Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol's evolution.

PURPOSE: This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations. METHODS: We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials. RESULTS: Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations. CONCLUSIONS: While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

Dissemination of healthy kids out of school principles for obesity prevention: A RE-AIM analysis.

Health-promoting behaviors for childhood obesity prevention are needed across multiple environments where children spend time, including out-of-school time (OST). Therefore Healthy Kids Out of School (HKOS) developed intervention strategies to promote three evidence-based principles (Drink Right, Move More, Snack Smart) for obesity prevention in OST. The strategies were developed with stakeholder input, disseminated, and evaluated (2012-2015) in two volunteer-led OST organizations, Boy Scouts of America (BSA) and 4-H, across three US states using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Mixed methods were used involving surveys, key informant interviews, and organizational-level data collection. Sixty out of 81 (74.1%) BSA districts and 4-H counties reaching 84,590 children (72% of children participating in BSA and 4-H in three states) adopted the strategies. 530 surveys completed by local OST leaders at baseline and 294 at follow-up showed the percentage of programs offering healthy beverages and opportunities for physical activity increased from baseline to follow-up (beverages 26% baseline, 35% follow-up, odds ratio (OR) 1.53; physical activity 31% baseline, 45% follow-up, OR 1.79; all p < 0.05). The increasing trend for healthy snacks was statistically non-significant (p = 0.09). Leaders interviewed reported the strategies were easy to implement, a good fit with their program, facilitated success, and they expected to maintain the changes. Integration of HKOS customized materials (BSA patch and 4-H pin) on BSA and 4-H national websites is a broader indicator of maintenance. Intervention strategies developed with stakeholder input and disseminated with training can effectively facilitate healthy environments for children, and have potential for national scale.

Snacks, beverages, and physical activity during volunteer-led out-of-school-time programs: a cross-sectional analysis.

BACKGROUND: Tens of millions of children regularly participate in out-of-school-time (OST) programs, providing an opportunity for child health promotion. Most research on OST has focused on structured, staff-led after-school programs, as opposed to volunteer-led programs such as enrichment programs and youth sports. The aim of this study was to describe snacks, beverages, and physical activity (PA) practices in volunteer-led OST programs across five organizations in three states. METHODS: An online survey including the Out-of-School-Time Snacks, Beverages, and Physical Activity Questionnaire was distributed to 1,695 adult leaders of enrichment and youth sports programs serving 5-12 year-old children in Maine, Massachusetts, and New Hampshire, USA. The response rate was 57.8%, with 980 leaders participating and 698 (136 youth sports, 562 enrichment) remaining after data cleaning procedures. Frequencies were calculated to describe snack, beverage, and PA offerings during typical meetings and whether healthy snack, beverage, and PA criteria were met. Criteria were developed a priori with the intent to capture co-occurring practices that together indicate healthy snack (fruits and vegetables or no snack over salty/sweet snacks); beverage (water over sugar-sweetened beverages); and PA environments (regular opportunities for >15 or 45 min of PA in enrichment and sports programs, respectively). RESULTS: About half of enrichment leaders reported that snacks and beverages were provided during typical meetings vs. one-fifth of sports leaders. In 28.4% of enrichment programs, PA was offered at every meeting vs. 98.5% of sports programs. Among enrichment programs, 50.4 and 25.8% met healthy snack and beverage criteria, respectively, and 29.4% met PA criteria, with 27.6% meeting criteria in two or more areas, and 5.0% in all three. Among sports programs, 72.8 and 78.7% met healthy snack and beverage criteria, respectively, and 71.3% met PA criteria. Eighty-two percent met criteria in two or more areas, and 46.3% met criteria in all three. CONCLUSIONS: Most programs did not meet criteria for healthier snacks and beverages and opportunities for PA during typical meetings, indicating room for improvement in encouraging widespread adoption of these practices. Efforts to improve the healthfulness of snacks and beverages and increase opportunities for PA during volunteer-led OST programs are warranted.

Engaging Stakeholders From Volunteer-Led Out-of-School Time Programs in the Dissemination of Guiding Principles for Healthy Snacking and Physical Activity.

