[Current data on rheumatological care: annual report from the National database (NDB) of the regional collaborative arthritis centres in Germany]. / Aktuelle Zahlen zur rheumatologischen Versorgung ­ Jahresbericht aus der Kerndokumentation der regionalen kooperativen Rheumazentren.

In the National database (NDB) of the German regional collaborative arthritis centres, annual data on the rheumatological care of patients with inflammatory rheumatic diseases have been collected since 1993. This first annual report presents current cross-sectional data on medication and patient-reported outcomes gathered in 2022.

The protective effect of tumor necrosis factor-alpha inhibitors in COVID-19 in patients with inflammatory rheumatic diseases compared to the general population-A comparison of two German registries.

Objectives: To investigate, whether inflammatory rheumatic diseases (IRD) inpatients are at higher risk to develop a severe course of SARS-CoV-2 infections compared to the general population, data from the German COVID-19 registry for IRD patients and data from the Lean European Survey on SARS-CoV-2 (LEOSS) infected patients covering inpatients from the general population with SARS-CoV-2 infections were compared. Methods: 4310 (LEOSS registry) and 1139 cases (IRD registry) were collected in general. Data were matched for age and gender. From both registries, 732 matched inpatients (LEOSS registry: n = 366 and IRD registry: n = 366) were included for analyses in total. Results: Regarding the COVID-19 associated lethality, no significant difference between both registries was observed. Age > 65°years, chronic obstructive pulmonary disease, diabetes mellitus, rheumatoid arthritis, spondyloarthritis and the use of rituximab were associated with more severe courses of COVID-19. Female gender and the use of tumor necrosis factor-alpha inhibitors (TNF-I) were associated with a better outcome of COVID-19. Conclusion: Inflammatory rheumatic diseases (IRD) patients have the same risk factors for severe COVID-19 regarding comorbidities compared to the general population without any immune-mediated disease or immunomodulation. The use of rituximab was associated with an increased risk for severe COVID-19. On the other hand, the use of TNF-I was associated with less severe COVID-19 compared to the general population, which might indicate a protective effect of TNF-I against severe COVID-19 disease.

Trends in health care of patients with vasculitides, including giant cell arteritis, Takayasu arteritis, ANCA-associated vasculitis and Behçet's disease: cross-sectional data of the German National Database 2007-2021.

The aim of this study is to present the current care situation of patients with giant cell arteritis (GCA), Takayasu arteritis (TAK), ANCA-associated vasculitis (AAV) and Behçet's disease (BD). Trends over the last 15 years will reflect improvements and remaining deficits in the management of vasculitides. Consecutive cross-sectional data from patients with vasculitides from the German National Database (NDB) of the Collaborative Arthritis Centres between 2007 and 2021 were included. Medication, physician- and patient-reported outcomes on disease activity and disease burden, inpatient stays and occupational participation are compared for different vasculitis entities and over time. Employment rates were compared to German population rates. Between 502 and 854 vasculitis patients were annually documented. GCA and AAV were the most common vasculitides. Median disease duration ranged from 2 to 16 years. Over the years, glucocorticoids decreased in proportion and dose, most markedly in GCA and TAK, while biologic therapies increased up to 27%. Physicians rated disease activity as low for the vast majority of patients, while patients-reported moderate outcomes in many dimensions. PROs remained largely unchanged. The proportion of employed patients (< 65 years) increased from 47 to 57%. In recent years, biologics are increasingly used in patients with vasculitides, while glucocorticoids decreased significantly. PRO's have not improved. Work participation increased but remains lower than that in the German population.

[Concept and implementation of an adaptive digital hearing training system for cochlear implant aftercare]. / Konzept und Umsetzung eines adaptiven digitalen Hörtrainingssystems für die Cochlea-Implantatnachsorge.

