A randomized controlled clinical trial of pacemaker follow-up in clinic and by telemedical interpretation of the pacemakers' magnet mode.

We assessed a two-stage follow-up procedure for cardiac pacemakers, where in-clinic follow-ups were partly replaced by telemedical follow-ups. This was compared with the standard follow-up regime (in-clinic follow-up only). The new procedure required an electronic patient record, a telemedical follow-up unit for recording ECGs while the pacemaker was temporarily set to magnet mode, an ECG processing unit, and a reviewing and reporting unit. A total of 177 (86 female) patients were randomized to the control group and 182 (98 female) patients to the telemedicine group. In the telemedicine group, 234 telemedical follow-ups were performed. Out of these, 68 required an additional in-clinic follow-up, while 166 were sufficient for assessing the pacemakers' working status. During the study, there were 19 deaths in the telemedicine group and 20 in the control group. There was no significant difference between the two groups(P = 0.40). The probability that an individual patient's pacemaker would not to be replaced over time was analysed in a similar way to the Kaplan-Meier survival function. Fewer pacemakers were replaced in the telemedicine group (14) than in the control group (18), but the difference was not significant (P = 0.26). We conclude that alternating telemedical and in-clinic follow-ups brings no additional risks for patients. The follow-up procedure is feasible and interpretation of the pacemakers' magnet effect provides an easy-to-use, manufacturer-independent method of assessing the pacemakers' working status. This should reduce the patient load on pacemaker centres and decrease the overall costs of pacemaker therapy.

An integrated healthcare information system for end-to-end standardized exchange and homogeneous management of digital ECG formats.

This paper investigates the application of the enterprise information system (EIS) paradigm to standardized cardiovascular condition monitoring. There are many specifications in cardiology, particularly in the ECG standardization arena. The existence of ECG formats, however, does not guarantee the implementation of homogeneous, standardized solutions for ECG management. In fact, hospital management services need to cope with various ECG formats and, moreover, several different visualization applications. This heterogeneity hampers the normalization of integrated, standardized healthcare information systems, hence the need for finding an appropriate combination of ECG formats and a suitable EIS-based software architecture that enables standardized exchange and homogeneous management of ECG formats. Determining such a combination is one objective of this paper. The second aim is to design and develop the integrated healthcare information system that satisfies the requirements posed by the previous determination. The ECG formats selected include ISO/IEEE11073, Standard Communications Protocol for Computer-Assisted Electrocardiography, and an ECG ontology. The EIS-enabling techniques and technologies selected include web services, simple object access protocol, extensible markup language, or business process execution language. Such a selection ensures the standardized exchange of ECGs within, or across, healthcare information systems while providing modularity and accessibility.

Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial.

BACKGROUND: Telemonitoring of patients with chronic heart failure (CHF) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization. OBJECTIVE: The goal of the MOBIle TELemonitoring in Heart Failure Patients Study (MOBITEL) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation. METHODS: Patients were randomly allocated to pharmacological treatment (control group) or to pharmacological treatment with telemedical surveillance for 6 months (tele group). Patients randomized into the tele group were equipped with mobile phone-based patient terminals for data acquisition and data transmission to the monitoring center. Study physicians had continuous access to the data via a secure Web portal. If transmitted values went outside individually adjustable borders, study physicians were sent an email alert. Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause. RESULTS: The study was stopped after randomization of 120 patients (85 male, 35 female); median age was 66 years (IQR 62-72). The control group comprised 54 patients (39 male, 15 female) with a median age of 67 years (IQR 61-72), and the tele group included 54 patients (40 male, 14 female) with a median age of 65 years (IQR 62-72). There was no significant difference between groups with regard to baseline characteristics. Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone ("never beginners"). Four patients did not finish the study due to personal reasons. Intention-to-treat analysis at study end indicated that 18 control group patients (33%) reached the primary endpoint (1 death, 17 hospitalizations), compared with 11 tele group patients (17%, 0 deaths, 11 hospitalizations; relative risk reduction 50%, 95% CI 3-74%, P = .06). Per-protocol analysis revealed that 15% of tele group patients (0 deaths, 8 hospitalizations) reached the primary endpoint (relative risk reduction 54%, 95% CI 7-79%, P= .04). NYHA class improved by one class in tele group patients only (P< .001). Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay (median 6.5 days, IQR 5.5-8.3) compared with control group patients (median 10.0 days, IQR 7.0-13.0; P= .04). The event rate of never beginners was not higher than the event rate of control group patients. CONCLUSIONS: Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations. Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept.

Feasibility and usability of a home monitoring concept based on mobile phones and near field communication (NFC) technology.

