Master's Thesis Opportunity | Working title: Methodological Approaches to Evaluating Patient-Relevant Structural and Procedural Improvements (pSVV) in Digital Health Applications (DiGA): A Scoping Review

Background

Digital health applications (DiGA), which are prescribable and reimbursable digital medical products, have been in the spotlight since their introduction in Germany in 2019 (Goeldner & Gehder, 2024). These applications can demonstrate a “positive care effect” not only through clinical outcomes, but also via patient-relevant structural and procedural improvements (pSVV) — a concept unique to the German healthcare system and defined by the DiGA ordinance (DiGAV)(Gehder & Goeldner, 2025a).

The regulation lists nine types of pSVV, including improved coordination of care, patient empowerment, health literacy, and adherence. These categories aim to reflect meaningful changes in patient care beyond traditional medical outcomes. However, while some DiGA manufacturers seek approval based on such effects, it remains unclear how these effects are scientifically evaluated in peer-reviewed studies (Gehder & Goeldner, 2025b).

Objective

The goal of this thesis is to systematically map the methodological approaches used in peer-reviewed literature to evaluate positive care effects comparable to the nine pSVV categories outlined in the DiGA regulation. The focus is not on verifying the presence or absence of these effects, but on analyzing how such outcomes are defined, measured, and supported by study designs and data sources.

Research Question

"Which methodologies are used in peer-reviewed studies to evaluate care effects that are comparable to the nine patient-relevant structural and procedural improvements (pSVV) listed in the DiGA regulation?"

Methodology (Suggested Approach)

• Conduct a scoping review following JBI (Peters et al., 2020, 2022) or PRISMA-ScR guidelines (Tricco et al., 2018)
• Develop a mapping framework based on the nine pSVV examples (e.g., coordination of care, patient empowerment)
• Identify and analyze studies from databases such as PubMed, Scopus, and Web of Science
• Chart how care effects are operationalized and what data sources (e.g., PROMs, usage data, adherence logs) and study designs (e.g., RWE studies, pre-post, quasi-experimental) are used
• Identify gaps and patterns across application domains (e.g., mental health, diabetes)

Requirements

• Strong interest in digital health, evidence generation, and healthcare evaluation
• Ability to work independently and structure a literature-based research project
• Familiarity with basic research methods (e.g., literature reviews, evidence hierarchies)
• Very good English skills (literature and writing); basic German is very helpful
• Enrollment in a relevant Master’s program (e.g., Biomedical Engineering, G-TIME, Industrial Engineering, or similar)

What we offer:

• Supervision from researchers with expertise in digital health policy, regulation, and evidence generation as well as the conduction of scoping reviews
• Access to resources for literature search, data extraction, and scientific writing
• The opportunity to contribute to a highly relevant, policy-oriented research topic

If you are interested, please contact sara.gehder@tuhh.de by e-mail. Please send the relevant documents (CV, transcript of records, etc.). 

Sources

Gehder, S., & Goeldner, M. (2025a). Unpacking Performance Factors of Innovation Systems and Studying Germany’s Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study. Journal of Medical Internet Research, 27. https://doi.org/10.2196/66356

Gehder, S., & Goeldner, M. (2025b). Struktur- und Verfahrensverbesserungen auf Rezept? Eine qualitative Analyse der Potenziale und Herausforderungen des pSVV-Konzepts bei Digitalen Gesundheitsanwendungen (DiGA). Zeitschrift Für Evidenz, Fortbildung Und Qualität Im Gesundheitswesen.

Goeldner, M., & Gehder, S. (2024). Digital Health Applications (DiGAs) on a Fast Track: Insights From a Data-Driven Analysis of Prescribable Digital Therapeutics in Germany From 2020 to Mid-2024. Journal of Medical Internet Research, 26, e59013. doi.org/10.2196/59013

Peters, M. D. J., Godfrey, C., McInerney, P., Khalil, H., Larsen, P., Marnie, C., Pollock, D., Tricco, A. C., & Munn, Z. (2022). Best practice guidance and reporting items for the development of scoping review protocols. JBI Evidence Synthesis, 20(4), 953–968. doi.org/10.11124/JBIES-21-00242

Peters, M. D. J., Marnie, C., Tricco, A. C., Pollock, D., Munn, Z., Alexander, L., McInerney, P., Godfrey, C. M., & Khalil, H. (2020). Updated methodological guidance for the conduct of scoping reviews. JBI Evidence Synthesis, 18(10), 2119–2126. doi.org/10.11124/JBIES-20-00167

Tricco, A. C., Lillie, E., Zarin, W., O’Brien, K. K., Colquhoun, H., Levac, D., Moher, D., Peters, M. D. J., Horsley, T., Weeks, L., Hempel, S., Akl, E. A., Chang, C., McGowan, J., Stewart, L., Hartling, L., Aldcroft, A., Wilson, M. G., Garritty, C., … Straus, S. E. (2018). PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Annals of Internal Medicine, 169(7), 467–473. doi.org/10.7326/M18-0850