Doubtful outcome of the validation of the Rome II questionnaire: validation of a symptom based diagnostic tool

<p>Abstract</p> <p>Background</p> <p>Questionnaires are used in research and clinical practice. For gastrointestinal complaints the Rome II questionnaire is internationally known but not validated. The aim of this study was to validate a printed and a computerized version of Rome II, translated into Swedish. Results from various analyses are reported.</p> <p>Methods</p> <p>Volunteers from a population based colonoscopy study were included (n = 1011), together with patients seeking general practice (n = 45) and patients visiting a gastrointestinal specialists' clinic (n = 67). The questionnaire consists of 38 questions concerning gastrointestinal symptoms and complaints. Diagnoses are made after a special code. Our validation included analyses of the translation, feasibility, predictability, reproducibility and reliability. Kappa values and overall agreement were measured. The factor structures were confirmed using a principal component analysis and Cronbach's alpha was used to test the internal consistency.</p> <p>Results and Discussion</p> <p>Translation and back translation showed good agreement. The questionnaire was easy to understand and use. The reproducibility test showed kappa values of 0.60 for GERS, 0.52 for FD, and 0.47 for IBS. Kappa values and overall agreement for the predictability when the diagnoses by the questionnaire were compared to the diagnoses by the clinician were 0.26 and 90% for GERS, 0.18 and 85% for FD, and 0.49 and 86% for IBS. Corresponding figures for the agreement between the printed and the digital version were 0.50 and 92% for GERS, 0.64 and 95% for FD, and 0.76 and 95% for IBS. Cronbach's alpha coefficient for GERS was 0.75 with a span per item of 0.71 to 0.76. For FD the figures were 0.68 and 0.54 to 0.70 and for IBS 0.61 and 0.56 to 0.66. The Rome II questionnaire has never been thoroughly validated before even if diagnoses made by the Rome criteria have been compared to diagnoses made in clinical practice.</p> <p>Conclusion</p> <p>The accuracy of the Swedish version of the Rome II is of doubtful value for clinical practice and research. The results for reproducibility and reliability were acceptable but the outcome of the predictability test was poor with IBS as an exception. The agreement between the digital and the paper questionnaire was good.</p

Self-reported abdominal symptoms in relation to health status in adult patients with familial adenomatous polyposis

BACKGROUND: Patients with familial adenomatous polyposis who undergo surgery to prevent colorectal cancer experience various abdominal symptoms that may affect their physical and mental health. OBJECTIVE: This study was designed to investigate self-reported presence, frequency, and troublesomeness of abdominal symptoms in such patients in relation to sex, type of surgery, and physical and mental health. DESIGN: A cohort study with a descriptive and comparative cross-sectional design. SETTING AND PARTICIPANTS: All adult patients in the Swedish Polyposis Registry (Karolinska University Hospital, Stockholm, Sweden) who were diagnosed with familial adenomatous polyposis, had undergone prophylactic colorectal surgery, and were aged 18 to 75 years were invited to return a mailed questionnaire. MAIN OUTCOME MEASURES: Self-reported presence, frequency, and troublesomeness of 21 abdominal symptoms were assessed with the Abdominal Symptom Questionnaire. Physical health and mental health were evaluated with the Medical Outcomes Study Short Form 36 Health Survey. RESULTS: Of 275 eligible patients, 209 (76%) responded. Of respondents, 91% reported having had at least 1 symptom during the last 3 months. All 21 symptoms investigated were reported. A higher number of symptoms was reported by women than by men: mean, 7.55 (SD, 4.89) vs 5.14 (4.49); P < .01. No significant difference was found between women and men in overall troublesomeness of symptoms: 3.15 (1.30) vs 3.09 (1.27); P = .763. Self-reported number of symptoms was an independent predictor of physical and mental health, with a high number of symptoms related to poor physical and mental health. LIMITATIONS: The Abdominal Symptom Questionnaire has not been previously used in patients with FAP, and measurement of physical and mental health with the Short Form 36 Health Survey may not capture all aspects of health status in patients with familial adenomatous polyposis. CONCLUSION: Patients with familial adenomatous polyposis suffer from a wide variety of abdominal symptoms after colorectal surgery. Identification of patients with a high number of abdominal symptoms is especially important because the number of abdominal symptoms affects patients’ physical and mental health

Economic Impact of Dyspepsia in Rural and Urban Malaysia: A Population-Based Study

