Dabigatran and vitamin K antagonists' use in naïve patients with non-valvular atrial fibrillation: a cross-sectional study of primary care-based electronic health records.

PURPOSE: The purpose of this study was to characterize the profile of patients with non-valvular atrial fibrillation who start an anticoagulant treatment after diagnosis with dabigatran and compare it with those who start with vitamin K antagonists (VKAs). METHODS: We analysed primary health care-based electronic health records data from 15,075 people with new diagnosis of atrial fibrillation who initiated treatment with dabigatran or VKA spanning 2011-2013. Logistic regression analysis for determination of factors associated with initiation of dabigatran was performed. RESULTS: We identified 14,266 (94.6%) people who initiated VKA and 809 (5.4%) who initiated dabigatran. Mean age of people treated with dabigatran was lower than in VKA patients (73.7 vs 75.5 years, p < 0.001). People (90.5%) in VKA group and 83.6% in the dabigatran group had a high risk of stroke, according to CHA2DS2VASc score. There was higher proportion of people with hypertension, diabetes mellitus, dyslipidaemia, and chronic kidney disease among people treated with VKA. The proportion of people with a history of cerebral haemorrhage and stroke was higher among dabigatran patients compared with VKA patients (1.4 vs 0.6%, p = 0.015 and 14.0% vs 10.8%, p = 0.006, respectively). Multivariable logistic model showed that treatment with dabigatran was associated with male sex, history of stroke and Mortalidad en áreas pequeñas Españolas y Desigualdades Socioeconómicas index. CONCLUSIONS: Most patients recently diagnosed with non-valvular atrial fibrillation initiated treatment with VKA. Primary healthcare patients with non-valvular atrial fibrillation initiating dabigatran are younger, had a lower risk of stroke or bleeding, fewer comorbidity and more history of stroke and intracranial haemorrhage compared to those who were initiated on VKA.

Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

BACKGROUND: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. DISCUSSION: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice. TRIAL REGISTRATION: NCT 02514538.

Primary health care research in COVID-19: analysis of the protocols reviewed by the ethics committee of IDIAPJGol, Catalonia.

BACKGROUND: Since March of 2020, the scientific community has been engaged a marathon to answer the different questions that COVID-19 pandemic has brought. During this time, Ethics Committees played an important role in reviewing the research protocols, COVID-19 or not, ensuring that the quality of scientific research is not relaxed by the hasty need for answers. METHODS: Descriptive study from January 2019 to December 2021, comparing COVID-19 protocols to those not COVID-19 related protocols and comparing the work overload. Variables related to the characteristics of the research protocols (i.e. study design, funding…), the principal investigators (gender, PhD degree, professional role…) and outcomes of the Ethics Committee process (requirements of modifications and time until approval) were analyze. RESULTS: The number of sessions increased during COVID-19 pandemics (12 in 2019, 25 in 2020 and 18 in 2021). In total 751 protocols were evaluated during the study period; 513 (68.3%) had an observational design and 434 (57.8%) had no funding. The principal investigator was a woman in 491 (65.4%) studies and a General Practitioner in 330 (43.9%). The mean of the days until the protocol approval was 42.09 days (SD 60.2) with a decrease of 20.1 days from 2019 to 2021. A total of 614 (81.7%) protocols were approved, 336 (54.7%) within the first month after their initial evaluation. Less than half of the protocols were COVID-19 related (208, 44.3%). The COVID-19 protocols main topics were impact on the population (71, 34.1%); and COVID-19 pharmacological treatments (including vaccines) showed a higher increase in 2021 (37, 30.3%). CONCLUSIONS: Despite the work overload during the pandemic due to the increase in the number of meetings and protocols, the IDIAPJGol EC reviewed all of them (COVID-19 or not) adapting to the new situation but according to its criteria of good practices to provide a quick response in the EC opinion. In Primary Health Care the most study designs have been observational studies, many of them with no funding and led by GPs. In 2021 there was an increase in the number of protocols focused on drugs, most likely related to COVID-19 vaccines studies.

Psychotropic use in children and adolescents in Scandinavia and Catalonia: a 10-year population-based study.

RATIONALE: The use of psychotropic drugs in the paediatric population has not been the subject of many studies, due to the fact that this population is generally not included in clinical trials and these drugs are not authorized for use on minors. OBJECTIVES: This study aims to provide an accurate description of psychotropic drug use in children and adolescents in the North of Europe and Catalonia. METHODS: Data from 2008 to 2017 on psychotropic drug consumption in children and adolescents were retrieved from the databases of Catalonia, Denmark, Norway and Sweden. Psychotropic drugs were divided into antipsychotics, anxiolytics (also hypnotics and sedatives), antidepressants and psychostimulants. Data were stratified by group of age (0-4, 5-9, 10-14 and 15-19/15-17 for Denmark and Catalonia) and sex. RESULTS: Overall, the group of anxiolytics shows the highest consumption and the group of antipsychotics the lowest. In 2017, Sweden was the country with the highest consumption of psychotropic drugs (6.67‰) and has the highest increase in consumption (152.8%), and Denmark has the lowest consumption for all groups (3.13‰). Catalonia shows a decrease in psychotropic drugs (-15.9%). Girls consume more than twice as many antidepressants as boys while the opposite is true for psychostimulants. Risperidone and quetiapine are among the most consumed antipsychotics in the Nordic countries, whereas in Catalonia they are risperidone and aripiprazole. Among antidepressants, sertraline is the most consumed. No differences are found among the psychostimulants. CONCLUSIONS: Psychotropic consumption in younger populations is increasing, although there are differences between the countries as far as which drugs are used. Nordic countries show a higher prevalence of use than Catalonia. Psychotropic drug consumption increases with age, except for psychostimulants, which have the highest utilization rate among 10-14-year-olds.

