Antonia Montserrat

Identification of factors that influence tolerance of upper gastrointestinal endoscopy.

OBJECTIVE Unsedated gastroscopy is unpleasant for some patients. The identification of factors related to tolerance would permit the selection of patients for sedation. The aim of the present study was to identify these factors. METHODS Five hundred and nine patients underwent diagnostic gastroscopy after the administration of topical pharyngeal anaesthesia, without sedation. Patients were grouped as to whether they had undergone prior examinations or not. Tolerance was assessed with a visual analogue scale and a questionnaire. RESULTS Two hundred and seventy-three (54%) patients underwent gastroscopy for the first time, and 236 (46%) patients had prior experience. Patient tolerance was poor in 84 of 273 (31%) patients undergoing gastroscopy for the first time, and in 61 of 236 (26%) patients with prior experience. Logistic regression analysis identified the following variables related to poor tolerance: (a) in patients undergoing gastroscopy for the first time: presence of gag reflex (odds ratio (OR) = 3.42, 95% confidence interval (CI) 1.90-6.17), apprehension (OR = 2.57, CI 1.33-4.95), young age (OR = 0.95, CI 0.93-0.98) and high level of anxiety (OR = 1.91, CI 0.96-3.89); (b) in patients with prior experience: apprehension (OR = 4.21, CI 1.93-9.20), poor tolerance of prior examinations (OR = 4.92, CI 1.93-12.5) and female (OR = 2.23, CI 1.09-4.57). CONCLUSIONS The above-mentioned factors are predictive of poor tolerance, and may enable the identification of those patients who might benefit more from sedation for gastroscopy.

Accuracy of Monoclonal Stool Tests for Determining Cure of Helicobacter pylori Infection After Treatment

Background:  Studies comparing new monoclonal fecal tests for evaluating cure of Helicobacter pylori infection after treatment are scarce. The objective was to compare the diagnostic accuracy of three monoclonal stool tests: two rapid in‐office tools –RAPID Hp StAR and ImmunoCard STAT! HpSA – and an EIA test – Amplified IDEIA Hp StAR.

Development and validation of the Crohn's disease perceived work disability questionnaire.

Background: No validated instruments have been developed to measure work disability in Crohns disease (CD). The aim of our study was to develop and validate a CD perceived work disability questionnaire (CPWDQ). Methods: Development phase: an initial questionnaire containing 52 items was obtained from patients’ interviews plus additional sources; it was completed by 106 patients and the 16 most significant items were selected using a psychometric method in order to create the CPWDQ. Validation phase: The validation assessed the questionnaires convergent validity, discriminant validity, test–retest reproducibility, and internal consistency in 108 patients. Spearman rank correlation, t‐test, intraclass correlation, and Cronbachs alpha were used for the analysis. Results: Convergent validity was confirmed by good correlations between the CPWDQ and: clinical activity (r = 0.59, P < 0.01), the Short Inflammatory Bowel Disease Questionnaire, IBDQ‐9, (r = 0.76, P < 0.001), Euroqol‐5D (r = 0.53, P < 0.01), and overall work impairment (WPAI_CD) r = 0.66 (P < 0.01). Discriminant validity: CPWQ scores were higher in patients expected to have more severe disability, that is, in patients with active disease (n = 38) 32.3 ± 7.3 versus inactive (n = 70) 22.6 ± 5.9 (P < 0.001), in those requiring previous sick leave 30.7 ± 7.5 (n = 45) versus no sick leave 22.6 ± 6.6 (n = 63) (P < 0.01), and in those requiring hospitalization 32.2 ± 8.6 (n = 18) versus no hospitalization 24.7 ± 7.1 (n = 90) (P < 0.01). Internal consistency was also good (Cronbachs alpha = 0.89). Reproducibility: CPWDQ measures obtained 2 weeks apart showed an excellent intraclass correlation coefficient: 0.89 (95% CI: 0.83–0.93). Conclusions: The CPWDQ seems to be a valid, reliable tool for measuring subjective work disability in CD. (Inflamm Bowel Dis 2011;)

A new validation of the Spanish Work Productivity and Activity Impairment Questionnaire-Crohn's disease version.

