Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study.

BACKGROUND: Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia. METHODS: 853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale. RESULTS: The internal consistency reliability of the GSRS was 0.43-0.87 and of the QOLRAD 0.79-0.95. Test-retest reliability of the GSRS was 0.36-0.75 and of the QOLRAD 0.41-0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity. CONCLUSION: The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.

Burden of illness in Italian patients with gastro-oesophageal reflux disease.

OBJECTIVE: Gastro-oesophageal reflux disease (GORD), characterized by frequent episodes of heartburn, imposes considerable burdens on both patients and health services. In addition to both patients and health services. In addition to gastrointestinal symptoms, GORD may precipitate a variety of extra-oesophageal complications, such as asthma and chest pain, which can significantly impair patients' quality of life. This paper aims to describe the impact of heartburn on patients' health-related quality of life (HRQL) in Italy. RESEARCH DESIGN AND METHODS: Consecutive patients from general practices and gastroenterology clinics who were experiencing heartburn were invited to complete a selection of standardized patient-reported outcomes instruments, including Italian translations of the Gastrointestinal Symptom Rating Scale (GSRS), Short-Form 36 (SF-36), Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) and Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn in the preceding week were recorded. RESULTS: Assessments were completed by 152 patients (mean age, 47 years), of whom 60% were female. Sixty-one per cent had moderate symptoms and 74% had symptoms on three or more days in the previous week. Patients were most bothered by reflux, abdominal pain and indigestion. As a result of their symptoms, patients experienced impaired vitality, sleep disturbance and other alimentary problems. This led to impaired HRQL across all but one SF-36 domain. According to the HAD scale, 21% of patients were depressed and 19% were anxious. CONCLUSION: GORD substantially impairs many aspects of HRQL, including sleep, vitality and emotional health.

Susceptibility to refractory ulcerative colitis is associated with polymorphism in the hMLH1 mismatch repair gene.

The hMLH1 gene lies in the linkage susceptibility region to inflammatory bowel disease (IBD) on 3p21. A single nucleotide polymorphism, 655A>G, in exon 8 of the gene causes an I219V change in the MLH1 protein. To test whether hMLH1 may confer susceptibility to ulcerative colitis (UC), we investigated an association between the 655A>G polymorphism and the disease. DNA-based technologies were used to analyze the 655A>G polymorphism in 201 UC patients and 126 healthy ethnically matched controls. The comparison of the allelic frequencies of the 655A>G polymorphism in UC patients and healthy controls did not show significant differences. However, genotype frequencies at the hMLH1 655 position were found to be significantly different when patients with and without refractory UC were compared. This was mainly attributable to a higher level of homozygosity for the G allele in refractory UC patients. Almost 5 times as many (4.9 times) refractory UC patients carried the GG genotype compared with nonrefractory patients (P < 0.0001). The present study provides evidence that the hMLH1 gene is involved in genetic susceptibility to refractory UC. If confirmed by other studies, the GG genotype at position 655 of the hMLH1 gene may represent a useful predictive factor for the clinical management of UC patients.

Psychometric validation of the italian translation of the gastrointestinal symptom-rating scale and quality of life in reflux and dyspepsia questionnaire in patients with gastro-oesophageal reflux disease.

BACKGROUND: Symptoms of heartburn and their impact on health-related quality of life (HR-QOL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. OBJECTIVE: To document the psychometric characteristics of the Italian translation of the Gastrointestinal Symptom-Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. PATIENTS AND METHODS: 152 consecutive patients with symptoms of heartburn (mean +/- SD age 46.5 +/- 16.2 years; 40.1% males) completed the Italian translation of GSRS, the heartburn version of QOLRAD, the 36-item Short-Form health survey (SF-36), and the Hospital Anxiety and Depression (HAD) scale. RESULTS: The internal consistency reliability of GSRS ranged from 0.62 to 0.76 and of QOLRAD from 0.77 to 0.89. The relevant domains of the GSRS ('Reflux', 'Abdominal Pain' and 'Indigestion') and QOLRAD domain scores significantly correlated. GSRS domains 'Reflux' and 'Abdominal Pain' strongly correlated (negatively) with most of the domains of the SF-36. Similarly, all QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSION: The psychometric characteristics of the Italian translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity.