Javier Zapardiel

Prevalence of gastro-oesophageal reflux disease in Spain and associated factors.

The prevalence of gastro‐oesophageal reflux disease (GERD), has not been characterized in Spain.

Validación psicométrica de la traducción al español de la escala de evaluación de síntomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD) en los pacientes con enfermedad por reflujo gastroesofágico

Introduccion Los sintomas de pirosis y su impacto en la calidad de vida relacionada con la salud (CVRS) son con frecuencia evaluados en los ensayos clinicos. Cuando un cuestionario es traducido a un idioma diferente al que se origino es necesaria una validacion linguistica, aunque no es suficiente a menos que hayan sido verificadas las caracteristicas psicometricas. El objetivo del trabajo es documentar las caracteristicas psicometricas de la traduccion al espanol de la escala de evaluacion de sintomas gastrointestinales (GSRS) y del cuestionario de calidad de vida de reflujo y dispepsia (QOLRAD). Material y metodo Ciento cincuenta y ocho pacientes con sintomas de pirosis (edad: 51,0; DE: 16,3 anos; varones: 42,4%) completaron la traduccion al espanol de la GSRS, la version de pirosis del QOLRAD, el Short-Form-36 (SF-36) y la escala hospitalaria de ansiedad y depresion (HAD). Setenta y seis pacientes fueron citados a una segunda visita pasada una semana para completar de nuevo la GSRS y el QOLRAD. Resultados La fiabilidad de la consistencia interna de la GSRS fue 0,59-0,83 y la del QOLRAD 0,87-0,95, y la fiabilidad del test-retest de la GSRS fue 0,44-0,63 y del QOLRAD 0,77-0,85. La puntuacion de los dominios importantes de la GSRS «reflujo», «dolor abdominal» e «indigestion» y todos los del QOLRAD se correlacionaron significativamente. El dominio «dolor abdominal» de la GSRS tuvo una fuerte correlacion (negativa) con los dominios relevantes del SF-36. Los dominios del QOLRAD se correlacionaron significativamente con todos los dominios relacionados del SF-36. Conclusiones Las caracteristicas psicometricas de la traduccion al espanol de la GSRS y del QOLRAD fueron buenas, con una fiabilidad y validez satisfactorias. Sin embargo, la fiabilidad test-retest del dominio «reflujo» de la GSRS no fue optima.

Repercusión de la enfermedad en pacientes con reflujo gastroesofágico. Evidencia de un estudio metodológico reciente en España

Introduccion La carga clinica y socioeconomica de la enfermedad por reflujo gastroesofagico es considerable. Objetivo Describir el impacto de la pirosis como sintoma principal de la enfermedad por reflujo gastroesofagico sobre la calidad de vida relacionada con la salud en Espana, usando instrumentos de medida de la enfermedad, genericos y especificos de los resultados comunicados por los pacientes. Pacientes y metodos Pacientes con pirosis completaron las versiones espanolas de la Escala de Evaluacion de Sintomas Gastrointestinales (GSRS), del Cuestionario de Calidad de Vida de Reflujo y Dispepsia (QOLRAD), el Short Form-36 (SF-36) y la Escala Hospitalaria de Ansiedad y Depresion (HAD). Tambien se registraron la frecuencia y gravedad de la pirosis durante los 7 dias previos. Resultados Completaron el seguimiento 158 pacientes (edad: 51 ± 16; mujeres: 58%). El 61% de los pacientes tenian sintomas moderados y el 73% habian presentado sintomas 3 o mas dias en la semana previa. Los pacientes estaban mas preocupados por los sintomas de reflujo (media del GSRS: 3,8, sobre una escala de 1 —no preocupado— a 7 —muy preocupado—), dolor abdominal (3,1) e indigestion (3,1). Como consecuencia de sus sintomas tuvieron problemas con la comida y la bebida (media del QOLRAD: 4,5, sobre una escala de 1 a 7, donde 1 representa el impacto mas grave sobre el funcionamiento diario), de vitalidad (4,7) y de estres emocional (4,8). Esto condujo a un empeoramiento global de la calidad de vida relacionada con la salud en todos sus dominios (media del SF-36 de esta poblacion con pirosis, comparada con la poblacion general espanola). Segun la escala de la HAD, el 28% de los pacientes tenian ansiedad y el 13% estaban deprimidos. Conclusion Existe una consistente evidencia de que la enfermedad por reflujo gastroesofagico empeora sustancialmente todos los aspectos de la calidad de vida relacionada con la salud.

Impact of gastroesophageal reflux disease on the quality of life of Spanish patients: the relevance of the biometric factors and the severity of symptoms.

