Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.

Using natural language processing for automated classification of disease and to identify misclassified ICD codes in cardiac disease.

Aims: ICD codes are used for classification of hospitalizations. The codes are used for administrative, financial, and research purposes. It is known, however, that errors occur. Natural language processing (NLP) offers promising solutions for optimizing the process. To investigate methods for automatic classification of disease in unstructured medical records using NLP and to compare these to conventional ICD coding. Methods and results: Two datasets were used: the open-source Medical Information Mart for Intensive Care (MIMIC)-III dataset (n = 55.177) and a dataset from a hospital in Belgium (n = 12.706). Automated searches using NLP algorithms were performed for the diagnoses 'atrial fibrillation (AF)' and 'heart failure (HF)'. Four methods were used: rule-based search, logistic regression, term frequency-inverse document frequency (TF-IDF), Extreme Gradient Boosting (XGBoost), and Bio-Bidirectional Encoder Representations from Transformers (BioBERT). All algorithms were developed on the MIMIC-III dataset. The best performing algorithm was then deployed on the Belgian dataset. After preprocessing a total of 1438 reports was retained in the Belgian dataset. XGBoost on TF-IDF matrix resulted in an accuracy of 0.94 and 0.92 for AF and HF, respectively. There were 211 mismatches between algorithm and ICD codes. One hundred and three were due to a difference in data availability or differing definitions. In the remaining 108 mismatches, 70% were due to incorrect labelling by the algorithm and 30% were due to erroneous ICD coding (2% of total hospitalizations). Conclusion: A newly developed NLP algorithm attained a high accuracy for classifying disease in medical records. XGBoost outperformed the deep learning technique BioBERT. NLP algorithms could be used to identify ICD-coding errors and optimize and support the ICD-coding process.

Validity and reliability of the Chinese version of digital health readiness questionnaire among hypertension patients in rural areas of China.

Introduction: Digital health has the potential to support health care in rural areas by overcoming the problems of distance and poor infrastructure, however, rural areas have extremely low use of digital health because of the lack of interaction with technology. There is no existing tool to measure digital health literacy in rural China. This study aims to test and validate the digital health readiness questionnaire for assessing digital readiness among patients in rural China. Methods: Due to the different Internet environments in China compared to Belgium, a cultural adaptation is needed to optimize the use of Digital Health Readiness Questionnaire in China. Then, a prospective single-center survey study was conducted in rural China among patients with hypertension. Confirmatory factor analysis was computed to test the measurement models. Results: A total of 330 full questionnaires were selected and included in the analysis. The model-fit measures were used to assess the model's overall goodness of fit (Chi-square/degrees of freedom = 5.060, comparative fit index = 0.889, Tucker-Lewis index (TLI) = 0.869, root mean square error of approximation (RMSEA) = 0.111, standardized root mean square residual (SRMR) = 0.0880). TLI is a little bit lower than the borderline (more than 0.9) and RMSEA is higher than it (less than 0.08 means good model fit). We deleted two items 2 and 4 and the result shows a better goodness of fit (Chi-square/degrees of freedom = 4.897, comparative fit index = 0.914, TLI = 0.895, RMSEA = 0.109, SRMR = 0.0765). Conclusion: To increase applicability and generalizability in rural areas, it should be considered to use the calculation of only the parts Digital skills, Digital literacy and Digital health literacy which are equally applicable in a Belgian population as in a rural Chinese population.

Cardiac telerehabilitation: current status and future perspectives.

Multidisciplinary cardiac rehabilitation (CR) improves the prognosis and quality of life of patients with cardiovascular disease and has therefore received strong recommendations in international guidelines for the treatment of patients with chronic coronary syndromes and chronic heart failure. Aiming to both resolve several barriers that impede participation in CR and to improve the effectiveness of CR, cardiac telerehabilitation (CTR) has emerged as a cost-effective alternative to traditional, centre-based CR. Although the body of evidence for the feasibility and effectiveness of CTR is large and still growing, real-life implementations are scarce, which may be due to insufficient knowledge about CTR interventions and due to the challenges its implementation comes with. Up to now, mainly exercise-related core components of CR and e­coaching have been investigated in the setting of CTR. Translation of research findings to clinical practice may be hampered by methodological limitations present in most CTR studies, being selection bias of participants, lack of long-term follow-up, heterogeneity of studied interventions and the lack of robust outcome measures. Besides conducting highly needed implementation studies for CTR interventions, their implementation could be facilitated by the development of guideline-based, multidisciplinary and personalised CTR programmes and widespread reimbursement for CTR.

Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals.

AIMS: Heart failure (HF) is a common cause of mortality and (re)hospitalizations. The NWE-Chance project explored the feasibility of providing hospitalizations at home (HH) supported by a newly developed digital health platform. The aim of this study was to explore the perceived usability by healthcare professionals (HCPs) of a digital platform in addition to HH for HF patients. METHODS AND RESULTS: A prospective, international, multicentre, single-arm interventional study was conducted. Sixty-three patients and 22 HCPs participated. The HH consisted of daily home visits by the nurse and use of the platform, consisting of a portable blood pressure device, weight scale, pulse oximeter, a wearable chest patch to measure vital signs (heart rate, respiratory rate, activity level, and posture), and an eCoach for the patient. Primary outcome was usability of the platform measured by the System Usability Scale halfway and at the end of the study. Overall usability was rated as sufficient (mean score 72.1 ± 8.9) and did not differ between the measurements moments (P = 0.690). The HCPs reported positive experiences (n = 7), negative experiences (n = 13), and recommendations (n = 6) for the future. Actual use of the platform was 79% of the HH days. CONCLUSION: A digital health platform to support HH was considered usable by HCPs, although actual use of the platform was limited. Therefore, several improvements in the integration of the digital platform into clinical workflows and in defining the precise role of the digital platform and its use are needed to add value before full implementation. REGISTRATION: clinicaltrials.gov NCT04084964.

Motivational communication skills to improve motivation and adherence in cardiovascular disease prevention: A narrative review.

Lifestyle optimization is one of the most essential components of cardiovascular disease prevention. Motivational counseling provided by health care professionals could promote lifestyle modification. The purpose of the review is to identify possible evidence-based psychological principles that may be applicable to motivational counseling in the prevention of cardiovascular disease. These motivational communication skills promote behavioral change, improved motivation and adherence to cardiovascular disease prevention. A personal collection of the relevant publications. The review identified and summarized the previous evidence of implementation intentions, mental contrasting, placebo effect and nocebo effects and identity-based regulations in behavior change interventions and proposed their potential application in cardiovascular disease prevention. However, it is challenging to provide real support in sustainable CVD-risk reduction and encourage patients to implement lifestyle changes, while avoiding being unnecessarily judgmental, disrespectful of autonomy, or engaging patients in burdensome efforts that have little or no effect on the long run. Motivational communication skills have a great potential for effectuating sustainable lifestyle changes that reduce CVD-related risks, but it is also surrounded by ethical issues that should be appropriately addressed in practice. It is key to realize that motivational communication is nothing like an algorithm that is likely to bring about sustainable lifestyle change, but a battery of interventions that requires specific expertise and long term joint efforts of patients and their team of caregivers.

Assessment of functionalities and attitude toward telemedicine for patients with cardiovascular disease.

Introduction: Many patients with cardiovascular diseases are only seen by a physician once or twice a year unless urgent symptoms. Recent years have shown an increase in digital technologies to follow patients remotely, that is, telemedicine. Telemedicine can be supportive for follow-up of patients at continuous risk. This study investigated patients' attitude toward telemedicine, the defined features they consider important and future willingness to pay. Methods: Cardiology patients with various types of prior telemedicine follow-up or who never had a telemonitoring follow-up were included. A new self-developed survey was implemented electronically and took 5-10 min to complete. Results: In total, 231 patients (191 telemedicine [T] and 40 controls [C]), were included. Most participants owned a smartphone (84.8%) and only 2.2% of the total participants did not own any digital device. The most important feature of telemedicine cited in both groups was personalization (i.e., personalized health tips based on medical history, 89.6%; personalized feedback on entered health parameters 86.1%). The most important motivating factor for the use of telemedicine is recommendation by a physician (84.8%), while the reduction of in-person visits is a minor reason (24.7%). Only half of the participants (67.1%) would be willing to pay for telemedicine tools in the future. Conclusion: Patients with cardiovascular disease have a positive attitude to telemedicine, especially when it allows for more personalized care, and when it is advocated by the physician. Participants expect that telemedicine becomes part of reimbursed care. This calls for interactive tools with proven efficacy and safety, while guarding unequal access to care.

Do we need to rethink the determination of exercise-related energy expenditure in cardiac telerehabilitation interventions?

