Patients treated with vitamin K oral anticoagulants in family practice: a new approach to bleeding risk assessment. An ancillary study by the CACAO prospective general practice cohort.

BACKGROUND: The ability of bleeding risk scores to predict major bleeding (MB) or clinically relevant nonmajor bleeding (CRNMB) remains a topic of contention, particularly in nonselected patients in family practice. In addition, the capacity to predict bleeding risk using simple variables has yet to be established. OBJECTIVES: The main objective was to confirm that severe anemia was the most predictive factor for the estimation of bleeding risk in patients treated with vitamin K antagonists (VKAs). Secondary objectives were to test the capacity of different bleeding scores to detect high-risk patients. Subsequently, the impact of functional decline on bleeding incidence was explored. METHODS: The CACAO study was a multicenter prospective cohort study of patients who, due to nonvalvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE), had been prescribed an oral anticoagulant by their general practitioner (GP) as a prophylactic measure. Patient characteristics were collected at the time of inclusion by GPs, who then monitored them in accordance with standard practice for one year. MB and CRNMB were the main outcomes for one year. By applying this approach, a total of 13 scores were analyzed. RESULTS: Aaemia was found to be strongly associated with MB (HR: 2.77, 95% CI: 1.2-6.36), with a particularly pronounced association observed in cases of severe anemia (HR: 12.9, 95% CI: 2.76-60.35). Twelve out of 27 MB cases were not identified by at least half of the scores. By contrast, functional decline was identified as a novel factor associated with MB (HR: 2.45, 95% CI: 1.13-5.31). CONCLUSIONS: Preexisting anemia is a major prognostic factor associated with the occurrence of bleeding. It seems relevant to suggest that functional decline should be considered by GPs when assessing bleeding risk.

Oral anticoagulant safety in family practice: prognostic accuracy of Bleeding Risk Scores (from the CACAO study).

BACKGROUND: To assess bleeding risk of patients treated by oral anticoagulants, several scores have been constructed to assist physicians in the evaluation of the benefit risk. Most of these scores lack a strong enough level of evidence for use in family practice. OBJECTIVE: To assess the predictive prognostic accuracy of 13 scores designed to assess the risk of major or clinically relevant non-major (CRNM) bleeding events in a French ambulatory cohort receiving Vitamin-K antagonists (VKA) or direct oral anticoagulants (DOACs) in a family practice setting. METHODS: CACAO (Comparison of Accidents and their Circumstances with Oral Anticoagulants) was a multicentre prospective cohort of ambulatory patients prescribed oral anticoagulants. We selected patients from the cohort who had received an oral anticoagulant because of non-valvular atrial fibrillation (NVAF) and/or venous thromboembolism (VTE) to be followed during one year by their GP. The following scores were calculated: mOBRI, Shireman, Kuijer, HEMORR2HAGES, ATRIA, HAS-BLED, RIETE, VTE-BLEED, ACCP score, Rutherford, ABH-Score, GARFIEL-AF, and Outcomes Registry for Better InformedTreatment of Atrial Fibrillation (ORBIT). Prognostic accuracy was assessed by using receiver operating characteristic curves and c-statistics. RESULTS: During 1 year, 3,082 patients were followed. All of the scores demonstrated only poor to moderate ability to predict major bleeding or CRNM in NVAF patients on DOACs (c-statistic: 0.41-0.66 and 0.45-0.58), respectively. The results were only slightly better for patients prescribed VKA (0.47-0.66 and 0.5-0.55, respectively) in this indication. The results were also unsatisfactory in patients treated for VTE. CONCLUSION: None of the scores demonstrated satisfactory discriminatory ability when used in family practice. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02376777.

Use and perceived effectiveness of non-pharmacological home remedies for digestive symptoms: a questionnaire-based survey among primary care patients.

BACKGROUND: Patients frequently visit their primary care physician (PCP) for digestive symptoms. We aimed to compile a list of non-pharmacological home remedies (NPHRs) that patients frequently use and find effective so that PCPs can then propose them to their patients with various digestive symptoms. METHODS: In this questionnaire-based survey on the use and perceived effectiveness of NPHRs for digestive symptoms, 50 randomly selected Swiss or French PCPs consecutively recruited 20-25 patients between March 2020 and July 2021. These patients were given a list of 53 NPHRs previously developed by our research team. They were asked whether they used them (Y/N) and whether they considered them to be ineffective, not very effective, moderately effective, or very effective in treating abdominal pain (14 NPHRs), bloating (2), constipation (5), diarrhoea (10), digestion trouble (12), nausea/vomiting (2) and stomach pain (8). We considered NPHRs to be perceived as effective if patients reported that they were moderately or very effective. RESULTS: A total of 1,012 patients agreed to participate in the study (participation rate = 84.5%, median age = 52 years, women = 61%). The two most frequently used NPHRs were rice cooking water for diarrhoea (29% of patients) and prunes for constipation (22%). The perceived effectiveness of the NPHRs ranged from 82% (fennel infusions for abdominal pain) to 95% (bicarbonate for stomach pain). CONCLUSION: Our data could be useful to PCPs interested in proposing NPHRs to their patients suffering from digestive disorders, and more generally to all PCPs interested in learning more about patients' use of NPHRs in primary care.

