[Influence of water immersion on the use of epidural anesthesia during labor]. / Influence de l'immersion dans l'eau sur le recours à la péridurale pendant le travail.

OBJECTIVE: Immersion in water during labor could reduce pain and use of epidural anesthesia during childbirth. The main objective of this study was to evaluate the influence of immersion in water during labor on the use of epidural anesthesia in a midwife care setting. METHODS: We conducted a single-center retrospective study of all women who gave birth in the physiological ward of Saint-Étienne University Hospital between October 2020 and December 2022. RESULTS: The study did not find difference between immersion group and control group concerning the use of epidural anesthesia (P=0.49). The immersion group counted more women with a duration of labor greater than 6hours than in the control group. The multivariate analysis adjusted for parity and duration of labor did not find difference between both groups [OR 0.58; 95% CI (0.30; 1.09)]. CONCLUSION: Even if it does not seem to modify the use of epidurals, immersion in water does not seem to increase maternal and neonatal morbidity and mortality. It represents a therapeutic alternative with reasonable cost to offer for pregnant women who wish to give birth without epidural anesthesia.

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.

Reorganisation of GP surgeries during the COVID-19 outbreak: analysis of guidelines from 15 countries.

BACKGROUND: General practitioners (GPs) play a key role in managing the COVID-19 outbreak. However, they may encounter difficulties adapting their practices to the pandemic. We provide here an analysis of guidelines for the reorganisation of GP surgeries during the beginning of the pandemic from 15 countries. METHODS: A network of GPs collaborated together in a three-step process: (i) identification of key recommendations of GP surgery reorganisation, according to WHO, CDC and health professional resources from health care facilities; (ii) collection of key recommendations included in the guidelines published in 15 countries; (iii) analysis, comparison and synthesis of the results. RESULTS: Recommendations for the reorganisation of GP surgeries of four types were identified: (i) reorganisation of GP consultations (cancelation of non-urgent consultations, follow-up via e-consultations), (ii) reorganisation of GP surgeries (area partitioning, visual alerts and signs, strict hygiene measures), (iii) reorganisation of medical examinations by GPs (equipment, hygiene, partial clinical examinations, patient education), (iv) reorganisation of GP staff (equipment, management, meetings, collaboration with the local community). CONCLUSIONS: We provide here an analysis of guidelines for the reorganisation of GP surgeries during the beginning of the COVID-19 outbreak from 15 countries. These guidelines focus principally on clinical care, with less attention paid to staff management, and the area of epidemiological surveillance and research is largely neglected. The differences of guidelines between countries and the difficulty to apply them in routine care, highlight the need of advanced research in primary care. Thereby, primary care would be able to provide recommendations adapted to the real-world settings and with stronger evidence, which is especially necessary during pandemics.

Inappropriate direct oral anticoagulant prescriptions in patients with non-valvular atrial fibrillation: cross-sectional analysis of the French CACAO cohort study in primary care.

BACKGROUND: Direct oral anticoagulants (DOACs) account for an increasing proportion of prescriptions in patients with non-valvular atrial fibrillation (NVAF) in primary care. Inappropriate dosing of DOACs is a common problem, with under-dosing being a particular issue. However, conflicting results have been reported about the factors independently associated with inappropriate dosing. AIM: To describe inappropriate prescriptions of DOACs among patients in the CACAO French nationwide general practice cohort, and to identify the factors independently associated with inappropriate DOAC doses. DESIGN AND SETTING: Cross-sectional baseline analysis of the CACAO French national multicentre prospective cohort of adult patients in primary care receiving an oral anticoagulant who were recruited between April and October 2014. METHOD: A total of 1111 patients from the CACAO cohort who received a DOAC for NVAF were included in this study. Inappropriate prescriptions of DOACs were described (inappropriate dosage, contraindications, non-indications, interactions, and non-compliance with the precautions for use). Multivariate logistic models were used to investigate factors associated with inappropriate DOAC dosing (under-dosing and over-dosing). RESULTS: Overall, 438 patients (39.4%) received at least one inappropriate DOAC prescription. The most common inappropriate prescription was inappropriate dosage (n = 374, 33.7%), particularly under-dosing (n = 348, 31.3%). Multivariate analysis revealed that factors independently associated with under-dosing were older age, prescription of apixaban or dabigatran, and a CHA2DS2-VASc score ≥2 vs. a score = 1. Factors with over-dosing were kidney failure, a HAS-BLED score ≥3, and older age. CONCLUSION: The appropriateness of DOAC prescribing for NVAF can be improved, especially in older patients, and in patients with kidney failure, a higher risk of ischaemic stroke, and/or a higher risk of bleeding. GPs have a key role in increasing the proportion of appropriate DOAC prescriptions via informational, educational, and/or management strategies.

