Huvudbild för Vitalis 2023
  1. Vitalis 2023
  2. Programpunkter
  3. WORKSHOP: Requirements for a Digital Therapeutics (DTx) Design and Trial Service: An Expert Workshop
Profilbild för WORKSHOP: Requirements for a Digital Therapeutics (DTx) Design and Trial Service: An Expert Workshop

WORKSHOP: Requirements for a Digital Therapeutics (DTx) Design and Trial Service: An Expert Workshop Har passerat

Tisdag 23 maj 2023 15:45 - 17:15 R23

Föreläsare: Kerstin Denecke, Tobias Kowatsch

Spår: MIE: Special Topic: Caring is Sharing - exploiting value in data for health and innovation

1. Background

Non-communicable diseases (NCDs), such as diabetes, hypertension, asthma, cancer or cardiovascular diseases, and common mental disorders (CMDs) including neurodegenerative diseases such as depression, anxiety or dementia lead to substantial health and economic burdens [1-9]. Risk factors related to NCDs and CMDs are smoking, excessive alcohol consumption, malnutrition, physical inactivity, overweight and obesity, and high levels of blood pressure, cholesterol, and glucose [10-12].


Digital therapeutics (DTx) are "evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease." [13] DTx have the potential to reduce the burden of NCDs and CMDs [2, 14]. Today, however, DTx are often limited in their scope and usefulness (e.g., DIGAs in Germany [15]) as they focus primarily on one social actor – the patient – and do not consider the orchestration of the broader social system (family, friends, or peers of patients) or more complex care cases that require multiple professions (e.g., patients suffering from multiple NCDs/CMDs) [16]. Especially the latter cases of multi- morbidity are getting increasingly important due to the aging population [3, 4, 17, 18]. These demographic trends also require new DTx technologies that are beyond today’s paradigm of web- or smartphone-based DTx, such as scalable voice assistants [19, 20], to increase access to healthcare services esp. in individuals with physical or mental disabilities. Moreover, the design and evaluation of DTx requires a significant amount of expertise in various areas, such as medicine, health and clinical psychology, software engineering, computer science, ethics, and regulation [21]. Moreover, each DTx requires a robust technology stack that supports DTx designers and other stakeholders, such as physicians, caretakers, and patients.

To this end and as a first step, it is of utmost importance to understand better the requirements for a DTx design and trial service that supports the design of DTx and their efficient evaluation via feasibility studies, optimization trials (e.g., micro-randomized trials), efficacy or effectiveness trials (e.g., randomized controlled trials). This workshop has, therefore, the objective of gathering such requirements by applying the World Café methodology and discussing several complex care scenarios. We welcome participants with various backgrounds (e.g., technical, regulatory, medical, ethical) who bring in different perspectives.


2. Outcomes

The following outcomes of this workshop are expected:

  1. List of requirements for a DTx design and trial service, esp. for complex care scenarios (immediate outcome)

  2. Scientific article on these requirements (mid-term outcome; interested participants who participate in follow-ups will be offered co-authorship)

  3. Community of experts interested in DTx design and trial services (mid-term outcome)

  4. Collaborative design, implementation, and maintenance of a globally scalable DTx design and trial service (long-term outcome)


3. Program

  1. Introductions (5 min, all participants)

  2. Motivating the workshop (15 min, workshop chairs)

  3. Requirements gathering with World Café methodology (30 min, all participants, moderation by workshop chairs)

  4. Presentation of the findings (20 min, workshop chairs)

  5. Wrap-up and next steps (10 min, workshop chairs)


References

[1]  G. B. D. Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1736-88. Epub 2018/11/30. doi: 10.1016/S0140- 6736(18)32203-7. PubMed PMID: 30496103; PubMed Central PMCID: PMC6227606.

[2]  Jacobson N, Kowatsch T, Marsch L, editors. Digital Therapeutics for Mental Health and Addiction: The State of the Science and Vision for the Future. 1st ed. Cambridge, MA, USA: Elsevier, Academic Press; 2023.

[3]  Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, et al. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011;10(4):430-9. Epub 2011/03/16. doi: 10.1016/j.arr.2011.03.003. PubMed PMID: 21402176.

[4]  Newman D, Tong M, Levine E, Kishore S. Prevalence of multiple chronic conditions by U.S. state and territory, 2017. PLoS One. 2020;15(5):e0232346. Epub 2020/05/06. doi: 10.1371/journal.pone.0232346. PubMed PMID: 32369509.

[5] Murphy A, Palafox B, Walli-Attaei M, Powell-Jackson T, Rangarajan S, Alhabib KF, et al. The household economic burden of non-communicable diseases in 18 countries. BMJ Glob Health. 2020;5(2):e002040. Epub 2020/03/07. doi: 10.1136/bmjgh-2019-002040. PubMed PMID: 32133191; PubMed Central PMCID: PMC7042605.

[6]  Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in the United States: RAND Corp; 2017. Available from: https://www.rand.org/pubs/tools/TL221.html.

[7]  Vandenberghe D, Albrecht J. The financial burden of non-communicable diseases in the European Union: a systematic review. Eur J Public Health. 2020;30(4):833-9. Epub 2019/06/21. doi: 10.1093/eurpub/ckz073. PubMed PMID: 31220862.

