Strategies for enhancing the representation of women in clinical trials: an evidence map.

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.

Easing Human Papillomavirus Vaccine Hesitancy: A Communication Experiment With U.S. Parents.

INTRODUCTION: The Announcement Approach using presumptive announcements increases human papillomavirus vaccine uptake. This study seeks to understand the impact of the final Announcement Approach steps-easing parents' vaccine concerns and then encouraging them to get human papillomavirus vaccine for their children-on parents' human papillomavirus vaccine hesitancy and confidence in the vaccine's benefits. METHODS: In 2017-2018, investigators recruited an online national sample of 1,196 U.S. parents of children aged 9-17 years who had not yet completed the human papillomavirus vaccine series. Following the steps of the Announcement Approach, participants viewed brief videos of a pediatrician announcing that a child was due for human papillomavirus vaccine (shown to all the parents). In the 2 × 2 experiment, parents saw (1) a video of the pediatrician attempting to ease a concern that the parent had raised earlier in the survey (Ease video), (2) a video of the pediatrician encouraging the parent to get their child vaccinated (Encourage video), (3) both videos, or (4) neither of the videos. Data analysis was conducted in spring 2020. RESULTS: Seeing the Ease video message led to lower human papillomavirus vaccine hesitancy than not seeing it (mean=2.71, SD=1.29 vs mean=2.97, SD=1.33; p<0.001). The beneficial impact of easing concerns on lower vaccine hesitancy was explained by higher confidence (p<0.05). By contrast, the Encourage video had no impact on human papillomavirus vaccine hesitancy or confidence. CONCLUSIONS: Addressing parents' concerns can decrease human papillomavirus vaccine hesitancy and increase confidence. On the basis of these findings, the Announcement Approach retained its emphasis on announcing that children are due for vaccination and easing parent concerns.

Misinformation and other elements in HPV vaccine tweets: an experimental comparison.

Our study examined how misinformation and other elements of social media messages affect antecedents to human papillomavirus (HPV) vaccination of adolescents. In 2017-2018, we randomly assigned a national sample of 1206 U.S. parents of adolescents to view one tweet using a 2 × 2 × 2 × 2 between-subjects factorial experiment. The 16 experimental tweets varied four messaging elements: misinformation (misinformation or not), source (person or organization), narrative style (storytelling or scientific data), and topic (effectiveness or safety). Parents reported their motivation to vaccinate (primary outcome), trust in social media content, and perceived risk about HPV-related diseases. Tweets without misinformation elicited higher HPV vaccine motivation than tweets with misinformation (25% vs. 5%, OR = 6.60, 95% CI:4.05, 10.75). Motivation was higher for tweets from organizations versus persons (20% vs. 10%, OR = 2.47, 95% CI:1.52, 4.03) and about effectiveness versus safety (20% vs. 10%, OR = 2.03, 95% CI:1.24, 3.30). Tweets with misinformation produced lower trust and higher perceived risk (both p < .01), with impact varying depending on source and topic. In conclusion, misinformation was the most potent social media messaging element. It may undermine progress in HPV vaccination.