Suprapubic versus transurethral catheterization for bladder drainage in male rectal cancer surgery (GRECCAR10), a randomized clinical trial.

BACKGROUND: Bladder drainage is systematically used in rectal cancer surgery; however, the optimal type of drainage, transurethral catheterization (TUC) or suprapubic catheterization (SPC), is still controversial. The aim was to compare the rates of urinary tract infection on the fourth postoperative day (POD4) between TUC and SPC, after rectal cancer surgery regardless of the day of removal of the urinary drain. METHODS: This randomized clinical trial in 19 expert colorectal surgery centers in France and Belgium was performed between October 2016 and October 2019 and included 240 men (with normal or subnormal voiding function) undergoing mesorectal excision with low anastomosis for rectal cancer. Patients were followed at postoperative days 4, 30, and 180. RESULTS: In 208 patients (median age 66 years [IQR 58-71]) randomized to TUC (n = 99) or SPC (n = 109), the rate of urinary infection at POD4 was not significantly different whatever the type of drainage (11/99 (11.1%) vs. 8/109 (7.3%), 95% CI, - 4.2% to 11.7%; p = 0.35). There was significantly more pyuria in the TUC group (79/99 (79.0%) vs. (60/109 (60.9%), 95% CI, 5.7-30.0%; p = 0.004). No difference in bacteriuria was observed between the groups. Patients in the TUC group had a shorter duration of catheterization (median 4 [2-5] vs. 4 [3-5] days; p = 0.002). Drainage complications were more frequent in the SPC group at all followup visits. CONCLUSIONS: TUC should be preferred over SPC in male patients undergoing surgery for mid and/or lower rectal cancers, owing to the lower rate of complications and shorter duration of catheterization. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02922647.

Reduced mortality by meeting guideline criteria before using recombinant activated factor VII in severe trauma patients with massive bleeding.

BACKGROUND: Management of trauma patients with severe bleeding has led to criteria before considering use of recombinant activated factor VII (rFVIIa), including haemoglobin >8 g dl-1, serum fibrinogen ≥1.0 g l-1, platelets >50,000 x 109 l-1, arterial pH ≥ 7.20, and body temperature ≥34 °C. We hypothesized that meeting these criteria is associated with improved outcomes. METHODS: In this prospective cohort study of 26 French trauma centres, subjects were included if they received rFVIIa for persistent massive bleeding despite appropriate care after severe blunt and/or penetrating trauma. RESULTS: After surgery and/or embolization as haemostatic interventions, 112 subjects received a first dose of 103 µg kg-1 rFVIIa (82-200) (median, 25th-75th percentile) at 420 min (285-647) post-trauma. Of these, 71 (63%) "responders" were still alive at 24h post-trauma and had their transfusion requirements reduced by > 2 packed red blood cell units after rFVIIa treatment. Mortality was 54% on day 30 post-trauma. There were 21%, 44% and 35% subjects who fulfilled 0-1, 2-3 or 4-5, respectively, of the guidelines before receiving rFVIIa. Survival at day 30 was 13%, 49% and 64% and the proportion of responders was 39%, 64% and 82%, when subjects fulfilled 0-1, 2-3 or 4-5 conditions, respectively (both P <0.01). CONCLUSIONS: In actively bleeding trauma patients, meeting guideline criteria before considering rFVIIa was associated with lower mortality and a higher proportion of responders to the rFVIIa.

Trends in pharmacists' medication order review in French hospitals from 2006 to 2009: analysis of pharmacists' interventions from the Act-IP© website observatory.