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.

Anemia and bleeding in patients receiving anticoagulant therapy for venous thromboembolism: comment.

Kuperman et al. found that patients with anemia had a higher risk of major bleeding (RR 2.84; 95% CI 2.52-3.39) in RIETE database. Anemia appeared to be an independent predictive factor for major bleeding [hazard ratio (HR) 1.95; 95% CI 1.72-2.20] in this registry. Unfortunately, selection bias due to enrolled patients does not allowed us to use these major results in ambulatory care. The aim of SCORE study was to refine bleeding risk estimation in French vitamin K antagonist (VKA) treated patients and to identifying one or several parameters of prognostic significance. We conducted a prospective, multi-center cohort study of 962 consecutive outpatients from private angiologic offices, clinics and hospitals enrolled in grenoble angiologic network for thromboembolic diseases between May 2009 and December 2010, followed during 1 year by their general practitioner. Main outcome was the occurrence of major bleeding or clinically non major relevant bleeding (CNMRB). Incidence rates major bleeding and CNMRB were 2.86 (95% CI 1.95-4.2) events per 100 patient-years and 12% (95% CI 9.89-14.11) respectively. Cox multivariate analyses showed that only anemia was strongly associated with a risk of major bleeding (HR 6.1; 95% CI 2.7-13.8; p = 0.001). Logistic regression analyses performed in CNMRB showed that anemia, prior gastro-intestinal bleeding and antiplatelet drug use were strongly associated with a risk of CNMRB at 1 year, respectively OR 2.53, 95% CI (1.4-4.56); p = 0.002, OR 3.32, 95% CI (1.51-7.31); p = 0.003 and OR 1.77, 95% CI (1.1-2.83); p = 0.017. These new data were consistent between major and CRNM bleeding in VKA treated patients. The key role of anemia should be confirmed in other prospective cohort studies, with different anticoagulants use such as direct oral anticoagulant in ambulatory care settings.

Factors affecting dementia screening by general practitioners in community-dwelling elderly populations: a large cross-sectional study in 2 areas of France.

In patients aged 75 years and above, dementia is associated with increased expenditure and high morbimortality. Although the incidence of dementia is well known, it is often underrecognized in primary care. We conducted a cross-sectional study in 2 areas in the southeast of France to identify the factors affecting dementia-screening implementation by the French general practitioners (GPs). In May 2008, an anonymized survey was sent by e-mail and/or post to all GPs with a large clinic practice. Two months later, reminder letters were sent. Overall, 493 GPs answered (26.8%) to self-reported behavior. Of these, 73.2% felt that annual screening was useful, although only 24.5% implemented it each year and 17.5% implemented it every 2 to 5 years. Factors that favorably influenced screening practices were: the older age of the GPs; belief in the usefulness of annual dementia screening; increased frequency of follow-up visits by elderly patients; and the proportion of dementia in the GP's practice. The main barrier to annual screening was the social problems encountered in the medical care of 75-year-old patients. Regardless of the differences in European national health policies or health care systems, all GPs encounter the same difficulties when dealing with elderly dementia patients.

[Care of patients in nursing homes, what stumbling blocks and stepping for general practitioners? A qualitative study]. / Prise en charge des patients en Ehpad, quels freins et leviers pour le médecin généraliste ? Une étude qualitative.

Due to increased dependency and health needs, the follow-up of the patients in nursing home (NH) by general practitioners (GP) is difficult, in a context of an aging population and declining medical density. This study sought to describe facilitating or limiting factors faced by GP in Drôme, Isère and Savoy in their NH patients' follow-up and to collect suggestions for improvement. A qualitative study, with phenomenological analysis, was identified factors linked to patients (complexity, specific needs, Doctor-patient relationship affected, ethical considerations), to physicians (to conjugate his office activity with visits and emergencies) and to NH (cooperation with information sharing amongst professional microcosm, their representations by GP). The Covid pandemic revived questions about the meaning of care but revealed adaptive work reveals the challenges GP face at NH, as well as prospects for improvment.

