

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 - Richards, Toby

AU - Lamy, Andre

AU - Lalu, Manoj

AU - Pearse, Rupert

AU - Mythen, Monty

AU - Canet, Jaume

AU - Moller, Ann

AU - Gin, Tony

AU - Schultz, Marcus

AU - Pelosi, Paolo

AU - Gabreu, Marcelo

AU - Futier, Emmanuel

AU - Creagh-Brown, Ben

AU - Fowler, Alexander

AU - Abbott, Tom

AU - Klein, Andy

AU - McIlroy, David

AU - Bellomo, Rinaldo

AU - Shaw, Andrew

AU - Prowle, John

AU - Karkouti, Keyvan

AU - Billings, Josh

AU - Mazer, David

AU - Jayarajah, Mohindas

AU - Murphy, Michael

AU - Bartoszko, Justyna

AU - Sneyd, Rob

AU - Morris, Steve

AU - George, Ron

AU - Moonesinghe, Ramani

AU - Shulman, Mark

AU - Lane-Fall, Meghan

AU - Nilsson, Ulrica

AU - Stevenson, Nathalie

AU - van Klei, Wilton

AU - Cabrini, Luca

AU - Miller, Tim

AU - Pace, Nathan

AU - Jackson, Sandy

AU - Buggy, Donal

AU - Short, Tim

AU - Riedel, Bernhard

AU - Gottumukkala, Vijay

AU - Alkhaffaf, Bilal

AU - Johnson, Mark

PY - 2019/4/1

Y1 - 2019/4/1

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

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U2 - 10.1016/j.bja.2019.01.009

DO - 10.1016/j.bja.2019.01.009

M3 - Review Article

VL - 122

SP - 500

EP - 508

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 4

ER -