The Data Governance Act and the EU's move towards facilitating data sharing

The implementation of the EU General Data Protection Regulation (GDPR) has had significant impacts on biomedical research, often complicating data sharing among researchers. The recently announced proposal for a new EU Data Governance Act is a promising step towards facilitating data sharing, if it can interplay well with the GDPR.Subject Categories: S&S: Ethics

The EU General Data Protection Regulation (GDPR) has affected biomedical research, often complicating data sharing. The recently announced proposal for a new EU Data Governance Act, is a promising step towards facilitating data sharing.

In an attempt to improve and increase data sharing in the EU and to optimize the re‐use of personal and non‐personal data, the European Commission has recently announced the proposal for a new EU Data Governance Act (https://ec.europa.eu/digital‐single‐market/en/news/proposal‐regulation‐european‐data‐governance‐data‐governance‐act). If approved, it will enable the creation and regulation of “secure spaces” where various types of data, including health data, can be shared and re‐used for both commercial and altruistic purposes, including scientific research. The Data Governance Act, within the framework of a European Strategy for Data, (https://ec.europa.eu/info/sites/info/files/communication‐european‐strategy‐dat‐19feb2020_en.pdf), would address some of the shortcomings and drawbacks of the current regulatory framework which holds back sharing and re‐using data for biomedical research purposes.While the proposed Act would apply to all types of personal and non‐personal data, the increasing demand for sharing health data has most likely been a major rationale for this new legislation of data governance. Notably, sharing health and genetic data for scientific research entails an extra layer of complexity, owing to concerns over data protection and privacy when sharing sensitive personal data. Vice versa, there are also concerns in the scientific community over the negative impact of regulatory restrictions on sharing health data in data‐driven biomedical research. The pressing question here is how far the EU’s proposed legislative and policy framework can offset either concerns?     

Patient Experience and Satisfaction with Inpatient Service: Development of Short Form Survey Instrument Measuring the Core Aspect of Inpatient Experience

Patient experience reflects quality of care from the patients’ perspective; therefore, patients’ experiences are important data in the evaluation of the quality of health services. The development of an abbreviated, reliable and valid instrument for measuring inpatients’ experience would reflect the key aspect of inpatient care from patients’ perspective as well as facilitate quality improvement by cultivating patient engagement and allow the trends in patient satisfaction and experience to be measured regularly. The study developed a short-form inpatient instrument and tested its ability to capture a core set of inpatients’ experiences. The Hong Kong Inpatient Experience Questionnaire (HKIEQ) was established in 2010; it is an adaptation of the General Inpatient Questionnaire of the Care Quality Commission created by the Picker Institute in United Kingdom. This study used a consensus conference and a cross-sectional validation survey to create and validate a short-form of the Hong Kong Inpatient Experience Questionnaire (SF-HKIEQ). The short-form, the SF-HKIEQ, consisted of 18 items derived from the HKIEQ. The 18 items mainly covered relational aspects of care under four dimensions of the patient’s journey: hospital staff, patient care and treatment, information on leaving the hospital, and overall impression. The SF-HKIEQ had a high degree of face validity, construct validity and internal reliability. The validated SF-HKIEQ reflects the relevant core aspects of inpatients’ experience in a hospital setting. It provides a quick reference tool for quality improvement purposes and a platform that allows both healthcare staff and patients to monitor the quality of hospital care over time.     

The Role of Geography in the Assessment of Quality: Evidence from the Medicare Advantage Program

The Affordable Care Act set in motion a renewed emphasis on quality of care evaluation. However, the evaluation strategies of quality by the Centers for Medicare and Medicaid Services do not consider geography when comparisons are made among plans. Using an overall measure of a plan’s quality in the public sector—the Medicare Advantage (MA) star ratings—we explored the impact of geography in these ratings. We identified 2,872 U.S counties in 2010. The geographic factor predicted a larger fraction of the MA ratings’ compared to socio-demographic factors which explained less. Also, after the risk adjustments, almost half of the U.S. states changed their ranked position in the star ratings. Further, lower MA star ratings were identified in the Southeastern region. These findings suggest that the geographic component effect on the ratings is not trivial and should be considered in future adjustments of the metric, which may enhance the transparency, accountability, and importantly level the playing field more effectively when comparing quality across health plans.     

