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1.
Sci Rep ; 11(1): 2388, 2021 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-33504923

RESUMO

Reverse transcriptase-polymerase chain reaction (RT-PCR) testing is an important tool for diagnosing coronavirus disease 2019 (COVID-19). However, performance concerns have emerged recently, notably regarding sensitivity. We hypothesized that the clinical, biological, and radiological characteristics of patients with a false-negative first RT-PCR test and a final diagnosis of COVID-19 might differ from those of patients with a positive first RT-PCR test. We conducted a multicenter matched case-control study in COVID-19 patients. Patients with a negative first RT-PCR test were matched to patients with a positive first RT-PCR test on age, sex, and initial admission unit (ward or intensive care). We included 80 cases and 80 controls between March 30, and June 22, 2020. Neither mortality at hospital discharge nor hospital stay length differed between the two groups (P = 0.80 and P = 0.54, respectively). By multivariate analysis, two factors were independently associated with a lower risk of a first false-negative test, namely, headache (adjusted OR [aOR], 0.07; 95% confidence interval [95% CI], 0.01-0.49]; P = 0.007) and fatigue/malaise (aOR, 0.16; 95% CI, 0.03-0.81; P = 0.027); two other factors were independently associated with a higher risk of a first false-negative test, namely, platelets > 207·103 mm-3 (aOR, 3.81; 95% CI, 1.10-13.16]; P = 0.034) and C-reactive protein > 79.8 mg·L-1 (aOR, 4.00; 95% CI, 1.21-13.19; P = 0.023). Patients with suspected COVID-19 whose laboratory tests indicating marked inflammation were at higher risk of a first false-negative RT-PCR test. Strategies involving serial RT-PCR testing must be rigorously evaluated.


Assuntos
/métodos , /virologia , /genética , Adulto , Idoso , /estatística & dados numéricos , Estudos de Casos e Controles , Reações Falso-Negativas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Sensibilidade e Especificidade
2.
Blood ; 2020 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-33270832

RESUMO

The optimal duration of eculizumab treatment in patients with atypical haemolytic uremic syndrome (aHUS) remains poorly defined. We conducted a prospective national multicentric open-label study in order to assess eculizumab discontinuation in children and adults with aHUS. Fifty-five patients (including 19 children) discontinued eculizumab (mean duration of treatment, 16.5 months). Twenty-eight (51%) patients had complement gene rare variants, mostly in MCP (n= 12, 22%), CFH (n= 6, 11%) and CFI (n=6, 10%) genes. At eculizumab discontinuation, 17 (30%) and 4 (7%) patients had chronic kidney disease stage 3 and 4, respectively. During follow-up, 13 (23%) patients (6 children and 7 adults) experienced aHUS relapse. In multivariable analysis, female gender and the presence of a rare complement gene variant were associated with an increased risk of aHUS relapse, whereas requirement for dialysis during previous episodes of acute aHUS was not. In addition, an increased soluble C5b-9 plasma level at eculizumab discontinuation was associated with a higher risk of aHUS relapse in all patients and in the subset of carriers of complement gene rare variants, in log rank test and in multivariable analysis. Among the 13 relapsing patients, who were all restarted on eculizumab, 11 regained their baseline renal function and two had a worsening of their pre-existing chronic kidney disease, including one patient who progressed to end-stage renal disease. A strategy of eculizumab discontinuation in aHUS patients based on complement genetics is reasonable and safe. It improves the management and quality of life of a sizeable proportion of aHUS patients while reducing the cost of treatment. Trail registration number: NCT02574403.

