Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey

Chevance, Astrid; Fortel, Axel; Jouannin, Adeline; Denis, Faustine; Mamzer-Bruneel, Marie-France; Ravaud, Philippe; Sidorkiewicz, Stéphanie

doi:10.2196/25597

Cited by 4 publications

(3 citation statements)

References 29 publications

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“…However, it is important to note that while our study indicated ethical considerations, contrasting results have been reported in other studies. Some of these studies raised concerns regarding data security, potential dependence on technology, and worrying about the consequence of technological failures (Chevance et al, 2022;Holender et al, 2018) The findings are in line with other studies, which were done in Kenya and South Africa among HIV infected women showing that neutral text message content provides confidentiality, minimize fear and provide self-confidence to women Odeny et al, 2014).…”

Section: Discussionsupporting

confidence: 74%

Assessment of needs and contents of a customized digital tool for retention to care and Medication adherence among pregnant and Breastfeeding women living with HIV/AIDS in Kilimanjaro

Maro

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Retention in care and adherence to medication among pregnant and breastfeeding women living with HIV (PBWLH) are crucial for prevention of mother to child transmission (PMTCT) of HIV. Wide coverage of mobile phones, digital tools, including the use of internet enabled medication dispensers and short message service (SMS), have been recommended as potential interventions to improve adherence to medication by PBWLH. The main objective of the study was to understand the needs and contents for a customized digital tool for retention in care and medication adherence among PBWLH. A mixed-methods study was conducted from September 2021 to March 2022 at five health facilities in Kilimanjaro region. Pregnant and breastfeeding women receiving PMTCT services were included in a survey using a semi-structured questionnaire. Among the interviewed, twenty breastfeeding women were purposively selected and enrolled to use an internet enabled Wisepill medication dispenser for one month. They received different types of SMS reminders for a period of one month and feedback on their adherence patterns was received after one month using adherence graph from the Wisepill digital tool. Later, exit interviews, in- depth interviews were conducted to explore needs and contents for a future customized digital adherence tool. Descriptive analyses for quantitative data and thematic content analyses for qualitative data were also done. Among 142 women interviewed, 42(30%) were pregnant and 100 (70%) were breastfeeding. A majority of 136 (95%) had access to mobile phones and used SMS daily, while 90% were interested in receiving reminder messages. Qualitative findings revealed more insights on reminders’ content and educational SMS. Most people preferred neutral SMS which does not contain the word “medication”. Health educational SMS content was preferred to be on breastfeeding, opportunistic diseases, nutrition and entrepreneurship education. Overall, SMSs were regarded helpful to remind clients on medication time and the medication dispenser provided them with privacy and safe storage for their medication. Findings from this study will help to construct useful content for future digital adherence tools to support the health of pregnant and breastfeeding women living with HIV.

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Section: Discussionsupporting

confidence: 74%

Assessment of needs and contents of a customized digital tool for retention to care and Medication adherence among pregnant and Breastfeeding women living with HIV/AIDS in Kilimanjaro

Maro

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“…Digital pills should not be seen as a simple change in how medications are taken, state Chevance et al ( Chevance et al, 2022 ). Instead, they should be seen as a complicated intervention that requires rigorous testing before being extensively employed in everyday clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Bibliometric analysis and evidence of clinical efficacy and safety of digital pills

et al. 2023

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Objectives: Digital pills are new technologies that aim to improve healthcare by increasing medication adherence. The aim of the work was a bibliometric analysis of clinical studies of digital pills and an assessment of the level of evidence of their effectiveness, safety, and prospects for the future.Materials and Methods: The studies were conducted using online databases such as ClinicalTrials.gov, Dimensions, and Web of Science for the period January 2012 to July 2022. The VOSviewer tool for building and visualizing bibliometric networks was used.Results: Bibliometric analysis of the scientific literature revealed that over the past 10 years, the number of publications about digital pills has noticeably increased, which indicates the increasing importance of this field of knowledge. The leading positions in this area are occupied by scientists from the United States, the United Kingdom, and India. Sources of financial support for authors of publications in the field of digital pills are funds from leading developer companies, budget allocations, and funds from non-commercial organizations. Public-private partnerships are an important path to develop and implement digital pills. The four main clusters of digital pill studies were highlighted and visualized: efficacy and safety analysis for serious mental disorders; treatment and costs of tuberculosis therapy; features of the treatment of diabetes, cardiovascular diseases, and AIDS; and usage monitoring. Available publications demonstrate the efficacy potential and safety of digital pills. Nevertheless, the effects of digital pills have not yet been fully studied.Conclusion: Priority areas for future research are further randomized controlled clinical trials and meta-analyses, which are necessary for a high level (I level) of evidence for therapeutic applications of digital pills, as well as pharmacoeconomic studies.

