Implementation factors of non-communicable disease policies and programmes for children and youth in low-income and middle-income countries: a systematic review.

INTRODUCTION: Despite declared life-course principles in non-communicable disease (NCD) prevention and management, worldwide focus has been on older rather than younger populations. However, the burden from childhood NCDs has mounted; particularly in low-income and middle-income countries (LMICs). There is limited knowledge regarding the implementation of paediatric NCD policies and programmes in LMICs, despite their disproportionate burden of morbidity and mortality. We aimed to understand the barriers to and facilitators of paediatric NCD policy and programme implementation in LMICs. METHODS: We systematically searched medical databases, Web of Science and WHOLIS for studies on paediatric NCD policy and programme implementation in LMICs. Screening and quality assessment were performed independently by researchers, using consensus to resolve differences. Data extraction was conducted within the WHO health system building-blocks framework. Narrative thematic synthesis was conducted. RESULTS: 93 studies (1992-2020) were included, spanning 86 LMICs. Most were of moderate or high quality. 78% reported on paediatric NCDs outside the four major NCD categories contributing to the adult burden. Across the framework, more barriers than facilitators were identified. The most prevalently reported factors were related to health service delivery, with system fragmentation impeding the continuity of age-specific NCD care. A significant facilitator was intersectoral collaborations between health and education actors to deliver care in trusted community settings. Non-health factors were also important to paediatric NCD policies and programmes, such as community stakeholders, sociocultural support to caregivers and school disruptions. CONCLUSIONS: Multiple barriers prevent the optimal implementation of paediatric NCD policies and programmes in LMIC health systems. The low sociopolitical visibility of paediatric NCDs limits their prioritisation, resulting in fragmented service delivery and constraining the integration of programmes across key sectors impacting children, including health, education and social services. Implementation research is needed to understand specific contextual solutions to improve access to paediatric NCD services in diverse LMIC settings.

The promise of POSIT: Real-world application of the Paediatric Oncology System Integration Tool.

Childhood cancer presents significant acute and long-term challenges for patients,families, communities, and health systems. Although meaningful strides have been made in research and treatment, severe outcome disparities prevail between low- and middle-income countries (LMICs) and high-income countries (HICs), with childhood cancer survival rates lower than 20% in LMICs, as compared with over 80% across many HICs. In recent years, greater emphasis has been placed on health system strengthening as a means to develop domestic policy and capacity for sustainable improvements in childhood cancer outcomes in LMICs. In pursuit of a systems approach to childhood cancer in LMICs, our research team developed the Paediatric Oncology System Integration Tool (POSIT)-the first comprehensive framework for the design and evaluation of childhood cancer systems. Since its development, POSIT has been applied in an exploration of key determinants of access to essential childhood cancer medicines across two separate multi-site studies. In this commentary, we explore the value of the POSIT framework and toolkit as a constructive systems-level guide for examining interactions between childhood cancer-specific programs and encompassing health system. socio-political, and economic contexts.

Access to essential cancer medicines for children: a comparative mixed-methods analysis of availability, price, and health-system determinants in east Africa.