3.
J Pediatr ; 2020 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-33307111

RESUMO

OBJECTIVE: To examine the effects of early echocardiography-targeted ibuprofen treatment of large patent ductus arteriosus (PDA) on survival without cerebral palsy (CP) at 24 months corrected age. STUDY DESIGN: We enrolled infants born at <28 weeks of gestation with a large PDA on echocardiography at 6-12 hours after birth to ibuprofen or placebo by 12 hours of age in a multicenter, double blind, randomized-controlled trial. Open-label ibuprofen was allowed for prespecified criteria of a hemodynamically significant PDA. The primary outcome was survival without CP at 24 months corrected age. RESULTS: Among 337 enrolled infants, 109 had a small or closed ductus and constituted a reference group; 228 had a large PDA and were randomized. The primary outcome was assessed at 2 years in 108/114 (94.7%) and 102/114 (89.5%) patients allocated to ibuprofen or placebo, respectively. Survival without CP occurred in 77/108 (71.3%) after ibuprofen, 73/102 (71.6%) after placebo (adjusted relative risk (aRR), 0.98, 95% confidence interval (CI) 0.83 to 1.16, P=.83), and 77/101 (76.2%) in reference group. Ibuprofen-treated infants had a lower incidence of PDA at day 3. Severe pulmonary hemorrhage during the first 3 days occurred in 2/114 (1.8%) ibuprofen and 9/114 (7.9%) placebo-treated infants (aRR, 0.22, 95% CI, 0.05 to 1.00, P=.05). Open-label rescue treatment with ibuprofen occurred in 62.3% placebo and 17.5% ibuprofen-treated infants (P<.001), at a median (IQR) age of 4 (3,5) and 4 (4,12) days, respectively. CONCLUSION: Early echocardiography-targeted ibuprofen treatment of a large PDA did not change the rate of survival without CP.

4.
Arch Gynecol Obstet ; 2020 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-33067708

RESUMO

PURPOSE: Placental modifications observed in women with subclinical hypothyroidism (SCH) should be associated with altered fetal development in women with gestational diabetes mellitus (GDM) and worsen perinatal outcome. We aim to determine if SCH is associated with neonatal morbidity in women with GDM. METHODS: A secondary analysis of data collected for a prospective population-based cohort study including all pregnant women with singleton pregnancies at diagnosis of GDM in a tertiary care university hospital. Thyroid-stimulating hormone and free thyroxine were measured at diagnosis of GDM. Perinatal outcome was compared between two groups-women with SCH and euthyroid. Neonatal morbidity was defined by at least one of the following criteria: preterm birth, macrosomia, shoulder dystocia, respiratory distress syndrome, 5-min Apgar score < 7, pH < 7.10, and admission to the NICU (neonatal intensive-care unit) for 24 h. RESULTS: Of the total 200 women enrolled, 150 were evaluable for the study. Of whom, 9 (6%) women presented SCH. The mean gestational age at diagnosis of GDM was 21.7 ± 7.0 weeks. Maternal outcome of women with SCH was similar to euthyroid women. Neonatal morbidity occurred in 17.3% (26/150). Women with SCH had higher rate of neonatal morbidity (44.4% vs. 15.6%; p = 0.03), specifically due to admission to the NICU for 24 h (33.3% vs. 5.7%; p = 0.02). SCH in women with GDM is not associated with neonatal morbidity after controlling for gestational age at birth and admission to NICU (adjusted OR 2.02, 95% CI 0.75-10.23). CONCLUSION: Subclinical hypothyroidism is not associated with neonatal morbidity in women with gestational diabetes mellitus.

5.
J Perinat Med ; 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33001855

RESUMO

Objectives Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days. The test is especially interesting, in that the repetition of antenatal corticosteroids for foetal lung maturation is no longer recommended in France and the effect of the initial administration is most beneficial in the 24 h to 7 days afterwards. Methods We included all studies listed in PubMed and clinicaltrials.gov with the terms "PAMG-1" and either "preterm labor" or "preterm labour", while excluding all studies on the subject of "rupture of the membranes" from 2000 through 2017. Ten studies were thus included. Results In women who had both the PAMG-1 and foetal fibronectin test, the PAMG-1 test was statistically superior to the measurement of cervical length for positive predictive value (p<0.0074), negative predictive value (p=0.0169) and specificity (p<0.001) for the prediction of spontaneous preterm delivery within 7 days. Conclusion The use of PAMG-1 may make it possible to target the women at risk with a shortened cervix on ultrasound (<25 mm) those with an imminent preterm delivery and therefore to adapt management, especially the administration of antenatal corticosteroid therapy.

