Sastre J.,HC San Carlos |
Gomez A.,Hospital Reina Sofia |
Rivera F.,Hospital Marques Of Valdecilla |
Massuti B.,Hospital Universitario Of Alicante |
And 6 more authors.
Clinical Colorectal Cancer | Year: 2013
Objective Circulating tumor cells (CTCs) and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status were identified as prognostic factors for progression-free survival (PFS) and overall survival (OS) in patients with metastatic colorectal cancer treated with chemotherapy and bevacizumab in analyses of the MACRO (Maintenance Treatment in Advanced Colorectal Cancer) trial. In this post hoc analysis of the MACRO trial, the potential additive effect of these 2 factors on patient outcomes was explored. Methods A total of 158 of the 480 patients involved in the MACRO trial were included in the biological marker substudy. CTC isolation and enumeration were centralized and performed using the CellSearch System (Veridex LLC, Raritan, NJ) in 7.5 mL of whole blood. Evaluation of KRAS status was performed retrospectively by the standard method used at each center. PFS and OS were analyzed by the Kaplan-Meier method according to CTC count and KRAS status. Results Patients with < 3 CTC per 7.5 mL blood at baseline and KRAS wild-type tumors had a median PFS of 14.2 months compared with 6.2 months in patients with ≥ 3 CTCs and KRAS mutated tumors (P <.0001; hazard ratio, 3.0; 95% confidence interval, 1.8-5.2). Similar findings were observed for OS (28.9 and 13.7 months, respectively, P =.0004; hazard ratio 2.8; 95% confidence interval, 1.6-4.9). Multivariate analyses showed that CTC count ≥ 3 and KRAS status were the only independent prognostic factors for both PFS and OS. Conclusions This post hoc analysis showed that CTC count and KRAS status were independent prognostic factors for outcomes in patients with metastatic colorectal cancer treated with bevacizumab ± chemotherapy. These factors should be taken into account in the design of future phase III trials. © 2013 Elsevier Inc. All rights reserved.
Munoz-Torrero J.F.S.,Hospital San Pedro Of Alcantara |
Bounameaux H.,University of Geneva |
Pedrajas J.M.,Hospital Clinico San Carlos |
Lorenzo A.,Hospital Universitario La Paz |
And 4 more authors.
Journal of Vascular Surgery | Year: 2011
Background: The risk of patients dying of pulmonary embolism (PE) or bleeding during the treatment of deep vein thrombosis (DVT), and whether these risks are influenced by patient age, has not been thoroughly studied. Methods: We used data from the Registro Informatizado de la Enfermedad TromboEmbólica (RIETE) to assess the risk of fatal PE and fatal bleeding in 16,199 patients with lower limb DVT (without symptomatic PE at the time of inclusion) during the 3 months after diagnosis, with patients categorized according to age. Results: During the 3 months of anticoagulant treatment, there were 31 fatal PEs (0.19%) and 83 fatal hemorrhages (0.51%). During the first 7 days of therapy, the frequency of fatal PEs was similar to that of fatal bleeding (12 vs 14 deaths, respectively; odds ratio [OR], 0.86; 95% confidence interval [CI], 0.39-1.87). However, from days 8 to 90, the frequency of fatal bleeding was greater than that of fatal PE (69 vs 19 deaths; OR, 3.64; 95% CI, 2.22-6.20). The higher frequency of fatal bleeding compared with fatal PE from days 8 to 90 appeared to be confined to patients who were aged ≥60 years. Multivariate analysis showed that patient age was independently associated with an increased risk of death from bleeding during the first 3 months: every 10 years the OR increased by 1.37 (95% CI, 1.12-1.67). Conclusions: During the first week of treatment, the risk of fatal bleeding and fatal PE were similar. Then, particularly in patients who were aged ≥60 years, the risk of dying from bleeding exceeded the risk of dying from PE. © 2011 Society for Vascular Surgery.
PubMed | Hospital Universitario Joan Xxii Of Tarragona, Hospital Universitari Clinic ovincial Of Barcelona, Servicio Of Cirugia Toracica Hospital Universitario Virgen Del Rocio Of Seville, Hospital Universitario Germans Trias i Pujol and 13 more.
