BACKGROUND AND PURPOSE: Recent single-center series and meta-analyses suggest that mechanical thrombectomy (MT) without prior intravenous thrombolysis (IVT) might be equally effective to bridging therapy. We analyzed, within the Endovascular Treatment in Ischemic Stroke (ETIS) prospective observational registry, the angiographic and clinical outcomes after IVT+MT versus MT alone. METHODS: From December 2012 to December 2016, a total of 1,507 consecutive patients with a proximal arterial occlusion of the anterior circulation were treated by MT. Of these, 975 (64.7%) received prior IVT. Immediate angiographic and clinical outcomes at 90 days (modified Rankin Scale [mRS]) were compared between the two groups while checking for propensity score, matched-propensity score and by inverse probability of treatment weighting (IPTW) propensity score method. RESULTS: Favorable outcome (mRS 0 to 2) was more frequently achieved after IVT+MT (n=523, 53.6%) than after MT alone (n=222, 41.8%) with an unadjusted odds ratio (OR) for bridging therapy of 1.61 (95% confidence interval [CI], 1. 29 to 2.01). This difference remained not significant in matched-propensity score cohort (OR, 1.21; 95% CI, 0.90 to 1.63) although it remained according to adjusted propensity score (OR, 1.31; 95% CI, 1.02 to 1.68) and IPTW (OR, 1.37; 95% CI, 1.09 to 1.73) analyses. A significant difference was found in terms of excellent outcome (mRS 0 to 1) (adjusted OR, 1.63; 95% CI, 1.25 to 2.11) and successful reperfusion (adjusted OR, 1.58; 95% CI, 1.33 to 2.15). No differences in intracerebral hemorrhage or in allcause mortality within 90 days were found between groups. CONCLUSIONS: IVT prior to MT is associated with increased excellent outcome and successful reperfusion rates. These findings support the use of bridging therapy.
Cerebral Hemorrhage ; Cohort Studies ; Humans ; Methods ; Mortality ; Odds Ratio ; Propensity Score ; Prospective Studies ; Reperfusion ; Silver* ; Stroke* ; Thrombectomy* ; Tissue Plasminogen Activator

Objective: Current nosology redefined agoraphobia as an autonomous diagnosis distinct from panic disorder. We investigated the lifetime prevalence of agoraphobia, its association with other mental disorders, and its impact on the health-related quality of life (HR-QoL). Methods: Community survey in 2,338 randomly selected adult subjects. Participants were interviewed with the Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS), administered by clinicians. The diagnoses were based on the ICD-10 criteria. The Short-Form Health Survey (SF-12) was used to quantify HR-QoL. Results: In the sample, 35 subjects met the criteria for agoraphobia (1.5%), with greater prevalence among women (2.0%) than men (0.9%): odds ratio (OR) 2.23; 95% CI: 1.0-5–2. Agoraphobia was more often seen among those with (n=26; 1.1%) than without (n=9; 0.4%) panic disorder: OR=8.3; 2.9–24.4. Co-morbidity with other mental disorders was substantial. The mean score of SF-12 in people with agoraphobia was 35.2±7.8, with similar levels of HR-QoL in people with (35.3±7.9) or without (34.8±7.3) panic disorder: ANOVA: F(1;33)=0.0; p=1.00. Conclusion One out of seventy people may suffer from agoraphobia in their lifetime. The attributable burden in terms of HR-QoL is substantial and comparable to the one observed for chronic mental disorders such as major depression, post-traumatic stress disorder, or obsessive-compulsive disorder.

Objective: Current nosology redefined agoraphobia as an autonomous diagnosis distinct from panic disorder. We investigated the lifetime prevalence of agoraphobia, its association with other mental disorders, and its impact on the health-related quality of life (HR-QoL). Methods: Community survey in 2,338 randomly selected adult subjects. Participants were interviewed with the Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS), administered by clinicians. The diagnoses were based on the ICD-10 criteria. The Short-Form Health Survey (SF-12) was used to quantify HR-QoL. Results: In the sample, 35 subjects met the criteria for agoraphobia (1.5%), with greater prevalence among women (2.0%) than men (0.9%): odds ratio (OR) 2.23; 95% CI: 1.0-5–2. Agoraphobia was more often seen among those with (n=26; 1.1%) than without (n=9; 0.4%) panic disorder: OR=8.3; 2.9–24.4. Co-morbidity with other mental disorders was substantial. The mean score of SF-12 in people with agoraphobia was 35.2±7.8, with similar levels of HR-QoL in people with (35.3±7.9) or without (34.8±7.3) panic disorder: ANOVA: F(1;33)=0.0; p=1.00. Conclusion One out of seventy people may suffer from agoraphobia in their lifetime. The attributable burden in terms of HR-QoL is substantial and comparable to the one observed for chronic mental disorders such as major depression, post-traumatic stress disorder, or obsessive-compulsive disorder.

