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PCV116 HEALTH-RELATED QUALITY OF LIFE OF DIABETES PATIENTS WITH AND WITHOUT MACROVASCULAR COMORBIDITIES IN THE UNITED STATES
Abstracts we calculated Pearson correlations between changes in KCCQ and Peak VO2 at 3 and 12 months. Confidence intervals of r’s were estimated via bootstrapping. RESULTS: The SIMPLE method produced a wider distribution of change scores than the other two methods. However, compared to BLUP-1 and BLUP-2, the SIMPLE method estimated lower correlations between changes in KCCQ and Peak VO2 at both 3 and 12 months: At 3 months, SIMPLE r (95% CI) = .16 (.11, .21), BLUP-1 r = .28 (.18, .38), and BLUP-2 r = .29 (.22, .40). At 12 months, SIMPLE r = .22 (.15, .27), BLUP-1 r = .27 (.21, .33), and BLUP-2 r = .31 (.25, .40). CONCLUSIONS: Compared to the SIMPLE approach, the BLUP approach has the following advantages: 1) uses all of the longitudinal data available; 2) estimates with reasonable assumptions about missing data; 3) accommodates nonlinear and differing longitudinal trajectories for the PRO and clinical measures; and 4) minimizes the influence of noisy data. PCV112 RESPONSIVENESS OF AF6, A NEW, SHORT, VALIDATED, AF-SPECIFIC QUESTIONNAIRE—SYMPTOMTIC BENEFIT OF DC CARDIOVERSION Edvardsson N1, Härdén M2, Nyström B2, Bengtson A2, Medin J3, Frison L3 1 Sahlgrenska Academy, Göteborg, Sweden, 2Sahlgrenska University Hospital, Göteborg, Sweden, 3AstraZeneca R&D, Mölndal, Sweden OBJECTIVES: The aim was to measure the effects on symptoms of a direct current cardioversion (DC) in patients with atrial fibrillation (AF) with a new, short, validated AF-specific questionnaire, the AF6. METHODS: One hundred and eleven patients (89 men, 22 women) were included in the study. Their symptoms were screened before and 12 ± 3 days after DC, using AF6, consisting of 6 items, representing the most common symptoms or experiences of patients in an AF clinic. Symptom scores were analyzed in the whole study population as well as in clinical responders and nonresponders, using sinus rhythm (SR) at follow-up as a clinical anchor. RESULTS: The total mean score in the study population decreased, (18 ± 12.4 to 13 ± 11.6, p < 0.0001), and in responders (n = 56), (22 ± 14 vs. 12 ± 12, p < 0.01), but not in nonresponders (n = 55), 14 ± 9 vs. 14 ± 11, N.S. The highest scoring items were ´breathing difficulties upon exertion´ and ´tiredness due to atrial fibrillation´, and they were also the most frequently scoring items (80% and 83%, respectively). The other items of the scale were present in 65%, 64%, 48% and 36% of the patients. ´Worry/anxiety due to atrial fibrillation´ was present in 48% of the patients, scoring high when present. ´Breathing difficulties at rest´ was the least and the lowest scoring item. Effect sizes ranged from 0 to 0.52, in responders from 0.10 to 0.85, and in non-responders from −0.23 to 0.34, the highest scores consistently relating to ´tiredness due to atrial fibrillation. CONCLUSIONS: AF6 demonstrated adequate responsiveness to change, and effect sizes were mostly moderate, in responders moderate to high. The symptom scores measured by AF6 decreased significantly after DC cardioversion, especially in responders in terms of SR, confirming, that SR is an important clinical anchor. PCV113 IMPACT OF STROKE ETIOLOGY ON CARE NEED AND LONG-TERM OUTCOMES Kolominsky-Rabas P, Dietl M, Graessel E, Drexler H, Schwab S University of Erlangen-Nurnberg, Erlangen, Germany OBJECTIVES: Stroke is the second leading cause of death worldwide and a major cause of long-term disability. Increasingly, stroke outcomes research is following clinical practice and not only considers all strokes together but divides them into various risk-profile subtypes. Following this approach, we performed a population-based study of all residents of Erlangen, Bavaria, Germany, to determine the risk profile distributions in a well-defined population and their long-term impact on disability and patterns of care. METHODS: Since 2000 the Erlangen Stroke Project (ESPro) is the reporting centre for stroke for the German Federal Government. As the only population-based stroke registry in Germany ESPro is recording each patient living in Erlangen, Bavaria, Germany (source population 100,500) who suffered from stroke. The patients were analysed at time points after admission as well as 3 and 12 month after the event. A total of 1355 patients with a first-stroke were registered in the ESPro. The cause of ischemic stroke was classified according to the TOAST criteria. Etiological TOAST classification was performed in 89% (1206) of ischemic strokes. RESULTS: The etiological classification of brain infarctions resulted in 12% large-artery atherosclerosis, 26% cardioembolism, 24% small-artery occlusion, 37% strokes of