Real-World-Evidence of Digital Health Applications (DiGAs) in Rheumatology: Insights from the DiGAReal Registry

Zimmermann J., Morf H., Scharf F., Knitza J., Moeller H., Muehlensiepen F., Nathrath M., Orlemann T., Voelker T., Deckers M.

Background The exponential growth of telehealth is revolutionizing health care delivery, but its evaluation has not matched the pace of its uptake. Various forms of assessment, from single-item to more extensive questionnaires, have been used to assess telehealth and digital therapeutics and their usability. The most frequently used questionnaire is the “Telehealth Usability Questionnaire” (TUQ). The use of the TUQ is limited by its restricted availability in languages other than English and its feasibility. Objective The aims of this study were to create a translated German TUQ version and to derive a short questionnaire for patients—“Telehealth Usability and Perceived Usefulness Short Questionnaire for patients” (TUUSQ). Methods As a first step, the original 21-item TUQ was forward and back-translated twice. In the second step, 13 TUQ items were selected for their suitability for the general evaluation of telehealth on the basis of expert opinion. These 13 items were surveyed between July 2022 and September 2023 in 4 studies with patients and family members of palliative care, as well as patients with chronic autoimmune diseases, evaluating 13 health care apps, including digital therapeutics and a telehealth system (n1=128, n2=220, n3=30, and n4=12). Psychometric exploratory factor analysis was conducted. Results The analysis revealed that a parsimonious factor structure with 2 factors (“perceived usefulness in health care” and “usability”) is sufficient to describe the patient’s perception. Consequently, the questionnaire could be shortened to 6 items without compromising its informativeness. Conclusions We provide a linguistically precise German version of the TUQ for assessing the usability and perceived usefulness of telehealth. Beyond that, we supply a highly feasible shortened version that is versatile for general use in telehealth, mobile health, and digital therapeutics, which distinguishes between the 2 factors “perceived usefulness in health care” and “usability” in patients. Trial Registration German Clinical Trials Register DRKS00030546; https://drks.de/search/de/trial/DRKS00030546

Cirkel L., Lechner F., Schlicker N., Leipe J., Mühlensiepen F., Grgic I., Hirsch M.C., Kuhn S., Knitza J.

Abstract Background Therapeutic digital health applications (DiGAs) are expected to significantly enhance access to evidence-based care. Since 2020, German physicians and psychotherapists have been able to prescribe approved DiGAs, which are reimbursed by statutory health insurance. This study investigates the usage, knowledge and perception of DiGAs as well as the growing digitalization among internal medicine physicians in Germany. Methods A web-based survey was distributed at the 2024 annual congress of the German Society for Internal Medicine. Participants could respond by scanning a QR code or directly on a tablet. Results A total of 100 physicians completed the survey, with a mean age of 43.4 years. The majority were internal medicine physicians (85%). Of the respondents, 31% had already prescribed DiGAs, and 29% had tested one. Self-rated knowledge of DiGAs was low (median score 3.17/10). The main barriers identified were lack of knowledge about effective implementation (60%), lack of time for patient onboarding (27%), and concerns about patient adherence (21%). However, 92% believed that DiGAs could improve care, and 88% expressed interest in specific digital health training. The majority (64%) stated that digitalization had a positive impact on medical care and 39% of physicians expected their daily workload to decrease due to digitalization. In addition, 38% believed that the physician-patient relationship would improve as a result of digitalization. Conclusions While physicians widely acknowledged the potential benefits of DiGAs, adoption and understanding remain limited. Specific training in digital health is crucial to accelerate digitalization in internal medicine.

Knitza J., Gupta L., Hügle T.

