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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators
Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

clinical indicators, clinical trials, outcome measures, patient safety, perioperative medicine, quality improvement, standardised endpoint
0007-0912
228-237
Haller, G.
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Bampoe, Sohail
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Cook, Tim
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Fleisher, L.A.
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Grocott, Michael P.W.
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Neuman, Mark
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Story, D.
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Myles, Paul S.
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Myles, P.
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Grocott, Michael P.W.
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Biccard, B.
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Blazeby, J.
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Boney, O.
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Chan, M.
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Diouf, E.
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Fleisher, L.
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Kalkman, C.
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Peyton, P.
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Sessler, D.
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Cyna, A.
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De Oliveira, G. S.
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Wu, C.
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Jensen, M.
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Kehlet, H.
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Botti, M.
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Haller, G.
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Cook, T.
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Neuman, M.
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Story, D.
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Gruen, R.
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Bampoe, S.
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Scott, D.
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Silbert, B.
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van Dijk, D.
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Grocott, H.
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Beattie, S.
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Richards, T.
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Shaw, A.
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Murphy, M.
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George, R.
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Cooper, J.D.J.
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Miller, T.
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Jackson, S.
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Johnson, M.
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the StEP-COMPAC Group
Haller, G.
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Bampoe, Sohail
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Cook, Tim
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Fleisher, L.A.
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Grocott, Michael P.W.
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Neuman, Mark
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Story, D.
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Myles, Paul S.
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Myles, P.
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Grocott, Michael P.W.
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Biccard, B.
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Blazeby, J.
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Boney, O.
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Chan, M.
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Diouf, E.
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Fleisher, L.
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Kalkman, C.
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Kurz, A.
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Moonesinghe, R.
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Wijeysundera, D.
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Gan, T. J.
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Peyton, P.
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Sessler, D.
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Tramèr, M.
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Cyna, A.
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De Oliveira, G. S.
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Wu, C.
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Jensen, M.
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Kehlet, H.
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Botti, M.
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Haller, G.
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Cook, T.
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Neuman, M.
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Story, D.
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Gruen, R.
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Bampoe, S.
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Evered, L.
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Scott, D.
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Silbert, B.
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van Dijk, D.
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Grocott, H.
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Beattie, S.
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Richards, T.
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Shaw, A.
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Murphy, M.
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George, R.
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Cooper, J.D.J.
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Miller, T.
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Jackson, S.
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Johnson, M.
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Haller, G., Bampoe, Sohail, Cook, Tim, Fleisher, L.A., Grocott, Michael P.W., Neuman, Mark, Story, D., Myles, Paul S., Myles, P., Grocott, Michael P.W., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T. J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Beattie, S., Richards, T., Shaw, A., Murphy, M., George, R., Cooper, J.D.J., Miller, T., Jackson, S. and Johnson, M. , the StEP-COMPAC Group (2019) Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators. British Journal of Anaesthesia, 123 (2), 228-237. (doi:10.1016/j.bja.2019.04.041).

Record type: Review

Abstract

Background: Clinical indicators are powerful tools to quantify the safety and quality of patient care. Their validity is often unclear and definitions extremely heterogeneous. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid clinical outcome indicators for use in perioperative clinical trials. Methods: We identified clinical indicators via a systematic review of the anaesthesia and perioperative medicine literature (PubMed/OVID, EMBASE, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 54 clinician–researchers worldwide. Indicators were first shortlisted and the most suitable definitions for evaluation of quality and safety interventions determined. Indicators were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 167 clinical outcome indicators. Participation in the three Delphi rounds was 100% (n=13), 68% (n=54), and 85% (n= 6), respectively. A final list of eight outcome indicators was generated: surgical site infection at 30 days, stroke within 30 days of surgery, death within 30 days of coronary artery bypass grafting, death within 30 days of surgery, admission to the intensive care unit within 14 days of surgery, readmission to hospital within 30 days of surgery, and length of hospital stay (with or without in-hospital mortality). They were rated by the majority of experts as valid, reliable, easy to use, and clearly defined. Conclusions: These clinical indicators can be confidently used as endpoints in clinical trials measuring quality, safety, and improvement in perioperative care. Registration: PROSPERO 2016 CRD42016042102 (http://www.crd.york.ac.uk/PROSPERO/display_record.php? ID=CRD42016042102).

Full text not available from this repository.

More information

Accepted/In Press date: 12 April 2019
e-pub ahead of print date: 23 May 2019
Published date: 1 August 2019
Keywords: clinical indicators, clinical trials, outcome measures, patient safety, perioperative medicine, quality improvement, standardised endpoint

Identifiers

Local EPrints ID: 434176
URI: https://eprints.soton.ac.uk/id/eprint/434176
ISSN: 0007-0912
PURE UUID: 3b9698cf-ff49-40ad-9840-66d6ca7a55a6
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581
ORCID for Michael P.W. Grocott: ORCID iD orcid.org/0000-0002-9484-7581

Catalogue record

Date deposited: 13 Sep 2019 16:30
Last modified: 04 Oct 2019 00:34

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Contributors

Author: G. Haller
Author: Sohail Bampoe
Author: Tim Cook
Author: L.A. Fleisher
Author: Mark Neuman
Author: D. Story
Author: Paul S. Myles
Author: P. Myles
Author: B. Biccard
Author: J. Blazeby
Author: O. Boney
Author: M. Chan
Author: E. Diouf
Author: L. Fleisher
Author: C. Kalkman
Author: A. Kurz
Author: R. Moonesinghe
Author: D. Wijeysundera
Author: T. J. Gan
Author: P. Peyton
Author: D. Sessler
Author: M. Tramèr
Author: A. Cyna
Author: G. S. De Oliveira
Author: C. Wu
Author: M. Jensen
Author: H. Kehlet
Author: M. Botti
Author: G. Haller
Author: T. Cook
Author: M. Neuman
Author: D. Story
Author: R. Gruen
Author: S. Bampoe
Author: L. Evered
Author: D. Scott
Author: B. Silbert
Author: D. van Dijk
Author: H. Grocott
Author: S. Beattie
Author: T. Richards
Author: A. Shaw
Author: M. Murphy
Author: R. George
Author: J.D.J. Cooper
Author: T. Miller
Author: S. Jackson
Author: M. Johnson

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