Osteoporosis screening and risk management

Osteoporosis is common among older adults and results in costly osteoporotic fractures. Screening for this metabolic bone disorder is warranted in most older adults and clinicians must be diligent in identifying persons at risk. The evaluation should include an assessment of risk factors for falls, a bone density test, and consideration of possible secondary causes of osteoporosis. Several medications are available to improve bone density and decrease fractures. Adequate calcium and vitamin D intake (and treatment of vitamin D deficiency) are paramount in the management of osteoporosis

Late life depression with cognitive impairment: Evaluation and treatment

Older adults with depression often present with signs and symptoms indicative of functional or cognitive impairment. These somatic symptoms make evaluating and treating depression in older adults more complex. Late life depression (LLD), depression in adults over the age of 65, is more frequently associated with cognitive changes. Cognitive impairment in LLD may be a result of the depressive disorder or an underlying dementing condition. Memory complaints are also common in older adults with depression. There is a wide range of cognitive impairment in LLD including decreased central processing speed, executive dysfunction, and impaired short-term memory. The etiology of cognitive impairment in LLD may include cerebrovascular disease, a significant risk factor for LLD, which likely interrupts key pathways between frontal white matter and subcortical structures important in mood regulation. Because depressive symptoms often coexist with dementia, it is important to determine the temporal relationship between depressive symptoms and cognitive change. If depressive symptoms pre-date the cognitive impairment and cognitive symptoms are mild and temporary, LLD is the likely etiology of the cognitive impairment. If cognitive changes appear prior to depressive symptoms and persist after LLD is successfully treated, an underlying dementia is more likely. Clinicians should be exclude common conditions such as thyroid disease which can contribute to depressive symptoms and cognitive impairment prior to treating LLD. Both antidepressants and psychotherapy can be effective in treating LLD. Subsequent evaluations following treatment should also reassess cognition

2491: Parental concerns about child participation in s reflect a need to move beyond traditional notions of trust and race

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to identify factors influencing parental willingness of adolescent participation in clinical trials. METHODS/STUDY POPULATION: We applied community engaged research principles to conduct a theory-based, cross-sectional study of parental willingness. Parents (N=307) were given a survey from November 2014 to April 2015. Factors influencing parental willingness were identified using binary logistic regression. SPSS version 22.0 was used to perform analyses, and

The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial

Introduction: Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a video educational program on clinical trial knowledge and enrollment in a sample of oncology outpatients.Methods: A randomized controlled trial was conducted with 63 oncology patients without previous history of clinical trial participation. Participants were randomly assigned to the intervention, to watch a clinical trial educational video in the office, or to the control group which did not receive in-office education. The Clinical Trial Knowledge survey was administered before the intervention and 1 week after the intervention. Participation in clinical trials was assessed 1-year post study participation. Results for white participants and ethnic minorities were compared. Ethnicity was self-reported through the electronic health record and confirmed by self-reporting on questionnaire.Results: Sixty-three participants were recruited in this study. At 1-year follow-up, 3 participants enrolled in clinical trials in the study group which had received office-based video intervention and 2 participants enrolled in the control group (Z = 0.39, p = 0.69). These results were not statistically significant. Impact of the intervention by ethnicity could not be assessed due to low total clinical trial enrollment. The video intervention did not change knowledge, attitudes, or barriers as measured by the Clinical Trial Knowledge Survey. Minority participants did report significantly more negative beliefs and barriers to participation than white participants.Conclusions: Increasing awareness and knowledge about clinical trials in underrepresented communities is an important step to providing opportunities for participation. Future studies should focus on how to address the negative expectations of clinical trials and the greater information needs in minority populations. Tailored or personalized messaging may address negative perceptions of clinical trial participation

Formative Research to Design a Culturally-appropriate Cancer Clinical Trial Education Program to Increase Participation of African American and Latino Communities

Background: Addressing knowledge deficiencies about cancer clinical trials and biospecimen donation can potentially improve participation among racial and ethnic minorities. This paper describes the formative research process used to design a culturally-appropriate cancer clinical trials education program for African American and Latino communities. We characterized community member feedback and its integration into the program. Methods: We incorporated three engagement approaches into the formative research process to iteratively develop the program: including community-based organization (CBO) leaders as research team members, conducting focus groups and cognitive interviews with community members as reviewers/consultants, and interacting with two community advisory groups. An iterative-deductive approach was used to analyze focus group data. Qualitative data from advisory groups and community members were compiled and used to finalize the program. Results: Focus group themes were: 1) Community Perspectives on Overall Presentation; 2) Community Opinions and Questions on the Content of the Presentation; 3) Culturally Specific Issues to Participation in Cancer Clinical Trials; 4) Barriers to Clinical Trial Participation; and 5) Perspectives of Community Health Educators. Feedback was documented during reviews by scientific experts and community members with suggestions to ensure cultural appropriateness using peripheral, evidential, linguistic, sociocultural strategies, and constituent-involving. The final program consisted of two versions (English and Spanish) of a culturally-appropriate slide presentation with speaker notes and videos representing community member and researcher testimonials. Conclusions: Incorporating multiple community engagement approaches into formative research processes can facilitate the inclusion of multiple community perspectives and enhance the cultural-appropriateness of the programs designed to promote cancer clinical trial participation among African Americans and Latinos

Adapting a conceptual framework to engage diverse stakeholders in genomic/precision medicine research

Introduction: Genomic/precision medicine offers a remarkable opportunity to improve health and address health disparities. Genomic medicine is the study of genes and their interaction with health. Precision medicine is an approach to disease prevention and treatment that considers individual variability in genes, environ- ment and lifestyle. Conclusions from studies lacking diversity may hinder general- izability as genomic variation occurs within and between populations. Historical factors, such as medical mistrust, ethical issues related to decision making, and data sharing pose complex challenges that may further widen inequities in genomic/ precision medicine if not appropriately addressed. Although few biomedical studies integrate priorities of community partners into their conceptual framework, effective implementation of genomic/precision medicine research calls for the involvement of diverse stakeholders to expand traditional unidirectional models of engagement in clinical research towards authentic bidirectional collaboration. Methods: A multipronged approach was used integrating an evidence-based literature review and best practices in developing and evaluating the engagement of diverse stakeholders in genomic and precision medicine research. This was combined with expert consensus building to adapt a conceptual model from a community engagement framework to addressing genomics to be scalable to engagement science, which is challenging to genomic/precision medicine research. Results: The final enhanced conceptual framework is composed of four overarching dimensions now inclusive of domains in trust, exploitation, discrimination, privacy risk, stigmatization, prior harms/injustices, failure to recognize coexisting governments, intersectionality and research transformation. This conceptual framework proposes effective participant research engagement strategies for upstream relationship building, distinct from downstream recruitment strategies in which the goal is enrolment. Conclusion: To further shape the evolution of genomic/precision medicine research, it is important to leverage existing partnerships, engage participants beyond recruitment and embrace diverse perspectives. Patient or Public Contribution: In preparation of this manuscript, the perspectives of the community partners on the impact of engaging in genomic/precision medicine research beyond research participation were integrated into this conceptual framework from various guided listening sessions held in diverse communitie

The RIC Recruitment & Retention Materials Toolkit – a resource for developing community-informed study materials

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study’s recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology