Anticoagulants' Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study.

PURPOSE: Most real-world studies on anticoagulants have been based on health insurance databases or performed in secondary care. The aim of this study was to compare safety and effectiveness between patients treated with vitamin K antagonists (VKAs) and patients treated with direct oral anticoagulants (DOACs) in a general practice setting. METHODS: The CACAO study (Comparison of Accidents and their Circumstances with Oral Anticoagulants) is a multicenter prospective cohort study conducted among ambulatory patients taking an oral anticoagulant. Participants were patients from the study's cross-sectional phase receiving oral anticoagulants because of nonvalvular atrial fibrillation, for secondary prevention of venous thromboembolism, or both. They were followed as usual for 1 year by their general practitioners, who collected data on changes in therapy, thromboembolic events, bleeding, and deaths. All events were adjudicated by an independent committee. We used a propensity score and a Cox regression model to derive hazard ratios. RESULTS: Between April and December 2014, a total of 3,082 patients were included. At 1 year, 42 patients (1.7%) had experienced an arterial or venous event; 151 (6.1%) had experienced bleeding, including 47 (1.9%) who experienced major bleeding; and 105 (4.1%) had died. There was no significant difference between the VKA and DOAC groups regarding arterial or venous events, or major bleeding. The VKA group had a lower risk of overall bleeding (hazard ratio = 0.65; 95% CI, 0.43-0.98) but twice the risk of death (hazard ratio = 1.98; 95% CI, 1.15-3.42). CONCLUSIONS: VKAs and DOACs had fairly similar safety and effectiveness in general practice. The substantially higher incidence of deaths with VKAs is consistent with known data from health insurance databases and calls for further research to understand its cause.

Areas of improvement in anticoagulant safety. Data from the CACAO study, a cohort in general practice.

BACKGROUND: Real-world studies on anticoagulants are mostly performed on health insurance databases, limited to reported events, and sometimes far from every-day issues in family practice. We assess the presence of data for safe monitoring of oral anticoagulants in general practice, and compare patients' knowledge of taking an anticoagulant between vitamin K antagonists (VKA) and direct anticoagulants (DOAC), and the general practitioner's perception of their adherence to anticoagulation. METHODS: The CACAO study is a national cohort study, conducted by general practitioners on ambulatory patients under oral anticoagulant. In the first phase, investigators provided safety data available from medical records at inclusion. They also evaluated patients' knowledge about anticoagulation and graded their perception of patients' adherence. RESULTS: Between April and December 2014, 463 general practitioners included 7154 patients. Renal and hepatic function tests were respectively unavailable in 109 (7.5%) and 359 (24.7%) DOAC patients. Among patients with atrial fibrillation, 345 patients (6.9%) had a questionable indication of anticoagulant (CHA2DS2-Vasc<2). One hundred and thirty-three VKA patients (2.3%) and 70 DOAC patients (4.9%) answered they took no anticoagulant (p<0.0001). According to general practitioners' perception, 430 patients (6.1%) were classified as "not very" or "not adherent", with no difference between groups. CONCLUSIONS: Our results highlight the efforts needed to improve anticoagulant safety in daily practice: decreasing the rate of unknown biological data in patients with DOACs or the rate of patients with VKA with no strong indication of anticoagulation, and improving patient knowledge with regard to their anticoagulant. Patients' adherence seems highly over-estimated by the general practitioners. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02376777.

Beliefs and attitudes of French family practitioners toward depression: the impact of training in mental health.

OBJECTIVE: To study, in a sample of French Family Practitioners (FPs), beliefs and attitudes toward depression and how they vary according to training received in mental health. METHODS: The Depression Attitude Questionnaire (DAQ) was completed by 468 FPs from all regions of France, recruited by pharmaceutical company representatives to attend focus groups on the management of depression in general practice. RESULTS: A three-factor model was derived from the DAQ, accounting for 37.7% of the total variance. The correlations between individual items of each component varied from 0.4 to 0.65, with an overall internal consistency of 0.47 (Cronbach's alpha). FPs had an overall neutral position on component 1, professional ease, a positive view on the origins of depression and its amenability to change (component 2), and a belief in the necessity of medication and the benefit of antidepressant therapy (component 3). Training in mental health, specifically through continuing medical education and postgraduate psychiatric hospital training, was significantly and positively associated with both professional ease and a medication approach to treating depression. CONCLUSION: This study is the first description of the beliefs and attitudes of French FPs toward depression using a standardized measure, the DAQ, despite the instrument's limited psychometric properties. It shows the positive effect of training in mental health on attitudes toward depression.