6.
BMC Pregnancy Childbirth ; 20(1): 442, 2020 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-32746802

RESUMO

BACKGROUND: Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. METHODS: This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation < 3 cm assessed by digital examination. According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). DISCUSSION: The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. TRIAL REGISTRATION: NCT03401255 (January 15, 2018).

7.
Ann Intensive Care ; 10(1): 116, 2020 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-32852675

RESUMO

BACKGROUND: Nonintubated chest trauma patients with fractured ribs admitted to the intensive care unit (ICU) are at risk for complications and may require invasive ventilation at some point. Effective pain control is essential. We assessed whether epidural analgesia (EA) in patients with fractured ribs who were not intubated at ICU admission decreased the need for invasive mechanical ventilation (IMV). We also looked for risk factors for IMV. STUDY DESIGN AND METHODS: This retrospective, observational, multicenter study conducted in 40 ICUs in France included consecutive patients with three or more fractured ribs who were not intubated at admission between July 2013 and July 2015. RESULTS: Of the 974 study patients, 788 were included in the analysis of intubation predictors. EA was used in 130 (16.5%) patients, and 65 (8.2%) patients required IMV. Factors independently associated with IMV were chronic respiratory disease (P = 0.008), worse SAPS II (P < 0.0001), flail chest (P = 0.02), worse Injury Severity Score (P = 0.0003), higher respiratory rate at admission (P = 0.02), alcohol withdrawal syndrome (P < 0.001), and noninvasive ventilation (P = 0.04). EA was not associated with decreases in IMV requirements, median numerical rating scale pain score, or intravenous morphine requirements from day 1 to day 7. CONCLUSIONS: EA was not associated with a lower risk of IMV in chest trauma patients with at least 3 fractured ribs, moderate pain, and no intubation on admission. Further studies are needed to clarify the optimal pain control strategy in chest trauma patients admitted to the ICU, notably those with severe pain or high opioid requirements.

8.
Ann Intensive Care ; 10(1): 82, 2020 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-32542577

RESUMO

BACKGROUND: Recent guidelines advise against prophylactic antibiotics in patients with necrotizing pancreatitis, advocating instead a step-up drainage and necrosectomy strategy with antibiotics as dictated by microbiological findings. However, prompt antibiotic therapy is recommended in patients with sepsis or septic shock, a possible presentation of infected pancreatic necrosis (IPN). Consequently, in many critically ill patients with IPN, pancreatic samples are collected only after broad-spectrum antibiotic therapy initiation. Whether this prior antibiotic exposure alters the microbiological findings is unknown. The main objective was to determine whether prior antibiotic exposure sterilized the samples collected during procedures for suspected IPN in patients admitted to the intensive care unit (ICU) for acute pancreatitis with suspected IPN. We retrospectively studied 56 consecutive ICU patients admitted with suspected IPN. We collected details on the microbiological samples and antimicrobials used. A definite diagnosis of IPN was given when bacteria were identified in pancreatic samples. RESULTS: In all, 137 pancreatic samples were collected, including 91 (66.4%) after antibiotic therapy initiation. IPN was confirmed in 48 (86%) patients. The proportion of positive samples was 74 (81.3%) in antibiotic-exposed patients and 32/46 (69.5%) in unexposed patients (p = 0.58). Of the 74 positive samples from exposed patients, 62 (84%) had organisms susceptible to the antibiotics used. One-third of samples contained more than one organism. Among patients with IPN, 37.5% had positive blood cultures. Multidrug- or extensively drug-resistant bacteria were identified at some point in half the patients. Enterobacter cloacae complex was more frequent in the exposed group (p = 0.02), as were Gram-negative anaerobic bacteria (p = 0.03). CONCLUSION: Antibiotic exposure before sampling did not seem to affect culture positivity of pancreatic samples to confirm IPN, but may affect microbiological findings. Our results suggest that, in patients with sepsis and suspected IPN, antibiotics should be started immediately and pancreatic samples obtained as soon as possible thereafter. In other situations, antibiotics can be withheld until the microbiological results of pancreatic samples are available, to ensure accurate targeting of the spectrum to bacterial susceptibility patterns. ClinicalTrials.gov number NCT03253861.

