[Attitudes toward digital tools in pain medicine : Survey of German Pain Society health professional members and members of self-help groups]. / Einstellung zur digitalen Medizin im Schmerzbereich : Eine Umfrage unter Ärzten und Patienten der Deutschen Schmerzgesellschaft und Patientenorganisationen.

Digital medicine has increasing influence on the German healthcare system. In times of social distancing during the ongoing coronavirus disease 2019 (COVID-19) pandemic, digital tools enable health professionals to maintain medical care. Furthermore, digital elements have potential to provide effective guideline-oriented treatment to a broad range of patients independently from location and time. This survey was used to assess the attitudes of members of the German Pain Society (health professionals) and of associated self-help groups (patients) towards digital medicine. It was sent out as an online survey to health professionals in September 2020 and to patients in February 2021. The survey referred especially to present usage, attitude and potential concerns regarding particular digital elements. Furthermore, technical affinity was assessed. In total, 250 health professionals and 154 patients participated in the survey. The results show that-although digital elements are already known-a substantial proportion of health professionals still lack broad transfer to regular treatment. The potential of digital tools seems to be recognized by both groups; interestingly, patients consider digital medicine as more useful than health professionals. Nevertheless, concerns about for example data security or digital competence remain in both groups. Taken together, our results indicate that disruptive changes, as the implementation of digital medicine in the healthcare system, have to be guided by intense education and channeled by political policies in order to successfully integrate digital elements into medicine on a long-term basis. This would be in favor for all involved parties and is demanded especially by patients.

[The digitalization of pneumology and the role of medical societies]. / Die Digitalisierung der Pneumologie und die Rolle der Fachgesellschaften.

BACKGROUND: Medicine is becoming increasingly digitalized. Digital applications are finding their way into health care. The aim of the study was to record the attitudes of members of the German Respiratory Society (DGP) towards digitalization. METHODS: The study was conducted in cooperation with the DGP, the German Respiratory League and the Health Innovation Hub (HIH) of the German Federal Ministry of Health. Data were gathered with the help of an online questionnaire (July/August 2021), analyzed descriptively and supplemented with a subgroup comparison regarding proactivity of the members. RESULTS: 284 questionnaires were complete and included in the analysis (31% female); 76.4% believed that digitalization would change their daily professional life within five years. 47.2% had prescribed or planned to prescribe Digital Health Applications (DiGA). Lack of technology skills of patients and the time required for health professionals were seen as critical (49.3 and 47.5%). Regarding DiGA, scientific proof of efficacy (48.9%) and ease of use for patients (47.9%) were rated as most important. The subgroup comparison showed that 42.7% actively informed themselves about digital medicine and that this group saw more opportunities for meaningful use of DiGA. CONCLUSION: The members of the DGP have mostly a positive view about the profound changes expected from digital medicine. The more active the role of DGP members and other professional societies, the more digital elements can add value to practice.

Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring.

In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern market access are often evolving slowly, sometimes creating market barriers. This article gives a brief overview of the existing clinical studies regarding the use of smart wearables in cardiac monitoring and provides insight into the main regulatory and legal aspects that need to be considered when such products are intended to be used in a health care setting. Based on this brief overview, the article elaborates on the specific requirements in the main areas of authorization/certification and reimbursement/compensation, as well as data protection and data security. Three case studies are presented as examples of specific market access procedures: the USA, Germany, and Belgium. This article concludes that, despite the differences in specific requirements, market access pathways in most countries are characterized by a number of similarities, which should be considered early on in product development. The article also elaborates on how regulatory and legal requirements are currently being adapted for digitally driven wearables and proposes an ongoing evolution of these requirements to facilitate market access for beneficial medical technology in the future.

[Digitized healthcare in 2030-a possible scenario]. / Digitalisierte Gesundheitsversorgung im Jahr 2030 ­ ein mögliches Szenario.

