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BACKGROUND: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of "Digitale Gesundheitsanwendungen" (DiGAs; Digital Health Applications) as collectively funded medical services through the "Digitale-Versorgung-Gesetz" (Digital Health Care Act) in 2019. OBJECTIVE: This article presents real-world prescription data collected through the smartphone-based home exercise program "Vivira," a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. METHODS: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. RESULTS: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). CONCLUSIONS: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051.
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Dor Musculoesquelética , Humanos , Feminino , Pessoa de Meia-Idade , Análise por Pareamento , Seguimentos , Fatores de Tempo , Terapia por ExercícioRESUMO
Health care delivery is undergoing a rapid change from traditional processes toward the use of digital health interventions and personalized medicine. This movement has been accelerated by the COVID-19 crisis as a response to the need to guarantee access to health care services while reducing the risk of contagion. Digital health scale-up is now also vital to achieve population-wide impact: it will only accomplish sustainable effects if and when deployed into regular health care delivery services. The question of how sustainable digital health scale-up can be successfully achieved has, however, not yet been sufficiently resolved. This paper identifies and discusses enablers and barriers for scaling up digital health innovations. The results discussed in this paper were gathered by scientists and representatives of public bodies as well as patient organizations at an international workshop on scaling up digital health innovations. Results are explored in the context of prior research and implications for future work in achieving large-scale implementations that will benefit the population as a whole.
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COVID-19 , Telemedicina , Humanos , Telemedicina/métodosRESUMO
BACKGROUND: Advancements in technology offer new opportunities for the prevention and management of type 2 diabetes. Venture capital companies have been investing in digital diabetes companies that offer digital behavior change interventions (DBCIs). However, little is known about the scientific evidence underpinning such interventions or the degree to which these interventions leverage novel technology-driven automated developments such as conversational agents (CAs) or just-in-time adaptive intervention (JITAI) approaches. OBJECTIVE: Our objectives were to identify the top-funded companies offering DBCIs for type 2 diabetes management and prevention, review the level of scientific evidence underpinning the DBCIs, identify which DBCIs are recognized as evidence-based programs by quality assurance authorities, and examine the degree to which these DBCIs include novel automated approaches such as CAs and JITAI mechanisms. METHODS: A systematic search was conducted using 2 venture capital databases (Crunchbase Pro and Pitchbook) to identify the top-funded companies offering interventions for type 2 diabetes prevention and management. Scientific publications relating to the identified DBCIs were identified via PubMed, Google Scholar, and the DBCIs' websites, and data regarding intervention effectiveness were extracted. The Diabetes Prevention Recognition Program (DPRP) of the Center for Disease Control and Prevention in the United States was used to identify the recognition status. The DBCIs' publications, websites, and mobile apps were reviewed with regard to the intervention characteristics. RESULTS: The 16 top-funded companies offering DBCIs for type 2 diabetes received a total funding of US $2.4 billion as of June 15, 2021. Only 4 out of the 50 identified publications associated with these DBCIs were fully powered randomized controlled trials (RCTs). Further, 1 of those 4 RCTs showed a significant difference in glycated hemoglobin A1c (HbA1c) outcomes between the intervention and control groups. However, all the studies reported HbA1c improvements ranging from 0.2% to 1.9% over the course of 12 months. In addition, 6 interventions were fully recognized by the DPRP to deliver evidence-based programs, and 2 interventions had a pending recognition status. Health professionals were included in the majority of DBCIs (13/16, 81%,), whereas only 10% (1/10) of accessible apps involved a CA as part of the intervention delivery. Self-reports represented most of the data sources (74/119, 62%) that could be used to tailor JITAIs. CONCLUSIONS: Our findings suggest that the level of funding received by companies offering DBCIs for type 2 diabetes prevention and management does not coincide with the level of evidence on the intervention effectiveness. There is considerable variation in the level of evidence underpinning the different DBCIs and an overall need for more rigorous effectiveness trials and transparent reporting by quality assurance authorities. Currently, very few DBCIs use automated approaches such as CAs and JITAIs, limiting the scalability and reach of these solutions.