The American College of Sports Medicine determined the energy consumption of daily activities and sports. Cardiac telerehabilitation (CTR) requires knowing how much energy people consume in daily life outside of cardiac rehabilitation activities. Therefore, we have investigated if the estimated values are valid in CTR. Data from two studies were incorporated. The first study measured ventilatory threshold (VT)1, VT2, and peak exercise on cardiopulmonary exercise testing (CPET) collected from 272 cardiac (risk) patients and compared them to the estimated oxygen consumption (VO2) at low-to-moderate-intense exercise (3-6 metabolic equivalents [METs]). Next, a patient-tailored application was developed to support CTR using these estimated values, and the intervention (the second study) was conducted with 24 coronary artery disease patients using this application during a CTR intervention. In the first study, VO2 at VT1, VT2 and peak exercise corresponded to 3.2 [2.8, 3.8], 4.3 [3.8, 5.3], and 5.4 [4.5, 6.2] METs, which are significantly different from the estimated VO2 at low-to-moderate-intense exercise, especially lower in older, obese, female, and post-myocardial infarction/heart failure patients. These VO2 varied considerably between patients. The telerehabilitation study did not show significant progress in peak VO2, but using the application's estimated target, 97.2% of the patients achieved their weekly target, which is a significant overestimate. The estimated and observed exercise-related energy expenditures by CPET were significantly different, resulting in an overestimation of the exercise done by the patients at home. The results can have a significant impact on the quantification of exercise dose during (tele)rehabilitation programs.

Development and Internal Validation of the Digital Health Readiness Questionnaire: Prospective Single-Center Survey Study.

BACKGROUND: While questionnaires for assessing digital literacy exist, there is still a need for an easy-to-use and implementable questionnaire for assessing digital readiness in a broader sense. Additionally, learnability should be assessed to identify those patients who need additional training to use digital tools in a health care setting. OBJECTIVE: The aim of the development of the Digital Health Readiness Questionnaire (DHRQ) was to create a short, usable, and freely accessible questionnaire that was designed from a clinical practice perspective. METHODS: It was a prospective single-center survey study conducted in Jessa Hospital Hasselt in Belgium. The questionnaire was developed with a panel of field experts with questions in following 5 categories: digital usage, digital skills, digital literacy, digital health literacy, and digital learnability. All participants who were visiting the cardiology department as patients between February 1, 2022, and June 1, 2022, were eligible for participation. Cronbach α and confirmatory factor analysis were performed. RESULTS: A total number of 315 participants were included in this survey study, of which 118 (37.5%) were female. The mean age of the participants was 62.6 (SD 15.1) years. Cronbach α analysis yielded a score of >.7 in all domains of the DHRQ, which indicates acceptable internal consistency. The fit indices of the confirmatory factor analysis showed a reasonably good fit: standardized root-mean-square residual=0.065, root-mean-square error of approximation=0.098 (95% CI 0.09-0.106), Tucker-Lewis fit index=0.895, and comparative fit index=0.912. CONCLUSIONS: The DHRQ was developed as an easy-to-use, short questionnaire to assess the digital readiness of patients in a routine clinical setting. Initial validation demonstrates good internal consistency, and future research will be needed to externally validate the questionnaire. The DHRQ has the potential to be implemented as a useful tool to gain insight into the patients who are treated in a care pathway, tailor digital care pathways to different patient populations, and offer those with low digital readiness but high learnability appropriate education programs in order to let them take part in the digital pathways.

Determinants of participation in cardiac telerehabilitation during the first surge of COVID-19.

BACKGROUND: Participation rates in cardiac rehabilitation (CR) are low. In multiple trials, telerehabilitation (TR) has been demonstrated to be effective. Still, real-life evidence is scarce. During the first surge of the COVID-19 pandemic our centre deployed a TR programme. This study aimed to characterise the patient population that had, for the first time, the opportunity to participate in cardiac TR and to analyse if there were determining factors for participation or non-participation in TR. METHODS: All patients enrolled in CR in our centre during the first wave of the COVID-19 pandemic were included in this retrospective cohort study. Data was collected from the hospital electronic records. RESULTS: 369 patients were contacted in the setting of TR. 69 patients could not be reached and were excluded from further analysis. 208 (69%) patients that were contacted agreed to participate in cardiac TR. No significant differences in baseline characteristics were seen between TR participants and TR non-participants. A full model logistic regression did not reveal any significant determinants on participation rate in TR. CONCLUSION: This study demonstrates that the rate of participation in TR was high (69%). Of the analysed characteristics, none was directly correlated with the willingness to participate in TR. Further research is needed to further assess determinants, barriers and facilitators of TR. Also, research is needed on better delineating digital health literacy and on how to reach also those patients that are less motivated and or less digitally literate.

