Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial.

INTRODUCTION: Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation. METHODS AND ANALYSIS: The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation. ETHICS AND DISSEMINATION: The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III-PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04273360.

Persistent headaches one year after bacterial meningitis: prevalence, determinants and impact on quality of life.

BACKGROUND: Little is known on headaches long-term persistence after bacterial meningitis and on their impact on patients' quality of life. METHODS: In an ancillary study of the French national prospective cohort of community-acquired bacterial meningitis in adults (COMBAT) conducted between February 2013 and July 2015, we collected self-reported headaches before, at onset, and 12 months (M12) after meningitis. Determinants of persistent headache (PH) at M12, their association with M12 quality of life (SF 12), depression (Center for Epidemiologic Studies Depression Scale) and neuro-functional disability were analysed. RESULTS: Among the 277 alive patients at M12 87/274 (31.8%), 213/271 (78.6%) and 86/277 (31.0%) reported headaches before, at the onset, and at M12, respectively. In multivariate analysis, female sex (OR: 2.75 [1.54-4.90]; p < 0.001), pre-existing headaches before meningitis (OR: 2.38 [1.32-4.30]; p < 0.01), higher neutrophilic polynuclei percentage in the CSF of the initial lumbar puncture (OR: 1.02 [1.00-1.04]; p < 0.05), and brain abscess during the initial hospitalisation (OR: 8.32 [1.97-35.16]; p < 0.01) were associated with M12 persistent headaches. Neither the responsible microorganism, nor the corticoids use were associated with M12 persistent headaches. M12 neuro-functional disability (altered Glasgow Outcome Scale; p < 0.01), M12 physical handicap (altered modified Rankin score; p < 0.001), M12 depressive symptoms (p < 0.0001), and M12 altered physical (p < 0.05) and mental (p < 0.0001) qualities of life were associated with M12 headaches. CONCLUSION: Persistent headaches are frequent one year after meningitis and are associated with quality of life alteration. CLINICAL TRIAL: NCT01730690.

Cytokine profiles in adults with imported malaria.

The increase in worldwide travel is making imported malaria a growing health concern in non-endemic countries. Most data on the pathophysiology of malaria come from endemic areas. Little is known about cytokine profiles during imported malaria. This study aimed at deciphering the relationship between cytokine host response and malaria severity among imported cases in France. This study reports cytokine profiles in adults with Plasmodium falciparum malaria included in the PALUREA prospective study conducted between 2006 and 2010. The patients were classified as having uncomplicated malaria (UM) or severe malaria (SM), with this last further categorized as very severe malaria (VSM) or less severe malaria (LSM). At hospital admission, eight blood cytokines were assayed in duplicate using Luminex® technology: interleukin (IL)-1α, IL-1ß, IL-2, IL-4, IL-10, tumor necrosis factor (TNF)α, interferon (IFN)γ, and macrophage migration inhibitory factor (MIF). These assays were repeated on days 1 and 2 in the SM group. Of the 278 patients, 134 had UM and 144 SM. At hospital admission, over half the patients had undetectable levels of IL-1α, IL-1ß, IL-2, IL-4, IFNγ, and TNFα, while IL-10 and MIF were significantly higher in the SM vs. the UM group. Higher IL-10 was significantly associated with higher parasitemia (R = 0.32 [0.16-0.46]; P = 0.0001). In the SM group, IL-10 elevation persisting from admission to day 2 was significantly associated with subsequent nosocomial infection. Of eight tested cytokines, only MIF and IL-10 were associated with disease severity in adults with imported P. falciparum malaria. At admission, many patients had undetectable cytokine levels, suggesting that circulating cytokine assays may not be helpful as part of the routine evaluation of adults with imported malaria. Persisting high IL-10 concentration was associated with subsequent nosocomial infection, suggesting its possible interest in immune monitoring of most severe patients.

[Therapeutic alliance between sectorial psychiatry inpatients and nurses and aides: A prospective, observational and cross-sectional study]. / Alliance Thérapeutique Entre Les Patients Hospitalisés En Psychiatrie De Secteur Et Les Infirmier(e)s Et Aide-Soignant(e)s: Une Etude Prospective, Observationnelle Et Transversale.

