Evaluation of data quality in the Spanish EURECCA Esophagogastric Cancer Registry.

BACKGROUND: Although the number of nationwide clinical registries in upper gastrointestinal cancer is increasing, few of them perform regular clinical audits. The Spanish EURECCA Esophagogastric Cancer Registry (SEEGCR) was launched in 2013. The aim of this study was to assess the reliability of the data in terms of completeness and accuracy. METHODS: Patients who were registered (2014-2017) in the online SEEGCR and underwent esophagectomy or gastrectomy with curative intent were selected for auditing. Independent teams of surgeons visited each center between July 2018 and December 2019 and checked the reliability of data entered into the registry. Completeness was established by comparing the cases reported in the registry with those provided by the Medical Documentation Service of each center. Twenty percent of randomly selected cases per hospital were checked during on-site visits for testing the accuracy of data (27 items per patient file). Correlation between the quality of the data and the hospital volume was also assessed. RESULTS: Some 1839 patients from 19 centers were included in the registry. The mean completeness rate in the whole series was 97.8% (range 82.8-100%). For the accuracy, 462 (25.1%) cases were checked. Out of 12,312 items, 10,905 were available for verification, resulting in a perfect agreement of 95% (87.1-98.7%). There were 509 (4.7%) incorrect and 35 (0.3%) missing entries. No correlation between hospital volume and the rate of completeness and accuracy was observed. CONCLUSIONS: Our results indicate that the SEEGCR contains reliable data.

A density functional study of the spin state energetics of polypyrazolylborato complexes of first-row transition metals.

Density Functional Theory (DFT) was used to analyse and explain spin state energetics of first-row transition metals (Mn(II), Fe(II), Co(II); Cr(III), Mn(III), Fe(III), Co(III); Mn(IV)) in polypyrazolylborato complexes. We explored the effects of substitutions at the 3 and 5 positions of the pyrazolyl rings, as well as the influence of Jahn-Teller (JT) distortions on spin-state switching. Although the stabilizations due to JT distortion are sometimes substantial, this does not lead to switching of the spin ground-state. On the other hand, electron withdrawing or donating substituents do lead to significant changes in the spin-crossover (SCO) properties of the investigated complexes.

Validez y sensibilidad al cambio de la versión española autoadministrada del cuestionario de la enfermedad respiratoria crónica (CRQ-SAS) / The Validity and Sensitivity to Change of the Spanish Self-Administered Version of the Chronic Respiratory Questionnaire (CRQ-SAS)

Introducción: El cuestionario de la enfermedad respiratoria crónica con entrevistador (CRQ-IA) ha demostradoexcelentes propiedades de medida de la calidad de vida relacionada con la salud (CVRS) en pacientescon enfermedad pulmonar obstructiva crónica (EPOC). La validación en español de la versión estandarizadaautoadministrada (CRQ-SAS) no se ha realizado. El objetivo de este estudio fue evaluar la validez yla sensibilidad a los cambios, de la versión española del CRQ-SAS en pacientes con EPOC.Pacientes y métodos: Aleatorizamos a 40 pacientes con EPOC (33 en tratamiento con rehabilitación respiratoriay 7 con oxígeno líquido) a uno de los dos métodos de administración del CRQ (SAS vs. IA) antesy 8 semanas después de la intervención. Los pacientes completaban el cuestionario SF-36, pruebas defunción pulmonar y prueba de los 6 min de marcha.Resultados: El CRQ-SAS ha demostrado una buena validez de constructo longitudinal en todas las áreascon un rango de correlaciones, para las puntuaciones del cambio, entre 0,46 (p = 0,05) y 0,71 (p = 0,01).En cuanto a la sensibilidad a los cambios, se observa un cambio mínimo clínicamente significativo en lamayoría de áreas (fatiga 0,71 [p = 0,02], factor emocional 0,62 [p = 0,04], control de la enfermedad 0,83[p = 0,06]).Conclusiones: La versión española del CRQ-SAS resulta ser válida para evaluar la CVRS de los pacientescon EPOC. Las correlaciones con otros instrumentos aportan validez de constructo y se demuestra unabuena sensibilidad a los cambios(AU)