OBJECTIVES The Work Productivity and Activity Impairment Questionnaire (WPAI) is an instrument that measures work impairment in the setting of different diseases. One previous study validating the WPAI in Crohns disease (CD) patients suggested that its reproducibility may be unsatisfactory. This study evaluated the validity and reproducibility of the Spain Spanish version of the WPAI questionnaire in CD patients. METHODS In a prospective study, convergent validity was tested comparing WPAI with quality of life and CD activity indices. Known-groups validity was assessed by comparing WPAI scores in CD patients with active versus inactive disease. Reproducibility of repeated tests was evaluated by comparing two WPAI measures obtained two to four weeks apart in stable patients. RESULTS One hundred eight patients were included in the various steps of the analysis. The WPAI showed adequate known groups validity and convergent validity. The reproducibility of the test and, specifically, that of the evaluation of presenteeism (the impairment of productivity while working) were good. CONCLUSIONS This study confirms the validity of WPAI for measuring work impairment in CD patients. In contrast to previous studies, the test reproducibility was adequate.

microRNA profiling in duodenal ulcer disease caused by Helicobacter pylori infection in a Western population

Although the connection of microRNAs (miRNAs) to some diseases is well established, their involvement in chronic infections such as Helicobacter pylori has received less attention. The aim was to compare miRNA expression profiling in patients with duodenal ulcer (DU) due to H. pylori infection with that in infected patients without DU and in uninfected patients. The miRNA expression profile was determined by microarrays in antral mucosal samples from well-characterized dyspeptic patients (n = 46). The most significant set of miRNAs was subsequently analysed in an independent validation group of patients (n = 42). Transcripts for IL8, IL12p40, IL12p35 and IL23p19, the signalling molecules MYD88, GATA6, SOCS2 and STAT6 and H. pylori virulence factors cagA and VacA were analysed. Microarray experiments showed that 17 miRNAs were deregulated in the mucosa of H. pylori-infected patients. No significant differences were observed between normal and DU patients. PCR confirmed the up-regulation of miR-9, miR-146a, miR-155 and miR-650 and the down-regulation of miR-96 and miR-204 in the independent validation set of patients. Importantly, miR-9, miR-96, miR-146a and miR-650 expression was specific to chronic-active gastritis. H. pylori-infected patients showed higher levels of IL8 and IL12p40 mRNAs and lower levels of GATA6 and SOCS2 mRNAs. The antral mucosa of patients with non-active or chronic-active gastritis showed significantly lower levels of GATA6, MYD88, SOCS2 and STAT6 mRNAs compared with patients without gastritis. The down-regulation of these factors was not correlated with the expression of any of the validated miRNAs. The exact role of the miRNA changes observed will require further study.

Evaluation of four different fecal tests for determination of cure after Helicobacter pylori treatment.

Background Data evaluating the monoclonal tests for determination of cure after Helicobacter pylori treatment are scarce. Goals This study was aimed to evaluate the usefulness of 4 stool tests—2 new RAPID monoclonal immunochromatographic tests (RAPID Hp StAR, DakoCytomation, Cambridge, UK and ImmunoCard STAT! HpSA, Meridian Diagnostics, Cincinnati, OH) a monoclonal EIA test (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK), and a polyclonal EIA test (Premier Platinum HpSA, Meridian Diagnostics, Cincinnati, OH)—to confirm cure of H. pylori infection after eradication treatment. Study Ninety-seven patients who underwent eradication treatment were included. Cure of H. pylori infection was determined using 2 consecutive reference tests. Fecal tests were performed according to the specifications of the manufacturer. Sensitivity, specificity, and positive and negative predictive values were calculated. Results After H. pylori eradication, the RAPID Hp StAR test has a sensitivity of 73% for detecting persistent infection, a specificity of 96% to 98%, a positive predictive value of 73% to 80% and a negative predictive value of 96%. For ImmunoCard STAT! HpSA the corresponding values were 91%, 97%, 77%, and 99%, for Amplified IDEIA Hp StAR 73%, 97%, 73%, and 97%, and for Premier Platinum HpSA 91%, 79%, 35%, and 98%. Conclusions All tests except Premier Platinum HpSA were highly accurate confirming eradication after treatment.