Rheumatology faces a critical shortage of health-care professionals, exacerbated by an ageing patient population and escalating costs, resulting in widening gaps in care. Exponential advances in digital health technologies (DHTs) in the past 5 years offer new opportunities to address these challenges and could contribute to overall improved health care. However, keeping pace with innovations and integrating them into clinical practice can be challenging. This Review explores the transformative potential of DHTs for rheumatology in reshaping the entire patient pathway and redefining the roles of patients and providers, and discusses the potential barriers to DHT integration. Key technologies, such as large language models, clinical decision-support systems, digital therapeutics, electronic patient-reported outcomes, digital biomarkers, robots, self-sampling devices and artificial intelligence-based scribes, can be implemented along the patient pathway. A digital-first hybrid stepped-care patient pathway could combine in-person and remote care, enabling personalized and continuous monitoring through a digital safety net. The potential benefits and risks of transforming the traditional patient–provider relationship into a digital health triad with technology are discussed. Collaborative efforts are needed to navigate the evolving digital health landscape and harness the potential of DHTs to improve rheumatology care. Digital health has the potential to improve patient care in rheumatology and alleviate strain on the health-care system. This Review explores the current status of the transition from traditional health care to a model that harnesses the potential of digital health technologies, including discussion of the main benefits and barriers.

Boy K., May S., Labinsky H., Morf H., Heinze M., Leipe J., Kuhn S., Schett G., Knitza J., Muehlensiepen F.

AbstractNon-specific low back pain (NLBP) is prevalent among patients with rheumatic conditions. Digital health applications (DiGAs) provide reimbursed, personalized home treatment for patients, promising to overcome limitations of traditional healthcare systems. However, the adoption and effectiveness of back pain-specific DiGAs in rheumatology are not well understood. This study aims to explore the experiences and perspectives of a diverse group of rheumatology stakeholders regarding the use of DiGAs for back pain management. Qualitative interviews and a focus group discussion were conducted with a wide range of stakeholders including rheumatic patients, rheumatologists, nurses and DiGA producers. The data were analysed using qualitative content analysis. The study included 15 interviews (10 rheumatic patients, 4 rheumatologists, 1 DiGA producer) and 1 focus group with mixed participants (n = 12). Most stakeholders valued the instant access to personalized and effective back pain treatment provided by DiGAs. Patients appreciated the flexibility and ease of use of DiGAs which can be used anywhere and anytime. Concerns were raised about insufficient guidance regarding correct execution of exercises, which was seen as potentially dangerous and unsettling for patients. Healthcare professionals (HCPs) highlighted barriers, such as the lack of reimbursement, time constraints, and inadequate DiGA-specific education as barriers to prescribing DiGAs. Additionally, poor patient onboarding often led to delays, increased skepticism, and premature discontinuation of therapy. Stakeholders emphasized the challenges of current care driven by a shortage of HCPs and generally supported usage of back pain DiGAs. Various barriers and solution approaches were identified to enhance the performance, usability, and implementation of DiGAs in rheumatology.

Knitza J., Krusche M., Chehab G., Specker C., Richter J.G.

ZusammenfassungDigitale Gesundheitsanwendungen (DiGA) revolutionieren die Patientenversorgung durch verbesserten Zugang zu evidenzbasierter Therapie und fördern aktives Selbstmanagement. Die kontinuierlich wachsende Anzahl an DiGA ermöglicht es Patient:innen, durch digitale Unterstützung eigenständiger zu handeln. Die budgetneutrale Verordnung und Kostenübernahme durch gesetzliche Krankenkassen senken finanzielle Barrieren für Behandler:innen und Patient:innen. Erste Studien belegen, dass DiGA erfolgreich zur Behandlung von Komorbiditäten und rheumatischen Erkrankungen eingesetzt werden können. Mehrere DiGA für entzündlich-rheumatische Erkrankungen befinden sich in fortgeschrittener Entwicklung. Die Identifikation geeigneter Patient:innen und die Unterstützung durch Shared Decision Making (SDM) sind entscheidend für die erfolgreiche Implementierung. Herausforderungen bestehen weiterhin in der Adhärenz und Akzeptanz der Anwendungen. Dieser Artikel bietet einen Überblick über die Verordnung in der Praxis, erste Daten und Erfahrungen aus der rheumatologischen Versorgungsrealität und berichtet über aktuelle Entwicklungen.

Betz L.T., Jacob G.A., Knitza J., Koehm M., Behrens F.

