Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.

BACKGROUND: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.

[Appointment Service Centres for Specialist Medical Appointments: How Effective are they?] / Terminservicestellen für die fachärztliche Terminvermittlung ­ Wie wirksam sind sie wirklich?

INTRODUCTION: To reduce outpatient specialist waiting times and to help patients with statutory health insurance to get appointments and urgent referrals within four weeks, phone appointment service centres (ASC) were introduced in Germany in January 2016. The aim of this study was to analyse these booking patterns in the Westphalia-Lippe (WL) region, and to compare the types of regular specialist referrals with those made by the centers. Furthermore, neurology services to patients with ASC referrals were compared to those without. METHODS: Appointment data from the second quarter of 2016 to the third quarter of 2019 were used, and an algorithm was developed to determine the range of services provided in appointments made by the ASCs. A total of 24,286,157 accounting slips were compared with 12,648 specialist service records from the Association of Statutory Health Insurance Physicians in the WL region. RESULTS: The average waiting time for an appointment with a specialist was 21 days for 84% of the callers with a referral (aged mostly 35-59 years). Requests for appointments with neurologists, internists, and radiologists were the most frequent ones; 45% of service centre specialist appointments were made with neurologists, despite these comprising only 4% of total referrals in WL. There were only a few differences in the use of services in neurologist appointments with and without the mediation of the ASC. The higher level of ASC used for making neurologist appointments for initial psychotherapeutic assessment was statistically significant. However, the effect was small. CONCLUSIONS: Despite its relatively low use (0.19% of specialist referrals in general), ASCs in the WL region are able to make urgent specialist appointments for patients with statutory insurance, with average waiting times significantly lower than the legally set maximum waiting period. However, patients also take other factors into account when making appointments. While the benefits of these centres, especially for three types of specialists, was demonstrated, further discussion on the form of the ASCs in their current form is warranted. This paper provides a basis for evaluation of methodology and content for further decision-making.

Assessing patients' acceptable and realised distances to determine accessibility standards for the size of catchment areas in outpatient care.

Healthcare planning aims to ensure availability of care in a needs-based, evenly distributed and locally available manner. However, many planning mechanisms lack accessibility standards. To determine standards, catchment areas must be derived from health-related travel assessments and a population's distance acceptance for different medical specialisation levels. We estimated distance acceptance using representative cross-sectional survey data (n = 1.598). Moreover, we used utilization data covering 88% of the German population (2014/15) to calculate realised travel distances for six medical specialties (n = 676.255.605 cases). We specified a gravity-based distance decay function and estimated regression-based distance thresholds from both samples. Realised distances were mostly below 30 min (90% of cases) indicating appropriate mean accessibility. The 5% observed distance threshold was between 23.7 min for GPs and 47.6 min for dermatologists. Depending on medical speciality, distance acceptance was mainly determined by distance, age, activity level and town size for GP visits and by health and income for specialist care. 5% acceptance thresholds varied between 27.9 min to GPs for elderly patients and 51.6 min to orthopaedists for younger patients. Acceptable distances for 90% of the population were 6 (8) minutes to GPs (specialists). The variation of thresholds, which depended on socio-demographic and health variables and the population share that is fully accepting, illustrates that healthcare planners should move beyond averages to realise equal access for equal need.