undetermined etiology and 2% strokes of other determined etiology. While 20% of the patients were independent functionally at the Barthel index at admission, the number was 39% after 12 month. The category large-artery atherosclerosis showed the strongest relationship with the occurring need of care. The OR with very strong care needs 12.79 (95% CI3.71 –44.07) lay particularly high in comparison with an OR of 6.95 (95% CI 2.16–22.33) in the category cardioembolism. CONCLUSIONS: The TOAST classification provides an appropriate tool for estimating the need of care. In particular the patients in the TOAST category large-artery atherosclerosis showed a high level of a need of care at the long-term follow-up. PCV114 HEALTH-RELATED QUALITY OF LIFE AMONG WOMEN WITH CORONARY ARTERY DISEASE TREATED WITH PSYCHOTROPIC MEDICATIONS Viswanathan S, Gemmen E, Bharmal M Quintiles, Falls Church, VA, USA OBJECTIVES: Recent studies have found that the use of psychotropic medications in women with coronary artery disease (CAD) led to long-term adverse outcomes such
A171 as cardiovascular adverse events. This study examined the effect of psychotropic medication use on the health-related quality of life (HRQoL) of women with CAD. METHODS: Analysis was conducted using the 2007 Medical and Expenditure Panel Survey (MEPS) database, which is nationally representative of the US civilian noninstitutionalized population. Female patients >= 18 years with CAD were included in this analysis. CAD patients were identified using a combination of International Classification of Diseases (ICD-9) diagnosis codes. HRQoL was measured using the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) of the Short-Form 12 Version 2 (SF-12). HRQoL and sociodemographic characteristics of female CAD patients who used at least one psychotropic medication were compared with those who did not use any psychotropic medications. Bivariate comparisons were made using t-tests for continuous variables and chi-square tests for categorical variables. Multivariate comparisons using analysis of covariance (ANCOVA) models were conducted to assess the association of HRQoL with psychotropic use after adjusting for age, race, education, marital status, insurance status, and the number of medical conditions in 2007. RESULTS: Of the 4,253,569 women with CAD in the US, 1,312,413 (30.9%) took psychotropic medications. Women taking psychotropic medications reported a significantly higher number of medical conditions compared to non-users (13.25 vs. 9.51, p < 0.0001). The mean unadjusted differences in PCS-12 and MCS-12 scores between psychotropic drug users versus non-users suggested worse scores among women taking psychotropic medications (PCS-12: −4.93; p = 0.03 and MCS-12: −9.46; p = 0.0006), and this trend in differences continued after adjusting for covariates (PCS-12: −2.23; p = 0.26 and MCS-12: −7.51; p = 0.0034). CONCLUSIONS: Consistent with findings of long-term adverse outcomes from previous studies, psychotropic medication use among women with CAD was associated with significantly worse HRQoL. PCV115 A SYSTEMATIC REVIEW OF QUALITY OF LIFE ASSESSMENT OF PATIENTS SUFFERING FROM THORACIC AORITC DISEASES Brasseur P1, Sidhu R2 1 Medtronic International SA, Tolochenaz, Vaud, Switzerland, 2LSE, London, UK OBJECTIVES: To review studies assessing the quality of life associated with thoracic aortic diseases (TADs) and their treatment with Open Aortic Repair (OAR), Thoracic Endovascular Aortic Repair (TEVAR) or medical management (MM). METHODS: PubMed and EMBASE were searched covering terms related to TADs and patient reported outcomes/quality of life. The search was limited to articles in English and to studies relating to humans. However, no time period was specified so as to enable a broad search. The studies obtained were analysed qualitatively. RESULTS: Eight studies met the review criteria. Published 1998 and 2009, four dealt with aneurysms, two with dissections and two with more than one of the TADs; all of them were based on assesment of quality of life after treatment rather than on the disease itself. Only one study covered emergency versus elective surgery. The number of patients was very small in all studies, ranging from 75 to 11. Mean follow-up varied from 7 to 76 months. The most commonly used instrument was the SF-36. Two studies also used the Hospital Anxiety and Depression Score (HADS) in addition to the SF-36. One study adopted the SWEDQUAL questionnaire ; another study had recourse to the Illness Intrusiveness Rating Scale (IIRS) and the Karnofsky Activity Scale (KAS), which lacked information on proper validation for this target population. All in all, none of the study conducted the quality of life assessment appropriately, particularly with regard to the follow-up period, the lack