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.

Very long-term risk of moderate-to-severe postthrombotic syndrome after deep vein thrombosis.

BACKGROUND: Postthrombotic syndrome (PTS) refers to manifestations of chronic venous insufficiency after a deep vein thrombosis (DVT). The risk of developing moderate-to-severe PTS in the very long term is largely unknown and particularly in case of distal DVT. Furthermore, the impact of DVT vs other causes of chronic venous insufficiency on long-term manifestations of PTS is also unknown. OBJECTIVES: To assess the very long-term risk of moderate-to-severe PTS after DVT and the role that DVT plays in PTS symptoms. METHODS: Patients with lower-limb DVT enrolled in the multicenter Optimisation de l'interrogatoire dans l'evaluation du risque thromboembolique veineux (OPTIMEV) study underwent a very long-term telephone follow-up. We assessed i) the proportion of moderate-to-severe PTS (assessed with the patient-reported Villalta score) according to DVT extent and ii) the population attributable fraction that DVT plays in patients' moderate-to-severe PTS manifestations. RESULTS: Fourteen years after DVT, moderate-to-severe PTS developed in 35 of 185 patients with distal DVT (18.9%; 95% CI, 13.5%-25.3%), 11 of 47 patients with popliteal DVT (23.4%; 95% CI, 12.3%-38.0%), and 27 of 74 patients with iliofemoral DVT (36.5%; 95% CI, 25.6%-48.5%). The population attributable fraction of DVT in moderate-to-severe symptoms of PTS was 25.7% (-18.1% to 53.3%) in patients with distal DVT, 27.3% (-63.7% to 67.7%) in patients with popliteal DVT, and 43.1% (+0.7%-67.4%) in patients with iliofemoral DVT. CONCLUSION: In the very long term after DVT, a quarter of patients have moderate-to-severe PTS manifestations. However, the impact of the DVT on these manifestations appears nonpredominant and varies according to DVT extent. Distal DVT does not significantly increase the risk of developing moderate-to-severe PTS.

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.

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.

Evidence-Based Pharmaceutical Care in Community Pharmacies: A Survey of 595 French Pharmacists.

We assessed the use of evidence-based practice (EBP) among pharmacists working in community pharmacies in France and the factors linked to this practice. During 3 months in 2018, an online survey was sent to over 7000 active pharmacists and posted on pharmacists' social media sites. In total, 595 pharmacists completed the questionnaire. The responders were on average younger than the general population of community pharmacists. The 40-item questionnaire described four fictional clinical cases reflecting typical situations (conventional medicine and complementary and alternative medicine) encountered daily by community pharmacists. Multiple-choice responses were proposed and scored according to whether they reflected EBP. A high total score indicated behaviour in line with EBP. We observed 344/595 participants with a positive EBP score (57.8% [53.7-61.8%]). Univariate and multivariate analyses were used to evaluate factors that might explain adherence to EPB (the pharmacy's characteristics, the pharmacist's status, the mode of continuing education and sources of information). The majority relied on pharmaceutical industry and other biased and/or non-evidence-based sources, particularly concerning information on homeopathic products. The consultation of independent reviews, health agency recommendations and peer-reviewed scientific journals was associated with evidence-based decisions. In contrast, reliance on pharmaceutical industry documents, personal experience and informal handbooks was linked to lower EBP scores. The level of EBP use by French community pharmacists needs to be improved to ensure that good-quality, science-based advice is given to customers.

Using national data to describe characteristics and determine acceptance factors of pharmacists' interventions: a six-year longitudinal study.

