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Quality of Life Research
Published in: Quality of Life Research 3/2015

Open Access 01-03-2015

The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine

Authors: Aaron Yarlas, Linnette Yen, Paul Hodgkins

Published in: Quality of Life Research | Issue 3/2015

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Abstract

Purpose

Ulcerative 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.

Methods

An 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.

Results

Changes 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).

Conclusion

While 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.
Footnotes
1
In the SIMPLE trial, quiescence was defined as no more than 1 additional bowel movement than normal and no rectal bleeding.
 
2
Scores were derived from multiple responses rather than from a single response to reduce error and thus increase precision of scores.
 
3
Cohen’s d effect sizes [45] were calculated using the following equation: \(d = 2*f = \sqrt {\eta^{2} /(1 - \eta^{2} )}\), where \(\eta^{2} = \left( {df_{\text{between - subjects}} *F} \right)/\left( {df_{\text{between - subjects}} *F + df_{\text{error}} } \right),\) and where F is derived from between-subjects ANCOVA with recurrent status as an independent factor, and age, gender, BMI, and maintenance baseline scale value as covariates.
 
4
Cohen’s d z effect sizes [45] were calculated using the following equation:
\(d_{z} = (M_{1} - M_{2} )/\sigma_{12} = \sqrt {(\sigma_{1} )^{2} + (\sigma_{2} )^{2} {-}[2*r_{12} *\sigma_{1} *\sigma_{2} ]} ,\) with \(r_{12}\)representing the correlation between scores at each time.
 
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Metadata
Title
The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine
Authors
Aaron Yarlas
Linnette Yen
Paul Hodgkins
Publication date
01-03-2015
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 3/2015
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-014-0797-2

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