of pre-operative assessment and lack of direct comparison between interventions. Lastly, there were no utility assessments to be found, which would be essential to arrive at QALY values and thus take the process of economic analysis forward. CONCLUSIONS: The studies available so far do not provide evidence of the quality of life associated with TADs, as well as conclusive evidence of the quality of life associated with OAR; TEVAR and/or MM. PCV116 HEALTH-RELATED QUALITY OF LIFE OF DIABETES PATIENTS WITH AND WITHOUT MACROVASCULAR COMORBIDITIES IN THE UNITED STATES Qiu Y1, Fu AZ2, Radican L1 1 Merck & Co., Inc., Whitehouse Station, NJ, USA, 2Cleveland Clinic, Cleveland, OH, USA OBJECTIVES: Diabetes mellitus has been defined as one of the global epidemics of chronic diseases by the World Health Organization. Patients with diabetes are at an increased risk of developing macrovascular disease. The purpose of this study was to examine the marginal impact of macrovascular comorbidities on health-related quality of life (HRQoL) of patients with diabetes in a United States nationally representative sample. METHODS: Using the pooled Medical Expenditure Panel Survey (MEPS) 2001 and 2003 data, a nationally representative adult sample (age ≥18) was included in the study. The HRQoL outcomes included the SF-12 physical component summary (PCS) score, SF-12 mental component summary (MCS) score, EQ-5D preference-based index score, and visual analog scale (VAS). Ordinary least square regressions were used to identify the relationship between macrovascular disease conditions and PCS (and MCS) after controlling for age, sex, race, ethnicity, education, income, smoking status, health insurance, proxy response, and number of other comorbid categories. Due to the distributions of the EQ-5D preference-based index and VAS score, censored linear deviations estimator (CLAD) regressions were employed. All statistics were adjusted using the proper sampling weight from the MEPS. RESULTS: The average PCS, MCS, EQ-5D index, and VAS scores for patients with diabetes were 40.5, 48.5, 0.75, and 66.6, respectively for the sample. Compared to diabetes patients without macrovascular comorbidities (N = 2,809), those with macrovascular comorbidities (N
A172 = 654) had statistically significant lower PCS (−3.38, p < 0.001), MCS (−1.43, p < 0.05), EQ-5D index (−0.024, p < 0.05), and VAS scores (−4.93, p < 0.001). Patients with diabetes also had significantly lower HRQoL outcomes than those without diabetes (N = 43,326) (p < 0.001). CONCLUSIONS: In summary, macrovascular comorbidities significantly decrease HRQoL in patients with diabetes. PCV117 QUALITY OF LIFE OF PATIENTS WITH HYPERTENSION USING THE 2007 NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY (NHANES) OF KOREA Kim J University of Utah, Salt Lake City, UT, USA OBJECTIVES: This study was to compare health-related quality of life of patients with hypertension to people without hypertension. METHODS: Using the 2007 NHANES of Korea, EuroQol (EQ-5D) was used to estimate a relation between quality of life and hypertension. In the analysis, adults (age ≥19 years old) at the time of the survey were included. EQ-5D as well as each 5 category such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression were considered for the analysis. For the estimation in EQ-5D, a generalized linear model with a logit link and the binomial family was used because EQ-5D was a proportion variable and had high negative skewness. In each specific category, there were 3 categories indicating good (1) to worse (3). Thus, ordered logit regressions were used for the analyses. In all analyses, age, gender, types of insurance, income, years of education and comorbid conditions were included. Survey weights were incorporated in the analyses to consider the survey design. RESULTS: A total of 2767 subjects was available. Among those, 518 (18.7%) subjects had a hypertension based on self-report on whether they had hypertension or not. Mean (SD) in quality-of-life of patients with hypertension was 0.84 (0.19), while mean (SD) of patients without hypertension was 0.93 (0.12). Among patients with hypertension, 51.7% were elderly (age >= 65 years) and 59.5% were female. Among patients without hypertension, 16.6% were elderly and 57.1% were female. Patients with hypertension as compare to people without hypertension were lower in quality of life by −0.20 (p-value: 0.038) after controlling other factors. Patients with hypertension were worsen in mobility and usual activity, but self-care, pain/discomfort and anxiety/depression had no difference from people without hypertension. CONCLUSIONS: Patients with hypertension as compared to people without hypertension were lower in quality of life mostly due to difficulties in mobility and usual activity.
