Practice patterns and 90-day treatment-related morbidity in early-stage cervical cancer

To evaluate the impact of the Laparoscopic Approach to Cervical Cancer (LACC) Trial on patterns of care and surgery-related morbidity in early-stage cervical cancer

Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Introduction Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked.This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register.MethodsThe Register collects, through a standardized Web-based Application, unique patients.Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated.ResultsThe Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients.The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000-2015) to 60% (enrolment period 2016-2022). In the cohort of patients registered after 2016, there were >= 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2).Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months.ConclusionsData from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications

Polysomnograph Chart View by Patients: A New Educational Strategy to Improve CPAP Adherence in Sleep Apnea Therapy

BACKGROUND: CPAP is currently the treatment of choice for obstructive sleep apnea syndrome, but therapy adherence is poor. Many educational trials have been proposed to increase CPAP adherence. We tested the hypothesis that polysomnograph chart viewing by patients would improve CPAP adherence. METHODS: A controlled parallel group study was performed with 206 newly diagnosed obstructive sleep apnea syndrome patients, randomized into 2 groups (n = 103 each): standard support group, and educational support group. Each educational support group subject viewed 2 consecutive polysomnograms on the computer screen: the first recorded during a standard diagnostic overnight polysomnography, and the second during a full-night polysomnography with nasal CPAP. The subject's attention was drawn only to the flow and oxyhemoglobin saturation curves. Clinical outcomes were assessed via polysomnography at CPAP initiation and after 1, 3, and 12 months. RESULTS: After 12 months of CPAP, 76% of the educational support group and 52% of the standard support group returned for a follow-up visit (P <.001). Statistical significance had already been reached after 1 and 3 months. Moreover, CPAP use (measured as hours of use per night) was higher in the educational support group at each control visit. CONCLUSIONS: Polysomnograph chart viewing by obstructive sleep apnea patients can increase CPAP adherence, as evaluated by rate of return for the follow-up visit and mean nightly CPAP use. © 2014 Daedalus Enterprises

Clinical and Functional Lung Parameters Associated With Frequent Exacerbator Phenotype in Subjects With Severe COPD

COPD is currently recognized as a syndrome associated with a high prevalence of comorbidities and various phenotypes. Exacerbations are very important events in the clinical history of COPD because they drive the decline in lung function. In the present study, we aim to identify whether there are any clinical and functional specific features of frequent exacerbators in a population of patients with severe COPD

Using PaCO2 values to grade obesity-hypoventilation syndrome severity: a retrospective study

Background: To date, an important aspect that has still not been clarified is the assessment of OHS severity. The purpose of this retrospective study was to evaluate whether grading OHS severity according to PaCO2 values may be useful in order to provide a more definite characterization and targeted management of patients. In this regard, baseline anthropometric and sleep polygraphic characteristics, treatment options, and follow up outcomes, were compared between OHS patients with different degree of severity (as assessed according to PaCO2 values). Methods: Patients were classified into three groups, according to PaCO2 values: 1) mild (46 mmHg ≤ PaCO2 ≤ 50 mmHg), moderate (51 mmHg ≤ PaCO2 ≤ 55 mmHg), severe (PaCO2 ≥ 56 mmHg). Therefore, differences among the groups in terms of baseline anthropometric, and sleep polygraphic characteristics, treatment modalities and follow up outcomes were retrospectively evaluated. Results: Patients with more severe degree of hypercapnia were assessed to have increased BMI and bicarbonate levels, worse diurnal and nocturnal hypoxemia, and a more severe impairment in pulmonary mechanics compared to milder OHS. CPAP responders rate significantly decreased from mild to severe OHS. After follow up, daytime sleepiness (as measure by the ESS), PaO2, and PaCO2 significantly improved with PAP therapy in all three groups. Discussion and Conclusions: Classification of OHS severity according to PaCO2 levels may be useful to provide a more defined characterization and, consequently, a more targeted management of OHS patients. Further studies are needed to confirm our findings

