Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.

Ten-Year Follow-Up of Clinical Governance Implementation in Primary Care: Improving Screening, Diagnosis and Control of Cardiovascular Risk Factors.

Current improvement strategies for the control of cardiovascular risk factors (CRFs) in Europe are based on quality management policies. With the aim of understanding the effect of interventions delivered by primary healthcare systems, we evaluated the impact of clinical governance on cardiovascular health after ten years of implementation in Catalonia. A cohort study that included 1878 patients was conducted in 19 primary care centres (PCCs). Audits that comprised 13 cardiovascular health indicators were performed and general practitioners received periodic (annual, biannual or monthly) feedback about their clinical practice. We evaluated improvement in screening, diagnosis and control of the main CRFs and the effects of the feedback on cardiovascular risk (CR), incidence of cardiovascular disease (CVD) and mortality, comparing baseline data with data at the end of the study (after a 10-year follow-up). The impact of the intervention was assessed globally and with respect to feedback frequency. General improvement was observed in screening, percentage of diagnoses and control of CRFs. At the end of the study, few clinically significant differences in CRFs were observed between groups. However, the reduction in CR was greater in the group receiving high frequency feedback, specifically in relation to smoking and control of diabetes and cholesterol (Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)). A protective effect of having a cardiovascular event (hazard ratio (HR) = 0.64, 95% confidence interval (CI) = 0.44-0.94) or death (HR = 0.55, 95% CI = 0.35-0.88) was observed in patients from centres where general practitioners received high frequency feedback. Additionally, these PCCs presented improved cardiovascular health indicators and lower incidence and mortality by CVD, illustrating the impact of this intervention.

Adherence to European Clinical Practice Guidelines for Secondary Prevention of Cardiovascular Disease: A Cohort Study.

To provide a better understanding of the actions taken within health systems and their results, this study aims to assess clinicians’ adherence to clinical practice guidelines regarding recommended treatments in patients with cardiovascular disease in primary care settings, and to determine the associated factors. We conducted an ambispective cohort study in 21 primary care centres in 8 Spanish regions. Patients diagnosed with coronary heart disease, stroke and/or peripheral arterial disease were included. Patients who received the treatment recommended in the European guidelines on cardiovascular disease prevention (CPG’s adherent group) were compared with patients who did not (CPG’s non-adherent group). The outcome variables were cardiovascular hospital admissions, all-cause and cardiovascular mortality during follow-up. Of the 438 participants, 38.6% (n = 169) received the drug therapies recommended in the guidelines. The factors that increased the likelihood of good adherence to CPG’s were being diagnosed with hypertension (p = 0.001), dyslipidaemia (p < 0.001) or diabetes (p = 0.001), and not having a psychiatric disorder (p = 0.005). We found no statistically significant association between good adherence to CPG’s and lower incidence of events (p = 0.853). Clinician adherence to guidelines for secondary prevention of cardiovascular disease was low in the primary care setting.

A new clinical decision support tool for improving the adequacy of anticoagulant therapy and reducing the incidence of stroke in nonvalvular atrial fibrillation: A randomized clinical trial in primary care.

INTRODUCTION: Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4 to 5-fold. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants. There is a trend toward inadequate AT in nonvalvular AF (NVAF) patients. AIM: To evaluate the impact of the implementation of a decision support tool linked to the digital clinical history on the adequacy of AT, the incidence of complications, and the mortality in patients with NVAF in primary care centers (PCCs) of the Catalan Institute of Health (ICS). METHODS AND ANALYSIS: Randomized clinical trial in 287 PCCs, formed by 2 groups (intervention and control). POPULATION: patients controlled in PCCs, diagnosed with NVAF 1 year before the implementation of the decision support tool and with VKA treatment over a minimum of 1 year. A simple randomization method will be performed at a sector level. The decision support tool will be available for 1 year. The time in therapeutic range (TTR) will be available in the digital clinical history only to professionals of the intervention group. The information system for primary care research development database will be used for the data extraction. Statistical analysis will be done at 3 time points: before the implementation of the tool, at 1 year, and at 2 years after the beginning of the intervention. Multilevel (patient and professional levels) logistic regression models will be used to estimate the effect of the intervention. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethical Committee of Clinical Investigation of the Institut Universitari d'Investigació en Atenció Primària Jordi Gol (code P17/091). Articles will be published in scientific journals. TRIAL REGISTRATION: Clinical-Trials.gov: NCT03367325.

