items related to the financial aspect of caring. The objective was to test the French translation of the PSQ III and evaluate its content validity considering the local health care system. METHODS: The French version of the PSQ-III was tested on 5 patients with rheumatoid arthritis. The aim of these cognitive interviews was to test clarity and comprehension of the translation but also the relevance of the 8 financial items to the French context from the patients’ point of view. RESULTS: A direct translation of the financial items didn’t prove difficult as they could be ren- dered literally. Cognitive interviews showed that the items were also easily under- stood. Respondents mostly didn’t consider the items, however, as relevant to their situation (e.g. “I worry sometimes about having to pay large medical bills” or “I have to pay for more of my medical care that I can afford”) although they showed some concern regarding future evolution of the reimbursement process in France. After consultation, the developer of the instrument confirmed that if needed, the items related to the financial domain could be left aside. Decision was made to create two versions of the translation: one including the eight financial items and another excluding them. CONCLUSIONS: As far as health care systems are concerned, lin- guistic validation goes beyond understanding the text and direct translation of the relevant items. It requires knowledge of the local context in order to collect mean- ingful data. The target healthcare system needs to be carefully considered and adequacy of the translation can be tested through cognitive interviews and con- sultation with experts in the domain. PMS43 QUALITY OF LIFE AND FIBROMYALGIA - A SYSTEMATIC LITERATURE REVIEW Lobo CP 1 , Kamal KM 2 1 Duquesne University Mylan School of Pharmacy, Pittsburgh, PA, USA, 2 Duquesne University, Pittsburgh, PA, USA OBJECTIVES: Fibromyalgia is a chronic musculoskeletal condition characterized by pain, fatigue, psychological distress, and sleep disturbances. The symptom com- plexity and existence of comorbid conditions such as anxiety and depression have been shown to negatively impact patient’s quality of life (QoL). The study objective is to identify the most commonly used QoL instruments in fibromyalgia and to examine the instruments’ psychometric properties. METHODS: A systematic search was conducted from 1990 to 2010 using PUBMED, EBSCOhost, OVID, and ScienceDirect databases. The search was limited to English language and key search terms (e.g., fibromyalgia, quality of life) were used to identify articles of interest. Articles identified were further screened to exclude clinical studies, re- view papers and studies that discussed development of QoL instruments. RESULTS: The search yielded 74 articles out of which 40 were included in the final review. The review identified 11 generic instruments, 6 disease-specific, and 20 condition-specific instruments that were used in fibromyalgia. Short Form 36 was the most commonly used generic instrument. Among disease-specific instru- ments, Fibromyalgia Impact Questionnaire (FIQ) was the most commonly used and has 10 domains (physical functioning, feeling well, work missed, job ability, pain, fatigue, morning tiredness, stiffness, anxiety, depression). FIQ was found to have good test-retest reliability (Pearson’s r 0.56-0.95) and construct validity. Beck Depression Inventory was most commonly used condition-specific instrument. Most of the reviewed studies assessed pain, fatigue, and sleep disorders using visual analog scale. CONCLUSIONS: Fibromyalgia has a profound impact on patient’s quality of life. Among the QoL instruments reviewed, FIQ justifies its use in research and clinical practice given its varied domains and strong psychometric properties. PMS44 ASSESSING VITALITY IN PATIENTS UNDERGOING ETANERCEPT THERAPY FOR RHEUMATOID ARTHRITIS Gandra SR 1 , Vernon M 2 , Cole JC 3 , Bitman B 1 , Park GS 1 , Wang B 4 , Chaudhari S 4 , Fleischmann RM 5 1 Amgen, Inc., Thousand Oaks, CA, USA, 2 United BioSource Corporation, Bethesda, MD, USA, 3 Covance Market