BACKGROUND: Therapeutic alliance represents a rarely studied object when it relates to nurses and care provided by a nursing team in acute care hospitalization. OBJECTIVE: The objective was to study how factors might influence the therapeutic alliance built between nurses and aides and adult inpatients in an acute care unit of sectorial general psychiatry. METHOD: This is a prospective, observational and cross-sectional study using a therapeutic alliance measurement scale. Therapeutic alliance (TA) score was measured with a STAR-P scale in a sample of 240 patients. RESULTS: The median score found is 33.4 (±7.8) out of a maximum theoretical score of 48. The global score of TA in patients aged 60 years old or more is significantly higher than the score of patients between 18 and 29 years old (p=0.021). The lack of external follow-up in the three months after hospital release is not associated with TA global score (p=0.73). If inpatients, no matter what their diseases or types of care are, under legal obligation or not, consider their TA is rather good after their hospital stay. Only sociodemographic factors like age, housing conditions (insecure or sustainable), having a job or not, living alone or with a partner affect TA and follow-up. CONCLUSION: Results evoke concepts of anomie and attachment, that seem to play an important role in the lack of follow-up after hospital stay, and indicate the mandatory global approach to care and an involvement of health professionals as well as social beings, where empathy must find its place.

CONTEXTE: L'alliance thérapeutique représente un objet très peu étudié quand il concerne les infirmiers et les soins prodigués par une équipe infirmière et dans le cadre de l'hospitalisation en soins aigus. OBJECTIF: L'objectif était d'étudier l'influence de facteurs sur l'alliance thérapeutique construite entre les infirmier(e)s et les aides-soignant(e)s et les patients adultes hospitalisés dans un service de soins aigus en psychiatrie générale de secteur. MÉTHODE: Il s'agit d'une étude prospective, observationnelle et transversale utilisant une échelle de mesure de l'alliance thérapeutique. Le score d'alliance thérapeutique (AT) a été mesuré à l'aide de l'échelle STAR-P sur un échantillon de 240 patients. RÉSULTATS: Le score moyen obtenu est de 33,4 (±7,8) sur un score maximum théorique de 48. Le score global d'AT des patients âgés de 60 ans ou plus, est significativement plus élevé que celui des patients ayant entre 18 et 29 ans (p = 0,021). L'absence de suivi ambulatoire au cours des trois mois suivant la sortie d'hospitalisation n'est pas associée au score global d'AT (p = 0,73). Si les patients hospitalisés, quelques soit leurs troubles et les différentes formes de soins, sous obligation légale ou non, jugent plutôt bonne l'AT à l'issue de leur hospitalisation. Seuls des facteurs sociaux-démographiques comme, l'âge, les conditions d'hébergement (précaire ou durable), avoir ou non un emploi, vivre seul ou avec un partenaire influent sur l'AT et le suivi. CONCLUSION: Les résultats convoquent les concepts d'anomie et d'attachement, qui semblent jouer un rôle important dans l'absence de suivi post-hospitalisation, ce qui indiquent la nécessaire approche globale des soins et une implication des professionnels de santé mais aussi du social où l'empathie doit trouver sa place.

Relationship between serotypes, disease characteristics and 30-day mortality in adults with invasive pneumococcal disease.

