Abstract
PurposeUlcerative colitis (UC) is associated with impaired health-related quality of life (HRQL) and work-related outcomes (WRO). This analysis examined correspondences among measures of HRQL and WRO in patients with UC, as well as the magnitude of each measure’s responsiveness to disease activity and treatment.MethodsAn open-label, prospective trial of delayed-release mesalamine tablets formulated with MMX® technology included 8 weeks of treatment for patients with active mild-to-moderate UC (n = 137) and 12 months of maintenance treatment for patients with quiescent UC (n = 206). Spearman correlations (ρ) measured inter-domain associations across measures of generic HRQL [12-item Short-Form Health Survey (SF-12v2)], disease-specific HRQL [Short Inflammatory Bowel Disease Questionnaire (SIBDQ)], and disease-specific WRO [Work Productivity and Activity Impairment for Specific Health Problems (WPAI:SHP)]. Responsiveness to disease activity and treatment was assessed for each instrument.ResultsChanges in scores from baseline to week 8 were moderately correlated across all instrument domains: 65 of 80 (81 %) between-instrument inter-domain correlations were of moderate magnitude (0.30 < ρ < 0.70), with an average magnitude of 0.42 [95 % confidence interval (CI) 0.38–0.46]. Associations between symptom measures were stronger for SIBDQ (|average ρ| = 0.41; 95 % CI 0.34–0.48) and WPAI:SHP (0.40; 0.30–0.47) than SF-12v2 (0.30; 0.27–0.34). SIBDQ was most sensitive to treatment [effect size (d z) for change from baseline to week 8 = 0.62; 95 % CI 0.35–0.89], followed by WPAI:SHP (d z = 0.43; 0.32–0.54) and SF-12v2 (d z = 0.33; 0.27–0.39).ConclusionWhile the SIBDQ showed the greatest overall responsiveness to disease activity and treatment, all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment.
Highlights
Ulcerative colitis (UC), an inflammatory bowel disease (IBD), is marked by chronic inflammation of the large intestine and rectum
The current analysis examines associations among patient-reported outcomes (PRO) instruments measuring generic and disease-specific health-related quality of life (HRQL) [the 12-item Short-Form Health Survey, version 2 (SF12v2) and the Short Inflammatory Bowel Disease Questionnaire (IBDQ) (SIBDQ), respectively] and disease-specific workrelated outcomes (WRO) [the Work Productivity and Activity Impairment survey (WPAI): Specific Health Problem (WPAI:SHP)] as well as the extent to which these outcomes are negatively associated with disease activity for patients with mild-to-moderate UC who participated in an open-label prospective trial of delayed-release mesalamine tablets formulated with MMXÒ (Cosmo Technologies Ltd, Wicklow, Ireland) technology
The inconsistency in findings across these two analytic approaches is consistent with the results reported by McColl et al [25], who found that a continuous measure of UC symptom activity was more strongly correlated with IBDQ scores than with social functioning (SF)-36 scores, but that the IBDQ was not better than the SF-36 at discriminating patients classified by disease extent
Summary
Ulcerative colitis (UC), an inflammatory bowel disease (IBD), is marked by chronic inflammation of the large intestine and rectum. Previous research on patients with UC shows improvements in HRQL [17,18,19,20,21,22] and WRO [18, 23] following treatment when accompanied by decreases in disease activity Both Irvine et al [20] and Reinisch et al [23] reported that patients with UC who demonstrated clinical response following treatment had significantly better scores on generic and disease-specific measures of HRQL [the 36-item Short-Form health outcomes survey (SF-36) and the Inflammatory Bowel Disease Questionnaire (IBDQ), respectively] than non-responders. Reinisch et al [23] found that clinical remission predicted significantly greater improvements in work attendance, and work productivity, and a decreased likelihood of receiving disability benefits
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