Digital health applications and the fast-track pathway to public health coverage in Germany: challenges and opportunities based on first results.

OBJECTIVES: Evidence-based decision-making is the sine qua non for safe and effective patient care and the long-term functioning of health systems. Since 2020 Digital Health Applications (DiHA) in Germany have been undergoing a systematic pathway to be reimbursed by statutory health insurance (SHI) which is attracting attention in other European countries. We therefore investigate coverage decisions on DiHA and the underlying evidence on health care effects, which legally include both medical outcomes and patient-centred structural and procedural outcomes. METHODS: Based on publicly available data of the Institute for Medicines and Medical Devices searched between 08/2021 and 02/2022, all DiHA listed in the corresponding registry and thus reimbursable by the SHI were systematically investigated and presented descriptively on the basis of predefined criteria, such as clinical condition, and costs. The clinical trials on DiHA permanently included in the registry were reviewed with regard to their study design, endpoints investigated, the survey instruments used, and whether an intention-to-treat analysis was performed. Risk of bias was assessed using the ROB II tool. RESULTS: By February 2022, 30 DiHA had been included in the DiHA registry, one third of them permanently and two thirds conditionally. Most DiHA were therapeutic applications for mental illness based on cognitive behavioural therapy. For all permanently included DiHA, randomised controlled trials were conducted to demonstrate the impact on health care effects. While medical outcomes were investigated for all of these DiHA, patient-centred structural and procedural outcomes were rarely investigated. The majority of clinical trials showed a high risk of bias, mainly due to insufficient reporting quality. Overall, the prices for DiHA covered by SHI are on average around € 150 per month (min. € 40; max. € 248). CONCLUSIONS: Evidence-based decision-making on coverage of DiHA leaves room for improvements both in terms of reporting-quality and the use of patient-centred structural and procedural outcomes in addition to medical outcomes. With appropriate evidence, DiHA can offer an opportunity as an adjunct to existing therapy while currently the high risk of bias of the trials raises doubts about the justification of its high costs.

[Direct admission of patients to doctors' offices by prehospital emergency services-an effective method to relieve emergency departments? : Analysis of routine pre- and in-hospital emergency data]. / Mit dem Rettungsdienst direkt in die Arztpraxis ­ eine wirkungsvolle Entlastung der Notaufnahmen? : Analyse von notfallmedizinischen Routinedaten aus Präklinik und Klinik.

BACKGROUND: In the 2018 advisory opinion concerning the realignment of healthcare, it is advocated that in order to relieve pressure on emergency departments (ED) prehospital medical emergency services should be given the option to directly transport suitable patients to doctors' offices. OBJECTIVES: To determine the prevalence of patients treated by prehospital emergency services that have the potential to be directly allocated to a primary care provider. MATERIALS AND METHODS: Preclinical and clinical data of adult patients who in a 2-month period were transported to the ED of a university hospital by an ambulance were evaluated. To determine a safe and meaningful transport directly to a doctor's office, a stepwise assessment was carried out: patients were categorized on the basis of the prehospital assessment of urgency as "urgent" (contact to doctor necessary within a maximum time of 30 min) and "less urgent" (contact to doctor not necessary within 30 min, maximum 120 min). "Less urgent" patients were further divided and those treated as outpatients were identified. This group was further restricted to cases whose administrative reception in the ED was documented Monday-Friday between 8 am and 7 pm. In addition, these cases were further differentiated with regard to medical content and compared with the triage results in the ED (Manchester Triage, MTS). RESULTS: In all, 1260 patients were brought to the ED by ambulance within the study period (total number of patients treated in this time period n = 11,506); 894 cases had a documented prehospital level of urgency and could therefore be included. Of these n = 477 (53.4%) were categorized as "less urgent"; 317 (66.5%) of these "less urgent" cases were treated as outpatients in the ED, and n = 114 (23.9%) in a time frame potentially suitable for direct transport to doctors' offices, which is 1% of all patients treated in the ED in the time period examined. However, 70 of the cases suitable for doctors' office (63.6% of n = 110 with documented MTS) were rated more urgent in the ED. With regards to prehospital complaints and documented diagnosis we assume employment of a relevant amount of resources in the treatment of these cases. CONCLUSIONS: EDs could be relieved from every tenth patient brought in by prehospital emergency services (1% of all patients treated) during normal offices hours by direct allocation to doctors' offices. Regarding patient's safety this process however has to be seen critically as > 60% of these cases were potentially undertriaged. Necessary resources for diagnostics and treatment have to be available in the doctors' offices and known to prehospital emergency services. Primary assignment of patients to doctors' offices by prehospital emergency can only relieve urban EDs to a negligible extent, is potentially dangerous and linked to a tremendous logistic effort.