Background Gastroesophageal reflux disease (GERD) has a negative impact on health-related quality of life (HRQoL). Aim (i) To evaluate HRQoL in the general Spanish population with GERD. (ii) To analyze the influence of biometric factors and symptoms profile on HRQoL. Materials and methods A multicenter and population-based evaluation was performed. Surveys were sent out to the general population and 335 responders (16%) fulfilled symptomatic criteria of GERD. They filled out two HRQoL questionnaires [Short Form-36 (SF-36) and Quality of Life in Reflux and Dyspepsia]. Biometric factors and symptoms profile were collected. The SF-36 physical and mental component summary scores were calculated. Results Two hundred and fifty-two individuals (75.2%) participated. SF-36 and Quality of Life in Reflux and Dyspepsia (QoLRAD) punctuations were lower compared with the general population. Female sex, severity of symptoms, and nocturnal symptoms were associated with a greater deterioration of HRQoL. Obese participants had a negative impact on the physical component summary score, but mental component summary score was better than in participants with normal weight. Adjusted by age, punctuations of smokers, exsmokers, and nonsmokers were similar. No differences in HRQoL with regard to alcohol consumption were observed. Conclusion In participants who fulfill symptomatic criteria of GERD, the HRQoL is very deteriorated. The factors that worsen the QoL are being female, increase in BMI, and nocturnal symptoms.

Frequency and clinical implications of supraesophageal and dyspeptic symptoms in gastroesophageal reflux disease.

Objective We studied the frequency of supraesophageal and dyspeptic symptoms and their impact on the quality of life (QoL) and treatment response in patients with gastroesophageal reflux disease (GERD). Methods Multicenter, prospective, observational study of patients who consulted a gastroenterologist because of typical GERD symptoms. Upper digestive symptoms were assessed using direct interviews. The Short Form-12 and the Quality of Life in Reflux and Dyspepsia questionnaires were used to measure QoL. Patients were treated with proton pump inhibitors (PPIs). Results A total of 301 patients (58% men; mean age, 45 years) were included. Baseline symptoms were heartburn (99% of cases; nocturnal heartburn 78%), regurgitation (86%), both heartburn and regurgitation (85%), dyspeptic symptoms (91%; epigastric pain syndrome 20%, postprandial distress syndrome 4%, both 75%), and supraesophageal symptoms (58%). In 56% of cases of heartburn, 35% of regurgitation, and 34% of nocturnal heartburn, symptoms were severe or very severe. One in six patients had dysphagia. Supraesophageal and/or dyspeptic symptoms were associated with worse scores on the Short Form-12 and Quality of Life in Reflux and Dyspepsia instruments. After treatment, heartburn and regurgitation disappeared in 93 and 87% of the patients, respectively. The percentage of patients responding to PPI treatment was significantly higher (P<0.05) in those with heartburn than those without heartburn (96 vs. 86%) and in those with regurgitation than without regurgitation (95 vs. 83%), whereas no differences were observed in those with and without supraesophageal or dyspeptic symptoms. Conclusion Patients with typical GERD symptoms (heartburn and/or regurgitation) very frequently have dyspeptic and supraesophageal manifestations, which are related to a worse QoL but unrelated to PPI response.

Management of gastroesophageal reflux disease in primary care settings in Spain: SYMPATHY I study.

Objective Our study was designed to assess the symptom loads, treatment strategies, and impact on daily life of patients with gastroesophageal reflux disease (GERD) symptoms who consulted primary care (PC) health care providers in Spain. Methods This was a multicenter, observational, cross-sectional study in a sample of 5735 consecutive patients visiting PC clinics with GERD symptoms. Participating primary care physicians (PCPs) collected clinical data by using a questionnaire, and completed a survey on their perceptions of diagnostic and therapeutic approaches to GERD. Patients self-completed the GERD Impact Scale during the study visit. Results In the week before visiting the PC clinic, typical GERD symptoms were present in a majority of patients (89.6% heartburn and 81.6% regurgitation), but extraesophageal symptoms were also frequent (55.6% reflux-related sleep disturbances, 45.7% noncardiac chest pain, 30.8% chronic cough, and 24.7% hoarseness), these being more prevalent in the patients diagnosed earlier. Although primary care physicians considered that 55.9% of the patients could be diagnosed on the basis of symptoms without further investigation, in their practice only one-third of new diagnoses of GERD and 71.1% of those already diagnosed were symptom-managed. Upon arrival at the clinic, patients with GERD symptoms were taking the following medications: 28.1% (47.8% in the case of those already diagnosed) proton pump inhibitors (PPIs), 16.6% antacids, 6.1% H2 antagonists, and 4.5% prokinetics. Most patients (90.2%) were treated with PPIs after the study visit. The evaluation of agreement between physicians and patients on the severity of GERD resulted in a κ index of 0.19. Conclusion There is a high occurrence of typical and extraesophageal symptoms in patients in Spain complaining of GERD symptoms in PC settings. Two-thirds of new GERD patients were referred for further investigation. PPIs were the treatment prescribed in almost all cases. The degree of agreement between physicians and patients about the severity of the symptoms was limited.

