Record linkage of routine and cohort data of children in Portugal: challenges and opportunities when using record linkage as a tool for scientific research.

Linking records could serve as a useful tool for scientific research and as a facilitator for local policymaking. This article examines the challenges and opportunities for researchers to lawfully link routinely collected health and education data with cohort data of children when using it as a tool for scientific research in Portugal. Such linking can be lawfully conducted in Portugal if three requirements are met. First, data processing pursues a legitimate purpose, such as scientific research. Secondly, data linking complies with the legal obligations of research entities and researchers, acting as data controllers or processors, and it respects the rights of children as data subjects. Finally, data linking is based on the explicit written consent of those with parental responsibility for the child. So far, the implementation of the General Data Protection Regulation in Portugal has not facilitated record linkage. It is argued that further harmonised implementation of that Regulation across European Union and European Economic Area Member States, establishing a minimum shared denominator for record linkage in scientific research for the common good, including without explicit consent, is needed.

Geoprivacy in Neighbourhoods and Health Research: A Mini-Review of the Challenges and Best Practices in Epidemiological Studies.

Neighbourhood and health research often relies on personal location data (e.g., home address, daily itineraries), despite the risks of geoprivacy breaches. Thus, geoprivacy is an important emerging topic, contemplated in international regulations such as the General Data Protection Regulation. In this mini-review, we briefly assess the potential risks associated with the usage of personal location data and provide geoprivacy-preserving recommendations to be considered in epidemiological research. Risks include inference of personal information that the individual does not wish to disclose, reverse-identification and security breaches. Various measures should be implemented at different stages of a project (pre-data collection, data processing, data analysis/publication and data sharing) such as informed consent, pseudo-anonymization and geographical methods.

Joint controllers in large research consortia: a funnel model to distinguish controllers in the sense of the GDPR from other partners in the consortium.

Large European research consortia in the health sciences face challenges regarding the governance of personal data collected, generated and/or shared during their collective research. A controller in the sense of the GDPR is the entity which decides about purposes and means of the data processing. Case law of the Court of Justice of the European Union (CJEU) and Guidelines of the European Data Protection Board (EDPB) indicate that all partners in the consortium would be joint controllers. This paper summarises the case law, the Guidelines and literature on joint controllership, gives a brief account of a webinar organised on the issue by Lygature and the MLC Foundation. Participants at the webinar agreed in large majority that it would be extreme if all partners in the consortium would become joint controllers. There was less agreement how to disentangle partners who are controllers of a study from those who are not. In order to disentangle responsibilities, we propose a funnel model with consecutive steps acting as sieves in the funnel. It differentiates between two types of partners: all partners who are involved in shaping the project as a whole versus those specific partners who are more closely involved in a sub-study following from the DoA or the use of the data Platform. If the role of the partner would be comparable to that of an outside advisor, that partner would not be a data controller even though the partner is part of the consortium. We propose further nuances for the disentanglement which takes place in various steps. Uncertainty about formal controllership under the GDPR can stifle collaboration in consortia due to concerns over (shared) responsibility and liability. Data subjects' ability to exercise their right can also be affected by this. The funnel model proposes a way out of this conundrum.

Is personal and social functioning associated with subjective quality of life in schizophrenia patients living in the community?

Subjective quality of life (QoL) and psychosocial functioning constitute important treatment outcomes in schizophrenia. We aimed to investigate the relationship between them in schizophrenia patients living in the community. Symptom severity and insight were assessed with the Positive and Negative Syndrome Scale (PANSS) in 76 community schizophrenia patients. Social functioning was measured with the Portuguese version of Personal and Social Performance (PSP) scale, and subjective QoL was measured with the Portuguese version of the WHO Quality of Life Measure-Abbreviated Version (WHOQOL-Bref). The majority of patients were single (78%) and unemployed/inactive (74%). Mean PSP total score was 55.5, and mean scores on WHOQOL-Bref domains ranged from 54.1 to 63.0. Greater symptom severity and worse insight were significantly associated with worse functioning in all PSP domains. Symptoms were more moderately correlated with QoL, with no significant correlations between QoL and positive symptoms and insight levels. Partial correlations controlling for symptom severity revealed no significant associations between social functioning and subjective QoL. Symptom severity may exert a greater influence on social functioning than on subjective QoL; however, social functioning was not associated with subjective QoL. The results suggest these constructs might be independent and should be assessed separately. A broader research approach, with increased attention to social and psychological factors, may help identify treatment targets to improve schizophrenia patients' social functioning and QoL.