BACKGROUND: Access to essential childhood cancer medicines is a core determinant of childhood cancer outcomes. Available evidence, although scarce, suggests that access to these medicines is highly variable across countries, particularly in low-income and middle-income countries, where the burden of childhood cancer is greatest. To support evidence-informed national and regional policies for improved childhood cancer outcomes, we aimed to analyse access to essential childhood cancer medicines in four east African countries-Kenya, Rwanda, Tanzania, and Uganda-by determining the availability and price of these medicines and the health system determinants of access. METHODS: In this comparative analysis, we used prospective mixed-method analyses to track and analyse the availability and price of essential childhood cancer medicines, investigate contextual determinants of access to childhood cancer medicines within and across included countries, and assess the potential effects of medicine stockouts on treatment. Eight tertiary care hospitals were included, seven were public sites (Kenyatta National Hospital [KNH; Nairobi, Kenya], Jaramogi Oginga Odinga Referral and Teaching Hospital [JOORTH; Kisumu, Kenya], Moi University Teaching and Referral Hospital [MTRH; Eldoret, Kenya], Bugando Medical Centre [BMC; Mwanza, Tanzania], Muhimbili National Hospital [MNH; Dar es Salaam, Tanzania], Butaro Cancer Centre of Excellence [BCCE; Butaro Sector, Rwanda], and Uganda Cancer Institute [UCI; Kampala, Uganda]) and one was a private site (Aga Khan University Hospital [AKU; Nairobi, Kenya]). We catalogued prices and stockouts for 37 essential drugs from each of the eight study siteson the basis of 52 weeks of prospective data that was collected across sites from May 1, 2020, to Jan 31, 2022. We analysed determinants of medicine access using thematic analysis of academic literature, policy documents, and semi-structured interviews from a purposive sample of health system stakeholders. FINDINGS: Recurrent stockouts of a wide range of cytotoxic and supportive care medicines were observed across sites, with highest mean unavailability in Kenya (JOORTH; 48·5%), Rwanda (BCCE; 39·0%), and Tanzania (BMC; 32·2%). Drugs that had frequent stockouts across at least four sites included methotrexate, bleomycin, etoposide, ifosfamide, oral morphine, and allopurinol. Average median price ratio of medicines at each site was within WHO's internationally accepted threshold for efficient procurement (median price ratio ≤1·5). The effect of stockouts on treatment was noted across most sites, with the greatest potential for treatment interruptions in patients with Hodgkin lymphoma, retinoblastoma, and acute lymphocytic leukaemia. Policy prioritisation of childhood cancers, health financing and coverage, medicine procurement and supply chain management, and health system infrastructure emerged as four prominent determinants of access when the stratified purposive sample of key informants (n=64) across all four countries (Kenya n=19, Rwanda n=15, Tanzania n=13, and Uganda n=17) was interviewed. INTERPRETATION: Access to childhood cancer medicines across east Africa is marked by gaps in availability that have implications for effective treatment delivery for a range of childhood cancers. Our findings provide detailed evidence of barriers to access to childhood cancer medicine at multiple points in the pharmaceutical value chain. These data could inform national and regional policy makers to optimise cancer medicine availability and affordability as part of efforts to improve childhood cancer outcomes specific regions and internationally. FUNDING: American Childhood Cancer Organization, Childhood Cancer International, and the Friends of Cancer Patients Ameera Fund.

The Implementation Playbook: study protocol for the development and feasibility evaluation of a digital tool for effective implementation of evidence-based innovations.

BACKGROUND: Evidence-based innovations can improve health outcomes, but only if successfully implemented. Implementation can be complex, highly susceptible to failure, costly and resource intensive. Internationally, there is an urgent need to improve the implementation of effective innovations. Successful implementation is best guided by implementation science, but organizations lack implementation know-how and have difficulty applying it. Implementation support is typically shared in static, non-interactive, overly academic guides and is rarely evaluated. In-person implementation facilitation is often soft-funded, costly, and scarce. This study seeks to improve effective implementation by (1) developing a first-in-kind digital tool to guide pragmatic, empirically based and self-directed implementation planning in real-time; and (2) exploring the tool's feasibility in six health organizations implementing different innovations. METHODS: Ideation emerged from a paper-based resource, The Implementation Game©, and a revision called The Implementation Roadmap©; both integrate core implementation components from evidence, models and frameworks to guide structured, explicit, and pragmatic planning. Prior funding also generated user personas and high-level product requirements. This study will design, develop, and evaluate the feasibility of a digital tool called The Implementation Playbook©. In Phase 1, user-centred design and usability testing will inform tool content, visual interface, and functions to produce a minimum viable product. Phase 2 will explore the Playbook's feasibility in six purposefully selected health organizations sampled for maximum variation. Organizations will use the Playbook for up to 24 months to implement an innovation of their choosing. Mixed methods will gather: (i) field notes from implementation team check-in meetings; (ii) interviews with implementation teams about their experience using the tool; (iii) user free-form content entered into the tool as teams work through implementation planning; (iv) Organizational Readiness for Implementing Change questionnaire; (v) System Usability Scale; and (vi) tool metrics on how users progressed through activities and the time required to do so. DISCUSSION: Effective implementation of evidence-based innovations is essential for optimal health. We seek to develop a prototype digital tool and demonstrate its feasibility and usefulness across organizations implementing different innovations. This technology could fill a significant need globally, be highly scalable, and potentially valid for diverse organizations implementing various innovations.

The Guideline Language and Format Instrument (GLAFI): development process and international needs assessment survey.