Type: Journal Article | Journal: Archivos de bronconeumologia | Year: 2016
Benchmarking entails continuous comparison of efficacy and quality among products and activities, with the primary objective of achieving excellence.To analyze the results of benchmarking performed in 2013 on clinical practices undertaken in 2012 in 17 Spanish thoracic surgery units.Study data were obtained from the basic minimum data set for hospitalization, registered in 2012. Data from hospital discharge reports were submitted by the participating groups, but staff from the corresponding departments did not intervene in data collection. Study cases all involved hospital discharges recorded in the participating sites. Episodes included were respiratory surgery (Major Diagnostic Category 04, Surgery), and those of the thoracic surgery unit. Cases were labelled using codes from the International Classification of Diseases, 9th revision, Clinical Modification. The refined diagnosis-related groups classification was used to evaluate differences in severity and complexity of cases.General parameters (number of cases, mean stay, complications, readmissions, mortality, and activity) varied widely among the participating groups. Specific interventions (lobectomy, pneumonectomy, atypical resections, and treatment of pneumothorax) also varied widely.As in previous editions, practices among participating groups varied considerably. Some areas for improvement emerge: admission processes need to be standardized to avoid urgent admissions and to improve pre-operative care; hospital discharges should be streamlined and discharge reports improved by including all procedures and complications. Some units have parameters which deviate excessively from the norm, and these sites need to review their processes in depth. Coding of diagnoses and comorbidities is another area where improvement is needed.
Naredo E.,Complutense University of Madrid |
Naredo E.,Hospital Universitario Severo Ochoa |
Uson J.,Hospital Universitario Of Mostoles |
Jimenez-Palop M.,Hospital Puerta Of Hierro |
And 12 more authors.
Annals of the Rheumatic Diseases | Year: 2014
Objective: The primary objective of this prospective case-control study was to assess the diagnostic value of several intra-articular and periarticular ultrasound (US)- detected abnormalities in the upper and lower limbs in gout. The secondary objective was to test the concurrent validity of US abnormalities using as gold standard the microscopic demonstration of monosodium urate (MSU) crystals. Methods: Ninety-one men with gout and 42 agematched controls were prospectively recruited. All patients with gout and controls underwent US assessment of several US abnormalities in 26 joints, six bursae, eight tendons, 20 tendon compartments, four ligaments, and 18 articular cartilages by experts in US blinded to the patients' group. Patients with gout and controls with US abnormalities were asked to undergo US-guided aspiration for microscopic identification of MSU crystals. Interobserver and intraobserver reliability of the US assessment was evaluated in a web-based exercise. Results: The assessment of one joint (ie, radiocarpal joint) for hyperechoic aggregates (HAGs), two tendons (ie, patellar tendon and triceps tendon) for HAGs and three articular cartilages (ie, first metatarsal, talar and second metacarpal/femoral) for double contour sign showed the best balance between sensitivity and specificity (84.6% and 83.3%, respectively). Intraobserver reliability was good (mean κ 0.75) and interobserver reliability was moderate (κ 0.52). The aspirated material from HAGs was positive for MSU crystals in 77.6% of patients with gout and negative in all controls. Conclusions: Our results suggest that US bilateral assessment of one joint, three articular cartilages and two tendons may be valid for diagnosing gout with acceptable sensitivity and specificity.
A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: The RIBS v clinical trial (restenosis intra-stent of bare metal stents: Paclitaxel-eluting balloon vs. everolimus-eluting stent)
Alfonso F.,Autonomous University of Madrid |
Alfonso F.,Hospital Universitario Clinico San Carlos |
Perez-Vizcayno M.J.,Hospital Universitario Clinico San Carlos |
Cardenas A.,Hospital Universitario Clinico San Carlos |
And 22 more authors.
Journal of the American College of Cardiology | Year: 2014
Objectives This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). Background Treatment of patients with ISR remains a challenge. Methods This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. Results A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. Conclusions In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).
Alfonso F.,Hospital Universitario Of La Princesa |
Perez-Vizcayno M.J.,Hospital Universitario Clinico San Carlos |
Cardenas A.,Hospital Universitario Clinico San Carlos |
Garcia Del Blanco B.,Hospital Universitario Vall dHebron |
And 17 more authors.
Journal of the American College of Cardiology | Year: 2015
Background Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. Objectives This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. Methods The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. Results A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 00.7 to 0.38), net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035). Conclusions In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940) © 2015 American College of Cardiology Foundation.
Zaballos P.,Hospital Sant Pau i Santa Tecla |
Carulla M.,Hospital Sant Pau i Santa Tecla |
Ozdemir F.,Ege University |
Zalaudek I.,Medical University of Graz |
And 5 more authors.