The importance of measuring psychosocial functioning in schizophrenia.

BACKGROUND: Schizophrenia is among the most disabling of mental illnesses and frequently causes impaired functioning. We explore issues of definition and terminology, and the relationship between social functioning, cognition, and psychopathology considering relevant research findings. METHODS: The present article describes measures of social functioning and outlines their psychometric properties. It considers their usefulness in research and clinical settings. Treatment aims and objectives are explored in the context of cognitive and social functioning. Finally, we identify areas for developing research and refining the measurement of social functioning. RESULTS: The definition and measurement of social functioning in schizophrenia remains a complex and disputed area. The relationships between symptoms, cognitive functioning and social functioning are complex but we are beginning to understand them better. Scales for measuring functioning in clinical practice must be brief and sensitive to change and the Personal and Social Performance (PSP) scale may offer several advantages in these regards. Brief cognitive assessments focusing upon the domains most commonly affected in schizophrenia, such as verbal memory and executive functions, should be coadministered with measures of functioning. CONCLUSIONS: The use of validated scales for schizophrenia that are sensitive to change over the course of the illness and its treatment, should allow for a better understanding of patients' functional disabilities, enabling better and more comprehensive monitoring and evaluation of both pharmacological and non-pharmacological treatment strategies.

Successful management of Listeria monocytogenes pericarditis: case report and review of the literature.

Listeria monocytogenes, although an uncommon cause of illness in the general population, is feared principally because of the morbidity and mortality associated with CNS infections. Cardiovascular involvement with L. monocytogenes is very rare, and has been limited to endocarditis. We describe a case of Listeria pericarditis, which occurred in a 60-year-old man with Child-Pugh B cirrhosis who presented to the emergency department with asthenia, anorexia, and respiratory distress. The echocardiogram showed severe pericardial effusion and after pericardiocentesis, L. monocytogenes was isolated in the culture of pericardial fluid. After surgical pericardiectomy with draining of the pericardial effusion and antibiotic treatment with ampicillin, the patient experienced a slow, but full recovery. Documentation of L. monocytogenes pericarditis is an extremely rare entity with very scarce reports in medical literature, and is usually associated with a very poor prognosis. A case report is presented together with a review of the literature.

Hyponatremia--an unusual trigger of Takotsubo cardiomyopathy.

Takotsubo cardiomyopathy is an acute cardiac entity with clinical manifestations similar to myocardial infarction, accounting for 1-2% of acute coronary syndrome admissions. Its underlying pathophysiology is not yet well established. It is usually associated with acute physical or emotional stress, but the list of potential triggers has grown as the condition attracts the attention of the medical community. In order to diagnose the condition correctly and to gain new insights into it, we need to know its potential triggers as well as its clinical presentation and diagnostic criteria. We report a case of takotsubo cardiomyopathy triggered by hyponatremia.

Record linkage of population-based cohort data from minors with national register data: a scoping review and comparative legal analysis of four European countries.

Background: The GDPR was implemented to build an overarching framework for personal data protection across the EU/EEA. Linkage of data directly collected from cohort participants, potentially serving as a prominent tool for health research, must respect data protection rules and privacy rights. Our objective was to investigate law possibilities of linking cohort data of minors with routinely collected education and health data comparing EU/EEA member states. Methods: A legal comparative analysis and scoping review was conducted of openly accessible published laws and regulations in EUR-Lex and national law databases on GDPR's implementation in Portugal, Finland, Norway, and the Netherlands and its connected national regulations purposing record linkage for health research that have been implemented up until April 30, 2021. Results: The GDPR does not ensure total uniformity in data protection legislation across member states offering flexibility for national legislation. Exceptions to process personal data, e.g., public interest and scientific research, must be laid down in EU/EEA or national law. Differences in national interpretation caused obstacles in cross-national research and record linkage: Portugal requires written consent and ethical approval; Finland allows linkage mostly without consent through the national Social and Health Data Permit Authority; Norway when based on regional ethics committee's approval and adequate information technology safeguarding confidentiality; the Netherlands mainly bases linkage on the opt-out system and Data Protection Impact Assessment. Conclusions: Though the GDPR is the most important legal framework, national legislation execution matters most when linking cohort data with routinely collected health and education data. As national interpretation varies, legal intervention balancing individual right to informational self-determination and public good is gravely needed for health research. More harmonization across EU/EEA could be helpful but should not be detrimental in those member states which already opened a leeway for registries and research for the public good without explicit consent.

