Aims: Randomised controlled trials (RCTs) are considered the ‘gold standard’ approach to determining effectiveness of healthcare interventions. However, such reductive, ‘medical model’ approaches may not fully determine effectiveness of complex, digital technology-enhanced behavioural interventions. Such interventions, formed of multiple components, may be tailorable to the needs of the individual, and may be continually updated as technological capabilities evolve. Therefore, published research examining effectiveness of computer-assisted therapy (CAT) programme for substance misuse, Breaking Free Online (BFO), has been informed by novel guidance from the Medical Research Council (MRC).
Methods: This MRC guidance recommends a perpetual cycle of development and evaluation, utilising multiple methodologies, to generate data spanning a ‘hierarchy of evidence’, from small-scale studies, to clinical trials and meta-analyses. The MRC framework examines ‘mechanisms of action’ of specific intervention components, which is important when evidencing continually evolving, tailorable interventions. The guidance also examines processes of implementation through healthcare systems, which is highly relevant for digital interventions which may be perceived as ‘disruptive’.
Results: Published BFO research demonstrates the utility of the MRC framework in understanding effectiveness and implementation of complex, digital, tailorable interventions. Informed by this research, the authors challenge the notion of a ‘hierarchy’ of evidence and propose a ‘spectrum’ of evidence may be more appropriate for complex, digital interventions such as BFO.
Conclusions: Though RCTs are important in determining effectiveness of interventions, complex, digital behavioural interventions may require an evolved research paradigm, with the MRC framework providing a promising alternative within the bourgeoning field of digital substance misuse interventions.