The EU Nitrates Directive: a European approach to combat water pollution from agriculture

From 1991 onward, the European Union (EU) member states have had to comply with the Nitrates Directive. The aim of this directive is to sustainably protect ground and surface waters from pollution with nitrogen (nitrate) originating from agriculture. Agriculture is, on an EU level, the largest single source of nitrate (runoff, leaching) pollution, although households and industries also contribute to some extent. An important element in the directive is the reporting every 4 years on the monitoring of ground- and surface-water quality. Furthermore, all 15 member states are compelled to designate so-called Nitrate Vulnerable Zones (NVZs). These are regions where the nitrate concentrations in the groundwater amount to 50 mg/l or more. In addition to Codes of Good Agricultural Practice, valid on a countrywide basis and often consisting of voluntary-based measures, specific Action Programmes with mandatory measures have to be developed for the NVZs. The first reporting period ended in 1995. This paper describes the progress in member states" compliance with the Nitrates Directive during the second period (1996-1999), with a focus on the agricultural practices and action programmes. An evaluation of the member states' reports shows that good progress is being made on the farmers" awareness of the need to comply with EU regulations on the protection of the aquatic environment. Action programmes are valuable tools to enforce measures that lead to a reduction of the water pollution by agricultural activities. Regional projects show that significant improvements can be achieved (e.g., reduced fertiliser inputs) while maintaining crop yields and thus maintaining the economic potential of agriculture.     

The EU’s GM crop conundrum: Did the EU policy strategy to convert EFSA GMO guidance into legislation deliver on its promises?

Efforts by the EU to improve its regulatory framework for importing GM food and feed have done nothing to make the process easier and more predictable for applicants. Subject Categories: Biotechnology & Synthetic Biology, Economics, Law & Politics, Plant Biology

The first genetically modified (GM) crops were introduced more than two decades ago and have been planted globally on more than 190 million hectares (ISAAA, 2020), a surface area larger than all the arable land in the EU. Thousands of risk assessments have consistently concluded that they are as safe as conventional crops in regard to human and animal health (Smyth et al, 2021) and many countries have been growing GM crops for years. Despite political commitments to innovation and investments into research (EC, 2010), the EU is still lagging behind in adopting this technology on a wider scale owing to diverging views among its member states, the European Commission (EC) and the European parliament. Various attempts to resolve this tension by legal and regulatory means have created the most cumbersome and byzantine regulatory system for GM crops in the world. The Implementing Regulation (EU) No 503/2013, meant to ease the regulatory process, has made things even more complicated.

Various attempts to resolve this tension by legal and regulatory means have created the most cumbersome and byzantine regulatory system for GM crops in the world.

A major conundrum for the EU is the need to import large quantities of protein‐rich crops such as soybean to supply the continent’s livestock industry with high‐quality feed.In the light of the current Russia–Ukraine situation, which has added a layer of instability to already tense markets, the importance of the global agricultural market to ensure food security is even more pronounced.Given the high adoption rate of GM crops outside the EU, most of these imported commodities inevitably contain GM crops. Under EU law, food and feed products that contain or were produced from GM crops need an import authorisation by the European Commission (EC), which is a lengthy, costly and unpredictable process.In 2002, the EU set up a centralised review system under Regulation (EC) 178/2002 (the General Food Law Regulation) and an independent scientific body to conduct this review: the European Food Safety Authority (EFSA). EFSA is responsible for performing the risk assessment for food and feed regulated products, including GM crops; their advice “opinion” is used by the EC to draft a decision whether or not to authorise import. EU member states then vote whether or not to follow the EC’s draft decision. To date, not a single GM product has received a qualified majority decision for authorisation. The EC then makes the final decision based on EFSA’s risk assessment.There are many reasons why the member states disagree, mostly owing to political and economic agendas. Some members with a large and important agri‐food sector tend to vote in line with EFSA’s opinions, while others consistently vote against authorisation or abstain their vote mainly for political reasons. This ongoing disagreement has made it very difficult to establish an EU‐wide policy for agricultural biotechnology.

…the continuous proliferation, update and reinterpretation of EU requirements means that studies that were conducted in compliance with the guidelines at a particular time may no longer comply with changed requirements…

     

Focus: Health Equity: The Sick Bias

This perspectives piece shares the experience of a trainee during the COVID-19 pandemic as it pertains to initial patient evaluations and the subsequent impact they have on patient outcomes. Specifically highlighting the value of approaching every patient as sick before deeming them as well – this approach to triaging is defined as a “sick bias” throughout the piece. Unfortunately, this initial evaluation can be influenced by explicit and implicit biases of the provider that highlight health inequities within their patient’s care.     

