Quality of life: A valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease

Irvine, E. Jan; Feagan, Brian G.; Rochon, James; Archambault, A; Fedorak, Richard N.; Groll, A.; Kinnear, Douglas G.; Saibil, Fred; McDonald, John W.D.

doi:10.1016/0016-5085(94)90585-1

Cited by 664 publications

(471 citation statements)

References 28 publications

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“…The MIBDI showed a high degree of sensitivity for classifying individuals with regard to their disease activity over time compared to these existing disease activity measures, and demonstrated excellent test-retest reliability. The correlations between the MIBDI and the HB, PT, and IBDQ indices were, in fact, similar to those reported by Irvine et al 23 for the IBDQ. Strong convergent validity with expected proxy measures of disease activity was found, and these relationships were consistent across a period of two years.…”

Section: Discussionsupporting

confidence: 89%

The Manitoba IBD Index: Evidence for a New and Simple Indicator of IBD Activity

et al. 2009

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Section: Discussionsupporting

confidence: 89%

The Manitoba IBD Index: Evidence for a New and Simple Indicator of IBD Activity

et al. 2009

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“…14 Briefly, participants were aged 18 to 50 years with continuing treatment refractory CD not amenable to surgery and impaired quality of life (Inflammatory Bowel Disease Questionnaire (IBDQ), 17 or European Quality of Life Visual analogue scale (EQ-VAS)) 18 …”

Section: Participantsmentioning

confidence: 99%

Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial

Lindsay

Allez

Clark

et al. 2017

The Lancet Gastroenterology & Hepatology

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BACKGROUND The randomised controlled ASTIC trial showed no benefit of mobilisation and autologous haematopoietic stem-cell transplantation (HSCT) compared with mobilisation followed by conventional therapy using a stringent primary endpoint (steroid-free clinical remission for 3 months with no endoscopic or radiological evidence of intestinal inflammation) in patients with treatment-refractory Crohn's disease. We now assess HSCT in patients enrolled in the ASTIC trial using endpoints that are traditional for clinical trials in Crohn's disease, and identify factors that predict benefit or harm. METHODS Patients who underwent mobilisation and were randomly assigned to conventional therapy in the ASTIC trial were offered HSCT at 1 year and underwent complete assessment for a further year. We report analyses of the combined cohort of patients who underwent HSCT at any time during the ASTIC trial programme. The primary outcome for this analysis was 3-month steroid-free clinical remission at 1 year after HSCT (Crohn's Disease Activity Index [CDAI] <150). We also examined the degree of endoscopic healing at 1 year. Multivariate analysis was performed to identify factors associated with achieving the primary endpoint by using logistic regression, and factors associated with experiencing a serious adverse event using Poisson regression. Participants were not masked to treatment, but the adjudication panel that reviewed radiology and endoscopy was masked to allocation and visits. All patients who underwent HSCT and had data available at baseline and 1-year follow-up were included in the primary and safety analysis. This trial is registered with ClinicalTrials.gov, number NCT00297193. FINDINGS Between June 28, 2007, and Sept 1, 2011, 45 patients were enrolled in the ASTIC trial from 11 European transplant units. 23 patients were randomly assigned to immediate HSCT, and 22 patients were assigned to mobilisation followed by conventional care. After completion of the ASTIC trial, 17 patients from the conventional care group received HSCT. In the combined cohort, data were available for 40 patients at baseline and 38 patients at 1 year after HSCT (one patient died, one withdrew). At 1 year after HSCT, 3-month steroid-free clinical remission was seen in 13 (38%, 95% CI 22-55) of 34 patients with available data for the whole year. Complete endoscopic healting was noted in 19 (50%, 34-66) of 38 patients. On multivariate analyses, factors associated with the primary outcome were short disease duration (odds ratio [OR] 0·64, 95% CI 0·41-0·997 per year; p=0·048) and low baseline CDAI (0·82, 0·74-0·98 per 10 units; p=0·031). 76 serious adverse events occurred in 23 of 40 patients with available data. The most common serious adverse event was infection, most of which were treatment related. Smoking and perianal disease at baseline were independent factors associated with the number of serious adverse events (OR 3·07 [95% CI 1·75-5·38; p=0·0001] for smoking and 3·97 [2·17-7·25; p<0·0001] for perianal disease) on multivariate...

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“…Additional outcomes includ-ed the serum level of C-reactive protein and the health-related quality of life, as measured by the Inflammatory Bowel Disease Questionnaire. 19 Scores on this instrument can range from 32 to 224, with higher scores indicating a better quality of life.…”

Section: Study Procedures and End Pointsmentioning

confidence: 99%

“…(%) 33 (52) 41 (60) 36 (55) (19) 30 (48) 31 (49) 22 (35) 10 (15) 41 (60) 31 (46) 26 (38) 9 (14) 41 (62) 37 (56) 17 (26) 5 (10) 30 (59) 32 (63) 9 (18) an improvement in the response rates were observed as early as two weeks after the first treatment. That natalizumab was better than placebo was further supported by post hoc analyses of the area under the curve of the scores on the Crohn's Disease Activity Index (P<0.02 for each natalizumab group), and these differences remained significant at a level of less than 0.05 after Bonferroni's adjustment for multiple comparisons for the groups given two infusions of 3 mg of natalizumab per kilogram (P=0.002) and two infusions of 6 mg of natalizumab per kilogram (P=0.009).…”

Section: Clinical Remissions and Responsesmentioning

confidence: 99%