A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways.

Reliance-based pathways for the marketing authorization of medical products have been identified as valuable regulatory tools for the timely provision of effective, safe, quality medicines for people worldwide; however, little research has been conducted on the best way to measure the public health impact of using reliance-based pathways. The current mixed methods study was designed to explore which characteristics or "metrics" could be used to measure the impact of reliance-based pathways. A quantitative survey (n = 70) and in-depth interviews (IDIs) (n = 10) were employed to query various stakeholders (e.g., industry, regulatory authorities, NGOs) about the metrics they believed would be important to include in a framework designed to measure the impact of reliance-based regulatory pathways on advancing public health. Based on survey results, (1) ability to meet targeted product assessment timeline, (2) increased access to expertise, which is limited or not available in the agency, (3) shortened median number of days (annually) to market for medical products, (4) lower morbidity and mortality rates due to greater access to medical products, and (5) movement toward technical standards harmonization were the Top Five most important metrics to be included in a framework. IDI results suggest that, while important, the relevance of the Top Five metrics may vary by region or regulatory authority. Interviewed stakeholders intuitively believe reliance-based regulatory pathways are a worthwhile endeavor; however, there must be "harmonization" within the reliance ecosystem that creates a strong understanding of the factors necessary for reliance-based pathways to be utilized in a successful manner.

Envisioning a transdisciplinary university.

Achieving social and economic growth requires collaboration, especially in global health. If universities are to improve health globally, they will need to train students and to support faculty who can effectively collaborate with those from other disciplines and cultures.

Improving Medical Education: Enhancing the Behavioral and Social Science Content of Medical School Curricula

Livro em versão eletrônica com disponibilidade de todo o seu conteúdo. Tem como principal interesse tratar da introdução das ciências sociais e do comportamento nos currículos das escolas médicas. Os capítulos podem ser consultados individualmente em formato html ou poderá ser feito download da sua íntegra em formato pdf.

Bioelectrical impedance analysis models for prediction of total body water and fat-free mass in healthy and HIV-infected children and adolescents.

BACKGROUND: Bioelectrical impedance analysis (BIA) is an attractive method of measuring pediatric body composition in the field, but the applicability of existing equations to diverse populations has been questioned. OBJECTIVE: The objectives were to evaluate the performance of 13 published pediatric BIA-based predictive equations for total body water (TBW) and fat-free mass (FFM) and to refit the best-performing models. DESIGN: We used TBW by deuterium dilution, FFM by dual-energy X-ray absorptiometry, and BIA-derived variables to evaluate BIA models in a cross-sectional study of 1291 pediatric subjects aged 4-18 y, from several ethnic backgrounds, including 54 children with HIV infection and 627 females. The best-performing models were refitted according to criterion values from this population, cross-validated, and assessed for performance. Additional variables were added to improve the predictive accuracy of the equations. RESULTS: The correlation between predicted and criterion values was high for all models tested, but bias and precision improved with the refitted models. The 95% limits of agreement between predicted and criterion values were 16% and 11% for TBW and FFM, respectively. Bias was significant for some subgroups, and there was greater loss of precision in specific age groups and pubertal stages. The models with additional variables eliminated bias, but the limits of agreement and the loss of precision persisted. CONCLUSION: This study confirms that BIA prediction models may not be appropriate for individual evaluation but are suitable for population studies. Additional variables may be necessary to eliminate bias for specific subgroups.

Bone mineral content is lower in prepubertal HIV-infected children.

Total body bone mineral content (TBBMC) was measured by dual energy x-ray absorptiometry in a cross-sectional study of 51 prepubertal HIV-infected children and 262 healthy prepubertal children aged 4.2 to 14.7 years. The mean TBBMC +/- SD was lower in HIV-positive children than in HIV-negative controls (955 +/- 325 vs. 1,106 +/- 273 g, respectively; p =.0006). Reductions in TBBMC remained in the HIV-positive group after adjusting for age, sex, and race by analysis of covariance (p <.001). Differences in TBBMC between HIV-positive and HIV-negative groups persisted when height and weight were also accounted for in the analysis (p =.027). The magnitude of the difference in TBBMC between the groups increased with age. In the HIV-positive group, no associations were observed between TBBMC and use of a protease inhibitor, duration of treatment with antiretroviral medications, viral load, or CD4 cell count. TBBMC is decreased in HIV-infected children. As a result of compromised bone mineral accrual, HIV-infected children may be at increased risk for osteoporosis and related complications.