ABSTRACT
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.
Subject(s)
Drainage , Postoperative Complications , Rectal Neoplasms , Urinary Catheterization , Urinary Tract Infections , Humans , Male , Rectal Neoplasms/surgery , Middle Aged , Aged , Urinary Catheterization/methods , Urinary Catheterization/adverse effects , Drainage/methods , Urinary Tract Infections/etiology , Urinary Tract Infections/prevention & control , Urinary Tract Infections/epidemiology , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Urinary Bladder/surgery , BelgiumABSTRACT
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.
Subject(s)
Erythrocyte Transfusion , Tranexamic Acid , Urologic Surgical Procedures , Humans , Erythrocyte Transfusion/statistics & numerical data , Male , Female , Middle Aged , Aged , Prospective Studies , Urologic Surgical Procedures/methods , Tranexamic Acid/therapeutic use , Tranexamic Acid/administration & dosage , Blood Loss, Surgical/prevention & control , Clinical Protocols , Antifibrinolytic Agents/therapeutic use , Antifibrinolytic Agents/administration & dosage , Cohort Studies , Adult , Anemia, Iron-Deficiency/prevention & controlABSTRACT
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.
Subject(s)
Neoplasms , Venous Thromboembolism , Venous Thrombosis , Humans , Venous Thromboembolism/complications , Prospective Studies , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiology , Venous Thrombosis/therapy , Risk Factors , Neoplasms/complicationsABSTRACT
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.
Subject(s)
COVID-19 , Cross Infection , Adult , Humans , COVID-19/epidemiology , SARS-CoV-2 , Hospitals, University , Cross Infection/epidemiology , Case-Control Studies , Risk FactorsABSTRACT
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.
Subject(s)
Influenza, Human , Physicians , Adult , Aged , Anti-Bacterial Agents/therapeutic use , Emergency Service, Hospital , Hospitals , Humans , Influenza, Human/diagnosis , Influenza, Human/drug therapy , Influenza, Human/epidemiology , Point-of-Care Systems , Prescriptions , Retrospective StudiesABSTRACT
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.
Subject(s)
Bicycling , Electricity , Electronics , Exercise , Adult , Aged , Bicycling/education , Female , Heart Rate , Humans , Male , Middle Aged , Pilot ProjectsSubject(s)
Ambulatory Surgical Procedures/statistics & numerical data , Pediatrics/statistics & numerical data , Adolescent , Anesthesia , Child , Child, Preschool , France/epidemiology , Humans , Infant , Infant, Newborn , Pain Measurement , Pain, Postoperative/drug therapy , Pain, Postoperative/epidemiology , Postoperative Nausea and Vomiting/epidemiology , Preanesthetic Medication , Surveys and QuestionnairesABSTRACT
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.
Subject(s)
Critical Care , Decontamination , Oropharynx , Pneumonia, Ventilator-Associated/prevention & control , Aged , Anti-Bacterial Agents/therapeutic use , Cohort Studies , Controlled Before-After Studies , Female , Humans , Incidence , Length of Stay , Male , Middle Aged , Pneumonia, Ventilator-Associated/epidemiology , Proportional Hazards Models , Respiration, ArtificialABSTRACT
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.
ABSTRACT
OBJECTIVE: Excepting life-threatening situations, improvement of health-related quality-of-life is the main therapeutic goal in chronic disease. The purpose of this review was to study the different ways of assessing Quality-of-Life (QoL) in patients with chronic venous disease (CVD) (CEAP classes C3 to C6). METHODS: A literature search was conducted with three databases: MEDLINE, WEB OF SCIENCE and COCHRANE LIBRARY in order to identify articles with the PRISMA reporting guidelines. Then we compared psychometric performance of general and specific QoL questionnaires for a French population with CVD. RESULTS: A total of 481 articles were identified, from which 25 were selected and analyzed. CIVIQ 20, CIVIQ 14 and VEINES Qol/sym are the specific health related QoL scales validated for a French population with CVD. VEINES Qol/sym was specifically validated in patients with leg ulcer or post-thrombotic syndrome (PTS). CIVIQ 14 is a CIVIQ 20 optimized to be used more widely in international studies and validated in milder forms of the CVD spectrum (C0 à C4). The general health related QoL scales are SF-36, SF-12 and EQ-5D. EQ-5D is simple and provides health state utility values. CONCLUSION: CIVIQ 14 is a simple specific health-related QoL scale for less severe CVD. VEINES Qol/sym was developed for severe CVD and PTS but clinically relevant point scales remain to be assessed. EQ-5D is a generic scale to be preferred to assess economic impact based on a cost-utility analysis.
