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.

Recommending COVID-19 vaccination for adolescents in primary care.

BACKGROUND: COVID-19 vaccines are available for adolescents in the United States, but many parents are hesitant to have their children vaccinated. The advice of primary care professionals strongly influences vaccine uptake. OBJECTIVE: We examined the willingness of primary care professionals (PCPs) to recommend COVID-19 vaccination for adolescents. METHODS: Participants were a national sample of 1,047 US adolescent primary care professionals. They participated in an online survey in early 2021, after a COVID-19 vaccine had been approved for adults but before approval for adolescents. Respondents included physicians (71%), advanced practice providers (17%), and nurses (12%). We identified correlates of willingness to recommend COVID-19 vaccination for adolescents using logistic regression. RESULTS: The majority (89%) of respondents were willing to recommend COVID-19 vaccination for adolescents, with advanced practice providers and nurses being less likely than paediatricians to recommend vaccination (84% vs. 94%, aOR 0.47, 95% CI 0.23-0.92). Respondents who had received at least one dose of a COVID-19 vaccine were more likely to recommend adolescent vaccination (92% vs. 69%, aOR 4.20, 95% CI 2.56-6.87) as were those with more years in practice (94% vs. 88%, aOR 2.93, 95% CI 1.79-4.99). Most respondents (96%) said they would need some measure of support in order to provide COVID-19 vaccination to adolescents, with vaccine safety and efficacy information being the most commonly cited need (80%). CONCLUSION: Adolescent primary care professionals were generally willing to recommend COVID-19 vaccination. However, most indicated a need for additional resources to be able to administer COVID-19 vaccines at their clinic.

Explaining higher Covid-19 vaccination among some US primary care professionals.

BACKGROUND AND OBJECTIVE: Research in several countries shows higher Covid-19 vaccination willingness and uptake among physicians than nurses. Our paper aims to characterize and explain this difference. METHODS: In early 2021, we surveyed 1047 U.S. primary care professionals who served adolescents, ages 11-17. The national sample included physicians (71%) as well as nurses and advanced practice providers. The survey assessed the three domains of the Increasing Vaccination Model: thinking and feeling, social processes, and direct behavior change. RESULTS: Covid-19 vaccine uptake was higher among physicians than among nurses and advanced practice providers (91% vs. 76%, p < .05). Overall, in the thinking and feeling domain, higher confidence in Covid-19 vaccination, higher perceived susceptibility to the disease, and stronger anticipated regret were associated with higher vaccine uptake (all p < .05). In the social processes domain, perceiving more positive social norms for Covid-19 vaccination, receiving recommendations to get the vaccine, and wanting to help others were associated with higher vaccine uptake (all p < .05). In the direct behavior change domain, receiving an invitation to get the vaccine and better access to vaccination were associated with higher uptake (both p < .05). Of these variables, most of the thinking and feeling and social processes variables mediated the association of training with vaccine uptake. CONCLUSIONS: Physicians had higher Covid-19 vaccine uptake than nurses and advanced practice providers, corresponding with their more supportive vaccine beliefs and social experiences. Efforts to reach the remaining unvaccinated cohort can build on these findings.

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.