Sharing Biomedical Data: Strengthening AI Development in Healthcare.

Artificial intelligence (AI)-based solutions have revolutionized our world, using extensive datasets and computational resources to create automatic tools for complex tasks that, until now, have been performed by humans. Massive data is a fundamental aspect of the most powerful AI-based algorithms. However, for AI-based healthcare solutions, there are several socioeconomic, technical/infrastructural, and most importantly, legal restrictions, which limit the large collection and access of biomedical data, especially medical imaging. To overcome this important limitation, several alternative solutions have been suggested, including transfer learning approaches, generation of artificial data, adoption of blockchain technology, and creation of an infrastructure composed of anonymous and abstract data. However, none of these strategies is currently able to completely solve this challenge. The need to build large datasets that can be used to develop healthcare solutions deserves special attention from the scientific community, clinicians, all the healthcare players, engineers, ethicists, legislators, and society in general. This paper offers an overview of the data limitation in medical predictive models; its impact on the development of healthcare solutions; benefits and barriers of sharing data; and finally, suggests future directions to overcome data limitations in the medical field and enable AI to enhance healthcare. This perspective is dedicated to the technical requirements of the learning models, and it explains the limitation that comes from poor and small datasets in the medical domain and the technical options that try or can solve the problem related to the lack of massive healthcare data.

Predictors of In-Hospital Mortality after Recovered Out-of-Hospital Cardiac Arrest in Patients with Proven Significant Coronary Artery Disease: A Retrospective Study.

INTRODUCTION: Recovered Out-of-Hospital Cardiac Arrest (rOHCA) population is heterogenous. Few studies focused on outcomes in the rOHCA subgroup with proven significant coronary artery disease (SigCAD). We aimed to characterize this subgroup and study the determinants of in-hospital mortality. METHODS: Retrospective study of consecutive rOHCA patients submitted to coronary angiography. Only patients with SigCAD were included. RESULTS: 60 patients were studied, 85% were male, mean age was 62.6 ± 12.1 years. In-hospital mortality rate was 43.3%. Patients with diabetes and history of stroke were less likely to survive. Significant univariate predictors of in-hospital mortality were further analysed separately, according to whether they were present at hospital admission or developed during hospital evolution. At hospital admission, initial non-shockable rhythm, low-flow time>12min, pH<7.25mmol/L and lactates >4.75mmol/L were the most relevant predictors and therefore included in a score tested by Kaplan-Meyer. Patients who had 0/4 criteria had 100% chance of survival till hospital discharge, 1/4 had 77%, 2/4 had 50%, 3/4 had 25%. Patients with all 4 criteria had 0% survival. During in-hospital evolution, a pH<7.35 at 24h, lactates>2mmol/L at 24h, anoxic brain injury and persistent hemodynamic instability proved significant. Patients who had 0/4 of these in-hospital criteria had 100% chance of survival till hospital discharge, 1/4 had 94%, 2/4 had 47%, 3/4 had 25%. Patients with all 4 criteria had 0% survival. Contrarily, CAD severity and ventricular dysfunction didn't significantly correlate to the outcome. CONCLUSION: Classic prehospital variables retain their value in predicting mortality in the specific group of OHCA with SigCAD. In-hospital evolution variables proved to add value in mortality prediction. Combining these simple variables in risk scores might help refining prognostic prediction in these patients's subset.

Cognitive function and serum levels of brain-derived neurotrophic factor in patients with bipolar disorder.