Care pathways for patients with cancer-associated thrombosis: From diagnosis to long-term follow-up.

Venous thromboembolism (VTE) in patients with cancer is associated with a high risk of bleeding complications and hospitalisation, as well as with increased mortality. Good practice recommendations for diagnosis and treatment of VTE in patients with cancer have been developed by a number of professional bodies. Although these guidelines provide consistent recommendations on what treatment should be offered to patients presenting with cancer-associated thromboembolism (CAT), many questions remain unanswered, in particular about the modalities of management (Who? When? Where?) and, for this reason, we have developed a consensus proposal for an appropriate multidisciplinary care pathway for patients with CAT, which is presented in this article. The proposal was informed by the recent scientific literature retrieved through a systematic literature review. This proposal is centred on the development of a shared care plan individualised to each patient's needs and expectations, patient information and shared decision-making to promote adherence, involvement of all relevant hospital- and community- based healthcare providers in the development and implementation of the care plan, and regular re-evaluation of the treatment strategy.

Home treatment for patients with cancer-associated venous thromboembolism.

Patients hospitalised with acute venous thromboembolism (VTE), and notably patients with pulmonary embolism, often remain in hospital for extended periods due to the perceived risk of complications. However, several studies have shown that home treatment of selected patients is feasible and safe, with a low incidence of adverse events. This may offer clear benefits for patients' quality of life, hospital planning and cost to the health service. Nonetheless, there is a need for a VTE risk-stratification tool specifically addressing prognosis in patients with cancer. This may aid in the selection of low-risk patients with cancer and VTE who are suitable for outpatient treatment. Although several prognostic scores have been proposed, we suggest using a pragmatic clinical decision-making tool such as the Hestia criteria for selecting patients for home care in everyday clinical practice. Once patients have been discharged, it is mandatory to monitor patients regularly (we suggest after 3 days, 10 days, 1 month and 3 months, or more frequently if needed) with the involvement of a multidisciplinary team, so that appropriate and timely remedial action can be taken in case of warning signs of complications. If patients are selected carefully and monitored effectively, many patients who experience acute VTE can be cared for safely at home.

[Translation into French and republication of: "Home treatment for patients with cancer-associated venous thromboembolism"]. / Traduction et republication de : « Traitement à domicile des patients atteints de maladie veineuse thromboembolique associée au cancer ¼.

Patients hospitalised with acute venous thromboembolism (VTE), and notably patients with pulmonary embolism, often remain in hospital for extended periods due to the perceived risk of complications. However, several studies have shown that home treatment of selected patients is feasible and safe, with a low incidence of adverse events. This may offer clear benefits for patients' quality of life, hospital planning and cost to the health service. Nonetheless, there is a need for a VTE risk-stratification tool specifically addressing prognosis in patients with cancer. This may aid in the selection of low-risk patients with cancer and VTE who are suitable for outpatient treatment. Although several prognostic scores have been proposed, we suggest using a pragmatic clinical decision-making tool such as the Hestia criteria for selecting patients for home care in everyday clinical practice. Once patients have been discharged, it is mandatory to monitor patients regularly (we suggest after 3 days, 10 days, 1 month and 3 months, or more frequently if needed) with the involvement of a multidisciplinary team, so that appropriate and timely remedial action can be taken in case of warning signs of complications. If patients are selected carefully and monitored effectively, many patients who experience acute VTE can be cared for safely at home.

Molecular Hydrogen for Outpatients with COVID-19 (Hydro-COVID): A Phase 3 Randomised, Triple-Blinded, Pragmatic, Placebo-Controlled, Multicentre Trial.

Background. Due to its antioxidant, anti-inflammatory, anti-apoptosis, and anti-fatigue properties, molecular hydrogen (H2) is potentially a novel therapeutic nutrient for patients with coronavirus acute disease 2019 (COVID-19). We determined the efficacy and safety profile of hydrogen-rich water (HRW) to reduce the risk of COVID-19 progression. Methods: We also conducted a phase 3, triple-blind, randomised, placebo-controlled trial to evaluate treatment with HRW initiated within 5 days after the onset of signs or symptoms in primary care patients with mild-to-moderate, laboratory-confirmed COVID-19. Participants were randomised to receive HRW or placebo twice daily for 21 days. The incidence of clinical worsening and adverse events were the primary endpoints. Results: A total of 675 participants were followed up to day 30. HRW was not superior to placebo in preventing clinical worsening at day 14: in H2 group, 46.1% in the H2 group, 43.5% in the placebo group, hazard ratio 1.09, 90% confidence interval [0.90-1.31]. One death was reported at day 30 in the H2 group and two in the placebo group at day 30. Adverse events were reported in 91 (27%) and 89 (26.2%) participants, respectively. Conclusions: HRW taken twice daily from the onset of COVID-19 symptoms for 21 days did not reduce clinical worsening.