WHAT IS KNOWN AND OBJECTIVES: The French Society of Clinical Pharmacy has developed a website, named Act-IP©, enabling hospital pharmacists to document and analyse pharmacists' interventions (PIs) proposed during medication order review when a drug-related problem is detected. This study analyses PIs documented in Act-IP© and assesses factors associated with physicians' acceptance of PIs. METHODS: PIs documented into Act-IP© over a 30-month period were analysed. Independent predictors of physicians' acceptance were assessed using multiple logistic regression. RESULTS AND DISCUSSION: A total of 34,522 PIs were registered by 201 pharmacists working in 59 hospitals. PIs were mostly related to 'dose adjustment' (25%), 'drug discontinuation' (20%) and 'drug switch' (19%). Of the 43,343 medications involved, 28% targeted drugs acting on the central nervous system, 17% anti-infective drugs and 16% cardiovascular drugs. Sixty-eight per cent of PIs were accepted by physicians (15% refusals and 17% non-assessable). Physicians' acceptance was significantly associated with 1/ drug group: antineoplastics and immunomodulators (OR = 2.29, CI 95[1.94-2.69]), anti-infectives (OR = 1.19, CI 95 [1.11-1.28]); 2/ type of intervention: drug switch (OR = 1.54, CI 95 [1.43-1.65]), drug discontinuation (OR = 1.38, CI 95 [1.29-1.48]), administration modality optimization (OR = 1.19, CI 95 [1.11-1.29]), addition of a new drug (OR = 1.12, CI 95 [1.00-1.24]); 3/ ward specialty: paediatrics (OR = 1.83, CI 95 [1.24-2.70]) and intensive care (OR = 1.34, CI 95 [1.10-1.64]); 4/ level of pharmacist integration in the ward: higher when the pharmacist is regularly in the ward compared with occasionally (OR = 0.74, CI 95 [0.70-0.79]) or never (OR = 0.68, CI 95 [0.60-0.75]) present. WHAT IS NEW AND CONCLUSION: This study highlights the role of routine pharmacist review of medication orders to prevent drug-related problems and gives new insights for a successful collaboration between physicians and pharmacists.

Reduction of red blood cell transfusion with a patient blood management protocol in urological and visceral surgery: a before-after study.

BACKGROUND: Although Patient Blood Management (PBM) is recommended by international guidelines, little evidence of its effectiveness exists in abdominal surgery. The aim of this study was to evaluate the benefits of the implementation of a PBM protocol on transfusion incidence and anaemia-related outcomes in major urological and visceral surgery. METHODS: In this before-after study, a three-pillar PBM protocol was implemented in 2020-2021 in a tertiary care centre, including preoperative correction of iron-deficiency anaemia, intraoperative tranexamic acid administration, and postoperative restrictive transfusion. A historical cohort (2019) was compared to a prospective cohort (2022) after the implementation of the PBM protocol. The primary outcome was the incidence of red blood cell transfusion intraoperatively or within 7 days after surgery. RESULTS: Data from 488 patients in the historical cohort were compared to 499 patients in the prospective cohort. Between 2019 and 2022, screening for iron deficiency increased from 13.9% to 69.8% (p < 0.01), tranexamic acid administration increased from 9.5% to 84.6% (p < 0.01), and median haemoglobin concentration before transfusion decreased from 77 g.L-1 to 71 g.L-1 (p = 0.02). The incidence of red blood cell transfusion decreased from 11.5% in 2019 to 6.6% in 2022 (relative risk 0.58, 95% CI 0.38-0.87, p = 0.01). The incidence of haemoglobin concentration lower than 100 g.L-1 at discharge was 24.2% in 2019 and 21.8% in 2022 (p = 0.41). The incidence of medical complications was comparable between the groups. CONCLUSION: The implementation of a PBM protocol over a two-year period was associated with a reduction of transfusion in major urological and visceral surgery.

Risk factors for nosocomial COVID-19 in a French university hospital.

