Advancing Alzheimer's disease diagnosis, treatment, and care: recommendations from the Ware Invitational Summit.

To address the pending public health crisis due to Alzheimer's disease (AD) and related neurodegenerative disorders, the Marian S. Ware Alzheimer Program at the University of Pennsylvania held a meeting entitled "State of the Science Conference on the Advancement of Alzheimer's Diagnosis, Treatment and Care," on June 21-22, 2012. The meeting comprised four workgroups focusing on Biomarkers; Clinical Care and Health Services Research; Drug Development; and Health Economics, Policy, and Ethics. The workgroups shared, discussed, and compiled an integrated set of priorities, recommendations, and action plans, which are presented in this article.

Community engagement and the resource centers for minority aging research.

The National Institute on Aging created the Resource Centers for Minority Aging Research (RCMARs) to address infrastructure development intended to reduce health disparities among older adults. The overall goals of the RCMARs are to (a) increase the size of the cadre of researchers conducting research on issues related to minority aging; (b) increase the diversity of researchers conducting research on minority aging; (c) create and test reliable measures for use in older diverse populations; and (d) conduct research on recruitment and retention of community-dwelling older adults for research addressing behavioral, social, and medical issues. Along with this latter goal, the RCMARs developed and maintain academic-community partnerships. To accomplish the recruitment and retention goal, the RCMARs established Community Liaison Working Groups using a collaborative approach to scientific inquiry; this special issue will identify research priorities for moving the science of recruitment and retention forward. In addition, sustainable and efficient methods for fostering long-term partnerships will be identified between community and academia. Evidence-based approaches to the recruitment and retention of diverse elders are explored. We expect this supplement to serve as a catalyst for researchers interested in engaging diverse community-dwelling elders in health-related research. In addition, this supplement should serve as a source of the most contemporary evidence-based approaches to the recruitment and retention of diverse older populations for participation in social, behavioral, and clinical research.

The Resource Centers for Minority Aging Research (RCMAR): community/researcher interaction and relationships.

For more than a decade, the National Institute on Aging (NIA) has led a program called the Resource Centers for Minority Aging Research (RCMAR). One of the four key components of the RCMARs is a Community Liaison Core whose objectives are to conduct research on recruiting community members for scientific studies and to facilitate working relationships with host communities. The articles in this supplement represent some of the scientific knowledge available on community-based participatory research (CBPR) at the RCMARs. The hope is that this supplement will motivate others involved in CBPR to more fully engage in the conduct of science related to relationships that mutually benefit communities and researchers.

Data and safety monitoring in social behavioral intervention trials: the REACH II experience.

BACKGROUND: Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials. PURPOSE: This paper summarizes how issues associated with safety monitoring and adverse event reporting were handled in the Resources for Enhancing Alzheimer's Caregiver Health (REACH II) program, a multi-site randomized clinical trial, funded by the National Institutes on Aging (NIA) and the National Institutes of Nursing Research (NINR), that tested the efficacy of a multicomponent social/behavioral intervention for caregivers of persons with Alzheimer's disease. METHODS: A task force was formed to define adverse events for the trial and protocols for reporting and resolving events that occurred. The task force conducted a review of existing polices and protocols for data and safety monitoring and adverse event reporting and identified potential risks particular to the study population. An informal survey regarding data and safety monitoring procedures with investigators on psychosocial intervention trials was also conducted. RESULTS: Two categories of events were defined for both caregivers and patients; adverse events and safety alerts. A distinction was also made between events detected at baseline assessment and those detected post-randomization. Standardized protocols were also developed for the reporting and resolution of events that occurred and training of study personnel. Results from the informal survey indicated wide variability in practices for data safety and monitoring across psychosocial intervention trials. CONCLUSIONS: Overall, the REACH II experience demonstrates that existing guidelines regarding safety monitoring and adverse event reporting pose unique challenges for social/behavioral intervention trials. Challenges encountered in the REACH II program included defining and classifying adverse events, defining "resolution" of adverse events and attributing causes for events that occurred. These challenges are highlighted and recommendations for addressing them in future studies are discussed.

Approaches to improving recruitment and retention of minority elders participating in research: examples from selected research groups including the National Institute on Aging's Resource Centers for Minority Aging Research.

This introductory overview addresses the importance of recruiting and retaining racial and ethnic minority elders in biopsychosocial research. It highlights developments by scholars, many associated with the National Institute on Aging's Resource Centers for Minority Aging Research, to develop and reinforce a research infrastructure intended to minimize the minority/nonminority differential in health and its social sequelae for older people.