9.
Trials ; 21(1): 522, 2020 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-32532310

RESUMO

BACKGROUND: Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. METHODS/DESIGN: The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75 mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. DISCUSSION: Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.

10.
J Antimicrob Chemother ; 75(6): 1618-1622, 2020 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-32211883

RESUMO

BACKGROUND: Few long-term data are available in subjects having initiated ART with an NRTI-sparing regimen. OBJECTIVES: Outcomes of subjects enrolled in the NEAT 001/ANRS 143 randomized clinical trial (comparing ritonavir-boosted darunavir + raltegravir versus ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were retrospectively collected, through anonymized electronic case report forms, up to 6 years post-enrolment. METHODS: The last NEAT 001 visit (Week 96) was conducted in 745/805 randomized subjects (363/401 ritonavir-boosted darunavir + raltegravir and 382/404 ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine). Of these, 430 were enrolled in NEAT 001/ANRS 143 LONG TERM (NLT) study (201 raltegravir, 229 tenofovir disoproxil fumarate/emtricitabine), with a median follow-up of 44.4 months. RESULTS: During NLT follow-up, the proportion of AIDS, non-AIDS events, virological rebound and serious adverse events, discontinuation for virological failure and for adverse events did not differ between groups; discontinuations for virological failure since NEAT 001 inclusion were more frequent in subjects with baseline CD4 <200 cells/mm3 (11.9% versus 5.3%; P = 0.077). At last follow-up, a quarter of subjects (22.2% for ritonavir-boosted darunavir + raltegravir and 29.7% for ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine) were still receiving their initial regimen. Integrase inhibitor exposure was not associated with weight gain (P = 0.48), while tenofovir disoproxil fumarate exposure was associated with a trend to higher creatinine increase (P = 0.067). CONCLUSIONS: After a median of 5.6 years, subjects initiating ritonavir-boosted darunavir + raltegravir or ritonavir-boosted darunavir + tenofovir disoproxil fumarate/emtricitabine experienced few serious clinical adverse events. Most discontinuations were for reasons unrelated to adverse events or virological failure.

11.
J Gynecol Obstet Hum Reprod ; 49(4): 101689, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31972352

RESUMO

INTRODUCTION: Bartholin's gland abscesses cause severe pain and are a source of frequent emergency room visits. The most widespread treatment in France is incision-drainage during hospitalisation. A Word catheter, whose efficiency and safety would be identical, could be used without the need for hospitalisation, thus reducing the costs of Bartholin's gland abscess management. DESIGN: Retrospective cohort study. SETTING: French hospital (PMSI) database 2016-2017. POPULATION: 3539 women with Bartholin's gland abscess. METHOD: From the PMSI database, we identified the population that was treated for incision-drainage of a Bartholin's gland abscess in 2016. We also looked for secondary hospitalisations occurring within 12 months of initial treatment of Bartholin's gland abscess using 2016 and 2017 PMSI database data. MAIN OUTCOME(S): The identified population was described in terms of age, hospitalisation, length of stay and readmissions within 12 months and provided a 5-year budget impact analysis of the use of the Word catheter in France from a National Health Insurance perspective. RESULTS: In 2016, 3539 women (36 +/- 11.8 years) were hospitalised for 3646 incisions of the major vestibular gland linked to a Bartholin's gland abscess. 11.38 % (403/3,539) underwent at least one new Bartholin's gland procedure during the following year. The use of the Word catheter would allow potential savings over 5 years of €7.4 million. CONCLUSION: The use of the Word catheter could be cost-saving. These results must be validated by a clinical research step evaluating efficiency in the French context, comparing the Word catheter and incision-drainage side-by-side.