Validación del Cuestionario sobre Alteraciones de Reflujo (RDQ) y de la Escala de Impacto de la Enfermedad por Reflujo Gastroesofágico (GIS) para población española

OBJECTIVES To assess the feasibility, reliability, validity and sensitivity of changes in the Reflux Disease Questionnaire (RDQ) and the Gastrointestinal Impact Scale (GIS). MATERIAL AND METHODS An observational, prospective, multicenter study was conducted in primary care centers on two visits (baseline and 16 days later) in a sample of patients with a diagnosis of gastroesophageal reflux disease (GERD) or suspicion of GERD requiring a therapeutic intervention (sensitivity to change group, n=230) and in another sample of patients with clinically controlled GERD (reliability group, n=51). RESULTS The RDQ questionnaire and GIS scale, both overall and for each domain, showed a Cronbachs alpha of greater than or equal to 0.70. All RDQ domains and the total score, as well as the total GIS score and impact dimension, showed a high correlation between the baseline evaluation and that performed 16 days later in stable patients. The RDQ and GIS showed very high correlations between the total scores and those of the quality of life in reflux and dyspepsia (QOLRAD) (-0.73 and 0.80, respectively), a reflux- and dyspepsia-specific quality of life scale, and a high correlation with the gastrointestinal symptoms rating scale (GSRS) (0.54 and -0.55, respectively), a general scale of gastrointestinal symptoms. Both the RDQ questionnaire and the GIS scale showed significant changes with a high effect size on improvement responses. CONCLUSIONS The RDQ and GIS questionnaires show very good psychometric properties, making them suitable for use in primary care.

Is the reflux disease questionnaire useful for identifying GERD according to the Montreal definition

BackgroundScales for aiding physicians diagnose gastro-oesophageal reflux disease (GERD) have not been evaluated in terms of their ability to discriminate between troublesome symptoms (TS) and non-troublesome symptoms (NTS). Our objective is to evaluate the ability of the Reflux Disease Questionnaire (RDQ) to identify GERD according to referral of TS, in patients without previous proton pump inhibitor (PPI) treatment and in patients on PPI treatment.MethodsPatients consulting physicians because of heartburn or acid regurgitation were recruited at 926 primary-care centres in Spain. They were asked to complete several questionnaires including the RDQ, and to define which of their symptoms were troublesome. Information on drug treatment was collected by the physician. We performed a receiver operating characteristic (ROC) curve analysis to ascertain the RDQs optimum cut-point for identifying TS.Results4574 patients were included, 1887 without PPI and 2596 on PPI treatment. Among those without PPI treatment, 1722 reported TS. The area under the curve (AUC) was 0.79 for the RDQ, and the optimum RDQ cut-point for identifying TS was 3.18 (sensitivity, 63.2%; specificity, 80.2%). A total of 2367 patients on PPI treatment reported TS, and the optimum RDQ cut-off value was 3.06 (sensitivity, 65.4%; specificity, 71.8%).ConclusionsAn RDQ score higher than 3 shows good sensitivity and specificity for differentiating TS from NTS among patients without PPI or on PPI treatment. The RDQ is useful in primary care for diagnosis of GERD based on the Montreal definition.

Consumo de recursos sanitarios y pérdida de productividad en la enfermedad por reflujo gastroesofágico: resultados de un estudio transversal en el ámbito de la atención primaria en España

OBJECTIVE To evaluate healthcare resource use and productivity in patients with gastro-esophageal reflux disease (GERD) and the influence of disease severity on these two factors. DESIGN Sub-analysis of the Spanish population of a multinational study with a 4-month retrospective period for the identification and selection of patients, and a clinical visit to obtain clinical information and data on use of healthcare resources, carried out between October 2007 and January 2008. POPULATION A total of 477 patients attending a Primary Care centre, with a medical consultation for GERD. MAIN VARIABLES Use of healthcare resources, changes in productivity based on the Work Productivity and Activity Impairment Questionnaire for GERD patients (WPAI-GERD). RESULTS Despite having received pharmacological treatment at the baseline visit, after a median of 5.1 months follow-up (range 2.1-8.1), up to 15.9% (95% CI; 12.8-19.5) patients still showed clinically relevant GERD symptoms. Direct medical costs per year associated with diagnostic tests and medical consultations in patients with or without clinically relevant GERD symptoms were 666 € (SD: 2,097 €) and 370 € (SD: 2,060 €), respectively. The mean annual cost of reduced productivity (17%) was 5,316 € (SD: 8,615 €). This cost was 4 times higher for patients with clinically relevant GERD symptoms than for patients with no relevant symptoms (15,188 € [SD: 11,206 €] vs 3,926 € [SD: 7,232 €]). CONCLUSION Patients with GERD use significant healthcare resources, attributable to associated medical costs and marked reduction in productivity, even though they receive pharmacological treatment.