Service for the Pseudonymization of Electronic Healthcare Records Based on ISO/EN 13606 for the Secondary Use of Information.

The availability of electronic health data favors scientific advance through the creation of repositories for secondary use. Data anonymization is a mandatory step to comply with current legislation. A service for the pseudonymization of electronic healthcare record (EHR) extracts aimed at facilitating the exchange of clinical information for secondary use in compliance with legislation on data protection is presented. According to ISO/TS 25237, pseudonymization is a particular type of anonymization. This tool performs the anonymizations by maintaining three quasi-identifiers (gender, date of birth, and place of residence) with a degree of specification selected by the user. The developed system is based on the ISO/EN 13606 norm using its characteristics specifically favorable for anonymization. The service is made up of two independent modules: the demographic server and the pseudonymizing module. The demographic server supports the permanent storage of the demographic entities and the management of the identifiers. The pseudonymizing module anonymizes the ISO/EN 13606 extracts. The pseudonymizing process consists of four phases: the storage of the demographic information included in the extract, the substitution of the identifiers, the elimination of the demographic information of the extract, and the elimination of key data in free-text fields. The described pseudonymizing system was used in three telemedicine research projects with satisfactory results. A problem was detected with the type of data in a demographic data field and a proposal for modification was prepared for the group in charge of the drawing up and revision of the ISO/EN 13606 norm.

Evaluation of a telemedicine service for the secondary prevention of coronary artery disease.

PURPOSE: Efficient ways are needed to implement the secondary prevention (SP) of coronary heart disease. Because few studies have investigated Web-based SP programs, our aim was to determine the usefulness of a new Web-based telemonitoring system, connecting patients provided with self-measurement devices and care managers via mobile phone text messages, as a tool for SP. METHODS: A single-blind, randomized controlled, clinical trial of 203 acute coronary syndrome (ACS) survivors, was conducted at a hospital in Madrid, Spain. All patients received lifestyle counseling and usual-care treatment. Patients in the telemonitoring group (TMG) sent, through mobile phones, weight, heart rate, and blood pressure (BP) weekly, and capillary plasma lipid profile and glucose monthly. A cardiologist accessed these data through a Web interface and sent recommendations via short message service. Main outcome measures were BP, body mass index (BMI), smoking status, low-density lipoprotein-cholesterol (LDL-c), and glycated hemoglobin A1c (HbA1c). RESULTS: At 12-month followup, TMG patients were more likely (RR = 1.4; 95% CI = 1.1-1.7) to experience improvement in cardiovascular risk factors profile than control patients (69.6% vs 50.5%, P = .010). More TMG patients achieved treatment goals for BP (62.1% vs 42.9%, P = .012) and HbA1c (86.4% vs 54.2%, P = .018), with no differences in smoking cessation or LDL-c. Body mass index was significantly lower in TMG (-0.77 kg/m² vs +0.29 kg/m², P = .005). CONCLUSIONS: A telemonitoring program, via mobile phone messages, appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention, especially for overweight patients.

Evaluation of a telemedicine-based service for the follow-up and monitoring of patients treated with oral anticoagulant therapy.

The authors have designed and developed a telemedicine-based service for the follow-up and monitoring of patients on oral anticoagulant therapy (OAT) that consists of two phases; the first involving self-testing and the second involving guided self-management. To evaluate the first phase of the protocol, a project was conducted with 108 patients, with a mean age of 72.7 years and a mean treatment time at the start of the study of 55.2 months, divided into two groups: telemedicine and control (conventional procedure). The degree of anticoagulation control was similar in the two groups: individual in-range international normalized ratios (59.2% vs 61.1%; p = 0.55) and individual time within target range (65.7% vs 66.4%; p = 0.85) showed no significant differences. The incidence of adverse events--death (5.5% vs 5.5%; p = 1.0), major hemorrhagic complications (0% vs 1.8%; p = 1.0), minor hemorrhagic complications (7.4% vs 3.7%; p = 0.67), and thromboembolism (1.8% vs 3.7%; p = 1.0)--was also similar, with no significant differences. Acceptability of the change, measured in terms of quality of life (SF-12 and Sawicki questionnaires) and anxiety (state-trait anxiety inventory questionnaire) at the beginning and end of the study period was higher in the telemedicine group, with statistically significant improvements in mental component summary (3.6 vs -6.2; p = 0.02), dissatisfaction (-0.8 vs 0.2; p = 0.001), stress (-0.3 vs 0.05; p = 0.03), limitations (-0.2 vs 0.3; p = 0.005), social problems (-0.1 vs 0.3; p = 0.03), and state anxiety (-2.5 vs 2.3; p = 0.04). Parameters related to costs, such as the mean number per patient of office visits due to OAT (1.7 vs 13.8; p << 0.001) and other office visits (10.1 vs 11.5; p = 0.028), were also more favorable in the telemedicine group, as were additional parameters that enabled an exhaustive evaluation of the service. The positive results obtained indicate that the second phase of the trial can be initiated.