The impact of dietary education and counselling with a smartphone application on secondary prevention of coronary artery disease: A randomised controlled study (the TeleDiet study).

Objective: In a secondary prevention of coronary artery disease (CAD), nutritional management is an integral part of lifestyle optimisation. However, few studies have investigated the potential of remote nutritional follow-up using digital solutions. This study investigates the effectiveness of a smartphone application for nutrition education and feedback with pictures of meals by a dietitian for patients with CAD. Methods: Sixty participants with CAD were randomised to either a TeleDiet group or a control group. Participants in the TeleDiet group participated in dietary education using a messaging application. The primary outcome was the change of the Mediterranean diet score (MedDietScore). The Nutrition-Score, a modification of the MedDietScore, blood tests (blood lipids, blood glucose and kidney function), body mass index, self-efficacy, medication adherence and health-related quality of life during the observation period were analysed as secondary outcomes. Results: Sixty participants participated in the study. The difference in the MedDietScore in the TeleDiet group was greater than in the control group, but not significant (2.0 [-1.0, 4.0] vs. 0.0 [-3.0, 1.5], p = 0.066). The difference in the Nutrition-Score in the TeleDiet group was significantly greater than in the control group (3.0 [1.0, 3.5] vs. 0.0 [-3.0, 2.0], p = 0.029). Nutrition knowledge of the TeleDiet group improved significantly compared to the control group (1.9 ± 1.7 vs. 0.8 ± 2.1, p = 0.048). Conclusions: A feedback system using a simple messaging application that allows patients with CAD to simply send a picture of their food has a positive effect on nutrition knowledge. It could be a hint for the implementation of the Mediterranean diet.

Bringing the hospital to home: Patient-reported outcome measures of a digital health-supported home hospitalisation platform to support hospital care at home for heart failure patients.

Background: Hospitalisations for heart failure are frequent and costly, linked with a lower quality of life, and lead to higher morbidity and mortality. Home hospitalisation interventions could be a substitute for in-hospital stays to reduce the burden on patients. The current study aims to investigate patient-reported satisfaction and usability in combination with the safety of a digital health-supported home hospitalisation intervention for heart failure patients. Methods: We conducted an international, multicentre, single-arm, interventional study to investigate the feasibility and safety of a digital health-supported home hospitalisation platform. Patients with acute decompensation of known and well-assessed chronic heart failure with an indication for hospital admission were included. The primary outcome was patient satisfaction. Secondary outcomes were usability, adherence, and safety. Results: A total number of 66 patients were included, of which the data of 65 patients (98.5%) was analysed. A total of 86.1% of patients reported being very satisfied or totally satisfied. No patients reported to be not satisfied with the home hospitalisation intervention. The patients reported a sufficient usability score (mean score: 75.8% of 100%) for the digital health-supported home hospitalisation platform. The adherence to the daily measurements of blood pressure and weight was very high, whereas the adherence to the daily interaction with the eCoach was lower (69.3%). In 7 patients (10.8%), a conversion from home hospitalisation to regular hospitalisation was needed. Furthermore, 6 patients (9.2%) had rehospitalisation within 30 days after the end of the home hospitalisation intervention. Conclusion: A digitally supported home hospitalisation intervention is feasible. This study demonstrates high patient satisfaction and sufficiently high usability scores. The safety outcomes are comparable with traditional heart failure hospitalisations. This indicates that digitally supported home hospitalisation could be an alternative to in-hospital care for all age groups, yet further research is needed to prove the (cost-) effectiveness.

Smartphone-based gamification intervention to increase physical activity participation among patients with coronary heart disease: A randomized controlled trial.