Management of superficial venous thrombosis in unevaluated situations: Cancer, severe renal impairment, pregnancy and post-partum.

BACKGROUND: Information is lacking as to the management of patients with superficial venous thrombosis (SVT) whose profile has been excluded from trials, such as patients with active cancer, severe renal impairment, or pregnancy. OBJECTIVES: To describe the frequency and management of SVT occurring in these situations. METHODS: We retrospectively analyzed the frequency, management and evolution of all patients with isolated SVT associated with either active cancer, severe renal impairment, or pregnant or postpartum women, diagnosed in 2 university hospital between January 1st, 2015 and December 31st, 2016. RESULTS: Of the 594 isolated SVTs individualized from the 7941 reports screened, 149 SVTs (105 in the upper extremity, 44 in the lower extremity) were analyzed: 94 (63%) associated with active cancer, 27 (18%) with severe renal impairment and 30 (20%) pregnant or postpartum women. SVT was treated with anticoagulant in 34 (36%) patients with cancer, 3 (11%) patients with severe renal impairment and 19 (63%) pregnant or postpartum women. At 3-month, 16 patients (10.8%) had a further venous thromboembolic event, 8 (5.4%) major bleeding, and 9 (6.1%) died. CONCLUSION: SVT in patients with active cancer, severe renal impairment and pregnant or postpartum women represents a quarter of isolated SVTs diagnosed. Heterogeneity of treatment patterns mainly affects patients with cancer and severe renal impairment. Poor outcomes, although probably linked to morbidity, call for dedicated research in these specific situations.

Vaccination for Human Papillomavirus: an historic and bibliometric study.

A systematic literature review was conducted to describe in a historical perspective the evolution of studies concerning HPV vaccination. The search identified 794 articles of which 568 were included. The first article was published in 2001, and the maximum annual number of publications was reached in 2014. The average number of authors per paper was 8.8. Papers originated from 49 different countries, with the USA accounted for the maximum number of publications (n = 217). Efficacy (46.5%) and safety (31.0%) were the most prevalent objectives. Clinical trials constituted the largest group of methods (37.9%). Chronological trends did not reveal any lasting curve-crossings, indicating that the priority topics have remained the same. The geographical origin of these studies raises questions about the transposability of the results to populations where HPV vaccination has been studied only a little. This study could help guide future research to less-studied research objectives, particularly for vaccines.

How GPs adapted their practices and organisations at the beginning of COVID-19 outbreak: a French national observational survey.

OBJECTIVES: To describe how general practitioners (GPs) adapted their practices to secure and maintain access to care in the epidemic phase. A secondary objective was to explore if GPs' individual characteristics and type of practice determined their adaptation. DESIGN: Observational study using an online questionnaire. Organisational changes were measured by a main question and detailed in two specific outcomes. To identify which GPs' characteristics impacted organisational changes, successive multivariate logistic modelling was performed. First, we identified the GPs' characteristics related to organisational changes with a univariate analysis. Then, we tested the adjusted associations between this variable and the following GPs' characteristics: age, gender and type of practice. SETTING: The questionnaire was administered online between 14 March and 21 March 2020. Practitioners were recruited by email using the contact lists of different French scientific GP societies. PARTICIPANTS: The target population was GPs currently practising in France (n=46 056). We obtained a total of 7481 responses. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: Proportion of GPs who adapted their practice. Secondary outcome: GPs' characteristics related to organisational changes. RESULTS: Among the 7481 responses, 5425 were complete and were analysed. 3849 GPs (70.9%) changed their activity, 3605 GPs (66.5%) increased remote consultations and 2315 GPs (42.7%) created a specific pathway for probable patients with COVID-19. Among the 3849 GPs (70.9%) who changed their practice, 3306 (91.7%) gave more answers by phone, 996 (27.6%) by email and 1105 (30.7%) increased the use of video consultations. GPs working in multi-professional group practices were more likely to have changed their activity since the beginning of the epidemic wave than GPs working in mono-professional group or single medical practices (adjusted OR: 1.32, 95% CI 1.12 to 1.56, p=0.001). CONCLUSIONS: French GPs adapted their practices regarding access to care for patients in the context of the COVID-19 epidemic. This adaptation was higher in multi-professional group practices.

