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

BACKGROUND: Scales 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. METHODS: Patients 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 RDQ's optimum cut-point for identifying TS. RESULTS: 4574 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%). CONCLUSIONS: An 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.

Prescription of and adherence to non-steroidal anti-inflammatory drugs and gastroprotective agents in at-risk gastrointestinal patients.

OBJECTIVES: Patients with gastrointestinal (GI) risk factors who take non-steroidal anti-inflammatory drugs (NSAIDs) should also take gastroprotective agents (GPAs). No studies have evaluated adherence and reasons for non-adherence to GPA and NSAID therapies. METHODS: This was a prospective, multicenter, observational, longitudinal study. Patients attending rheumatology/orthopedic clinics who were co-prescribed NSAID plus GPA for at least 15 days and had risk factors for GI complications were followed up by telephone call. Optimal adherence was defined as taking the drug for ≥ 80% of prescribed days. Multivariate logistic regression analysis was used to determine factors associated with non-adherence. RESULTS: Of 1,232 patients interviewed, 192 were excluded because of inaccurate data. Of the remaining 1,040 patients, 74 % were prescribed low-dose NSAIDs and 99.8 % were prescribed a standard or high-dose GPA. In all, 70 % of NSAIDs and 63.1 % of GPA prescriptions were short term (< 30 days). The majority of patients who were prescribed either an NSAID (92.5 % ) or GPA (85.9 % ) started therapy. Optimal adherence to GPA or NSAIDs was reported by 79.7 % (95 % confidence interval (CI): 76.9-82.2 % ) and 84.1 % (95 % CI: 81.7-86.3 % ) of patients, respectively. More adverse events occurred among patients who reported non-optimal adherence than among patients with optimal adherence to GPA (22.1 vs. 1.9 % , P < 0.0001). As reasons for non-adherence, patients most frequently cited infrequent/low-intensity rheumatic pain (NSAIDs) or forgetfulness (GPAs). Adverse events and short-term treatment were independent factors associated with poor adherence for both NSAIDs and GPAs. History of uncomplicated peptic ulcer and frequent dosing were additional factors associated with non-adherence to NSAIDs. CONCLUSIONS: Most frequent reasons for non-adherence are infrequent/low-intensity rheumatic pain (NSAIDs) or forgetfulness (GPAs). Short-term treatment and adverse events were associated with poor adherence for both therapies.

[Use of health resources and loss of productivity in gastroesophageal reflux disease: results of a cross-sectional study in a primary care setting in Spain]. / 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.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) universal screening in gravids during labor and delivery.

OBJECTIVE: To screen pregnant women at risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during delivery using reverse-transcription polymerase chain reaction (RT-PCR) test and serum immunoglobulin (Ig) testing. METHOD: Between March 31 st and August 31 st of 2020, consecutive pregnant women admitted for labor and delivery in a single hospital were screened for SARS-CoV-2 with nasopharyngeal RT-PCR swab tests and detection of serum IgG and IgM. RESULTS: We studied 266 pregnant women admitted for labor and delivery. The prevalence of acute or past SARS-CoV-2 infection was 9.0 %, including (i) two cases with respiratory symptoms of SARS-Co-V-2 infection and positive RT-PCR; (ii) four asymptomatic women with positive RT-PCR without clinical symptoms and negative serological tests between two and 15 weeks later; and (iii) two women with false positive RT-PCR due to technical problems. All newborns of the 6 pregnant women with RT-PCR positive had negative RT-PCR and did not require Neonatal Intensive Care Unit admission. There were eighteen asymptomatic women with positive serological IgG tests and negative RT-PCR. CONCLUSION: In our cohort of gravids, we found 2.2 % of women with positive RT-PRC tests and 6.7 % with positive serological tests during the first wave of the SARS-CoV-2 pandemic.

Screening of severe acute respiratory syndrome coronavirus-2 infection during labor and delivery using polymerase chain reaction and immunoglobulin testing.

