Reporting and analyses of sex/gender and race/ethnicity in randomized controlled trials of interventions published in the highest-ranking anesthesiology journals
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: We assessed reporting of data on sex/gender and race/ethnicity in randomized controlled trials of interventions published in the highest-ranking anesthesiology journals from 2014 to 2017. Methods: We extracted data regarding terminology for sex/gender, proportion of participants according to the race/gender and race/ethnicity, and results shown for the race/gender and race/ethnicity. Results: Among the analyzed 732 trials, few stratified allocation of participants on the basis of sex/gender and race/ethnicity, few reported results for sex/gender or race/ethnicity and the outcomes reported may be influenced by one or both. Conclusion: In conclusion, outcomes of anesthesiology trials could be vulnerable to an important and avoidable source of bias; trialists need to pay more attention to sex and race/ethnicity when designing and reporting their studies.
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References
Papers of special note have been highlighted as: • of interest
1.
Geller SE, Koch A, Pellettieri B, Carnes M. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress? J. Womens Health (Larchmt) 20(3), 315–320 (2011).
• Important baseline data from an older period compared with the current study.
2.
Avery E, Clark J. Sex-related reporting in randomised controlled trials in medical journals. Lancet 388(10062), 2839–2840 (2016).
• Important baseline data from an older period compared with the current study.
3.
Racine M, Tousignant-Laflamme Y, Kloda LA, Dion D, Dupuis G, Choiniere M. A systematic literature review of 10 years of research on sex/gender and pain perception – part 2: do biopsychosocial factors alter pain sensitivity differently in women and men? Pain 153(3), 619–635 (2012).
4.
Racine M, Tousignant-Laflamme Y, Kloda LA, Dion D, Dupuis G, Choiniere M. A systematic literature review of 10 years of research on sex/gender and experimental pain perception – part 1: are there really differences between women and men? Pain 153(3), 602–618 (2012).
5.
Boerner KE, Eccleston C, Chambers CT, Keogh E. Sex differences in the efficacy of psychological therapies for the management of chronic and recurrent pain in children and adolescents: a systematic review and meta-analysis. Pain 258(4), 569–582 (2016).
6.
Duan-Porter W, Goldstein KM, Mcduffie JR et al. Reporting of sex effects by systematic reviews on interventions for depression, diabetes, and chronic pain. Ann. Intern. Med. 165(3), 184–193 (2016).
7.
Martinez KA, Snyder CF, Malin JL, Dy SM. Is race/ethnicity related to the presence or severity of pain in colorectal and lung cancer? J. Pain Symptom Manage. 48(6), 1050–1059 (2014).
• Exploration of the impact of race/ethnicity on outcomes.
8.
Aseltine RH Jr, Yan J, Gruss CB, Wagner C, Katz M. Connecticut hospital readmissions related to chest pain and heart failure: differences by race, ethnicity, and payer. Conn. Med. 79(2), 69–76 (2015).
9.
Maher A, Leigh W, Brick M et al. Gender, ethnicity and smoking affect pain and function in patients with rotator cuff tears. ANZ J. Surg. 87(9), 704–708 (2017).
10.
Biocic M, Fidahic M, Puljak L. Reproducibility of search strategies of non-Cochrane systematic reviews published in anaesthesiology journals is suboptimal: primary methodological study. Brit. J. Anaesth. 122(6), e79–e81 (2019).
11.
Dosenovic S, Nikolic Z, Ivancev B, Kadic AJ, Puljak L. Awareness and acceptability of initiative on methods, measurement, and pain assessment in clinical trials core outcome set for chronic pain among surveyed neuropathic pain authors. J. Comp. Eff. Res. 8(9), 671–683 (2019).
12.
Boric K, Boric M, Dosenovic S et al. Authors' lack of awareness and use of core outcome set on postoperative pain in children is hindering comparative effectiveness research. J. Comp. Eff. Res. 7(5), 463–470 (2018).
13.
Puljak L, Dosenovic S, Boric K. Importance of consistent outcomes in randomized controlled trials and systematic reviews about anesthesiology and pain. Pain Manag. 8(4), 251–253 (2018).
14.
Leslie K, Edgley C, Lee AC, Sellar A, Sgroi J, Toh R. Reporting of sex and gender in human studies published in anaesthesia journals. Br. J. Anaesth. 120(5), 1128–1130 (2018).
15.
Prakash VS, Mansukhani NA, Helenowski IB, Woodruff TK, Kibbe MR. Sex bias in interventional clinical trials. J. Womens Health (Larchmt) 27(11), 1342–1348 (2018).
16.
Welch V, Doull M, Yoganathan M et al. Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study. Res. Integr. Peer Rev. 2, 15 (2017).
17.
Winter S, Diamond M, Green J et al. Transgender people: health at the margins of society. Lancet 388(10042), 390–400 (2016).
18.
Pariera KL, Murphy ST, Meng J, Mclaughlin ML. Exploring willingness to participate in clinical trials by ethnicity. J. Racial Ethn. Health Disparities 4(4), 763–769 (2017).
Information & Authors
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Published In
Pages: 1417 - 1423
PubMed: 31789050
Copyright
© 2019 Future Medicine Ltd.
History
Received: 8 June 2019
Accepted: 25 September 2019
Published online: 2 December 2019
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Reporting and analyses of sex/gender and race/ethnicity in randomized controlled trials of interventions published in the highest-ranking anesthesiology journals. (2019) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2019-0071
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