Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study DOI Creative Commons
Jessica Mogk, Abisola Idu, Jennifer F. Bobb

и другие.

JMIR Formative Research, Год журнала: 2024, Номер 8, С. e59088 - e59088

Опубликована: Сен. 2, 2024

Background Delivering prescription digital therapeutics (ie, evidence-based interventions designed to treat, manage, or prevent disorders via websites smartphone apps) in primary care could increase patient access substance use disorder (SUD) treatments. However, the optimal approach implementing remains unknown. Objective This pilot study is a precursor larger trial test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve delivery of for SUDs care. mixed methods describes outcomes among patients 2 clinics presents qualitative findings on implementation. Methods From February 10 August 6, 2021, total 3 mental specialists embedded practices same integrated system were tasked with offering app-based SUD. In first half pilot, activities included training supportive tools. PF (at 1 clinic) HC clinics) added second half. All analyses relied secondary data, including electronic records therapeutic vendor data. Primary proportion reached by fidelity related ideal use. We used assess adherence planned barriers facilitators therapeutics. Results Of all 18 prescribed apps, (56%) downloaded app activated their prescription, 8 (44%) completed at least module content. Patients who per week average. Ideal (fidelity) was defined as completing 4 modules having monthly SUD-related visit; (6%) met these criteria weeks (of 12-week period). A 5 (28%) had prescriptions while available, (11%) successfully contacted, both declined coaching. Clinicians reported competing clinical priorities, technical challenges, logistically complex workflows part because apps required prescription. Some impacted staff turnover that coincided COVID-19 pandemic. The high engagement perception meet needs. Conclusions encountered real-world setting, especially staffing shortages, turnover, priorities clinic teams. randomized will clarify extent which Trial Registration ClinicalTrials.gov NCT04907045; https://clinicaltrials.gov/study/NCT04907045

Язык: Английский

A scoping review and expert consensus on digital determinants of health DOI Creative Commons
Robin van Kessel,

Laure-Elise Seghers,

Michael Anderson

и другие.

Bulletin of the World Health Organization, Год журнала: 2025, Номер 103(02), С. 110 - 125H

Опубликована: Фев. 1, 2025

To map how social, commercial, political and digital determinants of health have changed or emerged during the recent transformation society to identify priority areas for policy action. We systematically searched MEDLINE, Embase Web Science on 24 September 2023, eligible reviews published in 2018 later. ensure we included most literature, supplemented our review with non-systematic searches PubMed® Google Scholar, along records identified by subject matter experts. Using thematic analysis, clustered extracted data into five societal domains affected digitalization. The clustering also informed a novel framework, which authors contributors reviewed comprehensiveness accuracy. two-round consensus process, rated high, moderate low urgency actions. 13 804 records, 204 met inclusion criteria. A total 127 were found (37 digital, 33 commercial economic determinants). Of these, 30 (23.6%) considered particularly urgent This offers comprehensive overview across economic, domains, highlighting decisions, individual behaviours broader factors influence findings deepen understanding outcomes manifest within ecosystem inform strategies addressing complex evolving networks determinants.

Язык: Английский

Процитировано

4

Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping DOI Creative Commons
Robin van Kessel, Divya Srivastava, Ilias Kyriopoulos

и другие.

JMIR mhealth and uhealth, Год журнала: 2023, Номер 11, С. e49003 - e49003

Опубликована: Сен. 29, 2023

Background The adoption of digital health care within systems is determined by various factors, including pricing and reimbursement. reimbursement landscape for in Europe remains underresearched. Although emergency decisions were made during the COVID-19 pandemic to enable delivery through videoconferencing asynchronous (eg, apps), research so far has primarily focused on policy innovations that facilitated this outside Europe. Objective This study examines strategies 8 European countries (Belgium, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom) Israel. Methods We mapped available using a scoping review mapping framework. reviewed literature MEDLINE, Embase, Global Health, Web Science databases. Supplementary records identified Google Scholar country experts. Results Our search strategy yielded total 1559 records, which 40 (2.57%) ultimately included study. As August 2023, solutions are reimbursable some extent all studied except although mechanism differs significantly across countries. At time writing, was mostly discussions between national or regional committees manufacturers absence value-based assessment mechanisms. Financing traditional schemes possible Poland typically occurs via innovation health–specific funding schemes. have frameworks range from nonexistent embryonic. Conclusions Studied show divergent approaches solutions. These differences may complicate ability patients seek cross-country another country, even if app both Furthermore, fragmented environment will present challenges developers such solutions, as they look expand their impact systems. An increased emphasis developing clear conceptualization health, well mechanisms, needed sustainable integration health. can therein serve basis further, more detailed field evolves.