Safety of the reuse of needles for subcutaneous insulin injection: A systematic review and meta-analysis.

OBJECTIVE: Many people with diabetes often reuse disposable needles for subcutaneous insulin injection. We aimed to identify, critically appraise and summarize the available evidence about the safety of this practice. DESIGN: Systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: MEDLINE (via PubMed), CINALH (via EBSCO), SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials and Open Grey were searched from their inception to December 2015, with no language restrictions. REVIEW METHODS: Epidemiologic and experimental studies assessing adverse effects of reusing needles in people of any age or sex, with or without diabetes, were included. Two reviewers independently assessed the methodological quality of included studies using a multi-design tool. RESULTS: In total, 25 studies were included. All studies had a high risk of bias and data from only nine studies could be pooled. Five studies showed no association between infection at site of injection and reuse of needles (risk difference=-0.00; 95% confidence interval=-0.12-0.11; P=0.99); heterogeneity between these studies was substantial (I(2)=66%; P=0.02). Five cross-sectional studies showed an association between lipohypertrophy and needle reuse (risk difference=0.16, 95% confidence interval=0.05-0.28, P=0.006); there was strong evidence of heterogeneity between these studies (I(2)=87%; P<0.001). Pooled data of two studies with no evidence of heterogeneity between them showed more perceived pain among reusers (risk difference=0.24; 95% confidence interval=0.06-0.43; P=0.006). Reusing a pen needle or disposable syringe-needle was not associated with worse glycaemic control. CONCLUSIONS: There is currently no clear scientific evidence to suggest for or against the reuse of needles for subcutaneous insulin injection. This practice is very common among people with diabetes; consequently, further research is necessary to establish its safety.

Trabajos de investigación y comités de ética en atención primaria / Research works and ethics committees in primary care

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La enfermedad de Alzheimer y otras demencias en el Sistema de Información para el Desarrollo de la Investigación en Atención Primaria (SIDIAP) / Alzheimer's disease and other dementias in the InformationSystem for Primary Care Research Development (SIDIAP)

La informatización de la historia clínica en el ámbito de la Atención Primaria proporciona un gran potencial para la investigación, particularmente en estudios de prevalencia e incidencia, en estudios de evaluación de servicios de salud y en estudios de farmacoepidemiología. El Institut Català de la Salut y el IDIAP Jordi Gol crearon SIDIAP en el año 2010. Esta base de datos contiene la información clínica registrada por profesionales de atención primaria de la salud (médicos y enfermeras) y personal administrativo de los registros médicos electrónicos, incluyendo las características sociodemográficas, la morbilidad (Clasificación Inter - nacional de Enfermedades, CIE-10), variables clínicas y de estilos de vida, pruebas de laboratorio y tratamientos (prescripciones médicas, medicamentos dispensados en la farmacia), y también información de las altas hospitalarias. La base de datos contiene esta información de cerca de cinco millones de personas, lo que representa aproximadamente el 80 % de la población total mayor de 15 años de edad de Cataluña. Las bases de datos de atención primaria como SIDIAP presentan unas claras ventajas en relación con otras fuentes de información: contienen grandes muestras, permiten seguimientos de larga duración, tienen bajo coste, permiten relación con múltiples fuentes de información, no interfieren en la práctica clínica, y aportan representatividad de la práctica real. La demencia de Alzheimer (DA) es un claro ejemplo de patología para la que la información adicional que pueden proporcionar estudios realizados en la base de datos SIDIAP puede ser de gran utilidad. SIDIAP permite diseñar estudios transversales para el análisis de patrones de tratamientos o comorbilidades asociadas a las demencias; estudios de cohortes con largos períodos de seguimiento o estudios de caso y control para evaluar factores de riesgo asociados a la aparición de las distintas demencias y estudios de efectividad de los tratamientos y las intervenciones preventivas (AU)

Computerized databases of primary care clinical records are widely used for epidemiological research, particularly in studies of disease prevalence and incidence, studies of health services and in pharmacoepidemiological research. The Information System for the Development of Research in Primary Care (SIDIAP) was created in 2010 by the Catalan Institute of Health (ICS) and the Jordi Gol Primary Care Research Institute (IDIAP Jordi Gol). SIDIAP comprises clinical information recorded by primary care health professionals (GPs and nurses) and administrative staff in electronic medical records, including sociodemographic characteristics, morbidity (International Classification of Diseases, ICD-10), clinical and lifestyle variables, laboratory tests and treatments (drug prescriptions, drugs purchased at the community pharmacy) and also hospital discharge information. The database contains this information for almost five million people, representing approximately 80% of the total population aged over 15 years old in Catalonia (north-east Spain). The fact that these databases can provide large sample sizes at a comparatively low cost and that they permit long follow-up periods without directly requiring the participation of the subjects, whilst minimizing biases such as the Healthy Worker and the Hawthorne effects, has made them especially interesting for public health research. Alzheimer's dementia is a clear example of pathology in which the information provided by SIDIAP can be very useful for research purposes. SIDIAP allows cross-sectional studies for the analysis of treatment patterns or co-morbidities associated with dementia; cohort studies with long follow- up periods or case-control study to evaluate risk factors associated with the onset of various dementias and also permit studies of effectiveness of treatments and preventive interventions (AU)