12.
JPEN J Parenter Enteral Nutr ; 44(1): 138-145, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31006879

RESUMO

BACKGROUND: Whether providing nutrition support is beneficial or deleterious during targeted temperature management (TTM) after cardiac arrest is unclear. We therefore performed a retrospective observational study to determine whether early nutrition was beneficial or deleterious during TTM. METHODS: We retrospectively studied patients admitted to our intensive care unit (ICU) between 2008 and 2014 after successfully resuscitated cardiac arrest. We compared the group given nutrition within 48 hours after ICU admission (E+ group) to the group given nutrition later on or not at all (E- group). RESULTS: Of the 203 included patients, 143 were in the E+ group and 60 in the E- group. The E+ group had a significantly higher proportion of patients with a good 3-month neurological outcome (42.7% vs 16.7%, P < 0.001). The difference remained significant after adjustment on a propensity score (odds ratio, 3.47; 95% confidence interval, 1.48-8.14; P = 0.004). The cumulative energy deficit for an energy goal of 20 kcal/kg/d from admission to day 7 was significantly lower in the E+ group (3304 ± 2863 kcal vs 5017 ± 2655 kcal, P < 0.001). Within the E+ group, the subgroups with nutrition initiation when body temperature was <36°C vs ≥36°C were not significantly different regarding the frequencies of early-onset pneumonia, ventilator-associated pneumonia, vomiting, and prokinetic drug use (all P-values > 0.05). CONCLUSIONS: Early nutrition after cardiac arrest during TTM appears safe and may be associated with better neurological outcomes. These findings warrant a randomized controlled trial to resolve the remaining issues.

13.
Clin Lung Cancer ; 21(1): e10-e14, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31648999

RESUMO

BACKGROUND: Osimertinib, a third-generation tyrosine kinase inhibitor, is a new therapeutic option in epidermal growth factor receptor (EGFR)-mutated non-pretreated advanced non-small-cell lung cancer (NSCLC). The tumor escape mechanisms after first-line treatment with osimertinib are partially known; most of the data being obtained by analysis of circulating tumor DNA (ctDNA) from the FLAURA phase III trial. STUDY DESIGN: The MELROSE study, a French multicentric, open label, phase II trial (ClinicalTrials.govNCT03865511) plans to enroll 150 patients with treatment-naive advanced EGFR-mutated (L858R or exon 19 deletion) NSCLC, age ≥ 18 years, with an Eastern Cooperative Oncology Group performance status 0 or 1. All patients will receive osimertinib at the dose of 80 mg/d. Tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria will be performed every 3 months, with brain and thoracoabdominal computed tomographic scan. The continuation of osimertinib is at the discretion of the referring physician, particularly if clinical benefit is observed. The primary objective is the genetic tumor profile, both on tissue biopsy and ctDNA analyses, at the time of disease progression. Other endpoints include kinetic studies of ctDNA, biological progression-free survival (bPFS) (time from first study dose to first biological event on ctDNA), median PFS according to RECIST criteria 1.1 (called radiological [r] PFS), and median clinical (c) PFS (time from the first study dose to off-osimertinib). This study started in April 2019, and 18 centers in France are participants.

14.
J Clin Med ; 8(11)2019 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-31699959

RESUMO

BACKGROUND: Presumed benign ovarian tumours (PBOT) are defined by the International Ovarian Tumour Analysis (IOTA) group, without suspected sonographic criteria of cancer, without ascites or metastasis. The aim is to evaluate the efficacy of human epididymis protein 4 (HE4), cancer antigen 125 (CA125), the risk of malignancy index (RMI) and the risk of ovarian malignancy index (ROMA) to predict ovarian cancer in women with PBOT. METHODS: It is a prospective, observational, multicentre, laboratory-based study including women with PBOT in four hospitals from 11 May 2015 through 12 May 2016. Preoperative CA125 and HE4 plasma levels were measured for all women. The primary endpoint was the specificity of CA125 and HE4 for diagnosing ovarian cancer. The main secondary endpoints were specificity and likelihood ratio of RMI, ROMA and tumours markers. RESULTS: Two hundred and fifty patients were initially enrolled and 221 patients were finally analysed, including 209 benign ovarian tumours (94.6%) and 12 malignant ovarian tumours (5.4%). The malignant group had significantly higher mean values of HE4, CA125, RMI and ROMA compared to the benign group (p < 0.001). Specificity was significantly higher using a combination of HE4 and CA125 (99.5%) compared to either HE4 or CA125 alone (90.4% and 91.4%, respectively, p < 0.001). Moreover, the positive likelihood ratio for combination HE4 and CA125 was significantly higher (104.5; 95% CI 13.6-800.0) compared to HE4 alone (5.81; 95% CI 2.83-11.90) or CA125 alone (6.97; 95% CI 3.91-12.41). CONCLUSIONS: The combination of HE4 and CA125 represents the best tool to predict the risk of ovarian cancer in patients with a PBOT.