Evaluación de un test rápido (ImmunoCard STAT! HpSA) para la detección de Helicobacter pylori en heces

Introduccion La utilizacion de una tecnica diagnostica rapida puede ser extremadamente util para el tratamiento de las enfermedades relacionadas con la infeccion por Helicobacter pylori. Recientemente se ha comercializado una prueba rapida inmunocromatografica en heces (ImmunoCard STAT! HpSA, Meridian Diagnosis Inc., Cincinnati, Ohio, EE.UU.) para la deteccion de H. pylori. El objetivo del estudio fue evaluar la fiabilidad diagnostica y reproducibilidad de ImmunoCard STAT! HpSA en pacientes dispepticos. Pacientes y metodos Se incluyo a 63 pacientes sometidos a endoscopia para estudio de sintomas dispepticos en los que se practicaron biopsias para CLO-test e histologia antral. Se consideraron infectados por H. pylori los pacientes que presentaban ambos tests positivos, y no infectados, los que dieron negativo en los dos. En heces se realizaron dos determinaciones seriadas de antigeno de H. pylori mediante ImmunoCard STAT! HpSA. Se calcularon la sensibilidad, la especificidad y los valores predictivos positivo y negativo de la tecnica. La concordancia entre las dos determinaciones se evaluo mediante el estadistico Kappa. Resultados De los 63 pacientes, 46 presentaron infeccion por H. pylori , 12 fueron negativos y tres se consideraron indeterminados. La sensibilidad, la especificidad y los valores predictivos positivo y negativo de las distintas determinaciones de ImmunoCard STAT! HpSA fueron del 89-91, el 86-93, el 96-98 y el 72-75%, respectivamente. El indice de concordancia entre determinaciones fue de 0,845. Conclusion ImmunoCard STAT! HpSA muestra una buena sensibilidad y reproducibilidad; por tanto, puede ser de gran utilidad en el tratamiento de las afecciones relacionadas con la infeccion por H. pylori.

Validation of the Spanish Work Productivity and Activity impairment questionnaire: Crohn's disease version.

Background The Work Productivity and Activity Impairment questionnaire has only been partially validated in Crohns disease. Objective To test the Work Productivity and Activity Impairment questionnaire for use in Crohns disease patients. Methods A validated Spanish translation of the test was assessed. ‘Discriminant validity’ was evaluated by comparing Work Productivity and Activity Impairment scores in Crohns disease patients with active versus inactive disease, and in patients versus healthy controls. ‘Convergent validity’ was tested comparing Work Productivity and Activity Impairment questionnaire with quality of life, Crohns disease activity index and a debriefing questionnaire. ‘Reproducibility’ of repeated tests was evaluated by comparing two Work Productivity and Activity Impairment measures obtained 2 weeks apart in stable patients. ‘Responsiveness’ was determined by comparing Work Productivity and Activity Impairment values in the same patients during a flare-up of Crohns disease and during remission. The Wilcoxon test for paired data and the Mann–Whitney U test for unpaired data were used for comparisons. Results One hundred and six patients were included in the various steps of the analysis. All Work Productivity and Activity Impairment parameters showed adequate discriminant and convergent validity and responsiveness. The tests reproducibility was also adequate, except for the evaluation of presenteeism (the impairment of productivity while working). Conclusion The Spanish Work Productivity and Activity Impairment questionnaire is a valid and reliable measurement of work impairment in Crohns disease. Unexpectedly, the test did not present satisfactory reproducibility for the evaluation of presenteeism. The reliability of this last finding should be evaluated in further studies.