OBJECTIVES: Prevention strategies implemented by hospitals to reduce nosocomial transmission of SARS-CoV-2 sometimes failed. Our aim was to determine the risk factors for nosocomial COVID-19. PATIENTS AND METHODS: A case-control study was conducted (September 1, 2020-January 31, 2021) with adult patients hospitalized in medical or surgical units. Infants or patients hospitalized in ICU were excluded. Cases were patients with nosocomial COVID-19 (clinical symptoms and RT-PCR + for SARS-CoV-2 or RT-PCR + for SARS-CoV-2 with Ct ≤ 28 more than 5 days after admission); controls were patients without infection (RT-PCR- for SARS-CoV-2 > 5 days after admission). They were matched according to length of stay before diagnosis and period of admission. Analyses were performed with a conditional logistic regression. RESULTS: A total of 281 cases and 441 controls were included. In the bivariate analysis, cases were older (OR per 10 years: 1.22; 95%CI [1.10;1.36]), had more often shared a room (OR: 1.74; 95%CI [1.25;2.43]) or a risk factor for severe COVID-19 (OR: 1.94; 95%CI [1.09;3.45]), were more often hospitalized in medical units [OR: 1.59; 95%CI [1.12;2.25]), had higher exposure to contagious health care workers (HCW; OR per 1person-day: 1.12; 95%CI [1.08;1.17]) and patients (OR per 1 person-day: 1.11; 95%CI [1.08;1.14]) than controls. In an adjusted model, risk factors for nosocomial COVID-19 were exposure to contagious HCW (aOR per 1person-day: 1.08; 95%CI [1.03;1.14]) and to contagious patients (aOR per 1person-day: 1.10; 95%CI [1.07;1.13]). CONCLUSIONS: Exposure to contagious professionals and patients are the main risk factors for nosocomial COVID-19.

Isolated distal deep vein thrombosis: What have we learnt from the OPTIMEV study?

The OPTIMEV (OPTimisation de l'Interrogatoire dans l'évaluation du risque throMbo-Embolique Veineux) study has provided some important and innovative information for the management of lower extremity isolated distal deep vein thrombosis (distal DVT). Indeed, if distal deep-vein thrombosis (DVT) therapeutic management is nowadays still debated, before the OPTIMEV study, the clinical relevance of these DVT itself was questioned. Via the publication of 6 articles, between 2009 and 2022, assessing risk factors, therapeutic management, and outcomes of 933 patients with distal DVT we were able to demonstrate that: - When distal deep veins are systematically screened for suspicion of DVT, distal DVT are the most frequent clinical presentation of the venous thromboembolic disease (VTE). This is also true in case of combined oral contraceptive related VTE. - Distal DVT share the same risk factors as proximal DVT and constitute two different clinical expressions of the same disease: the VTE disease. However, the weight of these risk factors differs: distal DVT are more often associated with transient risk factors whereas proximal DVT are more associated with permanent risk factors. - Deep calf vein and muscular DVT share the same risk factors, short and long-term prognoses. - In patients without history of cancer, risk of unknown cancer is similar in patients with a first distal or proximal DVT. - After 3years and once anticoagulation has been stopped, distal DVT recur twice less as proximal DVT and mainly as distal DVT; However, in cancer patients, prognosis of distal and proximal DVT appear similar in terms of death and VTE recurrence.

Effect of point-of-care influenza tests on antibiotic prescriptions by emergency physicians in a French hospital.

BACKGROUND: Influenza is a public health issue worldwide. Although antibiotics should not be used to treat viral infections, they are often prescribed to patients with influenza-like illness (ILI). Such misuse promotes antibiotic resistance. The role of rapid point-of-care tests (POCTs) in preventing antibiotic misuse in adults with ILI symptoms remains relatively unexplored. AIM: To evaluate whether POCT implemented in 2018-2019 to detect influenza viruses led to a decrease in antibiotic prescriptions compared with laboratory-based influenza tests. METHODS: Adult patients with ILI in one emergency department (ED) were retrospectively enrolled over three epidemic seasons (from 2016-2017 to 2018-2019). The primary outcome was the rate of antibiotic prescriptions, which was compared between the three seasons in bivariate and multivariate analyses. Prescriptions for ancillary laboratory tests, chest X-rays and oseltamivir were also compared, along with hospitalizations and length of stay (LOS) at the ED. FINDINGS: Overall, 1849 patients were included. Median age was over 70 years throughout all three seasons. The number of antibiotic prescriptions was significantly different between the three periods in bivariate analysis (48.3% in 2016/2017, 44% in 2017/2018 and 31.1% in 2018/2019; P<0,0001) and in multivariate analysis (adjusted odds ratio (aOR) = 0.48, 95% confidence interval (CI) = 0.30-0.76 for 2018/2019 and aOR = 0.99, 95%CI = 0.67-1.46 for 2017/2018, compared with 2016/2017). There were significantly fewer prescriptions of ancillary laboratory tests, X-rays, hospitalizations and more oseltamivir prescriptions in 2018/2019, compared with the previous seasons. LOS was significantly lower in 2018/2019 only for influenza-positive patients. CONCLUSIONS: ED influenza POCT decreased antibiotic use and led to less ancillary testing, X-rays and hospitalizations among patients with ILI. However, medico-economic studies are necessary before formulating definite recommendations.

Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial.

OBJECTIVE: To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. METHODS: Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). MAIN ENDPOINT: The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as > or =19.9 mm on the visual analogue pain scale and/or > or =9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. RESULTS: The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (chi(2)=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. CONCLUSION: For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated.

Ultrasound-guided sclerotherapy of the great saphenous vein with 1% vs. 3% polidocanol foam: a multicentre double-blind randomised trial with 3-year follow-up.

OBJECTIVES: The aim of this study was to compare the efficacy and side effects of ultrasound-guided foam sclerotherapy of the great saphenous vein using 1% and 3% polidocanol foam with a 3-year follow-up. DESIGN: A multicentre prospective double-blind randomised clinical trial comparing the efficacy of 1% vs. 3% polidocanol sclerosant foam. MATERIALS AND METHODS: Patients with incompetence of the great saphenous vein (GSV) in CEAP clinical classes C2-5 (CEAP, Clinical-Etiology-Anatomy-Pathophysiology), with or without incompetence of the sapheno-femoral junction, were included. The Turbofoam method was used to create 1% and 3% polidocanol foam, which was injected into the GSV under ultrasound guidance, with a volume not exceeding 10 ml. Further foam sclerotherapy was carried out at 6 weeks, 3 and 6 months if required to abolish persistent venous reflux. The main outcome measure was the absence of saphenous reflux as assessed by ultrasound imaging at 6 months, 1, 2 and 3 years. Clinical severity (Venous Clinical Severity score (VCSS)) and quality of life (the Chronic Venous Insufficiency Questionnaire (CIVIQ)) scores were assessed. RESULTS: A total of 143 patients were included; 1% group men = 18, women = 55, 3% group men = 19, women = 51. The abolition of venous reflux was: 1% group, 69% and 3% group, 85% at 6 months; 1% group, 79% and 3% group, 78% at 3 years (including additional injections at 6 months). Three asymptomatic thrombo-embolic events (2%) occurred. Local side effects (principally pigmentation and matting) were 9% in the 3% group and 6% in the 1% group at 3 years (N.S.). Clinical severity and quality of life scores improved by more than 20% at 6 months in both the groups, with no difference between the groups. CONCLUSIONS: This is the first randomised clinical trial of ultrasound-guided foam sclerotherapy which is a 3-year follow-up and shows equivalent efficacy of 1% and 3% sclerosant foam. CLINICAL TRIAL REGISTRATION NUMBER: 2006-07-05.

[Which factors are associated to hemorrhagic adverse drug events related to antivitamin K?]. / Quels facteurs associés à la survenue d'un événement iatrogène hémorragique chez les patients sous antivitamines K ?