CARDIOVASCULAR DISORDERS – Health Care Use & Policy Studies PCV118 CHARACTERIZATION OF COMMERCIALLY INSURED PATIENTS WITH ACUTE CORONARY SYNDROME (ACS) RECEIVING PERCUTANEOUS CORONARY INTERVENTION (PCI) Meadows E1, Sugihara T1, Zagar A1, Bae J1, Ramaswamy K2 1 Eli Lilly and Company, Indianapolis, IN, USA, 2Daiichi Sankyo, Inc., Parsippany, NJ, USA OBJECTIVES: To characterize ACS-PCI patients including the index hospitalization charges and length-of-stay (LOS) in a US health benefit plan. METHODS: The data source was Invision from i3, a division of UnitedHealth. ACS diagnoses were from ICD-9 codes 410.xx or 411.1. PCI procedure codes were 00.66, 36.0X, 92973, 92975, 92978 −92982, 92984, 92995/6, and G0290/1. The definition of ACS-PCI was PCI within 30 days of an ACS diagnosis. The diagnosis related group (DRG) codes (555, 556, 557, 558) and corresponding descriptions are from Version 23 and 24. Charges are in 2006 dollars. Continuous enrollment was required during the year 2006 and a minimum of 1 year before the index PCI. Patients with a history of transient ischemic attack or stroke were excluded. A clopidogrel claim was required within 60 days after hospitalization. RESULTS: Of the 6687 patients who had ACS-PCI and met the other inclusion criteria, 5174 (77.4%) were male, 5587 (83.6%) were under 65 years of age, and 1777 (26.6%) had a diabetes diagnosis. Drug-eluting stents (DES, n = 5541, 82.9%) were frequently used. The 3249 patients with DRG557, DES with a major cardiovascular diagnosis (CVDx), had a mean length of stay (LOS) of 2.9 days and mean charges of $54,271. The 2292 patients with DRG558, DES without major CVDx, had a mean LOS of 1.7 days and mean charges of $44,230. The corresponding cohorts receiving bare metal stents (BMS) with (DRG555, n = 602) and without (DRG556, n = 187) major CVDx had mean LOS of 2.9 and 1.8 days with mean hospital charges of $46,106 and $34,109 respectively. CONCLUSIONS: For ACS patients who underwent PCI, the mean charge was approximately $10,000 higher and the mean LOS was 1 day longer for the cohort with major CVDx, as per the DRG definition, compared to the cohort without major CVDx. PCV119 MANAGEMENT OF ACUTE ISCHEMIC STROKE IN THE USA Rouleau A1, Mouchet J2, Guilhaume C1, Milea D1, Maier W3 1 Lundbeck SAS, Issy-les-Moulineaux, France, 2MAPI Research Trust, Lyon, France, 3MAPI-EPI, London, UK OBJECTIVES: Describe the management of ischemic stroke patients in acute phase and its impact on long-term stroke evolution in the USA. METHODS: Medline was searched from 1999 to date and ISPOR Digest was screened to identify stroke cohorts and registries containing data for the last ten years in the USA. A ranking process was implemented to identify and select the relevant references. RESULTS: A total of 461
Abstracts references were retrieved. The selection process led to the identification of 78 publications (42 cohorts, 9 registries and 5 database studies) of which 41 focused on ischemic stroke only. Sixty-nine percent of the studies were hospital-based and 31% population-based. The studies aimed to characterise determinants that impact acute phase management and outcomes, in particular demographic and clinical factors. Hospital settings and associated care facilities were studied in order to improve disease management by identifying specific barriers to the administration of the only available thrombolytic treatment (recombinant tissue-type plasminogen activator, rt PA) in acute phase. Of these studies, many were not applicable to all ischemic stroke patients. Studies documenting the use of rt-PA showed that: less than 25% of patients arrived within 3 hours (i.e. time eligibility criteria for therapy) and 38.3% to 48.2% of them were excluded because of medical contraindications. Consequently, 10.9% to 14% of ischemic patients should have been given rt PA, but in natural settings, only 3.2% actually received it. In addition, long-term evolution of ischemic patients (mortality, stroke recurrence and cardiac events) was documented in several studies, but the evolution of disability after more than 3-months was not assessed. CONCLUSIONS: As shown above, general information about management of ischemic stroke in acute phase is lacking. New cohort or registry studies aiming to better describe patterns of ischemic stroke care that influence short and long-term clinical and associated economic outcomes need to be developed. PCV120 IMPACT OF THE MEDICARE PART D DONUT-HOLE ON PATIENTS WITH HYPERTENSION OR HYPERLIPIDEMIA Li P, McElligott S, Bergquist H, Schwartz S, Doshi JA University of Pennsylvania, Philadelphia, PA, USA OBJECTIVES: The impact of Medicare’s Part D coverage gap (donut hole) on drug utilization was examined among patients with hypertension and/or hyperlipidemia, comparing treatment for asymptomatic (hypercholesterolemia and hypertension) and symptomatic (GI, depression, and pain) conditions. METHODS: The study sample consisted of patients from the 5% Medicare (A, B, and D) files with a diagnosis of hypertension and/or hyperlipidemia in 2005 and full-year (2006) fee-for-service, Medicare Part D and low-income subsidy (LIS) or non-LIS eligibility. Study outcomes included any drug use, adherence (percent days covered (PDC) ≥0.8), and discontinuation (≥30-day continuous gap). The study employed a quasi-experimental design using a pre- (prior to donut hole) and post- (during donut hole) periods comparing three patient groups (non-LIS: without coverage, generic only coverage, and brand / generic coverage during the gap) with a contemporaneous control group (LIS: no coverage gap). A difference-in-difference approach was used with multiple regressions controlling for demographic characteristics, Medicare entitlement status, area-level information, and clinical risk. RESULTS: The donut hole was