AbstractCognitive behavioral therapy improves psychosocial outcomes in rheumatoid arthritis (RA), but access is limited. We conducted a randomized controlled trial to evaluate the efficacy of a cognitive-behavioral digital therapeutic, reclarit, on psychosocial outcomes in adult RA patients with impaired health-related quality of life. Participants were randomized to reclarit plus treatment as usual (TAU) or TAU plus educational and informational material (active control). The primary outcome was SF-36 mental (MCS) and physical (PCS) component summary scores at 3 months, with additional assessments at 6 months. reclarit significantly improved SF-36 MCS scores compared to control (mean difference 3.3 [95% CI 0.7, 5.9]; p = 0.014), with high user satisfaction and sustained improvements at 6 months. Depression, anxiety, fatigue, and social/work functioning also improved significantly, while SF-36 PCS, pain, and disability scores did not differ. In conclusion, reclarit offers immediate, effective, evidence-based and personalized psychological support for RA patients.

Braun J., Albrecht K., Callhoff J., Haase I., Krause A., Lakomek H.-., Meyer-Olson D., Schmale-Grede R., Wagner U., Zeidler J., Zinke S., Voormann A., Specker C.

Die Rheumatologie in Deutschland steht vor großen Herausforderungen: der Bedarf an rheumatologischer Versorgung steigt und kann aus Kapazitätsgründen bereits jetzt in einigen Regionen nicht mehr gedeckt werden. Zu viele Menschen mit einer entzündlich-rheumatischen Erkrankung (ERE) müssen auf eine angemessene Versorgung verzichten oder erhalten diese zu spät. Die 4. Neuauflage des Memorandums der Deutschen Gesellschaft für Rheumatologie und Klinische Immunologie e. V. (DGRh) informiert über die rheumatologische Versorgung in Deutschland. Es wurde unter Führung der DGRh mit dem Berufsverband Deutscher Rheumatologen (BDRh), dem Verband Rheumatologischer Akutkliniken (VRA), der Deutschen Rheuma-Liga (DRL) und dem Deutschen Rheuma-Forschungszentrum (DRFZ) erstellt. Das Memorandum beschreibt den aktuellen Stand und die Entwicklung folgender Bereiche: Anzahl der Personen mit ERE, ambulante, stationäre und rehabilitative Versorgungsstrukturen, Anzahl an Fachärzt:innen für Rheumatologie, Aus- und Weiterbildung, Versorgungsqualität, gesundheitsökonomische Aspekte und digitale Versorgungskonzepte. Vorschläge für gesundheitspolitische Maßnahmen zur Sicherung der rheumatologischen Versorgung werden dargestellt. Prävalenz: Etwa 1,8 Mio. Erwachsene in Deutschland haben eine ERE. Die Prävalenz steigt aus verschiedenen Gründen: Veränderungen der Altersstruktur der Bevölkerung, verbesserte Diagnostik und Therapie mit längerem Überleben. Versorgungsstrukturen: Neben der regulären kassenärztlichen Versorgung hat sich die ambulante spezialfachärztliche Versorgung (ASV) als sektorenübergreifendes Versorgungsmodell etabliert. Krankenhäuser können sich seit 2020 als rheumatologische Zentren zertifizieren lassen, was strukturelle Weiterentwicklungen ermöglicht. Fachärzt:innen (FÄ) für Rheumatologie: Zum 31.12.2023 waren in Deutschland 1164 FÄ für Rheumatologie berufstätig. Vertragsärztlich waren dies 715 FÄ, davon 39 % angestellt. In Krankenhäusern waren 39 % der FÄ in Teilzeit tätig. Für eine bedarfsgerechte ambulante Versorgung benötigen wir mindestens 2 FÄ für Rheumatologie pro 100.000 Erwachsene, das sind rund 1400. Es fehlen also allein im ambulanten Bereich zum jetzigen Zeitpunkt etwa 700 FÄ für Rheumatologie. Von allen berufstätigen FÄ sind 30 % derzeit 60 Jahre und älter. Ärztliche Ausbildung: Nur 10 von 38 (26 %) staatlichen Universitäten verfügen über einen eigenständigen rheumatologischen Lehrstuhl. Darüber hinaus sind 11 rheumatologisch geführte Abteilungen einem nicht-rheumatologischen Lehrstuhl untergeordnet. Nur 16 von 36 Fakultäten erfüllten in der RISA III-Studie die empfohlene Mindestzahl an Pflichtstunden studentischer rheumatologischer Lehre. Rheumatologische Weiterbildung: Die jährlichen Weiterbildungsabschlüsse für Rheumatologie decken nicht den Bedarf an rheumatologischen FÄ, der durch steigende Arbeitsbelastung, reduzierte Kapazitäten durch Pensionierung und zunehmende Teilzeittätigkeit noch zunimmt. Versorgungsqualität: Rheuma-Betroffene haben seit Einführung hochwirksamer Medikamente eine deutlich bessere Aussicht auf eine Remission ihrer Erkrankung. Bei frühzeitiger adäquater Therapie ist die Lebensführung vieler Betroffener kaum noch eingeschränkt. Die Wartezeit auf eine rheumatologische Erstvorstellung beträgt aber oft mehr als 3 Monate. Qualitätsziel ist eine Vorstellung innerhalb der ersten 6 Wochen nach Symptombeginn. Frühsprechstunden, Delegation ärztlicher Leistungen, strukturierte Patientenschulungen und digitale Versorgungskonzepte wurden positiv evaluiert, sind aber nicht finanziell gedeckt. Kosten: Die jährlichen Gesamtkosten allein für entzündliche Gelenkerkrankungen belaufen sich auf etwa 3 Mrd. €. Die direkten Kosten sind seit Einführung der Biologika deutlich gestiegen, während indirekte Kosten für Krankschreibung, Erwerbsunfähigkeit und stationäre Aufenthalte gesunken sind. Kernforderungen dieses Memorandums sind: die deutliche und nachhaltige Steigerung der Zahl von Weiterbildungsstellen im ambulanten und stationären Bereich, die Schaffung von Lehrstühlen oder mindestens eigenständigen Abteilungen für Rheumatologie an allen Universitäten sowie die weitere Umsetzung neuer und sektorenübergreifender Versorgungsformen. Dies stellt eine bedarfsgerechte, moderne rheumatologische Versorgung für alle Betroffenen auch in Zukunft sicher.