Intention to participate in a COVID-19 vaccine clinical trial and to get vaccinated against COVID-19 in France during the pandemic.

INTRODUCTION: The world is facing the COVID-19 pandemic. The development of a vaccine is challenging. We aimed to determine the proportion of people who intend to get vaccinated against COVID-19 in France or to participate in a vaccine clinical trial. METHODS: We conducted an anonymous on-line survey from the 26th of March to the 20th of April 2020. Primary endpoints were the intention to get vaccinated against COVID-19 if a vaccine was available or participate in a vaccine clinical trial. RESULTS: Three thousand two hundred and fifty nine individuals answered the survey; women accounted for 67.4% of the respondents. According to their statements, 2.512 participants (77.6%, 95% CI 76.2-79%) will certainly or probably agree to get vaccinated against COVID-19. Older age, male gender, fear about COVID-19, being a healthcare worker and individual perceived risk were associated with COVID-19 vaccine acceptance. Vaccine hesitancy was associated with a decrease in COVID-19 vaccine acceptance. One thousand and five hundred and fifty respondents (47.6% 95% CI 45.9-49.3%) will certainly or probably agree to participate in a COVID-19 vaccine clinical trial. Older age, male gender, being a healthcare worker and individual perceived risk were associated with potential acceptance to participate in a COVID-19 vaccine clinical trial. Vaccine hesitancy was associated with refusal for participation in a COVID-19 vaccine clinical trial. CONCLUSIONS: Nearly 75% and 48% of the survey respondents were respectively likely to accept vaccination or participation in a clinical trial against COVID-19. Vaccine hesitancy will be the major barrier to COVID-19 vaccine uptake.

Revue de la littérature sur les interventions en milieu scolaire concernant la vaccination anti-HPV.

INTRODUCTION: Human papillomavirus infection is the most common sexually transmitted infection and is associated with cervical cancer and several other cancers. Although the human papillomavirus vaccine is highly effective and has an excellent safety record, vaccination coverage rates vary around the world and are very low in France.Purpose of research: A literature review on the last five years in the MEDLINE and Public Health Databases was conducted in November 2017. Sixteen studies on school-based interventions for human papillomavirus vaccination in girls aged 11 to 19 years were selected and analyzed. RESULTS: Half of the studies concerned underage girls in middle and high schools or their parents and the other half major students. Education through written information, presentation or discussion increased knowledge about human papillomavirus infection and vaccine prevention, even in the medium term. The interventions that had the greatest impact were those that used personalization of the message, combining information or sources and implementing pre-intervention questionnaires. Knowledge was not always correlated with effective vaccination. CONCLUSIONS: Educational interventions increase knowledge about human papillomavirus and vaccination intention but not vaccination. Further studies seem necessary to understand the gap between the level of knowledge and its impact on immunization coverage.

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.

Impact of a Prescription Support Tool to Improve Adherence to the Guidelines for the Prescription of Oral Antithrombotics: The Combi-AT Randomized Controlled Trial Using Clinical Vignettes.