Due to the rapidly advancing digitalization, healthcare will also change significantly in the next few years. For example, in Germany, new legal framework conditions have already set the course for the electronic patient record (ePA), the e­prescription, and the integration of digital health applications (DiGA). The new fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM) for evaluating the reimbursability of DiGA is an important step that will be followed by others in the coming years.This article uses a future scenario for the year 2030 to describe the legal, technical, and practical changes that could occur by then. In 2030, healthcare could be organized in individual and integrated treatment pathways that offer comprehensive support to the insured. Interoperable digital components could, for example, make structured data available for research purposes. Doubts concerning data protection could become a thing of the past if data protection law is reformed and harmonized and new consent procedures for patients are developed. New professional fields could become established and market access for innovative digital medical products could be further improved.Another important aspect that can help to exploit the potential of digital healthcare is the creation of a European data space based on a technical infrastructure that upholds high ethical and social standards. Active measures on the part of legislators can create the necessary conditions for innovations to be incorporated into the system for the benefit of patients and for the German healthcare system to be able to cope with the ongoing changes in medical technology.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

[From idea to standard care-a field report]. / Der lange Weg von der Idee bis zur Erstattung ­ ein Reisebericht.

Digital health products and services have started to fundamentally change healthcare and prevention. Products intended for a medical use require CE-marking and potentially certification (ISO 13485) of the company. Startups play an important role in the development of new digital products and services. Two startups share their experience with these processes. Becoming a part of standard care and hence being reimbursed is a challenge for startups. For this reason, startups pursue alternative sources of income, too. The statutory health insurance's procedures for assessing new products and services are perceived as long. Startups are required to provide evidence of the benefit of their product at an early stage in the procedure. This requires time-consuming and costly studies. Startups would therefore appreciate support in generating this evidence, e. g. through adequate procedures for testing.

Connecting with suicidal patients in psychiatric wards: Therapist challenges.

In this qualitative interview study, the authors investigated how therapists experience and view treatment and care for suicidal patients in psychiatric wards. The focus is on aspects that may contribute toward shaping and possibly constraining therapists' connections with suicidal individuals. They conducted semistructured interviews of 4 psychiatrists and 4 psychologists and analyzed the data by means of thematic analysis. The findings suggest that high emphasis on diagnostics and standardized suicide risk assessments, limited direct care of suicidal patients, and fragmented mental health services may challenge therapists' connections with suicidal patients.

Mental Health Nurses' Experiences of Caring for Suicidal Patients in Psychiatric Wards: An Emotional Endeavor.

The purpose of the study is to investigate mental health nurses' experiences of recognizing and responding to suicidal behavior/self-harm and dealing with the emotional challenges in the care of potentially suicidal inpatients. Interview data of eight mental health nurses were analyzed by systematic text condensation. The participants reported alertness to patients' suicidal cues, relieving psychological pain and inspiring hope. Various emotions are evoked by suicidal behavior. Mental health nurses seem to regulate their emotions and emotional expressions, and balance involvement and distance to provide good care of patients and themselves. Mental health nurses have an important role and should receive sufficient formal support.

Relational Principles in the Care of Suicidal Inpatients: Experiences of Therapists and Mental Health Nurses.

This study explored and compared therapists' and mental health nurses' experiences of caring for suicidal inpatients in light of ethics of care and ethics of justice. Analysis of interview data from eight therapists and eight mental health nurses indicates two approaches: "connection and care" and "duty and control," reflecting aspects of both ethical perspectives. There are some differences between the two professional groups, and sometimes there might be conflicts between the two approaches and ethical perspectives. Clinical practice is increasingly shaped by standardization and guidelines, and it is important to promote professionals' efforts to provide relational-emotional care for suicidal patients.

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.

Advancing digital health applications: priorities for innovation in real-world evidence generation.

In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market. The pathway explicitly provides for flexibility in how researchers can present evidence for new digital products, including the use of real-world data and real-world evidence. Against this backdrop, the Digital Medicine Society and the Health Innovation Hub of the German Federal Ministry of Health convened a set of roundtable discussions to bring together international experts in evidence generation for digital medicine products. This Viewpoint highlights findings from these discussions with the aims of (1) accelerating and stimulating innovative approaches to digital medical product evaluation, and (2) promoting international harmonisation of best evidentiary practices. Advancing these topics and fostering international agreement on evaluation approaches will be vital to the safe, effective, and evidence-based deployment and acceptance of digital health applications globally.

Skin autofluorescence of advanced glycation end products and mortality in affective disorders in the lifelines cohort study: A mediation analysis.

