Human factors evaluation of a novel digital medicine system in psychiatry

Peters-Strickland, Timothy; Hatch, Ainslie; Adenwala, Anke; Atkinson, Katie; Bartfeld, Benjamin

doi:10.2147/ndt.s157102

Cited by 15 publications

(17 citation statements)

References 19 publications

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“…Only one study [34] reports that there were no adverse events related to DP usage. One study [47] hints at the possibility that "use errors [ …] might lead to a patient taking a one-pill extra dose", but then claims that these cases "were rare in the validation study". In terms of the beneficial impacts of DP, only a minority of the studies (n = 8) report them and considerations are quite disparate and cautious.…”

Section: Patient-relatedmentioning

confidence: 99%

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

et al. 2020

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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.

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Section: Patient-relatedmentioning

confidence: 99%

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

et al. 2020

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“…Patients need to be able to use/engage with the technology and replace the patch [42]. Human factor studies allowed for the testing of DMSs in SMI to identify user-related risks and make modifications based on the findings [41]. Studies of DMSs in SMI show generally good usability [27,28,42].…”

Section: Discussionmentioning

confidence: 99%

“…Peters-Strickland et al looked at the human factors (HF) of using a digital medicine system in psychiatry patients living with a serious mental illness to eliminate use-related risks which may impact usability. For example, including explicit instructions and eliminating ambiguous wording in the app allowed for decreasing the need for abstract thinking [41]. Other improvements allowed for decreasing the reliance on working memory and overall cognitive effort [41].…”

Section: Psychiatrymentioning

confidence: 99%

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Ingestible Sensors and Medication Adherence: Focus on Use in Serious Mental Illness

2020

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Background: Poor medication adherence is a major public health concern. Patients living with a serious mental illness (SMI) commonly present with non-adherence to their medication regimen, which can lead to relapse and hospitalizations. The high rates of antipsychotic non-adherence continue to persist despite several interventions and medication advances. This review evaluates the possible role of the ingestible sensor technology for medication adherence in different conditions, with a focus on use in the SMI schizophrenia. Methods: Literature searches were conducted in July 2019 in the PubMed database. Results: In small studies of ingestible sensor use, the average adherence ranged from 73.9% to 88.6% for SMI and ≥ 80% for cardiac and transplant (99.4%) patients. In SMI studies, patients were clinically stable, and the majority had a clinical global impression severity of “mild disease”. Patients generally experienced relatively minor dermatological adverse effects related to wearable sensor use. Conclusions: A medication with an ingestible sensor may help provide real-time objective medication-taking adherence information for clinicians. However, further studies are needed to understand the impact of use on adherence and improvement on treatment outcomes with the ingestible sensor technology.

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“…For example, the FDA has granted the first approval of a digital medicine system. Abilify MyCite ® (aripiprazole tablets that incorporate a digital sensor, Proteus Digital Health, 2017) records when patients take their medication and is approved for use in the treatment of schizophrenia, bipolar disorder and depression ( Peters-Strickland et al, 2018 ). The pill sends a signal to a wearable patch that transmits the information to a mobile device, such as a phone.…”

Section: Keynote: the Past Present And Future Of Pharmaceutical Medimentioning

confidence: 99%

The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development

Reijntjes¹,

Albayaty

Bush

et al. 2018

Front. Pharmacol.

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The Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) annual meeting focused on the changing face of early phase drug development and opened with a keynote speech concerning the revolution in pharmaceutical medicine over the last 30 years and the impact this has had on the way patients are treated. Examples were presented of how translational pharmaceutics is being used to tackle the high drug candidate failure rate and is improving productivity when moving drug candidates from the laboratory through to clinical proof of concept. The European Medicines Agency revised 2007 Risk Mitigation guideline on first in human (FIH) clinical trials was discussed. The focus of the revised guideline, which came into force in February 2018, is on risk mitigation and promotion of safety and will assist drug sponsors with the design and performance of early clinical studies. The use of integrated adaptive protocol designs in early clinical development was discussed in relation to the challenges involved when running early phase clinical trials in patients. The Health Regulatory Authority presented its strategies to ensure that following Brexit, the United Kingdom remains an attractive place to conduct Phase I clinical trials. The Medicines and Healthcare products Regulatory Agency confirmed that in the event of a “no deal” Brexit, it is well placed to implement and influence many provisions of the new EU CTR. The meeting provided an opportunity to discuss the changing regulatory environment and the opportunities and challenges facing the United Kingdom following Brexit with invited speakers from a range of disciplines including drug development, clinical trials and research organizations, government science policy and regulatory agencies.

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Human factors evaluation of a novel digital medicine system in psychiatry

Cited by 15 publications

References 19 publications

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

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

Ingestible Sensors and Medication Adherence: Focus on Use in Serious Mental Illness

The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development

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