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The “Dutch inflammatory bowel disease questionnaire”: validation and usefulness in clinical trials
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Abstracts/Netherlands
Journal of Medicine 48 (1996) Al -A42
mained and their small bowel biopsies (SBB) persistently showed mucosal abnormalities corresponding to the Marsh classification Type II or III (respectively hyperplastic and flat lesion). Dietary compliance was good, according to repeated interviews by the treatment team. All patients were treated, after an initial SBB with cyclosporine 5 mg/kg daily for a period of 2 months, after which control SBB’s were taken. Three patients started treatment with histological abnormalities corresponding to Marsh II and showed no clinical or histological improvement. Two patients started treatment having a flat lesion (Type III) and showed slight histological improvement, with re-appearance of villi and remaining hyperplasia of crypts and lymphocyte infiltration of surface epithelium (Type II). One of these 2 patients noted a definite clinical improvement. One patient started treatment having a flat lesion, which persisted after 2 months. Because of a clear clinical improvement, she remained on cyclosporine medication. Control SBB after 1 year showed a slight histological improvement to a hyperplastic lesion (Type II). No side-effects of cyclosporine were noticed during treatment (i.e., rheological, kidney-functional or infectious complications). Conclusion: Cyclosporine induces only slight improvement, if any, of histological abnormalities in patients with refractory coeliac disease. We therefore cannot confirm earlier reports of successful treatment and remain reserved in accepting cyclosporine as a therapeutic option for refractory coeliac disease. The “Dutch Inflammatory Bowel Disease Questionnaire”: validation and usefulness in clinical trials. M.G. Russel, S. Brandon, C. Pastoor, L. Engels, J. Rijken, R.W. Stockbriigger, and the South Limburg IBD Study Group. Department of Gastroenterology, lands.
University of Limburg,
Maastricht,
Nether-
Measurement of quality of life can be of importance in clinical trials in inflammatory bowel disease (IBD). The Inflammatory Bowel Disease Questionnaire (IBDQ), a diseasespecific quality-of-life questionnaire, has been developed in Canada. The aims of our study were, firstly, to investigate whether a translated version of this questionnaire could be used in a Dutch IBD population and, secondly, to evaluate content validity of the IBDQ in an ongoing multicentre randomised clinical trial in patients with inactive Crohn’s disease. The original IBDQ was translated into the Dutch language and subsequently 97 IBD patients, 52 males and 45 females, median age 43 years (16-811, 39 with Crohn’s disease (CD) and 58 with ulcerative colitis (UC), completed the Dutch IBDQ and a Visual Analogue Scale (VAS) concerning disease activity, emotional function and general-well being twice at an interval of 6 weeks. The second questionnaire included specific questions on change of those items. Next to this, the CDAI and IBDQ scores of 34 patients on 60 occasions (trial visits) participating in the Crohn Remission Trial (CRT) were compared. Linear regression analysis, Student’s f-test for paired observations and calculation of intraclass correlation coefficients were used for statistical evaluation. Construct validity: Linear regression analysis of the VAS
and IBDQ showed a positive correlation (r-values > 0.73; p < 0.005) for all categories (bowel and systemic symptoms; emotional and social function). In the patients participating in the CRT, linear regression analysis showed a negative correlation between total IBDQ score and CDAI (r = -0.65; p < 0.001). Responsiljeness: (sensitivity to change): In patients recording improvement (or deterioration) (n = 33) a significant change (p < 0.005) for the better (for the worse) in the total IBDQ score as well as the four subcategories of the IBDQ was observed between the two moments. Reproducibility: No significant difference between the two moments was observed in the 64 patients with stable disease activity (r = 0.93). Summary and conclusion: The Dutch IBDQ was shown to
be valid, responsive and reproducible. In a trial situation it correlated well with the CDAI. The Dutch IBDQ, therefore, seems suitable for use in Dutch IBD patients participating in clinical trials. Smoking influences quality of life in inflammatory bowel disease. M.G. Russel, C. van Deursen, F. Nieman, R.W. Stockbriigger, and the South Limburg IBD Study Group, Department of Gastroenterology and Statistics, Unioersity of Limburg, Maastricht, Netherlands.
Smoking might increase disease activity in Crohn’s disease (CD) while the opposite has been reported in ulcerative colitis (UC). The aim of our study was to evaluate the effect of smoking on different aspects of quality of life in CD and UC. For the purpose of this study all registered IBD patients in South Limburg (n = 1222) received a questionnaire by mail, including items on smoking habits and the Dutch Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ consists of 32 questions clustered in four dimensions, covering bowel and systemic symptoms, and emotional and social function A theoretical explanation model was developed which takes into account age, gender and the relations between the four dimensions of the IBDQ. Analysis of covariance was used for statistical evaluation (Manova SPSS pc 5.0). The response rate was 90.4%, resulting in 545 patients with CD (median age 37, females 60%, smokers 45%), 450 with UC (median age 42, females 43%, smokers 17%), and 110 with chronic proctitis (CP) (median age 44, females 440/o,smokers 10%). Controlled for age, smoking UC males had lower bowel symptoms than non-smoking UC males (p < 0.04), while no difference was found in UC females. In contrast, smoking CD females under the age of 45 years had more bowel symptoms than non-smokers in this group. Controlled for age. male smokers in all three disease groups had more systemic symptoms than non-smokers (CD p < 0.03, UC p < 0.02, CP p < 0.03). Concerning emotional and social function, only smoking CD females had more emotional dysfunction than non-smoking CD females (p < 0.001). Summary and conclusion: Smoking influences the quality of life in CD and UC in a differential way, also depending on the age and sex of the patients. The IBDQ allows one to separate the effect of smoking on the various aspects of quality of life (somatic, psychological and social).