BACKGROUND: In France, hospital pharmacists perform medication order reviews during patients' hospital stays. This activity can be centralized in the pharmacy or carried out directly in the ward, in collaboration with the healthcare team. During this review, pharmacists can make recommendations to optimize therapeutics. Since 2006, they can document their interventions, via the national Act-IP© observatory. AIM: To determine the characteristics of pharmacists' interventions and their acceptance by physicians in French hospitals. METHOD: A 6-year observational study of pharmacists' interventions documented on the Act-IP© French observatory between 2009 and 2014 was performed. Multiple logistic regression was undertaken to determine the predictors of physicians' acceptance of interventions. RESULTS: A total of 194,684 pharmacists' interventions were documented and concerned mainly "dosage adjustment" (25.6%). These interventions were mostly related to drugs from the central nervous system (23.7%). Seventy percent of pharmacists' interventions were accepted by physicians. Acceptance rate was higher when conducted by a pharmacist regularly practicing in the ward (ORa = 1.60, CI 95 [1.57-1.64]). Physicians' acceptance was significantly associated with (1) ward specialty: emergency (ORa = 1.24, CI 95 [1.14-1.35]); (2) type of intervention: "drug discontinuation", "drug switch" (ORa = 1.15, CI 95 [1.12-1.19]) and "addition of a new drug" (ORa = 1.15, CI 95 [1.12-1.19]); (3) drug group: antineoplastic and immunomodulators (ORa = 3.67, CI 95 [3.44-3.92]). CONCLUSION: This 6-year longitudinal study highlights the role of clinical pharmacists, and particularly the impact of those integrated into wards. This was found to improve intervention acceptance, potentially through collaboration with physicians in pursuit of patient care and drug safety.

25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial.

BACKGROUND: The optimal strength of compression needed to prevent post-thrombotic syndrome (PTS) after a proximal deep vein thrombosis (DVT) is debated. We aimed to assess whether 25 mm Hg elastic compression stockings (ECS) are non-inferior to 35 mm Hg ECS in preventing PTS after a DVT. METHODS: In this multicentre, double-blind, non-inferiority, randomised controlled trial, we enrolled adults (≥18 years) with a first ipsilateral proximal DVT attending 46 French vascular medicine hospital departments or private practices. Participants were randomly allocated (1:1, stratified by centre, age, and sex; with varying block sizes of two and four) to wear 25 mm Hg or 35 mm Hg ECS for 2 years. The primary outcome was the cumulative rate of PTS 2 years after inclusion, defined by a Villalta scale (≥5). Efficacy was assessed by intention-to-treat and in eligible participants who had complete primary outcome data. A per-protocol analysis was also conducted among compliant patients as a secondary outcome measure. Safety was assessed in all participants who used ECS at least once, and for which we have at least some tolerance information during follow-up. The margin for non-inferiority was 12·5%. This study is registered with ClinicalTrials.gov, NCT01578122, and has been completed. FINDINGS: Between June 28, 2012, and July 21, 2017, we enrolled 341 eligible participants who consented to randomisation. 233 (68%) were men and median age was 59 years (IQR 45-70). Collection of ethnicity and race as a routine research variable is not authorised in France. Median follow-up was 735 days (IQR 721-760). 249 (73%) had complete data at 2 years. For the primary analysis, 40 (31%) of 129 participants with complete data in the 25 mm Hg ECS group and 40 (33%) of 120 in the 35 mm Hg group had PTS (absolute difference -2·3% [90% CI -12·1 to 7·4], pnon-inferiority=0·0062; relative risk 0·93, 95% CI 0·65 to 1·33). Results remained similar after imputation of missing data in patients we were authorised to do so: the cumulative proportion of PTS was 45 (29%) of 154 in the 25 mm Hg ECS group versus 52 (35%) of 148 in the 35 mm Hg ECS group (relative risk 0·83, 95% CI 0·60 to 1·16). Absolute difference was -5·9%, (90% CI -14·7 to 2·9), p=0·0003 for non-inferiority. Adherence was optimal (>80% and modified GIRERD score of 0-2) for 75 (51%) of 146 patients assigned to 25 mm Hg ECS and for 56 (42%) of 134 patients assigned to 35 mm Hg ECS (p=0·11). Regarding major adverse events related to ECS, there were no between-group differences in rates of deep vein thrombosis (0 vs 1 [0·6%]), ipsilateral leg ulcer (0 vs 1 [0·6%]), infection (0 vs 0), or death (0 vs 0) between the 169 patients evaluated in the 25 mm Hg ECS group and the 159 patients in the 35 mm Hg ECS group. Two (1%) of 328 patients who ever wore ESC developed ECS-related serious adverse events, one distal DVT and one leg ulcer (both in the 35 mm Hg ECS group). In the 25 mm Hg group, 6 patients died, 14 had a venous thromboembolic recurrence (proximal DVT or pulmonary embolism), and 7 had a major bleed. In the 35 mm Hg group, 5 patients died, 10 had a venous thromboembolic recurrence (proximal DVT or pulmonary embolism), and 6 had a major bleed. INTERPRETATION: Although we did not reach the prespecified sample size, our results suggest that 25 mm Hg ECS are non-inferior to 35 mm Hg ECS in preventing PTS. Larger more powerful studies are needed. FUNDING: Laboratoires Innothera, France.