associated with statistically significant decreases in any drug use and PDC adherence, along with an increase in the likelihood of a discontinuation for both lipid lowering and antihypertensive drugs. The magnitude of impact was largest among patients without donut-hole drug coverage: 1.1% to 4.1% drop in probability of drug use; 4.4% to 12.1% decrease in adherence; and 4.5% to 12.5% increase in discontinuations (p < 0.01 for all). Impact was smallest among patients with both generic/brand drug coverage relative to the LIS controls. The donut hole had no impact on probability of using symptomatic drugs (anti-ulcer agents, antidepressants, and pain-killers). CONCLUSIONS: The donut hole was associated with statistically significant but modest drops in the use of drugs for asymptomatic conditions, but had no impact on drugs for symptomatic conditions. Patients with no coverage during the donut hole experienced the largest impacts. PCV121 THE IMPACT OF PART D ON PREVIOUSLY UNINSURED MEDICARE BENEFICIARIES WITH HYPERTENSION Shoemaker JS University of Maryland Baltimore, Baltimore, MD, USA OBJECTIVES: To assess the effect of Medicare Part D enrollment on changes in antihypertensive drug utilization for a nationally-representative sample of Medicare beneficiaries without prior prescription coverage. Part D enrollees have characteristics associated with above average drug use. To date, no nationally-representative studies have evaluated the impact of Part D on drug utilization controlling for these selection effects. Panel data methods address these biases in studying treatment for a chronic condition for which drug therapy can promote long term benefits. METHODS: Longitudinal Medicare Current Beneficiary Survey (MCBS) data from the year before and after implementation of Part D. Unit of observation is the person-trimester, defined as the interval between subsequent MCBS survey dates. Primary sample of beneficiaries reporting a diagnosis of hypertension without drug coverage in 2005 and completed all 6 survey rounds in 2005 and 2006 (N = 3039 person trimesters). Secondary control sample of beneficiaries continuously enrolled in employer-sponsored insurance (ESI) as a sensitivity analysis (N = 5,608 person trimesters). Fixed effects and difference-in-difference (DID) multivariate methods compare changes in drug fills over six 4-month periods for beneficiaries who enrolled in Part D and those who did not. RESULTS: A total of 67% of the primary sample enrolled in Part D. Descriptive trend analysis shows a monotonic increase in mean antihypertensive fills by trimester ranging from 4.0 to 7.1 for Part D enrollees, compared to a range from 2.7 to 4.4 for non-enrollees. In adjusted DID comparisons, Part D enrollees experienced 1.79 additional antihypertensive fills per trimester relative to non-enrollees (p < 0.05). Fixed effects methods suggest that Part D enrollees filled an additional 1.08 prescriptions per trimester (p < 0.05). Sensitivity analysis show comparable results. CONCLUSIONS: Enrollment in Part D increased drug utilization for a class of drugs known to
A171 as cardiovascular adverse events. This study examined the effect of psychotropic medication use on the health-related quality of life (HRQoL) of women with CAD. METHODS: Analysis was conducted using the 2007 Medical and Expenditure Panel Survey (MEPS) database, which is nationally representative of the US civilian noninstitutionalized population. Female patients >= 18 years with CAD were included in this analysis. CAD patients were identified using a combination of International Classification of Diseases (ICD-9) diagnosis codes. HRQoL was measured using the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) of the Short-Form 12 Version 2 (SF-12). HRQoL and sociodemographic characteristics of female CAD patients who used at least one psychotropic medication were compared with those who did not use any psychotropic medications. Bivariate comparisons were made using t-tests for continuous variables and chi-square tests for categorical variables. Multivariate comparisons using analysis of covariance (ANCOVA) models were conducted to assess the association of HRQoL with psychotropic use after adjusting for age, race, education, marital status, insurance status, and the number of medical conditions in 2007. RESULTS: Of the 4,253,569 women with CAD in the US, 1,312,413 (30.9%) took psychotropic medications. Women taking psychotropic medications reported a significantly higher number of medical conditions compared to non-users (13.25 vs. 9.51, p < 0.0001). The mean unadjusted differences in PCS-12 and MCS-12 scores between psychotropic drug users versus non-users suggested worse scores among women taking psychotropic medications (PCS-12: −4.93; p = 0.03 and MCS-12: −9.46; p = 0.0006), and this trend in differences continued after adjusting for covariates (PCS-12: −2.23; p = 0.26 and MCS-12: −7.51; p = 0.0034). CONCLUSIONS: Consistent with findings of long-term adverse outcomes from previous studies, psychotropic medication use among women with CAD was associated with significantly worse HRQoL. PCV115 A SYSTEMATIC REVIEW OF QUALITY OF LIFE ASSESSMENT OF PATIENTS SUFFERING FROM THORACIC AORITC DISEASES Brasseur P1, Sidhu R2 1 Medtronic International SA, Tolochenaz, Vaud, Switzerland, 2LSE, London, UK OBJECTIVES: To review studies assessing the quality of life associated with thoracic aortic diseases (TADs) and their treatment with Open Aortic Repair (OAR), Thoracic Endovascular Aortic Repair (TEVAR) or medical management (MM). METHODS: PubMed and EMBASE were searched covering terms related to TADs and patient reported outcomes/quality of life. The search was limited to articles in English and to studies relating to humans. However, no time period was specified so as to enable a broad search. The