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Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.

ABSTRACT: BACKGROUND:Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients' physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. METHODS:To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. RESULTS:Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users' interaction with DP, personal sphere, health-related risks and patients' benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. CONCLUSIONS:We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.

SUBMITTER: Martani A

PROVIDER: S-EPMC6950823 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.

Martani Andrea A Geneviève Lester Darryl LD Poppe Christopher C Casonato Carlo C Wangmo Tenzin T

BMC medical ethics 20200108 1

<h4>Background</h4>Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients' physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical ana ...[more]

PMID: 31914995

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Project description:Persons with severe and persistent mental illness (SPMI) make up a vulnerable group within mental healthcare and society. Not only do they suffer from long-term, serious psychiatric disorders; they often also experience considerable problems in their psychosocial functioning. Research has disclosed that the care needs of this target group are complex, and that the life expectancy of these persons is significantly lower than in the general population. Given (1) the lower life expectancy of persons with SPMI, (2) the higher suicide risk related to mental disorders, and (3) the legalization and practice of medical assistance in dying in an increasing number of countries, it is of utmost importance to map the ethical aspects and challenges of end-of-life care needs in persons with SPMI. Therefore, we charted the way end-of-life care is provided for them by means of a scoping review of the scientific literature, with an emphasis on the ethical aspects surrounding it. We explore existing ethical dilemmas; the underlying ethical values, principles and attitudes; and the locus and stakeholders of ethical dialog regarding end-of-life care in persons with SPMI. The results indicate that the four guiding principles of biomedical ethics can well be identified in the literature, and are each addressed in their own specific way: Autonomy in relation to questions regarding the decision-making capacity of persons with SPMI; Justice in relation to access to quality care and the presence of stigma; and Non-maleficence and Beneficence in relation to the ongoing debate regarding the benefits and obstacles in applying palliative care approaches in the context of psychiatry, and the status of the futility-concept therein. Personal virtues and attitudes in care professionals, like compassion, non-abandonment and upholding dignity are key, as care professionals are the main advocates of persons with SPMI, which often lack an extensive social network. Further, we find that the ethical dialog is mainly focused on care professionals and relatives, rather than the persons with SPMI themselves. This is reflected in the existing research that often had the voices of the latter missing. Future research may benefit from the inclusion of persons with SMPI’s first-hand accounts. End-of-life care for persons with SPMI may benefit from identifying and integrating (locally developed) good practices like cross-sectoral education, specific care models, and ethics support.

Project description:BackgroundHealthcare policy and academic literature have promoted improving the transitional care of young people leaving child and adolescent mental health services (CAMHS). Despite the availability of guidance on good practice, there seems to be no readily accessible, coherent ethical analysis of transition. The ethical principles of non-maleficence, beneficence, justice and respect for autonomy can be used to justify the need for further enquiry into the ethical pros and cons of this drive to improve transitional care. The objective of this systematic review was therefore to systematically search for existing ethical literature on child- to adult-orientated health service transitions and to critically appraise and collate the literature, whether empirical or normative.MethodsA wide range of bioethics, biomedical and legal databases, grey literature and bioethics journals were searched. Ancestral and forward searches of identified papers were undertaken. Key words related to transition, adolescence and young adulthood, ethics, law and health. The timeframe was January 2000 to at least March 2016. Titles, abstracts and, where necessary, full articles were screened and duplicates removed. All included articles were critically appraised and a narrative synthesis produced.ResultsEighty two thousand four hundred eighty one titles were screened, from which 96 abstracts were checked. Forty seven full documents were scrutinised, leading to inclusion of two papers. Ancestral and forward searches yielded four further articles. In total, one commentary, three qualitative empirical studies and two clinical ethics papers were found. All focused on young people with complex care needs and disabilities. The three empirical papers had methodological flaws. The two ethical papers were written from a clinical ethics context rather than using a bioethical format. No literature identified specifically addressed the ethical challenges of balancing the delivery of transitional care to those who need it and the risk of pathologizing transient and self-limited distress and dysfunction, which may be normal during adolescence.ConclusionsThere is very little research on ethical aspects of transitional care. Most existing studies come from services for young people with complex care needs and disabilities. There is much scope for improvement in the amount and quality of empirical research and ethical analysis in this area.

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Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.

Publications

Digital pills: a scoping review of the empirical literature and analysis of the ethical aspects.

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