Management of urgent invasive procedures in patients treated with direct oral anticoagulants: An observational registry analysis.

BACKGROUND: Patients treated with direct oral anticoagulants (DOACs) may require urgent procedures. Managing these patients is challenging due to different bleeding risks and may include laboratory testing, procedural delays, or haemostatic/reversal agent administration. OBJECTIVE: We evaluated management strategies and outcomes of urgent, non-haemostatic invasive procedures in patients treated with DOACs. METHODS AND RESULTS: In a descriptive cohort study, we prospectively evaluated 478 patients in the GIHP-NACO registry, from June 2013 to November 2015. Hospitalised patients receiving dabigatran (n = 160), rivaroxaban (n = 274), or apixaban (n = 44) requiring urgent, procedural interventions were evaluated, of which 384/478 (80 %) were surgical procedures. Orthopaedic surgery included 216/384 patients (56 %), while gastrointestinal surgery included 75/384 (20 %) patients. On admission, the median age was 79 (70-85), and creatinine clearance was <60 mL·min-1 in 316/478 (66 %) patients. DOAC concentration was determined in 277 (58 %) patients and was 85 ng·mL-1 (median; range 0-764), 61 ng·mL-1 (3-541), and 81 ng·mL-1 (26-354) for dabigatran, rivaroxaban, and apixaban, respectively. Procedures were delayed in 194/455 (43 %) of the cases. Excessive bleeding was observed in 62/478 (13 %) procedures, and haemostatic agents were administered in 76/478 (16 %) procedures. By day 30, major cerebral and cardiovascular events were observed in 38/478 (7.9 %) patients, and mortality was 28/478 (5.9 %). CONCLUSIONS: In the GIHP-NACO registry, before specific antidotes were available, DOAC treated patients undergoing urgent invasive procedures were delayed in nearly half of the cases, and showed a low rate of excessive bleeding, suggesting that most urgent procedures can be performed safely without DOAC reversal. CLINICAL TRIAL REGISTRATION: www. CLINICALTRIALS: gov. Identifier: NCT02185027.

Evaluation of the benefit of thermal spa therapy in plaque psoriasis: the PSOTHERMES randomized clinical trial.

Spa therapy is considered an add-on treatment for psoriasis, but without any objective evaluation in the absence of randomized trials. This multicenter, open-label, randomized trial compared immediate spa therapy versus a control group having usual treatments until study assessments at 4.5 months. Spa therapy was proposed in five French spa resorts with standardized programs. Inclusion criteria were adults with plaque psoriasis, Dermatology Life Quality Index (DLQI) > 10, and stable medical treatment in the last 6 months. The main objective was DLQI ≤ 10 at 4.5 months after inclusion. VQ-Dermato and EQ5D-3L also assessed quality of life (QoL), Perceived Stress Scale (PSS) stress, and visual analogue scales (VAS) pain and pruritus. Between January 2015 and November 2018, 128 patients were randomized to either immediate spa therapy (64) (within 34 days, median) or usual treatments (61) until assessment at 4.5 months. Most were first-time spa users (71.2%). Mean DLQI and Psoriasis Area and Severity Index at inclusion were 16.7 and 10.5, respectively. Immediate spa therapy patients achieved the primary objective for 66.1% [95% CI 52.6% > 77.9%] vs 41.4% [95% CI 28.6% > 55.1%] control group patients (p = 0.007). VQ-Dermato scores and pruritus VAS significantly improved. Outcomes at 12-month follow-up of the immediate spa therapy group showed persistent improvement of DLQI, VQ-Dermato, and pruritus. This randomized controlled trial demonstrated that a cure of spa therapy improves QoL and alleviates certain symptoms of psoriasis, in short and long terms. This justifies its integration in the therapeutic strategies for psoriasis. Trial registration number: ClinicalTrials.gov Identifier: NCT02098213.

Impact of a large interprofessional simulation-based training course on communication, teamwork, and safety culture in the operating theatre: A mixed-methods interventional study.

