Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania.

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention.

The Need for Global Application of the Accountability for Reasonableness Approach to Support Sustainable Outcomes Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".

The accountability for reasonableness (AFR) concept has been developed and discussed for over two decades. Its interpretation has been studied in several ways partly guided by the specific settings and the researchers involved. This has again influenced the development of the concept, but not led to universal application. The potential use in health technology assessments (HTAs) has recently been identified by Daniels et al as yet another excellent justification for AFR-based process guidance that refers to both qualitative and a broader participatory input for HTA, but it has raised concerns from those who primarily support the consistency and objectivity of more quantitative and reproducible evidence. With reference to studies of AFR-based interventions and the through these repeatedly documented motivation for their consolidation, we argue that it can even be unethical not to take AFR conditions beyond their still mainly formative stage and test their application within routine health systems management for their expected support to more sustainable health improvements. The ever increasing evidence and technical expertise are necessary but at times contradictory and do not in isolation lead to optimally accountable, fair and sustainable solutions. Technical experts, politicians, managers, service providers, community members, and beneficiaries each have their own values, expertise and preferences, to be considered for necessary buy in and sustainability. Legitimacy, accountability and fairness do not come about without an inclusive and agreed process guidance that can reconcile differences of opinion and indeed differences in evidence to arrive at a by all understood, accepted, but not necessarily agreed compromise in a current context - until major premises for the decision change. AFR should be widely adopted in projects and services under close monitoring and frequent reviews.

Effect of repeated mass drug administration with praziquantel and track and treat of taeniosis cases on the prevalence of taeniosis in Taenia solium endemic rural communities of Tanzania.

This study evaluated the effect of mass drug administration (MDA) with praziquantel administered to school-aged children (SAC) combined with 'track and treat' of taeniosis cases in the general population on the copro-antigen (Ag) prevalence of taeniosis. The study was conducted in 14 villages in Mbozi and Mbeya district, Tanzania. SAC made up 34% of the population and received MDA with praziquantel (40mg/kg) in 2012 (both districts) and in 2013 (Mbozi only). Three cross-sectional population-based surveys were performed in 2012 (R0), 2013 (R1), and 2014 (R2). In each survey approximately 3000 study subjects of all ages were tested for taeniosis using copro-Ag-ELISA. In total 9064 people were tested and copro-Ag-ELISA positive cases were offered treatment 6-8 months after sampling. The copro-Ag prevalence of taeniosis was significantly higher (Χ2-test, p=0.007) in Mbozi (3.0%) at R0 compared to Mbeya (1.5%). Twelve months after MDA in both districts (R1), the copro-Ag prevalence had dropped significantly in both Mbozi (2.0%, p=0.024) and in Mbeya (0.3%, p=0.004), but the significant difference between the districts persisted (Χ2-test, p<0.001). Ten months after the second round of MDA in Mbozi and 22 month after the first MDA (R2), the copro-Ag prevalence had dropped significantly again in Mbozi (0.8%, p<0.001), but had slightly increased in Mbeya (0.5%, p=0.051), with no difference between the two districts (Χ2-test, p=0.51). The taeniosis cases tracked and treated between round R0 and R2 represented 9% of the projected total number of taeniosis cases within the study area, based on the copro-Ag prevalence and village population data. Among SAC in Mbozi, infection significantly decreased at R1 (p=0.004, OR 0.12, CI: 0.02-0.41) and R2 (p=0.001, OR 0.24, CI: 0.09-0.53) when comparing to R0. In Mbeya infection significant decreased at R1 (p=0.013, OR 0.14, CI: 0.02-0.55), but no difference was found for R2 (p=0. 089), when comparing to R0 among SAC. This study showed that school-based MDA with praziquantel in combination with 'track and treat' of taeniosis cases significantly reduced the copro-Ag prevalence of taeniosis, and that annual MDA was significantly better than single MDA. The persistence of taeniosis cases illustrates that a One Health approach must be emphasized for effective control.

Effect of National Schistosomiasis Control Programme on Taenia solium taeniosis and porcine cysticercosis in rural communities of Tanzania.