Priebe J., Kerkemeyer L., Haas K., Achtert K., Moreno Sanchez L., Stockert P., Spannagl M., Wendlinger J., Thoma R., Jedamzik S., Reichmann J., Franke S., Sundmacher L., Amelung V., Toelle T.

Strunz P., Le Maire M., Heusinger T., Klein J., Labinsky H., Fleischer A., Luetkens K.S., Possler P., Gernert M., Leppich R., Schmieder A., Hammel L., Schulz E., Sperlich B., Froehlich M., et. al.

AbstractBackground: Patients with axial spondyloarthritis (axSpA) benefit from regular home-based exercise (HbE). In spite of recommendations, a relevant proportion of German axSpA patients does not adhere to recommended HbE practices. To enhance HbE care, we developed the novel digital therapeutic (DTx) “Axia” compliant with the European medical device regulation (MDR). Axia offers a modern app-based HbE solution with patient educative content and further integrated features. Objective: We aimed to assess Axia’s efficacy, attractiveness, and functionality through a survey among axSpA-patients involved in the first user tests. Methods: A mixed-method online questionnaire with 38 items was administered to 37 axSpA volunteers after using Axia. Numeric rating scales (NRS) and likelihood scales were primarily used. Results: HbE frequency significantly increased from a median of 1 day/week to 6 days/week (p < 0.001) by using Axia. Existing HbE practitioners also increased their frequency (median of 4 days/week before, 6 days/week with Axia, p < 0.05). Axia received a median rating of 5 out of 5 stars. On NRS scales, Axia scored a median of 9 for intuitiveness and design, and a median of 8 for entertainment. 64.9% reported improved range of motion, 43.2% reported reduced pain, and 93.6% enhanced disease-specific knowledge. All users recommended Axia to other patients. Conclusion: Axia increases axSpA patients HbE frequency, possibly due to its good intuitiveness and design, leading to reduction in pain and subjective improvement of range of motion. This warrants further investigation in large randomized controlled interventional trials to establish its efficacy conclusively and patients adherence to HbE.

