Facilitators and barriers to pediatric clinical trial recruitment and retention in rural and community settings: A scoping review of the literature.

Children in rural settings are under-represented in clinical trials, potentially contributing to rural health disparities. We performed a scoping review describing available literature on barriers and facilitators impacting participation in pediatric clinical trials in rural and community-based (nonclinical) settings. Articles identified via PubMed, CINAHL, Embase, and Web of Science were independently double-screened at title/abstract and full-text levels to identify articles meeting eligibility criteria. Included articles reported on recruitment or retention activities for US-based pediatric clinical studies conducted in rural or community-based settings and were published in English through January 2021. Twenty-seven articles describing 31 studies met inclusion criteria. Most articles reported on at least one study conducted in an urban or suburban or unspecified community setting (n = 23 articles; 85%); fewer (n = 10; 37%) reported on studies that spanned urban and rural settings or were set in rural areas. More studies discussed recruitment facilitators (n = 25 studies; 81%) and barriers (n = 19; 61%) versus retention facilitators (n = 15; 48%) and barriers (n = 8; 26%). Descriptions of recruitment and retention barriers and facilitators were primarily experiential or subjective. Recruitment and retention facilitators were similar across settings and included contacts/reminders, community engagement, and relationship-building, consideration of participant logistics, and incentives. Inadequate staff and resources were commonly cited recruitment and retention barriers. Few studies have rigorously examined optimal ways to recruit and retain rural participants in pediatric clinical trials. To expand the evidence base, future studies examining recruitment and retention strategies should systematically assess and report rurality and objectively compare relative impact of different strategies.

The impact of provider recommendation on human papillomavirus vaccine and other adolescent vaccines.

This study explored the association between provider recommendation and adolescent vaccine coverage. We analyzed data from the 2008 to 2018 National Immunization Survey-Teen including coverage with one dose of quadrivalent meningococcal conjugate vaccine (MenACWY), Tetanus-diphtheria-acellular pertussis vaccine (Tdap), and one and three doses of Human papillomavirus (HPV) vaccine. We compared vaccine coverage between those who recalled a provider recommendation and those who did not. Among those who received a provider recommendation for MenACWY, coverage trended from 67.8% (2008) to 88.1% (2013), contrasted to those who did not, trending from 30.9% to 73.1%. Among those with a provider recommendation for Tdap, coverage trended from 47.6% to 89.7%, contrasted to those who did not, trending from 35.6% to 82.2%. Among females with a provider recommendation for HPV vaccine, receipt of initial dose of HPV vaccine trended from 57.5% (2008) to 74.3% (2018), contrasted to those who did not, trending from 18.1% to 49.8%, and among males, trended from 17.2% (2010) to 75.1% (2018) for those with a provider recommendation, compared to 0.5% to 44.7% for those without. In 2013, coverage difference by provider recommendation was 26.0% among females for one dose of HPV vaccine and 21.9% for three doses, and among males was 44.8% and 20.8%, respectively, while it was lower at 15% for MenACWY and 7.6% for Tdap. For each vaccine, coverage was higher with a provider recommendation; the largest difference was noted for HPV vaccine. This finding verifies for providers the importance of their recommendation, especially for the HPV vaccine.

Direct-to-adolescent text messaging for vaccine reminders: What will parents permit?

BACKGROUND: Direct-to-adolescent text messaging may be a consideration for vaccine reminders, including human papilloma virus (HPV), but no studies have explored the minimum age at which parents would allow adolescents to receive a text message. METHODS: We distributed a survey to parents of 10-17 year olds during any office visit in two practice based research networks in South Carolina and Oklahoma. We asked about parental preference for receiving vaccine reminders for their adolescent, whether they would allow the healthcare provider to directly message their adolescent, and if so, what would be the acceptable minimum age. RESULTS: In 546 surveys from 11 practices, parents of females were more supportive of direct-to-teen text message reminders than were parents of males, (75% v. 60%, p < .001). The median age at which parents would allow direct text messages from physicians' offices was 14 in females compared to 15 in males, p = .049. We found a correlation between the child's age and the youngest age at which parents would allow a direct text message. Of the parents who permitted a text message directly to their adolescent, most reported an allowable age higher than their adolescent's current age until the age of 15. CONCLUSION: Our study suggests that direct-to-adolescent text messaging would be allowed by parents for older adolescents. This supports an intervention aimed at older adolescents, such as for receipt of MCV4 dose #2, delayed HPV vaccine series completion and annual influenza vaccination.

Adapting practice-based intervention research to electronic environments: opportunities and complexities at two institutions.

BACKGROUND AND PURPOSE: Primary care practice-based research has become more complex with increased use of electronic health records (EHRs). Little has been reported about changes in study planning and execution that are required as practices change from paper-based to electronic-based environments. We describe the evolution of a pediatric practice-based intervention study as it was adapted for use in the electronic environment, to enable other practice-based researchers to plan efficient, effective studies. METHODS: We adapted a paper-based pediatric office-level intervention to enhance parent-provider communication about subspecialty referrals for use in two practice-based research networks (PBRNs) with partially and fully electronic environments. We documented the process of adaptation and its effect on study feasibility and efficiency, resource use, and administrative and regulatory complexities, as the study was implemented in the two networks. RESULTS: Considerable time and money was required to adapt the paper-based study to the electronic environment, requiring extra meetings with institutional EHR-, regulatory-, and administrative teams, and increased practice training. Institutional unfamiliarity with using EHRs in practice-based research, and the consequent need to develop new policies, were major contributors to delays. Adapting intervention tools to the EHR and minimizing practice disruptions was challenging, but resulted in several efficiencies as compared with a paper-based project. In particular, recruitment and tracking of subjects and data collection were easier and more efficient. CONCLUSIONS: Practice-based intervention research in an electronic environment adds considerable cost and time at the outset of a study, especially for centers unfamiliar with such research. Efficiencies generated have the potential of easing the work of study enrollment, subject tracking, and data collection.