Experience, impact and needs of informal parental caregivers around the communication of a diagnosis of schizophrenia.

AIMS: To qualitatively characterize the experience, impact and needs of informal family caregivers around the communication of a diagnosis of schizophrenia. METHODS: In all, 13 informal family caregivers were recruited. All were parents. Semi-structured interviews were used to explore their experience of the diagnosis of schizophrenia, the impacts of the diagnosis and the needs related to the diagnosis around its communication. Interviews were recorded, transcribed, codes generated and mixed deductive-inductive thematic analysis undertaken. RESULTS: Participants described receiving the diagnosis of schizophrenia for their relative as a devastating experience, although some nuanced the experience with a sense of relief of finally naming the disorder and getting access to care. Caregivers' experience and representations prior to hearing the diagnosis played an important role in the way the 'news' was internalized. The communication of the diagnosis constituted a starting point for acceptance of the reality of the illness in participants. Numerous unmet needs around the communication of the diagnosis were reported by participants, including personnalized support, specific explanations about the disorder and guidance on their role as caregiver. CONCLUSION: A specific attention must be given to the communication of the diagnosis of schizophrenia to the informal family caregivers. Information giving must be early, comprehensive, personalized and embedded into tailored education and support programmes for caregivers to facilitate illness acceptance and adaptation.

General practitioners' perspectives on the use of nonpharmacological home remedies in two regions in Switzerland and France.

BACKGROUND: Nonpharmacological home remedies offer the potential for easily accessible and well-accepted management of common disorders in general practice. We aimed to assess general practitioners' (GPs') perspectives on these remedies in two French-speaking European countries. METHODS: In 2017, we conducted a cross-sectional study among community-based GPs in the Geneva (Switzerland) and Grenoble (France) regions. They completed an anonymous questionnaire about forty common home remedies. We asked how often they prescribed each type of remedy and how effective they found them. Descriptive statistics (proportions with 95% confidence intervals [CIs]) were used to summarise the data. RESULTS: 349 GPs returned the questionnaire (172 of 500 Swiss and 177 of 500 French; participation rate 35%; male:female ratio 1:1). In the week before the study, GPs had advised 8.2% patients to use at least one remedy. The remedies that were most frequently prescribed were saline water to treat common colds (69%), mobilising and/or stretching exercises for low back pain (67%) and applying cold water or cold pads for burns (60%). The remedies that were perceived to be most effective were squatting during defaecation as a treatment for constipation (89%), phoning a traditional healer to treat skin diseases or burns (84%) and applying cold water or pads for burns (82%). CONCLUSIONS: These findings suggest that GPs find certain nonpharmacological remedies very useful, even though they do not frequently prescribe them in practice. These remedies should receive more attention from researchers, as they could be considered by GPs as useful to treat a large number of benign conditions in primary care.

Anaemia as an independent key risk factor for major haemorrhage in patients treated with vitamin K antagonists: Results of the SCORE prospective cohort.

INTRODUCTION: Risk scores for the prediction of haemorrhage are poorly predictive of major bleeding. The aim of this study was to refine the estimation of bleeding risk by identifying one or several parameters of prognostic significance among these algorithms. MATERIALS AND METHODS: The SCORE study was a prospective, multicentre cohort study conducted in France in 2009-2010. Patients were eligible if they had received vitamin K antagonist (VKA) for any therapeutic indication for at least 3months. The primary outcome was the occurrence of major bleeding at 1-year follow-up. RESULTS: In total, 962 patients were included in this study and evaluated at 1year. The incidence of major bleeding at 1-year follow-up (Kaplan-Meier method) was 2.9% [95% confidence interval (CI) 1.9-4.2]. The rate of major bleeding was 8.2% (95 CI 3.4-16.2) per year in patients classified as high risk by at least four scores. In a multivariate Cox analysis, of the risk factors for the different scores, only anaemia <100g/l at inclusion was strongly associated with risk of major bleeding (hazard ratio 6.1, 95% CI 2.7-13.8, P<0.0001). Through an induction tree analysis performed to identify a common parameter in the majority of scores, anaemia was found to be the main predictor of correct classification as high risk by at least four scores (55% of patients classified as high risk by at least four scores vs 3.3% in the absence of anaemia). CONCLUSION: Anaemia with haemoglobin <100g/l is the most important predictor of high risk of bleeding in patients treated with VKA.