OBJECTIVES: Brain-derived neurotrophic factor (BDNF) is an important contributor to the pathophysiology of bipolar disorder (BD), and abnormalities in the BDNF-signaling system may be implicated in the cognitive decline observed in BD patients. We aimed to investigate serum BDNF levels in BD patients and its relation to neurocognitive function. METHODS: We measured serum BDNF levels using an enzyme-linked immunosorbent assay method in 65 euthymic type I BD patients and 50 healthy controls, and administered a neuropsychological test battery to assess attention and mental control, perceptual-motor skills, executive functions, verbal fluency and abstraction, visuospatial attention, and memory. RESULTS: We found no significant differences regarding serum BDNF levels in BD patients and healthy controls. We found significant positive associations between serum BDNF levels and illness duration, and manic and depressive episodes in female BD patients only. Serum BDNF levels were lower in patients medicated with antipsychotics and/or lithium, whereas patients on valproate and/or antidepressants showed higher serum BDNF levels. Patients performed significantly worse on 11 out of 16 neurocognitive tests as compared to controls. We found a significant positive association between serum BDNF levels and a test of verbal fluency in both BD patients and controls. CONCLUSIONS: Present results support the hypothesis that BDNF normalizes with mood stabilization and pharmacological treatment. Our findings in young and physically healthy patients with short illness duration and few mood episodes may explain the lack of association between serum BDNF levels and neurocognitive performance, even though cognitive performance in patients was overall significantly worse as compared to healthy controls.

Stunned myocardium following ischemic stroke. Case report.

Neuromediated stunned myocardium is a well-known complication of subarachnoid hemorrhage but has rarely been reported in association with other central nervous system disorders. The pathophysiology of this entity remains unclear, but a catecholamine-induced neurocardiogenic injury has been proposed as a causal factor. Typically, patients have rapid full cardiovascular recovery within a few days. We report a case of ischemic stroke, coexisting with ischemic electrocardiographic changes, increased cardiac-specific necrosis biomarkers, regional wall motion abnormalities and a cardiac SPECT consistent with inferior myocardial infarction despite normal coronary arteries. Interestingly, left-ventricular dysfunction in this case persisted longer than usually described despite full neurologic recovery. This case also illustrates the diagnostic challenges posed by this entity which frequently mimics acute myocardial infarction and emphasizes the investigation needed in this area.

Intramyocardial dissecting haematoma: a rare complication of acute myocardial infarction.

Intramyocardial dissecting haematoma (IDH) is a rare complication of myocardial infarction, with very scarce reports in medical literature. Before the advent of non-invasive imaging techniques, the diagnosis of IDH was only made by necropsy. It can develop in the left ventricular free wall, the right ventricle, or the interventricular septum. We present a case of a patient with an IDH after acute anterolateral myocardial infarction, focusing on the utility of echocardiography in the diagnosis and follow-up of this unusual complication. By this imaging modality, it was possible to see the various acoustic densities of the progressive clotting of the intramyocardial haematoma, its extension through the haemorrhagic dissection, as well as its independency in relation to ventricular cavities and extracardiac space by confirming intact epicardial and endocardial layers. Based on this report, we believe that serial two-dimensional echocardiography, added, when necessary, by the use of contrast agents is the non-invasive method ideally suited to confirm the diagnosis and monitor its evolution at the patient's bedside.

Insight, quality of life and cognitive functioning in euthymic patients with bipolar disorder.

INTRODUCTION: The relationship between insight, quality of life and cognition in bipolar disorder has not been clearly established. METHOD: A neuropsychological battery assessing attention, mental control, perceptual-motor skills, executive functions, verbal fluency, abstraction and visuo-spatial attention was administered to 70 remitted bipolar patients and 50 healthy controls. Insight was assessed using the Scale to Assess Unawareness of Mental Disorder; Quality of Life was assessed using the Portuguese version of the WHO Quality of Life Assessment--Abbreviated version (WHOQOL-BREF-PT). RESULTS: No differences in QoL and cognitive performance were observed between bipolar patients with 'impaired' and 'preserved' insight. Insight was found to be correlated with poorer psychological and environmental QoL. A multiple regression model showed that depressive symptoms were significant predictors of physical, psychological and environmental QoL. CONCLUSION: The present study adds to the notion that depressive symptoms, even of low intensity, are strong predictors of QoL. The present study suggests that the impact of insight on self-reported QoL may be subtle during remission and may be more substantially affected in the presence of manic symptoms.

