Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaire.

BACKGROUND: The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. AIMS: To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. METHODS: HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. RESULTS: High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. CONCLUSIONS: The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.

Impact of reflux disease on general and disease-related quality of life - evidence from a recent comparative methodological study in Germany.

BACKGROUND: 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. AIM: To describe the impact of heartburn on patients' Health-Related Quality of Life (HRQL) in Germany, using validated generic and disease-specific instruments to measure patient-reported outcomes. METHOD: Patients with symptoms of heartburn completed the German 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. RESULTS: 142 consecutive patients completed the assessments (mean age of 47.5 years, SD = 14.6; 55.6 % female). 70 % of patients had moderate symptoms. Over half (68 %) had symptoms on more than 4 days in the previous week. Patients were most bothered by symptoms of reflux with a mean GSRS score, (ranges from 1 [not bothered] to 7 [very bothered]), of 3.9, indigestion of 3.3 and abdominal pain of 3.0, respectively. As a result of their symptoms, patients experienced problems with food and drink. The mean QOLRAD score (ranges from 1 to 7; the lower the value the more severe the impact on quality of life) of daily functioning was 4.4, impaired vitality 4.6, emotional distress 5.0 and sleep disturbance 5.1, respectively. This led to impaired overall HRQL across all domains (mean SF-36 score of this heartburn population compared to a general population in Germany). Using HAD, 25 % of patients were anxious and 8 % were depressed. CONCLUSION: There is consistent evidence that heartburn substantially impairs all aspects of health-related quality of life.

An irritable bowel syndrome-specific symptom questionnaire: development and validation.

BACKGROUND: No self-assessment instruments are available to assess symptoms of irritable bowel syndrome (IBS). Our aim was to develop a disease-specific symptom questionnaire for use in patients with IBS. METHODS: Two-hundred-and-thirty-four patients (77% F) with a mean age of 44 years took part in a psychometric evaluation using the previously validated Gastrointestinal Symptom Rating Scale modified for use in patients with IBS (GSRS-IBS). This version was tested against several disease-specific health-related quality of life (HRQL) questionnaires. Items with a high ceiling effect, items that measured a different construct, and items showing high correlation (>0.80) to another item were removed. A confirmatory factor analysis was also performed. RESULTS: The final questionnaire included 13 items depicting problems with satiety, abdominal pain, diarrhoea, constipation and bloating. The internal consistency reliability was high, ranging from 0.74 (pain) to 0.85 (satiety). The associations between similar constructs in the GSRS-IBS and the various HRQL scores confirmed the construct validity. Pain, bloating and diarrhoea were the symptom clusters that impaired HRQL the most. CONCLUSION: The GSRS-IBS is a short and user-friendly instrument with excellent psychometric properties.

Characteristics of patients with irritable bowel syndrome recruited from three sources: implications for clinical trials.

BACKGROUND: Variation in the characteristics of irritable bowel syndrome patients recruited for clinical trials from different sources could affect their response and the generalizability of trial results. AIM: To describe and compare the characteristics of three different groups of irritable bowel syndrome patients recruited into a 'mock clinical trial.' METHODS: We enrolled 245 irritable bowel syndrome patients from three sources: (i) 121 from British primary practitioners; (ii) 72 from California newspaper advertisements; and (iii) 52 from a California gastroenterologist's practice. We obtained demographic, clinical, and Hospital Anxiety and Depression (HAD) Scale data. RESULTS: Most patients were young to middle-aged women; the majority reported symptoms for > 5 years in all three groups. Subject characteristics varied among the groups. Typically, primary care patients were anxious, smokers and daily alcohol drinkers who had sought care recently for irritable bowel syndrome and tried antispasmodic drugs. Their symptoms were intermediate in severity between those of the other two groups. Advertisement subjects were the oldest, most highly educated, most often depressed, and were least likely to have sought care recently for symptoms, which were almost uniformly only moderate in severity. Gastroenterologist patients tended to be anxious and had nearly all sought care recently for symptoms, which were the most severe and most likely to include all three pain-related Rome I criteria. CONCLUSION: Recruitment methodology affects important characteristics of an irritable bowel syndrome study group.

Effects of a standardized ginseng extract on quality of life and physiological parameters in symptomatic postmenopausal women: a double-blind, placebo-controlled trial. Swedish Alternative Medicine Group.

A randomized, multicenter, double-blind, parallel group study was performed to assess the effects of a standardized ginseng extract compared with those of a placebo on quality of life (QoL) and on physiological parameters in symptomatic postmenopausal women. Validated questionnaires [Psychological General Well-Being (PGWB) index, Women's Health Questionnaire (WHQ)] and Visual Analogue (VA) scales were used to assess the effects of the extract on QoL at baseline and after 16 weeks' treatment with either the ginseng extract or placebo. To assess the efficacy of ginseng on postmenopausal symptoms, physiological parameters [follicle-stimulating hormone (FSH) and estradiol levels, endometrial thickness, maturity index and vaginal pH] were recorded at the same time points. Of the 384 randomized patients (mean age 53.5 +/- 4.0 years), the questionnaires were completed by 193 women treated with ginseng and 191 treated with placebo. With regard to the primary endpoint (total score of the PGWB index) the extract showed only a tendency for a slightly better overall symptomatic relief (p < 0.1). Exploratory analysis of PGWB subsets, however, reported p-values < 0.05 for depression, well-being and health subscales in favor of ginseng compared with placebo. No statistically significant effects were seen for the WHQ and the VA scales or the physiological parameters, including vasomotor symptoms (hot flushes). The positive effects of ginseng on health-related QoL in menopausal women should be further investigated. This study shows, however, that the beneficial effects of ginseng are most likely not mediated by hormone replacement-like effects, as physiological parameters such as FSH and estradiol levels, endometrial thickness, maturity index and vaginal pH were not affected by the treatment.