Taenia solium is found throughout sub-Saharan Africa and co-endemic with schistosomiasis in many regions. Taenia solium leads to taeniosis and neurocysticercosis - the leading cause of preventable epilepsy globally. This study aimed to assess the effects of the National Schistosomiasis Control Programme on prevalence of taeniosis and porcine cysticercosis over a four year period in Tanzania. School-based mass drug administration (MDA) of praziquantel was carried out based on schistosomiasis endemicity. Four human and five porcine cross-sectional surveys were carried out from 2012 to 2015 in Mbozi and Mbeya district in Tanzania. Three rounds of school-based MDA of praziquantel were delivered in Mbozi and two in Mbeya. The prevalence of taeniosis and porcine cysticercosis was estimated annually. Stool samples were collected from humans and prevalence of taeniosis estimated by copro-Ag-ELISA. Blood samples from pigs were collected to estimate cysticercosis prevalence by Ag-ELISA. "Track-and-treat" of taeniosis cases was carried out after each survey. In total 12082 stool samples and 4579 porcine serum samples were collected. Significantly fewer children (≤ 15) from Mbozi were infected throughout the study than children from Mbeya who showed a significant decrease in copro-Ag prevalence after the first treatment only. During the final survey in Mbozi the prevalence of taeniosis in adults (1.8%) was significantly lower (p = 0.031, OR 0.40, CI: 0.17-0.89), compared to baseline (4.1%). The prevalence of porcine cysticercosis (8%) had also dropped significantly (p = 0.002, OR 0.49, CI: 0.32-0.76) in this district compared to baseline (13%), whereas no significant difference was seen in Mbeya compared to baseline. The study suggests that three rounds of MDA targeting schistosomiasis in school-aged children combined with 'track-and-treat' contributed to a reduction in prevalence of T. solium in this population, and also had a spillover effect on adults in treated areas as well as reducing the prevalence of T. solium in the intermediate pig host population. Elimination of T. solium in this area would require a One Health approach.

The accountability for reasonableness approach to guide priority setting in health systems within limited resources--findings from action research at district level in Kenya, Tanzania, and Zambia.

BACKGROUND: Priority-setting decisions are based on an important, but not sufficient set of values and thus lead to disagreement on priorities. Accountability for Reasonableness (AFR) is an ethics-based approach to a legitimate and fair priority-setting process that builds upon four conditions: relevance, publicity, appeals, and enforcement, which facilitate agreement on priority-setting decisions and gain support for their implementation. This paper focuses on the assessment of AFR within the project REsponse to ACcountable priority setting for Trust in health systems (REACT). METHODS: This intervention study applied an action research methodology to assess implementation of AFR in one district in Kenya, Tanzania, and Zambia, respectively. The assessments focused on selected disease, program, and managerial areas. An implementing action research team of core health team members and supporting researchers was formed to implement, and continually assess and improve the application of the four conditions. Researchers evaluated the intervention using qualitative and quantitative data collection and analysis methods. RESULTS: The values underlying the AFR approach were in all three districts well-aligned with general values expressed by both service providers and community representatives. There was some variation in the interpretations and actual use of the AFR in the decision-making processes in the three districts, and its effect ranged from an increase in awareness of the importance of fairness to a broadened engagement of health team members and other stakeholders in priority setting and other decision-making processes. CONCLUSIONS: District stakeholders were able to take greater charge of closing the gap between nationally set planning and the local realities and demands of the served communities within the limited resources at hand. This study thus indicates that the operationalization of the four broadly defined and linked conditions is both possible and seems to be responding to an actual demand. This provides arguments for the continued application and further assessment of the potential of AFR in supporting priority-setting and other decision-making processes in health systems to achieve better agreed and more sustainable health improvements linked to a mutual democratic learning with potential wider implications.

Involving decision-makers in the research process: Challenges of implementing the accountability for reasonableness approach to priority setting at the district level in Tanzania.

The past two decades have seen a growing call for researchers, policy-makers and health care providers to collaborate in efforts to bridge the gaps between research, policy and practice. However, there has been a little attention focused on documenting the challenges of dealing with decision-makers in the course of implementing a research project. This paper highlights a collaborative research project aiming to implement the accountability for reasonableness (AFR) approach to priority setting in accordance with the Response to Accountable Priority Setting for Trust in Health Systems (REACT) project in Tanzania. Specifically, the paper examines the challenges of dealing with decision-makers during the project-implementation process and shows how the researchers dealt with the decision-makers to facilitate the implementation of the REACT project. Key informant interviews were conducted with the Council Health Management Team (CHMT), local government officials and other stakeholders, using a semi-structured interview guide. Minutes of the Action Research Team and CHMT were analysed. Additionally, project-implementation reports were analysed and group priority-setting processes in the district were observed. The findings show that the characteristics of the REACT research project, the novelty of some aspects of the AFR approach, such as publicity and appeals, the Action Research methodology used to implement the project and the traditional cultural contexts within which the project was implemented, created challenges for both researchers and decision-makers, which consequently slowed down the implementation of the REACT project. While collaboration between researchers and decision-makers is important in bridging gaps between research and practice, it is imperative to understand the challenges of dealing with decision-makers in the course of implementing a collaborative research project. Such analyses are crucial in designing proper strategies for improved communication and for the utilisation of research projects over time.

