Evaluation of the Ghana Heart Initiative - Design and Rationale of a Pragmatic Mixed-Methods Study from Diverse Perspectives: A Study Protocol.

Background: Rigorous evaluations of health system interventions to strengthen hypertension and cardiovascular disease (CVD) care remain scarce in sub-Saharan Africa. This study aims to evaluate the reach, effectiveness, adoption / acceptability, implementation fidelity, cost, and sustainability of the Ghana Heart Initiative (GHI), a multicomponent supply-side intervention to improve cardiovascular health in Ghana. Methods: This study adopts a mixed- and multi-methods design comparing the effects of the GHI in 42 intervention health facilities (i.e. primary, secondary and tertiary) in the Greater Accra Region versus 56 control health facilities in the Central and Western Regions. The evaluation design is guided by the RE-AIM framework underpinned by the WHO health systems building blocks framework, integrated by the Institute of Medicine's six dimensions of health care quality: safe, effective, patient-centered, timely, effi cient, equitable. The assessment tools include: (i) a health facility survey, (ii) a healthcare provider survey assessing the knowledge, attitudes, and practices on hypertension and CVD management, (iii) a patient exit survey, (iv) an outpatient and in-patient medical record review and (v) qualitative interviews with patients and various health system stakeholders to understand the barriers and facilitators around the implementation of the GHI. In addition to primary data collection, the study also relies on secondary routine health system data, i.e., the District Health Information Management System to conduct an interrupted time series analysis using monthly counts for relevant hypertension and CVD specific indicators as outcomes. The primary outcome measures are performance of health service delivery indicators, input, process and outcome of care indicators (including screening of hypertension, newly diagnosed hypertension, prescription of guideline directed medical therapy, and satisfaction with service received and acceptability) between the intervention and control facilities. Lastly, an economic evaluation and budget impact analysis is planned to inform the nationwide scale-up of the GHI. Discussion: This study will generate policy-relevant data on the reach, effectiveness, implementation fidelity, adoption / acceptability, and sustainability of the GHI, and provide insights on the costs and budget-impacts to inform nation-wide scale-up to expand the GHI to other regions across Ghana and offer lessons to other low- and middle-income countries settings as well. RIDIE Registration Number: RIDIE-STUDY-ID-6375e5614fd49 (https://ridie.3ieimpact.org/index.php).

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

AIM: For over 15 years, the pharmaceutical industry has been engaged in developing medicines for children to comply with the European Union (EU) and the United States (US) regulatory requirements. We assessed the authorization availability of these medicines in countries without paediatric regulatory obligations. Special attention was given to the authorization availability of paediatric formulations. METHODS: Medicines for children were sampled from the US Food and Drug Administration and European Medicines Agency websites. We carried out systematic content analysis of product information and compared paediatric labelling in Australia, Brazil, Canada, Russia and South Africa with the EU or the US. The authorization availability of paediatric formulations in originator and generic medicines was reviewed. In Kenya, the authorization availability of sampled medicines and paediatric formulations was investigated. RESULTS: A total of 161 medicines authorized in the EU or the US were sampled. Whilst at least one paediatric indication was found in 70% of the medicines, the EU and US level of authorization was on average 38% in Australia, Brazil, Canada, Russia and South Africa. Paediatric formulations were authorized on average for 40% of originator and 36% of generic medicines. Kenya had the lowest authorization availability of medicines (40%) and formulations (26%). CONCLUSIONS: The authorization availability of novel medicines for children is lower in countries without paediatric regulatory obligations. Paediatric formulations often do not reach other countries if left unregulated, and their generic uptake is low. To increase authorization availability, submission of paediatric development results should become obligatory in each jurisdiction. Policy initiatives to stimulate the introduction of developed formulations should be encouraged.

Protocol for a scoping review of measures and definitions of gender-based discrimination linked to health outcomes in low and middle-income countries.

INTRODUCTION: Gender-based discrimination (GBD) is generally defined as unequal or disadvantageous treatment based on one's gender. Emerging evidence suggests that exposure to GBD in its various forms can yield negative consequences for women's health, including delaying access to healthcare services and lowering the quality of nutrition. Although consensus exists around the theoretical definitions of GBD, current studies are limited on how to measure GBD empirically in order to assess its true impact on women's health. Our mixed-methods scoping review aims at synthesising existing evidence by answering the question How is gender-based discrimination defined and measured in the health literature, with specific reference to Low and Middle-Income Countries (LMICs)?. Our ambition is to identify commonalities across definitions and measures to generate a dialogue towards reaching consensus around the development of a single standardised tool to be applied in health studies. METHODS AND ANALYSIS: Our mixed-method scoping review includes quantitative, qualitative and mixed-methods studies and unfolds according to the six stages proposed by Levac et al. Eligibility criteria for studies were defined in order to reflect the three core elements of the search, namely (1) the discrimination based on the gender, (2) the link to health outcomes and (3) the developing countries context. Four databases (PubMed, Web of Science, Cinahl and Econlit) were searched. We will extract and synthesise information from quantitative and qualitative studies following the framework proposed by Hong and use the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping review tool as a guide. ETHICS AND DISSEMINATION: Since our scoping review relies exclusively on information extracted from published articles, its conduct is not subjected to ethical clearance. Results will be described and discussed in a peer-reviewed article and presented at relevant workshops and conferences.