Diferencias entre MDRD-4 y CG en la prevalencia de la insuficiencia renal y sus variables asociadas en pacientes diabéticos tipo2 / Differences between MDRD-4 and CG in the prevalence of renal failure and its associated variables in type2 diabetic patients

OBJETIVO: Estimar la prevalencia de insuficiencia renal (IR) oculta en DM2, comparando 2 fórmulas de estimación de filtrado glomerular (EFG): Modification of Diet in Renal Disease 4 (MDRD-4) y Crockcoft-Gault (CG) y las variables clínicas asociadas. Diseño Analítico transversal multicéntrico. Emplazamiento. Dos áreas básicas de atención primaria a Terres de l'Ebre. PARTICIPANTES: Un total de 493 DM2 con médico asignado en las áreas incluidas y edad >18 años. Pérdidas de 9 y 11 casos en cada fórmula debido a falta de variables necesarias para EFG. MEDICIONES PRINCIPALES: Estimación del filtrado glomerular mediante las 2 fórmulas, valores de creatinina plasmática, clasificación de pacientes con IR establecida, IR oculta y sin IR, posibles variables clinicopatológicas asociadas a la IR. RESULTADOS: Un 45,2% fueron hombres, con una media de edad 70,4 años y un tiempo de evolución de diabetes de 7,5 años. La prevalencia de IR oculta con MDRD-4 fue del 18%, y del 22,6% con CG. Los casos detectados por CG y no por MDRD-4 fueron mayores y con peso menor. En ambas fórmulas, los pacientes con IR oculta presentaron más patologías crónicas, hipertensión y eventos cardiovasculares (CV) que los sin IR. Los factores de riesgo asociados a IR oculta fueron el ser mujer y el incremento de la edad y del colesterol LDL. CONCLUSIONES: La prevalencia de IR oculta fue del 20% en DM2 e, independientemente de la fórmula, se observó un peor control de factores CV, lo que les hace ser un grupo de mayor riesgo de sufrir un evento

OBJECTIVE: To estimate the prevalence of occult renal failure (RF) in DM2, by comparing two formulas for estimating glomerular filtration rate (GFR): Modification of Diet in Renal Disease 4 (MDRD-4) and Cockcroft-Gault (CG), as well as their associated clinical variables. DESIGN: Multicentre analytical cross-sectional. LOCATION: Two basic Primary Care areas in Terres de l'Ebre, in North-Eastern Spain. Participants. A total of 493 DM2 patients with age >18 years with an assigned doctor in the areas studied. There was a loss of 9 and 11 cases in each formula due to lack of variables necessary for the GFR. Main measurements. Estimated GFR using the two formulas, plasma creatinine values, classification of patients with established RF, occult RF and without RF, and possible clinical-pathological variables associated with RF. RESULTS: Of the total, 45.2% were men, the mean age was 70.4 years, and mean time since onset of diabetes of 7.5 years. The prevalence of occult RF with MDRD-4 was 18%, and 22.6% with CG. The cases detected by GC and not by MDRD-4 were higher, and with lower weight. In both formulas, occult RF patients had more chronic diseases, hypertension, and cardiovascular events (CV) than those without RF. Risk factors associated with occult RF were female, increasing age, and LDL cholesterol. CONCLUSIONS: The prevalence of occult RF was 20% in DM2, independently of the formula. A poorer control of cardiovascular risk factors was observed, which makes them a group at higher risk of suffering a CV event

[Differences between MDRD-4 and CG in the prevalence of renal failure and its associated variables in type2 diabetic patients]. / Diferencias entre MDRD-4 y CG en la prevalencia de la insuficiencia renal y sus variables asociadas en pacientes diabéticos tipo2.

