JMIR Publications

ABSTRACT

Background:

Digital pills (DPs) are pills combined with a sensor, which, when the pill is ingested, sends a signal to a patch connected to a smartphone. Healthcare professionals (HCPs) can access patient data from DPs online via their own interface, thus allowing to check whether a patient took the drug. DP were developed in the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pill (DP) in November 2017, but the manufacturer withdrew its application to the European Medicines Agency in July 2020 because of insufficient evaluation.

Objective:

As recommended for the evaluation of health technologies, this study assesses the prospective acceptability of and willingness to take DPs among patients, the public and healthcare professionals (HCPs).

Methods:

Participants were 1) patients with long-term treatment for a chronic disease, 2) public participants (both groups recruited from a representative sample) and 3) HCPs. Participants answered five open-ended questions regarding the acceptability of DPs and one close-ended question regarding the willingness to take DPs, developed in a preliminary qualitative study. We explored the 5 theoretical dimensions of acceptability by performing an abductive qualitative content analysis of all free-text responses. We assessed data saturation with mathematical models. Moreover, we fitted a multivariate logistic regression model to identify the socio-demographic and health characteristics associated with the willingness to take DPs.

Results:

Between January 29 and April 18, 2020, 767 patients, 1238 public participants and 246 HCPs provided 11 451 free-text responses. We identified 98 themes related to the acceptability of DPs, classified as perceived clinical effectiveness [29 themes, e.g. sensor safety, cited by 665 of 2251 (29.5%) participants], perceived burden [6 themes, e.g. increased doctors’ workload; 164 (7.3%)], perceived ethicality [25 themes, e.g. policing; 345 (15.3%)], perceived opportunity [30 themes, e.g. an exclusively negative perception; 690 (30.7%)], and affective attitude [8 themes, e.g. anger; 541 (24%)]. Overall, 271 (35.3%) patients, 376 (30.4%) public participants and 39 (15.8%) HCPs reported to agree to take DPs, which was associated with male sex (odds ratio 1.98, 95% confidence interval 1.62 to 2.43) and current use of a connected device to record health settings (with a dose–response relationship).

Conclusions:

The prospective acceptability of and willingness to take DPs was limited in the three subpopulations by clinical and ethical concerns both at an individual and societal level. Our results suggest that DPs should not be considered as a mere change in the form of drug administration but rather a complex intervention requiring specific evaluation before extended use in clinical routine practice requires and the development of an ethical and legal framework to ensure the safe and ethical collection and use of health data in a patient-centered approach.