Center effect on ankle-brachial index measurement when using the reference method (Doppler and manometer): results from a large cohort study.

BACKGROUND: The ankle-brachial index (ABI) is a simple and noninvasive tool used to detect peripheral arterial disease (PAD). We aimed to assess, in a French multicenter cohort, the center effect associated with arterial pressure (AP) and ABI measurements using the reference method and using a semiautomatic device. METHODS: This study included baseline and 9-year follow-up data from 3,664 volunteers of 10 health examination centers of the DESIR (Data from an Epidemiological Study on the Insulin Resistance) syndrome French cohort. Ankle and brachial AP were measured at inclusion by the reference method (a mercury sphygmomanometer coupled with a Doppler probe for ankle measurements) and at 9 years by a semiautomatic device (Omron HEM-705CP). The center effect was assessed by the intraclass correlation coefficient (ICC), ratio of the between-center variance to the total variance of the measurement. RESULTS: At inclusion, the sample mean age was 47.5 (s.d. 9.9) years; 49.3% were men. Although ICCs were smaller than 0.05 for brachial AP measurements, they were close to 0.18 and 0.20 for ankle systolic AP (SAP) and ABI measurements, respectively, when the reference method was used. No center effect for measures other than ankle SAP was detected. With the semiautomatic device method, all ICCs, including those for ankle SAP and ABI measurements, were between 0.005 and 0.04. CONCLUSIONS: We found an important center effect on ABI measured with a sphygmomanometer and a Doppler probe but not a semiautomatic device. A center effect should be taken into account when planning any multicenter study on ABI measurement.

[Improving care for depressed patients: what is added by GP's meetings?]. / Amélioration de la prise en charge des patients déprimés. L'apport de tables rondes de médecins généralistes.

PURPOSE: To show what French GP's have to say about their management of depressed patients, and how to improve it. METHODS: GP's forum discussions, as peer groups, controlled by an independent moderator and recorded by another, both Gp's. Reports have been synthesised through a list of items, until saturation. RESULTS: 83 reports have been analysed. The most important difficulties were about diagnosis of depression (patient's denial, multiplicity of complaints, polypathology), about treatment (bad acceptability of antidepressants, difficulties to access to a psychotherapy) and about care organisation (exchange between GP's and psychiatrists are difficult and unusual). DISCUSSION: Questions about quality of GP's care to depressed patients come from populations which differ from GP's patients. CONCLUSION: The specificity of primary care exercise should be taken into account to elaborate recommendations and to evaluate quality of care.

[Drug treatment of cardiovascular risk factors over six years of following the French DESIR cohort]. / Traitement des facteurs de risque cardiovasculaire dans la cohorte DESIR.

OBJECTIVE: To describe the treatment of cardiovascular risk factors within the context of a cohort study of adults, according to the risk estimated by the Framingham equation. METHOD: This prospective study, DESIR, followed 1526 men and 1652 women for six years. At the time of the study's initiation, all participants were aged 35 to 65, and none were being treated for hypertension or dyslipemia. Treatments for hypertension and dyslipemia initiated during the study were analyzed according to categories of cardiovascular risk based on the Framingham scale. RESULTS: At baseline, 24% of men and 5% of women had an estimated 10 years cardiovascular risk (for CHD) higher or equal to 10%. Three years later, only 19% of these men and 36% of these women had been treated, while 6% of men and 9% of women at risk < 10% had also been treated well. At six years, one third of men at high risk at baseline and/or at three years were treated, against half of the women. CONCLUSION: Despite a significant effort to communicate the importance of addressing and treating the individual risk factors, the currently prescribed treatments remain inadequate, especially given the necessity to treat them based on the assessment of the overall cardiovascular risk.

[Guidelines and practices for type 2 diabetes. Patients' and doctors' preconceptions prevent effective patient education]. / Ecarts entre le référentiel et la pratique dans le diabète de type 2. Les préjugés des médecins et des patients sont un obstacle à une éducation efficace des patients.