BACKGROUND: Little effort has focused on the role of volunteer-led out-of-school time (OST) programs (ie, enrichment and sports programs) as key environments for the promotion of healthy eating and physical activity habits among school-aged children. The Healthy Kids Out of School (HKOS) initiative developed evidence-based, practical guiding principles for healthy snacks, beverages, and physical activity. The goal of this case study was to describe the methods used to engage regional partners to understand how successful implementation and dissemination of these principles could be accomplished. COMMUNITY CONTEXT: HKOS partnered with volunteer-led programs from 5 OST organizations in Maine, Massachusetts, and New Hampshire to create a regional "learning laboratory." METHODS: We engaged partners in phases. In the first phase, we conducted focus groups with local volunteer program leaders; during the second phase, we held roundtable meetings with regional and state program administrators; and in the final phase, we conducted additional outreach to refine and finalize implementation strategies. OUTCOMES: Implementation strategies were developed based on themes and information that emerged. For enrichment programs, strategies included new patch and pin programs that were consistent with the organizations' infrastructure and usual practices. For sports programs, the main strategy was integration with online trainings for coaches. INTERPRETATION: Through the engagement process, we learned that dissemination of the guiding principles in these large and complex OST organizations was best accomplished by using implementation strategies that were customized, integrated, and aligned with goals and usual practices. The lessons learned can benefit future efforts to prevent obesity in complex environments.

Engaging Patient Advisory Committees to Inform a Genomic Cancer Risk Study: Lessons for Future Efforts.

Introduction The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish speakers, to vet study processes and materials. Stakeholder engagement in research is relatively new, and we know little about how stakeholders view their engagement. We wanted to learn how patient stakeholders viewed the process, to inform future patient engagement efforts. Methods Patients at 2 study sites were invited to serve on 2 PACs. We used an iterative engagement process to solicit and incorporate patient feedback. Much of the PAC feedback on study materials and processes was incorporated. Using surveys and exit interviews, we evaluated stakeholders' experiences as PAC members. Results Nearly all PAC members felt satisfied and included in the study decisions, but surveys and exit interviews suggested the need to improve communications. Discussion Although most believed their feedback was used, and most felt included in study decisions, some said they did not know whether their opinions were used to modify materials or approaches. This suggests the need to explain to patient stakeholders the extent to which their feedback was used and to inform them about the impact that other stakeholders, such as institutional review boards, have on decisions. Conclusion Our evaluation highlights the value of dedicating resources to stakeholder engagement. Although gathering patient feedback on study materials and processes introduced time constraints and complexity to our study, adaptations to materials and processes furthered study goals.

"Mejorando Nuestras Oportunidades": Engaging Urban Youth in Environmental Health Assessment and Advocacy to Improve Health and Outdoor Play Spaces.

Youth can be valuable partners in community health improvement efforts. Latino youth from Lawrence, MA were engaged in research and health promotion over an 11-month period. Utilizing their knowledge of the community, youth assessed local parks and carried out evidence-based health promotion efforts to communicate community resources to encourage physical activity, nurture community ownership of parks, and advocate for park improvements. Health promotion efforts can engage youth in strategies to address critical public health issues by leveraging their unique perspective and distinct location within communities. The communications developed by the youth were distributed within the community, benefiting residents directly. Youth were motivated to engage in the project by a sense of civic obligation, and upon completing the project, they expressed that they had gained research and communication skills and were inspired to continue to support their community. Youth engagement in applied research and health promotion at the local level can provide a foundation for community health improvement efforts that are relevant for distinct communities, while fostering the positive development of youth, and nurturing community-driven efforts to help create a healthier environment.

Validation of the Out-of-School-Time Snacks, Beverages, and Physical Activity Questionnaire.

BACKGROUND: Recent research has highlighted the potential for out-of-school-time (OST) environments to impact children's energy balance. Expanding upon this evidence requires validated measures to assess nutrition and physical activity (PA) environments across large samples of OST programs. The aim of this study was to assess the criterion validity of the Out-of-School-Time Snacks, Beverages, and Physical Activity Questionnaire (OST-SBPA), an online questionnaire designed to measure OST nutrition and PA environments by program leaders' reports. METHODS: The study consisted of two samples of OST programs (total n=65). Objective data across program meetings were compared to program leaders' reports of usual snack, beverage, and PA offerings. All 65 programs provided snack and beverage data; PA data were available from 31 programs. Validity was assessed using percent agreement, Cohen's kappa, and Spearman's correlations. RESULTS: All OST-SBPA items demonstrated agreement above 60% when dichotomized (e.g., none/some versus most/all of the time for frequency items). Most OST-SBPA items were significantly correlated with objective data, including how often fresh and processed fruits and vegetables, salty snacks, sweet snacks, protein snacks, milk, juice, and sweetened beverages were offered and four PA measures (r=0.43-0.78; p<0.01), whereas one item, the frequency that water was offered, was not (r=0.13; p=0.37). The water item demonstrated validity once water from water fountains was recoded and not considered a program-provided beverage. CONCLUSIONS: These findings fill a gap in the literature through the validation of a brief questionnaire that can be used to assess OST nutrition and PA environments. The current results support the use of the OST-SBPA in studies aiming to assess and impact these environments.