INTRODUCTION: Hemorrhagic events constitute a major risk for patients on oral anticoagulant therapy. PATIENTS AND METHODS: We conducted a prospective survey of all patients taking oral anticoagulants and admitted to the emergency room of Grenoble University Hospital over a period of 10 months. The objective was to identify the causes of drug-induced adverse hemorrhagic events, and whether they were related to health care practices or patient behavior concerning their treatment. RESULTS: Two hundred and sixteen patients treated with oral anticoagulants were identified and 68 of them had a hemorrhagic adverse drug event. Not taking into account prior medial history before prescribing an anticoagulant was noted for 21 of the patients who experienced a hemorrhagic event (p = 0.0003). In addition, compared with patients who had not had a hemorrhagic event, inadequate prescribing with regard to doses and administration frequency there were also more common in the hemorrhagic event group (p < 0.0001). Pharmacists delivering the drugs had not intervened to correct drug interactions, contraindications and inadequate doses in 72% of patients with hemorrhage (p < 0.0001). Other factors associated with increased the risk of hemorrhage were self-medication, not taking the prescribed drug at a predefined time of the day, insufficient INR monitoring and poor compliance (p < 0.0001). DISCUSSION AND CONCLUSION: To achieve the beneficial effects expected with anticoagulants, physicians must carefully comply with prescription recommendations, especially for elderly patients. Pharmacists delivering the drugs should also intervene more readily when required.

Use of a smart electrically assisted bicycle (VELIS) in the health field -Proof of concept.

Physical activity (PA) is highly recommended in the management of most chronic diseases. For these patients, the smart electric bicycle can be effective to improve adherence to this behavior. The E-bike used in this study (called VELIS) has an innovative onboard technology that allows for subject monitoring and the engine power is designed to adapt to the user's abilities. A prerequisite for the use of the VELIS with patients is to initially carry out a pilot study on healthy subjects. The objective was to evaluate the impact of the customizable settings on physiological parameters and to ensure this prototype's efficiency and safety of use. Twelve healthy participants with various profiles (physical condition, used to cycling or not) were included. They have completed four times a 14 km itinerary with various settings of the VELIS. We recorded GPS data, heart rate and perceived exertion. Based on exercise intensity, we confirm that riding an E-bike should be considered as a physical activity. Safety of the participants is ensured by the engine brake. Recordings show that it took between 1 and 3 min for the novice to become familiar with the VELIS and to get optimal assistance. The main finding of this pilot study confirms that VELIS is an easy to use and secure tool to make PA approachable, whatever the level of training in healthy subjects.

Drug-related problems in medical wards with a computerized physician order entry system.

OBJECTIVE: Identification and estimation, by clinical pharmacists participating in routine medical rounds, of drug-related problems (DRPs), arising despite the use of a computerized physician order entry (CPOE) system. METHODS: An 18-month prospective study of DRPs through a CPOE was conducted by seven clinical pharmacists participating in ward activity. DRPs were identified by two independent pharmacists using a structured order review (French Society of Clinical Pharmacy instrument). RESULTS: A total of 29 016 medication orders relating to 8152 patients were analysed, and 2669 DRPs, involving 1564 patients (56% female; mean age 72.6 years), were identified representing 33 DRPs per 100 admissions. The most commonly identified DRPs were non-conformity to guidelines or contra-indication (29.5%), improper administration (19.6%), drug interaction (16.7%) and overdosage (12.8%). There were 429 different drugs associated with these DRPs. Cardiovascular drugs were the most frequently implicated (22.2%), followed by antibiotics/anti-infectives (13.3%) and analgesics/antiinflammatory drugs (11.3%). Different types of DRPs were closely associated with specific classes of drugs. CONCLUSIONS: Drug-related problems are common even after implementation of CPOE. In this context, routine participation of clinical pharmacists in clinical medical rounds may facilitate identification of DRPs. Pharmacists should be able to enhance patient safety through such involvement.

[Hemorrhagic complications of anti-vitamin K]. / Complications hémorragiques des anti vitamine K: enquête de prévalence aux urgences du CHU de Grenoble.

