European Heart Network

BackgroundPatients and publics are generally positive about data-intensive health research. However, conditions need to be fulfilled for their support. Ensuring confidentiality, security, and privacy of patients’ health data is pivotal. Patients and publics have concerns about secondary use of data by commercial parties and the risk of data misuse, reasons for which they favor personal control of their data. Yet, the potential of public benefit highlights the potential of building trust to attenuate these perceptions of harm and risk. Nevertheless, empirical evidence on how conditions for support of data-intensive health research can be operationalized to that end remains scant.ObjectiveThis study aims to inform efforts to design governance frameworks for data-intensive health research, by gaining insight into the preferences of patients and publics for governance policies and measures.MethodsWe distributed a digital questionnaire among a purposive sample of patients and publics. Data were analyzed using descriptive statistics and nonparametric inferential statistics to compare group differences and explore associations between policy preferences.ResultsStudy participants (N=987) strongly favored sharing their health data for scientific health research. Personal decision-making about which research projects health data are shared with (346/980, 35.3%), which researchers/organizations can have access (380/978, 38.9%), and the provision of information (458/981, 46.7%) were found highly important. Health data–sharing policies strengthening direct personal control, like being able to decide under which conditions health data are shared (538/969, 55.5%), were found highly important. Policies strengthening collective governance, like reliability checks (805/967, 83.2%) and security safeguards (787/976, 80.6%), were also found highly important. Further analysis revealed that participants willing to share health data, to a lesser extent, demanded policies strengthening direct personal control than participants who were reluctant to share health data. This was the case for the option to have health data deleted at any time (P<.001) and the ability to decide the conditions under which health data can be shared (P<.001). Overall, policies and measures enforcing conditions for support at the collective level of governance, like having an independent committee to evaluate requests for access to health data (P=.02), were most strongly favored. This also applied to participants who explicitly stressed that it was important to be able to decide the conditions under which health data can be shared, for instance, whether sanctions on data misuse are in place (P=.03).ConclusionsThis study revealed that both a positive attitude toward health data sharing and demand for personal decision-making abilities were associated with policies and measures strengthening control at the collective level of governance. We recommend pursuing the development of this type of governance policy. More importantly, further study is required to understand how governance policies and measures can contribute to the trustworthiness of data-intensive health research.

The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication. The ESC is not responsible in the event of any contradiction, discrepancy and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies. Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver. Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations. It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.

This study tested the effectiveness of HeartMan—a mobile personal health system offering decisional support for management of congestive heart failure (CHF)—on health-related quality of life (HRQoL), self-management, exercise capacity, illness perception, mental and sexual health. A randomized controlled proof-of-concept trial (1:2 ratio of control:intervention) was set up with ambulatory CHF patients in stable condition in Belgium and Italy. Data were collected by means of a 6-min walking test and a number of standardized questionnaire instruments. A total of 56 (34 intervention and 22 control group) participants completed the study (77% male; mean age 63 years, sd 10.5). All depression and anxiety dimensions decreased in the intervention group (p < 0.001), while the need for sexual counselling decreased in the control group (p < 0.05). Although the group differences were not significant, self-care increased (p < 0.05), and sexual problems decreased (p < 0.05) in the intervention group only. No significant intervention effects were observed for HRQoL, self-care confidence, illness perception and exercise capacity. Overall, results of this proof-of-concept trial suggest that the HeartMan personal health system significantly improved mental and sexual health and self-care behaviour in CHF patients. These observations were in contrast to the lack of intervention effects on HRQoL, illness perception and exercise capacity.

Worldwide, the aging population, globalization, rapid urbanization, and population growth have fundamentally changed disease patterns. Noncommunicable diseases (NCDs), of which cardiovascular disease (CVD) accounts for nearly half, have overtaken communicable diseases as the world's major disease burden. CVD remains the No. 1 global cause of death, accounting for 17.3 million deaths per year, a number that is expected to grow to >23.6 million by 2030. Increasingly, the populations affected are those in low- and middle-income countries, where 80% of these deaths occur, usually at younger ages than in higher-income countries, and where the human and financial resources to address them are most limited.1 The epidemiological transition occurring is exacerbated by the lack of vital investment in sustainable health policies to address and curtail the risk factors associated with CVD and NCDs. Recognizing the profound mismatch between the need for investment in the prevention and control of CVD at the global and national level and the actual resources allocated, the international CVD community, under the umbrella of the World Heart Federation, joined the NCD community to call for a United Nations (UN) High-level Meeting on Non-communicable Diseases, held in September 2011. At this meeting, heads of state signed a Political Declaration that committed governments to the development of 4 specific measures to address the NCD burden in a specific timeline: (1) Recommendations for a global monitoring framework that included NCD targets to be completed by the end of 2012; (2) development of a plan for an effective multisector partnership by the end of 2012; (3) national NCD plans by 2013; and (4) a comprehensive review to evaluate progress, to take place in 2014.2 Celebrating the 1-year anniversary of the passage of the UN Political Declaration, it is timely that our respective organizations speak with a single voice to advocate …