Introduction: The interviewer-administered chronic respiratory questionnaire (CRQ-IA) is widely usedand has demonstrated excellent properties for measuring health-related quality of life (HRQL) in patientswith chronic obstructive pulmonary disease (COPD). However, the self-administered version (CRQ-SAS)in Spanish has not been validated.The aim of this trial was to evaluate the validity and the sensitivity of the Spanish version of the CRQ-SASin patients with COPD.Material and methods: We randomized 40 patients with COPD (33 treated with pulmonary rehabilitation and 7 with liquid oxygen therapy) to one of the two methods of administration of CRQ (SAS vs. IA) both before and 8 weeks after the treatment. In addition, patients completed the SF-36 questionnaire, pulmonary function tests, and six-minute walk test. Results: The CRQ-SAS demonstrated good longitudinal construct validity on all domains with a rangeof correlations, for the change scores, between 0.46 (P=.05) and 0.71 (P=.01). Regarding sensitivityto change, we observed a minimal clinically significant change in most domains (fatigue 0.71 [P = .02],emotional factor 0.62 [P=.04], control of the disease 0.83 [P=.06]).Conclusions: The Spanish version of CRQ-SAS is valid for evaluating HRQL in COPD patients. Thecorrelations of the CRQ-SAS with other tools provide construct validity and show good sensitivity tochange(AU)

[The validity and sensitivity to change of the Spanish self-administered version of the chronic respiratory questionnaire (CRQ-SAS)]. / Validez y sensibilidad al cambio de la versión española autoadministrada del cuestionario de la enfermedad respiratoria crónica (CRQ-SAS).

INTRODUCTION: The interviewer-administered chronic respiratory questionnaire (CRQ-IA) is widely used and has demonstrated excellent properties for measuring health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). However, the self-administered version (CRQ-SAS) in Spanish has not been validated. The aim of this trial was to evaluate the validity and the sensitivity of the Spanish version of the CRQ-SAS in patients with COPD. MATERIAL AND METHODS: We randomized 40 patients with COPD (33 treated with pulmonary rehabilitation and 7 with liquid oxygen therapy) to one of the two methods of administration of CRQ (SAS vs. IA) both before and 8 weeks after the treatment. In addition, patients completed the SF-36 questionnaire, pulmonary function tests, and six-minute walk test. RESULTS: The CRQ-SAS demonstrated good longitudinal construct validity on all domains with a range of correlations, for the change scores, between 0.46 (P=.05) and 0.71 (P=.01). Regarding sensitivity to change, we observed a minimal clinically significant change in most domains (fatigue 0.71 [P=.02], emotional factor 0.62 [P=.04], control of the disease 0.83 [P=.06]). CONCLUSIONS: The Spanish version of CRQ-SAS is valid for evaluating HRQL in COPD patients. The correlations of the CRQ-SAS with other tools provide construct validity and show good sensitivity to change.

Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-steroidal anti-inflammatory drugs, aspirin and combinations.