PURPOSE: The purpose of this study was to evaluate progression-free survival (PFS) and objective response rate (ORR) as surrogate endpoints of overall survival (OS) in modern clinical trials investigating the efficacy of targeted agents in the second-line treatment of metastatic colorectal cancer (mCRC). MATERIALS AND METHODS: A systematic search of literature pertaining to randomized phase II and III trials evaluating targeted agents as second-line treatments for mCRC was performed. The strength of the correlation between both PFS and ORR and OS was assessed based on the Pearson's correlation coefficient (R) and the coefficient of determination (R²). RESULTS: Twenty trials, including a total of 7,571 patients, met the search criteria. The median duration of post-progression survival (PPS) was 7.6 months. The median differences between experimental and control arms were 0.65 months (range, –2.4 to 3.4) for the median PFS and 0.7 months (range, –5.8 to 3.9) for the median OS. PFS and ORR showed moderate (R=0.734, R²=0.539, p < 0.001) and poor correlation (R=0.169, R²=0.029, p=0.476) with OS, respectively. No differences between anti-angiogenic agents and other drugs were evident. CONCLUSION: Targeted agents investigated in the second-line treatment of mCRC provided minimal PFS gains translating into modest OS improvements. Considering both the moderate correlation between PFS and OS and the short duration of PPS, the OS should remain the preferred primary endpoint for randomized clinical trials in the second-line treatment of mCRC.
Arm ; Biomarkers* ; Colorectal Neoplasms* ; Disease-Free Survival ; Humans ; Molecular Targeted Therapy ; Translating

PURPOSE: The purpose of this study was to evaluate progression-free survival (PFS) and objective response rate (ORR) as surrogate endpoints of overall survival (OS) in modern clinical trials investigating the efficacy of targeted agents in the second-line treatment of metastatic colorectal cancer (mCRC). MATERIALS AND METHODS: A systematic search of literature pertaining to randomized phase II and III trials evaluating targeted agents as second-line treatments for mCRC was performed. The strength of the correlation between both PFS and ORR and OS was assessed based on the Pearson's correlation coefficient (R) and the coefficient of determination (R²). RESULTS: Twenty trials, including a total of 7,571 patients, met the search criteria. The median duration of post-progression survival (PPS) was 7.6 months. The median differences between experimental and control arms were 0.65 months (range, –2.4 to 3.4) for the median PFS and 0.7 months (range, –5.8 to 3.9) for the median OS. PFS and ORR showed moderate (R=0.734, R²=0.539, p < 0.001) and poor correlation (R=0.169, R²=0.029, p=0.476) with OS, respectively. No differences between anti-angiogenic agents and other drugs were evident. CONCLUSION: Targeted agents investigated in the second-line treatment of mCRC provided minimal PFS gains translating into modest OS improvements. Considering both the moderate correlation between PFS and OS and the short duration of PPS, the OS should remain the preferred primary endpoint for randomized clinical trials in the second-line treatment of mCRC.
Arm ; Biomarkers* ; Colorectal Neoplasms* ; Disease-Free Survival ; Humans ; Molecular Targeted Therapy ; Translating

BACKGROUND AND PURPOSE: Ascertaining stroke severity and predicting risk of in-hospital mortality is crucial to advise patients and families about medical decisions. We developed and tested the validity of a new stroke score, the 6S Score (Stroke Severity Score based on Six Signs and Symptoms), for quantifying ischemic stroke severity and predicting in-hospital mortality. METHODS: We prospectively assessed 210 consecutive acute ischemic stroke patients. The cohort was further divided into a derivation (n=120) and a validation (n=90) sample. From a total of 10 stroke signs and symptoms, we selected those with likelihood ratio's P<0.005. We tested the validity of the score for predicting in-hospital mortality by using receiver operating characteristic curves. We used a scatterplot and the Spearman's test to evaluate the correlation between the 6S Score and the National Institutes of Health Stroke Scale as a marker of stroke severity. We used principal component and exploratory factor analyses for assessing qualitative aspects of the 6S Score. RESULTS: The C statistic for in-hospital mortality was 0.82 for the 6S Score and 0.86 for the National Institutes of health Stroke Scale, respectively, with no significant differences between each other (P=0.79). The correlation between both scores was strong (Spearman's rho 0.68, P<0.001). The factor analyses showed a good balance between left/right hemispheres and anterior/posterior circulations. CONCLUSIONS: The 6S Score may constitute a tool for easily assessing stroke severity and predicting stroke mortality. Further research is needed for further assessing its external validity.
Cohort Studies ; Hospital Mortality* ; Humans ; Mortality ; National Institutes of Health (U.S.) ; Prospective Studies ; ROC Curve ; Stroke*

