How do participatory methods shape policy? Applying a realist approach to the formulation of a new tuberculosis policy in Georgia.

OBJECTIVES: This paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt. METHODS: Guided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders' assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these. SETTING: The study was conducted in Tbilisi, Georgia. PARTICIPANTS: A total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops. RESULTS: Findings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement. CONCLUSIONS: Developing policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders' knowledge and expertise on TB service delivery and RBF to codesign a new policy.

A survey of nongovernmental organizations on their use of WHO's prequalification programme.

OBJECTIVE: To obtain the perspectives of some small- and medium-sized organizations on the World Health Organization (WHO) prequalification programme for medicines and to ascertain organizations' unmet needs. METHODS: We conducted an exploratory, qualitative study in 2018 among 17 representatives of 15 small- and medium-sized Belgian and non-Belgian organizations who purchase medicines for humanitarian, development or public programmes in low- and middle-income countries. We used semi-structured interviews to obtain respondents' views and experiences of using WHO prequalification guidance when procuring medicines. We identified emerging themes and formulated recommendations about the activities of the WHO Prequalification Team. FINDINGS: Most respondents suggested expanding prequalification to essential antibiotics, particularly paediatric formulations; and insulin, antihypertensives and cancer treatments. Respondents were concerned about irregular availability of WHO-prequalified medicines in the marketplace and sometimes high prices of prequalified products. Small organizations, in particular, had difficulties negotiating low-volume purchases. Organizations working in primary health care and hospitals seldom referred to the prequalified lists. CONCLUSION: We recommend that the WHO-prequalified products be expanded to include essential antibiotics and medicines for noncommunicable diseases. The WHO Prequalification Team could require prequalified manufacturers to make publicly available the details of their authorized distributors and facilitate a process of harmonization of quality assurance policies across all donors. Prequalification of distributors and procurement agencies could help create more transparent and stringent mechanisms. We urge WHO Member States and funders to sustain support for the WHO Prequalification Team, which remains important for the fulfilment of universal health coverage.

Designing and evaluating provider results-based financing for tuberculosis care in Georgia: a realist evaluation protocol.

INTRODUCTION: In 2016, Georgian researchers and policymakers were developing a policy to improve the performance of the national tuberculosis (TB) control programme. The research programme 'Designing and Evaluating Provider Results-Based Financing for Tuberculosis Care in Georgia: Understanding Costs, Mechanisms of Effect and Impact (Results4TB)' was initiated to inform the policy formulation phase, document the policy implementation and assess the effectiveness, cost-effectiveness and the processes of change. To achieve this, the research team intends to combine an impact evaluation, a cost-effectiveness study and a realist evaluation (RE) within an overarching theory-informed design. This protocol is the RE component of the programme. METHODS: A realist methodological approach will be adopted to guide the research design and evaluation. RE answers the question of 'what works in which conditions for whom?' and starts with the development of an initial programme theory (IPT). The IPT will feed into other phases of the realist research cycle (study design, data collection, data analysis and synthesis and theory refinement). Data will be collected in a multiple embedded case study design (five intervention and three control sites) through document reviews, in-depth interviews, non-participant observations and context mapping at facility and national levels. Additional data from other research components (cost-effectiveness and impact evaluation) will aid data triangulation. ETHICS AND DISSEMINATION: The Institutional Review Boards of the National Centre for Disease Control and Public Health in Georgia (ref. IRB # 2018-019) and the Institute of Tropical Medicine, Antwerp (ref. IRB #- 1240/18) have granted ethical approval to the study. TRIAL REGISTRATION NUMBER: ISRCTN14667607.