BACKGROUND: The risks and benefits of coxibs, non-steroidal anti-inflammatory drugs (NSAIDs), and aspirin treatment are under intense debate. OBJECTIVE: To determine the risk of peptic ulcer upper gastrointestinal bleeding (UGIB) associated with the use of coxibs, traditional NSAIDs, aspirin or combinations of these drugs in clinical practice. METHODS: A hospital-based, case-control study in the general community of patients from the National Health System in Spain. The study included 2777 consecutive patients with endoscopy-proved major UGIB because of the peptic lesions and 5532 controls matched by age, hospital and month of admission. Adjusted relative risk (adj RR) of UGIB determined by conditional logistic regression analysis is provided. RESULTS: Use of non-aspirin-NSAIDs increased the risk of UGIB (adj RR 5.3; 95% confidence interval (CI) 4.5 to 6.2). Among non-aspirin-NSAIDs, aceclofenac (adj RR 3.1; 95% CI 2.3 to 4.2) had the lowest RR, whereas ketorolac (adj RR 14.4; 95% CI 5.2 to 39.9) had the highest. Rofecoxib treatment increased the risk of UGIB (adj RR 2.1; 95% CI 1.1 to 4.0), whereas celecoxib, paracetamol or concomitant use of a proton pump inhibitor with an NSAID presented no increased risk. Non-aspirin antiplatelet treatment (clopidogrel/ticlopidine) had a similar risk of UGIB (adj RR 2.8; 95% CI 1.9 to 4.2) to cardioprotective aspirin at a dose of 100 mg/day (adj RR 2.7; 95% CI 2.0 to 3.6) or anticoagulants (adj RR 2.8; 95% CI 2.1 to 3.7). An apparent interaction was found between low-dose aspirin and use of non-aspirin-NSAIDs, coxibs or thienopyridines, which increased further the risk of UGIB in a similar way. CONCLUSIONS: Coxib use presents a lower RR of UGIB than non-selective NSAIDs. However, when combined with low-dose aspirin, the differences between non-selective NSAIDs and coxibs tend to disappear. Treatment with either non-aspirin antiplatelet or cardioprotective aspirin has a similar risk of UGIB.

Usefulness of a delayed test for the diagnosis of Helicobacter pylori infection in bleeding peptic ulcer.

AIM: To evaluate (i) the diagnostic usefulness of a delayed test in initially negative patients; and (ii) the reliability of the rapid urease test, histology or a combination of the two to diagnose Helicobacter pylori during emergency endoscopy in a large clinical practice series. PATIENTS AND METHODS: Records of patients with ulcer bleeding from 1995 to 2000 were reviewed. Patients with initially negative tests were retested 4-8 weeks after the bleeding episode. Sensitivity of urease, histology or a combination of the two to detect H. pylori at initial endoscopy and the efficacy of delayed Urea Breath Test in detecting missed infection was determined. RESULTS: The study included 429 patients. A delayed second test detected H. pylori infection in 57 out of 72 (79%) of initially negative patients. The sensitivity for detecting H. pylori was 76%, 78% and 86% for urease, histology and their combination, respectively. The prevalence of H. pylori was 95% in duodenal and 88% in gastric ulcer. In addition, only one test was performed in 17 of the 32 patients who were considered negative. CONCLUSION: Not even the combination of a negative urease and histology in the initial endoscopy is able to rule out infection in bleeding ulcer patients. A delayed test should be performed to rule out Helicobacter pylori infection completely.

Resultados iniciales del Registro Nacional de Cirugía Hepática por Laparoscopia / Initial results of the National Registry of Laparoscopic Liver Surgery