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“…Digital drugs raise ethical issues, 6 especially about coercion. Members from disadvantaged communities are more frequently subjected to involuntary and coercive psychiatric treatment.…”

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confidence: 99%

A Mirror-Image Trial or Smoke and Mirrors? Phase 3b Study on Digital Aripiprazole

Naudet¹,

Gillibert²,

Mintzes³

et al. 2022

J. Clin. Psychiatry

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the US Food and Drug Administration approved a version of a second-generation antipsychotic, aripiprazole, embedded with a sensor (AS; Abilify MyCite) despite a clear lack of rigorous evidence of benefit, 1 with no controlled trial. Only 3 non-comparative uncontrolled cohorts were found. None provided data on any clinical efficacy outcome.The authors of a recent phase 3b study published in this journal 2 claim to have addressed this gap for adults with schizophrenia. However, the flaws in design and reporting of this study provide a false impression of the efficacy of AS, compounded by the uncritical comment published concurrently. 3 We offer the following methodological and ethical critique.First, this uncontrolled cohort compares "retrospective" and "prospective" follow-up of the same patients, with no randomization, which is very low in the hierarchy of evidence, especially when a randomized controlled trial comparing AS versus aripiprazole is feasible and desirable.Second, results are reported for only a subset of patients. The analysis population is defined as "participants who completed the month 3 visit or had ≥ 80% of their study medication ingestions recorded by the AS system during prospective months 1-3. " 2(p e3) This is not a modified intention to treat (mITT), as stated, but rather a per protocol analysis including 113 of 277 enrolled patients (41%). The others were withdrawn, were lost to follow-up, or failed to take medication. Attempting to draw conclusions about medication adherence when fewer than half of the participants remained in the study flies in the face of common sense. Additionally, 50 patients were excluded from the analysis based on results of an interim analysis. Both post hoc exclusions and interim analyses are best avoided, especially in a single-arm trial.Third, the study compares past hospitalization rates when patients took standard oral therapy versus when they used digital aripiprazole. However, the main selection criterion (≥ 1 inpatient psychiatric hospitalization in the preceding 48 months) overlaps with the primary outcome definition (difference in proportions of participants with ≥ 1 inpatient psychiatric hospitalization between prospective and retrospective months 1-3). Regression toward the mean during follow-up is expected to artificially generate lower hospitalization rates. Therefore, the difference observed on the primary outcome reflects bias rather than a genuine efficacy of digital aripiprazole. This is confirmed by the high "efficacy" found in patients with poor adherence or lost to follow-up at 3 months, obtained by subtraction of the ITT and mITT samples. In this subsample of 164 patients, there were 3 (1.8%) hospitalizations in the 3-month prospective period vs 15 (9.1%) in the retrospective period.Such major flaws in design, conduct, and analysis and the central involvement of the sponsor are features of trials driven by marketing interests. 4 Small numbers of patients were recruited from 58 study sites over most American states. For such a common disease, ...

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Acceptability of and Willingness to Take Digital Pills by Patients, the Public, and Health Care Professionals: Qualitative Content Analysis of a Large Online Survey

Cited by 4 publications

References 29 publications

Assessment of needs and contents of a customized digital tool for retention to care and Medication adherence among pregnant and Breastfeeding women living with HIV/AIDS in Kilimanjaro

Assessment of needs and contents of a customized digital tool for retention to care and Medication adherence among pregnant and Breastfeeding women living with HIV/AIDS in Kilimanjaro

Bibliometric analysis and evidence of clinical efficacy and safety of digital pills

A Mirror-Image Trial or Smoke and Mirrors? Phase 3b Study on Digital Aripiprazole

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