studies obtained were analysed qualitatively. RESULTS: Eight studies met the review criteria. Published 1998 and 2009, four dealt with aneurysms, two with dissections and two with more than one of the TADs; all of them were based on assesment of quality of life after treatment rather than on the disease itself. Only one study covered emergency versus elective surgery. The number of patients was very small in all studies, ranging from 75 to 11. Mean follow-up varied from 7 to 76 months. The most commonly used instrument was the SF-36. Two studies also used the Hospital Anxiety and Depression Score (HADS) in addition to the SF-36. One study adopted the SWEDQUAL questionnaire ; another study had recourse to the Illness Intrusiveness Rating Scale (IIRS) and the Karnofsky Activity Scale (KAS), which lacked information on proper validation for this target population. All in all, none of the study conducted the quality of life assessment appropriately, particularly with regard to the follow-up period, the lack of pre-operative assessment and lack of direct comparison between interventions. Lastly, there were no utility assessments to be found, which would be essential to arrive at QALY values and thus take the process of economic analysis forward. CONCLUSIONS: The studies available so far do not provide evidence of the quality of life associated with TADs, as well as conclusive evidence of the quality of life associated with OAR; TEVAR and/or MM. PCV116 HEALTH-RELATED QUALITY OF LIFE OF DIABETES PATIENTS WITH AND WITHOUT MACROVASCULAR COMORBIDITIES IN THE UNITED STATES Qiu Y1, Fu AZ2, Radican L1 1 Merck & Co., Inc., Whitehouse Station, NJ, USA, 2Cleveland Clinic, Cleveland, OH, USA OBJECTIVES: Diabetes mellitus has been defined as one of the global epidemics of chronic diseases by the World Health Organization. Patients with diabetes are at an increased risk of developing macrovascular disease. The purpose of this study was to examine the marginal impact of macrovascular comorbidities on health-related quality of life (HRQoL) of patients with diabetes in a United States nationally representative sample. METHODS: Using the pooled Medical Expenditure Panel Survey (MEPS) 2001 and 2003 data, a nationally representative adult sample (age ≥18) was included in the study. The HRQoL outcomes included the SF-12 physical component summary (PCS) score, SF-12 mental component summary (MCS) score, EQ-5D preference-based index score, and visual analog scale (VAS). Ordinary least square regressions were used to identify the relationship between macrovascular disease conditions and PCS (and MCS) after controlling for age, sex, race, ethnicity, education, income, smoking status, health insurance, proxy response, and number of other comorbid categories. Due to the distributions of the EQ-5D preference-based index and VAS score, censored linear deviations estimator (CLAD) regressions were employed. All statistics were adjusted using the proper sampling weight from the MEPS. RESULTS: The average PCS, MCS, EQ-5D index, and VAS scores for patients with diabetes were 40.5, 48.5, 0.75, and 66.6, respectively for the sample. Compared to diabetes patients without macrovascular comorbidities (N = 2,809), those with macrovascular comorbidities (N
A172 = 654) had statistically significant lower PCS (−3.38, p < 0.001), MCS (−1.43, p < 0.05), EQ-5D index (−0.024, p < 0.05), and VAS scores (−4.93, p < 0.001). Patients with diabetes also had significantly lower HRQoL outcomes than those without diabetes (N = 43,326) (p < 0.001). CONCLUSIONS: In summary, macrovascular comorbidities significantly decrease HRQoL in patients with diabetes. PCV117 QUALITY OF LIFE OF PATIENTS WITH HYPERTENSION USING THE 2007 NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY (NHANES) OF KOREA Kim J University of Utah, Salt Lake City, UT, USA OBJECTIVES: This study was to compare health-related quality of life of patients with hypertension to people without hypertension. METHODS: Using the 2007 NHANES of Korea, EuroQol (EQ-5D) was used to estimate a relation between quality of life and hypertension. In the analysis, adults (age ≥19 years old) at the time of the survey were included. EQ-5D as well as each 5 category such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression were considered for the analysis. For the estimation in EQ-5D, a generalized linear model with a logit link and the binomial family was used because EQ-5D was a proportion variable and had high negative skewness. In each specific category, there were 3 categories indicating good (1) to worse (3). Thus, ordered logit regressions were used for the analyses. In all analyses, age, gender, types of insurance, income, years of education and comorbid conditions were included. Survey weights were incorporated in the analyses to consider the survey design. RESULTS: A total of 2767 subjects was available. Among those, 518 (18.7%) subjects had a hypertension based on self-report on whether they had hypertension or not. Mean (SD) in quality-of-life of patients with hypertension was 0.84 (0.19), while mean (SD) of patients without hypertension was 0.93 (0.12). Among patients with hypertension, 51.7% were elderly (age >= 65 years) and 59.5% were female. Among patients without hypertension, 16.6% were elderly and 57.1% were female. Patients with hypertension as compare to people without hypertension were lower in quality of life by −0.20 (p-value: 0.038) after controlling other factors. Patients with hypertension were worsen in mobility and usual activity, but self-care, pain/discomfort and anxiety/depression had no difference from people without hypertension. CONCLUSIONS: Patients with hypertension as compared to people without hypertension were lower in quality of life mostly due to difficulties in mobility and usual activity.