Adverse events related to oral anticoagulants represent a major public health problem. Hemorrhagic episodes are the most frequent complications and can be life-threatening. A 10 month prospective survey on all cases treated with anti-vitamin K (AVK), and admitted to emergency room of CHU Grenoble, was conducted to identify the hemorrhagic adverse drug events (HADE). The evaluation support was a directive questionnaire and consisted of 3 parts: patient characteristics, patient's medicated treatment and the hemorrhagic event. 216 patients treated with AVK were identified and 68 of them presented a hemorrhagic adverse drug event. 60 patients older than 65 years out of 158, presented HADE (38%); versus 8 patients < or = 65 years out of 58 (RR = 2.75; p = 0.0007). Among the patients who have their INR > or = 5, 79% developed HADE versus 16% in the group who had their INR < 5 (< 0.0001). In the group of patients who had a change in drug therapy within the 7 days preceding their admission, 47% developed HADE versus 25% of patients whose treatment was not modified: Anti-microbial agents were the drug most frequently involved. The patient's knowledge of INR value and signs of excess AVK were significant. Concerning missed dose, 48 patients declared taking the missed dose with the next dose or when they remembered: 35% of them developed HADE (p = 0.49).

[Propensity score analysis in observational research: application to a study of prophylaxis against venous thromboembolism]. / L'analyse par score de propension Exemple d'application à une étude observationnelle sur la prophylaxie de la maladie thromboembolique veineuse.

INTRODUCTION: In observational studies, a significant difference in the outcomes between treated and untreated patients may be observed in absence of treatment effect and caused by differences in baseline characteristics. EXEGESIS: Propensity score analysis is a post hoc adjustment method which consists in deriving the conditional probability of receiving the treatment for a patient given his measured baseline characteristics (i.e., the propensity score). Matching each treated patient to an untreated one who has the nearest propensity score tends to balance baseline characteristics between the two groups and reduce the risk for overt bias. Then, the outcomes can be compared between matched treated and untreated patients. CONCLUSION: Propensity score analysis is relevant for clinical conditions and treatments for which randomized controlled trials are unlikely to be conducted. However, propensity analysis cannot adjust for unmeasured characteristics and sensitivity analysis should be performed to assess how sensitive the conclusions are to potential confounding factors.

[Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial]. / Prolongation d'un traitement par antivitamine K pendant dix-huit mois versus placebo au décours d'un premier épisode d'embolie pulmonaire idiopathique traité six mois: un essai randomisé multicentrique en double aveugle. Essai "PADIS-EP".

BACKGROUND: After stopping a 3 to 6 months course of oral anticoagulation for a first episode of idiopathic venous thromboembolism (VTE), the risk of recurrent VTE is high (10% per year). In this setting, international guidelines recommend at least 6 months treatment. However, this recommendation is not satisfactory for the following reasons: (1) no randomized trial has compared 6 months to extended duration (2 years) anticoagulation; and (2), even though the frequency of recurrent VTE is similar after pulmonary embolism (PE) and deep vein thrombosis (DVT), the fatality rate of recurrent VTE after PE is higher than that after DVT. METHODS: A French multicentre double blind randomized trial. The main objective is to demonstrate, after a first episode of symptomatic idiopathic PE treated for 6 months using a vitamin K antagonist, that extended anticoagulation for 18 months (INR between 2 and 3) is associated with an increased benefit / risk ratio (recurrent VTE and severe anticoagulant-related bleeding) compared to placebo. The double blind evaluation is ensured using by active warfarin and placebo, and blinded INR. The protocol was approved by the ethics board of the Brest Hospital on the 7th of March 2006. For an alpha risk of 5% and a beta risk of 20%, the estimated sample size is 374 patients. EXPECTED RESULTS: This study has the potential to: (1) demonstrate that the benefit / risk ratio of extended anticoagulation for 18 months is higher than that observed with placebo in patients with a first episode of idiopathic PE initially treated for 6 months, during and after the treatment period; and (2) to validate or invalidate the contribution of isotope lung scans, lower limb Doppler ultrasound and D-Dimer at 6 months of treatment as predictors of recurrent VTE (medico-economic analysis included).

Impact of a multifaceted prevention program on ventilator-associated pneumonia including selective oropharyngeal decontamination.

