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.

[Psychometric validation of the Polish translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) Questionnaire in patients with reflux disease]. / Psychometryczna walidacja polskiego tlumaczenia Skali Ilosciowej Oceny Objawów Zolkdkowo-Jelitowych (GSRS, Gastrointestinal Symptom Rating Scale) oraz Kwestionariusza Oceny Jakosci Zycia w Chorobie Refluksowej i Dyspepsji (QOLRAD, Quality of Life in Reflux and Dyspepsia Questionnaire) u pacjentów z choroba refluksowa.

UNLABELLED: Symptoms of heartburn and their impact on health-related quality of life (HRQL) 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. The aim of the study is to document the psychometric characteristics of the Polish translation of the Gastrointestinal Symptom Rating Scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) questionnaire. One hundred and thirty-five patients with symptoms of heartburn (mean age: 44, SD = 14.6; females % = 60.7) completed the Polish translation of GSRS, the heartburn version of QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Seventy patients were scheduled for a second visit a week later to complete the GSRS and QOLRAD again. The internal consistency reliability of GSRS ranged from 0.58 to 0.88 and of QOLRAD from 0.84 to 0.95, and the test-retest reliability of GSRS ranged from 0.34 to 0.63 and of QOLRAD from 0.51 to 0.74. The relevant domains of the GSRS, "reflux", "abdominal pain" and "indigestion", and all QOLRAD domain scores significantly correlated. GSRS domains "abdominal pain" and "indigestion" were related to all SF-36 domains. All QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSIONS: the psychometric characteristics of the Polish translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The test-retest reliability of the GSRS "reflux" domain was however not optimal.

[Burden of illness in Polish patients with reflux disease]. / Obciazenie polskich pacjentów zwiazane z choroba refluksowa przelyku.

The clinical and socioeconomic burden of gastro-esophageal reflux disease (GERD) is considerable. The primary symptom of GERD is heartburn, but it may also be associated with extraesophageal manifestations, such as asthma, chest pain and otolaryngologic disorders. The objective of the study was to describe the impact of heartburn on patients' Health-Related Quality of Life (HRQL) in Poland, using validated generic and disease-specific instruments to measure patient-reported outcomes. Patients with symptoms of heartburn completed the Polish versions of the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), the Short Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn during the previous 7 days were also recorded. 135 patients completed the assessments (mean age of 44 years, SD = 15; 61% female). 55% of patients had moderate symptoms and nearly two thirds (64%) had symptoms on 5 or more days in the previous week. Patients were most bothered by symptoms of reflux (mean GSRS score of 4.1, on a scale of 1 [not bothered] to 7 [very bothered]), indigestion (3.5) and abdominal pain (3.2). As a result of their symptoms, patients experienced impaired vitality (mean QOLRAD score of 3.8, on a scale of 1 to 7, where 1 represents the most severe impact on daily functioning), problems with food and drink (3.9), emotional distress (4.1) and sleep disturbance (4.7). Using HAD, 32% of heartburn patients were anxious and 10% were depressed. In conclusion it should be stated that there is consistent evidence that GERD substantially impairs all aspects of health-related quality of life.

Impact of irritable bowel syndrome on patients' lives: development and psychometric documentation of a disease-specific measure for use in clinical trials.

OBJECTIVE: To develop a disease-specific questionnaire to capture the impact of irritable bowel syndrome (IBS) and its treatment on patients' lives, the Irritable Bowel Syndrome Impact Scale (IBS-IS). PATIENTS AND METHODS: One hundred and fifty-five IBS patients participated (126 (81%) female; age (mean+/-SD) 45.5+/-12.4 years). We developed the initial 39 items from the literature, available IBS-specific instruments and input from physicians, nurses and patients. We deleted IBS-IS items with a high ceiling effect, items that measured a different construct and items showing a high correlation (r>0.90) with another item and with Rasch analysis, leaving 26 items. We then applied exploratory factor analysis to examine domain groupings. Subjects completed the IBS-IS instrument, the Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS), Short Form-36 (SF-36), Visceral Sensitivity Index (VSI), and Hospital Anxiety and Depression (HAD) scale. Internal consistency, construct validity and discriminate validity were assessed. RESULTS: The 26 items represented five domains: fatigue, impact on daily activities, sleep disturbance, emotional distress and eating habits. The internal consistency reliability for the domains was 0.87 to 0.96. Most associations between similar constructs in the IBS-IS, GSRS-IBS, SF-36, VSI, and HAD were >0.40. Each IBS-IS domain score decreased with increasing IBS symptom severity (P<0.05), and the patients scored >5 score units lower than a US general population scored on all eight SF-36 dimensions. CONCLUSION: The IBS-IS is a short, user-friendly instrument with excellent psychometric properties that has potential usefulness for clinical trials.

An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire.