OBJECTIVE: Life expectancy in patients suffering from affective disorders is considerably diminished. We investigated whether skin autofluorescence (SAF), indicating concentration of advanced glycation end products in the skin and oxidative stress, mediates the association between affective disorders and excess mortality. METHODS: Included were 81,041 participants of the Lifelines cohort study. Presence of major depressive disorder, dysthymia, generalised anxiety disorder, panic disorder or social phobia was assessed with the Mini-International Neuropsychiatric Interview. SAF was assessed as mediator in Cox proportional hazards models for all-cause or natural-cause mortality. RESULTS: Mortality was increased in cases with major depression compared to controls (36.4 vs. 22.5 per 100,000 person years). Partial mediation by SAF of the association between affective disorders and mortality was shown (9.0-10.5%, P<.001-.002), although attenuated by cardiometabolic parameters and history of physical illness. For major depressive disorder, partial mediation by 5.5-10.3% was shown (crude model: P<.001; fully adjusted model: P=.03). LIMITATIONS: The relatively short duration of follow-up and the relatively young cohort resulted in a lack of power to detect an association between mortality and dysthymia, social phobia and two or more comorbid disorders. CONCLUSION: Evidence of partial mediation by SAF of the association between affective disorders and all-cause and natural-cause mortality was demonstrated, although attenuated by health factors. For major depression, mediation by SAF was largest and remained significant after adjustment for sociodemographic and health factors, identifying oxidative stress as possible determinant of premature death.

Ethnic discrimination and depressed mood: The role of autonomic regulation.

Perceived ethnic discrimination (PED) is thought to underlie increased prevalence of depressed mood in ethnic minorities. Depression is associated with increased sympathetic and decreased parasympathetic activity. We investigated a biopsychosocial model linking PED, disrupted sympathovagal balance and depressed mood. Baseline data of HELIUS, a cohort study on health among a multi-ethnic population, was used. Heart rate variability (HRV), baroreflex sensitivity (BRS), PED (evaluated with the Everyday Discrimination Scale) and presence of depressed mood (evaluated with the Patient Health Questionnaire-9) were assessed. Associations of PED, HRV/BRS and depressed mood were analyzed with linear and logistic regression analyses. Mediation of the association of PED and depressed mood by HRV/BRS was assessed in a potential outcomes model and four steps mediation analysis. Of 9492 included participants, 14.7% fulfilled criteria for depressed mood. Higher PED was associated with depressed mood (P < .001). Lower autonomic regulation indexes were associated with depressed mood (deltaR2 = 0.4-1.1%, P < .001) and at most weakly with PED (deltaR2 = 0.2-0.3%, P < .001). A very modest mediating effect by HRV/BRS in the association between PED and depressed mood was attenuated after adjustment for socioeconomic status. To conclude, we found no support for the hypothesis that autonomic regulation relevantly mediates the association between PED and depression.

" I felt completely stranded": liminality and recognition of personhood in the experiences of suicidal women admitted to psychiatric hospital.

Purpose: The purpose of this study is to explore how patients experience their suicidality and how they experience being in a psychiatric hospital.Methods: This is part of a field study, and the article is based on data collected in interactions with 11 women who were admitted to a psychiatric hospital and were struggling with suicidality. Data were collected through interviews, conversations, and participatory observation. We analysed the data by means of Systematic Text Condensation, followed by a deductive process where the data and preliminary findings were interpreted in light of the theory of liminality.Results: We found that the patients' experiences of suicidality and being a patient in a psychiatric acute ward involve "Liminality and weakened sense of personhood," and from their perspective, "Recognition of personhood" is an important aspect of care.Conclusion: Our study indicates that suicidality and psychiatric hospitalization involve liminality and weakened sense of personhood, aspects that are important to consider in the care of the patients. Professionals need to acknowledge more the importance of recognition of personhood in care, since this can strengthen the patient's self-worth and empower the person. Lack of recognition may increase the patient's suffering and suicidality.

Accumulation rate of advanced glycation end products in recent onset psychosis: A longitudinal study.