PURPOSE: Invasive pneumococcal disease (IPD) is responsible for substantial mortality and morbidity worldwide. We aimed to identify host and bacterial factors associated with 30-day mortality in 18-year-old patients hospitalized with IPD in France from 2013 to 2015. METHODS: This study analyzed data collected from consecutives IPD cases included in two parallel multi-center cohort studies: COMBAT study (280 patients with pneumococcal community-acquired bacterial meningitis) and SIIP study (491 patients with non-meningitis IPD). Factors associated with 30-day mortality were identified using logistic regression. RESULTS: Among the 771 enrolled patients (median age 66 years, IQR [52.0-79.7]), 592/767 (77.2%) had at least one chronic disease. Patients with meningitis were younger (60.2 vs 70.9 years; p < 0.001) and had fewer chronic diseases than those with non-meningitis IPD (73.3% vs 79.4%; p = 0.05). Non-vaccine serotypes were more frequent in meningitis patients than in those with other IPD (36.1% vs 23.1%; p < 0.001). The overall 30-day mortality was 16.7% and patients with concurrent meningitis and extra-cerebral IPD had the highest 30-day mortality rate (26.5%). On multivariate analyses, older age, history of malignant solid tumor, meningeal IPD and serotypes previously identified with high mortality potential were independently associated with 30-day mortality. Of the serotypes with high mortality potential, 80% were included in licensed (PCV13 or PPV23) vaccines. CONCLUSION: We observed an effect of both host factors and pneumococcal serotypes on 30-day mortality in IPD. This highlights the need for a focused strategy to vaccinate at-risk patients. CLINICAL TRIAL: ClinicalTrial. Gov identification number: NCT01730690.

Rivaroxaban Prophylaxis in Noncirrhotic Portal Vein Thrombosis.

Rivaroxaban Prophylaxis in Noncirrhotic PVTThis trial assessed the effects of rivaroxaban on the risk of venous thromboembolism and portal hypertension-related bleeding in patients with noncirrhotic chronic portal vein thrombosis without major risk factors for thrombosis. Daily rivaroxaban use reduced the incidence of venous thromboembolism and did not increase major bleeding events.

[Impact of a coordinated regional organization to secure the management of patients on oral anticancer drugs: CHIMORAL, a comparative trial]. / Impact d'une organisation régionale coordonnée pour sécuriser la prise en charge des patients sous anticancéreux oraux : CHIMORAL, une étude comparative.

INTRODUCTION: Oral anticancer drugs have disrupted hospital and community practices. A better coordination and patient support for medication and adverse events management by primary care providers (general practitioner, community pharmacist and liberal nurse) could improve the situation. The CHIMORAL study evaluated a model of coordination by territorial health networks. METHODS: A here and elsewhere, prospective and multicentric study, comparing coordinated care with standard care. Primary outcome was the use of the hospital structure for adverse events within 6 months of initiating treatment. RESULTS: In all, 283 patients were included. 92% had at least one adverse event, with a higher median number in the coordinated group (12.5 vs. 9.0, P=0.02). No difference in hospital use by arm (P=0.502). Increase in the use of community care for adverse events in the coordinated group (27% vs. 16%, P=0.009). No observed impact on progression rates, quality of life and treatment adherence. The overall survival rate at 6 months is numerically higher in the coordinated group (87% vs. 76%, P=0.064). DISCUSSION: This model does not show any difference on the primary endpoint. The lack of randomization, patient selection, power loss, and local initiatives to monitor these patients may have biased the analysis. A large number of uses of the healthcare system were observed. These results confirm the need for a dedicated care pathway for the patient with oral anticancer drugs.

Prevention of shoulder dystocia: A randomized controlled trial to evaluate an obstetric maneuver.

OBJECTIVE: Shoulder dystocia is a major obstetric emergency defined as a failure of delivery of the fetal shoulder(s). This study evaluated whether an obstetric maneuver, the push back maneuver performed gently on the fetal head during delivery, could reduce the risk of shoulder dystocia. STUDY DESIGN: We performed a multicenter, randomized, single-blind trial to compare the push back maneuver with usual care in parturient women at term. The primary outcome, shoulder dystocia, was considered to have occurred if, after delivery of the fetal head, any additional obstetric maneuver, beginning with the McRoberts maneuver, other than gentle downward traction and episiotomy was required. RESULTS: We randomly assigned 522 women to the push back maneuver group (group P) and 523 women to the standard vaginal delivery group (group S). Finally, 473 women assigned to group P and 472 women assigned to group S delivered vaginally. The rate of shoulder dystocia was significantly lower in group P (1·5%) than in group S (3·8%) (odds ratio [OR] 0·38 [0·16-0·92]; P = 0·03). After adjustment for predefined main risk factors, dystocia remained significantly lower in group P than in group S. There were no significant between-group differences in neonatal complications, including brachial plexus injury, clavicle fracture, hematoma and generalized asphyxia. CONCLUSION: In this trial in 945 women who delivered vaginally, the push back maneuver significantly decreased the risk of shoulder dystocia, as compared with standard vaginal delivery.