INTRODUCTION: Despite proven benefits, patients with coronary heart disease (CHD) typically fail to participate in sufficient physical activity (PA). Effective interventions should be implemented to help patients maintain a healthy lifestyle and modify their present behavior. Gamification is the use of game design features (such as points, leaderboards, and progress bars) to improve motivation and engagement. It shows the potential for encouraging patients to engage in PA. However, empirical evidence on the efficacy of such interventions among patients with CHD is still emerging. PURPOSE: The aim of the study is to explore whether a smartphone-based gamification intervention could increase PA participation and other physical and psychological outcomes in CHD patients. METHODS: Participants with CHD were randomly assigned to three groups (control group, individual group, and team group). The individual and team groups received gamified behavior intervention based on behavioral economics. The team group combined gamified intervention with social interaction. The intervention lasted for 12 weeks, and the follow-up was12 weeks. The primary outcomes included the change in daily steps and the proportion of patient days that step goals were achieved. The secondary outcomes included competence, autonomy, relatedness, and autonomous motivation. RESULTS: For the individual group, smartphone-based gamification intervention significantly increased PA among CHD patients over the 12-week period (step count difference 988; 95% CI 259-1717; p < 0.01) and had a good maintenance effect during the follow-up period (step count difference 819; 95% CI 24-1613; p < 0.01). There are also significant differences in competence, autonomous motivation, body mass index (BMI), and waist circumference in 12 weeks between the control group and individual group. For the team group, gamification intervention with collaboration didn't result in significant increases in PA. But patients in this group had a significant increase in competence, relatedness, and autonomous motivation. CONCLUSION: A smartphone-based gamification intervention was proven to be an effective way to increase motivation and PA engagement, with a substantial maintenance impact (Chinese Clinical Trial Registry Identifier: ChiCTR2100044879).

The need for long-term personalized management of frail CVD patients by rehabilitation and telemonitoring: A framework.

Due to advances in cardiovascular medicine and preventive cardiology, patients benefit from a better prognosis, even in case of significant disease burden such as acute and chronic coronary syndromes, advanced valvular heart disease and chronic heart failure. These advances have allowed CVD patients to increase their life expectancy, but on the other hand also experience aging-related syndromes such as frailty. Despite being underrecognized, frailty is a critical, common, and co-existent condition among older CVD patients, leading to exercise intolerance and compromised adherence to cardiovascular rehabilitation (CR). Moreover, frail patients need a different approach for CR and are at very high risk for adverse events, but yet are underrepresented in conventional CR. Fortunately, recent advances have been made in technology, allowing remote monitoring, coaching and supervision of CVD patients in secondary prevention programs with promising benefits. Similarly, we hypothesized that such programs should also be implemented to treat frailty in CVD patients. However, considering frail patients' particular needs and challenges, telerehabilitation interventions should thus be appropriately adapted. Our purpose is to provide, for the first time and based on expert opinions, a framework of how such a cardiac telerehabilitation program could be developed and implemented to manage a prevention and rehabilitation program for CVD patients with frailty.

Heart Rate Variability for the Early Detection of Cardiac Autonomic Dysfunction in Type 1 Diabetes.

Type 1 diabetes mellitus (T1DM) has an important impact on morbidity and mortality because it may start early in life. Therefore, the early detection of cardiovascular autonomic neuropathy (DCAN) in T1DM patients is important to intervene quickly and prevent further deterioration. Traditional autonomic function tests detect abnormalities in severely symptomatic patients but they are difficult to be standardized, require the patient's active participation and their sensitivity to the early disease is limited. In comparison, heart rate variability (HRV) is easier to be measured and standardized. Therefore, we aim to find the HRV indexes that better identify DCAN at an early stage in T1DM patients, and evaluate if HRV is a valid alternative to traditional tests. For this aim, we administered the SCOPA-AUT questionnaire on symptoms of autonomic dysfunction as well as deep breathing, Valsalva, handgrip, head-up tilt (HUT), and cold-pressor tests, to 52 T1DM patients and 27 controls. We calculated HRV indexes during supine rest (SUP) and HUT, assessing differences between groups and postures by a linear mixed-effect model for repeated measures. Receiver Operating Characteristic (ROC) analysis quantified how each HRV index and autonomic test distinguishes between patients and controls. We found that the SCOPA-AUT score was slightly but significantly (p < 0.05) greater in patients, indicating an early DCAN. T1DM patients preserved the HRV response to changing posture but in SUP they showed significantly lower standard deviation and vagal indexes of HRV than controls. The area under the ROC curve of these HRV indexes was not lower than 0.68. By contrast, traditional autonomic tests did not differ between groups. Therefore, early DCAN initially causes an impairment of the cardiac vagal control manifest in conditions of elevated vagal tone, as in SUP. Compensatory adjustments of the sympathetic control might explain the unaltered response to traditional autonomic tests. In conclusion, vagal HRV indexes in SUP help to identify early DCAN better than traditional tests, potentially allowing rapid interventions.

Smartwatch-Based Blood Pressure Measurement Demonstrates Insufficient Accuracy.