PURPOSE: We describe the impact of a multifaceted program for decreasing ventilator-associated pneumonia (VAP) after implementing nine preventive measures, including selective oropharyngeal decontamination (SOD). METHODS: We compared VAP rates during an 8-month pre-intervention period, a 12-month intervention period, and an 11-month post-intervention period in a cohort of patients who received mechanical ventilation (MV) for > 48 h. The primary objective was to assess the effect on first VAP occurrence, using a Cox cause-specific proportional hazards model. Secondary objectives included the impact on emergence of antimicrobial resistance, antibiotic consumption, duration of MV, and ICU mortality. RESULTS: Pre-intervention, intervention and post-intervention VAP rates were 24.0, 11.0 and 3.9 VAP episodes per 1000 ventilation-days, respectively. VAP rates decreased by 56% [hazard ratio (HR) 0.44, 95% CI 0.29-0.65; P < 0.001] in the intervention and by 85% (HR 0.15, 95% CI 0.08-0.27; P < 0.001) in the post-intervention periods. During the intervention period, VAP rates decreased by 42% (HR 0.58, 95% CI 0.38-0.87; P < 0.001) after implementation of eight preventive measures without SOD, and by 70% after adding SOD (HR 0.30, 95% CI 0.13-0.72; P < 0.001) compared to the pre-intervention period. The incidence density of intrinsically resistant bacteria (to colistin or tobramycin) did not increase. We documented a significant reduction of days of therapy per 1000 patient-days of broad-spectrum antibiotic used to treat lower respiratory tract infection (P < 0.028), median duration of MV (from 7.1 to 6.4 days; P < 0.003) and ICU mortality (from 16.2 to 13.5%; P < 0.049) for patients ventilated > 48 h between the pre- and post-intervention periods. CONCLUSIONS: Our preventive program produced a sustained decrease in VAP incidence. SOD provides an additive value.

Reduction of Prolonged Excessive Pressure in Seated Persons With Paraplegia Using Wireless Lingual Tactile Feedback: A Randomized Controlled Trial.

Pressure ulcers (PU) are known to be a high-cost disease with a risk of severe morbidity. This paper evaluates a new clinical strategy based on an innovative medical device [Tongue Display Unit (TDU)] that implements perceptive supplementation in order to reduce prolonged excessive pressure, recognized as one of the main causes of PU. A randomized, controlled, and parallel-group trial was carried out with 12 subjects with spinal cord injuries (SCI). Subjects were assigned to the control (without TDU, [Formula: see text]) or intervention (with TDU, [Formula: see text]) group. Each subject took part in two sessions, during which the subject, seated on a pressure map sensor, watched a movie for one hour. The TDU was activated during the second session of the intervention group. Intention-to-treat analysis showed that the improvement in adequate weight shifting between the two sessions was higher in the intervention group (0.84 [0.24; 0.89]) than in the control group (0.01 [-0.01; 0.09]; [Formula: see text]) and that the ratio of prolonged excessive pressure between the two sessions was lower in the intervention group (0.74 [0.37; 1.92]) than in the control group (1.72 [1.32; 2.56]; [Formula: see text]). The pressure map sensor was evaluated as being convenient for use in daily life; however, this was not the case for the TDU. This paper shows that persons with SCI could benefit from a system based on perceptive supplementation that alerts and guides the user on how to adapt their posture in order to reduce prolonged excessive pressure, one of the main causes of PU.

One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study.

AIM: Conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) was compared with intensive coaching using the Web and the cellular phone network for retrospective data transmission and short message service (SMS). METHODS: Thirty poorly controlled patients (HbA1c 7.5-10%) were enrolled in a bicenter, open-label, randomized, 12-month, two-period, crossover study. After a 1-month run-in period, 15 patients were randomly assigned to receive weekly medical support through SMS based upon weekly review of glucose values, while 15 patients continued to download self-monitored blood glucose (SMBG) values on a weekly basis without receiving SMS. After 6 months, patients crossed over to the alternate sequence for 6 additional months. Visits at the clinic were maintained every 3 months. RESULTS: Patients with long-standing inadequately controlled diabetes (24 +/- 13 years) were included. A non-significant trend to reduction in HbA(1c) (-0.25+/-0.94%, P<0.10) and mean glucose values (-9.2+/-25 mg/dl, P=0.06) during the 6-month SMS sequence was observed as compared with the no-SMS period. No safety issue (hypoglycemia, glucose variability) was reported. Adherence to SMBG was not affected by the trial. Quality of life analysis suggests a significant improvement in DQOL global score, as well as the DQOL satisfaction with life subscale, during the SMS sequence. CONCLUSIONS: Long-term telemedical follow-up of insulin pump-treated patients using a cellular phone-, SMS- and Web-based platform is feasible, safe, does not alter quality of life and associated with a trend toward improved metabolic control.

