Conceptual framework of equity-focused implementation research for health programs (EquIR).

BACKGROUND: Implementation research is increasingly used to identify common implementation problems and key barriers and facilitators influencing efficient access to health interventions. OBJECTIVE: To develop and propose an equity-based framework for Implementation Research (EquIR) of health programs, policies and systems. METHODS: A systematic search of models and conceptual frameworks involving equity in the implementation of health programs, policies and systems was conducted in Medline (PubMed), Embase, LILACS, Scopus and grey literature. Key characteristics of models and conceptual frameworks were summarized. We identified key aspects of equity in the context of seven Latin American countries-focused health programs We gathered information related to the awareness of inequalities in health policy, systems and programs, the potential negative impact of increasing inequalities in disadvantaged populations, and the strategies used to reduce them. RESULTS: A conceptual framework of EquIR was developed. It includes elements of equity-focused implementation research, but it also links the population health status before and after the implementation, including relevant aspects of health equity before, during and after the implementation. Additionally, health sectors were included, linked with social determinants of health through the "health in all policies" proposal affecting universal health and the potential impact of the public health and public policies. CONCLUSION: EquIR is a conceptual framework that is proposed for use by decision makers and researchers during the implementation of programs, policies or health interventions, with a focus on equity, which aims to reduce or prevent the increase of existing inequalities during implementation.

Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America.

OBJECTIVE: Our objective was to describe the risk of hospital admission for virologically confirmed dengue (VCD) and the risk of clinically severe hospitalized VCD occurring up to 4 years after the first dose (years 1 to 4) in three randomized clinical trials comparing tetravalent dengue vaccine with placebo. METHODS: The relative risks (RR) for hospitalized VCD from first dose to year 4 were estimated by year and age-group in individual and combined studies. RESULTS: Overall, from Year 1 to Year 4, 233 and 228 participants had at least one episode of hospitalized VCD in the vaccinated (n = 22 603) and placebo (n = 11 301) groups, respectively (RR = 0.511, 95% CI 0.42-0.62). Among these, 48 and 47 cases, respectively, were classified as clinically severe. In children aged ≥9 years, 88 and 136 participants had at least one episode of hospitalized VCD in the vaccinated (n = 17 629) and placebo (n = 8821) groups, respectively (RR = 0.324; 95% CI 0.24-0.43). In vaccinated participants aged <9 years, particularly in those aged 2-5 years, there were more hospitalized VCD cases compared with the control participants in Year 3 but not in Year 4. The overall RR in those aged <9 years for Year 1 to Year 4 was 0.786 (95% CI 0.60-1.03), with a higher protective effect in the 6-8 year olds than in the 2-5 year olds. CONCLUSIONS: The overall benefit-risk remained positive in those aged ≥9 years up to year 4, although the protective effect was lower in years 3 and 4 than in years 1 and 2.

A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC).

This was an open-label randomized Phase III study of 207 patients with either unresectable or metastatic non-small cell lung cancer (NSCLC) who were treated with docetaxel plus best supportive care (BSC) or best supportive care alone. Patients in the chemotherapy arm of the study received docetaxel 100 mg/m(2) as a 1 h intravenous infusion every 21 days until they showed evidence of progressive disease, or estimated maximum benefit obtained or unacceptable side effects. Patients who received docetaxel were pretreated with oral dexamethasone. Patients in the BSC arm should not receive chemotherapy or anticancer therapy except for palliative radiotherapy. Overall survival obtained in the docetaxel arm was significantly longer than in the BSC arm (P=0.026). Two-year survival in the docetaxel arm was 12%, whereas none of the BSC patients survived after 20 months. The response rate was 13.1% (95% CI, 7.5-18.8%). There was a significantly longer time to progression in the docetaxel versus the BSC arm (P<0.001), and statistically significant improvement of clinical symptoms with docetaxel compared to BSC. The quality-of-life descriptors were in favor of docetaxel, and the difference was significant for pain, dyspnea and emotional functioning. The safety profile of docetaxel for this study was similar to that already reported in this patient population.