Patient education in gastro-oesophageal reflux disease: Validation of a digestive symptoms and impact questionnaire and a randomised controlled trial of patient education
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Patient education in gastro-oesophageal reflux disease. Validation of a digestive symptoms and impact questionnaire and a randomised controlled trial of patient education Background and purpose Gastro-oesophageal reflux disease (GORD) is a common disease with a prevalence of 8-20 %. The main symptoms are heartburn, acid regurgitation and upper abdominal pain caused by retrograde reflux of gastric contents into the oesophagus. Several lifestyle factors like meal rhythm, obesity, foods, alcohol etc are associated with GORD. Adequate medication reducing gastric acid has been shown to reduce symptoms and normalize quality of life in most patients. Many of those who consult a doctor for reflux symptoms tend to be anxious of having serious diseases like cancer or heart disease. We hypothesized that a patient education programme on GORD would reassure the patients, reduce their anxiety about serious disease and improve patient competency in taking adequate lifestyle measures and adjusting medical treatment, thereby reducing the impact of symptoms and improving quality of life. To study this we needed a valid measure of quality of life in digestive disease to be used in a randomised controlled trial where one group of GORD patients were allocated to a patient education program and the other group to “treatment as usual”. Material and methods We developed the Digestive Symptoms and Impact Questionnaire, DSIQ, consisting of 18 questions which were completed by 356 patients prior to gastroscopy. At gastroscopy, patients who declared to be much worse, unchanged (test-retest reliability) or much better (responsiveness) were asked to complete the questionnaire once more. Patients who later attended a control gastroscopy were also asked to complete the questionnaire once more (responsiveness). In addition, baseline data from patients in the randomised controlled trial of Patient Education in GORD were used for establishing criterion validity (article I). In the randomised controlled trial of Patient Education in GORD, 211 patients with mild GORD participated. The education program was 3 two hour lessons spaced over 2 weeks. Data were collected in an interview (medication, health care use, global quality of life) and by completing the DSIQ and the General Health Questionnaire (GHQ 30) at baseline, and at 2 and 12 months follow-up (article II). The patients were asked to complete a GORD-knowledge test at the 2 and 12 months follow-up (article III). Results The DSIQ decomposes to 4 subscales: abdominal pain and bowel symptoms; gastric dysfunction; health impairment and impairment of everyday life. Reflux is retained as a single item without subscale association. Test-retest reliability in stable patients and internal consistency reliability were satisfactory. Criterion validity to patients’ globally assessed quality of life and the GHQ-30 were satisfactory. Responsiveness statistic ranged from acceptable to very good (article I). No statistically significant differences were found in consumption of health care or medication, GHQ-30, DSIQ or global quality of life at 2 or 12 months’ follow-up between the GORD education group and controls. In the GORD education group, patients who had completed primary school only showed improved quality of life. Patients allocated to education achieved higher knowledge test-scores than controls at both 2 and 12 months. In addition, knowledge test score was positively associated with having completed advanced school and inversely related to psychiatric illness and poor quality of life at the time of inclusion. Overall, changes in knowledge test score were not associated with change in quality of life. Conclusion The DSIQ proved to have excellent properties as a measure of disease specific quality of life. Patient education in GORD improved disease knowledge but not quality of life, or use of health care or medication. Disease knowledge was not associated with improved quality of life. For patients with primary school only, patient education improved both disease specific and general quality of life at a statistically significant level. This indicates that patient education must be adjusted to the target groups; and further research is needed to explore this.