Serum uric acid levels are associated with cardiovascular risk score: A post hoc analysis of the EURIKA study.

BACKGROUND: Reports are conflicting on whether serum uric acid (sUA) levels are independently associated with increased cardiovascular (CV) death risk. METHODS: This post hoc analysis assessed the relationship between sUA levels and CV death risk score in 7531 patients from the cross-sectional, multinational EURIKA study (NCT00882336). Patients had at least one CV risk factor but no clinical CV disease. Ten-year risk of CV death was estimated using SCORE-HDL and SCORE algorithms, categorized as low (<1%), intermediate (1% to <5%), high (≥5% to <10%) or very high (≥10%). RESULTS: Mean serum sUA levels increased significantly with increasing CV death risk category in the overall population and in subgroups stratified by diuretics use or renal function (all P<0.0001). Multivariate ordinal logistic regression analyses, adjusted for factors significantly associated with CV death risk in univariate analyses (study country, body mass index, number of CV risk factors and comorbidities, use of lipid lowering therapies, antihypertensives and antidiabetics), showed a significant association between sUA levels and SCORE-HDL category in the overall population (OR: 1.39 [95% CI: 1.34-1.44]) and all subgroups (using diuretics: 1.32 [1.24-1.40]; not using diuretics: 1.46 [1.39-1.53]; estimated glomerular filtration rate [eGFR]<60ml/min/1.73m2: 1.30 [1.22-1.38]; eGFR≥60ml/min/1.73m2: 1.44 [1.38-1.51]; all P<0.0001). Similar results were obtained when using SCORE. CONCLUSIONS: Higher sUA levels are associated with progressively higher 10-year CV death risk score in patients with at least one CV risk factor but no CV disease.

Effect of a Red Blood Cell Transfusion on Biological Markers Used to Determine the Cause of Anemia: A Prospective Study.

BACKGROUND: Blood test results required for the evaluation of anemia are considered difficult to interpret after red blood cell transfusion. However, this hypothesis is neither supported by a strong physiological rationale nor is it evidence based. METHODS: We conducted a prospective multicenter study to compare the values of key assays prior to and after a course of red blood cell transfusion in the emergency or internal medicine units in 4 university hospitals. The following parameters were measured prior to and within 48 to 72 hours after transfusion: complete blood count with reticulocyte count, direct Coombs' test, ferritin, transferrin saturation, soluble transferrin receptor, serum and erythrocyte folate, cobalamin, lactate dehydrogenase, bilirubin, haptoglobin, and C-reactive protein. We investigated the impact of transfusion on these parameters and assessed whether abnormal values prior to the transfusion became normal after transfusion (or conversely). RESULTS: There were 77 patients included in the study. Changes in mean values of mean corpuscular volume, soluble transferrin receptor, erythrocyte folate, cobalamin, haptoglobin, lactate dehydrogenase, C-reactive protein, and direct Coombs' test were not statistically significant. Changes in reticulocyte count, ferritin, transferrin saturation, serum folate, and total bilirubin concentrations were statistically significant, but they remained in the same diagnostic category (normal or abnormal) in 79% to 98% of the cases; 97% of patients with iron deficiency still had low ferritin or transferrin saturation after a transfusion. CONCLUSION: Blood tests performed after a one-time red blood cell transfusion can be used to establish the cause of anemia when they have not been performed before.

Correction to: Imported falciparum malaria in adults: host- and parasite-related factors associated with severity. The French prospective multicenter PALUREA cohort study.

The members of the Palurea Study Group were provided in such a way that they could not be indexed as collaborators on PubMed. The publisher apologizes for this error and is pleased to list the members of the group here.

Skeletal evolution in Marfan syndrome: growth curves from a French national cohort.

