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

Barnes J1, Hunter J2, Harris S3, Shankar-Hari M4, Diouf E5, Jammer I6, Kalkman C7, Klein AA8, Corcoran T9, Dieleman S10, Grocott MPW11, Mythen MG12; StEP-COMPAC group.

Collaborators (118)

Myles P, Gan TJ, Kurz A, Peyton P, Sessler D, Tramèr M, Cyna A, De Oliveira GS Jr, Wu C, Jensen M, Kehlet H, Botti M, Boney O, Haller G, Grocott M, Cook T, Fleisher L, Neuman M, Story D, Gruen R, Bampoe S, Evered L, Scott D, Silbert B, van Dijk D, Kalkman C, Chan M, Grocott H, Haller G, Eckenhoff R, Rasmussen L, Eriksson L, Beattie S, Wijeysundera D, Fleisher L, Landoni G, Leslie K, Biccard B, Howell S, Grocott H, Nagele P, Richards T, Lamy A, Lalu M, Pearse R, Mythen M, Canet J, Moller A, Gin T, Schultz M, Pelosi P, Gabreu M, Futier E, Creagh-Brown B, Lalu M, Fowler A, Abbott T, Mythen M, Kalkman C, Klein A, Corcoran T, Cooper DJ, Dieleman S, Diouf E, McIlroy D, Bellomo R, Shaw A, Prowle J, Karkouti K, Billings J, Wijeysundera D, Klein A, Richards T, Mazer D, Myles P, Jayarajah M, Karkouti K, Murphy M, Lamy A, Bartoszko J, Sneyd R, Beattie S, Fleisher L, Grocott M, Sessler D, Morris S, George R, Moonesinghe R, Chan M, Cook T, Myles P, Shulman M, Neuman M, Kalkman C, Lane-Fall M, Nilsson U, Stevenson N, Grocott M, Myles P, Pearse R, Kurz A, Moonesinghe R, Cooper JD, van Klei W, Cabrini L, Miller T, Pace N, Jackson S, Buggy D, Sessler D, Leslie K, Short T, Kurz A, Riedel B, Gottumukkala V, Pace N, Alkhaffaf B, Johnson M.

Author information

1

Department of Anaesthesia, Great Western Hospital, Swindon, UK.

2

Department of Anaesthesia and Perioperative Medicine, University College Hospital, London, UK.

3

Bloomsbury Institute of Intensive Care Medicine, University College London Hospital, London, UK. Electronic address: doc@steveharris.me.

4

School of Immunology & Microbial Sciences, Kings College London, UK; Guy's and St Thomas' NHS Foundation Trust, London, UK.

5

Anesthesia and Intensive Care Unit, Le Dantec Hospital, Cheikh Anta DIOP University, Dakar, Senegal.

6

Department of Anaesthesiology and Intensive Care, Haukeland University Hospital, Bergen, Norway; Department of Clinical Medicine, University of Bergen, Bergen, Norway.

7

Division of Anesthesiology, Intensive Care and Emergency Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

8

Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridgeshire, UK.

9

Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.

10

Department of Anaesthesia & Perioperative Medicine Westmead Hospital, Sydney, Australia.

11

Anaesthesia and Critical Care Research Group, NIHR Biomedical Research Centre, UK; Faculty of Medicine, University of Southampton, Southampton, UK; Department of Anaesthesiology, Duke University School of Medicine, Durham, NC, USA.

12

Department of Anaesthesia and Perioperative Medicine, University College Hospital, London, UK; National Institute of Health Research Biomedical Research Centre, London, UK.

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.

Copyright © 2019 British Journal of Anaesthesia. All rights reserved.

KEYWORDS:

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

Comment in

• Patient-important outcomes and core outcome sets: increased attention needed! [Br J Anaesth. 2019]

PMID:

 

30857606

 

PMCID:

 

PMC6435904

 

DOI:

 

10.1016/j.bja.2019.01.009

[Indexed for MEDLINE] 

Free PMC Article

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