BACKGROUND AND OBJECTIVE: Within the context of an interdisciplinary research project, we created a cutting-edge prototype of an adaptive digital auditory training system designed for cochlear implant (CI) users. By leveraging the evidence-centered design (ECD) framework, we integrated a dynamic difficulty adjustment feature that tailors the experience to the unique performance capabilities of each individual user. METHODS: The ECD provides a conceptual design framework suitable for complex assessments of competence and dynamic performance. In the first phase, the domain of hearing was first defined in the context of CI users. In the development phase the three core models of the ECD, the competence model, the evidence model, and the task model, were developed and implemented. In addition, an asset pool of sound and language files was created, which included comprehensive linguistic feature descriptions for calculating item difficulties. RESULTS: Based on the requirements described, an adaptive exercise generator, an AI service, and other components were implemented. This included the development of a game environment and a dashboard for patient data management. The exercises' difficulty levels were determined based on various parameters (e.g., sound, word frequency and number of words, grammatical properties) in combination with defined task types and levels. CONCLUSION: An adaptive digital auditory training system can help to supervise and train CI patients in a continuous, interactive process based on their individual needs. We see the ECD as an effective way to build a user-based adaptive system.

High Frequency of Osteophytes Detected by High-Resolution Ultrasound at the Finger Joints of Asymptomatic Factory Workers.

Hand Osteoarthritis (HOA) is a frequently occurring musculoskeletal disease that impacts health. Diagnostic criteria often incorporate osteophytes documented through imaging procedures. Radiographic imaging is considered the gold standard; however, more sensitive and safer methods like ultrasound imaging are becoming increasingly important. We conducted a population-based cross-sectional study to examine the prevalence, grade, and pattern of osteophytes using high-resolution ultrasound investigation. Factory workers were recruited on-site for the study. Each participant had 26 finger joints examined using ultrasonography to grade the occurrence of osteophytes on a semi-quantitative scale ranging from 0-3, where higher scores indicate larger osteophytes. A total of 427 participants (mean age 53.5 years, range 20-79 years) were included, resulting in 11,000 joints scored. At least one osteophyte was found in 4546 out of 11,000 (41.3%) joints or in 426 out of 427 (99.8%) participants, but only 5.0% (553) of the joints showed grade 2 or 3 osteophytes. The total osteophyte sum score increased by 0.18 per year as age increased (p < 0.001). The distal interphalangeal joints were the most commonly affected, with 61%, followed by the proximal interphalangeal joints with 48%, carpometacarpal joint 1 with 39%, and metacarpophalangeal joints with 16%. There was no observed impact of gender or workload. In conclusion, ultrasound imaging proves to be a practical screening tool for osteophytes and HOA. Grade 1 osteophytes are often detected in the working population through ultrasound assessments and their incidence increases with age. The occurrence of grade 2 or 3 osteophytes is less frequent and indicates the clinical presence of HOA. Subsequent evaluations are imperative to ascertain the predictive significance of early osteophytes.

Sustained agreement rates in the longitudinal assessment of lupus patients to a Broad Consent for personal data and specimen usage in the RHINEVIT biobank.

Background: Biobanks are essential structures for scientific research. The RHINEVIT biobank is used to recruit biomaterials from rheumatology patients in outpatient care and to conduct clinical research studies (e.g., cohort studies) and basic research. RHINEVIT established Broad Consents (BC) to allow extensive and relevant usage of data and biospecimens without the need for specific project restrictions. For quality assurance, we compared the consent rate of individual items of the BC versions in patients with systemic lupus erythematosus (SLE) in the longitudinal study. Methods: BCs were used for biomaterial donation. Informed consent data from RHINEVIT were analyzed. Due to the content restructuring of the BC items due to changes from the templates of the working group of the Medical Ethics Commissions in the Federal Republic of Germany and GDPR requirements, content mapping of the items was performed for the analysis. Results: From September 2015 to March 2022, 291 SLE outpatients donated biomaterials. In 119 patients, the BC was renewed at least once in a subsequent biomaterial donation. Three biomaterial donations were obtained from 21 patients and four from six patients using the respective BC. However, one consent was later revoked. Consent to the BC topics showed consistently high rates of agreement (range 97.5%-100%), with only some patients disagreeing with individual topics. This remained stable over time (median 526 days [Q1 400, Q3 844]). None of the patients disagreed with a certain topic in two consecutive visits. Conclusion: Modifications to the BC did not result in any relevant changes in the approval rates for SLE patients. RHINEVIT's BC is successfully used for the quality-assured handling of excellently annotated biomaterial. The long-term use of these highly valuable biospecimens for unrestricted research, also in an international context, remains assured.

