A QUALITY-OF-LIFE INDEX FOR INFLAMMATORY BOWEL-DISEASE

Health related quality of life (HRQOL) is a subjective quantitative measure of health perception and function in the physical, social and emotional domains. Such health status measures can be exploited to evaluate the natural history of disease, identify patient needs and research questions, quantify the effect of specific interventions in clinical trials and to monitor change. Conventional disease activity indices have failed to measure the impact of inflammatory bowel disease (IBD) and its consequences on family, social and working life. General measures of HRQOL fail to reflect impairment experienced by a young population with predominant gastrointestinal symptoms. A specific quality of life index for IBD patients - IBDQ - has been developed. The IBDQ contains 32 items in four domains (bowel, systemic, social and emotional) with responses graded on a seven-point Likkert scale from 7 (not a problem) to 1 (a severe problem). In 97 IBD patients bowel and systemic function were most notably impaired. A modified IBDQ was mailed to 182 well IBD patients and 48 normals. Total IBDQ and all dimensional scores were significantly worse in patients than in controls (P<0.01). Two clinical trials in Crohn's disease have used the IBDQ as an outcome measure of therapeutic efficacy. The largest, the Canadian Crohn's Relapse Prevention Trial, evaluated continuous low dose cyclosporine versus placebo in 305 patients and further established the IBDQ as a valid, reproduCible and responsive measure. Changes in IBDQ scores paralleled changes in standard disease activity scores and changes in therapy. Similar correlations were observed in a trial of oral 5-aminosalicylic acid or prednisone in mild to moderate ileocolonic Crohn's disease. Although the IBDQ has previously been interviewer-administered, preliminary analysis of a nurse-administered versus a self-administered questionnaire suggests that either method detects clinically important change and that the IBDQ can be reliably self-administered after a brief training period. Therefore, the IBDQ reflects HRQOL and ought to be a critical outcome measure in all clinical trails of IBD. Future work in HRQOL to evaluate adverse drug effects or identify patient subgroups which might benefit from nondrug therapies is warranted.