15.
Intensive Care Med ; 45(12): 1763-1773, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31654079

RESUMO

PURPOSE: To report the incidence, risk factors, clinical presentation, and outcome predictors of severe leptospirosis requiring intensive care unit (ICU) admission in a temperate zone. METHODS: LEPTOREA was a retrospective multicentre study conducted in 79 ICUs in metropolitan France. Consecutive adults admitted to the ICU for proven severe leptospirosis from January 2012 to September 2016 were included. Multiple correspondence analysis (MCA) and hierarchical classification on principal components (HCPC) were performed to distinguish different clinical phenotypes. RESULTS: The 160 included patients (0.04% of all ICU admissions) had median values of 54 years [38-65] for age, 40 [28-58] for the SAPSII, and 11 [8-14] for the SOFA score. Hospital mortality was 9% and was associated with older age; worse SOFA score and early need for endotracheal ventilation and/or renal replacement therapy; chronic alcohol abuse and worse hepatic dysfunction; confusion; and higher leucocyte count. Four phenotypes were identified: moderately severe leptospirosis (n = 34, 21%) with less organ failure and better outcomes; hepato-renal leptospirosis (n = 101, 63%) with prominent liver and kidney dysfunction; neurological leptospirosis (n = 8, 5%) with the most severe organ failures and highest mortality; and respiratory leptospirosis (n = 17, 11%) with pulmonary haemorrhage. The main risk factors for leptospirosis contamination were contact with animals, contact with river or lake water, and specific occupations. CONCLUSIONS: Severe leptospirosis was an uncommon reason for ICU admission in metropolitan France and carried a lower mortality rate than expected based on the high severity and organ-failure scores. The identification in our population of several clinical presentations may help clinicians establish an appropriate index of suspicion for severe leptospirosis.


Assuntos
Mortalidade Hospitalar , Unidades de Terapia Intensiva/estatística & dados numéricos , Leptospirose/complicações , Leptospirose/epidemiologia , Leptospirose/mortalidade , Insuficiência de Múltiplos Órgãos/epidemiologia , Insuficiência de Múltiplos Órgãos/mortalidade , Adulto , Idoso , Feminino , França/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco
16.
Rech Soins Infirm ; 137(2): 91-98, 2019 06.
Artigo em Francês | MEDLINE | ID: mdl-31453676

RESUMO

Introduction: Treating venous leg ulcers involves replacing dressings and applying compression bandages (CB). The technique for applying these bandages set out in the best practice guidelines shows nurses how to achieve the required level of pressure. Considerable differences have been observed between these guidelines and the actual application of CB. Methodology: An observational study combining a quantitative and a qualitative component was conducted to analyze CB application and explore the elements taken into account by nurses when they perform this procedure. Results: For the 261 patients included in the study, 27% of CB were applied as described in the guidelines. The main difference was that the heel was not included in the bandage in 48% of patients. The freelance nurses interviewed reported taking patient views into account in order to encourage adherence. Discussion: The nursing knowledge identified from the nurse interviews was compared to Carper's "Patterns of Knowing" classification. It would seem that Carper's empirical knowledge is not the only "pattern of knowing" taken into consideration. Patient involvement in the choice of CB application technique, which could be likened to Carper's "esthetic knowledge," helps guide nursing practice.