Quality of life in bipolar type I disorder and schizophrenia in remission: clinical and neurocognitive correlates.

This cross-sectional study examined the relationships between clinical and neuropsychological variables and self-reported quality of life (QoL) in 30 euthymic bipolar I patients, 23 remitted schizophrenic patients, and 23 healthy controls. Participants were administered the World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF) to assess QoL. Moreover, a broad neuropsychological battery was also administered. Bipolar disorder (BD) and schizophrenia patients demonstrated significantly lower scores on the physical, psychological, and social domains of the WHOQOL-BREF compared with controls, but there were no significant differences between the two patient groups on those domains. More symptomatic BD patients reported worse QoL, especially in the physical and environmental domains, which was also associated with worse neurocognitive performance. In schizophrenic patients, neurocognitive performance was not associated with self-reported QoL, but more symptomatic patients reported lower QoL. Substantial impairments in QoL, similar in severity, were found in both patient groups. In patients with schizophrenia, QoL was more strongly related to levels of psychopathology, whereas in BD patients, both psychopathology and neurocognitive deficits were strongly associated with lower QoL. Clinical recovery is essential in schizophrenia and BD. The association between cognitive functioning and QoL in bipolar patients suggests that these patients may also benefit from psychological interventions addressed to improve cognitive deficits and enhance the functional recovery.

The impact of co-morbid alcohol use disorder in bipolar patients.

Alcohol use is highly prevalent in patients with bipolar disorder (BD) and is associated with significant mortality and morbidity. The detrimental effects of each condition are compounded by the presence of the other. The objective of this study was to examine the impact of alcohol abuse and of alcohol dependence in BD in a Brazilian sample, as indicated by clinical severity, functional impairment, and quality of life (QOL). A cross-sectional survey of 186 bipolar outpatients were interviewed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-4th Edition. The primary outcome measures were functioning, as indicated by the Global Assessment of Functioning Scale scores and QOL, as indicated by the World Health Organization Quality of Life Instrument. Secondary outcomes were clinical severity features. Alcohol abuse and dependence were associated with male gender, lower education, earlier age of onset, psychosis within first episode, depressive symptoms, and worse functioning. In addition, the presence of alcohol abuse or dependence was associated with remarkably high rates of suicide attempt. Our findings suggest that the co-occurrence of alcohol abuse/dependence with BD increases the risk for suicide attempt, which may reflect in part the greater severity of symptoms and impaired functioning. This subgroup of bipolar patients requires a treatment tailored to address both conditions.

Lack of Benefit of Ischemic Postconditioning After Routine Thrombus Aspiration During Reperfusion: Immediate and Midterm Results.

OBJECTIVES: The underutilization of manual thrombus aspiration (MTA) may have reduced the benefits of ischemic postconditioning (PostCon), as it reduces thrombus embolization. We aimed to assess the benefits of PostCon in patients with ST-segment elevation myocardial infarction (STEMI) after the systematic utilization of MTA. METHODS: A total of 87 patients were enrolled in a prospective, randomized trial (43 PostCon and 44 controls). After MTA, PostCon was performed on the treatment group by applying 4 cycles of alternate reperfusion and reocclusion (60 seconds each) using the angioplasty balloon. The primary end point was infarct size assessed by the area under the curve (AUC) of troponin T (TnT) activity. The secondary end points were left ventricle ejection fraction (LVEF) and major cardiac events (new myocardial infarction or cardiac death) both at discharge and at follow-up. RESULTS: The AUC for TnT was no different with respect to study arms (median [interquartile range]): PostCon = 8.9 (10.6) versus control = 8.2 (10.6), P = .68. Left ventricle ejection fraction improved from in-hospital to follow-up (9 ± 3 months) for the entire cohort (46.3% ± 7.3% vs 52.2% ± 10.7%, P < .001), with no differences between PostCon and controls (51.6% ± 9.5% vs 52.7% ± 11.9%, P = .89); major cardiac events at 14 ± 4 months of follow-up were also no different (PostCon = 1.0 (2.3%) vs control = 0, P = .49). CONCLUSION: In patients with STEMI treated with MTA, PostCon offered no benefits to infarct size, LVEF, or major cardiac events.