Impact of patient-general practitioner short-messages-based interaction on the control of hypertension in a follow-up service for low-to-medium risk hypertensive patients: a randomized controlled trial.

The evaluation in real-life settings of services for the follow-up and control of hypertensive patients is a complex intervention, which still needs analysis of the roles, tasks, and resources involved in the basic items: patient, healthcare professional, and the interaction between the two. To evaluate the impact of patient-general practitioner (GP) short-messages-based interaction, isolated from other items, on the degree of hypertension control in the follow-up of medium-to-low-risk patients in primary care, a randomized controlled trial has been performed: 38 GPs enrolled 285 hypertensive patients who recorded the results of self-blood-pressure (BP) monitoring, heart rate, and body weight, and completed an optional questionnaire in an identical manner over a six-month period. The telemedicine group (TmG) sent the data to a telemedicine-based system that enabled patient-GP interaction; the control group (CG) recorded the data on paper and could only deliver it to their GP personally in the routine visits. In the TmG, the results were better, but not significantly so, for: 1) degree of hypertension control, in terms of the percentage of uncontrolled hypertensives at the final visit (TmG versus CG: 31.7% versus 35.6%; p = 0.47); 2) reduction in hypertension during follow-up, comparing measurements (performed by a professional) at the initial and final visits of systolic BP (15.5 versus 11.9; p = 0.13) and diastolic BP (9.6 versus 4.4; p = 0.40); and 3) adherence to the protocol within compliance levels of interest in a real-life follow-up service: >>50% (84.8% versus 73.3%) and >>25% (92.4.8% versus 75.4%) ( p = 0.053). Other factors such as average values of self-measured systolic BP, diastolic BP and heart rate, acceptability of the protocol, and median number of consultations and hospital admissions were similar in both groups. Outcomes show that, taken alone, the patient-GP short-messages-based interaction has very little impact on the degree of hypertension control in patients with this profile. In complex interventions, to discriminate the impact of each of its components in isolation will enable us to design an efficient follow-up service, little demanding in terms of healthcare professional dedication, and optimized in other basic aspects.

Proof-of-concept design and development of an EN13606-based electronic health care record service.

OBJECTIVE: The authors present an Electronic Healthcare Record (EHR) server, designed and developed as a proof of concept of the revised prEN13606:2005 European standard concerning EHR communications. METHODS: The development of the server includes five modules: the libraries for the management of the standard reference model, for the demographic package and for the data types; the permanent storage module, built on a relational database; two communication interfaces through which the clients can send information or make queries; the XML (eXtensible Markup Language) process module; and the tools for the validation of the extracts managed, implemented on a defined XML-Schema. RESULTS: The server was subjected to four phases of trials, the first three with ad hoc test data and processes to ensure that each of the modules complied with its specifications and that the interaction between them provided the expected functionalities. The fourth used real extracts generated by other research groups for the additional purpose of testing the validity of the standard in real-world scenarios. CONCLUSION: The acceptable performance of the server has made it possible to include it as a middleware service in a platform for the out-of-hospital follow-up and monitoring of patients with chronic heart disease which, at the present time, supports pilot projects and clinical trials for the evaluation of eHealth services.