Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

BACKGROUND: New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. METHODS: We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. MAIN OUTCOME MEASURES: The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. RESULTS: Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. CONCLUSION: Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

The role of translational research in addressing health disparities: a conceptual framework.

Translational research has tremendous potential as a tool to reduce health disparities in the United States, but a lack of common understanding about the scope of this dynamic, multidisciplinary approach to research has limited its use. The term "translational research" is often associated with the phrase "bench to bedside," but the expedited movement of biomedical advances from the laboratory to clinical trials is only the first phase of the translational process. The second phase of translation, wherein innovations are moved from the bedside to real-world practice, is equally important, but it receives far less attention. Due in part to this imbalance, tremendous amounts of money and effort are spent expanding the boundaries of understanding and investigating the molecular underpinnings of disease and illness, while far fewer resources are devoted to improving the mechanisms by which those advances will be used to actually improve health outcomes. To foster awareness of the complete translational process and understanding of its value, we have developed two complementary models that provide a unifying conceptual framework for translational research. Specifically, these models integrate many elements of the National Institutes of Health roadmap for the future of medical research and provide a salient conceptualization of how a wide range of research endeavors from different disciplines can be used harmoniously to make progress toward achieving two overarching goals of Healthy People 2010--increasing the quality and years of healthy life and eliminating health disparities.

Addressing health disparities through multi-institutional, multidisciplinary collaboratories.

The national research leadership has recently become aware of the tremendous potential of translational research as an approach to address health disparities. The Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) is a research network that supports multi-institutional, multidisciplinary collaboration with a focus on key diseases and conditions for which disproportionately adverse racial and ethnic health disparities exist. The RTRN is designed to facilitate the movement of scientific advances across the translational research spectrum by providing researchers at different institutions with the infrastructure and tools necessary to collaborate on interdisciplinary and transdisciplinary research projects relating to specific health outcomes for which major racial/ethnic disparities exist. In the past, the difficulty of overcoming the restrictions imposed by time and space have made it difficult to carry out this type of large-scale, multilevel collaboration efficiently. To address this formidable challenge, the RTRN will deploy a translational research cluster system that uses "cyber workspaces" to bring researchers with similar interests together by using online collaboratory technology. These virtual meeting environments will provide a number of tools, including videoconferences (seminars, works in progress, meetings); project management tools (WebCT, Microsoft Share Point); and posting areas for projects, concepts, and other research and educational activities. This technology will help enhance access to resources across institutions with a common mission, minimize many of the logistical hurdles that impede intellectual exchange, streamline the planning and implementation of innovative interdisciplinary research, and assess the use of protocols and practices to assist researchers in interacting across and within cyber workspaces.

An ethno-medical perspective on research participation: a qualitative pilot study.

BACKGROUND: Recruitment of racial/ethnic minorities for clinical research continues to be problematic, yet critical to ensuring that research data will be applicable to diverse populations. There is a paucity of information about culturally appropriate methods for recruiting and retaining racial/ethnic minorities in research. OBJECTIVE: To cross-culturally assess perceptions of research participation by African American and immigrant Latinos living in the inner-city community of Watts, Los Angeles, California, using qualitative methods. DESIGN: Focus groups using ethnically matched moderators were convened with African American and immigrant Latino participants. Discussion was facilitated using a script that focused on perceived "feelings" and "perceptions" about research. Discussions were audiotaped, transcribed, and analyzed using manual and computerized statistically based software (mixed) methods. RESULTS: African Americans and immigrant Latinos shared several barriers and motivators to research. However, they also reported barriers and motivators to research that were distinct to each group. Latinos were more interested in healthcare and health information, and African Americans were more concerned with issues of trust and quality of care. Most participants said they would participate in research if they were better informed, or if they or a family member had an illness. Improving communication was reported as being important for motivating participation in clinical research. Overall, socioecologically and socioeconomically based domains were shared, whereas historically and/or socioculturally based domains were distinct. CONCLUSIONS: Using an ethno-medical science model, we demonstrated that it is possible to identify shared barriers and motivators to research participation between 2 distinct cultural groups. This approach can be useful in developing targeted community-based strategies to increase minority participation in clinical trials.

Use of Medicare services by elderly residents of Puerto Rico.

OBJECTIVES: We describe hospitalization rates among Medicare beneficiaries resident in Puerto Rico compared to beneficiaries in the mainland U.S., in 1999. METHODS: A cross-sectional analysis using Medicare Denominator and hospitalization files. RESULTS: The rate ratio (PR/U.S.) of age, gender-adjusted hospitalizations among elderly Medicare beneficiaries with Part A coverage was 0.78, compared with 0.92 among beneficiaries with both Part A and Part B coverage. Among the latter, the rate ratios were 0.78 for surgical admissions, 1.08 for low-variation medical conditions, and 0.97 for high variation medical conditions. They were higher for younger elderly beneficiaries. CONCLUSIONS: Rates of hospitalization in Puerto Rico may be lower, the same or exceed those of the mainland U.S. depending on the age of the beneficiary and the type of hospitalization.

Differences in patient mix: a partial explanation for the excessive medicare mortality observed in some Pueto Rican hospitals

Data from a census in a Puerto Rican community were used to retrospectively compare patients admitted to government hospitals in terms of demographic variables, mental status and functional status in the community prior to admission. A total of 268 patients admitted to a hospital at least once during the study period were identified. Patients admitted to government hospitals were poorer, less educated, less functional and had a higher level of mental impairment. However, in comparison to private hospitals, stratified analysis showed consistently higher in-hospital mortality rates among patients admitted to government hospitals when other variables were taken into account

El envejeciente de Guarabo: un perfil biosicosocial del envejeciente en una comunidad de Puerto Rico / The aging person in Gurabo: a bio-psychosocial profile of the aging person in a community in Puerto Rico

The Department of Family Medicine of the University of Puerto Rico Medicine School performed a census of the inhabitants 60 years and older in the community of Gurabo. A total of 1,890 elderly were interviewed 51% were female and 49% male. Sixty percent were married and twenty-five percent were widowed. Eighty two percent still lived within a family setting and only seventeen percent lived alone 86% owned their own home despite ninety percent reporting incomes below $400.00 per month. Ninety five percent have access to medical services but 63% receive services in multiples sites. Eighteen percent were functionally impaired, fourteen percent intelectually impaired and five percent had impairment in both areas. Preliminary data show that the latter group had an annual mortality rate of 15% compared to only 3.6% and 1.3% respectively in the other two group. We concluded that: 1) functional and mental impairment are indicators of increased mortality. 2) although access to health care is not a problem this health care is episodic and interrupted being provided in multiple different sites