BACKGROUND: Communication and teamwork are critical non-technical skills in the operating theatre. However, prevention of events associated with communication failures by large simulation-based programs remains to be evaluated. The objective was to assess the impact of an interprofessional simulation-based training course on communication, teamwork, checklist adherence, and safety culture. METHODS: We aimed to assess the impact of an interprofessional simulation-based training course on communication, teamwork, checklist adherence, and safety culture. We conducted a before-and-after interventional study based on a mixed-methods approach combining qualitative and quantitative evaluation criteria. The study was performed in a University Hospital with 39 operating theatres operated by 300 providers before (period 1) and after (period 2) an interprofessional simulation-based training course. Surgical procedures were observed, and the primary outcome measure was the rate of procedures with at least one communication failure associated with adverse event. Additional outcomes measured included the rate of other communication failures, checklist adherence, while teamwork and safety culture were assessed by questionnaires. RESULTS: In total, 46 970 communication episodes were analysed during 131 (period 1) and 122 (period 2) surgical procedures. One hundred sixty-four professionals attended 40 simulation-based sessions. The rate of procedures with at least one communication failure associated with adverse events was not significantly different between the 2 periods (38% in period 1 and 43% in period 2; P = 0.47). Nevertheless, the rate of communication failures reduced between period 1 and 2 (8117/28 303 (29%) vs. 3868/18 667 (21%), respectively; P < 0.01). Teamwork scores and checklist adherence increased significantly after the intervention (8.1 (7.2-8.7) in period 1 vs. 8.6 (8.0-9.2) in period 2; P < 0.01 and 17% (0-35 %) in period 1 vs. 44% (26-57 %) in period 2; P < 0.01). Safety culture ratings did not change significantly. CONCLUSION: This study shows that although the rate of procedures with at least one communication failure associated with adverse event (primary endpoint) was not significantly different, a large interprofessional simulation-based training course has a positive effect on communication failures, teamwork, and checklist adherence.

Characteristics of pharmacist's interventions triggered by prescribing errors related to computerised physician order entry in French hospitals: a cross-sectional observational study.

OBJECTIVES: Computerised physician order entry (CPOE) systems facilitate the review of medication orders by pharmacists. Reports have emerged that show conception flaws or the misuse of CPOE systems generate prescribing errors. We aimed to characterise pharmacist interventions (PIs) triggered by prescribing errors identified as system-related errors (PISREs) in French hospitals. DESIGN: This was a cross-sectional observational study based on PIs prospectively documented in the Act-IP observatory database from January 2014 to December 2018. SETTING: PISREs from 319 French computerised healthcare facilities were analysed. PARTICIPANTS: Among the 319 French hospitals, 232 (72.7%) performed SRE interventions, involving 652 (51%) pharmacists. RESULTS: Among the 331 678 PIs recorded, 27 058 were qualified as due to SREs (8.2%). The main drug-related problems associated with PISREs were supratherapeutic (27.5%) and subtherapeutic dosage (17.2%), non-conformity with guidelines/contraindications (22.4%) and improper administration (17.9%). The PI prescriber acceptation rate was 78.9% for SREs vs 67.6% for other types of errors. The PISRE ratio was estimated relative to the total number of PIs. Concerning the certification status of CPOE systems, the PISRE ratio was 9.4% for non-certified systems vs 5.5% for certified systems (p<0.001). The PISRE ratio for senior pharmacists was 9.2% and that for pharmacy residents 5.4% (p<0.001). Concerning prescriptions made by graduate prescribers and those made by residents, the PISRE ratio was 8.4% and 7.8%, respectively (p<0.001). CONCLUSION: Computer-related prescribing errors are common. The PI acceptance rate by prescribers was higher than that observed for PIs that were not CPOE related. This suggests that physicians consider the potential clinical consequences of SREs for patients to be more frequently serious than interventions unrelated to CPOE. CPOE medication review requires continual pharmacist diligence to catch these errors. The significantly lower PISRE ratio for certified software should prompt patient safety agencies to undertake studies to identify the safest software and discard software that is potentially dangerous.

Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial.

Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia. PERSPECTIVE: A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02265029.

Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial.