AIMS: To assess severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during labor and delivery with polymerase chain reaction (PCR) and using immunoglobulin G and M testing to correlate with maternal and perinatal outcomes. MAIN METHODS: Pregnant women admitted for labor and delivery at two Spanish hospitals were screened for SARS-CoV-2 infection by PCR test and by detection of serum immunoglobulins G and M. Maternal and perinatal outcomes were compared in women with laboratory evidence of SARS-CoV-2 infection with those with negative tests. KEY FINDINGS: Between March 31st and September 30th, 2020, 1211 pregnant women were screened for SARS-CoV-2 infection. The prevalence of laboratory evidence of SARS-CoV-2 infections was 5.4% (n = 65), corresponding to (i) 22 ongoing infections at admission, including two with mild clinical symptoms and 20 asymptomatic women; (ii) 43 cases of previous SARS-CoV-2 exposure; (iii) and 1146 women who were negative for both SARS-CoV-2 PCR and serological test. None of the screened mothers required hospital admission for coronavirus disease before or after delivery, nor were any of the newborns admitted to the intensive care unit. All newborns from mothers with positive PCR on admission were PCR negative. There were no significant differences in maternal or perinatal outcomes among the three studied groups. SIGNIFICANCE: Ongoing or previous SARS-CoV-2 infection with asymptomatic or mild clinical symptoms detected during screening in pregnant women at labor and delivery do not have a higher rate of adverse maternal or perinatal outcomes.

[Study of the clinical profile and management of patients with gastroesophageal reflux disease in primary care in Spain]. / Estudio de síntomas relevantes y atención clínica en la enfermedad por reflujo gastroesofágico en atención primaria en España.

OBJECTIVE: To assess the clinical profile and management of patients with gastroesophageal reflux disease (GERD) in primary care. METHODS: A multinational, multicenter study was performed comprising a 4-month retrospective phase for the screening, selection and assessment of patients who had consulted for any GERD-related cause (index visit), and a cross-sectional phase in which clinical data were recorded and the following questionnaires were administered: the Reflux Disease Questionnaire and the Gastroesophageal Reflux Disease Impact Scale (GIS). RESULTS: Among the 24 participating Spanish centers, 2.7% of the patients (95% CI: 2.6-2.9) had consulted at least once because of GERD. Approximately 50% of the patients showed frequent (2 or more days a week) or moderate to severe symptoms of heartburn, acid regurgitation or chest pain. Although the patients received effective pharmacological treatment at the index visit, clinically relevant GERD symptoms persisted in 16% after a median follow-up of 5 months. These symptoms were associated with a strong disease impact as evaluated with the GIS. CONCLUSION: GERD represents a substantial burden for primary care physicians. Although effective drugs are used for the treatment of this condition, clinically relevant symptoms persist in a substantial proportion of patients.

[Symptom profile in gastroesophageal reflux disease in untreated patients and those with persistent symptoms despite treatment]. / Perfil sintomático en la enfermedad por reflujo gastroesofágico en pacientes no tratados y en los que persisten los síntomas a pesar del tratamiento.

AIM: 1. To analyze the symptom profile of gastroesophageal reflux disease (GERD) with typical clinical manifestations (heartburn and/or regurgitation); 2. to compare untreated patients with those with persistent symptoms despite treatment; 3. to evaluate severity according to physicians' and patients' opinions; and 4. to determine the diagnostic and therapeutic approaches used. METHODS: We performed a prospective, observational, cross-sectional study under conditions of standard clinical practice. RESULTS: A total of 2356 patients were included. Dyspeptic symptoms were highly frequent (close to 90% in both groups) and supraesophageal symptoms were also common (50-60%). Patients with persistent symptoms despite treatment were older, and had more supraesophageal symptoms; in addition, the typical supraesophageal and dyspeptic symptoms of GERD were more severe in these patients. Severity evaluations by patients and doctors were concordant but patients considered severity to be greater. Older age was a risk factor for supraesophageal symptoms, female gender for dyspeptic symptoms and body mass index for greater severity of GERD symptoms. Endoscopy was requested in about 60% of the patients. Diet counseling was advised in most patients and postural recommendations were made in more than half. Proton pump inhibitors were prescribed in almost all patients, and were associated with prokinetics and/or antacids in many patients. CONCLUSIONS: Dyspeptic symptoms should not be considered as independent of GERD, and typical and atypical symptoms are associated in 50% of patients. Gastroenterologists follow clinical practice guidelines fairly closely but diagnostic procedures seem to be overindicated.