Evaluación de un nuevo test rápido para la detección de Helicobacter pylori en heces

Fundamento El objetivo del presente estudio fue evaluar la fiabilidad diagnostica y reproducibilidadde una nueva prueba rapida inmunocromatografica (Stick H. pyl, Operon SA, Zaragoza),que utiliza anticuerpos monoclonales para la deteccion de antigeno de Helicobacter pylori enheces, y compararla con la prueba actualmente comercializada (HpSA, EIA, Premier PlatinumHpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). Metodo Se incluyo a 71 pacientes sometidos a endoscopia para estudio de sintomas dispepticos.Se practicaron biopsias para CLO-test e histologia antral. Se considero infectados por Helicobacterpylori a aquellos pacientes que presentaban histologia y CLO-test positivos, y no infectadosa aquellos con ambos tests negativos. En heces se realizaron 2 determinaciones seriadasde antigeno de Helicobacter pylori mediante HpSA y 4 determinaciones consecutivas con StickH. pyl. Se calcularon la sensibilidad, la especificidad y los valores predictivos positivo y negativo.La concordancia entre determinaciones se evaluo mediante el estadistico kappa. Resultados De los 68 pacientes evaluables, 48 presentaban infeccion por Helicobacter pylori.La sensibilidad, la especificidad y los valores predictivos positivo y negativo en las distintas determinacionesoscilaron entre 89-96%, 60-70%, 85-88% y 74-87% respectivamente paraStick H. pyl frente al 70-75%, 60-85%, 85-92% y 55-80% para HpSA. Los indices de concordanciavariaron entre 0,82 y 0,93 para Stick H. pyl frente a 0,57 para HpSA. Conclusiones Stick H. pyl en heces presenta excelentes sensibilidad y reproducibilidad para eldiagnostico de la infeccion por Helicobacter pylori. Su fiabilidad es superior a la de HpSA.

Validation of phone interview for follow-up in clinical trials on dyspepsia : evaluation of the Glasgow Dyspepsia Severity Score and a Likert-scale symptoms test

Objective To validate two widely used dyspepsia scores performed by phone interview. Design Spanish translations of the Glasgow Dyspepsia Severity Score and a Likert‐scale symptomatic test were evaluated. Responsiveness to the treatment, validity of the tests, and reproducibility of tests performed by phone interview were assessed. Setting Gastroenterology and endoscopy unit of a county hospital. Participants Group I consisted of 16 ulcer patients undergoing Helicobacter pylori eradication; Group II consisted of 29 healthy volunteers; and Group III consisted of 95 patients undergoing upper endoscopy. Measurements Glasgow Severity Dyspepsia Score and Likert test. Results Both tests showed adequate improvement (responsiveness) after H. pylori eradication. With regard to validity, the Glasgow and Likert test were significantly higher in 95 patients undergoing endoscopy than in 29 healthy controls. Analysis of reproducibility showed that intraobserver variation was low on both the Glasgow and Likert scores. No differences were found between consecutive tests regardless of whether both were performed by phone (24 patients) or one by phone and the other by clinical interview (40 patients). Interobserver variation analysis showed that the Glasgow test remained highly reproducible even when performed by different observers using different methods (clinical interview 8.83, phone 8.44, P = 0.12). By contrast, Likert‐scale tests showed significant differences between observers for all symptoms except abdominal pain. Conclusions (1) The Glasgow score is highly reproducible even when performed by different observers and using different methods. (2) By contrast, Likert tests show greater variability. To be reproducible in different conditions, they need to be performed by the same observer. Eur J Gastroenterol Hepatol 12:949‐953