1. EQ-5D AND QUALITY OF LIFE OF OSTEOPOROSIS AT-RISK PATIENTS IN A SWEDISH OSTEOPOROSIS PATIENT REGISTRY Arun Krishna 1, Dan Mellström 2, Zhiyi Li 3, Chun-Po Steve Fan 3, Stina Salomonsson 4, Ewa Waern 2 1 Merck & Co. Inc, US, 2 Centre for Bone and Arthritis Research at Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden, 3 AsclepiusAnalytics Ltd., Hong Kong, 4 Merck & Co. Inc., Sweden Background Osteoporosis (OP) can be associated with profound physical, psychological, and social disability in addition to skeletal fracture, musculoskeletal pain, kyphosis, and loss of weight Studies of health-related quality of life (HRQoL) in OP have been largely limited to cohorts of patients with established OP and prevalent fractures Costs and effects of OP-related fracture study (KOFOR-study) in Sweden showed the decrease in quality of life compared for having hip, vertebral, and wrist fracture was 0.17, 0.26, and 0.06, respectively (Borgström 2005, Ström 2008) Previous study on HRQoL among patients who’re at risk for OP was limited and results were ambiguous The causal relationship between OP and HRQoL was unclear in a study on 325 female subjects who had been referred for bone mass measurement (Dhillon 2005) Data Swedish Osteoporosis Patient Registry Data Collected from Göteborg region in West Sweden (~2 million inhabitants); available from 1991 to 2009 Patients referred to the clinic for DXA to estimate BMD and diagnosis of OP by GPs, Gynacologists,etc. Questionnaire including: Prior History of Fracture Baseline OP characteristics (Smoking, alcohol, back pain, family history) EQ-5D (added in 2004) Treatment (Currently and previously taken and reasons) Co morbid conditions and concomitant medication BMD scan results (HIP and LUMBAR SPINE) Diagnosis (Normal, Osteopenia, established OP, OP, OP (Men)) Table 2. Analysis of HRQoL by age, gender, medication use, and types of visit EQ-5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions (Figure1) EQ-5D-3L descriptive system may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. HRQoL was calculated using response from EQ-5D using European weights. Conclusions In a Swedish OP registry, the average HRQoL based on EQ-5D was 0.7. 34% reported some or extreme problems in mobility; 8% reported some or extreme problems in self-care; 28% reported some or extreme problems in activities; 75% reported some or extreme problems in pain/discomfort; and 43% reported some or extreme problems in anxiety/depression. Clinical factors that were identified to impact patient reported QoL: Previous fractures (post age 40), especially in arm, hip and vertebral; Falls during last year; Back pain; Comorbidities (especially asthma, arthritis, and hypertension); Elder age; and Male. Table 1. Patient selection Objective To assess health-related quality of life (HRQ0L) among all patients who’re at risk for osteoporosis To identify and quantify risk factors affecting HRQ0L among all patients who’re at risk for osteoporosis WCO-IOF- ESCEO Seville, Spain April 2 - 5 Study Design and Methods A descriptive study using Swedish patient registry data Inclusion criteria: All patients in the registry with EQ-5D measurement Cross-sectional study due to the fact that each patient in the study had only one EQ-5D measurement EQ-5D/HRQoL compared by Age (≤65 vs. >65), Gender (Female vs. Male), Medication use (Without vs. With OP medication), and Types of visit (First vs. Subsequent) Fracture (Yes vs. No), and further by type (e.g. wrist, ankle etc) In additional, multivariate analysis conducted using GLM, controlling for additional comorbidities Poster P385 Figure 1. EQ-5D survey N% Patient profile Female 2,88489.0% Age (mean, std) 66 11.9 Height (cm) (mean, std) 164 8.3 Weight (kg) (mean, std) 67 16.6 Never smoked 1,51946.9% Currently suffering from daily back pain 1,53147.3% Falls Number of falls during the last year None 48915.1% 1 1,57048.5% 2 91728.3% 3 1554.8% 4 952.9% 5 140.4% BMD at the time of patient visit T-score Lumbar spine Normal (T-score≥ 1) 93929.5% Osteopenia (-2.5< T-score < -1) 1,28840.5% Osteoporosis (T-score≤ -2.5) 95730.1% Total hip Normal (T-score≥ 1) 1,11535.4% Osteopenia (-2.5< T-score < -1) 1,56349.6% Osteoporosis (T-score≤ -2.5) 47415.0% Patient-reported drug treatment received at the time of patient visit BIS 77123.8% Teriparatide 190.6% Raloxifene 1865.7% Estrogen 66420.5% Calcium + D-vitamin 1,82256.2% Results 3,240 patients completed the EQ-5D questionnaire. 