Threlfall Anthony G, Meah Soraya, Fischer Alastair J, Cookson Richard, Rutter Harry, Kelly Michael P
Theorize Ltd, Manchester, UK.
Independent Researcher, Liverpool, UK.
J Public Health (Oxf). 2015 Mar;37(1):166-71. doi: 10.1093/pubmed/fdu044. Epub 2014 Jul 11.
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.
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.
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.
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.
公共卫生决策受到阻碍，因为人们不恰当地依赖效力不足的随机对照试验（RCT），这些试验结果不明确，导致决策者不愿推荐那些有强有力理论和观察支持的干预措施。
我们概述了在没有试验证据的情况下也能对健康干预措施做出可靠决策的情形。我们提出了一种新方法，即在决策过程中要适当考虑理论、因果模型和过去的观察结果。
运用我们的方法，我们给出了一些例子，比如在减盐、戒烟以及园艺改善心理健康等领域，使用因果理论和观察结果足以判定这些干预措施对改善健康有效，而无需效力不足的随机对照试验的支持。特别是在随机对照试验证据不明确的情况下，我们的方法可能以低得多的成本为社会带来类似的总体健康效益。
当知识和理论理解不足以充分减少对干预效果方向的疑虑时，应采用循证医学方法做出决策。然而，在许多情况下，强有力的理论、因果理解和观察结果相结合能够提供足够的证据证明干预效果的方向，此时就应该改变当前的做法。
