P S Myles1, O Boney2, M Botti3, A M Cyna4, T J Gan5, M P Jensen6, H Kehlet7, A Kurz8, G S De Oliveira9, P Peyton10, D I Sessler11, M R Tramèr12, C L Wu13, Paul Myles14, Michael Grocott15, Bruce Biccard16, Jane Blazeby15, Oliver Boney15, Matthew Chan17, Elisabeth Diouf18, Lee Fleisher19, Cor Kalkman20, Andrea Kurz19, Ramani Moonesinghe15, Duminda Wijeysundera21. 1. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia. Electronic address: p.myles@alfred.org.au. 2. Surgical Outcomes Research Centre, University College Hospital, London, UK. 3. School of Nursing and Midwifery, Deakin University, Geelong, Australia. 4. Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; Department of Anaesthesia and Pain Management, Nepean Hospital, University of Sydney, Sydney, Australia. 5. Department of Anesthesiology, Stony Brook University, Stony Brook, NY, USA. 6. Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. 7. Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark. 8. Department of Anesthesiology, Cleveland Clinic, Cleveland, OH, USA. 9. Department of Anesthesiology, Center for Healthcare Studies, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA. 10. Anaesthesia, Perioperative and Pain Medicine Unit, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia. 11. Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA. 12. Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland. 13. Department of Anesthesiology, The Johns Hopkins Hospital, Baltimore, MD, USA. 14. Australia. 15. UK. 16. South Africa. 17. Hong Kong. 18. Senegal. 19. USA. 20. The Netherlands. 21. Canada.
Abstract
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.
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.
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