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Diabetes Mellitus Tipo 2 , Aplicativos Móveis , Diabetes Mellitus Tipo 2/prevenção & controle , HumanosRESUMO
The prevalence of anxiety disorders and depression are rising worldwide. Studies investigating risk factors on a societal level leading to these rises are so far limited to social-economic status, social capital, and unemployment, while most such studies rely on self-reports to investigate these factors. Therefore, our study aims to evaluate the impact of an additional factor on a societal level, namely digitalization, by using a linguistic big data approach. We extend related work by using the Google Books Ngram Viewer (Google Ngram) to retrieve and adjust word frequencies from a large corpus of books (8 million books or 6 percent of all books ever published) and to subsequently investigate word changes in terms of anxiety disorders, depression, and digitalization. Our analyses comprise and compare data from six languages, British English, German, Spanish, Russian, French, and Italian. We also retrieved word frequencies for the control construct "religion". Our results show an increase in word frequency for anxiety, depression, and digitalization over the last 50 years (r = .79 to .89, p < .001), a significant correlation between the frequency of anxiety and depression words (r = .98, p < .001), a significant correlation between the frequency of anxiety and digitalization words (r = .81, p < .001), and a significant correlation between the frequency of depression and anxiety words (r = .81, p < .001). For the control construct religion, we found no significant correlations for word frequency over the last 50 years and no significant correlation between the frequency of anxiety and depression words. Our results showed a negative correlation between the frequency of depression and religion words (r = -.25, p < .05). We also improved the method by excluding terms with double meanings detected by 73 independent native speakers. Implications for future research and professional and clinical implications of these findings are discussed.
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Depressão , Ferramenta de Busca , Humanos , Depressão/epidemiologia , Idioma , Ansiedade/epidemiologia , Transtornos de Ansiedade/epidemiologiaRESUMO
BACKGROUND: Slow-paced breathing training can have positive effects on physiological and psychological well-being. Unfortunately, use statistics indicate that adherence to breathing training apps is low. Recent work suggests that gameful breathing training may help overcome this challenge. OBJECTIVE: This study aimed to introduce and evaluate the gameful breathing training app Breeze 2 and its novel real-time breathing detection algorithm that enables the interactive components of the app. METHODS: We developed the breathing detection algorithm by using deep transfer learning to detect inhalation, exhalation, and nonbreathing sounds (including silence). An additional heuristic prolongs detected exhalations to stabilize the algorithm's predictions. We evaluated Breeze 2 with 30 participants (women: n=14, 47%; age: mean 29.77, SD 7.33 years). Participants performed breathing training with Breeze 2 in 2 sessions with and without headphones. They answered questions regarding user engagement (User Engagement Scale Short Form [UES-SF]), perceived effectiveness (PE), perceived relaxation effectiveness, and perceived breathing detection accuracy. We used Wilcoxon signed-rank tests to compare the UES-SF, PE, and perceived relaxation effectiveness scores with neutral scores. Furthermore, we correlated perceived breathing detection accuracy with actual multi-class balanced accuracy to determine whether participants could perceive the actual breathing detection performance. We also conducted a repeated-measure ANOVA to investigate breathing detection differences in balanced accuracy with and without the heuristic and when classifying data captured from headphones and smartphone microphones. The analysis controlled for potential between-subject effects of the participants' sex. RESULTS: Our results show scores that were significantly higher than neutral scores for the UES-SF (W=459; P<.001), PE (W=465; P<.001), and perceived relaxation effectiveness (W=358; P<.001). Perceived breathing detection accuracy correlated significantly with the actual multi-class balanced accuracy (r=0.51; P<.001). Furthermore, we found that the heuristic significantly improved the breathing detection balanced accuracy (F1,25=6.23; P=.02) and that detection performed better on data captured from smartphone microphones than than on data from headphones (F1,25=17.61; P<.001). We did not observe any significant between-subject effects of sex. Breathing detection without the heuristic reached a multi-class balanced accuracy of 74% on the collected audio recordings. CONCLUSIONS: Most participants (28/30, 93%) perceived Breeze 2 as engaging and effective. Furthermore, breathing detection worked well for most participants, as indicated by the perceived detection accuracy and actual detection accuracy. In future work, we aim to use the collected breathing sounds to improve breathing detection with regard to its stability and performance. We also plan to use Breeze 2 as an intervention tool in various studies targeting the prevention and management of noncommunicable diseases.
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BACKGROUND: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. OBJECTIVE: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as "program"), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. METHODS: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. RESULTS: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. CONCLUSIONS: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. TRIAL REGISTRATION: German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS00021785.