Ensuring the appropriateness of prescriptions of oral antithrombotics (ATs, including antiplatelet and anticoagulant agents) is a crucial safety issue, particularly for patients with multiple chronic conditions. Our main objective was to assess the impact of a prescription support tool, synthesized from international guidelines on oral ATs in adult outpatients, on improving physician adherence to the guidelines for prescription of oral ATs. A web-based, open randomized controlled trial using clinical vignettes was conducted in France from November 2018 to February 2019. General practitioners and cardiologists with outpatient practice were contacted to participate in a web-based survey involving three clinical vignettes illustrating cases of adult outpatients with common neuro-cardiovascular diseases. They were asked to answer four multiple-choice questions related to the number of oral AT(s), drug class, dosage and duration of the prescription. Physicians assigned to the experimental arm had access to the prescription support tool. Physicians assigned to the control arm had no access to the tool. The primary outcome measure was the appropriate prescription of oral ATs (i.e., complied with guidelines in terms of the number, drug class, dosage and duration of prescription). An intent-to-treat analysis was performed using a logistic mixed model with a clinical vignette effect and a physician effect nested in the arm of the trial. Four hundred and forty-one general practitioners and 37 cardiologists were randomized to the experimental (n = 238) and to the control arm (n = 240), respectively. In the experimental arm, 55.0% of the prescriptions were appropriate versus 29.4% in the control arm (Odds Ratio (OR): 3.61 (2.60 to 5.02)). Access to the first prescription support tool synthesizing the use of oral ATs for outpatients significantly improved the rate of appropriate oral AT prescriptions according to the guidelines.

Avoiding disease mongering: A checklist for vascular physicians and researchers.

Disease mongering is an expression created in 1992 by a medical journalist, Lynn Payer, to qualify the "selling of sickness that widens the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments". This interesting concept led us to question whether, as researchers with publication and career interests in superficial vein thrombosis, we were not shaping a benign condition into a disease. Since the publication of the CALISTO trial in 2010, anticoagulant management of superficial vein thrombosis remains debated. Issues raised, such as the cost-effectiveness of the treatment strategy, the use of a composite endpoint including death, the low event rate without mortality reduction and conflict of interest due to industrial funding. We searched Embase, Medline, Web of science, and Opengrey databases to review all aspects about disease mongering raised in the literature and created a checklist with seventeen items. We used this checklist as support for a narrative review, questioning known literature on superficial vein thrombosis. The main issues pointing towards disease mongering concerned definition and promotion; whereas management seemed rather spared. Many arguments could be counterbalanced, but researchers should pay particular attention to three major points: exaggeration of the severity of the disease and potential adverse outcomes without treatment, promotion by opinion leaders, and an openly declared, yet undoubtedly present, conflict of interest situation.

Evaluation of a prescription support-tool for chronic management of oral antithrombotic combinations in adults using clinical vignettes: protocol of a randomised controlled trial.

INTRODUCTION: Improving the appropriateness of prescriptions of oral antithrombotic (AT) drugs, especially AT combinations, is crucial because these drugs are implicated in bleeding events. We developed a prescription support-tool synthesising guidelines on chronic management of oral AT combinations. Our main objective is to assess the impact of this tool on improving the prescription of oral ATs to comply with guidelines. METHODS AND ANALYSIS: A randomised controlled trial will be conducted among French general practitioners and cardiologists involved in outpatient settings. Physicians will be invited to participate to an online survey by email via physician associations, social networks or word of mouth. They will be randomised to two arms: the experimental arm (access to the prescription support-tool) or the control arm (no prescription support-tool). Then, all participants will be presented three different clinical vignettes illustrating outpatient clinical situations and will be asked to propose prescriptions for each vignette (number of ATs, type, dosage and duration). A computer-generated randomisation scheme implemented in the online survey will be used to allocate physicians to the experimental or control arm and then stratified by medical specialty. The primary outcome will be fully appropriate prescription of oral ATs ie, that comply with the guidelines in terms of number of drugs, drug class, dosage and duration. To demonstrate a 5% increase in this proportion, we will need to include a minimum of 230 physicians per arm. A logistic mixed model with a clinical vignette-effect and a physician-effect nested in the arm of the study will be used. ETHICS AND DISSEMINATION: The Institutional Review Board of Inserm (IRB00003888) approved our research project (no. 18-492). If the prescription support-tool improves the prescription of oral ATs, we will create an interactive web tool and will assess its impact in terms of clinical outcomes in real-life. TRIAL REGISTRATION NUMBER: NCT03630874; Pre-results.

Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial.