89% were female, average age was 66 [SD=11.9] (Table 1) For EQ-5D measures, 34.1% reported problems in mobility, 8.0% in self-care, 27.8% in usual activities, 74.7% in pain/discomfort, and 43.3% in anxiety/depression. Average HRQoL was 0.7 [SD=0.2]. (Table 2) Compared with patients receiving OP medication (bisphosphonates, raloxifene, teriparatide, estrogen), those without reported more pain or discomfort (77% vs. 73%; p=0.01). New patients had lower HRQoL than returning patients (0.68 vs. 0.72; p<0.01). (Table 2) Patients with a history of fractures had lower HRQoL than those without fractures (0.69 vs. 0.71; p<0.01). Among those with fractures, lower HRQoL was indicated in patients with hip (0.62), vertebral (0.63) and arm (0.66) fractures. (Table 3) Based on GLM, other factors affecting HRQoL included elder age, history of falls and comorbidities (hypertension, arthritis, and asthma). (Not shown) All patients Age groupGenderMedication useTypes of visit Young (<=65) Old (>65)P-valueFemaleMaleP-value Without OP Med With OP Med P-valueFirst visit Subsequen t visit P-value N 3,240 1,472 1,768 2,884 356 1,811 1,429 1,569 1,671 EQ5D Mobility 0.0000 0.0015 0.0898 0.0054 1= I have no problems in walking about 65.9%73%60% 67%59% 67%65%63%68% 2= I have some problems in walking about 33.7%27%39% 33%40% 33%35%36%31% 3= I am confined to bed 0.4%0% 1% 0%1%0% Self-care 0.2318 0.0007 0.4582 0.1427 1= I have no problems with self-care 92.0%93%91% 93%87% 92% 91%93% 2= I have some problems washing or dressing myself 7.1%7%8% 7%12% 7% 8%6% 3= I am unable to wash or dress myself 0.9%1% Activities 0.5015 0.0091 0.3243 0.0084 1= I have no problems with performing my usual activities 72.2%73%71% 73%66% 71%74%70%75% 2= I have some problems with performing my usually activities 24.1%23%25% 24%28% 25%23%26%22% 3= I am unable to perform my usual activities 3.6%4% 3%6% 4%3%4%3% Pain/discomfort 0.0022 0.8770 0.0146 0.0001 1= I have no pain or discomfort 25.3%28%23% 25%26% 27%23% 28% 2= I have moderate pain or discomfort 62.9%60%65% 63%62% 61%66%63%62% 3= I have extreme pain or discomfort 11.7%12% 11%14%10% Anxiety/Depression 0.1356 0.0829 0.1370 0.0000 1= I am not anxious or depressed 56.7%57% 56%61% 55%59%52%61% 2= I am moderately anxious or depressed 39.9%39%40% 41%35% 41%38%44%36% 3= I am extremely anxious or depressed 3.5%4%3% 4% 3%4%3% Mean QOL Score Euro 0.700.710.69 0.00100.700.69 0.24550.700.71 0.95530.680.72 0.0000 Table 3. Analysis of HRQoL by fracture FractureTypes of fracture No FractureFractureP-valueWristAnkleArmVertebralHip N 1,782 1,458 655 274 190 287 199 EQ5D Mobility 0.0000 1= I have no problems in walking about70%61% 66%58%51% 39% 2= I have some problems in walking about30%39% 34%42%48% 61% 3= I am confined to bed0% 2%1% Self-care 0.1023 1= I have no problems with self-care93%91% 93% 85%89%81% 2= I have some problems washing or dressing myself6%8% 7% 12%10%17% 3= I am unable to wash or dress myself1% 0%3%1%3% Activities 0.0029 1= I have no problems with performing my usual activities74%69% 73%70%61%58%57% 2= I have some problems with performing my usually activities23%26% 25%27%33%36%32% 3= I am unable to perform my usual activities3%4% 3%2%6%7%12% Pain/discomfort 0.4603 1= I have no pain or discomfort26%24% 29%23%24%12%21% 2= I have moderate pain or discomfort62%64% 61%63%61%70%61% 3= I have extreme pain or discomfort11%12% 11%14%15%18% Anxiety/Depression 0.2354 1= I am not anxious or depressed58%56% 59%57%56%48%54% 2= I am moderately anxious or depressed39%40% 38% 37%49%40% 3= I am extremely anxious or depressed3%4% 3%6%7%3%6% Mean QOL Score Euro0.710.69 0.00080.720.690.660.630.62