Impact of gastroesophageal reflux disease on patients' daily lives: a European observational study in the primary care setting.

BACKGROUND: The impact of gastroesophageal reflux disease (GERD) on the daily lives of patients managed in primary care is not well known. We report the burden of GERD in a large population of patients managed in primary care, in terms of symptoms and impact on patients' daily lives. METHODS: RANGE (Retrospective ANalysis of GERD) was an observational study that was conducted at 134 primary care sites across six European countries. All adult subjects who had consulted their primary care physician (PCP) during a 4-month identification period were screened retrospectively and those consulting at least once for GERD-related reasons were identified. From this population, a random sample of patients was selected to enter the study and attended a follow-up appointment, during which the Reflux Disease Questionnaire (RDQ), the GERD Impact Scale (GIS) and an extra-esophageal symptoms questionnaire were self-administered. Based on medical records, data were collected on demographics, history of GERD, its diagnostic work-up and therapy. RESULTS: Over the 4-month identification period, 373,610 subjects consulted their PCP and 12,815 (3.4%) did so for GERD-related reasons. From 2678 patients interviewed (approximately 75% of whom reported taking medication for GERD symptoms), symptom recurrence following a period of remission was the most common reason for consultation (35%). At the follow-up visit, with regard to RDQ items (score range 0-5, where high score = worse status), mean Heartburn dimension scores ranged from 0.8 (Sweden) to 1.2 (UK) and mean Regurgitation dimension scores ranged from 1.0 (Norway) to 1.4 (Germany). Mean overall GIS scores (range 1-4, where low score = worse status) ranged from 3.3 (Germany) to 3.5 (Spain). With regard to extra-esophageal symptoms, sleep disturbance was common in all countries in terms of both frequency and intensity. CONCLUSION: In this large European observational study, GERD was associated with a substantial impact on the daily lives of affected individuals managed in the primary care setting.

[Validation of the Reflux Disease Questionnaire (RDQ) and Gastrointestinal Impact Scale (GIS) in patients with gastroesophageal reflux disease in the Spanish population]. / 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 Cronbach's 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.

Comparison of automated devices UX-2000 and SediMAX/AutionMax for urine samples screening: A multicenter Spanish study.

OBJECTIVES: In this study we aim to compare UX2000 (Sysmex Corp, Japan) and SediMAX/AutionMax (Arkray Factory Inc., Japan), totally automatized analyzers, against Fuchs-Rosenthal counting chamber, the gold standard technique for sediment analysis. DESIGN AND METHODS: Urine samples of 1454 patients from three Spanish hospitals were assessed for red and white blood cells (RBC; WBC) using three different techniques: flow cytometry, image-based method and Fuchs-Rosenthal counting chamber. Test strip results were subjected to concordance evaluation. Agreement was assessed by Cohen's weighted kappa for multinomial results. Sensitivity (SE) and specificity (SP) were calculated. RESULTS: The categorization of the results showed that UX-2000 had higher concordance over SediMAX for WBC (0.819 vs. 0.546) and similar for RBC (0.573 vs. 0.630). For RBC, UX-2000 had higher SE (92.7% vs. 80.3%) but lower SP (77.1% vs. 87.4%), and showed higher both SE (94.3% vs. 76.7%) and SP (94.7% vs. 88.2%) for WBC. Inter-devices test strip agreement was substantial (kappa>0.600) for all variables except for bilirubin (kappa: 0.598). Intra-device test strip agreement was similar for UX2000 and SediMAX with regard to RBC (kappa: 0.553 vs. 0.482) but better for UX2000 with regard to WBC (0.688 vs. 0.465). CONCLUSIONS: Both analyzers studied are acceptable for daily routine lab work, even though SediMAX is easier to use in laboratories thanks to its lower maintenance procedure. UX-2000 has shown to have better concordance with the gold standard method. However, it needs some improvements such as an image module in order to decrease manual microscopy review for urine samples.