Subject(s)
Patient Reported Outcome Measures , Quality of Life , Venous Insufficiency , Chronic Disease , Humans , Venous Insufficiency/diagnosisABSTRACT
OBJECTIVE: Determine the frequency of preconception care use in France and factors impacting preconception visit. MATERIALS AND METHODS: An epidemiological study was conducted from September 2015 to October 2015 in 5 maternity hospitals within the "Alpes-Isère" perinatal network, comprising of French-speaking women, with uncomplicated pregnancies, who delivered a healthy term baby (≥37 weeks of gestational age). Two groups were compared: patients with and without preconception care. Descriptive, univariate and multivariate analyses were performed for the sociodemographic, the environmental characteristics and the gynecologic obstetric history. RESULTS: Among the 392 patients included in this study, only 62 (15.8% [12.0-20.0]) had used preconception care before their pregnancy. Multivariate analysis showed that the primiparous women (adjusted OR 2.47 [1.37-4.46]) and the women with a high socio-professional category (adjusted OR 2.32 [1.13-4.77]) were more likely to used preconception care. CONCLUSION: Despite the positive effects on mother and baby's health, preconception care is insufficiently used in France. Every effort must be made to improve awareness of preconception care among health workers and patients.
Subject(s)
Health Behavior , Mothers/statistics & numerical data , Patient Participation/statistics & numerical data , Preconception Care/statistics & numerical data , Adult , Community Networks , Female , France/epidemiology , Humans , Maternal-Child Health Services/organization & administration , Maternal-Child Health Services/standards , Mothers/psychology , Preconception Care/organization & administration , Pregnancy , Pregnancy Outcome/epidemiology , Prenatal Care/organization & administration , Prenatal Care/statistics & numerical data , Socioeconomic Factors , Surveys and Questionnaires , Young AdultABSTRACT
Essentials Long-term risk of recurrence of isolated superficial vein thrombosis (SVT) is under-studied. We analyzed data from a cohort of first SVT and proximal deep vein thrombosis (DVT) without cancer. The risk of recurrence as DVT or pulmonary embolism is twice lower in SVT patients. However, overall risk of recurrence is similar between SVT and proximal DVT patients. Click to hear Dr Decousus' perspective on superficial vein thrombosis SUMMARY: Background Isolated superficial vein thrombosis (iSVT) (without concomitant deep vein thrombosis [DVT] or pulmonary embolism [PE]) is a frequent event, but available data on long-term outcomes are scarce and retrospective. Therefore, we aimed to determine prospectively the risk and type of venous thromboembolism (VTE) recurrence after iSVT and compare them with those of proximal DVT. Methods Using data from the prospective, multicenter, observational, OPTIMEV study, we assessed, at 3 years and after anticoagulants were stopped, the incidence and the type of VTE recurrence (iSVT/DVT/PE) of patients with a first objectively confirmed iSVT without cancer (n = 285), and compared these with those of patients with a first proximal DVT without cancer (n = 262). Results As compared with proximal DVT patients, iSVT patients had a similar overall incidence of VTE recurrence (5.4% per patient-year [PY] versus 6.5% per PY, adjusted hazard ratio [aHR] 0.9, 95% confidence interval [CI] 0.5-1.6), but iSVT recurred six times more often as iSVT (2.7% versus 0.6%, aHR 5.9, 95% CI 1.3-27.1) and 2.5 times less often as deep-VTE events (2.5% versus 5.9%, aHR 0.4, 95% CI 0.2-0.9). Varicose vein status did not influence the risk or the type of VTE recurrence. Saphenian junction involvement by iSVT was not associated with a higher risk of recurrence (5.2% per PY versus 5.4% per PY), but was associated with recurrence exclusively as deep-VTE events. Conclusion In patients with a first iSVT without cancer, after stopping anticoagulants, the incidence of deep-VTE recurrence is half that of DVT patients, but the overall risk of recurrence is similar. Ssaphenian junction involvement seems to influence the risk of deep-VTE recurrence, whereas varicose vein status has no impact or a low impact on VTE recurrence.