BackgroundTo describe the growth patterns of children affected by Marfan syndrome (MFS) compared with those of unaffected children and to create growth charts.MethodsAn observational study of children referred to the French National MFS Reference Centre. A total of 259 children carrying an FBN1 gene mutation and fulfilling Ghent 1 criteria (MFS group) and 474 mutation-negative sibling controls (non-MFS group) were evaluated. Both groups were compared with French-accepted reference nomograms (Reference group).ResultsBoys and girls from the MFS group were significantly taller than those in the non-MFS group and in the reference group at all ages (P<0.0001). But, MFS children's overgrowth reduced with age. At 17 years of age, the mean height (MFS vs. non-MFS) was 191.2±8.4 cm (+2.9 SD) vs. 182.9±8.1 (+1.6 SD) for boys and 178.3±7.6 cm (+2.7 SD) vs. 169.5±6.8 (+1.2 SD) for girls, respectively. By contrast, the mean BMI of children in the MFS group was similar to those in the non-MFS group and inferior to the values of French general population, evolving around -1 SD.ConclusionGrowth patterns differ in patients with an FBN1 mutation. Knowing the growth parameters should allow physicians to better counsel patients and detect the associated diseases. The provided curves could also help to predict the final height.

Prevalence and treatment of atherogenic dyslipidemia in the primary prevention of cardiovascular disease in Europe: EURIKA, a cross-sectional observational study.

BACKGROUND: Atherogenic dyslipidemia is associated with poor cardiovascular outcomes, yet markers of this condition are often ignored in clinical practice. Here, we address a clear evidence gap by assessing the prevalence and treatment of two markers of atherogenic dyslipidemia: elevated triglyceride levels and low levels of high-density lipoprotein cholesterol. METHODS: This cross-sectional observational study assessed the prevalence of two atherogenic dyslipidemia markers, high triglyceride levels and low high-density lipoprotein cholesterol levels, in the study population from the European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice (EURIKA; N = 7641; of whom 51.6% were female and 95.6% were White/Caucasian). The EURIKA population included European patients, aged at least 50 years with at least one cardiovascular risk factor but no history of cardiovascular disease. RESULTS: Over 20% of patients from the EURIKA population have either triglyceride or high-density lipoprotein cholesterol levels characteristic of atherogenic dyslipidemia. Furthermore, the proportions of patients with one of these markers were higher in subpopulations with type 2 diabetes mellitus or those already calculated to be at high risk of cardiovascular disease. Approximately 55% of the EURIKA population who have markers of atherogenic dyslipidemia are not receiving lipid-lowering therapy. CONCLUSIONS: A considerable proportion of patients with at least one major cardiovascular risk factor in the primary cardiovascular disease prevention setting have markers of atherogenic dyslipidemia. The majority of these patients are not receiving optimal treatment, as specified in international guidelines, and thus their risk of developing cardiovascular disease is possibly underestimated. TRIAL REGISTRATION: The present study is registered with ClinicalTrials.gov (ID: NCT00882336).

Perip7lakin is a target for autoimmunity in asthma.

The role of autoimmunity targeting epithelial antigens in asthma has been suggested, in particular in non-atopic and severe asthma. Periplakin, a desmosomal component, is involved in epithelial cohesion and intracellular signaling. We detected anti-periplakin IgG antibodies in 47/260 (18 %) patients with asthma, with no association with severity or atopy. In addition, anti-periplakin IgE antibodies were detected in 12 of 138 tested patients (8.7 %) and were more frequently observed in patients with than without nasal polyposis. This study identifies a new autoimmune epithelial target in asthma. Whether periplakin autoimmunity (both IgG and IgE auto-antibodies) is involved in asthma pathogenesis remains to be studied during the disease course of these patients.

The association between blood pressure and lipid levels in Europe: European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice.