BACKGROUND: Health insurance data show that general practitioners (GPs) do not strictly apply clinical practice guidelines for the management of patients with type 2 diabetes. METHOD: The Health insurance fund of the Centre region assessed doctors' practices in diabetes management and found sharp disparities. Our study sought to explain these differences by questioning (through interviews and questionnaires) a cross-section of GPs and patients with diabetes. RESULTS: Interviews and questionnaires show that doctors are well aware of the recommendations for follow-up and generally agree with them. Their systematic application, however, runs up against the concrete conditions of daily practice, especially in terms of diabetes education. CONCLUSION: GPs see the management of patients with diabetes as a combination of their own skills (decisions and advice) and of responsible patient behavior. Our results, however, suggest that GPs fail to counsel their patients properly because they cannot communicate to their patients the importance of diet and physical activity. Optimum management requires that doctors develop a cooperative relation with other health professionals and improve the patient-doctor relation to promote patients' understanding of the principles of their treatment and help them to accept responsibility for managing their disease.

ABCA1 single nucleotide polymorphisms on high-density lipoprotein-cholesterol and overweight: the D.E.S.I.R. study.

The adenosine triphosphate-binding cassette A1 (ABCA1) gene plays a key role in reverse cholesterol transport. Some ABCA1 gene polymorphisms have been associated with high-density lipoprotein-cholesterol (HDL-C) concentrations. The aim of this study was to assess the effect of three polymorphisms, C69T, G378C, and G1051A (R219K), on HDL-C levels and their interaction with BMI in more than 5000 French whites from the D.E.S.I.R. (Data from an Epidemiological Study on the Insulin Resistance syndrome) cohort study. The T allele of the C69T single nucleotide polymorphism (SNP) was associated with higher HDL-C levels in normal-weight men (BMI <25 kg/m(2)). The C allele of the G378C SNP was associated with lower HDL-C in overweight subjects (BMI > or =25 kg/m(2)). For the G1051A SNP, in the normal-weight group, the minor A allele was significantly associated with higher HDL-C levels. In contrast, in overweight people, the minor allele was associated with lower HDL-C levels. After accounting for multiple testing, empiric p values remained significant for the associations between G378C SNP and HDL-C in the overweight group and between G1051A SNP and HDL-C in the normal-weight group. This study suggests that ABCA1 gene polymorphisms modulate HDL-C concentrations, in interaction with BMI, and, thus, they might influence cardiovascular risk in the general population.

Avoidance of anticipated regret: the ordering of prostate-specific antigen tests.

OBJECTIVE: When making decisions, people are known to try to minimize the regret that would be provoked by unwanted consequences of these decisions. The authors explored the strength and determinants of such anticipated regret in a study of physicians' decisions to order prostate-specific antigen (PSA) tests. METHODS: 32 US and 33 French primary care physicians indicated the likelihood they would order a PSA for 32 hypothetical men presenting for routine physical exams. They then indicated how much regret they would feel if they found advanced prostate cancer in 12 other patients for whom they had chosen not to order PSAs several years before. The latter patients differed according to age (55, 65, or 75 years), a prior request or not for PSA testing, and no or some irregularity of the prostate on the earlier rectal exam. RESULTS: ANOVA found that regret was higher when the patient had requested a PSA, the prostate was irregular, and the patient was younger. Shape had less effect when the patient had requested a PSA. US physicians had more regret than the French, patient request had a greater impact on the Americans, and increasing patient age reduced regret more among the French. In a 1-way correlation, the regret score was associated with the likelihood of ordering PSAs for both the French (r = 0.64, P < 0.005) and the Americans (r = 0.42, P< 0.02). In a regression analysis too, the regret score was the most important predictor of the likelihood of ordering a PSA (beta = 0.37, P < 0.0001). CONCLUSIONS: Regret over failing to diagnose aggressive prostate cancer is associated with a policy of ordering PSAs. This regret appears to be culturally sensitive.

Why do primary care physicians in the United States and France order prostate-specific antigen tests for asymptomatic patients?

PURPOSE: To understand why many primary care physicians in the United States and France order prostate-specific antigen (PSA) tests routinely for their asymptomatic male patients despite "evidence-based" recommendations. METHODS: Thirty-two U.S. general internists and family practitioners and 33 French generalists judged, for 32 hypothetical male patients seen for routine preventive care, the probability that the patients had asymptomatic prostate cancer and the likelihood that they would order PSA tests. They were also asked about beliefs, attitudes, and knowledge related to prostate cancer. RESULTS: The significant predictors of ordering more PSA tests in the scenarios were physicians' higher ratings of regret if untested patients were found to have advanced cancer, their greater discomfort if they suspected that patients had illnesses but could not know for sure, and their perceptions of official recommendations as favoring routine testing. IMPLICATIONS: Nonrational factors can impede physicians' adoption of "evidence-based" recommendations.