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.

Barriers to and promoters of screening for falls in elderly community-dwelling patients by general practitioners: a large cross-sectional survey in two areas of France.

The objective was to determine the factors affecting French GPs' implementation of annual screening for falls among patients of 75 years old and over. We conduct a cross-sectional study in two areas in the South-east of France (Savoie and Isère). An anonymized survey was sent by e-mail and/or post in May 2008 to all GPs with a large practice. Reminder letters were sent to GPs who hadn't answered between June and July 2008. Potentials barriers were measured by dichotomous scale. On GPs characteristics (socio-demographic, knowledge, attitude and practice), a multiple logistic regression was performed to identify others factors affecting falls screening. 493 questionnaires were analyzed (26.8%). 65.3% of respondents considered annual screening for falls to be useful, though only 28.8% of them implemented it each year and 9.3% every two to five years. Barriers to achieving annual screening included patient selecting (56.3%), forgetting to screen (26.6%), unsuitable working conditions (18.5%), lack of time (13.3%), of knowledge (13.3%), or of financial compensation (11.1%). Perception of the usefulness of annual screening for falls (OR=5.38 (2.07-14.08); p=0.001), satisfaction with medical care for falls (OR=1.34 (1.09-1.65); p=0.006) and increased consultation time (OR=2.65 (1.37-5.13); p=0.004), were found to have a significant impact on the implementation of annual screening for falls. Asking your patient each year if s/he has had any falls, inquiring about gait and balance disturbance is not time consuming. Finally, to improve a health-related quality of life, GPs should consider fall assessment as a fundamental feature of medical care.

[Comparison of the HAS-BLED and ATRIA scores for the risk of bleeding in patients aged 75 and over receiving vitamin K antagonist (VKA) therapy and educated VKA-management]. / Comparaison de l'efficacité des scores HAS-BLED et ATRIA dans la prédiction du risque hémorragique des patients de plus de 75 ans traités par anti-vitamine K (AVK) après démarche d'éducation thérapeutique.

Bleeding is the main complication on vitamin K antagonist treatment (VKA), particularly in elderly patients. However, the bleeding risk prediction in geriatric patients remains difficult. We evaluated the predictive value of the HAS-BLED and ATRIA bleeding scores in VKA-treated patients aged 75 and over. Various clinical bleeding risk factors in elderly were also studied. 208 patients were included in a case-control study: 52 hemorrhages cases were compared to 156 hemorrhage-free cases (controls), mean age 83.1 years in cases and 82.6 in controls. This elderly subgroup was provided from the prospective SCORE cohort study (study designed to validate the use of bleeding scores in an ambulatory population). The patients were included during a VKA-therapeutic education between May 2009 and May 2010 in 4 French hospitals, and followed for 1 year. The primary endpoint, collected prospectively, was the occurrence of severe and clinically relevant bleeding events. According to the Receiver operating characteristics (ROC), the ATRIA score was as effective as HAS- BLED to predict all bleeding (c-statistic: 0.59 [95% CI 0.50-0.68] vs 0.56 [0.48-0.65]) including severe bleeding (c-statistic: 0.64 [95% CI 0.49-0.79] vs 0.62 [0.49-0.75]). Multivariate Cox regression analysis showed increasing bleeding risk with anemia (OR = 2.6 [95% CI 1.34-5.23], p = 0.005), serotonin reuptake inhibitors (2.8 [1.08-7.47], 0.034), and family-management of VKA-treatment (2.8 [1.28-6.15], 0.01). ATRIA hemorrhage predictive value can be improved by adding such parameters as family-management of VKA-treatment and serotonin reuptake inhibitors treatment. ATRIA appears as relevant as HAS-BLED in predicting all bleeding including major hemorrhages in elderly patients educated VKA-management. The ATRIA bleeding score is improved by including items of serotonin reuptake inhibitors treatment and family-management of VKA-treatment.

CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption--study protocol for a randomized controlled trial.

BACKGROUND: Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age. METHODS: A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhône - Alpes), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30% of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk α = 5%; power = 90%; intra-cluster correlation coefficient ρ = 0.2; Hawthorne effect = 15%; lost to follow-up rates for GPs = 10% and for patients = 20%). This plan is replicated for the three areas, and therefore a total of 750 patients are expected.The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption. DISCUSSION: Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training. TRIAL REGISTRATION: CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental Fund, Health Ministry). Date first patient randomized: March 2012.