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.

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.