Assuntos
Bandagens Compressivas , Úlcera Varicosa/enfermagem , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Pesquisa em Avaliação de Enfermagem , Participação do Paciente , Guias de Prática Clínica como Assunto , Pesquisa Qualitativa
17.
BMJ Open ; 9(1): e022553, 2019 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-30782680

RESUMO

INTRODUCTION: Osteoarthritis of the trapeziometacarpal joint affects approximately 10%-25% of women, especially those who are postmenopausal. It may result in thumb dysfunction. Among the treatments, intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) are both effective and recommended. However, clinical trials have shown that HA improves functional capacity, whereas CS only produces a decrease in pain. The synergy of these two drugs has not been evaluated. The primary goal of this study was to determine whether the association between HA and CS produce an additional decrease of more pain during thumb movement at three months postinjection, compared to the level of pain relief from CS alone. METHODS AND ANALYSIS: RHIZ'ART is a prospective, multicentre, comparative, randomised, controlled, double-blind trial. Patients referred to the rheumatology department for thumb rhizarthrosis will receive an injection of betamethasone with HA or placebo (serum saline) based on central randomisation and stratification by centre. Injections will be given under ultrasound guidance. The primary outcome will compare the pain Visual Analogue Scale with motion at three months for both groups using a mixed model. The expected decrease in pain intensity in the CS group is 25% and 35% in the CS with HA group. In order to achieve a 80% power for detecting this difference with α set at 5%, 73 patients are needed in each group (146 total). The main secondary outcomes are the Cochin score (hand function) and grip strength. Follow-up visits are at 1, 3, 6 and 12 months. ETHICS AND DISSEMINATION: The study project has been approved by the appropriate ethics committee (CPP île de France III, 2017-002298-20). In agreement with current French regulations, a signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03431584.


Assuntos
Corticosteroides/administração & dosagem , Ácido Hialurônico/administração & dosagem , Osteoartrite/tratamento farmacológico , Polegar , Pesquisa Comparativa da Efetividade , Método Duplo-Cego , Quimioterapia Combinada , França , Humanos , Injeções Intra-Articulares , Estudos Multicêntricos como Assunto , Medição da Dor/métodos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
18.
Crit Care Med ; 47(4): e340-e348, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30707125

RESUMO

OBJECTIVES: Severe hypoxemia is the most common serious adverse event during endotracheal intubation. Preoxygenation is performed routinely as a preventive measure. The relative efficacy of the various available preoxygenation devices is unclear. Here, our objective was to assess associations between preoxygenation devices and pulse oximetry values during endotracheal intubation. DESIGN: Post hoc analysis of data from a multicenter randomized controlled superiority trial (McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope [MACMAN]) comparing videolaryngoscopy to Macintosh laryngoscopy for endotracheal intubation in critical care. SETTING: Seven French ICUs. PATIENTS: Three-hundred nineteen of the 371 critically ill adults requiring endotracheal intubation who were included in the MACMAN trial. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Minimal pulse oximetry value during endotracheal intubation was the primary endpoint. We also sought risk factors for pulse oximetry below 90%. Of 319 patients, 157 (49%) had bag-valve-mask, 71 (22%) noninvasive ventilation, 71 (22%) non-rebreathing mask, and 20 (7%) high-flow nasal oxygen for preoxygenation. Factors independently associated with minimal pulse oximetry value were the Simplified Acute Physiology Score II severity score (p = 0.03), baseline pulse oximetry (p < 0.001), baseline PaO2/FIO2 ratio (p = 0.02), and number of laryngoscopies (p = 0.001). The only independent predictors of pulse oximetry less than 90% were baseline pulse oximetry (odds ratio, 0.71; 95% CI, 0.64-0.79; p < 0.001) and preoxygenation device: with bag-valve-mask as the reference, odds ratios were 1.10 (95% CI, 0.25-4.92) with non-rebreathing mask, 0.10 (95% CI, 0.01-0.80) with noninvasive ventilation, and 5.75 (95% CI, 1.15-28.75) with high-flow nasal oxygen. CONCLUSIONS: Our data suggest that the main determinants of hypoxemia during endotracheal intubation may be related to critical illness severity and to preexisting hypoxemia. The differences across preoxygenation methods suggest that noninvasive ventilation may deserve preference in patients with marked hypoxemia before endotracheal intubation. Ongoing studies will provide further clarification about the optimal preoxygenation method for endotracheal intubation in critically ill patients.