[With RheMIT rheumatology centers can participate in the German national database-Expansion of the long-term rheumatological documentation]. / Mit RheMIT können Rheumazentren an der bundesweiten Kerndokumentation teilnehmen ­ Erweiterung der rheumatologischen Langzeitdokumentation.

The national database (NDB) of the German regional collaborative rheumatology centers was switched to the RheMIT documentation software last year. Rheumatology centers that already use RheMIT for care contracts or other research projects can therefore use the software to also participate in the NDB. Experiences from a hospital, a medical care center and a specialist practice show how the changeover to RheMIT from an existing documentation system or a new participation in the NDB with RheMIT can be implemented. The NDB team at the German Rheumatism Research Center in Berlin (DRFZ) welcomes new participating rheumatology centers.

Beneficial effects associated to a healthy lifestyle in systemic lupus erythematosus: A cross-sectional study.

OBJECTIVE: To assess whether a healthy lifestyle is associated to beneficial effects on various systemic lupus erythematosus (SLE) health domains. METHODS: In a cross-sectional study, Mediterranean Diet Adherence Score (MEDAS), physical activity energy expenditure (PAEE), and smoking status were assessed by questionnaires, along with clinical parameters and various health domains including Systemic Lupus Disease Activity Score (SLEDAI), Depression Scale (CES-D), Fatigue Severity (FSS), functional status (FFbH), physical and mental quality of life (PCS, MCS). Lifestyle choices were assessed with respect to health domains by linear regression modeling. Additionally, SLE patients with a healthy lifestyle (MEDAS ≥ 4, ≥ 1 h sport per week, no smoking) were compared to those without by Wilcoxon's signed-rank test. RESULTS: 49 of 145 SLE patients (44.3 ± 31.7 years, 87.6% female) followed a healthy lifestyle and showed a higher physical quality of life (ß = 4.5 (95%-CI 1.5-7.9) p = 0.01), lower depression (ß = -5.0 (-8.2 to -0.2) p = 0.02) and lower fatigue (ß = -0.8 (-1.5 to -0.2) p = 0.01) independently of SLE disease activity. Furthermore, dsDNA-antibodies were lower (146 ± 540 vs 266 ± 146 U/mL, p = 0.049). In a more detailed analysis, physical activity had the highest impact on the various health domains when compared to smoking or diet adherence, which was consistent even after adjusting for multiple potential confounders. Each 1,000 kcal of weekly PAEE was associated to a 1.8 (0.9-2.6) point increase in the PCS (p = 0.0001), a 0.2 (0.03-0.4) point decrease in the CES-D (p = 0.01) and a 2.8 (1.2-4.4) point increase in the FFbH (p = 0.0006). CONCLUSION: A healthy lifestyle, especially physical activity is associated with beneficial effects including quality of life, depression and fatigue in SLE.

Characteristics and outcomes of SARS-CoV-2 breakthrough infections among double-vaccinated and triple-vaccinated patients with inflammatory rheumatic diseases.

OBJECTIVE: To analyse the clinical profile of SARS-CoV-2 breakthrough infections in at least double-vaccinated patients with inflammatory rheumatic diseases (IRDs). METHODS: Data from the physician-reported German COVID-19-IRD registry collected between February 2021 and July 2022 were analysed. SARS-CoV-2 cases were stratified according to patients' vaccination status as being not vaccinated, double-vaccinated or triple-vaccinated prior to SARS-CoV-2 infection and descriptively compared. Independent associations between demographic and disease features and outcome of breakthrough infections were estimated by multivariable logistic regression. RESULTS: In total, 2314 cases were included in the analysis (unvaccinated n=923, double-vaccinated n=551, triple-vaccinated n=803, quadruple-vaccinated n=37). SARS-CoV-2 infections occurred after a median of 151 (range 14-347) days in patients being double-vaccinated, and after 88 (range 14-270) days in those with a third vaccination. Hospitalisation was required in 15% of unvaccinated, 8% of double-vaccinated and 3% of triple-vaccinated/quadruple-vaccinated patients (p<0.001). Mortality was 2% in unvaccinated, 1.8% in the double-vaccinated and 0.6% in triple-vaccinated patients. Compared with unvaccinated patients, double-vaccinated (OR 0.43, 95% CI 0.29 to 0.62) and triple-vaccinated (OR 0.13, 95% CI 0.08 to 0.21) patients showed a significant lower risk of COVID-19-related hospitalisation. Using multivariable analysis, the third vaccination was significantly associated with a lower risk for COVID-19-related death (OR 0.26; 95% CI 0.01 to 0.73). CONCLUSIONS: Our cross-sectional data of COVID-19 infections in patients with IRD showed a significant reduction of hospitalisation due to infection in double-vaccinated or triple-vaccinated patients compared with those without vaccination and even a significant reduction of COVID-19-related deaths in triple-vaccinated patients. These data strongly support the beneficial effect of COVID-19 vaccination in patients with IRD. TRIAL REGISTRATION NUMBER: EuDRACT 2020-001958-21.

