A Digital Infrastructure for Cardiovascular Patient Care Based on Mobile Health Data and Patient-Reported Outcomes: Concept Details of the Helios TeleWear Project Including Preliminary Experiences.

BACKGROUND: Mobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients' quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined. OBJECTIVE: Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease. METHODS: The specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures). RESULTS: With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform's functionality and usability. CONCLUSIONS: TeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth.

Feasibility and Reliability of Smartwatch to Obtain Precordial Lead Electrocardiogram Recordings.

The Apple Watch is capable of recording single-lead electrocardiograms (ECGs). To incorporate such devices in routine medical care, the reliability of such devices to obtain precordial leads needs to be validated. The purpose of this study was to assess the feasibility and reliability of a smartwatch (SW) to obtain precordial leads compared to standard ECGs. We included 100 participants (62 male, aged 62.8 ± 13.1 years) with sinus rhythm and recorded a standard 12-lead ECG and the precordial leads with the Apple Watch. The ECGs were quantitively compared. A total of 98 patients were able to record precordial leads without assistance. A strong correlation was observed between the amplitude of the standard and SW-ECGs' waves, in terms of P waves, QRS-complexes, and T waves (all p-values < 0.01). A significant correlation was observed between the two methods regarding the duration of the ECG waves (all p-values < 0.01). Assessment of polarity showed a significant and a strong concordance between the ECGs' waves in all six leads (91-100%, all p-values < 0.001). In conclusion, 98% of patients were able to record precordial leads using a SW without assistance. The SW is feasible and reliable for obtaining valid precordial-lead ECG recordings as a validated alternative to a standard ECG.

[Psychiatric Emergency Admissions and Inpatient Length of Stay Before and During the COVID-19 Pandemic in Germany]. / Psychiatrische Notfallaufnahmen und stationäre Aufenthaltsdauer vor und während der COVID-19-Pandemie in Deutschland.

OBJECTIVE: The impact of the COVID-19 year on the number of daily psychiatric emergency admissions and length of stay was compared with previous years. METHODS: In a retrospective study, the four quarters of 2020 of several psychiatric hospitals in Germany were statistically compared with the respective quarters of 2018 and 2019. RESULTS: A total of 73,412 cases was analyzed. In the 2nd quarter of 2020, the number of daily admissions was significantly lower as compared to the control period (59.1 vs. 70.7; incidence rate ratio [95 % confidence interval] 0.81 [0.69; 0.96]; p = 0.012). Length of stay was numerically but not significantly different as compared to the control periods. CONCLUSION: The COVID-19 pandemic had a strong impact on inpatient psychiatric care. In the future, multimodal care structures must ensure the care of severely mentally ill people in crisis situations.

Impact of COVID-19 pandemic on involuntary and urgent inpatient admissions for psychiatric disorders in a German-wide hospital network.

The impact of COVID-19 on urgent and involuntary inpatient admissions, as well as coercive measures, has not been assessed so far. A retrospective study was performed analyzing claims data for inpatient psychiatric admissions between 2018 and 2020 (total n = 64,502) from a large German Hospital network. Whilst the total number of urgent admissions decreased in 2020 (12,383) as compared to 2019 (13,493) and 2018 (13,469), a significant increase in the percentage of urgent admissions was observed in 2020 (62.9%) as compared to 2019 (60.6%) and 2018 (59.7%). Compared to this study period, Odds ratio (OR) for proportion were 0.87 (0.84, 0.91) and 0.91 (0.87, 0.95) for 2018 and 2019, respectively (both p < 0.00001). Percentage of involuntary psychiatric admissions also significantly increased in 2020 and OR compared to this study period ranged from 0.86 (0.81, 0.93) in 2019 (p < 0.0001) to 0.88 (0.82, 0.95) in 2018 (p < 0.001). Proportion of coercive measures significantly increased in 2020 as compared to 2019 (p = 0.004). Taken together, the present study shows an increase in the proportion of involuntary and urgent psychiatric admissions during the whole pandemic year 2020 as compared to 2018 and 2019. The long-term impact of these COVID-19 pandemic-related trends on psychiatric health care needs to be assessed in further studies.

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.

Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry.

Aims: Digital health technologies have the potential to improve patient care sustainably. A digital capturing of patient-reported outcome measures (PROMs) could facilitate patients' surveillance and endpoint assessment within clinical trials especially in heart failure (HF) patients. However, data regarding the availability of digital infrastructure and patients' willingness to use digital health solutions are scarce. Therefore, we conducted a survey as part of a digital-based HF registry. Methods and results: The Helios Heart registry (H2-registry) has been introduced as a prospective registry being based on digitally augmented processes throughout the whole trial conduction from patients' selection to data collection and follow-up (FU). Patient-reported outcome measures are captured paper-based at recruitment, but patients are offered two digital solutions for FU. Overall, 125 patients (mean age 67.8 years, 34.4% female) were included in the single-centre run-in phase of 16 weeks. Of them, 52.0% were not interested in any digital contact as part of the FU. If digital PROM capturing was conceivable, a web-based solution (70.0%) was preferred to an application-based approach (30.0%). Discrepancies occurred regarding the availability of email accounts and smartphones. Patients in the non-digital group were older (72.0 years vs. 63.2 years, P < 0.01) and more frequently female (female sex, non-digital vs. digital group: 47.7% vs. 20.0%, P < 0.01). Conclusions: Our survey illustrated difficulties of implementing a digital FU to record PROMs in a contemporary HF cohort in particular among older patients. Further research is required to specify reasons in case of patients' unwillingness and to better tailor digital health solutions to patients' specific needs.

Feasibility and Reliability of SmartWatch to Obtain 3-Lead Electrocardiogram Recordings.

Some of the recently released smartwatch products feature a single-lead electrocardiogram (ECG) recording capability. The reliability of obtaining 3-lead ECG with smartwatches is yet to be confirmed in a large study. This study aimed to assess the feasibility and reliability of smartwatch to obtain 3-lead ECG recordings, the classical Einthoven ECG leads I-III compared to standard ECG. To record lead I, the watch was worn on the left wrist and the right index finger was placed on the digital crown for 30 s. For lead II, the watch was placed on the lower abdomen and the right index finger was placed on the digital crown for 30 s. For lead III, the same process was repeated with the left index finger. Spearman correlation and Bland-Altman tests were used for data analysis. A total of 300 smartwatch ECG tracings were successfully obtained. ECG waves' characteristics of all three leads obtained from the smartwatch had a similar duration, amplitude, and polarity compared to standard ECG. The results of this study suggested that the examined smartwatch (Apple Watch Series 4) could obtain 3-lead ECG tracings, including Einthoven leads I, II, and III by placing the smartwatch on the described positions.