BACKGROUND: Successful guideline implementation depends both on factors extrinsic to guidelines and their intrinsic features. In the Guideline Implementability for Decision Excellence Model (GUIDE-M), "communicating" content (language and format) is one of three core determinants of intrinsic implementability, but is seldom addressed. Our aims were to develop a tool that could be used by guideline developers to optimize language and format during development; identify gaps in this type of guidance in existing resources; and evaluate the perceived need for and usefulness of such a tool among guideline developers. METHODS: Our mixed-methods design consisted of (1) content development (selection and organization of evidence-based constructs from the GUIDE-M into a prototype Guideline Language and Format Instrument (GLAFI), followed by face validation with guideline developers); (2) document analysis (duplicate) of seven existing guideline tools to measure coverage of GLAFI items and identify new items; and (3) an international survey of guideline developers (corresponding authors of recent Canadian Medical Association or Guidelines International Network database guidelines) to measure perceived importance of language and format, quality of existing resources, and usefulness of a language and format tool. RESULTS: GLAFI items were organized into 4 language and 4 format subdomains. In face validation with guideline developers (17 clinicians, 1 methodologist), all agreed that the tool would improve guideline implementability and 93% indicated a desire for regular use. In the existing guideline tool document analysis, only 14/44 (31.8%) GLAFI items were operationalized in at least one tool. We received survey responses from 148/674 (22.0%) contacted guideline authors representing 45 organizations (9 countries). Language was rated as "extremely important" or "important" in determining uptake by 94% of respondents, and format by 84%. Correspondingly, 72% and 70% indicated that their organization would likely use such a tool. CONCLUSIONS: Optimal language and format are fundamental to guideline implementability but often overlooked. The GLAFI tool operationalizes evidence-based constructs, most of which are absent in existing guideline tools. Guideline developers perceive these concepts to be important and express a willingness to use such a tool. The GLAFI should be further tested and refined with guideline developers and its impact on end-users measured.

Determinants of access to childhood cancer medicines: a comparative, mixed-methods analysis of four Caribbean countries.

BACKGROUND: Equitable access to essential medicines is a key facet of childhood cancer care, recognised by WHO as vital to improved childhood cancer outcomes globally. In the Caribbean, childhood cancer outcomes are poorer than those in most high-income countries. We aimed to generate in-depth comparative evidence of the current challenges and opportunities related to access to childhood cancer medicines in the Caribbean to identify context-sensitive health systems strategies to improve drug access and inform evidence-based paediatric cancer policies in the region. METHODS: In this convergent, parallel, mixed-methods study, we mapped and analysed the determinants of access to childhood cancer medicines in four Caribbean countries (The Bahamas, Barbados, Jamaica, and Trinidad and Tobago). We analysed contextual determinants of access to medicines within and across study site jurisdictions, alignment of childhood cancer medicine inclusion between each country's national essential medicines list (NEML) and WHO's 2017 Essential Medicines List for Children, and availability and cost of chemotherapeutic agents at five tertiary care hospitals. We used a mixed-effects logistic regression model to analyse the association of medicine price, procurement efficiency (via median price ratio [MPR]), and site with drug availability. The fixed effect evaluated the effect of site and MPR on the probability of stockout in a given month. We assessed determinants of medicine access via thematic analysis of semi-structured qualitative interviews, literature, and policy documents. FINDINGS: We collected and analysed data for 28 childhood cancer medicines from Barbados, 32 from The Bahamas, 30 from Trinidad and Tobago, and 31 from Jamaica. Despite stepwise inclusion of childhood cancer medicines in NEMLs, all four countries had frequent and recurrent stockouts for many cytotoxic medicines, showing no consistent relationship between NEML inclusion and availability. A mean MPR of greater than 3·0 in Trinidad and Tobago, The Bahamas, and Barbados suggests uniformly high procurement inefficiency, resulting in significant effects on drug stockout days. For each one unit increase in MPR the adjusted odds ratio (OR) of stockout increased by 10% (adjusted OR 1·10, 95% CI 1·04-1·16; p<0·01). These challenges in access to childhood cancer medicines stem from health system and policy dynamics at institutional, national, and supranational levels that cause price volatility and erratic medicine availability. Key challenges include disparate policy commitments (eg, among sites), inefficient procurement and supply chain management practices, and local effects of international market pressures. INTERPRETATION: The Caribbean region exemplifies deficiencies in access to childhood cancer medicines that might be overcome by improved regional harmonisation of drug registration, pharmacovigilance, and procurement alongside national forecasting to strengthen global pharmaceutical planning and prioritisation. Focused political attention to address these challenges is required to ensure efficient, reliable, and sustained availability of cancer mediciness. FUNDING: The SickKids-Caribbean Initiative.

Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial.