Postthrombotic syndrome (PTS) is a burdensome and costly complication of deep vein thrombosis (DVT) that develops in 20%-40% of patients within 2 years after proximal DVT. In the absence of effective curative treatment, management of PTS relies on its prevention after DVT. The effectiveness of elastic compression stockings (ECS) to prevent PTS is uncertain. We present an overview of published studies assessing the efficacy of ECS to prevent PTS and present the protocol for the CELEST clinical trial. While previous open-label randomized trials have reported a 50% risk reduction in PTS in patients treated with >30 mm Hg ankle pressure ECS, a large double-blind trial reported no effect of ECS. We discuss the main potential limitations of these trials, including a placebo effect and suboptimal compliance to ECS. We present the protocol of the CELEST double-blind randomized trial comparing 2 years of high strength (ankle pressure 35 mm Hg) versus lower strength (ankle pressure 25 mm Hg) ECS in the prevention of PTS after a first acute symptomatic, unilateral, proximal DVT. The use of lower-strength ECS than that used in previous studies should favor compliance. CELEST may provide important evidence about the efficacy of ECS in the prevention of PTS after DVT. The results will be interpreted in the light of results from recent clinical trials assessing ECS for PTS prevention that reported that the duration of ECS use should be tailored to the individual, if ECS are efficacious in the prevention of PTS.

Risk factors for Staphylococcus aureus surgical site infections after orthopaedic and trauma surgery in a French university hospital.

BACKGROUND: Surgical site infections (SSI) after orthopaedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. The most commonly identified organism is Staphylococcus aureus but risk factors for S. aureus SSI are not well-known. The aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years and risk factors of these infections in a French University Hospital. METHODS: SSI rates were expressed as cumulative incidence rates per year. A case-control study nested within a prospective cohort of patients undergoing orthopaedic or trauma surgery from January 1st, 2012 to April 30th, 2015 was performed. Cases were patients with S. aureus SSI; controls were patients without SSI. Risk factors of S. aureus SSI were identified by univariate and multivariable analysis. RESULTS: Of 7438 interventions, 50 (0.7%) S. aureus SSI were identified, without significant increase by years. A total of 46 S. aureus SSI was matched to 91 controls. Risk factors for S. aureus SSI were smoking (odds-ratio (OR) = 8.4, 95%CI 1.2-59.6) and National Nosocomial Infections Surveillance System score (NNISS) ≥1 (OR = 5.8, 95%CI 1.8-19.1). Having 1 or 2 preoperative antiseptic showers (OR = 0.3, 95%CI 0.1-0.7) was a protective factor. CONCLUSION: The rate of S. aureus SSI is not negligible after orthopaedic and trauma surgery. It seems imperative to strengthen smoking cessation recommendations, and to recall the importance of preoperative antiseptic showers. Systematic screening and decolonization for S. aureus carriage before orthopaedic and trauma surgery could be a means to prevent these infections.

Subjects with venous insufficiency have high risk of obstructive sleep apnea in relationship to fluid shift.

BACKGROUND: Obstructive sleep apnea (OSA) is highly prevalent in conditions characterized by fluid overload. Chronic venous insufficiency (CVI) is associated to fluid overload that might interfere with OSA occurrence and severity. METHODS: A total of 180 patients with symptomatic CVI completed the Berlin questionnaire and were assessed for the presence of symptoms and signs of OSA and fluid shift. RESULTS: According to the Berlin questionnaire, 59 patients (33%) had high risk of OSA. The predictors of having a positive Berlin questionnaire were male sex, body mass index and symptoms possibly related to fluid shift. CONCLUSIONS: Patients with CVI, a disease characterized by fluid overload, present high risk of OSA, which might be related to fluid shift.

Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study.

OBJECTIVE: Supervised exercise training is part of first-line therapies for intermittent claudication. Short periods of intensive treadmill training have been found efficient; however, the optimal modalities remain to be determined, especially interval training with active recovery (ITAR). In this prospective assessor-blinded single-centre pilot study, we assessed the feasibility of a randomised controlled trial comparing parallel 4-week intensive rehabilitation programs comprising treadmill training performed as ITAR or conventional training with constant slope and speed interspersed with rest periods (CT). METHODS: A total of 38 in- or out-patients were randomised to the ITAR or CT program for 5 days/week for 4weeks. The primary outcome was change in maximum walking distance measured on a graded treadmill before and after the program. RESULTS: Adherence was high. All training sessions were completed in the ITAR program and only a few were not completed in the CT program (median 100% [Q1-Q3 96-100]). Tolerance was excellent (no adverse events). VO2peak was low in both groups, corresponding to moderate to severe exercise intolerance. The 2 groups did not differ in the primary outcome (median ITAR vs CT 480 [135-715] vs 315m [0-710]; p=0.62) or other walking distances (constant speed and gradient treadmill test). For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test: median 415 [240-650] to 995m [410-1490], with a large effect size (p<10-4). CONCLUSION: A 4-week intensive rehabilitation program with ITAR or CT for intermittent claudication showed high adherence, was well tolerated, and improved walking distance as much as that reported for longer conventional programs. These findings prompt the design of a larger multicenter randomised controlled trial. TRIAL REGISTRATION: NCT01734603.