CARDIOVASCULAR DISORDERS – Health Care Use & Policy Studies PCV118 CHARACTERIZATION OF COMMERCIALLY INSURED PATIENTS WITH ACUTE CORONARY SYNDROME (ACS) RECEIVING PERCUTANEOUS CORONARY INTERVENTION (PCI) Meadows E1, Sugihara T1, Zagar A1, Bae J1, Ramaswamy K2 1 Eli Lilly and Company, Indianapolis, IN, USA, 2Daiichi Sankyo, Inc., Parsippany, NJ, USA OBJECTIVES: To characterize ACS-PCI patients including the index hospitalization charges and length-of-stay (LOS) in a US health benefit plan. METHODS: The data source was Invision from i3, a division of UnitedHealth. ACS diagnoses were from ICD-9 codes 410.xx or 411.1. PCI procedure codes were 00.66, 36.0X, 92973, 92975, 92978 −92982, 92984, 92995/6, and G0290/1. The definition of ACS-PCI was PCI within 30 days of an ACS diagnosis. The diagnosis related group (DRG) codes (555, 556, 557, 558) and corresponding descriptions are from Version 23 and 24. Charges are in 2006 dollars. Continuous enrollment was required during the year 2006 and a minimum of 1 year before the index PCI. Patients with a history of transient ischemic attack or stroke were excluded. A clopidogrel claim was required within 60 days after hospitalization. RESULTS: Of the 6687 patients who had ACS-PCI and met the other inclusion criteria, 5174 (77.4%) were male, 5587 (83.6%) were under 65 years of age, and 1777 (26.6%) had a diabetes diagnosis. Drug-eluting stents (DES, n = 5541, 82.9%) were frequently used. The 3249 patients with DRG557, DES with a major cardiovascular diagnosis (CVDx), had a mean length of stay (LOS) of 2.9 days and mean charges of $54,271. The 2292 patients with DRG558, DES without major CVDx, had a mean LOS of 1.7 days and mean charges of $44,230. The corresponding cohorts receiving bare metal stents (BMS) with (DRG555, n = 602) and without (DRG556, n = 187) major CVDx had mean LOS of 2.9 and 1.8 days with mean hospital charges of $46,106 and $34,109 respectively. CONCLUSIONS: For ACS patients who underwent PCI, the mean charge was approximately $10,000 higher and the mean LOS was 1 day longer for the cohort with major CVDx, as per the DRG definition, compared to the cohort without major CVDx. PCV119 MANAGEMENT OF ACUTE ISCHEMIC STROKE IN THE USA Rouleau A1, Mouchet J2, Guilhaume C1, Milea D1, Maier W3 1 Lundbeck SAS, Issy-les-Moulineaux, France, 2MAPI Research Trust, Lyon, France, 3MAPI-EPI, London, UK OBJECTIVES: Describe the management of ischemic stroke patients in acute phase and its impact on long-term stroke evolution in the USA. METHODS: Medline was searched from 1999 to date and ISPOR Digest was screened to identify stroke cohorts and registries containing data for the last ten years in the USA. A ranking process was implemented to identify and select the relevant references. RESULTS: A total of 461
Abstracts references were retrieved. The selection process led to the identification of 78 publications (42 cohorts, 9 registries and 5 database studies) of which 41 focused on ischemic stroke only. Sixty-nine percent of the studies were hospital-based and 31% population-based. The studies aimed to characterise determinants that impact acute phase management and outcomes, in particular demographic and clinical factors. Hospital settings and associated care facilities were studied in order to improve disease management by identifying specific barriers to the administration of the only available thrombolytic treatment (recombinant tissue-type plasminogen activator, rt PA) in acute phase. Of these studies, many were not applicable to all ischemic stroke patients. Studies documenting the use of rt-PA showed that: less than 25% of patients arrived within 3 hours (i.e. time eligibility criteria for therapy) and 38.3% to 48.2% of them were excluded because of medical contraindications. Consequently, 10.9% to 14% of ischemic patients should have been given rt PA, but in natural settings, only 3.2% actually received it. In addition, long-term evolution of ischemic patients (mortality, stroke recurrence and cardiac events) was documented in several studies, but the evolution of disability after more than 3-months was not assessed. CONCLUSIONS: As shown above, general information about management of ischemic stroke in acute phase is lacking. New cohort or registry studies aiming to better describe patterns of ischemic stroke care that influence short and long-term clinical and associated economic outcomes need to be developed. PCV120 IMPACT OF THE MEDICARE PART D