BACKGROUND: Few studies have evaluated patient-reported outcomes in connection with a primary event of deep venous thrombosis, partly due to a lack of disease-specific measures. The aim here was to develop a disease-specific health-related quality of life (HRQL) measure, the deep venous thrombosis quality of life questionnaire (DVTQOL), for patients with recent exposition and treatment of proximal deep venous thrombosis. METHODS: A total of 121 consecutive outpatients (50 % males; mean age 61.2 +/- 14 years) treated with warfarin (Waran) for symptomatic proximal deep venous thrombosis were included in the study. Patients completed the SF-36, EQ-5D and the pilot version of the DVTQOL. RESULTS: Items having: high ceiling and floor effect, items with lower factor loadings than 0.50 and items loading in several factors were removed from the pilot version of DVTQOL. In addition, overlapping and redundant items identified by the Rasch analysis were excluded. The final DVTQOL questionnaire consists of 29 items composing six dimensions depicting problems with: emotional distress; symptoms (e.g. pain, swollen ankles, cramp, bruising); limitation in physical activity; hassle with coagulation monitoring; sleep disturbance; and dietary problems. The internal consistency reliability was high (alpha value ranged from 0.79 to 0.93). The relevant domains of the SF-36 and EQ-5D significantly correlated with DVTQOL, thereby confirming its construct validity. CONCLUSIONS: The DVTQOL is a short and user-friendly instrument with good reliability and validity. Its test-retest reliability and responsiveness to change in clinical trials, however, must be explored.

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.

Psychometric validation of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in patients with reflux disease.

BACKGROUND: Symptoms of heartburn has an impact on health-related quality of life (HRQL). When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim is to document the psychometric characteristics of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. METHODS: 142 patients with symptoms of heartburn (Age: M = 47.5, +/- 14.6; Males = 44.4%) completed the German translation of GSRS, the QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. RESULTS: The internal consistency reliability of GSRS ranged from 0.53-0.91 and of QOLRAD from 0.90-0.94, respectively. The test-retest reliability of GSRS ranged from 0.49-0.73 and of QOLRAD from 0.70-0.84. The relevant domains of the GSRS and QOLRAD domain scores significantly correlated. GSRS domains of Abdominal Pain and Constipation correlated (negatively) with most of the domains of the SF-36. The relevant QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSIONS: The psychometric characteristics of the German translation of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The reliability of the GSRS Abdominal Pain domain was moderate.

Factor structure of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire evaluated in patients with heartburn predominant reflux disease.

AIM: To test whether the original factor structure of the Quality of Life in Reflux and Dyspepsia (QOLRAD) can be replicated in Nordic patients and English speaking patients. PATIENTS AND METHODS: Clinical trial patients with heartburn without esophagitis completed the Swedish, Norwegian, Finnish and Danish versions (n = 634) and the English version (n = 1185). The factor structure was examined using models generated by exploratory and confirmatory factor analysis. RESULTS: The exploratory factor analysis suggested that the original five-factor structure solution was the most optimal. The Nordic versions explained 67% and the English version 72% of the variance. The factor loading of 22 out of 25 items was >0.55. In the confirmatory factor analysis, because of the sample size, only the Swedish and Norwegian data were used. Confirmatory factor analysis indicated an acceptable goodness of fit of the five-factor solution to the data with a goodness of fit index of 0.85 in the Swedish, 0.77 in the Norwegian and 0.91 in the English speaking population. The internal consistency reliability ranged from 0.70 to 0.94 (in the Nordic translations) and from 0.85 to 0.92 (in the English version), supporting the homogeneity of the items within the factors and thus their construct validity. The QOLRAD distinguished severity and frequency of heartburn, thereby documenting its known-group validity to distinguish between groups of patients. CONCLUSIONS: The factor structure and dimensionality of the English version and the Swedish and Norwegian translations of the QOLRAD could be replicated by the exploratory and confirmed by the confirmatory factor analysis. The QOLRAD is a valid and reliable instrument for use in clinical trials.

A qualitative analysis of patient-centered dentistry in consultations with dental phobic patients.

Dental phobia is regarded as one of the greatest obstructions to adequate dental care. It has long been established that fearful dental patients are particularly sensitive to dentists' behavior and performance of dental care. There is a need for the establishment of a systematic theory of dentist-patient communication and new methods analyzing how dentists interact with their patients. In this qualitative study, thirty semi-structured interviews were conducted in 1998 and 1999 with five dentists (three male and two female). Dentists consulted on two occasions with 15 newly enrolled, consecutive dental phobic patients (2 male and 13 female) in a Swedish clinic specializing in the treatment of odontophobia. The time interval between consultation one and two was approximately 2-3 weeks. Analysis of the transcribed interviews was based by the principles of Grounded Theory. The study identified one core category, "Holistic perception and understanding of the patient", two categories, "The dentist's positive outlook on people" and "The dentist's positive view of patient contact", and six further subcategories. Findings support previous models of patient-centered medicine and contribute to a better understanding of how patient-centered dentists interact with dental phobic patients.