Benning L., Teepe G.W., Pooth J., Hans F.P.

Background Germany has one of the oldest social security systems in the world. Population coverage has subsequently increased, reaching coverage of approximately 90% of the population in the statutory health insurance (SHI) system today. Before this background, Germany has been pioneering the integration of digital therapeutics (DTx) into its SHI system by the introduction of the Digital Healthcare Law (Digitale-Versorgung-Gesetz, DVG) in 2019. Thereby, patients became eligible for digital health applications (Digitale Gesundheitsanwendungen, DiGA), which are available upon prescription by qualified healthcare professionals. Challenge As conventional healthcare delivery often lacks direct outcome measures as and is mostly still reimbursed on a fee-for-service basis, DiGA offer the opportunity to continuously provide individual outcome and performance data. They are, therefore, well-suited for a performance-based payment framework. While the DVG introduced the option for performance-based reimbursement components in 2019 already, the ongoing debate about the value of DiGA and to what extent they can contribute to the healthcare system has now been reflected in a 2023 health policy bill by the German Federal Ministry of Health, which aims to introduce a mandatory performance-based reimbursement component for DiGA. Proposal In this light, we propose a framework for performance-based reimbursement of DiGA, involving an intervention-specific, performance-linked reimbursement framework with shared accountability between manufacturers and payers. The approach aims to align the often contradicting interests of the involved stakeholders to incentivize the delivery of high-value digital health care. Yet, the proposal also acknowledges the need for further research to establish a robust foundation for implementing such a framework.

Li L.C., Xie H., Feehan L.M., Shaw C., Lu N., Ramachandran S., Wang E., Therrien S., Mucha J., Hoens A.M., English K., Davidson E., Liu-Ambrose T., Backman C.L., Esdaile J.M., et. al.

Abstract Objectives To assess a remote physiotherapist (PT) counselling intervention using self-monitoring tools for improving self-management ability, physical activity participation and health outcomes in people with rheumatoid arthritis (RA). Methods Eligible participants were randomly assigned to receive group education, a Fitbit®, a self-monitoring app, and PT counselling phone calls (Immediate Group). The Delayed Group received a monthly e-newsletter until week 26, and then the intervention. The primary outcome was Patient Activation Measure (PAM-13). Participants were assessed at baseline, 27 weeks (the primary end point) and 53 weeks. Secondary outcomes included disease activity, pain, fatigue, depression, sitting/walking habits, daily physical activity time and daily awake sedentary time. Generalized Linear Mixed-effect Models (GLMMs) were used to assess the effect of the intervention on the change of each outcome measure from the initiation to 27 weeks after the intervention. Results Analysis included 131 participants (91.6% women; 80.2% completed during the COVID-19 pandemic). The mean change of PAM-13 at 27 weeks was 4.6 (Standard Deviation [SD] = 14.7) in the Immediate Group vs −1.6 (SD = 12.5) in the Delayed Group. The mean change in Delayed Group at 53 weeks (after the 26-week intervention) was 3.6 (SD = 14.6). Overall, the intervention improved PAM-13 at 27 weeks post-intervention from the GLMM analysis (adjusted coefficient: 5.3; 95% CI: 2.0, 8.7; P ≤ 0.001). Favourable intervention effects were also found in disease activity, fatigue, depression and self-reported walking habit. Conclusion Remote counselling paired with self-monitoring tools improved self-management ability in people with RA. Findings of secondary outcomes indicate that the intervention had a positive effect on symptom management.

Scheibe M., Knapp A., Harst L., Schmitt J.