Proof-of-Concept Double-Blind Placebo-Controlled Trial Measuring Cartilage Composition in Early Rheumatoid Arthritis under TNF-α-Inhibitor Therapy.

Low levels of delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) values are indicative of cartilage degeneration. Patients with early rheumatoid arthritis are known to have low dGEMRIC values due to inflammatory activity. The additional effect of biological disease-modifying antirheumatic drug (bDMARD) and conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment on cartilage status is still unclear. In this prospective, double-blinded, randomized proof-of-concept clinical trial, patients with early rheumatoid arthritis (disease duration less than 12 months from symptoms onset) were treated with methotrexate + adalimumab (10 patients: 6/4 (f/m)). A control group with methotrexate alone (four patients: 2/2 (f/m)) was used. Cartilage integrity in the metacarpophalangeal joints was compared using dGEMRIC at baseline, 12, and 24 weeks after treatment initiation. A statistically significant increase in dGEMRIC levels was found in the adalimumab group considering the results after 12 and 24 weeks of therapy (p < 0.05) but not in the control group (p: non-significant). After 24 weeks, a tendency towards increased dGEMRIC values under combination therapy was observed, whereas methotrexate alone showed a slight decrease without meeting the criteria of significance (dGEMRIC mean change: +85.8 ms [-156.2-+346.5 ms] vs. 30.75 ms [-273.0-+131.0 ms]; p: non-significant). After 24 weeks of treatment with a combination of methotrexate and adalimumab, a trend indicating improvement in cartilage composition is seen in patients with early rheumatoid arthritis. However, treatment with methotrexate alone showed no change in cartilage composition, as observed in dGEMRIC sequences of metacarpophalangeal joints.

Digitalization and disruptive change in rheumatology.

INTRODUCTION: Recently, many sectors have seen disruptive changes due to the rapid progress in information and communication technology (ICT). The aim of this systematic literature review was to develop a first understanding of what is known about new ICTs in rheumatology and their disruptive potential. METHODS: PubMed, LIVIVO, and EBSCO Discovery Service (EDS) databases were searched for relevant literature. Use of new ICTs was identified, categorized, and disruptive potential was discussed. Articles from 2008 to 2021 in German and English were considered. RESULTS: A total of 3539 articles were identified. After application of inclusion/exclusion criteria, 55 articles were included in the analyses. The majority of articles (48) used a non-experimental design or detailed expert opinion. The new ICTs mentioned in these articles could be allocated to four main categories: technologies that prepare for the development of new knowledge by data collection (n = 32); technologies that develop new knowledge by evaluation of data (e.g., by inventing better treatment; n = 11); technologies that improve communication of existing knowledge (n = 32); and technologies that improve the care process (n = 29). Further assessment classified the ICTs into different functional subcategories. Based on these categories it is possible to estimate the disruptive potential of new ICTs. CONCLUSION: ICTs are becoming increasingly important in rheumatology and may impact patients' lives and professional conduct. The properties and disruptive potential of technologies identified in the articles differ widely. When looking into ICTs, doctors have focused on new diagnostic and therapeutic procedures but rarely on their disruptive potential. We recommend putting more effort into investigation of whether ICTs change the way rheumatology is performed and who is in control of it. Especially technologies that potentially replace physicians with machines, take control over the definition of quality in medicine, and/or create proprietary knowledge that is not accessible for doctors need more research.

Evaluation of the use of video consultation in German rheumatology care before and during the COVID-19 pandemic.

