Methodological Issues of using Placebos in Interventions Based on Digital Technology

Abstract

Background/Aims: Use of placebo is the ideal for comparison in clinical trials to reduce biases. With digital technology being used more frequently in healthcare interventions, how do we determine the placebo effect where interventions exploit technology? If placebo in medicine is traditionally defined by a lack of pharmacological agents, how might we begin to move towards controlling for effects of digital technology? Method: This paper explores the traditional placebo effect and discusses its impact in healthcare contexts with digital technology with reference to a particular trial. Different meanings of placebo in the context of evaluating technology suggest new challenges and positive consequences. Results: Methodological considerations are discussed, which enabled the development of a placebocontrolled evaluation of a digital technology in healthcare and rehabilitation. Conclusion: Digital placebo was controlled in our trial by employing technology across all groups in the absence of evidence-based practice and shows how to control for unknown and hidden effects of technology.