Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes

S R Moonesinghe; A I R Jackson; O Boney; N Stevenson; M T V Chan; T M Cook; M Lane-Fall; C Kalkman; M D Neuman; U Nilsson; M Shulman; P S Myles; Standardised Endpoints in Perioperative Medicine-Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAC) Group

doi:10.1016/j.bja.2019.07.020

Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes

Br J Anaesth. 2019 Nov;123(5):664-670. doi: 10.1016/j.bja.2019.07.020. Epub 2019 Sep 5.

Affiliations

¹ UCL/UCLH Surgical Outcomes Research Centre, Centre for Perioperative Medicine, Department for Targeted Intervention, University College London, London, UK; Health Services Research Centre, National Institute for Academic Anaesthesia, Royal College of Anaesthetists, London, UK; National Institute for Health Research, Biomedical Research Centre, University College London Hospitals, London, UK. Electronic address: ramani.moonesinghe@nhs.net.
² Anaesthesia and Critical Care Research Area, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Integrative Physiology and Critical Illness Group, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
³ UCL/UCLH Surgical Outcomes Research Centre, Centre for Perioperative Medicine, Department for Targeted Intervention, University College London, London, UK; Health Services Research Centre, National Institute for Academic Anaesthesia, Royal College of Anaesthetists, London, UK.
⁴ Department of Anaesthesia and Intensive Care Medicine, Barnet General Hospital, Royal Free London NHS Foundation Trust, London, UK.
⁵ Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, the Hong Kong Special Administrative Region of China.
⁶ Department of Anaesthesia and Intensive Care Medicine, Royal United Hospital Bath NHS Foundation Trust, Bath, UK; School of Medicine, University of Bristol, Bristol, UK.
⁷ Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, PA, USA; Penn Center for Perioperative Outcomes Research and Transformation, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁸ Division of Anesthesiology, Intensive Care and Emergency Medicine, University Medical Centre, Utrecht, the Netherlands.
⁹ Leonard David Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.
¹⁰ Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden; Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
¹¹ Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anaesthesia and Perioperative Medicine, Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.

PMID: 31493848
DOI: 10.1016/j.bja.2019.07.020

Abstract

Background: Patient-centred outcomes are increasingly used in perioperative clinical trials. The Standardised Endpoints in Perioperative Medicine (StEP) initiative aims to define which measures should be used in future research to facilitate comparison between studies and to enable robust evidence synthesis.

Methods: A systematic review was conducted to create a longlist of patient satisfaction, health-related quality of life, functional status, patient well-being, and life-impact measures for consideration. A three-stage Delphi consensus process involving 89 international experts was then conducted in order to refine this list into a set of recommendations.

Results: The literature review yielded six patient-satisfaction measures, seven generic health-related quality-of-life measures, eight patient well-being measures, five functional-status measures, and five life-impact measures for consideration. The Delphi response rates were 92%, 87%, and 100% for Rounds 1, 2, and 3, respectively. Three additional measures were added during the Delphi process as a result of contributions from the StEP group members. Firm recommendations have been made about one health-related quality-of-life measure (EuroQol 5 Dimension, five-level version with visual analogue scale), one functional-status measure (WHO Disability Assessment Schedule version 2.0, 12-question version), and one life-impact measure (days alive and out of hospital at 30 days after surgery). Recommendations with caveats have been made about the Bauer patient-satisfaction measure and two life-impact measures (days alive and out of hospital at 1 yr after surgery, and discharge destination).

Conclusions: Several patient-centred outcome measures have been recommended for use in future perioperative studies. We suggest that every clinical study should consider using at least one patient-centred outcome within a suite of endpoints.

Keywords: clinical indicators; clinical trials; outcome measures; patient well-being; perioperative medicine; quality of life; standardised endpoint.

Publication types

Consensus Development Conference
Research Support, Non-U.S. Gov't
Systematic Review

MeSH terms

Activities of Daily Living
Delphi Technique
Endpoint Determination / standards*
Humans
Patient Outcome Assessment*
Patient Satisfaction
Perioperative Care / methods
Perioperative Care / standards*
Psychometrics
Quality of Life
Surgical Procedures, Operative / rehabilitation