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Introduction Implementation of evidence-informed health guidelines tailored to the health system contexts of low- and middle-income countries is needed to improve health outcomes. Evidence-informed health guidelines are documents containing clinical, [...], Problem Many national child health guidelines In Malawi, Nigeria and South Africa are outdated and score poorly on rigorous methods and stakeholder participation. Approach In line with the World Health Organization's (WHO) emphasis on local guideline contextualization, the Global Evidence-Local Adaptation (GELA) project supported multistakeholder processes to adapt evidence-informed recommendations for child health in Malawi, Nigeria and South Africa. The GELA project team convened national steering groups, which conducted structured, iterative priority-setting exercises to identify priority topics. We identified appropriate source guidelines by systematically searching and screening available guidelines. We then matched recommendations in potential source guidelines to the relevant questions, and assessed the guidelines for timeliness and quality. Drawing on WHO's guideline process, we applied the GRADE-ADOLOPMENT process to develop contextualized recommendations from existing guidelines. If no source guideline or reviews were identified, we conducted new evidence syntheses. Local setting Malawi, Nigeria and South Africa are countries with varying health priorities and systems, all transitioning to universal health coverage. Guideline structures differ between countries, with processes largely led from national health ministries. Relevant changes National guideline groups, supported by GELA researchers and government-academic partners, developed five contextually-tailored child health recommendations. For most of these recommendations, additional evidence was required to inform contextually appropriate national decision-making. Formal capacity-building and on-the-job learning enhanced the competencies of national contributors and researchers in evidence-informed decision-making. Lessons learnt Developing context-relevant recommendations requires considerable resources and time. Further investment in strengthening local capacity is needed for sustainable national guideline development. [phrase omitted] Probleme En Afrique du Sud, au Malawi et au Nigeria, de nombreuses lignes directrices nationales relatives a la sante infantile sont obsoletes et affichent de pietres resultats en termes de rigueur des methodes et d'implication des parties prenantes. Approche S'alignant sur l'importance accordee par l'Organisation mondiale de la Sante (OMS) a la contextualisation des lignes directrices locales, le projet Global Evidence - Local Adaptation (GELA) a apporte son soutien a divers processus de collaboration multilaterale afin d'adapter des recommandations sur la sante infantile etayees par des faits en Afrique du Sud, au Malawi et au Nigeria. L'equipe du projet GELA a constitue des groupes de pilotage nationaux, charges d'effectuer des exercices iteratifs et structures de definition des priorites afin de repertorier les principaux themes. Nous avons identifie des lignes directrices de reference en procedant a une recherche et une selection parmi celles disponibles. Ensuite, nous avons compare les recommandations de ces potentielles lignes directrices de reference avec les questions pertinentes, puis nous avons evalue leur qualite et leur actualite. En nous fondant sur le processus d'elaboration de lignes directrices de l'OMS, nous avons applique la methodologie GRADEADOLOPMENT pour formuler des recommandations contextualisees a partir de lignes directrices existantes. Si aucune analyse ni ligne directrice de reference n'avait pu etre degagee, nous etablissions de nouvelles syntheses de preuves. Environnement local L'Afrique du Sud, le Malawi et le Nigeria sont des pays aux priorites et systemes de sante variables, qui operent tous trois une transition vers une couverture sanitaire universelle. Les structures des lignes directrices different d'un pays a l'autre, les processus etant generalement menes par les Ministeres nationaux de la Sante. Changements significatifs Les groupes charges d'elaborer des lignes directrices nationales, avec l'aide des chercheurs GELA et des partenaires gouvernementaux et universitaires, ont emis cinq recommandations adaptees au contexte en matiere de sante infantile. Dans la plupart des cas, la prise de decisions nationales contextualisees necessitait des preuves supplementaires. Le programme de renforcement des capacites et l'apprentissage sur le terrain ont permis d'ameliorer les competences des chercheurs et contributeurs nationaux dans les processus decisionnels etayes par des faits. Lecons tirees Mettre au point des recommandations propres a chaque contexte demande du temps et des ressources considerables. D'autres investissements dans le renforcement des capacites locales sont indispensables pour perenniser le developpement national de lignes directrices. [phrase omitted] Situacion Muchas directrices nacionales de salud infantil en Malawi, Nigeria y Sudafrica estan obsoletas y obtienen una puntuacion baja respecto a los metodos rigurosos y la participacion de las partes interesadas. Enfoque En consonancia con el enfasis de la Organizacion Mundial de la Salud (OMS) en la contextualizacion local de las directrices, el proyecto Global Evidence-Local Adaptation (GELA) apoyo procesos multisectoriales para adaptar las recomendaciones basadas en la evidencia a la salud infantil en Malawi, Nigeria y Sudafrica. El equipo del proyecto GELA convoco a grupos directivos nacionales, que realizaron ejercicios estructurados e iterativos de fijacion de prioridades para identificar los temas prioritarios. Se identificaron las directrices fuente apropiadas mediante la busqueda sistematica y el analisis de las directrices disponibles. A continuacion, se compararon las recomendaciones de las posibles directrices fuente con las preguntas pertinentes y se evaluo la oportunidad y la calidad de las directrices. A partir del proceso de elaboracion de directrices de la OMS, se aplico el proceso GRADE-ADOLOPMENT para desarrollar recomendaciones contextualizadas partiendo de las directrices existentes. Si no se identificaba ninguna directriz o revision fuente, se realizaban nuevas sintesis de la evidencia. Marco regional Malawi, Nigeria y Sudafrica son paises con prioridades y sistemas sanitarios diversos, todos ellos en transicion hacia la cobertura sanitaria universal. Las estructuras de las directrices difieren de un pais a otro, y los procesos se dirigen en gran medida desde los ministerios de sanidad nacionales. Cambios importantes Los grupos nacionales de directrices, apoyados por investigadores del GELA y socios gubernamentales y academicos, elaboraron cinco recomendaciones de salud infantil adaptadas a cada contexto. Para la mayoria de estas recomendaciones, se necesitaron pruebas adicionales para fundamentar una toma de decisiones nacional adecuada al contexto. La capacitacion formal y el aprendizaje en el lugar de trabajo mejoraron las competencias de los colaboradores e investigadores nacionales en la toma de decisiones basada en evidencias. Lecciones aprendidas La elaboracion de recomendaciones adaptadas al contexto requiere recursos y tiempo considerables. Se necesita una mayor inversion en el fortalecimiento de la capacidad local para el desarrollo sostenible de directrices nacionales.