Background: The COVID-19 pandemic led to transformations in healthcare infrastructures and increased use of (innovative) telemedicine (TM) tools. Comparison of the use of video consultation (VC) in rheumatology in the pre-pandemic period and during the pandemic might allow for evaluating this new form of consultancy in healthcare due to changing conditions and possibilities. Materials and methods: Cross-sectional nationwide online survey among German rheumatologists and rheumatologists in training between March and May 2021 promoted by newsletters and Twitter posts. Results: Results refer to 205 participants. The majority was male (59%), older than 40 years (90%). Thirty-eight percent stated to have employed TM before ("digital users"), 27% were using VC as part of their TM expertise ("VC-users"), 10% stated to have experience with TM but not VC ("TM-users"). Those negating the use of any TM (62%) were designated as "digital non-users." TM-Knowledge was self-rated as 4 [median on a Likert Scale 1 (very high) to 6 (very low)] with a significant difference between digital users (VC-user 2.7 ± 1.2, TM-user 3.2 ± 1.1) and digital non-users (4.4 ± 1.3). The reported significant increase of VC use during the lockdown periods and between the lockdowns compared to the pre-pandemic phase was regarded as a proxy for VC acceptance in the pandemic. Reasons for VC non-use were administrative/technical efforts (21%), lack of technical equipment (15%), time constraints (12%), time required for individual VC sessions (12%), inadequate reimbursement (11%), lack of demand from patients (11%), data security concerns (9%), poor internet connection (8%), and lack of scientific evaluation/evidence (5%). Physicians considered the following clinical situations to be particularly suitable for VC: follow-up visits (VC-user 79%, TM-user 62%, digital non-user 47%), emergency consultations (VC-user 20%, TM-user 33%, digital non-user 20%), and patients presenting for the first time (VC-user 11%, TM-user 19%, digital non-user 8%). Conclusion: Even though the pandemic situation, with social distancing and several lockdowns, provides an ideal environment for the implementation of new remote care forms as VC, its use and acceptance remained comparatively low due to multiple reasons. This analysis may help identify hurdles in employing innovative digital care models for rheumatologic healthcare.

One year of digital health applications (DiGA) in Germany - Rheumatologists' perspectives.

Background: Based on given legislation the German approach to digital health applications (DiGA) allows reimbursed prescription of approved therapeutic software products since October 2020. For the first time, we evaluated DiGA-related acceptance, usage, and level of knowledge among members of the German Society for Rheumatology (DGRh) 1 year after its legal implementation. Materials and methods: An anonymous cross-sectional online survey, initially designed by the health innovation hub (think tank and sparring partner of the German Federal Ministry of Health) and the German Pain Society was adapted to the field of rheumatology. The survey was promoted by DGRh newsletters and Twitter-posts. Ethical approval was obtained. Results: In total, 75 valid response-sets. 80% reported to care ≥ 70% of their working time for patients with rheumatic diseases. Most were working in outpatient clinics/offices (54%) and older than 40 years (84%). Gender distribution was balanced (50%). 70% knew the possibility to prescribe DiGA. Most were informed of this for the first time via trade press (63%), and only 8% via the scientific/professional society. 46% expect information on DiGA from the scientific societies/medical chambers (35%) but rarely from the manufacturer (10%) and the responsible ministry (4%). Respondents would like to be informed about DiGA via continuing education events (face-to-face 76%, online 84%), trade press (86%), and manufacturers' test-accounts (64%). Only 7% have already prescribed a DiGA, 46% planned to do so, and 47% did not intend DiGA prescriptions. Relevant aspects for prescription are provided. 86% believe that using DiGA/medical apps would at least partially be feasible and understandable to their patients. 83% thought that data collected by the patients using DiGA or other digital solutions could at least partially influence health care positively. 51% appreciated to get DiGA data directly into their patient documentation system/electronic health record (EHR) and 29% into patient-owned EHR. Conclusion: Digital health applications awareness was high whereas prescription rate was low. Mostly, physician-desired aspects for DiGA prescriptions were proven efficacy and efficiency for physicians and patients, risk of adverse effects and health care costs were less important. Evaluation of patients' barriers and needs is warranted. Our results might contribute to the implementation and dissemination of DiGA.