Promoting community participation in priority setting in district health systems: experiences from Mbarali district, Tanzania.

BACKGROUND: Community participation in priority setting in health systems has gained importance all over the world, particularly in resource-poor settings where governments have often failed to provide adequate public-sector services for their citizens. Incorporation of public views into priority setting is perceived as a means to restore trust, improve accountability, and secure cost-effective priorities within healthcare. However, few studies have reported empirical experiences of involving communities in priority setting in developing countries. The aim of this article is to provide the experience of implementing community participation and the challenges of promoting it in the context of resource-poor settings, weak organizations, and fragile democratic institutions. DESIGN: Key informant interviews were conducted with the Council Health Management Team (CHMT), community representatives, namely women, youth, elderly, disabled, and people living with HIV/AIDS, and other stakeholders who participated in the preparation of the district annual budget and health plans. Additionally, minutes from the Action Research Team and planning and priority-setting meeting reports were analyzed. RESULTS: A number of benefits were reported: better identification of community needs and priorities, increased knowledge of the community representatives about priority setting, increased transparency and accountability, promoted trust among health systems and communities, and perceived improved quality and accessibility of health services. However, lack of funds to support the work of the selected community representatives, limited time for deliberations, short notice for the meetings, and lack of feedback on the approved priorities constrained the performance of the community representatives. Furthermore, the findings show the importance of external facilitation and support in enabling health professionals and community representatives to arrive at effective working arrangement. CONCLUSION: Community participation in priority setting in developing countries, characterized by weak democratic institutions and low public awareness, requires effective mobilization of both communities and health systems. In addition, this study confirms that community participation is an important element in strengthening health systems.

Implementing accountability for reasonableness framework at district level in Tanzania: a realist evaluation.

BACKGROUND: Despite the growing importance of the Accountability for Reasonableness (A4R) framework in priority setting worldwide, there is still an inadequate understanding of the processes and mechanisms underlying its influence on legitimacy and fairness, as conceived and reflected in service management processes and outcomes. As a result, the ability to draw scientifically sound lessons for the application of the framework to services and interventions is limited. This paper evaluates the experiences of implementing the A4R approach in Mbarali District, Tanzania, in order to find out how the innovation was shaped, enabled, and constrained by the interaction between contexts, mechanisms and outcomes. METHODS: This study draws on the principles of realist evaluation -- a largely qualitative approach, chiefly concerned with testing and refining programme theories by exploring the complex interactions of contexts, mechanisms, and outcomes. Mixed methods were used in data collection, including individual interviews, non-participant observation, and document reviews. A thematic framework approach was adopted for the data analysis. RESULTS: The study found that while the A4R approach to priority setting was helpful in strengthening transparency, accountability, stakeholder engagement, and fairness, the efforts at integrating it into the current district health system were challenging. Participatory structures under the decentralisation framework, central government's call for partnership in district-level planning and priority setting, perceived needs of stakeholders, as well as active engagement between researchers and decision makers all facilitated the adoption and implementation of the innovation. In contrast, however, limited local autonomy, low level of public awareness, unreliable and untimely funding, inadequate accountability mechanisms, and limited local resources were the major contextual factors that hampered the full implementation. CONCLUSION: This study documents an important first step in the effort to introduce the ethical framework A4R into district planning processes. This study supports the idea that a greater involvement and accountability among local actors through the A4R process may increase the legitimacy and fairness of priority-setting decisions. Support from researchers in providing a broader and more detailed analysis of health system elements, and the socio-cultural context, could lead to better prediction of the effects of the innovation and pinpoint stakeholders' concerns, thereby illuminating areas that require special attention to promote sustainability.

Improving district level health planning and priority setting in Tanzania through implementing accountability for reasonableness framework: Perceptions of stakeholders.