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.

Clinical usefulness of adherence to gastro-esophageal reflux disease guideline by Spanish gastroenterologists.

AIM: To investigate usefulness of adherence to gastro-esophageal reflux disease (GERD) guideline established by the Spanish Association of Gastroenterology. METHODS: Prospective, observational and multicentre study of 301 patients with typical symptoms of GERD who should be managed in accordance with guidelines and were attended by gastroenterologists in daily practice. Patients (aged > 18 years) were eligible for inclusion if they had typical symptoms of GERD (heartburn and/or acid regurgitation) as the major complaint in the presence or absence of accompanying atypical symptoms, such as dyspeptic symptoms and/or supraesophageal symptoms. Diagnostic and therapeutic decisions should be made based on specific recommendations of the Spanish clinical practice guideline for GERD which is a widely disseminated and well known instrument among Spanish in digestive disease specialists. RESULTS: Endoscopy was indicated in 123 (41%) patients: 50 with alarm symptoms, 32 with age > 50 years without alarm symptom. Seventy-two patients (58.5%) had esophagitis (grade A, 23, grade B, 28, grade C, 18, grade D, 3). In the presence of alarm symptoms, endoscopy was indicated consistently with recommendations in 98% of cases. However, in the absence of alarm symptoms, endoscopy was indicated in 33% of patients > 50 years (not recommended by the guideline). Adherence for proton pump inhibitors (PPIs) therapy was 80%, but doses prescribed were lower (half) in 5% of cases and higher (double) in 15%. Adherence regarding duration of PPI therapy was 69%; duration was shorter than recommended in 1% (4 wk in esophagitis grades C-D) or longer in 30% (8 wk in esophagitis grades A-B or in patients without endoscopy). Treatment response was higher when PPI doses were consistent with guidelines, although differences were not significant (95% vs 85%). CONCLUSION: GERD guideline compliance was quite good although endoscopy was over indicated in patients > 50 years without alarm symptoms; PPIs were prescribed at higher doses and longer duration.

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 kappa 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.

Education-based approach to addressing non-evidence-based practice in preventing NSAID-associated gastrointestinal complications.

AIM: To evaluate an evidence-based educational program for improving strategies for prevention of nonsteroidal anti-inflammatory drug (NSAID)-associated gastrointestinal (GI) complications. METHODS: Four hundred and fifty-six specialists replied to a questionnaire that covered issues related to NSAID-induced adverse effects. They also collected data from their last five consecutive patients before and after they had attended an evidence-based seminar on GI prevention strategies. RESULTS: Four hundred and forty-one of 456 specialists (96.7%) participated in the survey, and 382 (83.7%) in the education-based study that recorded data from 3728 patients. The specialists overestimated the risk of GI complications with NSAIDs, underestimated the GI safety profile of coxibs, but were aware of the risk factors and of the current prevention strategies. Proton pump inhibitors were co-prescribed with NSAIDs in > 80% of patients with and without risk factors. The educational program had little impact on prescribing habits. CONCLUSION: Specialists are informed of advances in NSAID-associated adverse effects and have high rates of GI-prevention therapy. Our educational program did not alter these rates.

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.