[Evidence of positive care effects by digital health apps-methodological challenges and approaches]. / Nachweis positiver Versorgungseffekte von digitalen Gesundheitsanwendungen ­ methodische Herausforderungen und Lösungsansätze.

Since 2020, digital health applications (DiGA) can be prescribed at the expense of the German statutory health insurance (SHI) system after undergoing an approval procedure by the Federal Institute for Drugs and Medical Devices (BfArM). DiGA can be approved provisionally for 1 year (with the option of extension) or permanently. The latter is dependent on scientific evidence of a positive effect on care, which can be a medical benefit or a patient-relevant structural and procedural improvement in care. However, it is apparent that the investigation of DiGA in scientific studies is challenging, as they are often complex interventions whose success also includes user and prescriber factors. In addition, health services research data underpinning the benefits of DiGA are lacking to date. In the current article, methodological considerations for DiGA research are presented, and a selection of internal medicine DiGAs is used to critically discuss current research practice.

[Functional vascular acrosyndromes]. / Funktionelle akrale Durchblutungsstörungen.

Vascular acrosyndromes are characterized by sparse, uniform clinical manifestations and a variety of possible pathomechanisms. The present article focuses on the functional entities. Raynaud phenomenon is based on cold- or stress-induced vasospasms of acral arteries. It is defined by the color changes of the skin, in the typical case white-blue-red (tricolore). The long fingers are most commonly affected. The etiology is unknown, and the pathophysiology is poorly understood. A distinction is made between primary and a secondary Raynaud phenomenon. The most important underlying diseases include collagenosis, primarily systemic sclerosis, and malignancies; furthermore, medications and drugs may promote vasospasm. Treatment is aimed at preventing or breaking the vasospasm, but has been only partially effective in doing so. Acrocyanosis is a vasospastic dystonic acral disorder that results in permanent reddish-livid discoloration, especially of the hands and feet. Secondary forms occur in collagenosis, malignancies, and myelodysplastic syndromes. The etiology and pathophysiology are virtually unknown. Targeted pharmacological intervention is not possible. Unlike all other vascular acrosyndromes, erythromelalgia is characterized by hyperemia. The primary form is a genetic sodium channelopathy, while secondary forms include malignancies, connective tissue diseases, and myelodysplastic syndromes. The symptoms are often distressing and disabling. Therapy requires a multimodal approach that includes both nonpharmacological and pharmacological strategies. Close interdisciplinary collaboration is essential for the management of this disease.

Development of a Prediction Model for COVID-19 Acute Respiratory Distress Syndrome in Patients With Rheumatic Diseases: Results From the Global Rheumatology Alliance Registry.

OBJECTIVE: Some patients with rheumatic diseases might be at higher risk for coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS). We aimed to develop a prediction model for COVID-19 ARDS in this population and to create a simple risk score calculator for use in clinical settings. METHODS: Data were derived from the COVID-19 Global Rheumatology Alliance Registry from March 24, 2020, to May 12, 2021. Seven machine learning classifiers were trained on ARDS outcomes using 83 variables obtained at COVID-19 diagnosis. Predictive performance was assessed in a US test set and was validated in patients from four countries with independent registries using area under the curve (AUC), accuracy, sensitivity, and specificity. A simple risk score calculator was developed using a regression model incorporating the most influential predictors from the best performing classifier. RESULTS: The study included 8633 patients from 74 countries, of whom 523 (6%) had ARDS. Gradient boosting had the highest mean AUC (0.78; 95% confidence interval [CI]: 0.67-0.88) and was considered the top performing classifier. Ten predictors were identified as key risk factors and were included in a regression model. The regression model that predicted ARDS with 71% (95% CI: 61%-83%) sensitivity in the test set, and with sensitivities ranging from 61% to 80% in countries with independent registries, was used to develop the risk score calculator. CONCLUSION: We were able to predict ARDS with good sensitivity using information readily available at COVID-19 diagnosis. The proposed risk score calculator has the potential to guide risk stratification for treatments, such as monoclonal antibodies, that have potential to reduce COVID-19 disease progression.

[Digital Transformation of Healthcare: A Delphi Study of the Working Groups Digital Health and Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF)]. / Digitale Transformation des Gesundheitswesens ­ eine Delphi-Studie der Arbeitsgruppen Digital Health und Validierung und Linkage von Sekundärdaten des Deutschen Netzwerk Versorgungsforschung (DNVF).

