EQ-5D Scores for Diabetes-Related Comorbidities

Background A single-source catalogue of nationally representative EuroQol five-dimensional questionnaire (EQ-5D) scores for chronic conditions in the United States and the United Kingdom from the Medical Expenditure Panel Survey (MEPS) has been published and has been used extensively for public health and cost-effectiveness modeling. Objectives To estimate EQ-5D scores for diabetes-related chronic conditions that are consistent with the previous catalogue. Methods The MEPS is a nationally representative survey of the US civilian population. EQ-5D-3L questionnaire responses were mapped from short-form 12 health survey responses in 2000 to 2011 MEPS data using multinomial logistic regression. Country-specific tariffs were applied to the mapped EQ-5D responses for the United Kingdom, the United States, France, and Spain. EQ-5D scores were regressed on diabetes-related comorbidities controlling for sociodemographic characteristics, body mass index, and comorbidity using robust (median) regression. Methods were consistent with the previously published catalogue of EQ-5D scores for the United States. Results There were 20,705 individuals with diabetes and a valid mapped EQ-5D score in the 2000 to 2011 MEPS data. Unadjusted mapped EQ-5D scores for individuals with diabetes varied by country-specific tariff from 0.70 (France) to 0.79 (United States). Regression results reflecting marginal disutility estimates for EQ-5D scores are provided for 17 diabetes-related comorbidities and body mass index categories for US, UK, French, and Spanish tariffs. Conclusions The estimates provided in this research may be useful for analysts attempting to model the impact of diabetes and diabetes-related comorbid conditions on utility. They are derived from a single-source, nationally representative population and augment the existing “off-the-shelf” catalogue of EQ-5D scores for chronic conditions

Estimating asthma control questionnaire (ACQ) scores from claims data

Background: Asthma control is the main focus of treatment guidelines. Valid instruments such as the Asthma Control Questionnaire (ACQ) require prospective survey. These surveys may be challenging for large population health applications. Objective: To develop an algorithm for estimating ACQ-5 scores from commonly available claims data. Methods: Data was derived from four prospective surveys including the ACQ-5 combined with retrospective claims of Kaiser Permanente of Colorado (KPCO) patients. The statistical approach consisted of derivation and validation of a prediction algorithm including medical and pharmacy claims data using stepwise regression elimination. Validation was conducted by estimating mean squared error (MSE) and mean absolute error (MAE) in one hundred split-sample iterations. Ordinary least squares (OLS), Tobit and Median regression were used. Results: There were 2,657 individuals with valid ACQ-5 scores, claims and eligibility at baseline. The following had statistically significant associations with ACQ-5 scores: gender, use of oral corticosteroids and short-acting beta agonists, the number of asthma drug classes, and emergency and outpatient visits. Average MSE and MAE were similar for the estimation and validation samples. Conclusion: This research provides preliminary results of the feasibility of predicting ACQ-5 scores using commonly available medical and pharmacy claims data. The resulting algorithm may facilitate public health and population level analyses of asthma control. Future studies in different populations will be important to validate the algorithm

Health-related quality of life associated with systemic corticosteroids

Background: Systemic corticosteroids (SCS) are commonly used but are associated with adverse effects. Given their prevalent use, the potential impact of SCS use on health-related quality of life (HRQoL) is important to characterize. Objective: To assess the HRQoL of patients taking SCS. Methods: The 2000–2003 Medical Expenditure Panel Survey was used to examine EQ-5D and SF-6D scores associated with SCS use in adults. The study sample was restricted to those with a condition for which SCS are prescribed. SCS use was categorized into three levels: none; 1–3; and ≥4 prescriptions per year. HRQoL scores were regressed on SCS use (1–3 or ≥4 annual prescriptions) controlling for age, gender, race, ethnicity, education, income category, geographic region, number of ER visits, number of outpatient visits, total number of chronic conditions (for which SCS are not used) and conditions for which SCS are clinically indicated. Results: There were 54,856 individuals with no SCS exposure, 2245 with 1–3 and 624 with ≥4 annual SCS prescriptions. In adjusted analyses, use of ≥4 annual SCS prescriptions appeared to be associated with significantly lower EQ-5D (US), EQ-5D (UK), SF-6D and EQ-5D VAS scores compared to no exposure: −0.032, −0.047, −0.036, and −7.58. Conclusion: While SCS are efficacious and widely used for numerous conditions, results suggest that their use may be associated with a substantial deleterious impact on HRQoL. This potential negative effect should be considered in balance with the cost and efficacy of comparable treatments