Язык: Английский

Процитировано

36

Digital Therapeutics for Improving Effectiveness of Pharmaceutical Drugs and Biological Products: Preclinical and Clinical Studies Supporting Development of Drug + Digital Combination Therapies for Chronic Diseases DOI Open Access

Zack Biskupiak,

Victor Vinh Ha,

Aarushi Rohaj

и другие.

Journal of Clinical Medicine, Год журнала: 2024, Номер 13(2), С. 403 - 403

Опубликована: Янв. 11, 2024

Limitations of pharmaceutical drugs and biologics for chronic diseases (e.g., medication non-adherence, adverse effects, toxicity, or inadequate efficacy) can be mitigated by mobile medical apps, known as digital therapeutics (DTx). Authorization adjunct DTx the US Food Drug Administration draft guidelines on “prescription drug use-related software” illustrate opportunities to create + combination therapies, ultimately leading towards drug–device products (DTx has a status devices). Digital interventions (mobile, web-based, virtual reality, video game applications) demonstrate clinically meaningful benefits people living with Alzheimer’s disease, dementia, rheumatoid arthritis, cancer, pain, epilepsy, depression, anxiety. In respective animal disease models, preclinical studies environmental enrichment other non-pharmacological modalities (physical activity, social interactions, learning, music) surrogates “active ingredients” also show improved outcomes. this narrative review, we discuss how therapies impact translational research, discovery development, generic repurposing, gene therapies. Market-driven incentives are illustrated Humira® (adalimumab) facing “patent-cliff” competition cheaper more effective biosimilars seamlessly integrated DTx. conclusion, pharma biotech companies, patients, healthcare professionals will benefit from accelerating integration pharmacotherapies.

Язык: Английский

Процитировано

11

Mapping the regulatory landscape for artificial intelligence in health within the European Union DOI Creative Commons

Jelena Schmidt,

Nienke Schutte, S Buttigieg

и другие.

npj Digital Medicine, Год журнала: 2024, Номер 7(1)

Опубликована: Авг. 27, 2024

Abstract Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare population health. In this article, we present a synthesis 141 binding policies applicable health EU 10 European countries. The Act sets overall regulatory framework AI, other legislations set social, health, human rights standards, address safety technologies innovation, ensure protection safe use data. Regulation specifically pertaining is still nascent scarce, though combination data, technology, policy has already formed baseline Future work should explore specific challenges, especially with respect medical devices, data protection, enablement.

Язык: Английский

Процитировано

10

Exploring potential drivers of patient engagement with their health data through digital platforms: A scoping review DOI Creative Commons
Robin van Kessel, Sruthi Ranganathan, Michael Anderson

и другие.

International Journal of Medical Informatics, Год журнала: 2024, Номер 189, С. 105513 - 105513

Опубликована: Июнь 5, 2024

Patient engagement when providing patient access to health data results from an interaction between the available tools and individual capabilities. The recent digital advancements of healthcare field have altered manifestation importance engagement. However, a comprehensive assessment what factors contribute remain absent. In this review article, we synthesised most frequently discussed that can foster with their data.

Язык: Английский

Процитировано

7

Understanding factors impacting patient-reported outcome measures integration in routine clinical practice: an umbrella review DOI Creative Commons
Michael Anderson, Robin van Kessel,

Eleanor Wood

и другие.

Quality of Life Research, Год журнала: 2024, Номер 33(10), С. 2611 - 2629

Опубликована: Июль 18, 2024

Abstract Purpose Patient-report outcome measures (PROMs) have gained widespread support as a mechanism to improve healthcare quality. We aimed map out key enablers and barriers influencing PROMs implementation strategies in routine clinical practice. Methods An umbrella review was conducted identify reviews exploring related the integration of practice from January 2000 June 2023. Information on extracted summarised thematically according Theoretical Domains Framework. Results 34 met our criteria for inclusion. Identified highlighted such limited awareness among clinicians patients, perceived low value by that were too complex or difficult patients complete, poor usability systems, delayed feedback data, clinician concerns use performance management tool, patient regarding privacy security, resource constraints. Enablers encompassed phased implementation, professional training, stakeholder engagement prior clear goals, ‘change champions’ systems respond issues raised PROMs, into pathways. No consensus favoured paper electronic yet offering both options mitigate digital literacy bias integrating health records emerged important facilitators. Conclusions The sustainable is process requires multicomponent organisational covering training guidance, necessary time resources, roles responsibilities, consultation with clinicians.

