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

clinical indicators

G. Haller, Sohail Bampoe, T. Cook, Lee A. Fleisher, Michael P.W. Grocott, Mark Neuman, David Story, P. Myles, on behalf of the StEP-COMPAC Group

Research output: Contribution to journalReview ArticleResearchpeer-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).

Original languageEnglish
Pages (from-to)228-237
Number of pages10
JournalBritish Journal of Anaesthesia
Volume123
Issue number2
DOIs
Publication statusPublished - Aug 2019

Keywords

  • clinical indicators
  • clinical trials
  • outcome measures
  • patient safety
  • perioperative medicine
  • quality improvement
  • standardised endpoint

Cite this

Haller, G. ; Bampoe, Sohail ; Cook, T. ; Fleisher, Lee A. ; Grocott, Michael P.W. ; Neuman, Mark ; Story, David ; Myles, P. ; on behalf of the StEP-COMPAC Group. / Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative : clinical indicators. In: British Journal of Anaesthesia. 2019 ; Vol. 123, No. 2. pp. 228-237.
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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).",
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Haller, G, Bampoe, S, Cook, T, Fleisher, LA, Grocott, MPW, Neuman, M, Story, D, Myles, P & on behalf of the StEP-COMPAC Group 2019, 'Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators', British Journal of Anaesthesia, vol. 123, no. 2, pp. 228-237. https://doi.org/10.1016/j.bja.2019.04.041

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative : clinical indicators. / Haller, G.; Bampoe, Sohail; Cook, T.; Fleisher, Lee A.; Grocott, Michael P.W.; Neuman, Mark; Story, David; Myles, P.; on behalf of the StEP-COMPAC Group.

In: British Journal of Anaesthesia, Vol. 123, No. 2, 08.2019, p. 228-237.

Research output: Contribution to journalReview ArticleResearchpeer-review

TY - JOUR

T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative

T2 - clinical indicators

AU - Haller, G.

AU - Bampoe, Sohail

AU - Cook, T.

AU - Fleisher, Lee A.

AU - Grocott, Michael P.W.

AU - Neuman, Mark

AU - Story, David

AU - Myles, P.

AU - on behalf of the StEP-COMPAC Group

PY - 2019/8

Y1 - 2019/8

N2 - 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).

AB - 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).

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KW - clinical trials

KW - outcome measures

KW - patient safety

KW - perioperative medicine

KW - quality improvement

KW - standardised endpoint

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