Introducción. La experiencia en cirugía hepática por laparoscopia es limitada; para realizar una valoración crítica son necesarias series amplias y multicéntricas. Objetivo. Analizar los resultados del registro nacional de cirugía hepática por vía laparoscópica. Valorar las indicaciones, los aspectos técnicos, el índice de conversión y la morbimortalidad. Pacientes y método. Se incluye a 74 pacientes de 10 centros de febrero de 2000 a abril de 2005. Cincuenta y ocho mujeres y 16 varones, con una edad media de 55 años. Dieciséis pacientes presentaban más de una lesión, por lo que se trató a 74 pacientes con 156 lesiones. Resultados. Cuarenta y seis pacientes presentaban lesiones quísticas (26 quistes simples, 13 enfermedad poliquística, 5 quistes hidatídicos y 2 cistoadenomas). Se practicaron 37 fenestraciones, 5 quistoperiquistectomías, 2 resecciones limitadas, 1 segmentectomía y 1 bisegmentectomía II-III. En 28 pacientes las lesiones eran sólidas (4 adenomas, 6 hiperplasias nodulares focales, 3 hemangiomas, 4 hepatocarcinomas, 5 metástasis colorrectales, 2 metástasis de pulmón, 1 metástasis de mama, 1 metástasis de melanoma maligno, 1 metástasis de vipoma pancreático y 1 linfoma). Se realizaron 10 bisegmentectomias II-III, 17 resecciones limitadas y 1 segmentectomía del segmento III. En 23 casos se asoció otra cirugía. El tiempo quirúrgico medio fue de 160,5 min y el índice de conversión, del 8%. La estancia media fue de 5,6 días, y el 78% de los pacientes estuvo menos de 5 días. En el 55% la analgesia se administró menos de 48 h. La morbilidad fue de 8 casos (11%). Tres casos fueron reintervenidos. No existió mortalidad en la serie. Conclusiones. La resección hepática laparoscópica es factible y segura en casos seleccionados. Se hace necesario disponer de series amplias y controladas para conocer los resultados a largo plazo. El registro nacional es una buena alternativa para valorar la cirugía hepática realizada por vía laparoscópica en España (AU)

Introduction. Experience in laparoscopic liver surgery is limited, and multicenter studies with large series are required for a critical evaluation of this type of surgery. Objective. To analyze the results of the National Registry of Laparoscopic Liver Surgery. Indications, technical features, conversion rates, morbidity, and mortality were analyzed. Patients and method. Seventy-four patients from 10 centers who underwent surgery between February 2000 and April 2005 were included. There were 58 women and 16 men, with a mean age of 55 years. More than one lesion was present in 16 patients. Consequently, 74 patients with 156 lesions were treated. Results. Forty-six patients had cystic lesions (26 simple cysts, 13 polycystic disease, five hydatid cysts and two cystic adenomas). Surgical treatment consisted of 37 fenestrations, five cystopericystectomies, two atypical resections, one segmentectomy and one bisegmentectomy of segments II-III. In 28 patients the lesions were solid (four adenomas, six focal nodular hyperplasias, three hemangiomas, four hepatocarcinomas, five colorectal metastases, two lung metastases, one breast metastasis, one malignant melanoma metastasis, one pancreatic vipoma metastasis, and one lymphoma). Ten bisegmentectomies of segments II-III, 17 atypical resections and one segmentectomy of segment III were performed. Other surgery was associated in 23 patients. The mean operating time was 160.5 minutes and the conversion rate was 8%. The mean length of hospital stay was 5.6 days and was less than 5 days in 78% of the patients. Analgesia was administered for less than 48 hours in 55%. Morbidity was observed in eight patients (10.8%). Reoperations were performed in three patients. There was no mortality in this series. Conclusions. Laparoscopic hepatic resection is safe and feasible in selected patients. Large, controlled series are required to determine long-term outcomes. The national registry provides a good basis for evaluating laparoscopic liver surgery in Spain (AU)

[Initial results of the National Registry of Laparoscopic Liver Surgery]. / Resultados iniciales del Registro Nacional de Cirugía Hepática por Laparoscopia.