BACKGROUND: In 2006, researchers and decision-makers launched a five-year project - Response to Accountable Priority Setting for Trust in Health Systems (REACT) - to improve planning and priority-setting through implementing the Accountability for Reasonableness framework in Mbarali District, Tanzania. The objective of this paper is to explore the acceptability of Accountability for Reasonableness from the perspectives of the Council Health Management Team, local government officials, health workforce and members of user boards and committees. METHODS: Individual interviews were carried out with different categories of actors and stakeholders in the district. The interview guide consisted of a series of questions, asking respondents to describe their perceptions regarding each condition of the Accountability for Reasonableness framework in terms of priority setting. Interviews were analysed using thematic framework analysis. Documentary data were used to support, verify and highlight the key issues that emerged. RESULTS: Almost all stakeholders viewed Accountability for Reasonableness as an important and feasible approach for improving priority-setting and health service delivery in their context. However, a few aspects of Accountability for Reasonableness were seen as too difficult to implement given the socio-political conditions and traditions in Tanzania. Respondents mentioned: budget ceilings and guidelines, low level of public awareness, unreliable and untimely funding, as well as the limited capacity of the district to generate local resources as the major contextual factors that hampered the full implementation of the framework in their context. CONCLUSION: This study was one of the first assessments of the applicability of Accountability for Reasonableness in health care priority-setting in Tanzania. The analysis, overall, suggests that the Accountability for Reasonableness framework could be an important tool for improving priority-setting processes in the contexts of resource-poor settings. However, the full implementation of Accountability for Reasonableness would require a proper capacity-building plan, involving all relevant stakeholders, particularly members of the community since public accountability is the ultimate aim, and it is the community that will live with the consequences of priority-setting decisions.

Decentralized health care priority-setting in Tanzania: evaluating against the accountability for reasonableness framework.

Priority-setting has become one of the biggest challenges faced by health decision-makers worldwide. Fairness is a key goal of priority-setting and Accountability for Reasonableness has emerged as a guiding framework for fair priority-setting. This paper describes the processes of setting health care priorities in Mbarali district, Tanzania, and evaluates the descriptions against Accountability for Reasonableness. Key informant interviews were conducted with district health managers, local government officials and other stakeholders using a semi-structured interview guide. Relevant documents were also gathered and group priority-setting in the district was observed. The results indicate that, while Tanzania has a decentralized public health care system, the reality of the district level priority-setting process was that it was not nearly as participatory as the official guidelines suggest it should have been. Priority-setting usually occurred in the context of budget cycles and the process was driven by historical allocation. Stakeholders' involvement in the process was minimal. Decisions (but not the reasoning behind them) were publicized through circulars and notice boards, but there were no formal mechanisms in place to ensure that this information reached the public. There were neither formal mechanisms for challenging decisions nor an adequate enforcement mechanism to ensure that decisions were made in a fair and equitable manner. Therefore, priority-setting in Mbarali district did not satisfy all four conditions of Accountability for Reasonableness; namely relevance, publicity, appeals and revision, and enforcement. This paper aims to make two important contributions to this problematic situation. First, it provides empirical analysis of priority-setting at the district level in the contexts of low-income countries. Second, it provides guidance to decision-makers on how to improve fairness, legitimacy, and sustainability of the priority-setting process.

Accountable priority setting for trust in health systems--the need for research into a new approach for strengthening sustainable health action in developing countries.

Despite multiple efforts to strengthen health systems in low and middle income countries, intended sustainable improvements in health outcomes have not been shown. To date most priority setting initiatives in health systems have mainly focused on technical approaches involving information derived from burden of disease statistics, cost effectiveness analysis, and published clinical trials. However, priority setting involves value-laden choices and these technical approaches do not equip decision-makers to address a broader range of relevant values - such as trust, equity, accountability and fairness - that are of concern to other partners and, not least, the populations concerned. A new focus for priority setting is needed.Accountability for Reasonableness (AFR) is an explicit ethical framework for legitimate and fair priority setting that provides guidance for decision-makers who must identify and consider the full range of relevant values. AFR consists of four conditions: i) relevance to the local setting, decided by agreed criteria; ii) publicizing priority-setting decisions and the reasons behind them; iii) the establishment of revisions/appeal mechanisms for challenging and revising decisions; iv) the provision of leadership to ensure that the first three conditions are met.REACT - "REsponse to ACcountable priority setting for Trust in health systems" is an EU-funded five-year intervention study started in 2006, which is testing the application and effects of the AFR approach in one district each in Kenya, Tanzania and Zambia. The objectives of REACT are to describe and evaluate district-level priority setting, to develop and implement improvement strategies guided by AFR and to measure their effect on quality, equity and trust indicators. Effects are monitored within selected disease and programme interventions and services and within human resources and health systems management. Qualitative and quantitative methods are being applied in an action research framework to examine the potential of AFR to support sustainable improvements to health systems performance.This paper reports on the project design and progress and argues that there is a high need for research into legitimate and fair priority setting to improve the knowledge base for achieving sustainable improvements in health outcomes.