Subject(s)
Pulmonary Embolism/drug therapy , Veins/pathology , Venous Thromboembolism/drug therapy , Adult , Aged , Anticoagulants/therapeutic use , Female , Follow-Up Studies , France , Humans , Incidence , Male , Middle Aged , Proportional Hazards Models , Prospective Studies , Pulmonary Embolism/epidemiology , Pulmonary Embolism/prevention & control , Recurrence , Risk Assessment , Risk Factors , Saphenous Vein/pathology , Time Factors , Treatment Outcome , Venous Thromboembolism/epidemiology , Venous Thromboembolism/prevention & controlABSTRACT
Essentials Clinical significance of cancer-related isolated distal deep vein thrombosis (iDDVT) is unknown. We studied patients with iDDVT, with and without cancer, and proximal DVT with cancer. Cancer-related iDDVT patients have a much poorer prognosis than iDDVT patients without cancer. Cancer-related iDDVT patients have a similar prognosis to cancer-related proximal DVT patients. SUMMARY: Background Isolated distal deep vein thrombosis (iDDVT) (infra-popliteal DVT without pulmonary embolism [PE]) is a frequent event and, in the absence of cancer, is usually considered to be a minor form of venous thromboembolism (VTE). However, the clinical significance of cancer-related iDDVT is unknown. Methods Using data from the observational, prospective multicenter OPTIMEV cohort, we compared, at 3 years, the incidences of death, VTE recurrence and major bleeding in patients with cancer-related iDDVT with those in cancer patients with isolated proximal DVT (matched 1:1 on age and sex) and patients with iDDVT without cancer (matched 1:2 on age and sex). Results As compared with patients with cancer-related isolated proximal DVT (n = 92), those with cancer-related iDDVT (n = 92) had a similar risk of death (40.8% per patient-year (PY) vs. 38.3% per PY; aHR = 1.0, 95% CI[0.7-1.4]) and of major bleeding (3.8% per PY vs. 3.6% per PY, aCHR = 0.9 [0.3-3.2]) and a higher risk of VTE recurrence (5.4% per PY vs. 11.5% per PY; aCHR = 1.8 [0.7-4.5]). As compared with patients with iDDVT without cancer (n = 184), those with cancer-related iDDVT had a nine times higher risk of death (3.5% per PY vs. 38.3% per PY; aHR = 9.3 [5.5-15.9]), a higher risk of major bleeding (1.8% per PY vs. 3.6% per PY; aCHR = 2.0 [0.6-6.1]) and a higher risk of VTE recurrence (5.0% per PY vs. 11.5% per PY; aCHR = 2.0 [1.0-3.7]). The results remained similar in the subgroup of patients without history of VTE. Conclusion Patients with cancer-related iDDVT seem to have a prognosis that is similar to that of patients with cancer-related isolated proximal DVT and a dramatically poorer prognosis than patients with iDDVT without cancer. This underlines the high clinical significance of cancer-related iDDVT and the need for additional studies.
Subject(s)
Neoplasms/epidemiology , Popliteal Vein , Venous Thromboembolism/epidemiology , Venous Thrombosis/epidemiology , Aged , Aged, 80 and over , Female , France/epidemiology , Hemorrhage/epidemiology , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Neoplasms/blood , Neoplasms/diagnosis , Neoplasms/mortality , Prognosis , Proportional Hazards Models , Prospective Studies , Recurrence , Risk Assessment , Risk Factors , Time Factors , Venous Thromboembolism/blood , Venous Thromboembolism/diagnosis , Venous Thromboembolism/mortality , Venous Thrombosis/blood , Venous Thrombosis/diagnosis , Venous Thrombosis/mortalityABSTRACT
BACKGROUND: Recent studies have shown lower rates of cancer following venous thromboembolism (VTE) than previously described. OBJECTIVES: To reassess the risk of cancer in patients with clinical symptoms of VTE with or without confirmed VTE. PATIENTS: We used data from OPTIMEV, a French prospective multicenter observational study of patients presenting to hospital and community vascular medicine specialists with suspected VTE. Patients with confirmed VTE (1565) and matched controls without VTE (1847) were followed for 3 years (2006-2009). The main outcome was occurrence of cancer at 3 years, and death was a censoring event. RESULTS: A total of 5.0% [4.0-6.3] of patients with VTE and 3.8% [3.0-4.9] without VTE developed cancer during follow-up. The adjusted hazard ratio (HR) was 1.2 [0.9-1.8] for patients with confirmed VTE (P=0.22). The overall standardized incidence ratio (SIR) was 1.4 [1.1-1.6] for our population, VTE+ and VTE-, compared with the general population, statistically significant (P<0.05). CONCLUSIONS: We found a lower occurrence of cancer after VTE than previously described, with no significant difference between patients whether VTE was confirmed or not. Our results (low incidence and no difference between patients VTE+ or VTE-) provide no argument in favor of an extensive screening for cancer in case of VTE.
Subject(s)
Neoplasms/epidemiology , Venous Thromboembolism/epidemiology , Aged , Cohort Studies , Female , France/epidemiology , Humans , Male , Middle Aged , Prospective Studies , Risk FactorsABSTRACT
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.
Subject(s)
Factor VIIa/therapeutic use , Guideline Adherence , Hemorrhage/drug therapy , Wounds and Injuries/mortality , Adult , Factor VIIa/adverse effects , Female , Humans , Male , Middle Aged , Practice Guidelines as Topic , Prospective Studies , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic useABSTRACT
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.