Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.
- Myles PS Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia. Electronic address: p.myles@alfred.org.au.
- Boney O Surgical Outcomes Research Centre, University College Hospital, London, UK.
- Botti M School of Nursing and Midwifery, Deakin University, Geelong, Australia.
- Cyna AM Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; Department of Anaesthesia and Pain Management, Nepean Hospital, University of Sydney, Sydney, Australia.
- Gan TJ Department of Anesthesiology, Stony Brook University, Stony Brook, NY, USA.
- Jensen MP Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.
- Kehlet H Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark.
- Kurz A Department of Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.
- De Oliveira GS Department of Anesthesiology, Center for Healthcare Studies, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA.
- Peyton P Anaesthesia, Perioperative and Pain Medicine Unit, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.
- Sessler DI Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.
- Tramèr MR Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland.
- Wu CL Department of Anesthesiology, The Johns Hopkins Hospital, Baltimore, MD, USA.
- Myles P UK.
- Grocott M South Africa.
- Biccard B UK.
- Blazeby J UK.
- Boney O Hong Kong.
- Chan M Senegal.
- Diouf E USA.
- Fleisher L The Netherlands.
- Kalkman C USA.
- Kurz A UK.
- Moonesinghe R Canada.
- Wijeysundera D
- 2018-03-27
Published in:
- British journal of anaesthesia. - 2018
anaesthesia
clinical trials
patient-reported outcomes
surgery
Consensus
Delphi Technique
Humans
Patient Comfort
Perioperative Care
Practice Guidelines as Topic
Research Design
English
BACKGROUND
Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.
METHODS
We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures.
RESULTS
We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality.
CONCLUSIONS
As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.
Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.
METHODS
We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures.
RESULTS
We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n=22), 90% (n=79), and 100% (n=13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0-6 h, 6-24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality.
CONCLUSIONS
As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.bja.2017.12.037
- PMID 29576111
- Persistent URL
- https://sonar.ch/global/documents/76544
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