OBJECTIVE: To estimate the prevalence of occult renal failure (RF) in DM2, by comparing two formulas for estimating glomerular filtration rate (GFR): Modification of Diet in Renal Disease 4 (MDRD-4) and Cockcroft-Gault (CG), as well as their associated clinical variables. DESIGN: Multicentre analytical cross-sectional. LOCATION: Two basic Primary Care areas in Terres de l'Ebre, in North-Eastern Spain. PARTICIPANTS: A total of 493 DM2 patients with age >18years with an assigned doctor in the areas studied. There was a loss of 9 and 11 cases in each formula due to lack of variables necessary for the GFR. MAIN MEASUREMENTS: Estimated GFR using the two formulas, plasma creatinine values, classification of patients with established RF, occult RF and without RF, and possible clinical-pathological variables associated with RF. RESULTS: Of the total, 45.2% were men, the mean age was 70.4 years, and mean time since onset of diabetes of 7.5 years. The prevalence of occult RF with MDRD-4 was 18%, and 22.6% with CG. The cases detected by GC and not by MDRD-4 were higher, and with lower weight. In both formulas, occult RF patients had more chronic diseases, hypertension, and cardiovascular events (CV) than those without RF. Risk factors associated with occult RF were female, increasing age, and LDL cholesterol. CONCLUSIONS: The prevalence of occult RF was 20% in DM2, independently of the formula. A poorer control of cardiovascular risk factors was observed, which makes them a group at higher risk of suffering a CV event.

Clinical inertia in the treatment of hyperglycemia in type 2 diabetes patients in primary care.

OBJECTIVE: To assess clinical inertia, defined as failure to intensify antidiabetic treatment of patients who have not achieved the HbA1c therapeutic goal (≤7%). RESEARCH DESIGN AND METHODS: Multicenter cross-sectional study. Clinical inertia was assessed in a random sample of type 2 diabetes mellitus (T2DM) patients seen in primary care centers. RESULTS: A total of 2783 patients (51.3% males; mean age: 68 [±11.5] years; diabetes duration: 7.1 [±5.6] years; mean HbA1c: 6.8 [±1.5]) were analyzed. Of those, 997 (35.8%) had HbA1c >7%. Treatment was intensified in 66.8% and consisted of: dose increase (40.5%); addition of oral antidiabetic (45.8%); or insulin treatment initiation (3.7%). Mean HbA1c values in patients for whom treatment was intensified vs. non-intensified were 8.4% (±1.2) vs. 8.2% (±1.2), p < 0.05. Clinical inertia was detected in 33.2% of patients and diminished along with treatment complexity: lifestyle changes only (38.8%), oral monotherapy (40.3%), combined oral antidiabetics (34.5%), insulin monotherapy (26.1%) and combination of insulin and oral antidiabetics (21.4%). Clinical inertia decreased as HbA1c increased: 37.3% for HbA1c values ranging between 7.1%-8%; 29.4% for the 8.1%-9% HbA1c range and 27.1% for HbA1c ≥9%. Multivariate analysis confirmed that diabetes duration, step of treatment and HbA1c were related to inertia. For each unit of HbA1c increase clinical inertia decreased 47% (OR: 0.53). LIMITATIONS: The retrospective design of the study precluded an accurate investigation about reasons for lack of intensification that could actually be justified by some patient conditions, especially patients' lack of adherence. CONCLUSIONS: Clinical inertia affected one third of T2DM patients with poor glycemic control and was greater in patients treated with only lifestyle changes or oral monotherapy. Treatment changes were performed when mean HbA1c values were 1.4 points above therapeutic goals.