Obstructive Sleep Apnea, Hypertension, and Their Additive Effects on Atherosclerosis

Background and Aims. It is widely accepted that obstructive sleep apnea (OSA) is independently associated with atherosclerosis. Similar to OSA, hypertension (HTN) is a condition associated with atherosclerosis. However, to date, the impact of the simultaneous presence of OSA and HTN on the risk of atherosclerosis has not been extensively studied. The aim of this study was to evaluate the consequences of the coexistence of OSA and HTN on carotid intima-media thickness (IMT) and on inflammatory markers of atherosclerosis (such as interleukin- [IL-] 6 and pentraxin- [PTX-] 3). Methods. The study design allowed us to define 4 groups: (1) controls (n=30); (2) OSA patients without HTN (n=30); (3) HTN patients without OSA (n=30); (4) patients with OSA and HTN (n=30). In the morning after portable monitoring (between 7 am and 8 am), blood samples were collected, and carotid IMT was measured. Results. Carotid IMT, IL-6, and PTX-3 in OSA normotensive patients and in non-OSA HTN subjects were significantly higher compared to control subjects; in addition, in OSA hypertensive patients they were significantly increased compared to OSA normotensive, non-OSA HTN, or control subjects. Conclusions. OSA and HTN have an additive role in the progression of carotid atherosclerosis and in blood levels of inflammatory markers for atherosclerosis, such as interleukin-6 and pentraxin-3

Noninvasive ventilation : education and training. A narrative analysis and an international consensus document

Noninvasive ventilation (NIV) is an increasingly used method of respiratory support. The use of NIV is expanding over the time and if properly applied, it can save patients’ lives and improve long-term prognosis. However, both knowledge and skills of its proper use as life support are paramount. This systematic review aimed to assess the importance of NIV education and training. Literature search was conducted (MEDLINE: 1990 to June, 2018) to identify randomized controlled studies and systematic reviews with the results analyzed by a team of experts across the world through e-mail based communications. Clinical trials examining the impact of education and training in NIV as the primary objective was not found. A few studies with indirect evidence, a simulation-based training study, and narrative reviews were identified. Currently organized training in NIV is implemented only in a few developed countries. Due to a lack of high-grade experimental evidence, an international consensus on NIV education and training based on opinions from 64 experts across the twenty-one different countries of the world was formulated. Education and training have the potential to increase knowledge and skills of the clinical staff who deliver medical care using NIV. There is a genuine need to develop structured, organized NIV education and training programs, especially for the developing countries

Pharmacogenomics of cetuximab in metastatic colorectal carcinoma

Cetuximab is a chimeric monoclonal antibody that has revolutionized the treatment of metastatic colorectal cancer. Knowledge of the mechanisms that underlie its effectiveness, as well as the primary and secondary resistance mechanisms, have led to important developments in the understanding of cetuximab biology. In light of knowledge gained from recent trials, the efficacy of cetuximab has been clearly demonstrated to depend upon RAS mutational status, moreover cetuximab should only be used in a subset of patients who may benefit. In this article, we critically review clinical and pharmacogenetic issues of cetuximab, focusing on the cost-effectiveness involved with the use of the drug

Expression of CD73 on CD8+/PD-1+cells as a new possible biomarker for advanced melanoma patients treated with nivolumab