Abstract Background In October 2020, digital health applications (DiGAs) became part of standard care in Germany. For approval, DiGA manufacturers must demonstrate medical benefit or patient-relevant improvement of structure and processes (PISP). PISP refers to an innovative outcome core area in terms of proof of benefits and reimbursement decisions. These are subdivided into 9 outcome domains, including for example health literacy, facilitating access to care, and coping with illness-related difficulties in everyday life. Their implementation aims at empowering patients, encouraging shared decision-making, and increasing patient-centeredness in healthcare delivery. Given the novelty of PISP, no standardized set of outcomes and outcome measurement instruments currently exists to operationalize the domains. Learning from previous evaluation studies can help operationalize and standardize PISPs for evaluation studies of digital health applications. Therefore, we investigated the outcomes and outcome measurement instruments, used in controlled trials to assess DiGA-compliant applications, published before the Digital Health Applications Ordinance of April 2020. Methods We conducted a systematic review of studies published between 01/2015 and 04/2020, via MEDLINE and Embase, complemented by forward/backward searches. Controlled trials assessing interventions adhering to the definition of DiGA were eligible, if they applied a validated outcome measurement instrument, and if results were presented in German or English. Title-abstract screening, full-text screening, data extraction and narrative synthesis were conducted independently by two researchers. Results Out of 2,671 references identified, 6 studies collecting a total of 48 outcomes were included. 14 outcomes (29.2%) addressed PISP by using 13 different measurement instruments. The outcomes corresponded to 5 of 9 PISP outcome domains with health literacy being the most common (7/14, 50.0%). Conclusions This review provides an overview of the characteristics of PISPs used in previous evaluation studies of DiGA-compliant applications. It shows which outcomes and validated outcome measurement instruments can be used to measure PISP and where knowledge is still lacking. These results serve as a starting point for operationalizing and standardizing PISPs and help to increase the outcome measurement quality of PISPs.

Knitza J., Muehlensiepen F., Kuhn S.

