A narrative review completed by GetReal examined the literature related to the concept of the efficacy-effectiveness gap. The authors used inductive analysis to identify the different ways, referred to here as ‘paradigms’, of understanding the efficacy-effectiveness gap (see definition here) that have evolved over the last few decades. These are summarised in the table below.
|1. Method used to assess the effects of a medicine||
|2. Impact of patient and clinician’s behaviour or real-life characteristics of the healthcare system||
|3. Interaction between a medicine’s biological effect and contextual factors||
Current view on the efficacy-effectiveness gap
The third and current paradigm provides the opportunity to look beyond the differences between ‘standardised’ and ‘real-life’ characteristics of the healthcare system and study designs. Many authors would rather consider a continuum between explanatory and pragmatic trials: ‘the explanatory‑pragmatic continuum’ (see the description of pragmatic trials here). Future research will determine if the identification of these contextual factors can help to design RCTs that provide better estimates of drug effectiveness.
Clementine Nordon, LASER