The combined effect of the Lymphatic Filariasis Elimination Programme and the Schistosomiasis and Soil-transmitted Helminthiasis Control Programme on soil-transmitted helminthiasis in schoolchildren in Tanzania.

The combined effect of the Lymphatic Filariasis Elimination Programme (LFEP) and the National Schistosomiasis and Soil-transmitted Helminthiasis Control Programme (NSSCP) on soil-transmitted helminthiasis (STH) was evaluated. In September 2004, before mass drug administration (MDA) with ivermectin and albendazole by the LFEP in October, the prevalence and intensity of STH were recorded in 228 pupils in one primary school. After 8 months, all available pupils were re-examined, and the prevalence of Ascaris lumbricoides, Trichuris trichiura and hookworm had decreased from 0.9 to 0.7% (P=0.84), from 4.8 to 0.7% (P=0.004) and from 45.6 to 11.9% (P<0.001), respectively. Overall, 81.2% of the schoolchildren stated that they were treated by the LFEP in October 2004. After the 8 months follow-up, pupils were treated with praziquantel and albendazole by the present project (substitute for the NSSCP). After another 4 months (at 12 months follow-up), the prevalence of hookworm infection was reduced to 4.8% (P=0.003), while the prevalence of T. trichiura was reduced to 0.3% (P=0.54) and the prevalence of A. lumbricoides remained unchanged. Mass co-administration of ivermectin and albendazole by the LFEP had a significant effect on STH, which was further amplified by treatment with praziquantel and albendazole 4 months later.

The effect of the community-directed treatment approach versus the school-based treatment approach on the prevalence and intensity of schistosomiasis and soil-transmitted helminthiasis among schoolchildren in Tanzania.

This study compared the effect of the community-directed treatment (ComDT) approach and the school-based treatment approach on the prevalence and intensity of schistosomiasis and soil-transmitted helminthiasis (STH) among schoolchildren. Following a parasitological survey in a randomly selected sample of 1140 schoolchildren, school-age children in 10 study villages received one dose of praziquantel (40 mg/kg body weight) against schistosomiasis and one dose of albendazole (400mg) against STH. Five of these villages implemented the ComDT approach and received treatment by community drug distributors, while school teachers administered treatment in five other villages using the school-based approach. At 12 months follow-up, the prevalence of Schistosoma mansoni and Trichuris trichiura infections were similar between the ComDT and the school-based approaches when examined in randomly selected schoolchildren (10.1 vs. 9.4%, P=0.66 and 0.8 vs. 1.4%, P=0.37). However, the prevalence of S. haematobium and hookworm infections were significantly lower in the ComDT approach villages compared to the school-based approach villages (10.6 vs. 16.3%, P=0.005 and 2.9 vs. 5.8%, P=0.01, respectively). The results showed that the ComDT approach is at least as effective as the school-based approach in reducing prevalence and intensity of schistosomiasis and STH among schoolchildren.

What do district health planners in Tanzania think about improving priority setting using 'Accountability for reasonableness'?

BACKGROUND: Priority setting in every health system is complex and difficult. In less wealthy countries the dominant approach to priority setting has been Burden of Disease (BOD) and cost-effectiveness analysis (CEA), which is helpful, but insufficient because it focuses on a narrow range of values - need and efficiency - and not the full range of relevant values, including legitimacy and fairness. 'Accountability for reasonableness' is a conceptual framework for legitimate and fair priority setting and is empirically based and ethically justified. It connects priority setting to broader, more fundamental, democratic deliberative processes that have an impact on social justice and equity. Can 'accountability for reasonableness' be helpful for improving priority setting in less wealthy countries? METHODS: In 2005, Tanzanian scholars from the Primary Health Care Institute (PHCI) conducted 6 capacity building workshops with senior health staff, district planners and managers, and representatives of the Tanzanian Ministry of Health to discussion improving priority setting in Tanzania using 'accountability for reasonableness'. The purpose of this paper is to describe this initiative and the participants' views about the approach. RESULTS: The approach to improving priority setting using 'accountability for reasonableness' was viewed by district decision makers with enthusiastic favour because it was the first framework that directly addressed their priority setting concerns. High level Ministry of Health participants were also very supportive of the approach. CONCLUSION: Both Tanzanian district and governmental health planners viewed the 'accountability for reasonableness' approach with enthusiastic favour because it was the first framework that directly addressed their concerns.