Digital health applications (DHAs) offer a versatile approach to overcome current medical care gaps. DHA are essentially mobile applications used for medical purposes. The omnipresence of smartphones promises to reach patients even in remote areas and provide continuous medical care in between face-to-face visits. DHA can be implemented along the entire patient pathway, starting with symptom checking, remote patient monitoring, and digital therapeutics (DTx). The number of DHA is continuously growing, and it is becoming increasingly difficult to identify high-quality DHA for health care professionals (HCPs) and patients alike.1Knitza J. Tascilar K. Messner E.M. et al.German mobile apps in rheumatology: review and analysis using the mobile application rating scale (MARS).JMIR Mhealth Uhealth. 2019; 7e14991https://doi.org/10.2196/14991Google Scholar Successful clinical use of DHA is based on 4 interlocking pillars, as follows: (1) DHA development; (2) DHA evaluation; (3) DHA implementation; and (4) DHA education. To really improve a relevant care problem, early and close collaboration with patients and HCPs is essential. To ensure the best possible functionality and acceptance, early feasibility or usability studies are necessary. Qualitative research, including focus groups and interviews, complements classical quantitative research and enables in-depth feedback to improve DHA. To become a certified or even a prescription medical product, DHA needs to prove its safety and efficacy in clinical studies and postmarketing real-world studies. Organizational and health system-specific frameworks must be in place to implement DHA into standard care. Patients and HCPs need dedicated training to realize the full potential of DHA. In this issue of Mayo Clinic proceedings: digital health Gilbert et al2Gilbert S. Pimenta A. Stratton-Powell A. Welzel C. Melvin T. Continuous Improvement of Digital Health Apps Linked to Real-World Performance Monitoring: Safe Moving Targets?.Mayo Clinic Proceeding. 2023; 1: 276-287Google Scholar inform us about the purpose, regulations, different methods, and quality of DHA real-world performance monitoring. The authors stress the need for regular updates to DHA to continuously improve the quality and ensure safety and performance. Regulators increasingly understand that existing frameworks need to be adapted for DHA. The authors highlight that real-world evidence (RWE), on the basis of high-quality surveys, patient and clinician reported outcomes, is essential to enable a continuous DHA assessment. We agree that the collection of RWE is crucial to continuously improve DHA quality and would like to draw the reader’s attention to the DHA lifecycle framework presented by Tarricone et al.3Tarricone R. Petracca F. Cucciniello M. Ciani O. Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps.Health Econ. 2022; 31: 73-97https://doi.org/10.1002/hec.4505Google Scholar Similarly, the authors pointed out the low adoption of DHA in clinical care and the lack of regulatory guidance. On the basis of a thorough review and focus group discussion, the authors formulated 10 recommendations. The framework stresses the early inclusion of end-users during DHA development and the measurement of patient empowerment associated with DHA use. We strongly agree and believe that patient empowerment and improved patient-doctor interaction are the main benefits of DHA usage. In line with Gilbert et al,2Gilbert S. Pimenta A. Stratton-Powell A. Welzel C. Melvin T. Continuous Improvement of Digital Health Apps Linked to Real-World Performance Monitoring: Safe Moving Targets?.Mayo Clinic Proceeding. 2023; 1: 276-287Google Scholar the authors recommend including economic evaluations; however, also recommend evaluating the effect of DHA on equity with regard to the existing digital divide.4Knitza J. Simon D. Lambrecht A. et al.Mobile health usage, preferences, barriers, and ehealth literacy in rheumatology: patient survey study.JMIR mHealth uHealth. 2020; 8e19661https://doi.org/10.2196/19661Google Scholar European regulators are increasingly adapting to the use of RWE, profiting from longer experiences in the United States.5Stern A.D. Brönneke J. Debatin J.F. et al.Advancing digital health applications: priorities for innovation in real-world evidence generation.Lancet Digit Health. 2022; 4: e200-e206https://doi.org/10.1016/S2589-7500(21)00292-2Google Scholar In another highly recommended viewpoint, Stern et al5Stern A.D. Brönneke J. Debatin J.F. et al.Advancing digital health applications: priorities for innovation in real-world evidence generation.Lancet Digit Health. 2022; 4: e200-e206https://doi.org/10.1016/S2589-7500(21)00292-2Google Scholar share thoughts from roundtable discussions regarding a fast-track reimbursement and evaluation pathway for DHA in the German market. This accelerated pathway enables provisional reimbursement in a trial phase of 1 year (or in exceptions of up to 2 years) during which the manufacturer needs to complete a clinical study. In this study, the manufacturer needs to provide the necessary evidence to become permanently a prescription medical product. Results of our recent German DHA pilot study6Labinsky H. Gupta L. Raimondo M.G. Schett G. Knitza J. Real-world usage of digital health applications (DiGA) in rheumatology: results from a German patient survey.Rheumatol Int. 2023; 43: 713-719https://doi.org/10.1007/s00296-022-05261-7Google Scholar highlighted poor adherence as a main and persistent DHA burden. Only 13% of the patients used the DHA regularly over 3 months. We believe that DHA and DTx particularly, are perfectly suited for pay-for-performance models linking RWE and reimbursement to limit unnecessary costs. A stepwise value-based approach could enable DTx reimbursement if the patient completed the DTx program, a stricter pay-for-performance approach would only enable reimbursement if the patient experienced a relevant benefit owing to DTx usage. Hopefully the stimulating thoughts by Gilbert et al2Gilbert S. Pimenta A. Stratton-Powell A. Welzel C. Melvin T. Continuous Improvement of Digital Health Apps Linked to Real-World Performance Monitoring: Safe Moving Targets?.Mayo Clinic Proceeding. 2023; 1: 276-287Google Scholar and others will prompt a rise in RWE collection, improved regulations, and overall implementation of DHA. Author JK declares Non-Financial Interests being part of the Digital Rheumatology Network steering board and the following Competing Financial Interests: he has or has had consulting relationships with ABATON, Abbvie, BMS, Böhringer Ingelheim, Chugai, Galapagos, Gilead, GSK, Lilly, Medac, Novartis, UCB, Vila Health, Werfen and received study support from Abbvie, ABATON, DFG, EIT Health, Novartis, Sanofi, Thermo Fisher, UCB; Author FM declares that he received study support from Abbvie and Novartis; Author SK is the founder and shareholder of MED digital. Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?Mayo Clinic Proceedings: Digital HealthVol. 1Issue 3PreviewReal-time high-quality data on the performance of digital health applications is needed for feedback-led optimization and to ensure safety and performance, particularly if they will have on-market updates. Developers must verify that applications accurately and consistently fulfill their intended purpose in real-world use. In particular, new thinking from regulators recognizes the importance of monitoring real-world performance. It is acknowledged that real-world data can deliver information from wider patient populations than are generally included in controlled studies, and in certain circumstances, this can enable extensions of the application’s intended purpose. Full-Text PDF Open Access