INTRODUCTION: In response to the burden of chronic disease among older adults, different chronic disease self-management tools have been created to optimise disease management. However, these seldom consider all aspects of disease management are not usually developed specifically for seniors or created for sustained use and are primarily focused on a single disease. We created an eHealth self-management application called 'KeepWell' that supports seniors with complex care needs in their homes. It incorporates the care for two or more chronic conditions from among the most prevalent high-burden chronic diseases. METHODS AND ANALYSIS: We will evaluate the effectiveness, cost and uptake of KeepWell in a 6-month, pragmatic, hybrid effectiveness-implementation randomised controlled trial. Older adults age ≥65 years with one or more chronic conditions who are English speaking are able to consent and have access to a computer or tablet device, internet and an email address will be eligible. All consenting participants will be randomly assigned to KeepWell or control. The allocation sequence will be determined using a random number generator.Primary outcome is perceived self-efficacy at 6 months. Secondary outcomes include quality of life, health background/status, lifestyle (nutrition, physical activity, caffeine, alcohol, smoking and bladder health), social engagement and connections, eHealth literacy; all collected via a Health Risk Questionnaire embedded within KeepWell (intervention) or a survey platform (control). Implementation outcomes will include reach, effectiveness, adoption, fidelity, implementation cost and sustainability. ETHICS AND DISSEMINATION: Ethics approval has been received from the North York General Hospital Research and Ethics Board. The study is funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health. We will work with our team to develop a dissemination strategy which will include publications, presentations, plain language summaries and an end-of-grant meeting. TRIAL REGISTRATION NUMBER: NCT04437238.

The cost-effectiveness of treating childhood cancer in 4 centers across sub-Saharan Africa.

BACKGROUND: The treatment of childhood cancer often is assumed to be costly in African settings, thereby limiting advocacy and policy efforts. The authors determined the cost and cost-effectiveness of maintaining childhood cancer centers across 4 hospitals throughout sub-Saharan Africa. METHODS: Within hospitals representing 4 countries (Kenya, Nigeria, Tanzania, and Zimbabwe), cost was determined either retrospectively or prospectively for all inputs related to operating a pediatric cancer unit (eg, laboratory costs, medications, and salaries). Cost-effectiveness was calculated based on the annual number of newly diagnosed patients, survival rates, and life expectancy. RESULTS: Cost per new diagnosis ranged from $2400 to $31,000, attributable to variances with regard to center size, case mix, drug prices, admission practices, and the treatment abandonment rate, which also affected survival. The most expensive cost input was found to be associated with medication in Kenya, and medical personnel in the other 3 centers. The cost per disability-adjusted life-year averted ranged from 0.3 to 3.6 times the per capita gross national income. Childhood cancer treatment therefore was considered to be very cost-effective by World Health Organization standards in 2 countries and cost-effective in 1 additional country. In all centers, abandonment of treatment was common; modeling exercises suggested that public funding of treatment, additional psychosocial personnel, and modifications of inpatient policies would increase survival rates while maintaining or even improving cost-effectiveness. CONCLUSIONS: Across various African countries, childhood cancer treatment units represent cost-effective interventions. Cost-effectiveness can be increased through the control of drug prices, appropriate policy environments, and decreasing the rate of treatment abandonment. These results will inform national childhood cancer strategies across Africa.

Health system determinants of access to essential medicines for children with cancer in Ghana.

BACKGROUND: Evidence of the context-specific challenges related to childhood cancer drug (CCD) access is vital to improving outcomes for children with cancer in low- and middle-income countries, such as Ghana. We sought to determine the availability and cost of essential CCD in Ghana and identify the underlying determinants of access. METHODS: Our study integrated quantitative data on drug prices and availability with qualitative insights into health system and sociopolitical determinants of CCD access in Ghana. We analysed retrospective monthly price and stock data for 41 cancer and supportive care drugs on the WHO Essential Medicines List (EML) from private retail and public institutional pharmacies. Non-parametric analyses evaluated relationships between drug price and availability, and impacts of drug class and formulation on availability and procurement efficiency. We assessed the determinants of drug access through thematic analysis of policy documents and semi-structured interviews (n=21) with key health system stakeholders. RESULTS: Ghana lists only 47% of essential CCD on its National EML, revealing gaps in domestic formulary inclusion. Stock-outs occurred for 88% of essential CCD, with a 70-day median stock-out duration; 32% had median price ratios above internationally-accepted efficiency thresholds. Drugs procured inefficiently were more susceptible to stock-outs (p=0.0003). Principal determinants of drug access included: (1) lack of sociopolitical priority afforded childhood cancer and (2) the impact of policy and regulatory environments on drug affordability, availability and quality. Establishment of a population-based cancer registry, a nationally-coordinated procurement strategy for CCD, public financing for childhood cancer care and policies to control drug costs emerged as priority interventions to improve drug access in Ghana. CONCLUSION: Our study provides context-specific evidence to enable responsive policy development for efficient drug procurement and supply management in Ghana and establishes a rigorous approach to the analysis of childhood cancer drug access in similar health system settings.

