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

Guy Haller; Sohail Bampoe; Tim Cook; Lee A Fleisher; Michael P W Grocott; Mark Neuman; David Story; Paul S Myles; StEP-COMPAC Group

doi:10.1016/j.bja.2019.04.041

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

Br J Anaesth. 2019 Aug;123(2):228-237. doi: 10.1016/j.bja.2019.04.041. Epub 2019 May 23.

Authors

Guy Haller¹, Sohail Bampoe², Tim Cook³, Lee A Fleisher⁴, Michael P W Grocott⁵, Mark Neuman⁴, David Story⁶, Paul S Myles⁷; StEP-COMPAC Group

Collaborators

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

Affiliations

¹ Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. Electronic address: Guy.Haller@hcuge.ch.
² Centre for Perioperative Medicine, University College London, UK.
³ Department of Anaesthesia and Intensive Care, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.
⁴ Departments of Anesthesiology and Critical Care and Medicine, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA.
⁵ Integrative Physiology and Critical Illness Group, Clinical and Experimental Sciences, Faculty of Medicine, University Hospital Southampton, Southampton, UK; Anaesthesia, Perioperative and Critical Care Research Group, Southampton NIHR Biomedical Research Centre, University Hospital Southampton, Southampton, UK.
⁶ Centre for Integrated Critical Care, University of Melbourne, Melbourne, Australia.
⁷ Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia; Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia.

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).

Keywords: clinical indicators; clinical trials; outcome measures; patient safety; perioperative medicine; quality improvement; standardised endpoint.

Publication types

Systematic Review

MeSH terms

Clinical Trials as Topic
Consensus*
Humans
Outcome Assessment, Health Care / standards*
Patient Safety / standards*
Perioperative Care / standards*
Quality of Health Care / standards*
Reference Standards
Reproducibility of Results

Grants and funding

DRF-2015-08-023/DH_/Department of Health/United Kingdom