Abstract
The precautionary principle (PP) has been used in the evaluation of the effectiveness and/or cost-effectiveness of interventions designed to prevent future harms in a range of activities, particularly in the area of the environment. Here, we provide details of circumstances under which the PP can be applied to the topic of harm reduction in Public Health. The definition of PP that we use says that the PP reverses the onus of proof of effectiveness between an intervention and its comparator when the intervention has been designed to reduce harm. We first describe the two frameworks used for health-care evaluation: evidence-based medicine (EBM) and decision theory (DT). EBM is usually used in treatment effectiveness evaluation, while either EBM or DT may be used in evaluating the effectiveness of the prevention of illness. For cost-effectiveness, DT is always used. The expectation in Public Health is that interventions employed to reduce harm will not actually increase harm, where “harm” in this context does not include opportunity cost. That implies that an intervention’s effectiveness can often be assumed. Attention should therefore focus on its cost-effectiveness. This view is consistent with the conclusions of DT. It is also very close to the PP notion of reversing the onus of proof, but is not consistent with EBM as normally practiced, where the onus is on showing a new practice to be superior to usual practice with a sufficiently high degree of certainty. Under our definitions, we show that where DT and the PP differ in their evaluation is in cost-effectiveness, but only for decisions that involve potential catastrophic circumstances, where the nation-state will act as if it is risk-averse. In those cases, it is likely that the state will pay more, and possibly much more, than DT would allow, in an attempt to mitigate impending disaster. That is, the rules that until now have governed all cost-effectiveness analyses are shown not to apply to catastrophic situations, where the PP applies.
Highlights
Pregnant women and those who hope to become pregnant in the near future should take precautions so that they are not exposed to the Zika virus during or just before pregnancy
Other criteria generally play a role in the decision-making process only after effectiveness from randomized controlled trials (RCTs) has been established with sufficient certainty
For cost-effectiveness analysis that is able to compare disparate interventions anywhere in health care, the health effects of an intervention are converted into one of two similar generic measures known as a quality-adjusted life-year (QALY) or a Evidence-based medicine
Summary
Pregnant women and those who hope to become pregnant in the near future should take precautions so that they are not exposed to the Zika virus during or just before pregnancy. RCTs find themselves at the top of a hierarchy of evidence in which Hill’s other criteria play a secondary role This is true in the appraisal of health technology assessment (HTA), where RCTs are used to establish the direction of the effect of an intervention, where the estimated effect is sufficiently large (compared with its SD) to have only a specified small probability of being due to chance. The methodology is that of DT apart from the need to ensure that an intervention has a very low probability of doing harm (see Table 1 for a comparison of EBM and DT characteristics) These measures are generally used when the appropriate RCTs are underpowered, or where RCT evidence does not exist, and include prior beliefs about the effectiveness of an intervention, the use of non-controlled studies, the role of established theory, and expert opinion about current best practice [19]. For cost-effectiveness analysis that is able to compare disparate interventions anywhere in health care, the health effects of an intervention are converted into one of two similar generic measures known as a quality-adjusted life-year (QALY) or a
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