Making Contributions and Defining Success: An eDelphi Study of the Inaugural Cohort of CIHR Health System Impact Fellows, Host Supervisors and Academic Supervisors.

CONTEXT: The Health System Impact (HSI) Fellowship, an innovative training program developed by the Canadian Institutes of Health Research's Institute of Health Services and Policy Research, provides PhD-trained health researchers with an embedded, experiential learning opportunity within a health system organization. METHODS/DESIGN: An electronic Delphi (eDelphi) study was conducted to: (1) identify the criteria used to define success in the program and (2) elucidate the main contributions fellows made to their organizations. Through an iterative, two-round eDelphi process, perspectives were elicited from three stakeholder groups in the inaugural cohort of the HSI Fellowship: HSI fellows, host supervisors and academic supervisors. DISCUSSION: A consensus was reached on many criteria of success for an embedded research fellowship and on several perceived contributions of the fellows to their host organization and academic institutions. This work begins to identify specific criteria for success in the fellowship that can be used to improve future iterations of the program.

Advancing methods for health priority setting practice through the contribution of systems theory: Lessons from a case study in Ethiopia.

Setting priorities for health services is a complex and value laden process. Over the past twenty years, there has been considerable scholarly attention paid to strengthening fairness and legitimacy using the prominent ethical framework, Accountability for Reasonableness (A4R). A variety of case studies applying A4R have advanced our conceptual understanding of procedural fairness, and have highlighted the significance of context through its application. There is a paucity of research, however, that rigorously examines how and to what extent context influences health priority setting processes and the establishment of procedural fairness. We argue here that to study context rigorously requires taking a holistic view of the system by examining the dynamics and interrelationships within it. Using the Transformative Systems Change Framework (TSCF), this investigation sought to examine the influence of system factors on priority setting practice and procedural fairness. A qualitative case study of Ethiopian district health planning was undertaken in 2010 and 2011. Methods included 58 qualitative interviews with decision makers, participant observation, and document analysis. Data analysis followed in three phases: i) an inductive analysis of district health priority setting to highlight experiences across each of the three districts selected, ii) deductive analysis applying A4R and the TSCF independently; and iii) a synthesis of concepts of priority setting practice and procedural fairness within a broader, theoretical understanding of the system. Through the application of the TSCF, a nuanced understanding of priority setting practice is revealed that situates this process within a system of interdependent components that include: norms, operations, regulations, and resources. This paper offers a practical guide attuned to system features influencing the design, implementation, and sustainability of greater fairness in health priority setting practice.

Conceptualizations of fairness and legitimacy in the context of Ethiopian health priority setting: Reflections on the applicability of accountability for reasonableness.

A critical element in building stronger health systems involves strengthening good governance to build capacity for transparent and fair health planning and priority setting. Over the past 20 years, the ethical framework Accountability for Reasonableness (A4R) has been a prominent conceptual guide in strengthening fair and legitimate processes of health decision-making. While many of the principles embedded within the framework are congruent with Western conceptualizations of what constitutes procedural fairness, there is a paucity in the literature that captures the degree of resonance between these principles and the views of decision makers from non-Western settings; particularly in Africa, where many countries have only recently, within the last 20-30 years, become more democratic. This paper contributes to the ethics literature by examining how Ethiopian decision makers conceptualize fair and legitimate health decision-making, and reflects on the degree of conceptual resonance between these views and the principles embedded in A4R. A qualitative case study approach from three districts in Ethiopia was undertaken. Fifty-eight decision makers from district, regional, zonal, and national levels were interviewed to describe their conceptualization of fairness and legitimacy in the district health planning process. Findings revealed that Ethiopians have a broad conception of fairness and legitimacy that while congruent with procedural justice, also aligned with principles of distributive and organizational justice. Researchers and practitioners seeking to strengthen procedural fairness in health priority setting must therefore recognize the significance of other philosophical dimensions influencing how fairness and legitimacy of health decision-making are constructed within the Ethiopian setting.

The WHF Roadmap for Reducing CV Morbidity and Mortality Through Prevention and Control of RHD.

Rheumatic heart disease (RHD) is a preventable non-communicable condition that disproportionately affects the world's poorest and most vulnerable. The World Heart Federation Roadmap for improved RHD control is a resource designed to help a variety of stakeholders raise the profile of RHD nationally and globally, and provide a framework to guide and support the strengthening of national, regional and global RHD control efforts. The Roadmap identifies the barriers that limit access to and uptake of proven interventions for the prevention and control of RHD. It also highlights a variety of established and promising solutions that may be used to overcome these barriers. As a general guide, the Roadmap is meant to serve as the foundation for the development of tailored plans of action to improve RHD control in specific contexts.