Parodis I., Girard-Guyonvarc’h C., Arnaud L., Distler O., Domján A., Van den Ende C.H., Fligelstone K., Kocher A., Larosa M., Lau M., Mitropoulos A., Ndosi M., Poole J.L., Redmond A., Ritschl V., et. al.

ObjectiveTo develop evidence-based recommendations for the non-pharmacological management of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).MethodsA task force comprising 7 rheumatologists, 15 other healthcare professionals and 3 patients was established. Following a systematic literature review performed to inform the recommendations, statements were formulated, discussed during online meetings and graded based on risk of bias assessment, level of evidence (LoE) and strength of recommendation (SoR; scale A–D, A comprising consistent LoE 1 studies, D comprising LoE 4 or inconsistent studies), following the European Alliance of Associations for Rheumatology standard operating procedure. Level of agreement (LoA; scale 0–10, 0 denoting complete disagreement, 10 denoting complete agreement) was determined for each statement through online voting.ResultsFour overarching principles and 12 recommendations were developed. These concerned common and disease-specific aspects of non-pharmacological management. SoR ranged from A to D. The mean LoA with the overarching principles and recommendations ranged from 8.4 to 9.7. Briefly, non-pharmacological management of SLE and SSc should be tailored, person-centred and participatory. It is not intended to preclude but rather complement pharmacotherapy. Patients should be offered education and support for physical exercise, smoking cessation and avoidance of cold exposure. Photoprotection and psychosocial interventions are important for SLE patients, while mouth and hand exercises are important in SSc.ConclusionsThe recommendations will guide healthcare professionals and patients towards a holistic and personalised management of SLE and SSc. Research and educational agendas were developed to address needs towards a higher evidence level, enhancement of clinician–patient communication and improved outcomes.

England B.R., Smith B.J., Baker N.A., Barton J.L., Oatis C.A., Guyatt G., Anandarajah A., Carandang K., Chan K.K., Constien D., Davidson E., Dodge C.V., Bemis‐Dougherty A., Everett S., Fisher N., et. al.

ObjectiveTo develop initial American College of Rheumatology (ACR) guidelines on the use of exercise, rehabilitation, diet, and additional interventions in conjunction with disease‐modifying antirheumatic drugs (DMARDs) as part of an integrative management approach for people with rheumatoid arthritis (RA).MethodsAn interprofessional guideline development group constructed clinically relevant Population, Intervention, Comparator, and Outcome (PICO) questions. A literature review team then completed a systematic literature review and applied the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate the certainty of evidence. An interprofessional Voting Panel (n = 20 participants) that included 3 individuals with RA achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations.ResultsThe Voting Panel achieved consensus on 28 recommendations for the use of integrative interventions in conjunction with DMARDs for the management of RA. Consistent engagement in exercise received a strong recommendation. Of 27 conditional recommendations, 4 pertained to exercise, 13 to rehabilitation, 3 to diet, and 7 to additional integrative interventions. These recommendations are specific to RA management, recognizing that other medical indications and general health benefits may exist for many of these interventions.ConclusionThis guideline provides initial ACR recommendations on integrative interventions for the management of RA to accompany DMARD treatments. The broad range of interventions included in these recommendations illustrates the importance of an interprofessional, team‐based approach to RA management. The conditional nature of most recommendations requires clinicians to engage persons with RA in shared decision‐making when applying these recommendations.