Abstract
Because public health must operate at scale in widely diverse, complex situations, randomized controlled trials (RCTs) have limited utility for public health. Other methodologies are needed. A key conceptual backbone is a detailed "theory of change" to apply appropriate evidence for each operational component. Synthesizing patterns of findings across multiple methodologies provides key insights. Programs operating successfully across a variety of settings can provide some of the best evidence. Challenges include judging the quality of such evidence and assisting programs to apply it. WHO and others should shift emphasis from RCTs to more relevant evidence when assessing public health issues.
Highlights
Because public health must operate at scale in widely diverse, complex situations, randomized controlled trials (RCTs) have limited utility for public health
The hallmark of Evidence-based medicine (EBM) is the randomized controlled trial (RCT) with its potentially strong ‘‘internal validity’’ to answer precise questions under narrow conditions—generally whether and how well an intervention such as a drug works for individuals
We use the term ‘‘efficacy’’ to mean how well an intervention works under the best circumstances, typically based on RCT evidence, and ‘‘effectiveness’’ to mean actual results, especially at scale, which are usually attenuated under real-world conditions
Summary
Because public health must operate at scale in widely diverse, complex situations, randomized controlled trials (RCTs) have limited utility for public health. Public health must operate at large scale, addressing the needs of large populations across clinical, behavior, and structural platforms, and necessarily entails crucial operational issues, variability, and complexity as well as consideration of resource requirements and sustainability. We use the term ‘‘efficacy’’ to mean how well an intervention works under the best circumstances, typically based on RCT evidence, and ‘‘effectiveness’’ to mean actual results, especially at scale, which are usually attenuated under real-world conditions. To decision-making address such questions, evidence-based public requires health (EBPH) must go well beyond RCTs to knowledge of not include other valid methodologies to arrive at just whether optimal public health programming. Under particular circumstances but LIMITATIONS OF RCTS FOR PUBLIC HEALTH how, when, RCT methodology entails a host of challenges, and why for including burdensome cost and time requirebroad application. RCTs are ‘‘controlled,’’ they are typically carried out under optimal and rather artificial conditions, which are frequently difficult to transfer to practical real-world conditions
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