Schizophrenia is associated with excessive oxidative stress. Production of advanced glycation end products (AGEs) in the skin is strongly associated with oxidative stress. Increased skin AGE-levels have been demonstrated at cross-sectional level in recent onset psychosis and chronic schizophrenia, indicating increased cardiovascular risk. We aimed to investigate factors underlying AGE-accumulation and accumulation rate of AGEs in recent onset psychosis. From December 2016 through May 2017, 66 patients and 160 (highly educated) healthy controls from a previous case-control study of AGE-levels were assessed for a follow-up measurement 12-24 months after baseline. Possible determinants of AGE-accumulation were analyzed. AGE-accumulation rates in patients and controls were compared adjusted for relevant confounders. In healthy controls, a significant association of AGE-accumulation with ethnicity and tobacco exposure was found. An indication of a markedly higher AGE-accumulation rate was found in patients suffering from recent onset psychosis compared to healthy controls, independent of ethnicity and tobacco smoking, but not independent of cannabis use (more prevalent in patients than controls), although results were not significant.

Association between skin autofluorescence of advanced glycation end products and affective disorders in the lifelines cohort study.

BACKGROUND: Oxidative stress may be a mechanistic link between affective disorders (depressive and anxiety disorders) and somatic disease. Advanced glycation end products are produced under the influence of oxidative stress and in the skin (measured by skin autofluorescence [SAF]) serve as marker for cumulative oxidative stress. Aim of study was to determine whether SAF is associated with presence of affective disorders. METHODS: Participants in the Lifelines cohort study who had completed the Mini-International Neuropsychiatric Interview for affective disorders and a SAF-measurement were included. Cross-sectional associations between SAF and presence of the following psychiatric disorders were investigated through logistic regression analyses adjusted for sociodemographic factors, cardiometabolic parameters, and somatic morbidities: major depressive disorder, dysthymia, generalised anxiety disorder, panic disorder or social phobia. RESULTS: Of 81,041 included participants (41.7% male, aged 18-91 years), 6676 (8.2%) were cases with an affective disorder. SAF was associated with presence of affective disorders (OR=1.09 [95%CI 1.07-1.12], P<.001 adjusted for sociodemographic factors). Association with major depressive disorder was strongest and significant after adjustment for all confounders (OR=1.31 [95%CI 1.25-1.36], P<.001 in the crude model; OR=1.12 [95%CI 1.07-1.17], P<.001 in the fully adjusted model). For other disorders, associations lost significance after adjustment for cardiometabolic parameters and somatic morbidities. LIMITATIONS: Persons of non-Western descent and severely (mentally or physically) ill individuals were underrepresented. CONCLUSIONS: SAF was associated with presence of affective disorders, suggesting a link between these disorders and cumulative oxidative stress. For major depressive disorder, this association was strongest and independent of sociodemographic, cardiometabolic factors, and somatic morbidities.

Skin autofluorescence of advanced glycation end products and course of affective disorders in the lifelines cohort study, a prospective investigation.

BACKGROUND: Skin autofluorescence (SAF), indicating concentration of advanced glycation end products in the skin and oxidative stress, is cross-sectionally associated with affective disorders. Prospective studies of oxidative stress markers will help to clarify the pathophysiological role of oxidative stress. METHODS: Data of a population-based cohort study were used. Presence of major depressive disorder, dysthymia, generalised anxiety disorder, panic disorder or social phobia was assessed at baseline and at 5-year follow-up with the Mini-International Neuropsychiatric Interview. Associations between SAF at baseline and incidence and persistence/recurrence of affective disorders were assessed with logistic regression. RESULTS: Of 43,267 participants with no disorder at baseline, 2885 (6.7%) developed an incident disorder during follow-up. In 1360 of 3648 participants (37.3%) with an affective disorder at baseline, a persisting/recurrent disorder was present at follow-up. A modest association existed between SAF and incident affective disorders (OR=1.07 [95%CI 1.03-1.12], P<.001), specifically major depressive disorder (OR=1.11 [95%CI 1.04-1.19], P=.003); this association lost statistical significance after adjustment for sociodemographic factors. Associations between SAF and persistence/recurrence were not significant. LIMITATIONS: Many confounders might also act as intermediate: extensive adjustment for confounders caused overfitting and possibly masked effects of SAF on course of affective disorders. Relatively small sample sizes for analyses of SAF and persistence/recurrence of affective disorders resulted in a low power. CONCLUSIONS: Increased SAF modestly raises the odds of incident affective disorders, particularly major depressive disorder, providing evidence that oxidative stress plays a role in subsequent occurrence of affective disorders. However, significance of effects faded after adjustment for socioeconomic status.