Abstracts/Netherlands
Journal of Medicine 48 (1996) Al -A42
mained and their small bowel biopsies (SBB) persistently showed mucosal abnormalities corresponding to the Marsh classification Type II or III (respectively hyperplastic and flat lesion). Dietary compliance was good, according to repeated interviews by the treatment team. All patients were treated, after an initial SBB with cyclosporine 5 mg/kg daily for a period of 2 months, after which control SBB’s were taken. Three patients started treatment with histological abnormalities corresponding to Marsh II and showed no clinical or histological improvement. Two patients started treatment having a flat lesion (Type III) and showed slight histological improvement, with re-appearance of villi and remaining hyperplasia of crypts and lymphocyte infiltration of surface epithelium (Type II). One of these 2 patients noted a definite clinical improvement. One patient started treatment having a flat lesion, which persisted after 2 months. Because of a clear clinical improvement, she remained on cyclosporine medication. Control SBB after 1 year showed a slight histological improvement to a hyperplastic lesion (Type II). No side-effects of cyclosporine were noticed during treatment (i.e., rheological, kidney-functional or infectious complications). Conclusion: Cyclosporine induces only slight improvement, if any, of histological abnormalities in patients with refractory coeliac disease. We therefore cannot confirm earlier reports of successful treatment and remain reserved in accepting cyclosporine as a therapeutic option for refractory coeliac disease. The “Dutch Inflammatory Bowel Disease Questionnaire”: validation and usefulness in clinical trials. M.G. Russel, S. Brandon, C. Pastoor, L. Engels, J. Rijken, R.W. Stockbriigger, and the South Limburg IBD Study Group. Department of Gastroenterology, lands.
University of Limburg,
Maastricht,
Nether-
Measurement of quality of life can be of importance in clinical trials in inflammatory bowel disease (IBD). The Inflammatory Bowel Disease Questionnaire (IBDQ), a diseasespecific quality-of-life questionnaire, has been developed in Canada. The aims of our study were, firstly, to investigate whether a translated version of this questionnaire could be used in a Dutch IBD population and, secondly, to evaluate content validity of the IBDQ in an ongoing multicentre randomised clinical trial in patients with inactive Crohn’s disease. The original IBDQ was translated into the Dutch language and subsequently 97 IBD patients, 52 males and 45 females, median age 43 years (16-811, 39 with Crohn’s disease (CD) and 58 with ulcerative colitis (UC), completed the Dutch IBDQ and a Visual Analogue Scale (VAS) concerning disease activity, emotional function and general-well being twice at an interval of 6 weeks. The second questionnaire included specific questions on change of those items. Next to this, the CDAI and IBDQ scores of 34 patients on 60 occasions (trial visits) participating in the Crohn Remission Trial (CRT) were compared. Linear regression analysis, Student’s f-test for paired observations and calculation of intraclass correlation coefficients were used for statistical evaluation. Construct validity: Linear regression analysis of the VAS
and IBDQ showed a positive correlation (r-values > 0.73; p < 0.005) for all categories (bowel and systemic symptoms; emotional and social function). In the patients participating in the CRT, linear regression analysis showed a negative correlation between total IBDQ score and CDAI (r = -0.65; p < 0.001). Responsiljeness: (sensitivity to change): In patients recording improvement (or deterioration) (n = 33) a significant change (p < 0.005) for the better (for the worse) in the total IBDQ score as well as the four subcategories of the IBDQ was observed between the two moments. Reproducibility: No significant difference between the two moments was observed in the 64 patients with stable disease activity (r = 0.93). Summary and conclusion: The Dutch IBDQ was shown to
be valid, responsive and reproducible. In a trial situation it correlated well with the CDAI. The Dutch IBDQ, therefore, seems suitable for use in Dutch IBD patients participating in clinical trials. Smoking influences quality of life in inflammatory bowel disease. M.G. Russel, C. van Deursen, F. Nieman, R.W. Stockbriigger, and the South Limburg IBD Study Group, Department of Gastroenterology and Statistics, Unioersity of Limburg, Maastricht, Netherlands.
Smoking might increase disease activity in Crohn’s disease (CD) while the opposite has been reported in ulcerative colitis (UC). The aim of our study was to evaluate the effect of smoking on different aspects of quality of life in CD and UC. For the purpose of this study all registered IBD patients in South Limburg (n = 1222) received a questionnaire by mail, including items on smoking habits and the Dutch Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ consists of 32 questions clustered in four dimensions, covering bowel and systemic symptoms, and emotional and social function A theoretical explanation model was developed which takes into account age, gender and the relations between the four dimensions of the IBDQ. Analysis of covariance was used for statistical evaluation (Manova SPSS pc 5.0). The response rate was 90.4%, resulting in 545 patients with CD (median age 37, females 60%, smokers 45%), 450 with UC (median age 42, females 43%, smokers 17%), and 110 with chronic proctitis (CP) (median age 44, females 440/o,smokers 10%). Controlled for age, smoking UC males had lower bowel symptoms than non-smoking UC males (p < 0.04), while no difference was found in UC females. In contrast, smoking CD females under the age of 45 years had more bowel symptoms than non-smokers in this group. Controlled for age. male smokers in all three disease groups had more systemic symptoms than non-smokers (CD p < 0.03, UC p < 0.02, CP p < 0.03). Concerning emotional and social function, only smoking CD females had more emotional dysfunction than non-smoking CD females (p < 0.001). Summary and conclusion: Smoking influences the quality of life in CD and UC in a differential way, also depending on the age and sex of the patients. The IBDQ allows one to separate the effect of smoking on the various aspects of quality of life (somatic, psychological and social).