학술논문
Inclusion, characteristics, and outcomes of male and female participants in large international perioperative studies.
Document Type
Academic Journal
Author
Leslie K; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia; Department of Anaesthesiology and Perioperative Medicine, Central Clinical School, Monash University, Melbourne, VIC, Australia; Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, VIC, Australia. Electronic address: kate.leslie@mh.org.au.; Martin C; School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.; Myles PS; Department of Anaesthesiology and Perioperative Medicine, Central Clinical School, Monash University, Melbourne, VIC, Australia; Department of Anaesthesiology and Perioperative Medicine, Alfred Health, Melbourne, VIC, Australia.; Devereaux PJ; Division of Perioperative Care, McMaster University, Hamilton, ON, Canada; Anesthesiology, Perioperative Medicine, and Surgical Research Group, Population Health Research Institute, Hamilton, ON, Canada.; Peyton PJ; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia; Department of Anaesthesia, Austin Health, Heidelberg, VIC, Australia.; Story DA; Department of Critical Care, University of Melbourne, Melbourne, VIC, Australia; Department of Anaesthesia, Austin Health, Heidelberg, VIC, Australia.; Wijeysundera DN; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Department of Anesthesia, St Michael's Hospital, Toronto, ON, Canada.; Cuthbertson BH; Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, ON, Canada; Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, ON, Canada.; Short TG; Department of Anaesthesiology, Auckland University, Auckland, New Zealand; Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand.; Corcoran TB; School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; School of Medicine and Pharmacology, University of Western Australia, Perth, WA, Australia; Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, Perth, WA, Australia.; Kasza J; School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 0372541 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-6771 (Electronic) Linking ISSN: 00070912 NLM ISO Abbreviation: Br J Anaesth Subsets: MEDLINE
Subject
Language
English
Abstract
Background: We compared baseline characteristics and outcomes and evaluated the subgroup effects of randomised interventions by sex in males and females in large international perioperative trials.
Methods: Nine randomised trials and two cohort studies recruiting adult patients, conducted between 1995 and 2020, were included. Baseline characteristics and outcomes common to six or more studies were evaluated. Regression models included terms for sex, study, and an interaction between the two. Comparing outcomes without adjustment for baseline characteristics represents the 'total effect' of sex on the outcome.
Results: Of 54 626 participants, 58% were male and 42% were female. Females were less likely to have ASA physical status ≥3 (56% vs 64%), to smoke (15% vs 23%), have coronary artery disease (21% vs 32%), or undergo vascular surgery (10% vs 23%). The pooled incidence of death was 1.6% in females and 1.8% in males (risk ratio [RR] 0.92; 95% confidence interval [CI]: 0.81-1.05; P=0.20), of myocardial infarction was 4.2% vs 4.5% (RR 0.92; 95% CI: 0.81-1.03; P=0.10), of stroke was 0.5% vs 0.6% (RR 1.03; 95% CI: 0.79-1.35; P=0.81), and of surgical site infection was 8.6% vs 8.3% (RR 1.03; 95% CI: 0.79-1.35; P=0.70). Treatment effects of three interventions demonstrated statistically significant effect modification by sex.
Conclusions: Females were in the minority in all included studies. They were healthier than males, but outcomes were comparable. Further research is needed to understand the reasons for this discrepancy.
Clinical Trial Registration: International Registry of Meta-Research (UID: IRMR_000011; 5 January 2021).
(Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)
Methods: Nine randomised trials and two cohort studies recruiting adult patients, conducted between 1995 and 2020, were included. Baseline characteristics and outcomes common to six or more studies were evaluated. Regression models included terms for sex, study, and an interaction between the two. Comparing outcomes without adjustment for baseline characteristics represents the 'total effect' of sex on the outcome.
Results: Of 54 626 participants, 58% were male and 42% were female. Females were less likely to have ASA physical status ≥3 (56% vs 64%), to smoke (15% vs 23%), have coronary artery disease (21% vs 32%), or undergo vascular surgery (10% vs 23%). The pooled incidence of death was 1.6% in females and 1.8% in males (risk ratio [RR] 0.92; 95% confidence interval [CI]: 0.81-1.05; P=0.20), of myocardial infarction was 4.2% vs 4.5% (RR 0.92; 95% CI: 0.81-1.03; P=0.10), of stroke was 0.5% vs 0.6% (RR 1.03; 95% CI: 0.79-1.35; P=0.81), and of surgical site infection was 8.6% vs 8.3% (RR 1.03; 95% CI: 0.79-1.35; P=0.70). Treatment effects of three interventions demonstrated statistically significant effect modification by sex.
Conclusions: Females were in the minority in all included studies. They were healthier than males, but outcomes were comparable. Further research is needed to understand the reasons for this discrepancy.
Clinical Trial Registration: International Registry of Meta-Research (UID: IRMR_000011; 5 January 2021).
(Copyright © 2022 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)