Physicians' Own Health—Some Advice for the Advisors

Information about physicians'' health and health practices is sparse and scattered. With a few exceptions, however—notably suicide and substance abuse—it appears that physicians'' health and health-promotion activities are at least similar to those of the general public. In some areas, such as smoking cessation, physicians have far outstripped the general public. As physicians gain more insight into their own health and health habits, advice to patients can be realistic and effective. Indeed, several personal health activities, including immunization, have direct, salutary impacts on patient care. Physicians should analyze and change their own health practices as indicated and pay special attention to “high yield” health habits, such as seat-belt use.     

Patients as Partners: A Qualitative Study of Patients’ Engagement in Their Health Care

To advocate for patients to be more actively involved with the healthcare services they receive, particularly patients living with chronic illness, the Faculty of Medicine of the University of Montreal and its affiliated hospitals developed the Patients as Partners concept where the patient is considered a full-fledged partner of the health care delivery team and the patient’s experiential knowledge is recognized. This study aims to show how patients view their engagement with healthcare professionals regarding their direct care. Using theoretical sampling, 16 semi-structured interviews were conducted with patients with chronic illness who were familiar with the concept of Patients as Partners. Data analysis followed a constructivist grounded theory approach. Patients describe themselves as proactively engaging in three types of practice, regardless of health professionals’ openness to their role as partners. The first is a process of continuous learning that allows them to acquire experiential knowledge about their health, as well as scientific information and technical know-how. The second involves their assessment of the healthcare they receive, in terms of its quality and how it aligns with their personal preferences. It includes their assessment of the quality of their relationship with the health professional and of the latter’s scientific knowledge and technical know-how. The third type, adaptation practices, builds on patients’ learning and assessments to compensate for and adapt to what has been perceived as optimal or non-optimal health or healthcare circumstances. Patients appear to play a more active and less docile role in their own direct care than suggested so far in the literature, regardless of the degree of reciprocity of the partnership or the degree to which the health professional seeks to encourage patient engagement.     

No Negative Impact of Palliative Sedation on Relatives’ Experience of the Dying Phase and Their Wellbeing after the Patient’s Death: An Observational Study

Background

Palliative sedation is the widely-used intervention of administering sedating agents to induce a state of unconsciousness to take away a dying patient’s perception of otherwise irrelievable symptoms. However, it remains questionable whether this ethically complex intervention is beneficial for patients and whether the associated lack of communication in the last phase of life has a negative impact on relatives’ wellbeing.

Methods

An observational questionnaire study was conducted among relatives of a consecutive sample of patients who died a non-sudden death in the Erasmus MC Cancer Institute or in the hospice ‘Laurens Cadenza’ (both in Rotterdam) between 2010 and 2013.

Results

Relatives filled in questionnaires regarding 151 patients who had been sedated and 90 patients who had not been sedated. The median time since all patients had passed away was 21 (IQR 14–32) months. No significant differences were found in relatives´ assessments of the quality of end-of-life care, patients´ quality of life in the last week before death and their quality of dying, between patients who did and did not receive sedation, or in relatives’ satisfaction with their own life, their general health and their mental wellbeing after the patient’s death.

Conclusions

The use of sedation in these patients appears to have no negative effect on bereaved relatives’ evaluation of the patient’s dying phase, or on their own wellbeing after the patient’s death.     

Criticism and Depression among the Caregivers of At-Risk Mental State and First-Episode Psychosis Patients