Background/Aims : The economic impact of dyspepsia in regions with a diverse healthcare system remains uncertain. This study aimed to estimate the costs of dyspepsia in a rural and urban population in Malaysia.Methods Economic evaluation was performed based on the cost-of-illness method. Resource utilization and quality of lifedata over a specific time frame, were collected to determine direct, indirect and intangible costs related to dyspepsia. Results The prevalences of dyspepsia in the rural (n = 2,000) and urban (n = 2,039) populations were 14.6% and 24.3% respectively. Differences in socioeconomic status and healthcare utilisation between both populations were considerable. The cost of dyspepsia per 1,000 population per year was estimated at USD14,816.10 and USD59,282.20 in the rural and urban populations respectively. The cost per quality adjusted life year for dyspepsia in rural and urban adults was USD16.30 and USD69.75, respectively.Conclusions The economic impact of dyspepsia is greater in an urban compared to a rural setting. Differences in socioeconomic status and healthcare utilisation between populations are thought to contribute to this difference

Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study

<p>Abstract</p> <p>Background</p> <p>The RANGE (<it>R</it>etrospective <it>AN</it>alysis of <it>G</it>astro<it>E</it>sophageal reflux disease [GERD]) study assessed differences among patients consulting a primary care physician due to GERD-related reasons in terms of: symptoms, diagnosis and management, response to treatment, and effects on productivity, costs and health-related quality of life. This subanalysis of RANGE determined the impact of GERD on productivity in work and daily life.</p> <p>Methods</p> <p>RANGE was conducted at 134 primary care sites across six European countries (Germany, Greece, Norway, Spain, Sweden and the UK). All subjects (aged ≥18 years) who consulted with their primary care physician over a 4-month identification period were screened retrospectively, and those consulting at least once for GERD-related reasons were identified (index visit). From this population, a random sample was selected to enter the study and attended a follow-up appointment, during which the impact of GERD on productivity while working (absenteeism and presenteeism) and in daily life was evaluated using the self-reported Work Productivity and Activity Impairment Questionnaire for patients with GERD (WPAI-GERD).</p> <p>Results</p> <p>Overall, 373,610 subjects consulted with their primary care physician over the 4-month identification period, 12,815 for GERD-related reasons (3.4%); 2678 randomly selected patients attended the follow-up appointment. Average absenteeism due to GERD was highest in Germany (3.2 hours/week) and lowest in the UK (0.4 hours/week), with an average of up to 6.7 additional hours/week lost due to presenteeism in Norway. The average monetary impact of GERD-related work absenteeism and presenteeism were substantial in all countries (from €55/week per employed patient in the UK to €273/patient in Sweden). Reductions in productivity in daily life of up to 26% were observed across the European countries.</p> <p>Conclusion</p> <p>GERD places a significant burden on primary care patients, in terms of work absenteeism and presenteeism and in daily life. The resulting costs to the local economy may be substantial. Improved management of GERD could be expected to lessen the impact of GERD on productivity and reduce costs.</p

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>RANGE (<it>R</it>etrospective <it>AN</it>alysis of <it>GE</it>RD) 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.</p> <p>Results</p> <p>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.</p> <p>Conclusion</p> <p>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.</p

The influence of calcium and magnesium in drinking water and diet on cardiovascular risk factors in individuals living in hard and soft water areas with differences in cardiovascular mortality

BACKGROUND: The role of water hardness as a risk factor for cardiovascular disease has been widely investigated and evaluated as regards regional differences in cardiovascular disease. This study was performed to evaluate the relation between calcium and magnesium in drinking water and diet and risk factors for cardiovascular disease in individuals living in hard and soft water areas with considerable differences in cardiovascular mortality. METHODS: A random sample of 207 individuals living in two municipalities characterised by differences in cardiovascular mortality and water hardness was invited for an examination including a questionnaire about health, social and living conditions and diet. Intake of magnesium and calcium was calculated from the diet questionnaire with special consideration to the use of local water. Household water samples were delivered by each individual and were analysed for magnesium and calcium. RESULTS: In the total sample, there were positive correlations between the calcium content in household water and systolic blood pressure (SBP) and negative correlations with s-cholesterol and s-LDL-cholesterol. No correlation was seen with magnesium content in household water to any of the risk factors. Calcium content in diet showed no correlation to cardiovascular risk factors. Magnesium in diet was positively correlated to diastolic blood pressure (DBP). In regression analyses controlled for age and sex 18.5% of the variation in SBP was explained by the variation in BMI, HbA1c and calcium content in water. Some 27.9% of the variation in s-cholesterol could be explained by the variation in s-triglycerides (TG), and calcium content in water. CONCLUSIONS: This study of individuals living in soft and hard water areas showed significant correlations between the content of calcium in water and major cardiovascular risk factors. This was not found for magnesium in water or calcium or magnesium in diet. Regression analyses indicated that calcium content in water could be a factor in the complexity of relationships and importance of cardiovascular risk factors. From these results it is not possible to conclude any definite causal relation and further research is needed