Background: South Africa has a high HIV incidence and oral preexposure prophylaxis (PrEP) is available as public-sector standard of care. Access to alternative prevention methods for women may further reduce HIV acquisition. Setting: South African public sector. Methods: We performed a systematic search for high-quality upto-date guidelines recommending dapivirine rings as PrEP using the Grading of Recommendations Assessment, Development, and Evaluation-Adolopment process. We appraised the systematic review and randomized controlled trial (RCT) evidence underpinning the selected guideline’s recommendations and conducted a costeffectiveness analysis. The Grading of Recommendations Assessment, Development, and Evaluation evidence-to-decision framework guided the adaptation of source guideline recommendations, according to our local context. Results: We identified the 2021 World Health Organization PrEP Guidelines, informed by 2 placebo-controlled RCTs, which were included in a contemporaneous systematic review. There were 23 fewer HIV acquisitions per 1000 clients with dapivirine ring vs placebo (95% confidence interval: 10 to 34), with no increase in adverse events (moderate certainty evidence). We found no RCTs comparing dapivirine to oral PrEP or among adolescent/pregnant/ breastfeeding clients. Dapivirine is less cost-effective than oral PrEP at $14.59/ring, at the current price. Conclusions: The source guideline recommendation was adapted for the local context. Dapivirine ring seems to be less efficacious than oral PrEP, although comparative studies are lacking. Data on adolescents and pregnancy are also lacking, currently limiting the use of dapivirine as an alternative for women unable to take oral PrEP. At the current price, dapivirine is not cost-effective and unaffordable for inclusion in the South African Essential Medicines List. [ABSTRACT FROM AUTHOR]

South Africa has embarked on major health policy reform to deliver universal health coverage through the establishment of National Health Insurance (NHI). The aim is to improve access, remove financial barriers to care, and enhance care quality. Health technology assessment (HTA) is explicitly identified in the proposed NHI legislation and will have a prominent role in informing decisions about adoption and access to health interventions and technologies. The specific arrangements and approach to HTA in support of this legislation are yet to be determined. Although there is currently no formal national HTA institution in South Africa, there are several processes in both the public and private healthcare sectors that use elements of HTA to varying extents to inform access and resource allocation decisions. Institutions performing HTAs or related activities in South Africa include the National and Provincial Departments of Health, National Treasury, National Health Laboratory Service, Council for Medical Schemes, medical scheme administrators, managed care organizations, academic or research institutions, clinical societies and associations, pharmaceutical and devices companies, private consultancies, and private sector hospital groups. Existing fragmented HTA processes should coordinate and conform to a standardized, fit-for-purpose process and structure that can usefully inform priority setting under NHI and for other decision makers. This transformation will require comprehensive and inclusive planning with dedicated funding and regulation, and provision of strong oversight mechanisms and leadership. [ABSTRACT FROM AUTHOR]

Background: Constrained resources under universal health coverage (UHC) necessitate a balance between medication costs and essential health system requirements. Policymakers practice priority-setting, as either implicit or explicit rationing, embedded in evidence-informed decision-making processes to guide funding decisions. Health technology assessment (HTA) is a method that may assist explicit evidence-informed priority setting. South Africa developed an official HTA methods guide in 2022, however before this, commissioning and performing economic evaluations was not standardized., Methods: We conducted a descriptive collective case study to explore the impact of economic analyses on the selection of, and access to, essential medicines in South Africa. Four cases were purposefully selected, and both official information and secondary data, including media reports, were reviewed. Data elements were extracted and organized in a matrix. Cases were reported narratively with a positivist epistemological approach, presenting the authors' reflections., Results: We found economic analyses that reflected methodologies described in the HTA guide: international reference pricing, cost-minimization, cost-effectiveness, cost-utility, and budget impact analyses. Economic analyses informing the 'resource-use' domain in the GRADE evidence-to-decision framework supported decision-making, influenced market-shaping with price reductions of interventions through benchmarking (fosfomycin, flucytosine), improved equitable access nationally (flucytosine), and prioritized a defined patient group in a justifiable and transparent manner (bortezomib)., Conclusion: A standardized HTA evaluation process guided by a nationally accepted framework is necessary for evidence-informed decision-making. Economic analyses (cost-effectiveness, affordability, and resource use) should be consistently included when making decisions on new interventions.