Background: Clinicians, the public (including patients), policymakers, payers, regulators, and science communities invest considerable amounts of resources in making decisions at various levels using systematic reviews, health technology assessments (HTA), guideline recommendations, coverage decisions, selection of essential medicines and diagnostics, quality improvement, and policy and evidence briefs. With the World Health Organization (WHO), we have developed a conceptual approach that we call “Theory of Everything (ToE) in health decision-making” to connect the actors in this ecosystem. Our work, focusing on high-income countries, shows that criteria and methods that these actors use differ but that they frequently overlap and exist together (Schünemann et al., Lancet PH 2022). The widely used Evidence to Decision (EtD) frameworks form the connecting framework for our conceptual approach (Figure 1). This work has received broad attention, in particular by regulators, and in the guideline, HTA, and health policy community. These actors need to be linked together, and capacity is required to create interaction and decision consensus in and across jurisdictions. However, particularly in emerging economies and low and middle income countries (LMIC), the risk of sparse, redundant or conflicting decisions across the decision ecosystem may be costly. In particular, without coordination, actions by different stakeholders might contribute to decision instability and volatile national health policies.
Objectives: We are evaluating the flexibility, gradualism, and completeness of the ToE through consideration of new perspectives and exploration of its applicability at LMIC level to understand barriers-enablers and necessary prerequisites.
Methods: We are using a mixed-methods approach including surveys of existing and new stakeholders who play a role in the ecosystem, including regulators and industry, in high-income countries and LMIC, a Delphi approach, and actual work with countries to gain further insights regarding the applicability of the approach. Anticipated results and conclusions: At the Cochrane Colloquium we will report on 1) the update and expansion of the ToE; 2) case examples for countries of connecting the decision-making actors, and 3) a draft blueprint and roadmap for operationalization of the ToE in various settings.

ToE slide original.pdf