Access Services, Inc., San Diego, CA, USA, 4 KForce Clinical Research, Tampa, FL, USA, 5 University of Texas Southwestern Medical Center, Dallas, TX, USA OBJECTIVES: To assess effects of etanercept therapy on vitality using the Health Assessment Questionnaire (HAQ). METHODS: Eighty-nine patients with moderate to severe rheumatoid arthritis (RA) were randomized in a phase 2/3 study to eval- uate efficacy/safety of 25 mg etanercept twice weekly given in combination with methotrexate. Fifty-nine patients were randomized to etanercept/methotrexate and 30 to placebo/methotrexate. The HAQ was administered at baseline, Days 8/15, and every 4 weeks from Weeks 424. Vitality was assessed using 4 items: Feel full of pep? Feel worn out? Have enough energy to do the things you want to do? Feel tired? Patients responded on a 5-point scale ranging from All the time to Never. Using standard scoring algorithms, the vitality score ranged from 0 (worst) to 100 (best). Anchor and distribution-based methods were employed to estimate the minimally important difference (MID) for improvement. A repeated measures model was used to compare change from baseline over time between groups. RESULTS: At baseline, mean vitality scores were 34 with 95% confidence interval (CI) of 30 to 39 for etan- ercept/methotrexate patients versus 40 (95% CI 33 to 47) for placebo/methotrexate patients. At Week 24, the unadjusted mean improvements in vitality scores from baseline were 22 (95% CI 17 to 28) for etanercept/methotrexate versus 8 (95% CI 2 to 15) for placebo/methotrexate patients. The MID was established at 9.0, and 37% etanercept/methotrexate patients achieved the MID at Day 8 versus 17% placebo/ methotrexate patients. The percentage rose to 67% versus 42% at Week 12, and to 74% versus 38% at Week 24 for etanercept/methotrexate versus placebo/metho- trexate patients, respectively. The repeated measures model indicated a statisti- cally significant difference in vitality change from baseline over time between the treatments (P 0.025). CONCLUSIONS: The vitality MID was achieved by 74% of patients on etanercept/methotrexate by Week 24 versus 38% on placebo/metho- trexate. PMS45 WILLINGNESS TO PAY FOR OSTEOPOROSIS TREATMENT TO PREVENT FRACTURE IN KOREAN POPULATION Suh HS, Kim Y, Park J, Park S, Hyun MK, Ahn J National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, South Korea OBJECTIVES: To examine willingness-to-pay (WTP) and factors influencing WTP for treatment to prevent osteoporotic fractures with the stated preference data in Korean population METHODS: A questionnaire was administered via a trained interviewer to adult Korean general population. Subjects were selected by a non- probability sampling via a quota-sampling to reflect the national distribution of gender and age in Korea. Each respondent answered questions about eight differ- ent scenarios, each of which specified as different types of fracture (hip and verte- brae), efficacy of treatment (10% and 50%), and subjects to whom fracture occurred (self and family). WTP per annum was elicited with an open question per scenario. The demographic characteristics of respondents were also collected. A multivari- ate regression using a generalized linear model with a gamma distribution and log-link function was performed to identify factors influencing the level of WTP. RESULTS: Of one hundred and one respondents who completed the survey, the average of WTP per annum for respondent itself was 550 USD and 1,125 USD for treatment with 10% and 50% efficacy to reduce vertebral fracture risk, respectively. Similarly, the average of WTP per annum for respondent’s family member was 683 USD and 1,333 USD. The annual WTP for respondent itself was 1,017 USD and 1,950 USD for treatment with 10% and 50% efficacy to reduce hip fracture risk, respec- tively. Education level, income level, the treatment efficacy, age, self-rated health status, and subjects to whom fracture occurred were significantly associated with the level of WTP. CONCLUSIONS: Respondents’ preferences for osteoporosis treat- ment to reduce fracture risk reflected