Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke

Cheryl Carcel; Mark Woodward; Grace Balicki; Georgia Louise Koroneos; Diana Aguiar de Sousa; Charlotte Cordonnier; Caroline Lukaszyk; Kelly Thompson; Xia Wang; Leo Davies; Meenakshi Bassi; Craig S Anderson; Sanne Ae Peters; Else Charlotte Sandset

doi:10.1177/1747493019851292

Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke

Cheryl Carcel^*, Mark Woodward, Grace Balicki, Georgia Louise Koroneos, Diana Aguiar de Sousa, Charlotte Cordonnier, Caroline Lukaszyk, Kelly Thompson, Xia Wang, Leo Davies, Meenakshi Bassi, Craig S Anderson, Sanne Ae Peters, Else Charlotte Sandset

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all.

AIM: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials.

METHODS: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords "stroke" and "cerebrovascular accidents." Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus).

RESULTS: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008-2009 and 2012-2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%).

CONCLUSION: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.

Original language	English
Pages (from-to)	931-938
Number of pages	8
Journal	International Journal of Stroke
Volume	14
Issue number	9
DOIs	https://doi.org/10.1177/1747493019851292
Publication status	Published - Dec 2019

Keywords

Asia
Australia
Europe
Female
Humans
Male
North America
Patient Selection
Randomized Controlled Trials as Topic
Sex Factors
Stroke
Women

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Carcel, C., Woodward, M., Balicki, G., Koroneos, G. L., Sousa, D. A. D., Cordonnier, C., Lukaszyk, C., Thompson, K., Wang, X., Davies, L., Bassi, M., Anderson, C. S., Peters, S. A., & Sandset, E. C. (2019). Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke. International Journal of Stroke, 14(9), 931-938. https://doi.org/10.1177/1747493019851292

@article{945790469b994cf9be62ba47d288de61,

title = "Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke",

abstract = "BACKGROUND: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all.AIM: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials.METHODS: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords {"}stroke{"} and {"}cerebrovascular accidents.{"} Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus).RESULTS: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008-2009 and 2012-2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%).CONCLUSION: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.",

keywords = "Asia, Australia, Europe, Female, Humans, Male, North America, Patient Selection, Randomized Controlled Trials as Topic, Sex Factors, Stroke, Women",

author = "Cheryl Carcel and Mark Woodward and Grace Balicki and Koroneos, {Georgia Louise} and Sousa, {Diana Aguiar de} and Charlotte Cordonnier and Caroline Lukaszyk and Kelly Thompson and Xia Wang and Leo Davies and Meenakshi Bassi and Anderson, {Craig S} and Peters, {Sanne Ae} and Sandset, {Else Charlotte}",

note = "Publisher Copyright: {\textcopyright} 2019 World Stroke Organization.",

year = "2019",

month = dec,

doi = "10.1177/1747493019851292",

language = "English",

volume = "14",

pages = "931--938",

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Carcel, C, Woodward, M, Balicki, G, Koroneos, GL, Sousa, DAD, Cordonnier, C, Lukaszyk, C, Thompson, K, Wang, X, Davies, L, Bassi, M, Anderson, CS, Peters, SA & Sandset, EC 2019, 'Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke', International Journal of Stroke, vol. 14, no. 9, pp. 931-938. https://doi.org/10.1177/1747493019851292

TY - JOUR

T1 - Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke

AU - Carcel, Cheryl

AU - Woodward, Mark

AU - Balicki, Grace

AU - Koroneos, Georgia Louise

AU - Sousa, Diana Aguiar de

AU - Cordonnier, Charlotte

AU - Lukaszyk, Caroline

AU - Thompson, Kelly

AU - Wang, Xia

AU - Davies, Leo

AU - Bassi, Meenakshi

AU - Anderson, Craig S

AU - Peters, Sanne Ae

AU - Sandset, Else Charlotte

PY - 2019/12

Y1 - 2019/12

N2 - BACKGROUND: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all.AIM: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials.METHODS: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords "stroke" and "cerebrovascular accidents." Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus).RESULTS: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008-2009 and 2012-2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%).CONCLUSION: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.

AB - BACKGROUND: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all.AIM: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials.METHODS: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords "stroke" and "cerebrovascular accidents." Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus).RESULTS: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008-2009 and 2012-2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%).CONCLUSION: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.

KW - Asia

KW - Australia

KW - Europe

KW - Female

KW - Humans

KW - Male

KW - North America

KW - Patient Selection

KW - Randomized Controlled Trials as Topic

KW - Sex Factors

KW - Stroke

KW - Women

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U2 - 10.1177/1747493019851292

DO - 10.1177/1747493019851292

M3 - Article

C2 - 31132968

SN - 1747-4930

VL - 14

SP - 931

EP - 938

JO - International Journal of Stroke

JF - International Journal of Stroke

IS - 9

ER -

Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke

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