OBJECTIVES: Several studies have suggested a positive association between serum lipid levels and blood pressure (BP). This study investigated this association in a large population from 12 European countries. METHODS: Data were taken from the European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice (ClinicalTrials.gov identifier: NCT00882336). Associations between BP and lipid levels in patients free from cardiovascular disease and with at least one major cardiovascular disease risk factor (N = 7641) were assessed using linear regression analyses. RESULTS: Overall, 72.8 and 64.8% of patients had hypertension and dyslipidaemia, respectively; 47.0% had both conditions. Regression coefficients (95% confidence interval) for the associations of LDL cholesterol, non-HDL cholesterol, total cholesterol and apolipoprotein B levels with SBP, adjusted for age, sex and BMI, were 0.93 mmHg/mmol per l (0.54-1.31), 1.07 mmHg/mmol per l (0.73-1.40), 1.02 mmHg/mmol per l (0.69-1.35) and 4.94 mmHg/g per l (3.43-6.46), respectively. The corresponding values (95% confidence interval) for the associations with DBP were 0.96 mmHg/mmol per l (0.73-1.19), 0.95 mmHg/mmol per l (0.75-1.15), 0.87 mmHg/mmol per l (0.67-1.07) and 4.33 mmHg/g per l (3.42-5.23), respectively. Most of these associations remained significant whether patients were treated with statins or not. CONCLUSION: Small but statistically significant associations between lipid levels and BP were observed in a large, multinational European population. Further research is warranted to assess the causality of this association and its implications on the management of patients with both hypertension and dyslipidaemia.

Imported falciparum malaria in adults: host- and parasite-related factors associated with severity. The French prospective multicenter PALUREA cohort study.

PURPOSE: Prospective data on potential factors associated with severity of imported Plasmodium falciparum malaria are lacking. We evaluated whether several host- and parasite-related biomarkers may improve early severity evaluation. METHODS: Prospective multicenter observational study comparing uncomplicated and severe imported falciparum malaria in adults conducted in France in 52 units, from 2007 to 2010. Association of several host- and parasite-related biomarkers with severity of malaria was tested using univariate and multivariate analyses. RESULTS: Of 295 patients, 140 had uncomplicated malaria and 155 severe malaria (including very severe and less severe cases according to predefined criteria). Curative intravenous quinine treatment was used in 154/155 patients with severe malaria and atovaquone/proguanil in 74 % of patients with uncomplicated malaria. Hospital mortality was 5.2 % (8 patients), all in the severe malaria group. Among host-related biomarkers, CRP, procalcitonin, and sTREM-1 were significantly higher and albumin was significantly lower in severe versus uncomplicated malaria; only the last three biomarkers also differed significantly between the very and less severe malaria groups. Among parasite-related biomarkers, only plasma PfHRP2 was significantly higher in severe versus uncomplicated malaria and in very severe versus less severe malaria; parasitemia did not differ between very and less severe malaria. By multivariate analysis, only lower plasma albumin and higher sTREM-1 were associated with greater severity, with intermediate accuracies. CONCLUSIONS: During imported malaria, the most useful biomarkers associated with severity seem to be plasma albumin and sTREM-1; and among parasite-related parameters, PfHRP2 was more strongly associated with severity than parasitemia was.

Lack of control of hypertension in primary cardiovascular disease prevention in Europe: Results from the EURIKA study.

BACKGROUND: The prevalence of and factors associated with uncontrolled hypertension and apparent resistant hypertension were assessed in the European Study on Cardiovascular Risk Prevention and Management in Usual Daily Practice (EURIKA; NCT00882336). METHODS: EURIKA was a cross-sectional observational study including patients being treated for the primary prevention of cardiovascular disease in 12 European countries. Patients were assessed if they were being treated for hypertension (N=5220). Blood pressure control was defined according to European guidelines, with sensitivity analysis taking account of patients' age and diabetes status. Associated factors were assessed using multivariate analysis. RESULTS: In the primary analysis, a total of 2691 patients (51.6%) had uncontrolled hypertension. Factors significantly associated with an increased risk of having uncontrolled hypertension included female sex (odds ratio [OR]: 2.29; 95% confidence interval [CI]: 1.93-2.73), body mass index (BMI; OR per kg/m(2): 1.03; 95% CI: 1.01-1.04), and geographic location. A total of 749 patients (14.3%) had apparent resistant hypertension. Factors significantly associated with an increased risk of having apparent resistant hypertension included BMI (OR per kg/m(2): 1.06; 95% CI: 1.04-1.08), diabetes (OR: 1.28; 95% CI: 1.06-1.53), use of statins (OR: 1.36; 95% CI: 1.15-1.62), serum uric acid levels (OR: 1.16; 95% CI: 1.09-1.23), and geographic location. Similar results were seen in sensitivity analyses. CONCLUSIONS: Over 50% of patients treated for hypertension continued to have uncontrolled blood pressure and 14.3% had apparent resistant hypertension. Positive associations were seen with other cardiovascular risk factors.