Background: Novel smartwatch-based cuffless blood pressure (BP) measuring devices are coming to market and receive FDA and CE labels. These devices are often insufficiently validated for clinical use. This study aims to investigate a recently CE-cleared smartwatch using cuffless BP measurement in a population with normotensive and hypertensive individuals scheduled for 24-h BP measurement. Methods: Patients that were scheduled for 24-h ambulatory blood pressure monitoring (ABPM) were recruited and received an additional Samsung Galaxy Watch Active 2 smartwatch for simultaneous BP measurement on their opposite arm. After calibration, patients were asked to measure as much as possible in a 24-h period. Manual activation of the smartwatch is necessary to measure the BP. Accuracy was calculated using sensitivity, specificity, positive and negative predictive values and ROC curves. Bland-Altman method and Taffé methods were used for bias and precision assessment. BP variability was calculated using average real variability, standard deviation and coefficient of variation. Results: Forty patients were included. Bland-Altman and Taffé methods demonstrated a proportional bias, in which low systolic BPs are overestimated, and high BPs are underestimated. Diastolic BPs were all overestimated, with increasing bias toward lower BPs. Sensitivity and specificity for detecting systolic and/or diastolic hypertension were 83 and 41%, respectively. ROC curves demonstrate an area under the curve (AUC) of 0.78 for systolic hypertension and of 0.93 for diastolic hypertension. BP variability was systematically higher in the ABPM measurements compared to the smartwatch measurements. Conclusion: This study demonstrates that the BP measurements by the Samsung Galaxy Watch Active 2 show a systematic bias toward a calibration point, overestimating low BPs and underestimating high BPs, when investigated in both normotensive and hypertensive patients. Standards for traditional non-invasive sphygmomanometers are not met, but these standards are not fully applicable to cuffless devices, emphasizing the urgent need for new standards for cuffless devices. The smartwatch-based BP measurement is not yet ready for clinical usage. Future studies are needed to further validate wearable devices, and also to demonstrate new possibilities of non-invasive, high-frequency BP monitoring.

A Mobile Application to Perform the Six-Minute Walk Test (6MWT) at Home: A Random Walk in the Park Is as Accurate as a Standardized 6MWT.

The six-minute walk test (6MWT) provides an objective measurement of a person's functional exercise capacity. In this study, we developed a smartphone application that allows cardiac patients to do a self-administered 6MWT at home on a random trajectory. In a prospective study with 102 cardiovascular disease patients, we aimed to identify the optimal circumstances to perform a smartphone-measured 6MWT, i.e., the best algorithm and the best position to wear the smartphone during the test. Furthermore, we investigated if a random walk is as accurate as a standardized 6MWT. When considering both the reliability and accuracy of the distance walked, the best circumstances to perform a standardized smartphone-measured 6MWT are wearing the smartphone in a strap around the patient's arm and using an algorithm that relies on the processed step count data acquired from Google Fit. Furthermore, we demonstrated that a smartphone-measured walk along a random trajectory is as accurate to determine a cardiac patient's functional exercise capacity as a standardized (smartphone-measured) 6MWT. We conclude this paper by presenting how our 6MWT application can be used in a home setting to remotely follow up on cardiac patients' functional exercise capacity.

Frailty Test Battery Development including Physical, Socio-Psychological and Cognitive Domains for Cardiovascular Disease Patients: A Preliminary Study.

Frailty is an age-related decline in physical, socio-psychological and cognitive function that results in extreme vulnerability to stressors. Therefore, this study aimed to elucidate which tests have to be selected to detect frailty in a comprehensive and feasible manner in cardiovascular disease (CVD) patients based on multivariate regression and sensitivity/specificity analyses. Patients (n = 133, mean age 78 ± 7 years) hospitalised for coronary revascularisation or heart failure (HF) were examined using the Fried and Vigorito criteria, together with some additional measurements. Moreover, to examine the association of frailty with 6-month clinical outcomes, hospitalisations and mortality up to 6 months after the initial hospital admission were examined. Some level of frailty was detected in 44% of the patients according to the Vigorito criteria and in 65% of the patients according to the Fried criteria. Frailty could best be detected by a score based on: sex, Mini Nutritional Assessment (MNA), Katz scale, timed up-and-go test (TUG), handgrip strength, Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS-15) and total number of medications. Frailty and specific markers of frailty were significantly associated with mortality and six-month hospitalisations. We thus can conclude that, in patients with CVD, sex, MNA, Katz scale, TUG, handgrip strength, MMSE, GDS-15 and total number of medications play a key role in detecting frailty, assessed by a new time- and cost-efficient test battery.