Core Outcome Measures in Effectiveness Trials

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

General Information

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% (n¼8), 67% (n¼62), and 80% (n¼8), 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.

Authors:
Jonathan Barnes, Jennifer Hunter, Steve Harris, Manu Shankar-Hari, Elisabeth Diouf, Ib Jammer, Cor Kalkman, Andrew A. Klein10, Tomas Corcoran, Stefan Dieleman, Michael P. W. Grocott, Michael G. Mythen, and the StEP-COMPAC group

Publication

Journal:
British Journal of Anaesthesia
Volume:
Issue:
Pages:
-
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Anaesthesia & pain control
Infectious disease

Disease Name
Perioperative infection
Sepsis

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Delphi process
Systematic review

Stakeholders Involved

Clinical experts

Study Type

COS for clinical trials or clinical research

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