[Validation of an emergency care physician training program "two-point flash US"]. / Validation d'une formation des urgentistes au flash-écho-deux points (FEDP).

BACKGROUND: The development of a short training program for emergency care physicians for rapid ultrasound assessment of two points (the groin and popliteal areas) could be useful for later implementation of a safe home care strategy for patients with suspected deep vein thrombosis before the results of a complete duplex-Doppler exploration are available. PURPOSE: Validation of the proposed training program by studying inter-operator agreement (trainee versus vascular physician) in a multicentric assessment of 60 emergency care physicians. Establish the learning curve. METHODOLOGY: Theoretical training: two-page document with schematic drawings and consultation of image bank on the Web. Practical training: 25 patients in all, the last 15 as an independent operator, writing a standardized report. Interoperator agreement: (a) centralized data collection and independent analysis of the report written by the trainee and a vascular physician for the same patients (n(o) 11 to 25); (b) determination of the coefficient of variance, kappa, and construction of the learning curve (900 agreement points for 60 trainees). INCLUSION CRITERIA: (a) Treated distal or proximal thrombosis recruited by the vascular physician (blinded to the result of the flash US); patient's oral consent. EXPECTED RESULTS: Learning curve leveling off at about the 20th patient with a kappa>0.61 or even 0.80. ORIGINAL CONTRIBUTION OF THE PROJECT: (a) Prospective, multicentric, blinded study: (i) confirming the feasibility of a two-point venous ultrasound performed by emergency care physicians; (ii) validation of the contents and duration of a short simplified training program; (b) Validation of a decision criterion for home care; If validated, this type of training program might be applied in other disciplines (intensive care, geriatrics).

Non-conform diagnostic management of pulmonary embolism suspected patients is responsible for a higher risk of thrombotic event occurrence.

The aim of this 3-month follow-up prospective pragmatic study was to evaluate the implementation of a pulmonary embolism (PE) diagnostic strategy in clinical practice. One thousand and one hundred thirty-four consecutive in- and outpatients with clinically suspected PE were enrolled into a sequential diagnostic algorithm in which vascular medical unit plays a pivotal role in advising physicians and suggesting the most appropriate tests according to the diagnostic algorithm. In this observational study, patients that followed the proposed work-up were attributed to a so-called "conform group". Patients in whom diagnostic work-up was not according to protocol were attributed to a "non-conform group". Nine hundred and ninety-seven patients (87.9%) had a conform work-up, and 137 patients a non-conform work-up according to the proposed diagnostic algorithm. The non-conform work-up directly increased in relation to the age of the referred patients. PE was ruled out in 907 (80%) patients of whom 787 (86.8%) were in the conform group. Of the 797 patients who did not receive anticoagulant drugs, follow-up was obtained in 792 (99.4%). Among these patients, the incidence of acute thromboembolic events during the 3-month follow-up period was different in the group of patients that had a conform work-up (1%, [95% CI, 0.5-2.1%]) from the non-conform group patients (4.5%, [95% CI, 2-10.2%]. Therefore patients from the non-conform group have an independent increased risk to develop a thromboembolic event during the follow-up, adjusted odds ratio 3.3 [1.1-10, 95% CI]. Therefore we demonstrated that a non-conform diagnostic management strategy is associated with a higher risk of thrombotic event occurrence.