Strategies for enhancing the representation of women in clinical trials: an evidence map
Abstract Background Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutra...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Systematic Reviews |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13643-023-02408-w |
| _version_ | 1797363599226699776 |
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| author | Karen M. Goldstein Lindsay Chi Yan Kung Susan Alton Dailey Aimee Kroll-Desrosiers Colleen Burke Megan Shepherd-Banigan Rebecca Lumsden Catherine Sims Julie Schexnayder Dhara Patel Sarah Cantrell Kate L. Sheahan Jennifer M. Gierisch |
| author_facet | Karen M. Goldstein Lindsay Chi Yan Kung Susan Alton Dailey Aimee Kroll-Desrosiers Colleen Burke Megan Shepherd-Banigan Rebecca Lumsden Catherine Sims Julie Schexnayder Dhara Patel Sarah Cantrell Kate L. Sheahan Jennifer M. Gierisch |
| author_sort | Karen M. Goldstein |
| collection | DOAJ |
| description | Abstract Background Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials. Methods We used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials. Results We identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as “women” or “female”. The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases. Conclusions Most of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation. |
| first_indexed | 2024-03-08T16:23:29Z |
| format | Article |
| id | doaj.art-8a7ccc4375ba4857b56e92f8b05fa5e6 |
| institution | Directory Open Access Journal |
| issn | 2046-4053 |
| language | English |
| last_indexed | 2024-03-08T16:23:29Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Systematic Reviews |
| spelling | doaj.art-8a7ccc4375ba4857b56e92f8b05fa5e62024-01-07T12:13:46ZengBMCSystematic Reviews2046-40532024-01-0113111210.1186/s13643-023-02408-wStrategies for enhancing the representation of women in clinical trials: an evidence mapKaren M. Goldstein0Lindsay Chi Yan Kung1Susan Alton Dailey2Aimee Kroll-Desrosiers3Colleen Burke4Megan Shepherd-Banigan5Rebecca Lumsden6Catherine Sims7Julie Schexnayder8Dhara Patel9Sarah Cantrell10Kate L. Sheahan11Jennifer M. Gierisch12Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemHealth Management & Policy, Graduate School of Public Health, San Diego State UniversityCenter of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemVA Central Western Massachusetts Healthcare SystemDepartment of Population Health Sciences, Duke University School of MedicineCenter of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemDivision of General Internal Medicine, Duke University School of MedicineCenter of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemUniversity of Alabama at Birmingham School of NursingCenter of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemDuke University Medical Center Library & Archives, Duke University School of Medicine 10 Searle DriveJSICenter of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Health Care SystemAbstract Background Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials. Methods We used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials. Results We identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as “women” or “female”. The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases. Conclusions Most of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation.https://doi.org/10.1186/s13643-023-02408-wWomenClinical trialsRepresentationParticipation |
| spellingShingle | Karen M. Goldstein Lindsay Chi Yan Kung Susan Alton Dailey Aimee Kroll-Desrosiers Colleen Burke Megan Shepherd-Banigan Rebecca Lumsden Catherine Sims Julie Schexnayder Dhara Patel Sarah Cantrell Kate L. Sheahan Jennifer M. Gierisch Strategies for enhancing the representation of women in clinical trials: an evidence map Systematic Reviews Women Clinical trials Representation Participation |
| title | Strategies for enhancing the representation of women in clinical trials: an evidence map |
| title_full | Strategies for enhancing the representation of women in clinical trials: an evidence map |
| title_fullStr | Strategies for enhancing the representation of women in clinical trials: an evidence map |
| title_full_unstemmed | Strategies for enhancing the representation of women in clinical trials: an evidence map |
| title_short | Strategies for enhancing the representation of women in clinical trials: an evidence map |
| title_sort | strategies for enhancing the representation of women in clinical trials an evidence map |
| topic | Women Clinical trials Representation Participation |
| url | https://doi.org/10.1186/s13643-023-02408-w |
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