National Heart, Lung, and Blood Institute cardiovascular clinical trial perspective.

The National Heart, Lung, and Blood Institute (NHLBI) has played an important role in funding the clinical science that supports many contemporary cardiology practice guidelines and in shaping the conduct of cardiovascular clinical trials. This Perspective outlines contemporary funding options as well as select important NHLBI policies, philosophy, and priorities.

Ten-year incidence of Chagas cardiomyopathy among asymptomatic Trypanosoma cruzi-seropositive former blood donors.

BACKGROUND: Very few studies have measured disease penetrance and prognostic factors of Chagas cardiomyopathy among asymptomatic Trypanosoma cruzi-infected persons. METHODS AND RESULTS: We performed a retrospective cohort study among initially healthy blood donors with an index T cruzi-seropositive donation and age-, sex-, and period-matched seronegatives in 1996 to 2002 in the Brazilian cities of São Paulo and Montes Claros. In 2008 to 2010, all subjects underwent medical history, physical examination, ECGs, and echocardiograms. ECG and echocardiogram results were classified by blinded core laboratories, and records with abnormal results were reviewed by a blinded panel of 3 cardiologists who adjudicated the outcome of Chagas cardiomyopathy. Associations with Chagas cardiomyopathy were tested with multivariate logistic regression. Mean follow-up time between index donation and outcome assessment was 10.5 years for the seropositives and 11.1 years for the seronegatives. Among 499 T cruzi seropositives, 120 (24%) had definite Chagas cardiomyopathy, and among 488 T cruzi seronegatives, 24 (5%) had cardiomyopathy, for an incidence difference of 1.85 per 100 person-years attributable to T cruzi infection. Of the 120 seropositives classified as having Chagas cardiomyopathy, only 31 (26%) presented with ejection fraction <50%, and only 11 (9%) were classified as New York Heart Association class II or higher. Chagas cardiomyopathy was associated (P<0.01) with male sex, a history of abnormal ECG, and the presence of an S3 heart sound. CONCLUSIONS: There is a substantial annual incidence of Chagas cardiomyopathy among initially asymptomatic T cruzi-seropositive blood donors, although disease was mild at diagnosis.

Methodological Guidelines for Reducing the Complexity of Data Warehouse Development for Transactional Blood Bank Systems.

Over time, data warehouse (DW) systems have become more difficult to develop because of the growing heterogeneity of data sources. Despite advances in research and technology, DW projects are still too slow for pragmatic results to be generated. Here, we address the following question: how can the complexity of DW development for integration of heterogeneous transactional information systems be reduced? To answer this, we proposed methodological guidelines based on cycles of conceptual modeling and data analysis, to drive construction of a modular DW system. These guidelines were applied to the blood donation domain, successfully reducing the complexity of DW development.

Who donates blood at five ethnically and geographically diverse blood centers in China in 2008.

BACKGROUND: In China recruitment and retention of sufficient numbers of safe blood donors continues to be a challenge. Understanding who donates blood, particularly those who donate larger (>200 mL) whole blood (WB) units, will help blood centers to target more effective recruitment and retention strategies. STUDY DESIGN AND METHODS: Demographic characteristics of 226,489 allogeneic WB donors from January to December 2008 at five geographically and ethnically diverse, urban blood centers were analyzed. RESULTS: The typical Chinese WB donor can be characterized as first-time volunteer (67.9%), male (56.9%), less than 45 years old (93.8%), and Han ethnicity (86.1%). Most donors had some college or below educational level (77.5%), donated at a mobile collection site (97.6%), and donated 300- or 400-mL units (76.0%). Differences in WB volume donations and donor demographics exist among the five centers. CONCLUSION: In China compared to the United States, donations are made by younger donors and donors give infrequently and make smaller WB donations. To help ensure supply adequacy, continued efforts are needed to have donors give larger volumes of WB in China.