1	Improving Quality of Life for Patients With Crohn’s Disease
2	Health-Related Quality of Life Multidimensional Physical and role functioning Psychological well-being Social functioning Disease-related and treatment-related symptoms Subjective Patient’s perspective of the impact of disease and treatment on health status Self-administered
3	Generic Measures of HRQoL Assess all aspects of health-related quality of life (HRQoL) Appropriate for evaluating differences among diseases Two subcategories Psychometric Short Form-36 (SF-36) McMaster Health Status Questionnaire Sickness impact profile (SIP) Utilities Standard gamble Time trade-off Visual analog scale (VAS)
4	SF-36 Overview Assesses function and well-being in any patient population with chronic disease Easy to administer Age-specific normative data are available for most countries Norms established for a number of chronic disease states Each scale ranges 0 to 100 Higher score indicates better function
5	SF-36 Assessments 36 items in 8 domains Physical function Social function Limitations due to physical problems Limitations due to emotional problems Mental health Energy/vitality Pain General health perception 2 summary measures Physical component summary (PCS) Mental component summary (MCS)
6	Disease-Specific Measures of HRQoL Only useful to assess a single disorder Very sensitive to changes in health status of patients with that disease Measures for inflammatory bowel disease (IBD) Inflammatory bowel disease questionnaire (IBDQ) Rating form of IBD patient concerns (RFIPC)
7	IBDQ
8	IBDQ Range of scores: 32 to 224 Higher scores = better QoL Scores £130 = severe, active disease Tested/validated in clinical trials Responsive, reliable tool for determining changes in health status An increase in IBDQ scores corresponds to a decrease in CDAI scores
9	RFIPC 25 items query most frequent concerns of IBD patients 4 indices Impact of disease Sexual intimacy Complications Body stigma Severity scores differ across countries Greater in southern countries Country-related differences in individual items
10	Crohn’s Disease: Impact on QoL Many distressing physical symptoms Adverse effects on psychological/social functioning Most common concerns Uncertain nature of Crohn’s disease (CD) Decreased energy Medication adverse effects Need for surgery or an ostomy bag Diminished QoL even with mild disease
11	HRQoL in IBD: Functional Status
12	Impact of CD on QoL IBDQ scores of clinical trial patients were compared with those of community-surveyed IBD patients and healthy non-IBD patients Scores were similar in clinical trial and community IBD patients Scores were significantly lower in community IBD patients than in healthy non-IBD patients Relatively “well” IBD patients had an impaired QoL
13	QoL in Patients With Moderate-to-Severe CD^*
14	Normalization of QoL^* by Achieving Clinical Remission
15	QoL: Measuring Therapeutic Efficacy Traditional disease activity measures (eg, CDAI) do NOT reflect impaired QoL Improvement in QoL is an important treatment goal In the past, clinical trials in IBD often relied only on traditional measures Validated measures of HRQoL (eg, IBDQ) have been developed for application in clinical IBD trials
16	CD: Clinical Trials for the Effect of Treatment on QoL
17	QoL Effects* of Mesalamine in CD
18	Improvement in QoL With Controlled Ileal-Release Budesonide in Active CD
19	Improvement in QoL With Oral Budesonide in Active CD
20	Improvement in IBDQ Scores With Methotrexate in CD
21	Improvement in QoL With Natalizumab in Active CD Randomized, double-blind, placebo-controlled study of 248 patients Mean IBDQ compared with placebo at Week 6 Natalizumab 3 mg/kg at Week 0 (p=0.008) Natalizumab 3 mg/kg at Week 0 and Week 4 (p<0.001) Natalizumab 6 mg/kg at Week 0 and Week 4 (p<0.001) Patients receiving 2 infusions of natalizumab Statistically greater improvement in all 4 IBDQ dimensions compared with placebo (p<0.05)
22	Short-Term Improvement in QoL With Infliximab
23	Short-Term Improvement in QoL With Infliximab Measured by IBDQ
24	IBDQ Score With Infliximab Maintenance Therapy Every 8 Weeks
25	Effects of Infliximab on QoL: SF-36 Scores^*
26	QoL Improvement With Infliximab Maintenance Therapy in CD^*
27	Employment Status of Patients With CD^*
28	Factors Predicting Employment Status in Patients With CD^*
29	Effect of Prior Surgery on Likelihood of Disability Compensation^*
30	Infliximab-Induced Remission and Employment Status: Employed vs. Unemployed*
31	Infliximab-Induced Remission and Employment Status: Full Time vs. Part Time*
32	Increased Employment for Patients in Remission* With Infliximab Maintenance Therapy
33	QoL in CD: Conclusions CD is associated with a diminished QoL Distressing physical symptoms Impaired psychological and social functioning Trials have shown improvements in QoL for patients treated with mesalamine, budesonide, and methotrexate Impact of infliximab on QoL has been well studied Significant improvements in overall QoL scores and many individual dimensions Improvements observed with single and multiple infusions Further research is needed
34	Improving Quality of Life for Patients With Crohn’s Disease: Library Slide
35	Cost of IBD Reflects Employment Status of Patients