“…By using an app, there would be a continuous measurement of PD fluctuation. Another use relates to the test of adherence using ingestible sensors . There are several medical‐grade apps in development that require regulatory agency clearance for marketing.…”
Pharmaceutical development is witnessing an increase in the use of digital technologies in the delivery of pharmaceutical substances, data generation, and data interpretation. These digital technologies offer the valuable benefits of speed, enhanced integration with various other components, visualization of a continuum, and improving precision of delivery or measurement. The adoption of these opportunities in early clinical development has been slow and sparse. This commentary analyzes these benefits, including the socialization and adoption of such practices.
“…By using an app, there would be a continuous measurement of PD fluctuation. Another use relates to the test of adherence using ingestible sensors . There are several medical‐grade apps in development that require regulatory agency clearance for marketing.…”
Pharmaceutical development is witnessing an increase in the use of digital technologies in the delivery of pharmaceutical substances, data generation, and data interpretation. These digital technologies offer the valuable benefits of speed, enhanced integration with various other components, visualization of a continuum, and improving precision of delivery or measurement. The adoption of these opportunities in early clinical development has been slow and sparse. This commentary analyzes these benefits, including the socialization and adoption of such practices.
“…Digital pills have been developed for the stated goal of improving medication adherence and optimizing treatment management; these are used to identify nonadherence to first-line therapies before more expensive second-line therapies can be considered [10,13]. The European Medicines Agency declared that the evaluation for the digital pill submitted was inadequate and withdrew the application on July 26, 2020; the quality of the available studies (observational studies or small trials) and the lack of clinical relevance of the outcomes (short-term outcomes related to adherence to digital pills, safety outcomes restricted to tolerance of the patch) were points of criticism that led to this withdrawal [12,[14][15][16][17].…”
Background
Digital pills are pills combined with a sensor, which sends a signal to a patch connected to a smartphone when the pills are ingested. Health care professionals can access patient data from digital pills online via their own interface, thus allowing them to check whether a patient took the drug. Digital pills were developed for the stated goal of improving treatment adherence. The US Food and Drug Administration approved the first digital pills 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 digital pills among patients, the public, and health care professionals.
Methods
Participants were patients who were receiving long-term treatment for a chronic condition, public participants (both groups recruited from a representative sample), and health care professionals. Participants answered 5 open-ended questions regarding the acceptability of digital pills and 1 close-ended question regarding the willingness to take digital pills, which were 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. We fitted a multivariate logistic regression model to identify the sociodemographic and health characteristics associated with the willingness to take digital pills.
Results
Between January 29, 2020, and April 18, 2020, 767 patients, 1238 public participants, and 246 health care professionals provided 11,451 free-text responses. We identified 98 codes related to the acceptability of digital pills: 29 codes on perceived clinical effectiveness (eg, sensor safety cited by 66/2251 participants, 29.5%), 6 on perceived burden (eg, increased doctors’ workload, 164/2251 participants, 7.3%), 25 on perceived ethicality (eg, policing, 345/2251 participants, 15.3%), 30 codes on perceived opportunity (eg, exclusively negative perception, 690/2251 participants, 30.7%), and 8 on affective attitude (eg, anger, 541/2251, 24%). Overall, 271/767 (35.3%) patients, 376/1238 (30.4%) public participants, and 39/246 (15.8%) health care professionals reported willingness to take digital pills. This willingness was associated with male sex (odds ratio 1.98, 95% CI 1.62-2.43) 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 digital pills were limited by clinical and ethical concerns both at the individual and societal level. Our results suggest that digital pills should not be considered a mere change in the form of drug administration but a complex intervention requiring specific evaluation before extended use in clinical routine practice as well as an ethical and legal framework to ensure safe and ethical collection and use of health data through a patient-centered approach.
“…Preliminary results among patients with uncontrolled hypertension and diabetes found that 84% of those who used the DMP met their blood pressure targets after 4 weeks, compared to 33% of usual care patients. 17 The aim of this work was to develop a conceptual framework based on existing literature, augmented by expert and patient feedback, to understand how DMPs influence adherence. Our initial analysis of how DMP affects patient adherence behavior focuses on a patient's decision to take the Nth dose of a prescribed medication to treat a chronic disease.…”
Section: Introductionmentioning
confidence: 99%
“…Preliminary results among patients with uncontrolled hypertension and diabetes found that 84% of those who used the DMP met their blood pressure targets after 4 weeks, compared to 33% of usual care patients. 17 Figure 1.DMP for hypertensive therapy, modified from Noble et al [2016].…”
Section: Introductionmentioning
confidence: 99%
“…When patients take these medications, sensors send a signal that is communicated to patients and providers. Preliminary evidence suggests that such digital medicine programs (DMPs) improve adherence, [15][16][17][18] yet little is known about how DMPs affect adherence behavior, nor about the way they impact patient-provider interactions.…”
Digital medicine programs (DMPs) are emerging technologies that use sensor-enabled medicine to detect when patients have taken their medication and then provide feedback about adherence. We use qualitative methods to understand how patients change their behavioral patterns while participating in a DMP intervention. An influence diagram outlining the factors hypothesized to affect adherence in DMPs constructed from prior scientific research and expert input was created. Subsequently, we conducted semi-structured interviews with 10 patients to see if their experience supported the relationships outlined in the model. We identified three pathways by which DMPs are likely to change behavior around medication adherence: (1) providing patients and providers with accurate, personalized information about adherence; (2) improving patient–provider interactions by structuring them around this information; and (3) facilitating routines and habits for medication use. Chronically ill patients often fail to adhere to drug regimens. Patients in a DMP intervention used the DMP-provided information to better understand drug efficacy and collaborated with their physician to develop adherence strategies. DMPs can promote medication adherence among patients who are willing to use them and may be most effective if physicians are active partners in the DMP.
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