INTRODUCTION: Experience in laparoscopic liver surgery is limited, and multicenter studies with large series are required for a critical evaluation of this type of surgery. OBJECTIVE: To analyze the results of the National Registry of Laparoscopic Liver Surgery. Indications, technical features, conversion rates, morbidity, and mortality were analyzed. PATIENTS AND METHOD: Seventy-four patients from 10 centers who underwent surgery between February 2000 and April 2005 were included. There were 58 women and 16 men, with a mean age of 55 years. More than one lesion was present in 16 patients. Consequently, 74 patients with 156 lesions were treated. RESULTS: Forty-six patients had cystic lesions (26 simple cysts, 13 polycystic disease, five hydatid cysts and two cystic adenomas). Surgical treatment consisted of 37 fenestrations, five cystopericystectomies, two atypical resections, one segmentectomy and one bisegmentectomy of segments II-III. In 28 patients the lesions were solid (four adenomas, six focal nodular hyperplasias, three hemangiomas, four hepatocarcinomas, five colorectal metastases, two lung metastases, one breast metastasis, one malignant melanoma metastasis, one pancreatic vipoma metastasis, and one lymphoma). Ten bisegmentectomies of segments II-III, 17 atypical resections and one segmentectomy of segment III were performed. Other surgery was associated in 23 patients. The mean operating time was 160.5 minutes and the conversion rate was 8%. The mean length of hospital stay was 5.6 days and was less than 5 days in 78% of the patients. Analgesia was administered for less than 48 hours in 55%. Morbidity was observed in eight patients (10.8%). Reoperations were performed in three patients. There was no mortality in this series. CONCLUSIONS: Laparoscopic hepatic resection is safe and feasible in selected patients. Large, controlled series are required to determine long-term outcomes. The national registry provides a good basis for evaluating laparoscopic liver surgery in Spain.

Evaluation of three different tests for the detection of stool antigens to diagnose Helicobacter pylori infection in patients with upper gastrointestinal bleeding.

AIM: To evaluate the accuracy of several methods aimed to detect Helicobacter pylori stool antigens in patients with upper gastrointestinal bleeding. METHODS: Thirty-four patients with upper gastrointestinal bleeding because of peptic ulcer were included. The first stool sample during hospitalization was collected, and stool antigens were determined with: polyclonal enzyme-linked immunosorbent assay (Premier-Platinum-HpSA); monoclonal enzyme-linked immunosorbent assay (Amplified-IDEIA-HpStAR); and rapid monoclonal immunochromatographic test (ImmunoCard-STAT HpSA). A patient was considered infected when H. pylori was diagnosed with invasive tests (rapid urease test or histology) or with (13)C-urea breath test. When all tests were negative, a new breath test was repeated after stopping proton pump inhibitors. RESULTS: All patients were infected and, therefore, only sensitivity of the tests could be calculated: polyclonal enzyme-linked immunosorbent assay (74%), monoclonal enzyme-linked immunosorbent assay (94%), and rapid monoclonal immunochromatographic test (60%; concordance between the two observers was high, kappa = 0.9). Neither the presence of maelena nor the delay in obtaining stool samples explained false negatives. CONCLUSIONS: Neither the polyclonal enzyme-linked immunosorbent assay stool antigen test nor the rapid immunochromatographic stool antigen test can be recommended to diagnose H. pylori infection in patients with upper gastrointestinal bleeding. However, the monoclonal enzyme-linked immunosorbent assay stool antigen test is highly sensitive for detecting the infection in patients with this complication, although more studies are necessary to evaluate the specificity of the method.

[Prevalence of digestive symptoms in normal adult women and its association with cholelithiasis]. / Prevalencia de síntomas digestivos en mujeres adultas normales y su asociación a la litiasis biliar.

The aim of this work was to study the prevalence of biliary diseases and digestive symptoms in normal adult women. Four hundred nineteen women were chosen; of these 145 were discarded due to previous gastrointestinal diseases (20), previous gastrointestinal complaints (38) and previous cholecystectomy (85). Two hundred seventy six women were subjected to abdominal ultrasound examination; of these 53 had cholelithiasis and in three a gallbladder cancer was suspected (and confirmed by surgery). Considering women with previous cholecystectomy, cholelithiasis and gallbladder cancer, a 33.6% prevalence of biliary diseases can be inferred. An interrogation about gastrointestinal symptoms was performed to women subjected to ultrasound examinations, by 2 professionals unaware of ultrasound results. A high frequency of pyrosis, food intolerance and constipation was found, not observing differences between women with or without cholelithiasis. However, these last women had a higher frequency of upper abdominal pain. Both groups had also a high rate of previous surgical procedures.