health and non-health related factors. This research provides useful information to expand the coverage of osteoporosis treat- ment which reduces the risk of costly fractures. Further research using a double- bounded, dichotomous-choice type questions utilizing the WTP range based on this study is ongoing. PMS46 IMPACT OF ETANERCEPT ON WORK AND ACTIVITY IMPAIRMENT IN EMPLOYED PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS Watson C 1 , Cheng A 2 , Hone D 3 , Huang B 3 , Bitman B 1 , Huang XY 1 , Gandra SR 1 1 Amgen, Inc., Thousand Oaks, CA, USA, 2 McKesson Corporation, East Palo Alto, CA, USA, 3 McKesson Specialty, Toronto, ON, Canada OBJECTIVES: To quantify the impact of etanercept (ETN) on work and activity impairment in employed patients with moderate to severe rheumatoid arthritis (RA) in US community practices. METHODS: In this prospective, observational study, 55 sites across the US enrolled employed, TNF-naïve, moderate to severe RA patients who initiated 50 mg/week ETN between January 1, 2009 and March 5, 2010. Telephone interviews were conducted at baseline (prior to or at the time of their first ETN dose) and 6 months (after the start of ETN), collecting patient demo- graphic and clinical information, in addition to evaluating work and activity im- pairment using the Work Productivity and Activity Impairment Questionnaire (WPAI). The change in WPAI outcomes after 6 months was assessed through a Wilcoxon signed rank test on all enrolled patients. RESULTS: At baseline, 204 en- rolled patients (mean age, 46.6 years (SD: 10.9); 72.6% female, 83.8% in full-time employment; mean duration of RA, 5.2 years) reported that the overall work im- pairment, work absenteeism, work presenteeism (reduction in productivity at work) and total activity impairment due to RA were 43.2%, 9.9%, 39.7% and 56.1%, respectively. All four WPAI outcomes improved after initiation of ETN therapy. At 6 months, 153 patients remained on therapy and the overall respective WPAI scores demonstrated a mean percent improvement from baseline of 28.7% (p0.0001), 54.6% (p0.0009), 33.2% (p0.0001) and 37.3% (p0.0001). In addition, mean hours lost from work over the last 7 days because of RA decreased from 3.8 hours at baseline to 1.6 hours at 6 months (62.5% decrease in hours lost; p0.0005). CONCLUSIONS: In working patients with moderate to severe RA, ETN had a signif- icant impact on reducing overall work impairment, absenteeism, presenteeism, and activity impairment. Data demonstrate the positive impact of ETN on the ability to work and perform regular activities when used under real world condi- tions. PMS47 EMPLOYABILITY-ADJUSTED-LIFE-YEARS IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH GOLIMUMAB PLUS METHOTREXATE OR METHOTREXATE ALONE Han C 1 , Gathany T 1 , Tandon N 2 , Hsia E 3 1 Johnson & Johnson Pharmaceutical Services, LLC, Malvern, PA, USA, 2 Centocor Ortho Biotech Services, LLC, Horsham, PA, USA, 3 Centocor R&D, Inc, Malvern, PA, USA OBJECTIVES: Estimate/compare employability-adjusted-life-years (EALYs) over time for rheumatoid arthritis (RA) patients treated with golimumab (GLM)methotrexate (MTX) vs. placeboMTX in the GO-FORWARD study. METHODS: GO-FORWARD is a double-blind, placebo-controlled study of adults with active RA (4 tender and 4 swollen joints) and inadequate response to MTX. This analysis included patients 65yrs old who received placeboMTX (MTX) or GLM (50 or 100mg)MTX (GLM) q4wks. Self-reported employment status and Health Assessment Questionnaire (HAQ) were assessed through 3 years. A patient was ’unemployable’ if unemployed and felt unable to work even if a job was available or ’employable’ if employed or felt well enough to work if a job was available. Long-term (over a 10-yr period) employability was estimated via logistic regression modeling incorporating age, gender and HAQ. HAQ was derived using progression rates of 0.045/year for MTX group and 0 (base case) to 0.025/year (sensitivity analysis) for GLM group. RESULTS: At baseline, the mean HAQ score was 1.36, and 61.9% and 44.8% of patients 65 A131 VALUE IN HEALTH 14 (2011) A1–A214