TY - JOUR
T1 - Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative
T2 - patient-centred outcomes
AU - Moonesinghe, S. R.
AU - Jackson, A. I.R.
AU - Boney, O.
AU - Stevenson, N.
AU - Chan, M. T.V.
AU - Cook, T. M.
AU - Lane-Fall, M.
AU - Kalkman, C.
AU - Neuman, M. D.
AU - Nilsson, U.
AU - Shulman, M.
AU - Myles, P. S.
N1 - Funding Information:
The Health Foundation (Improvement Science Fellowship), the National Institute for Health Research University College London Hospitals Biomedical Research Centre , and Royal College of Anaesthetists (to SRM). University of Southampton National Institute of Health Research Academic Clinical Fellowship Scheme (to AIRJ).
Funding Information:
The authors give their sincere thanks to James Goodwin and Laura Farmer of the Health Services Research Centre at the Royal College of Anaesthetists for supporting the administrative work associated with this project.The Health Foundation (Improvement Science Fellowship), the National Institute for Health Research University College London Hospitals Biomedical Research Centre, and Royal College of Anaesthetists (to SRM). University of Southampton National Institute of Health Research Academic Clinical Fellowship Scheme (to AIRJ).
Publisher Copyright:
© 2019 British Journal of Anaesthesia
Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
PY - 2019/11
Y1 - 2019/11
N2 - 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.
AB - 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.
KW - clinical indicators
KW - clinical trials
KW - outcome measures
KW - patient well-being
KW - perioperative medicine
KW - quality of life
KW - standardised endpoint
KW - Surgical Procedures, Operative/rehabilitation
KW - Humans
KW - Psychometrics
KW - Patient Outcome Assessment
KW - Patient Satisfaction
KW - Activities of Daily Living
KW - Delphi Technique
KW - Perioperative Care/methods
KW - Quality of Life
KW - Endpoint Determination/standards
UR - http://www.scopus.com/inward/record.url?scp=85071695569&partnerID=8YFLogxK
U2 - 10.1016/j.bja.2019.07.020
DO - 10.1016/j.bja.2019.07.020
M3 - Review article
C2 - 31493848
AN - SCOPUS:85071695569
SN - 0007-0912
VL - 123
SP - 664
EP - 670
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 5
ER -