DONUT-HOLE ON PATIENTS WITH HYPERTENSION OR HYPERLIPIDEMIA Li P, McElligott S, Bergquist H, Schwartz S, Doshi JA University of Pennsylvania, Philadelphia, PA, USA OBJECTIVES: The impact of Medicare’s Part D coverage gap (donut hole) on drug utilization was examined among patients with hypertension and/or hyperlipidemia, comparing treatment for asymptomatic (hypercholesterolemia and hypertension) and symptomatic (GI, depression, and pain) conditions. METHODS: The study sample consisted of patients from the 5% Medicare (A, B, and D) files with a diagnosis of hypertension and/or hyperlipidemia in 2005 and full-year (2006) fee-for-service, Medicare Part D and low-income subsidy (LIS) or non-LIS eligibility. Study outcomes included any drug use, adherence (percent days covered (PDC) ≥0.8), and discontinuation (≥30-day continuous gap). The study employed a quasi-experimental design using a pre- (prior to donut hole) and post- (during donut hole) periods comparing three patient groups (non-LIS: without coverage, generic only coverage, and brand / generic coverage during the gap) with a contemporaneous control group (LIS: no coverage gap). A difference-in-difference approach was used with multiple regressions controlling for demographic characteristics, Medicare entitlement status, area-level information, and clinical risk. RESULTS: The donut hole was associated with statistically significant decreases in any drug use and PDC adherence, along with an increase in the likelihood of a discontinuation for both lipid lowering and antihypertensive drugs. The magnitude of impact was largest among patients without donut-hole drug coverage: 1.1% to 4.1% drop in probability of drug use; 4.4% to 12.1% decrease in adherence; and 4.5% to 12.5% increase in discontinuations (p < 0.01 for all). Impact was smallest among patients with both generic/brand drug coverage relative to the LIS controls. The donut hole had no impact on probability of using symptomatic drugs (anti-ulcer agents, antidepressants, and pain-killers). CONCLUSIONS: The donut hole was associated with statistically significant but modest drops in the use of drugs for asymptomatic conditions, but had no impact on drugs for symptomatic conditions. Patients with no coverage during the donut hole experienced the largest impacts. PCV121 THE IMPACT OF PART D ON PREVIOUSLY UNINSURED MEDICARE BENEFICIARIES WITH HYPERTENSION Shoemaker JS University of Maryland Baltimore, Baltimore, MD, USA OBJECTIVES: To assess the effect of Medicare Part D enrollment on changes in antihypertensive drug utilization for a nationally-representative sample of Medicare beneficiaries without prior prescription coverage. Part D enrollees have characteristics associated with above average drug use. To date, no nationally-representative studies have evaluated the impact of Part D on drug utilization controlling for these selection effects. Panel data methods address these biases in studying treatment for a chronic condition for which drug therapy can promote long term benefits. METHODS: Longitudinal Medicare Current Beneficiary Survey (MCBS) data from the year before and after implementation of Part D. Unit of observation is the person-trimester, defined as the interval between subsequent MCBS survey dates. Primary sample of beneficiaries reporting a diagnosis of hypertension without drug coverage in 2005 and completed all 6 survey rounds in 2005 and 2006 (N = 3039 person trimesters). Secondary control sample of beneficiaries continuously enrolled in employer-sponsored insurance (ESI) as a sensitivity analysis (N = 5,608 person trimesters). Fixed effects and difference-in-difference (DID) multivariate methods compare changes in drug fills over six 4-month periods for beneficiaries who enrolled in Part D and those who did not. RESULTS: A total of 67% of the primary sample enrolled in Part D. Descriptive trend analysis shows a monotonic increase in mean antihypertensive fills by trimester ranging from 4.0 to 7.1 for Part D enrollees, compared to a range from 2.7 to 4.4 for non-enrollees. In adjusted DID comparisons, Part D enrollees experienced 1.79 additional antihypertensive fills per trimester relative to non-enrollees (p < 0.05). Fixed effects methods suggest that Part D enrollees filled an additional 1.08 prescriptions per trimester (p < 0.05). Sensitivity analysis show comparable results. CONCLUSIONS: Enrollment in Part D increased drug utilization for a class of drugs known to