Assuntos
Estado Terminal/terapia , Intubação Intratraqueal/métodos , Oxigenoterapia/métodos , Oxigênio/administração & dosagem , Insuficiência Respiratória/terapia , Adulto , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
19.
Int J Gynaecol Obstet ; 144(3): 265-270, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30578686

RESUMO

OBJECTIVE: To determine maternal and biological parameters at diagnosis of gestational diabetes mellitus (GDM) as predictors of antenatal insulin therapy (AIT) for glycemic control. METHODS: In this planned secondary analysis of a prospective observational study, we recruited women diagnosed with GDM between July 1, 2014, and October 31, 2015. Maternal and biological parameters were analyzed as predictors of AIT using multivariable logistic regression analyses. Predictive accuracy of a cut-off value for a biological predictor was determined using the area under the receiver operating characteristic curve (AUC) and the Youden index (J). RESULTS: Of 200 women included (mean gestational age 22 ± 6 weeks), 72 (36%) required AIT. No maternal characteristic was associated with AIT. Glycated hemoglobin (HbA1c; adjusted odds ratio [aOR] 3.15, 95% CI 1.03-9.69) and elevated 1-hour oral glucose tolerance test (OGTT; aOR 1.23, 95% CI 1.13-1.46) were predictors of AIT. Analyses suggested inaccurate prediction of AIT, with an optimal cut-off HbA1c value of 5.4% (J=0.14; AUC 0.58, 95% CI 0.48-0.67), and an optimal 1-hour plasma glucose OGTT value of 1.77 mg/dL (J=0.24; AUC 0.62, 95% CI 0.50-0.74). CONCLUSION: HbA1c at diagnosis of GDM and elevated 1-hour OGTT were independent predictors of AIT for glycemic control. Clinicaltrials.gov: NCT02159378.


Assuntos
Diabetes Gestacional/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Adulto , Diabetes Gestacional/sangue , Feminino , Teste de Tolerância a Glucose , Hemoglobina A Glicada/análise , Humanos , Razão de Chances , Valor Preditivo dos Testes , Gravidez , Estudos Prospectivos
20.
Anesthesiology ; 129(6): 1111-1120, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30234580

RESUMO

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Craniotomy for brain tumor displays significant morbidity and mortality, and no score is available to discriminate high-risk patients. Our objective was to validate a prediction score for postoperative neurosurgical complications in this setting. METHODS: Creation of a score in a learning cohort from a prospective specific database of 1,094 patients undergoing elective brain tumor craniotomy in one center from 2008 to 2012. The validation cohort was validated in a prospective multicenter independent cohort of 830 patients from 2013 to 2015 in six university hospitals in France. The primary outcome variable was postoperative neurologic complications requiring in-intensive care unit management (intracranial hypertension, intracranial bleeding, status epilepticus, respiratory failure, impaired consciousness, unexpected motor deficit). The least absolute shrinkage and selection operator method was used for potential risk factor selection with logistic regression. RESULTS: Severe complications occurred in 125 (11.4%) and 90 (10.8%) patients in the learning and validation cohorts, respectively. The independent risk factors for severe complications were related to the patient (Glasgow Coma Score before surgery at or below 14, history of brain tumor surgery), tumor characteristics (greatest diameter, cerebral midline shift at least 3 mm), and perioperative management (transfusion of blood products, maximum and minimal systolic arterial pressure, duration of surgery). The positive predictive value of the score at or below 3% was 12.1%, and the negative predictive value was 100% in the learning cohort. In-intensive care unit mortality was observed in eight (0.7%) and six (0.7%) patients in the learning and validation cohorts, respectively. CONCLUSIONS: The validation of prediction scores is the first step toward on-demand intensive care unit admission. Further research is needed to improve the score's performance before routine use.


Assuntos
Neoplasias Encefálicas/cirurgia , Craniotomia/efeitos adversos , Doenças do Sistema Nervoso/epidemiologia , Procedimentos Neurocirúrgicos/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Encefálicas/patologia , Estudos de Coortes , Feminino , Escala de Coma de Glasgow , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/normas , Unidades de Terapia Intensiva/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/etiologia , Doenças do Sistema Nervoso/mortalidade , Procedimentos Neurocirúrgicos/métodos , Admissão do Paciente/normas , Complicações Pós-Operatórias/mortalidade , Valor Preditivo dos Testes , Estudos Prospectivos , Fatores de Risco
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