AIM OF THE STUDY: The digital transformation in healthcare is also of fundamental importance for healthcare research. For this reason, experts should agree on, prioritize and identify key topics for a medium-term strategy of the German Network for Health Services Research and classify the general development of digital health in the context of health services research. METHODS: Between April and September 2018, the working groups "Digital Health" and "Validation and Linkage of Secondary Data" of the German Network for Health Services Research were asked to submit their expertise online using the methodological approach of a Delphi study. For this purpose, a multi-stage modified Delphi method with quantitative and qualitative approaches was chosen. Initially, a list of theses was drawn from the network's published position papers on digital health applications and medical apps. A total of 131 statements were formulated. The final survey instrument included questions on the biographical background of the participants, 42 developed items (33 statements and 8 open-ended questions), and one free-text field to add further aspects. Items were evaluated with a five-point Likert scale. A statement was accepted if the agreement rate was 75% or higher. RESULTS: Of the 110 potential participants, 50 (46%) took part in the first round and 39 (36%) in the second round of the Delphi survey. In the first round, there was a clear result for 24 of 33 statements. There were 20 statements "agreed with" and four "disagreed with." Nine statements were between 60 and 75% and were presented to the participants again for evaluation in the second round. In round two, of these nine statements, four statements were "agreed with" and five statements were "disagreed with." Digital Health Literacy" emerged as a particular focus in this Delphi study. CONCLUSION: In this Delphi study, experts were involved in selecting and prioritizing possible topics for the Digital Health working group and assessing future developments in digital health in the context of health services research. The results reflect both the expectations and interests of the members and are largely consistent with the recommendations of the report "Digitalization for Health" made by the expert council for assessing developments in the health sector.

Monitoring of Disease Activity With a Smartphone App in Routine Clinical Care in Patients With Axial Spondyloarthritis.

OBJECTIVE: To investigate the performance of a health app with respect to usability, adherence, and equivalence of data in daily care of patients with axial spondyloarthritis (axSpA). METHODS: Consecutive patients with axSpA were asked to export patient-reported outcomes (PRO) electronically with the AxSpA Live App regularly every 2 weeks over a period of 6 months. The first clinical visit was followed by 2 further personal visits after 3 and 6 months. Patients completed paper-based PRO at every visit; they also completed the Mobile App Rating Scale and the System Usability Scale after 3 and 6 months. RESULTS: Of 103 patients with axSpA, 69 agreed to participate (67.0%): age 41.5 (11.3) years, 58.0% male, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 4.3 (2.0), and 76.8% treated with biologic disease-modifying antirheumatic drugs. Patients' adherence to regular app exports was 29.0% and 28.4% after 3 and 6 months, respectively. Significant predictors for good adherence were high disease activity (P = 0.02) and older age (P = 0.04). No systematic differences between digital and paper-based BASDAI scores were found (intraclass correlation coefficients 0.99 [95% CI 0.98-0.99]). Performance of the app was rated as good. CONCLUSION: Collection of digital PROs by AxSpA Live App may be successfully used in patients with axSpA with high disease activity. Our study showed equivalence of digital data, but adherence to the app after 6 months was poor. Higher disease activity and older age resulted in increased adherence to the app. This suggests that the use of health apps like this should concentrate on more severely affected patients.

[Practical use of digital health applications (DiGA) in internal medicine]. / Praktische Anwendung digitaler Gesundheitsanwendungen (DiGA) in der Inneren Medizin.

Since 2020 physicians can prescribe digital health applications (DiGA), also colloquially known as apps on prescription, which are reimbursed by the statutory health insurance when they are approved by the Federal Institute for Drugs and Medical Devices (BfArM) and are included in the DiGA Ordinance. Currently, there is one approved DiGA (indication obesity) for internal medicine. There are many questions on the practical use of the DiGA, ranging from the prescription, the effectiveness, the complexities and reimbursement as well as the liability risks. The DiGA are innovative new means, which maybe support internal medicine physicians in the diagnostics and treatment in the future. The benefits in this field of indications are limited by unclarified issues, especially on the prescription practice and the currently low number of DiGA available in internal medicine.