Evidence map›Paper›PMID 31914995›Full record

ArticleBMC medical ethics2020

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

Andrea Martani, Lester Darryl Geneviève, Christopher Poppe, Carlo Casonato, Tenzin Wangmo

Abstract readScoping Review
In one paragraph

Article in BMC medical ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  11. Digital Pills with Ingestible Sensors: Patent Landscape Analysis.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Andrea MartaniInstitute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, Basel, Switzerland. andrea.martani@unibas.ch.ORCID 0000-0003-2113-1002
Lester Darryl GenevièveInstitute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, Basel, Switzerland.
Christopher PoppeInstitute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, Basel, Switzerland.
Carlo CasonatoFaculty of Law, University of Trento, Trento, Italy.
Tenzin WangmoInstitute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDigital 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.

methodsTo 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.

resultsOur 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.

conclusionsWe 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.

Indexed as

Ethical AnalysisMedical Informatics ApplicationsMedication AdherenceBiosensing TechniquesCapsulesHumansCapsulesDigital medicineDigital pillsEthics of technologyMobile healthMonitoring devicesScoping review

Identifiers

PMID31914995
PMCPMC6950823

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.