Proposal for a Global Adherence Scale for Acute Conditions (GASAC): A prospective cohort study in two emergency departments.

BACKGROUND: Adherence in the context of patients with acute conditions is a major public health issue. It is neglected by the research community and no clinically validated generic scale exists to measure it. OBJECTIVE: To construct and validate a Global Adherence Scale usable in the context of Acute Conditions (GASAC) that takes into account adherence both to advice and to all types of prescriptions that the doctor may give. To measure adherence and to study its determinants. MATERIALS AND METHOD: We based the construction of the GASAC questionnaire on a theoretical model and a literature search. Then, between 2013 and 2014, we validated it in a prospective observational study in two hospital emergency departments. Patients were contacted by phone about one week after their consultation to answer several questionnaires, including GASAC and the Girerd self-administered questionnaire about medication adherence as a control. RESULTS: GASAC consists of four adherence subscales: drug prescriptions; blood tests/ radiography prescriptions; lifestyle advice and follow-up instructions. An analysis of the 154 sets of answers from patients showed that the GASAC drug subscale had satisfactory internal coherence (Cronbach's alpha = 0.78) and was correlated with the Girerd score, as was GASAC as a whole (p<0.01). The median score was 0.93 IQR [0.78-1] for a maximum value of 1 (n = 154). In multivariaable analysis, infection was more conducive of good adherence (cut off at ≥ 0.8; n = 115/154; 74.7% [67.0-81.3]) than trauma (OR 3.69; CI [1.60-8.52]). The Doctor-Patient Communication score (OR 1.06 by score point, CI [1.02-1.10]) also influenced adherence. CONCLUSIONS: GASAC is a generic score to measure all dimensions of patient adherence following emergency departments visits, for use in clinical research and the evaluation of clinical practice. The level of adherence was high for acute conditions and Doctor-Patient Communication was a major determinant of adherence.

Impact of patient information leaflets on doctor-patient communication in the context of acute conditions: a prospective, controlled, before-after study in two French emergency departments.

OBJECTIVE: In the context of acute conditions seen in an emergency department, where communication may be difficult, patient information leaflets (PILs) could improve doctor-patient communication (DPC) and may have an impact on other outcomes of the consultation. Our objective was to assess the impact of PILs on DPC, patient satisfaction and adherence, and on patient and doctor behaviours. DESIGN: Prospective, controlled, before-after trial between November 2013 and June 2015. SETTING: Two French emergency departments. PARTICIPANTS: Adults and adolescents >15 years diagnosed with ankle sprain or an infection (diverticulitis, infectious colitis, pyelonephritis, pneumonia or prostatitis). INTERVENTION: Physicians in the intervention group gave patients a PIL about their condition along with an oral explanation. MAIN OUTCOME MEASURES: 7-10 days later, patients were contacted by phone to answer questionnaires. Results were derived from questions scored using a 4-point Likert scale. MAIN FINDINGS: Analysis of the 324 patients showed that PILs improved the mean DPC score (range: 13-52), with 46 (42-49) for 168 patients with PILs vs 44 (38-48) for 156 patients without PILs (p<0.01). The adjusted OR for good communication (having a score >35/52) was 2.54 (1.27 to 5.06). The overall satisfaction and adherence scores did not show significant differences. In contrast, satisfaction with healthcare professionals and timing of medication intake were improved with PILs. The overall satisfaction score improved significantly on per-protocol analysis. When using PILs, doctors prescribed fewer drugs and more examinations (radiology, biology, appointment with a specialist); the need for a new medical consultation for the same pathology was reduced from 32.1% to 17.9% (OR 0.46 [0.27 to 0.77]), particularly revisiting the emergency department. CONCLUSION: In emergency departments, PILs given by doctors improve DPC, increase patients' satisfaction with healthcare professionals, reduce the number of emergency reconsultations for the same pathology and modify the doctor's behaviour. TRIAL REGISTRATION NUMBER: NCT02246361.

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.