caa a22 4500 606179054 CHVBK 20210128100759.0 cr unu---uuuuu 210128e20150301xx s 000 0 eng 10.1007/s11136-014-0797-2 doi (NATIONALLICENCE)springer-10.1007/s11136-014-0797-2 The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine [Elektronische Daten] [Aaron Yarlas, Linnette Yen, Paul Hodgkins] 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 8weeks of treatment for patients with active mild-to-moderate UC (n=137) and 12months 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. The Author(s), 2014 Delayed-release mesalamine nationallicence MMX® mesalamine nationallicence Ulcerative colitis nationallicence Work productivity nationallicence Health-related quality of life nationallicence ANCOVA : Analysis of covariance nationallicence ANOVA : Analysis of variance nationallicence BP : Bodily pain domain of the SF-12v2 nationallicence BS : Bowel symptoms domain of the SIBDQ nationallicence EF : Emotional functioning domain of the SIBDQ nationallicence GH : General health domain of the SF-12v2 nationallicence HRQL : Health-related quality of life nationallicence IBD : Inflammatory bowel disease nationallicence IBDQ : Inflammatory Bowel Disease Questionnaire nationallicence MH : Mental health domain of the SF-12v2 nationallicence MMX : Multi Matrix System nationallicence PF : Physical functioning domain of the SF-12v2 nationallicence PRO : Patient-reported outcome nationallicence RBS : Rectal bleeding severity nationallicence RE : Role emotional domain of the SF-12v2 nationallicence RP : Role physical domain of the SF-12v2 nationallicence SF : Social functioning domain of the SF-12v2 nationallicence SF-12v2 : 12-Item Short-Form Health Survey, version 2 nationallicence SF-36 : 36-Item Short-Form Health Survey nationallicence SIBDQ : Shortened Version of the Inflammatory Bowel Disease Questionnaire nationallicence SIMPLE : Strategies in Maintenance for Patients Receiving Long-term Therapy study nationallicence SS : Systemic symptoms domain of the SIBDQ nationallicence STF : Stool frequency nationallicence UC : Ulcerative colitis nationallicence WPAI : Work Productivity and Activity Impairment Questionnaire nationallicence WPAI:SHP : Work Productivity and Activity Impairment Questionnaire: Specific Health Problem nationallicence WRO : Work-related outcomes nationallicence VT : Vitality domain of the SF-12v2 nationallicence Yarlas Aaron Life Sciences, Optum, 24 Albion Road, Building 400, 02865, Lincoln, RI, USA aut Yen Linnette Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, PA, USA aut Hodgkins Paul Health Economics and Outcomes Research, Vertex Pharmaceuticals, Cambridge, MA, USA aut Quality of Life Research Springer International Publishing 24/3(2015-03-01), 671-683 0962-9343 24:3<671 2015 24 11136 https://doi.org/10.1007/s11136-014-0797-2 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-014-0797-2 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Yarlas Aaron Life Sciences, Optum, 24 Albion Road, Building 400, 02865, Lincoln, RI, USA aut NATIONALLICENCE 700 1- Yen Linnette Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, PA, USA aut NATIONALLICENCE 700 1- Hodgkins Paul Health Economics and Outcomes Research, Vertex Pharmaceuticals, Cambridge, MA, USA aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/3(2015-03-01), 671-683 0962-9343 24:3<671 2015 24 11136