ABSTRACT
BACKGROUND: Public health decision-making is hampered by inappropriate adherence to underpowered randomized controlled trials (RCTs) which give inconclusive results and lead to decision-makers being loath to recommend interventions with strong theoretical and observational support. METHODS: We outline situations in which robust decisions about health interventions can be made without trial evidence. We present a new approach in which theory, causal models and past observations are given proper regard in the decision-making process. RESULTS: Using our approach, we provide examples where the use of causal theories and observations in areas, such as salt reduction, smoking cessation and gardening to improve mental health, is sufficient for deciding that such interventions are effective for improving health without needing the support of underpowered RCTs. Particularly where RCT evidence is inconclusive, our approach may provide similar aggregate health outcomes for society for vastly lower cost. CONCLUSIONS: When knowledge and theoretical understanding are unable sufficiently to reduce doubt about the direction of effect from an intervention, decisions should be made using evidence-based medicine approaches. There are, however, many cases where the combination of robust theory, causal understanding and observation are able to provide sufficient evidence of the direction of effect from an intervention that current practice should be altered.