Quality of life in different gastrointestinal conditions.

In recent years, there has been increasing interest in how gastrointestinal symptoms relate to and impact on patients' health-related quality of life. This is particularly the case for functional gastrointestinal disorders that are characterized by a lack of biological markers for disease activity. There is only a slight variation in the type of gastrointestinal symptoms reported with different gastrointestinal disorders, and patients with dyspepsia or irritable bowel syndrome, for example, often describe a variety of gastrointestinal symptoms with considerable overlap between them. The same pattern has been observed in patients with gastroesophageal reflux disease, even though heartburn and acid regurgitation are easier to distinguish from other gastrointestinal symptoms, particularly in patients in whom objective reflux is verified. Most aspects of health-related quality of life in patients with gastrointestinal disorders are compromised, irrespective of diagnosis. Patients with functional disorders seem, if anything, to display more emotional distress than those with organic disorders. Given the considerable overlap between different gastrointestinal symptom clusters, it is not surprising that these conditions have a similar impact in terms of perceived health status and quality of life. The key factors associated with the degree of perceived distress and dysfunction relate to disease severity and the presence of abdominal pain symptoms.

Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD).

OBJECTIVE: To develop a disease-specific QOL instrument (QOLRAD) addressing patient concerns in gastroesophageal reflux disease (GERD) and dyspepsia. Patients. 759 male (45%) and female (55%) patients with a mean age of 48.4 years (sd 15.2) were used in the psychometric evaluation. MAIN OUTCOME MEASURES: A pilot version of QOLRAD, the Gastrointestinal Symptoms Rating Scale (GSRS) and the SF-36 were completed prior to endoscopy. Items with a high ceiling effect, items measuring a different construct, i.e. with a low squared multiple correlation (R < 0.5) with the other items, items that showed redundancy by a high correlation (>0.80) with another item were removed. A confirmatory factor analysis was also performed. RESULTS: The final questionnaire included 25 items depicting problems with emotions, vitality, sleep, eating/drinking, and physical/social functioning. The internal consistency reliability was high (alpha value overall 0.97, dimensions 0.89-94). Construct validity, i.e. the associations between similar constructs in the QOLRAD, the SF-36 and the GSRS scores was confirmed. Pain and symptom severity were markers of impaired QOL. The impact on health-related QOL was similar across the functional gastrointestinal disorders with the exception of patients with a normal endoscopy, who did slightly worse. CONCLUSION: The QOLRAD is a short and user-friendly instrument with excellent psychometric properties. Its responsiveness to change in (AVMC1) clinical trials is currently being explored.

Validation of seven graded diary cards for severity of dyspeptic symptoms in patients with non ulcer dyspepsia.

The diary card as a measure of the severity of pain or discomfort in the stomach on a 7 graded scale was validated using data from a randomised placebo controlled clinical trial in patients with non-ulcer dyspepsia (NUD). The diary card measure was compared to two other measures: a symptom question in a gastro-intestinal symptom questionnaire and a symptom severity rating made by the investigator based on an interview with the patient at the clinical visit. The reliability coefficient for the mean of the diary card scores from 7 consecutive days was estimated to 0.71. The mean of the scores from 7 consecutive days was approximately as sensitive to change as the other two measures.

Defining quality of life in medicine.

In recent years, there has been increasing interest in incorporating the concept of "Quality of Life" in the evaluation of medical interventions. The lack of a general definition which can function as a basis for the scientific evaluation of medical treatment is, however, a problem. The definition proposed in this paper contains three main factors: Subjective well-being, Health and Welfare. "Subjective well-being" is the central component in the evaluation of Quality of Life, referring to the individual's perception of his life situation, "Health" is a subjective as well as objective evaluation of physical and mental status, while "Welfare" reflects the objective environmental factors. Thus, the evaluation of Quality of Life in medicine should ideally address these three main factors. Although the importance of any particular component may vary, subjective well-being and health should always be included.

Differences in the subjective well-being and symptoms of normotensives, borderline hypertensives and hypertensives.

In this study, previously untreated subjects were randomly recruited from a blood pressure screening programme. After repeated measurement of blood pressure levels, the subjects were divided into three major groups: normotensives (n = 95), borderline hypertensives (n = 69) and hypertensives (n = 30). Three self-administered standardized questionnaires were used to measure different aspects of subjective well-being and symptoms: the Nottingham Health Profile (NHP), the Subjective Symptoms Assessment Profile (SSAP) and the Minor Symptoms Evaluation Profile (MSEP). The results indicate gradual differences between the three groups, the most pronounced symptoms being seen among the hypertensives. Statistically significant differences were found for cardiac and gastrointestinal symptoms as well as for emotional reactions, home life, social life, sex life and sleep. The differences in well-being and subjective symptoms noted between the groups are important in the evaluation of new antihypertensive agents. Self-administered questionnaires of the type used in this study could also be valuable in identifying symptoms and disturbances in subjective well-being related to the antihypertensive medication per se.