Anti-Saccharomyces cerevisiae antibodies (ASCA) in spondyloarthritis: Prevalence and associated phenotype.

OBJECTIVE: The aim of the study was to compare the prevalence of ASCA in spondyloarthrites (SpA) patients and to investigate the association between ASCA status and disease phenotype. METHODS: We performed a case-control study including SpA individuals fulfilling the ESSG SpA criteria. The following data were collected for analysis: gender, age, disease duration, clinical or associated features of SpA, treatments, HLAB27 and ASCA status. A control group of patients without SpA was also analyzed. RESULTS: A total of 235 patients with SpA and 54 control patients were studied. The median age of SpA patients (53.6% of male patients, 52.2% of HLAB27) was 46.0 [IQR 35.0-57.0] years old. Disease duration was 60.0 [IQR 24.0-156.0] months. Inflammatory bowel diseases were observed in 11% of SpA patients. ASCA positivity was significantly higher in SpA patients than in control patients (25.5% [95% CI 20.1-31.6] (IgG: 9.8%; IgA: 21.7%) vs. 7.4% [95% CI 2.1-17.9], P=0.004). Multivariate analysis revealed that ASCA positivity was associated with peripheral involvement (OR: 3.30 [1.26-8.62], P=0.015), presence of IBD (OR: 3.43 [1.15-10.20], P=0.026), past of present history of uveitis (OR: 4.36 [1.08-17.64], P=0.039) and arthritis (OR: 3.78 [1.57-9.15], P=0.003). CONCLUSION: Our results provided evidence that SpA patients had an increased prevalence of ASCA and that ASCA positivity might be associated with a particular phenotype, notably peripheral involvement and uveitis.

Increased volume of conducting airways in idiopathic pulmonary fibrosis is independent of disease severity: a volumetric capnography study.

Bronchiectasis, bronchiolectasis, and bronchiolisation of alveolar regions are salient features of idiopathic pulmonary fibrosis (IPF). We asked whether IPF was associated with physiological changes consistent with increases in the volume of conducting airways, and whether airway volume was related to the severity of lung fibrosis. Patients with IPF (N = 57, vital capacity-VC: 73 ± 20%), patients with non-IPF interstitial lung disease (non-IPF ILD, N = 24, VC = 78 ± 18%) and controls without lung disease (N = 51, VC = 112 ± 21%) underwent volumetric capnography for the determination of conducting airway volume using Fletcher's equal area method, reported to predicted total lung capacity to control for the effect of lung size (VDaw/TLCp, mL/L). VDaw/TLCp was higher in patients with IPF (45.3 ± 12.8 ml L(-1)) in comparison with controls (34.2 ± 11.0 ml L(-1), p < 0.0001) and patients with non-IPF ILD (39.5 ± 9.2 ml L(-1), p = 0.0496). The same differences were observed when analysis was restricted to subjects with moderate IPF (VC ⩾ 80% predicted). Among IPF patients, VDaw/TLCp was correlated with neither the mMRC dyspnea scale, nor VC, nor carbon monoxide transfer factor, nor computed tomography fibrosis scores. Volumetric capnography showed higher conducting airway volume in IPF patients in comparison with controls and non-IPF ILDs, independent of disease severity. This result is consistent with either anatomical predisposition or dilation/longitudinal growth of conducting airways in IPF.