Objective To evaluate the in vitro anti-Trypanosoma cruzi (T. cruzi) activity of organic extracts prepared from halophyte species collected in the southern coast of Portugal (Algarve), and chemically characterize the most active samples. Methods Acetone, dichloromethane and methanol extracts were prepared from 31 halophyte species and tested in vitro against trypomastigotes and intracellular amastigotes of the Tulahuen strain of T. cruzi. The most active extract was fractionated by preparative HPLC-DAD, affording 11 fractions. The most selective fraction was fully characterized by

The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colon-Proctologia, SIUCP) on the diagnosis and management of hemorrhoidal disease, with the goal of guiding physicians in the choice of the best treatment option. A panel of experts was charged by the Board of the SIUCP to develop key questions on the main topics related to the management of hemorrhoidal disease and to perform an accurate and comprehensive literature search on each topic, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in multiple rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to PICO (patients, intervention, comparison, and outcomes) criteria, and the statements were developed adopting the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology. In cases of grade 1 hemorrhoidal prolapse, outpatient procedures including hemorrhoidal laser procedure and sclerotherapy may be considered the preferred surgical options. For grade 2 prolapse, nonexcisional procedures including outpatient treatments, hemorrhoidal artery ligation and mucopexy, laser hemorrhoidoplasty, the Rafaelo procedure, and stapled hemorrhoidopexy may represent the first-line treatment options, whereas excisional surgery may be considered in selected cases. In cases of grades 3 and 4, stapled hemorrhoidopexy and hemorrhoidectomy may represent the most effective procedures, even if, in the expert panel opinion, stapled hemorrhoidopexy represents the gold-standard treatment for grade 3 hemorrhoidal prolapse.

The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colon-Proctologia, SIUCP) on the diagnosis and management of hemorrhoidal disease, with the goal of guiding physicians in the choice of the best treatment option. A panel of experts was charged by the Board of the SIUCP to develop key questions on the main topics related to the management of hemorrhoidal disease and to perform an accurate and comprehensive literature search on each topic, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in multiple rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to PICO (patients, intervention, comparison, and outcomes) criteria, and the statements were developed adopting the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology. In cases of grade 1 hemorrhoidal prolapse, outpatient procedures including hemorrhoidal laser procedure and sclerotherapy may be considered the preferred surgical options. For grade 2 prolapse, nonexcisional procedures including outpatient treatments, hemorrhoidal artery ligation and mucopexy, laser hemorrhoidoplasty, the Rafaelo procedure, and stapled hemorrhoidopexy may represent the first-line treatment options, whereas excisional surgery may be considered in selected cases. In cases of grades 3 and 4, stapled hemorrhoidopexy and hemorrhoidectomy may represent the most effective procedures, even if, in the expert panel opinion, stapled hemorrhoidopexy represents the gold-standard treatment for grade 3 hemorrhoidal prolapse.

The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (Società Italiana Unitaria di Colon-Proctologia, SIUCP) on the diagnosis and management of hemorrhoidal disease, with the goal of guiding physicians in the choice of the best treatment option. A panel of experts was charged by the Board of the SIUCP to develop key questions on the main topics related to the management of hemorrhoidal disease and to perform an accurate and comprehensive literature search on each topic, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in multiple rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to PICO (patients, intervention, comparison, and outcomes) criteria, and the statements were developed adopting the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology. In cases of grade 1 hemorrhoidal prolapse, outpatient procedures including hemorrhoidal laser procedure and sclerotherapy may be considered the preferred surgical options. For grade 2 prolapse, nonexcisional procedures including outpatient treatments, hemorrhoidal artery ligation and mucopexy, laser hemorrhoidoplasty, the Rafaelo procedure, and stapled hemorrhoidopexy may represent the first-line treatment options, whereas excisional surgery may be considered in selected cases. In cases of grades 3 and 4, stapled hemorrhoidopexy and hemorrhoidectomy may represent the most effective procedures, even if, in the expert panel opinion, stapled hemorrhoidopexy represents the gold-standard treatment for grade 3 hemorrhoidal prolapse.