[8]  Chen S, Kuhn M, Prettner K, Bloom DE. The macroeconomic burden of noncommunicable diseases in the United States: Estimates and projections. PLoS One. 2018;13(11):e0206702. Epub 2018/11/02. doi: 10.1371/journal.pone.0206702. PubMed PMID: 30383802.

[9]  Hajat C, Stein E. The global burden of multiple chronic conditions: A narrative review. Prev Med Rep. 2018;12:284-93. Epub 2018/11/09. doi: 10.1016/j.pmedr.2018.10.008. PubMed PMID: 30406006; PubMed Central PMCID: PMC6214883.

[10]  WHO. Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Geneva: World Health Organization, 2020.

[11]  Kvedar JC, Fogel AL, Elenko E, Zohar D. Digital medicine's march on chronic disease. Nat Biotechnol. 2016;34(3):239-46. Epub 2016/03/11. doi: 10.1038/nbt.3495. PubMed PMID: 26963544.

[12]  Katz DL, Frates EP, Bonnet JP, Gupta SK, Vartiainen E, Carmona RH. Lifestyle as Medicine: The Case for a True Health Initiative. Am J Health Promot. 2018;32(6):1452-8. Epub 2017/05/20. doi: 10.1177/0890117117705949. PubMed PMID: 28523941.

[13]  DTA. Digital Therapeutics Definition and Core Principles 2019 [9 February 2023]. Available from: https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf.

[14]  Kowatsch T, Fleisch E. Digital Health Interventions. In: Gassmann O, Ferrandina F, editors. Connected Business: Create Value in a Networked Economy. Cham: Springer International Publishing; 2021. p. 71-95.

[15]  FIDMD.TheFast-TrackProcessforDigitalHealthApplications(DiGA)accordingtoSection139eSGBV: A Guide for Manufacturers, Service Providers and Users. 2020.

[16]  Kowatsch T, Schachner T, Harperink S, Dittler U, Xiao G, Stanger C, et al. Conversational Agents as Mediating Social Actors in Chronic Disease Management Involving Healthcare Professionals, Patients, and Family Members: Intervention Design and Results from a Multi-site, Single-arm Feasibility Study. Journal of medical Internet research. 2021;23(2). doi: 10.2196/25060.

[17]  Bayliss EA, Ellis JL, Steiner JF. Subjective assessments of comorbidity correlate with quality of life health outcomes: initial validation of a comorbidity assessment instrument. Health Qual Life Outcomes. 2005;3:51. Epub 2005/09/03. doi: 10.1186/1477-7525-3-51. PubMed PMID: 16137329; PubMed Central PMCID: PMC1208932.

[18]  Newman AB, Boudreau RM, Naydeck BL, Fried LF, Harris TB. A physiologic index of comorbidity: relationship to mortality and disability. J Gerontol A Biol Sci Med Sci. 2008;63(6):603-9. Epub 2008/06/19. doi: 10.1093/gerona/63.6.603. PubMed PMID: 18559635; PubMed Central PMCID: PMC2496995.

[19]  Bérubé C, Fleisch E. Voice-based conversational agents for sensing and support: Examples from academia and industry. In: Jacobson N, Kowatsch T, Marsch LA, editors. Digital Therapeutics for Mental Health and Addiction. Cambridge, MA, USA: Elsevier; 2023.

[20]  Bérubé C, Schachner T, Keller R, Fleisch E, v. Wangenheim F, Barata F, et al. Voice-based Conversational Agents for the Prevention and Management of Chronic and Mental Conditions: A Systematic Literature Review. Jounral of Medical Internet Research. 2021;23(3). doi: 10.2196/25933.

[21]  Kowatsch T, Otto L, Harperink S, Cotti A, Schlieter H. A design and evaluation framework for digital health interventions. it - Information Technology. 2019;61(5-6):253-63. doi: 10.1515/itit-2019-0019.


Språk

English

Seminarietyp

Enbart på plats

Kunskapsnivå

Avancerad

Konferens

MIE

Författare

Tobias Kowatsch, Kerstin Denecke

Föreläsare

Profilbild för Kerstin Denecke

Kerstin Denecke Föreläsare

Professor
Bern University of Applied Sciences

I am a researcher in medical informatics, focussing on natural language processing, participatory health informatics, chatbots.

Profilbild för Tobias Kowatsch

Tobias Kowatsch Föreläsare

Professor
University of Zurich, University of St.Gallen, ETH Zurich

Research areas:
- Digital therapeutics for healthy longevity (e.g., metabolic health interventions)
- Digital health interventions (e.g., just-​in-time adaptive interventions)
Digital clinical pathways and working alliance between patients, relatives, health professionals and digital coaches (e.g., conversational agents, voice assistants)
- Digital biomarker (e.g., detection of biological age, emotional states, stress, breathing)


Prof. Dr. Tobias Kowatsch is Associate Professor for Digital Health Interventions at the external pageInstitute for Implementation Science in Health Carecall_made, external pageUniversity of Zurichcall_made (UZH), and Director at the external pageSchool of Medicinecall_made, external pageUniversity of St.Gallencall_made (HSG). He is also the Scientific Director of the external pageCentre for Digital Health Interventionscall_made, a joint initiative of UZH, HSG, and ETH Zurich. Moreover, Dr. Kowatsch is an advisor to the external pageCenter for Technology and Behavioral Healthcall_made at Dartmouth, USA, and Lead Principal Investigator for Mobile Health Interventions within the Future Health Technologies Programme at the Singapore-​ETH Centre.