Utilization of mobile information and communication technologies in home monitoring applications is becoming more and more common. The mobile phone, acting as a patient terminal for patients suffering from chronic diseases, provides an active link to the caregiver to transmit health status information and receive feedback. In such a concept the usability is still limited by the necessity of entering the values via the mobile phone's small keypad. The near field communication technology (NFC), a touch-based wireless interface that became available recently, may improve the usability level of such applications significantly. The focus of this paper is to describe the development of a prototype application based on this technology embedded in a home monitoring system. The feasibility and usability of this approach are evaluated and compared with concepts used in previous approaches. The high quantifier with respect to overall usability indicates that NFC may be the technology of choice for some tasks in home monitoring applications.

Feasibility of a telemedicine framework for collaborative pacemaker follow-up.

We propose a telemedicine framework for remote and manufacturer independent pacemaker (PM) follow-up. The main goal is to provide the caregiver at the point-of-care with an efficient screening method to identify possible malfunction of the pacing system in collaboration with the specialist at the PM clinic. The concept was evaluated in a clinical trial on 44 patients (mean age 76 years). A total of 62 electrocardiogram (ECG) recordings were transmitted using a mobile PM follow-up unit. Using the automatic classification algorithm, 32 PMs were classified as 'OK' and eight PMs were classified as 'not OK'. In four cases a prediction regarding the working status of the PM was not possible. The signal processing classification was confirmed by expert classification (manual review of the ECG). The results indicate that the proposed PM follow-up concept has the potential to work as an efficient screening method and may spare a significant number of patients the burden of having to travel to specialized PM clinics.

Predicting initiation and termination of atrial fibrillation from the ECG.

Atrial fibrillation is the most common cardiac arrhythmia, affecting more than two million people in the US. Several therapies for patients with atrial fibrillation are available, but methods to help physicians select the optimal therapy for an individual patient are still required. Knowledge of whether a patient with a normal ECG will exhibit atrial fibrillation in the future, as well as whether atrial fibrillation will terminate spontaneously, would be very useful in clinical routine. The paper presents a software system for predicting the initiation and termination of atrial fibrillation from the ECG. The algorithms have been validated on ECGs from several signal databases. Prediction of the initiation of atrial fibrillation was achieved by detecting premature heart beats and analyzing the morphology of their P waves. Prediction of the termination of atrial fibrillation was based on calculation of the major atrial frequency. This frequency has been shown to decrease significantly prior to the termination of atrial fibrillation. Nevertheless, the effect is much less distinct in the large data set used for this study compared to previous studies. The initiation of atrial fibrillation, however, could be correctly predicted in approximately 75% of the data analyzed.

Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients.

BACKGROUND: Patients with type 1 diabetes mellitus (DM1) have to be active participants in their treatment because they are inevitably responsible for their own day-to-day-care. Availability of mobile Internet access is advancing rapidly and mobile phones are now widely available at low cost. Thus, mobile phones have the potential to assist in daily diabetes management and to enable a telemedical interaction between patients and health care professionals. OBJECTIVE: The aim of the study was to evaluate the feasibility and user acceptance of a mobile phone-based data service to assist DM1 patients on intensive insulin treatment. METHODS: A software application called Diab-Memory (based on Java 2 Mobile Edition) has been developed to support patients when entering diabetes-related data with synchronization to the remote database at the monitoring center. The data were then processed to generate statistics and trends, which were provided for the patient and his/her health care professional via a Web portal. The system has been evaluated in the course of a clinical before-after pilot trial. Outcome measures focused on patients' adherence to the therapy, availability of the monitoring system, and the effects on metabolic status. General user acceptance of the system was evaluated using a questionnaire. RESULTS: Ten patients (four female) with DM1 participated in the trial. Mean age was 36.6 years (+/- 11.0 years) and prestudy glycated hemoglobin (HbA(1c)) was 7.9% (+/- 1.1%). A total of 3850 log-ins were registered during the 3 months of the study. The total number of received datasets was 13003, which equates to an average of 14 transmitted parameters per patient per day. The service was well accepted by the patients (no dropouts), and data transmission via mobile phone was successful on the first attempt in 96.5% of cases. Upon completion of the study, a statistically significant improvement in metabolic control was observed (HbA(1c): prestudy 7.9% +/- 1.1% versus poststudy 7.5% +/- 0.9%;P= .02). While there was a slight decrease in average blood glucose level (prestudy 141.8 mg/dL +/- 22.5 mg/dL vs poststudy 141.2 mg/dL +/- 23.1 mg/dL;P= .69), the difference was not statistically significant. CONCLUSION: The results of the clinical pilot trial indicate that this proposed diabetes management system was well accepted by the patients and practical for daily usage. Thus, using the mobile phone as patient terminal seems to provide a ubiquitous, easy-to-use, and cost efficient solution for patient-centered data acquisition in the management of DM1. To confirm the promising results of the pilot trial further research has to be done to study long-term effects on glycemic control and cost-effectiveness.