Expressed emotion (EE), especially criticism, is an important predictor of outcomes for the patient for a wide range of mental health problems. To understand complex links between EE and various relevant variables in early phase psychosis, this study examined criticism, distress of caregivers, other patients’, and caregivers’ variables, and links between criticism and these variables in those with at-risk mental state (ARMS) for psychosis and first-episode psychosis (FEP). The participants were 56 patients (mean age 18.8 ± 4.2 years) with ARMS and their caregivers (49.4 ± 5.8 years) and 43 patients (21.7 ± 5.2 years) with FEP and their caregivers (49.3 ± 7.4 years). We investigated criticisms made by caregivers using the Japanese version of the Family Attitude Scale and caregiver depressive symptoms via the self-report Beck Depression Inventory. We also assessed psychiatric symptoms and functioning of the patients. Approximately one-third of caregivers of patients with ARMS or FEP had depressive symptoms, predominately with mild-to-moderate symptom levels, whereas only a small portion exhibited high criticism. The level of criticism and depression were comparable between ARMS and FEP caregivers. The link between criticism, caregivers’ depression, and patients’ symptoms were observed in FEP but not in ARMS caregivers. These findings imply that the interaction between criticism and caregivers’ and patients’ mental states may develop during or after the onset of established psychosis and interventions for the caregivers should be tailored to the patient’s specific stage of illness. Interventions for FEP caregivers should target their emotional distress and include education about patient’s general symptoms.     

Do Physical Proximity and Availability of Adequate Infrastructure at Public Health Facility Increase Institutional Delivery? A Three Level Hierarchical Model Approach

This study aims to examine the inter-district and inter-village variation of utilization of health services for institutional births in EAG states in presence of rural health program and availability of infrastructures. District Level Household Survey-III (2007–08) data on delivery care and facility information was used for the purpose. Bivariate results examined the utilization pattern by states in presence of correlates of women related while a three-level hierarchical multilevel model illustrates the effect of accessibility, availability of health facility and community health program variables on the utilization of health services for institutional births. The study found a satisfactory improvement in state Rajasthan, Madhya Pradesh and Orissa, importantly, in Bihar and Uttaranchal. The study showed that increasing distance from health facility discouraged institutional births and there was a rapid decline of more than 50% for institutional delivery as the distance to public health facility exceeded 10 km. Additionally, skilled female health worker (ANM) and observed improved public health facility led to significantly increase the probability of utilization as compared to non-skilled ANM and not-improved health centers. Adequacy of essential equipment/laboratory services required for maternal care significantly encouraged deliveries at public health facility. District/village variables neighborhood poverty was negatively related to institutional delivery while higher education levels in the village and women’s residing in more urbanized districts increased the utilization. “Inter-district” variation was 14 percent whereas “between-villages” variation for the utilization was 11 percent variation once controlled for all the three-level variables in the model. This study suggests that the mere availability of health facilities is necessary but not sufficient condition to promote utilization until the quality of service is inadequate and inaccessible considering the inter-districts variation for the program implementation.     

Perception of Antiretroviral Generic Medicines: One-Day Survey of HIV-Infected Patients and Their Physicians in France

BackgroundIn the interest of cost effectiveness, switching antiretroviral brand name medications to generics is recommended in France since 2013. The study objective was to evaluate the perception of generics per se and antiretroviral generics in HIV-infected patients and their hospital physiciansConclusionsAcceptability of antiretroviral generics in this French population was mostly dictated by the patient’s and physician’s knowledge and use of generics overall. It should be improved with an efficient information of both patients and physicians.     

Implicit and Explicit Anti-Fat Bias among a Large Sample of Medical Doctors by BMI,Race/Ethnicity and Gender

Overweight patients report weight discrimination in health care settings and subsequent avoidance of routine preventive health care. The purpose of this study was to examine implicit and explicit attitudes about weight among a large group of medical doctors (MDs) to determine the pervasiveness of negative attitudes about weight among MDs. Test-takers voluntarily accessed a public Web site, known as Project Implicit®, and opted to complete the Weight Implicit Association Test (IAT) (N = 359,261). A sub-sample identified their highest level of education as MD (N = 2,284). Among the MDs, 55% were female, 78% reported their race as white, and 62% had a normal range BMI. This large sample of test-takers showed strong implicit anti-fat bias (Cohen’s d = 1.0). MDs, on average, also showed strong implicit anti-fat bias (Cohen’s d = 0.93). All test-takers and the MD sub-sample reported a strong preference for thin people rather than fat people or a strong explicit anti-fat bias. We conclude that strong implicit and explicit anti-fat bias is as pervasive among MDs as it is among the general public. An important area for future research is to investigate the association between providers’ implicit and explicit attitudes about weight, patient reports of weight discrimination in health care, and quality of care delivered to overweight patients.     