Язык: Английский

Процитировано

5

A group concept mapping study of stakeholder perspectives on digital therapeutics economic value drivers DOI Creative Commons
Yoann Sapanel, L. Martin Cloutier, Gabriel Tremblay

и другие.

npj Digital Medicine, Год журнала: 2025, Номер 8(1)

Опубликована: Апрель 10, 2025

Язык: Английский

Процитировано

0

Core elements of national policy for digital health technology evidence and access DOI Creative Commons
Megan Coder, L. McBride, Samantha J. McClenahan

и другие.

npj Digital Medicine, Год журнала: 2024, Номер 7(1)

Опубликована: Авг. 13, 2024

Digital health technologies (DHT) offer the ability to deliver personalized care, lower barriers access, and positively impact outcomes. However, DHT utilization is impacted by insufficient market access pathways. A policy "full-stack"—including regulatory authorization, product value assessment, pricing reimbursement, patient infrastructure—offers a framework for integration into national healthcare ecosystems. Consistent clinical evidence requirements across jurisdictions will further increase scalability.

Язык: Английский

Процитировано

4

Socio-ethical challenges and opportunities for advancing diversity, equity, and inclusion in digital medicine DOI Creative Commons
Ivana Paccoud, Anja Leist, Isabel Schwaninger

и другие.

Digital Health, Год журнала: 2024, Номер 10

Опубликована: Янв. 1, 2024

Digitalization in medicine offers a significant opportunity to transform healthcare systems by providing novel digital tools and services guide personalized prevention, prediction, diagnosis, treatment disease management. This transformation raises number of socio-ethical considerations for individuals society as whole, which need be appropriately addressed ensure that medical devices (DMDs) are widely adopted benefit all patients well service providers. In this narrative review, based on broad literature search PubMed, Web Science, Google Scholar, we outline five core intersect with the notions equity inclusion: (i) access, use engagement DMDs, (ii) inclusiveness DMD clinical trials, (iii) algorithm fairness, (iv) surveillance datafication, (v) data privacy trust. By integrating from multidisciplinary fields, including social, medical, computer sciences, shed light challenges opportunities related development adoption DMDs. We begin an overview different types followed in-depth discussions implications associated their deployment. Concluding our provide evidence-based multilevel recommendations aimed at fostering more inclusive landscape integration DMDs mitigate rather than cause, maintain or exacerbate health inequities.

Язык: Английский

Процитировано

4

Adoption and perception of prescribable digital health applications (DiGA) and the advancing digitalization among German internal medicine physicians: a cross-sectional survey study DOI Creative Commons

Lasse Cirkel,

Fabian Lechner,

Nadine Schlicker

и другие.

BMC Health Services Research, Год журнала: 2024, Номер 24(1)

Опубликована: Ноя. 6, 2024

Abstract Background Therapeutic digital health applications (DiGAs) are expected to significantly enhance access evidence-based care. Since 2020, German physicians and psychotherapists have been able prescribe approved DiGAs, which reimbursed by statutory insurance. This study investigates the usage, knowledge perception of DiGAs as well growing digitalization among internal medicine in Germany. Methods A web-based survey was distributed at 2024 annual congress Society for Internal Medicine. Participants could respond scanning a QR code or directly on tablet. Results total 100 completed survey, with mean age 43.4 years. The majority were (85%). Of respondents, 31% had already prescribed 29% tested one. Self-rated low (median score 3.17/10). main barriers identified lack about effective implementation (60%), time patient onboarding (27%), concerns adherence (21%). However, 92% believed that improve care, 88% expressed interest specific training. (64%) stated positive impact medical care 39% their daily workload decrease due digitalization. In addition, 38% physician-patient relationship would result Conclusions While widely acknowledged potential benefits adoption understanding remain limited. Specific training is crucial accelerate medicine.

Язык: Английский

Процитировано

4