Measuring quality of technology and innovation in cardiac care Legal and practical aspects

The subject of this PhD thesis is how to measure quality of new technology and process innovation in cardiac care. It describes legal and practical aspects of implementing new technology and process innovation in daily care in cardiology and cardiothoracic surgery while using outcome indicators. In general, the goal of medical treatment is to improve the clinical condition or the quality of life of a patient. The quality of care is therefore primarily measured on the basis of clinical outcome indicators. Examples of outcome indicators are mortality, treatment success rate, complications and quality of life. A focus on these outcomes that matter most to patients combined with awareness of costs of care is the concept of value-based healthcare.
Part I includes the background of measuring quality of care.
Chapter 1 describes the outline of the thesis. Chapter 2 introduces the concept of regulated competition into healthcare in the Netherlands: a booster for measuring outcome indicators. Chapter 3 summarizes the concept and current regulatory framework of quality of healthcare.
Part II describes the EU regulatory framework applicable to measurement of outcome indicators in cardiology and cardiothoracic surgery.
Chapter 4 gives an overview of quality of care measurement by outcome indicators by current quality-of-care registries in cardiology and cardiothoracic surgery in Europe.
Chapter 5 and chapter 6 describe the challenges quality-of-care registries and healthcare professionals using mHealth (mobile health) face when dealing with applicable privacy legislation protecting patient data. Patient data from registries may only be used for medical data research after informing patients and obtaining their explicit consent.
Chapter 7 describes how outcome indicators can be incorporated in the multidisciplinary decision-making process deciding on invasive interventions for patients with cardiovascular disease. Chapter 8 describes how the new European law on medical devices (Medical Device Regulation, MDR) which came into force on May 25th 2021 sets high safety standards for medical devices, yet does not obligate to include outcome indicators from quality-of-care registries to improve post-marketing surveillance.
Part III describes the use of outcome indicators in an innovative care project started by healthcare professionals. In this project patients with worsening heart failure are treated with intravenous diuretics at the outpatient department and not in the hospital. Heart failure is a very frequent medical condition and patients with worsening heart failure experience severe symptoms of shortness of breath.
Chapter 9 gives an overview of the available evidence in medical literature for the effectiveness and safety of this treatment strategy. Chapter 10 shows the results of a multicenter observational registry (259 patients were included). In a total of 322 individual outpatient treatments with intravenous diuretics, only one adverse event was registered. Chapter 11 describes a how handheld echocardiography can identify patients with worsening heart failure quicker and how it can be used to monitor success of treatment.
Chapter 12 in Part IV describes the current state of outcome indicators measurement in the Netherlands, existing practical and legal barriers and promising future directions.