Learning Biomarker Models for Progression Estimation of Alzheimer’s Disease

Being able to estimate a patient’s progress in the course of Alzheimer’s disease and predicting future progression based on a number of observed biomarker values is of great interest for patients, clinicians and researchers alike. In this work, an approach for disease progress estimation is presented. Based on a set of subjects that convert to a more severe disease stage during the study, models that describe typical trajectories of biomarker values in the course of disease are learned using quantile regression. A novel probabilistic method is then derived to estimate the current disease progress as well as the rate of progression of an individual by fitting acquired biomarkers to the models. A particular strength of the method is its ability to naturally handle missing data. This means, it is applicable even if individual biomarker measurements are missing for a subject without requiring a retraining of the model. The functionality of the presented method is demonstrated using synthetic and—employing cognitive scores and image-based biomarkers—real data from the ADNI study. Further, three possible applications for progress estimation are demonstrated to underline the versatility of the approach: classification, construction of a spatio-temporal disease progression atlas and prediction of future disease progression.     

Institutions of the European Union: medical perspective

The way through the institutions of the European Union (EU) is very difficult. The difficulties will increase with the expansion of EU to 25 member states, and even more so in the area of medical societies. Following the agenda of the EU, an efficient public health service is a responsibility of every member country. The possibilities of medical interest are pointed out in this paper     

Five Classic Articles in Public Health

In this brief review, Dr. Jonathan Borak comments on five seminal papers that helped shape the fields of epidemiology and public health. These papers include Hill’s criteria for inferring causality; the first proof of the multistage theory of cancer; the first evidence that subclinical lead exposures can cause neurobehavioral impairment in children; a simple yet robust study that had a major influence on setting current air pollution policies; and a landmark review of the general public’s perception of risk in relation to actual public health hazard.Dr. Jonathan Borak is a Clinical Professor of Epidemiology and Public Health at the Yale School of Public Health, Clinical Professor of Internal Medicine at the Yale School of Medicine, and Director of the Yale Interdisciplinary Risk Assessment Forum. In this article, Dr. Borak provides his perspective on five publications that significantly influenced the study and practice of epidemiology and public health. This article is the first in a series that will identify and provide commentary on the top five seminal papers published in a field related to biology and medicine.A former student, a member of the Yale Journal of Biology and Medicine’s Editorial Board, reminded me of a comment I made in class. I had described a particular assigned reading as “one of those classic articles” that should be read by everyone studying public health. Okay, he challenged me, what other “classic articles” were on my list? And so began the following: my short list of five articles that represent “must reading” for all students in public health.First, note that I do not speak for public health in general, a field of great breadth of interest and activity, but only the narrower slice, including toxicology, risk assessment, and related interests. Also, I was principally concerned to identify articles that provide models of critical thinking, addressed issues of substantial public health importance, and served as stepping stones for subsequent research and the formulation of public health policy. I also wanted to include articles that were observational and opportunistic, i.e., based on real world observations and available data, not complex laboratory models.My five choices below include: 1) a landmark presentation of criteria for inferring causality from observational data (Hill 1965); 2) a thought experiment based on the re-analysis of publicly available cancer mortality data, which shaped the fields of cancer biology and risk assessment (Armitrage & Doll, 1954); 3) an early study of the effects of lead exposure in school children (Needleman, 1979); 4) a study of the impact of air pollution on children’s health, which was enabled by a fortuitous labor dispute that shuttered a polluting steel mill (Ransom & Pope, 1992); and, 5) a critical literature review of cognitive psychology research that shaped our understanding about how public health risks are perceived (Slovic, 1987).     

From empathy to caring: defining the ideal approach to a healing relationship

In recent years, “empathy” has been identified as a form of emotional engagement beneficial to patient care. Although usage varies, the term refers to sharing the feelings of another as a means of coming to a direct appreciation of the other. Defined this way, however, empathy may lead to mistaken assumptions and an absence of corrective curiosity: Once we think we understand what another is experiencing, we perceive less need to ask, listen, and learn. We propose the process of “caring” in place of “empathy” to embody the ideal emotional and behavioral approach to patient care. Caring refers to both an emotional reaction to another and the expression of that reaction in action, independent of the sharing of the other’s emotion or experience. The expression of caring in the clinical context is close observation, precise listening, and responsive questioning, in concert with committed engagement and actions directly addressing the patient’s problem, stripped of any assumptions about what the other might or might not be experiencing.