TY - JOUR
T1 - Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC)
T2 - a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia
AU - The StEP-COMPAC Group
AU - Boney, Oliver
AU - Moonesinghe, S. Ramani
AU - Myles, Paul S.
AU - Grocott, Michael P.W.
AU - Bartoszko, J.
AU - Beattie, W. S.
AU - Bellomo, R.
AU - Buggy, D.
AU - Cabrini, L.
AU - Canet, J.
AU - Cook, T.
AU - Cooper, D. J.
AU - Corcoran, T.
AU - Devereaux, P. J.
AU - Eckenhoff, R.
AU - Evered, L.
AU - Gan, T. J.
AU - Gin, T.
AU - Grocott, H.
AU - Haller, G.
AU - Howell, Simon
AU - Jayarajah, M.
AU - Kalkman, C.
AU - Karkouti, K.
AU - Kavanagh, B.
AU - Klein, A.
AU - Landoni, G.
AU - Leslie, K.
AU - McIlroy, D. R.
AU - Mazer, D.
AU - Moller, A.
AU - Mythen, M.
AU - Neuman, M.
AU - Pearse, R.
AU - Peyton, P.
AU - Prowle, J.
AU - Richards, T.
AU - Scott, D. A.
AU - Sessler, D.
AU - Shaw, Andrew D.
AU - Short, Timothy G.
AU - Shulman, M.
AU - Silbert, B.
AU - Singer, M.
AU - Sneyd, J. R.
AU - Story, D.
AU - van Dijk, D.
AU - van Klei, W.
PY - 2022/1
Y1 - 2022/1
N2 - Background: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. Methods: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. Results: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). Conclusions: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.
AB - Background: Outcome selection underpins clinical trial interpretation. Inconsistency in outcome selection and reporting hinders comparison of different trials' results, reducing the utility of research findings. Methods: We conducted an iterative consensus process to develop a set of Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC), following the established Core Outcome Measures for Effectiveness Trials (COMET) methodology. First, we undertook a systematic review of RCTs in high-impact journals to describe current outcome reporting trends. We then surveyed patients, carers, researchers, and perioperative clinicians about important outcomes after surgery. Finally, a purposive stakeholder sample participated in a modified Delphi process to develop a core outcome set for perioperative and anaesthesia trials. Results: Our systematic review revealed widespread inconsistency in outcome reporting, with variable or absent definitions, levels of detail, and temporal criteria. In the survey, almost all patients, carers, and clinicians rated clinical outcome measures critically important, but clinicians rated patient-centred outcomes less highly than patients and carers. The final core outcome set was: (i) mortality/survival (postoperative mortality, long-term survival); (ii) perioperative complications (major postoperative complications/adverse events; complications/adverse events causing permanent harm); (iii) resource use (length of hospital stay, unplanned readmission within 30 days); (iv) short-term recovery (discharge destination, level of dependence, or both); and (v) longer-term recovery (overall health-related quality of life). Conclusions: This core set, incorporating important outcomes for both clinicians and patients, should guide outcome selection in future perioperative medicine or anaesthesia trials. Mapping these alongside standardised endpoint definitions will yield a comprehensive perioperative outcome framework.
KW - anaesthesia
KW - core outcome
KW - patient-centred outcome
KW - perioperative medicine
KW - standardised endpoints
KW - surgery
UR - http://www.scopus.com/inward/record.url?scp=85118545507&partnerID=8YFLogxK
U2 - 10.1016/j.bja.2021.09.027
DO - 10.1016/j.bja.2021.09.027
M3 - Article
C2 - 34740438
AN - SCOPUS:85118545507
SN - 0007-0912
VL - 128
SP - 174
EP - 185
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 1
ER -