Essentials Management of patients with calf deep vein thrombosis remains controversial. We conducted a post-hoc analysis of a placebo controlled LMWH randomized clinical trial. Pain was assessed using visual analogue scale at inclusion, one and six weeks. There was no difference in pain control between the two arms. SUMMARY: Background The optimal management of distal deep vein thrombosis (DVT) is highly debated. The only available placebo-controlled trial suggested the absence of clear benefit of anticoagulation. Many physicians feel that, beyond preventing thromboembolic complications, anticoagulation with low-molecular-weight heparin (LMWH) has the potential to improve pain control. Objectives To analyze whether LMWHs decrease pain in patients with distal deep vein thrombosis. Patients and methods Two-hundred and fifty-two patients included in a multicenter, placebo-controlled, randomized clinical trial of LMWH in patients with acute distal DVT and who were asked to rate their pain at inclusion and at each medical visit, using a visual analogue pain scale (VAS). Results One hundred and thirty patients were randomized in the therapeutic nadroparin arm and 122 patients were randomized in the placebo arm. Mean VAS values were 4.6 (standard deviation [SD] 2.5) at inclusion, 2.1 (SD 2.0) at 1 week and 0.4 (SD 1.2) at 6 weeks. We calculated the individual variation in VAS between inclusion and 1 week in patients in whom VAS was available at the two study time-points. There was no difference in the mean VAS reduction between patients treated with therapeutic nadroparin (n = 106) and with placebo (n = 109): -2.6 (SD 2.4) vs. -2.3 (SD 2.0) after 1 week and -4.4 (SD 2.8) vs. -4.0 (SD 2.4) after 6 weeks, respectively. The use of compression stockings was associated with a reduction in pain. Conclusion These data suggests that LMWH use does not improve pain control as compared with placebo in patients with acute distal DVT.

Ruling out deep vein thrombosis in patients with superficial vein thrombosis: external validation of the ICARO score.

A clinical score was recently proposed to rule out concomitant DVT in patients with a clinical suspicion of SVT. This study aimed to assess the external validity of this score in patients from the STEPH study. We performed a post-hoc analysis of data from the STEPH study. The STEPH study was a prospective multicenter community-based study conducted during a 1-year period in the resident adult population of the Greater Saint-Etienne urban area (France). Every patient with a clinical suspicion of SVT underwent a venous compression ultrasonography, to confirm SVT and to assess the presence of a concomitant DVT or not. Odds ratios for concomitant DVT were calculated for each item of the ICARO score. We then computed the score for each patient, and performed a receiver operating characteristic (ROC) curve analysis. In univariate analysis, none of the ICARO items were significantly different given the presence of a concomitant DVT. Given computed scores, 55 patients (45.1%) had a low risk, 17 (13.9%) had an intermediate risk and 50 (41.0%) had a high risk of a concomitant DVT. The area under the ROC curve was 0.386 [95% CI, 0.268-0.504]. When risk levels were dichotomized as low vs intermediate-high risk, the ICARO score had a sensitivity of 36.0%, a specificity of 40.2%, a positive predictive value of 13.4% and a negative predictive value of 70.9%. Our study does not confirm the utility of the ICARO clinical score to rule out concomitant DVT in case of SVT.

Cross-sectional multicentre study on the cohort of all the French junior lecturers in general practice.

BACKGROUND: General practice became an academic discipline quite recently in many western countries. In France, junior lecturer work is specified in a three-part mandate: medical work in general practice, teaching in the university, and research. Since 2007, 130 junior lecturers have been appointed in general practice. The aim of the creation of junior lecturer status was to align general practice with other specialties and to develop research and education in primary care. OBJECTIVES: To describe the healthcare, teaching and research undertaken by junior lecturers in general practice, practising in October 2014. METHODS: A cross-sectional multicentre study using an online self-administered questionnaire on the cohort composed of all the junior lecturers in general practice with open questions and the qualitative analysis of written verbatim accounts. RESULTS: Of the 95 junior lecturers practising at the date of the study, 75 (79%) responded; average age 32 years; gender ratio (F/M) 2.4:1. They spent five, two and three half-days per week respectively in healthcare, teaching and research. The healthcare activity was predominantly carried out in the community (73%). Thirty-nine per cent worked as part of a multi-professional team taking on 50 consultations per week. Most of the educational work involved lecturing and mentoring students specializing in general practice (median 86 hours per year). Research output increased during the fellowship. Research topics were varied and relevant to the disciplinary field. CONCLUSION: During the fellowship, the balancing, and even the reinforcement, of healthcare and research contributions were accompanied by a significant investment in educational provision.