Background: Anti-programmed death (PD)-1 monoclonal antibodies have changed the prognosis of metastatic melanoma, improving overall survival [1]. However, still a proportion of patients is unresponsive to these compounds, indicating the presence of other immunosuppressive mechanisms. Thus, the identification of reliable biomarkers to predict the response to checkpoint blockades is still an unmet need. Recent findings showed a tumor-induced immunosuppressive pathway, in which the extracellular adenosine produced by tumor-derived enzyme CD73 (5′-ectonucleotidase) promotes tumor growth by inhibiting immunosuppressive T-cell action [2]. Targeting adenosine generation by blockade of CD73 significantly enhances anti-tumor activity of anti-PD-1 drugs, inducing full regression in some tumor models [3]. The aim of the study was to investigate whether baseline levels of CD73+ on circulating CD8+, CD4+ and MDSCs cells could be considered as potential biomarkers in stage IV melanoma patients treated with nivolumab. Materials and methods: Blood samples from 36 advanced melanoma patients were taken before nivolumab treatment; blood populations were measured in frozen peripheral blood mononuclear cells (PBMCs) that were thawed and then rested briefly, and subjected to flow cytometry analysis for myeloid-derived suppressor cells (MDSCs: CD14+ CD33+ CD11b+ HLA-DR-/low), CD8+ and CD4+, alone or in association with PD-1 and CD73+. Results: Our data demonstrated that patients with lower baseline values of CD8+/PD-1+/CD73+ had high OS and PFS (34.8 and 19.2 months, respectively); conversely, patients with higher baseline frequency of these cells experienced lower OS and PFS (9.5 and 2.8 months, respectively; OS p &lt; 0.003, PFS p &lt; 0.007) (Tables 1, 2). In addition, increasing number of total CD8+ cells (p &lt; 0.05) and especially of CD8+/PD-1+ cells (p &lt; 0.04) were negatively correlated with survival (Table 1). Furthermore, the baseline values of MDSCs/CD73+ and CD4+/CD73+ cells showed no significant differences in survival. Conclusions: Our work indicates that the analysis of CD8+/PD-1+/CD73+ baseline levels in advanced melanoma patients treated with nivolumab could be associate to treatment outcome. Also, these preliminary results strengthen the therapeutic potential of anti-CD73 inhibitors, which are still in phase I of clinical trials, increasing the development of new treatment combinations strategies with other immune checkpoint monoclonal antibodies. Further studies on a larger number of patients are ongoing to confirm the data obtained

Correlation between Inflammatory Markers of Atherosclerosis and Carotid Intima-Media Thickness in Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is a sleep-related breathing disorder associated with the development of cardiovascular diseases and atherosclerosis. Systemic inflammation plays an important role in the development of cardiovascular complications in OSA patients. The aim of the study was to evaluate the relationship between carotid intima-media thickness (cIMT) and inflammatory markers plasma levels in OSA patients. We enrolled 80 OSA patients and 40 controls matched for age and body mass index (BMI). The presence and severity of sleep apnea was determined by in-laboratory portable monitoring (PM). Demographic data, blood pressure, heart rate, and cIMT were measured. High-sensitive C-Reactive Protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-α and pentraxin (PTX)-3 serum concentrations were detected. cIMT was higher in OSA patients than controls (0.89 ± 0.13 mm vs. 0.65 ± 0.1 mm, p &lt; 0.01). Moderate-severe OSA patients (0.95 ± 0.09 mm) had significantly increased cIMT than mild OSA (0.76 ± 0.1 mm; p &lt; 0.01) and control (0.65 ± 0.1 mm; p &lt; 0.01). hsCRP, IL-6, TNF-α, and PTX-3 in patients with OSA (1.67 ± 0.66 mg/L, 2.86 ± 1.39 pg/mL, 20.09 ± 5.39 pg/mL, 2.1 ± 0.59 ng/mL, respectively) were significantly higher than in controls (1.08 ± 0.53 mg/L, p &lt; 0.01; 1.5 ± 0.67 pg/mL, p &lt; 0.01; 12.53 ± 3.48 pg/mL, p &lt; 0.01; 1.45 ± 0.41 ng/mL, p &lt; 0.01, respectively). Carotid IMT was significantly correlated to CRP (r = 0.44; p &lt; 0.01), IL-6 (r = 0.42; p &lt; 0.01), TNF-α (r = 0.53; p &lt; 0.01), and PTX-3 (r = 0.49; p &lt; 0.01). OSA patients showed increased cIMT, CRP, IL-6, TNF-α, and PTX-3 levels. Inflammatory markers levels are correlated to cIMT in OSA patients