TY - JOUR
T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative
T2 - clinical indicators
AU - Haller, Guy
AU - Bampoe, Sohail
AU - Cook, Tim
AU - Fleisher, L. A.
AU - Grocott, Michael P.W.
AU - Neuman, Mark
AU - Story, D.
AU - Myles, Paul S.
AU - Myles, P.
AU - Grocott, M.
AU - Biccard, B.
AU - Blazeby, J.
AU - Boney, O.
AU - Chan, M.
AU - Diouf, E.
AU - Fleisher, L.
AU - Kalkman, C.
AU - Kurz, A.
AU - Moonesinghe, R.
AU - Wijeysundera, D.
AU - Gan, T. J.
AU - Peyton, P.
AU - Sessler, D.
AU - Tramèr, M.
AU - Cyna, A.
AU - De Oliveira, G. S.
AU - Wu, C.
AU - Jensen, M.
AU - Kehlet, H.
AU - Botti, M.
AU - Haller, G.
AU - Cook, T.
AU - Neuman, M.
AU - Story, D.
AU - Gruen, R.
AU - Bampoe, S.
AU - Evered, L.
AU - Scott, D.
AU - Silbert, B.
AU - van Dijk, D.
AU - Grocott, H.
AU - Eckenhoff, R.
AU - Rasmussen, L.
AU - Eriksson, L.
AU - Beattie, S.
AU - Landoni, G.
AU - Leslie, K.
AU - Dieleman, S.
AU - van Klei, W.
AU - Jackson, S.
N1 - Funding Information:
We thank Mafalda Burri, librarian at the University of Geneva, for assistance in the literature search, Angela Lowe and Sophie Wallace (Alfred Hospital, Melbourne) for assistance with the Delphi surveys, and all members of the StEP-COMPAC Group who responded in a timely fashion. We thank the British Journal of Anaesthesia for sponsoring a workshop on this topic at the Monash University Prato Centre, Italy, in June 2015.
Publisher Copyright:
© 2019 British Journal of Anaesthesia
PY - 2019/8/1
Y1 - 2019/8/1
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).
KW - clinical indicators
KW - clinical trials
KW - outcome measures
KW - patient safety
KW - perioperative medicine
KW - quality improvement
KW - standardised endpoint
KW - Quality of Health Care/standards
KW - Outcome Assessment, Health Care/standards
KW - Reproducibility of Results
KW - Humans
KW - Clinical Trials as Topic
KW - Consensus
KW - Patient Safety/standards
KW - Reference Standards
KW - Perioperative Care/standards
UR - http://www.scopus.com/inward/record.url?scp=85065874262&partnerID=8YFLogxK
U2 - 10.1016/j.bja.2019.04.041
DO - 10.1016/j.bja.2019.04.041
M3 - Article
C2 - 31128879
AN - SCOPUS:85065874262
SN - 0007-0912
VL - 123
SP - 228
EP - 237
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 2
ER -