British Journal of Dermatology | Year: 2010
Summary Background Pyogenic granuloma is a common, benign, vascular lesion of the skin and mucous membranes which is a simulator of amelanotic/ hypomelanotic melanoma and other tumours. Objectives To determine the diagnostic significance of dermoscopic structures and patterns associated with pyogenic granulomas in a large series of cases. Methods Digital dermoscopic images of histopathologically proven cases of 122 pyogenic granulomas and 140 other tumours (28 amelanotic melanomas, seven melanoma metastases, 22 basal cell carcinomas and 83 other tumours) were collected from university hospitals in Spain, Italy, Austria and Turkey. The frequency, sensitivity, specificity, positive predictive value, negative predictive value, intraobserver agreement and interobserver agreement of the dermoscopic structures and patterns associated with pyogenic granulomas were calculated. Results Vascular structures were observed in 45% of pyogenic granulomas (sensitivity of 45·1% and specificity of 17·9%; both P < 0·001). Seven exclusive patterns were made up from the combination of the structures 'reddish homogeneous area' (RHA), 'white collarette' (WC), 'white rail lines' (WRL) and 'vascular structures' (VS). The pattern composed of RHA, WC and WRL showed the highest sensitivity (22·1%; P < 0·001) and a specificity of 100% (P < 0·001) for pyogenic granulomas. Two other patterns (RHA + WC and RHA + WC + WRL + VS) showed 100% specificity when compared with melanoma (P < 0·001 and P < 0·05, respectively). Conclusions Even though some dermoscopic patterns are useful in the recognition of pyogenic granulomas, dermoscopy is not a substitute for histology, mostly when vessels are present, as melanoma cannot be ruled out. © 2010 British Association of Dermatologists.
PubMed | Medical Affairs, Hospital Universitario Of Canarias, Hospital Marina Baixa, Hospital Universitario Gregorio Maranon and 11 more.
Type: | Journal: Clinical and experimental rheumatology | Year: 2016
To evaluate non-adherence to prescribed subcutaneous biologicals in rheumatoid arthritis (RA) patients in Spain.ARCO (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs) was a multicentre, non-interventional retrospective study involving 42 rheumatology clinics from representative hospitals throughout Spain. The primary objective was to assess the percentage of patients (aged 18 years with an established RA diagnosis) with non-adherence to prescribed subcutaneous biologicals using clinical records and hospital pharmacy dispensing logs as the primary information sources. Adherence was assessed using the Medication Possession Ratio (MPR). Additionally, patients completed the Morisky-Green Medication Adherence Questionnaire.A total of 364 patients (77.5% females, mean age 54.9 years, median RA duration since diagnosis 7.8 years) were enrolled in ARCO. Non-adherence (MPR 80%) was reported in 52/363 evaluable patients (14.3%), and was lower in patients receiving initial monthly drug administration (6.4%) than with weekly (17.4%; p=0.034) or every two weeks (14.4%; p=0.102) administration. By multivariate analysis, non-adherence was positively associated with RA duration above the median and with using induction doses. Monthly administration, compared to weekly administration, was inversely associated with non-adherence. Age, gender, order of administration, and changes in the interval of administration, showed no association with non-adherence. Compared with the MPR, the Morisky-Green questionnaire performed poorly in detecting non-adherence.Non-adherence to the prescribed subcutaneous biological drug occurred in 14.3% of patients with RA. Patients using the most convenient administration period (i.e. monthly) had better adherence than those using more frequent dosing schedules.
Zaballos P.,Hospital Of Sant Pau I Santa Tecla |
Banuls J.,Hospital Universitario Of Alicante |
Medina C.,Hospital Universitario Of Gran Canaria Doctor Negrin |
Salsench E.,Hospital Of Sant Pau I Santa Tecla |
And 2 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2014
Background The dermoscopic morphology of apocrine hidrocystomas remains to be elucidated. Objective To evaluate the morphological findings of apocrine hidrocystomas under dermoscopic observation. Methods Dermoscopic examination of 22 cases of apocrine hidrocystomas was performed to evaluate specific dermoscopic criteria and patterns. Results The most frequently occurring dermoscopic features were found to be: (i) A translucent to opaque, homogeneous area which occupies the whole lesion in all apocrine hidrocystomas (100%). The colour of this homogeneous area was skin-colored in 31.8% of our cases; yellow, in 31.8% and blue, in 22.7% of apocrine hidrocystomas. (ii) Vascular structures were identified in 81.8% of our cases; arborizing vessels, in 68.2% and linear-irregular vessels in 9.1% of our cases; and (iii) Whitish structures were identified in 22.7% of the lesions. The results of our study reveal that the presence of a homogeneous area that occupies the whole lesion and arborizing vessels is the most common dermoscopic pattern in apocrine hidrocystomas (68.2%). Conclusion Apocrine hidrocystomas, above all in its pigmented variant, may represent a dermoscopic pitfall, being difficult to differentiate clinically and dermoscopically from basal cell carcinomas. © 2012 European Academy of Dermatology and Venereology.