The impact of co-morbidity burden on preference-based health-related quality of life in the United States

Background: Many statistical analyses, clinical trials and cost-utility analyses designed to measure the impact of a particular disease on utility scores often overlook the important influence of co-morbidity burden. Objectives: This study aims to examine the impact of co-morbidity burden on EQ-5D index scores in a nationally representative sample of the US. Methods: The pooled 2001 and 2003 Medical Expenditure Panel Survey was used. The total number of chronic conditions for each individual was calculated based on Clinical Classification Categories codes. Spline regression was used to identify nonlinear age effects: individuals were separated into four quartiles based on age. Censored least absolute deviation was used to regress EQ-5D index scores on age and chronic co-morbidity, controlling for income, gender, race, ethnicity, education, physical activity and smoking status. Interactions between age and chronic conditions were also explored. Results: The coefficients for chronic co-morbidities were highly statistically significant with large magnitudes for those with two or more chronic conditions (coefficient two chronic conditions=-0.16; coefficient nine chronic conditions=-0.28). After controlling for chronic co-morbidities and other confounders, age was not statistically significant except for those aged \u3e58 years and the magnitude of this coefficient was very small (coefficient aged \u3e58 years=-0.0006). The interactions between age and chronic comorbidity were significant, but the deleterious impact of their interaction was largely dominated by the existence and number of chronic conditions. Conclusions: Chronic conditions have a significant deleterious impact on EQ-5D index scores that is much more pronounced than age and other sociodemographic and behavioural characteristics. Future analyses and costutility models should incorporate the impact of multiple morbidity. © 2012 Springer International Publishing AG. All rights reserved

Oral corticosteroid exposure and adverse effects in asthmatic patients

Background Significant adverse effects (AEs) have been associated with continuous exposure to oral corticosteroids (OCSs). The potential association with intermittent exposure is unknown. Objective We sought to assess the association between OCSs and AEs based on the number of OCS prescriptions. Methods This was a retrospective cohort study of asthmatic patients 18 years and older in the 2000-2014 MarketScan data set. Propensity score matching was used at baseline (12 months before the index date: first OCS use). Logistic regression was used to examine the association between OCSs and new incident AEs (either combined or individual) controlling for covariates. Follow-up continued for 24 months minimum and 10 years maximum after the index date. Results There were 72,063 and 156,373 subjects in the OCS and no OCS cohorts, respectively. Subjects taking 4 or more OCS (1-3) prescriptions within the year had 1.29 (1.04) times the odds of experiencing a new AE within the year. Each year of exposure to 4 or more OCS prescriptions (current and past) resulted in 1.20 times the odds of having an AE in the current year. Exposure to 4 or more prescriptions was associated with significantly greater odds of AEs for osteoporosis, hypertension, obesity, type 2 diabetes, gastrointestinal ulcers/bleeds, fractures, and cataracts (odds, 1.21-1.44 depending on the AE). Conclusion Although previous research has documented the deleterious effect of continuous OCS exposure in patients with severe asthma, our results suggest that each OCS prescription might result in a cumulative burden on current and future health regardless of dose and duration. OCS-sparing strategies are extremely important to improve patient outcomes

Outcomes before and after treatment escalation to Global Initiative for Asthma steps 4 and 5 in severe asthma

Background Little is known about health outcomes in severe asthma reflected by Global Initiative for Asthma steps 4 and 5. Objective To analyze control, risk, economic, and health resource use (HRU) outcomes associated with treatment escalation to Global Initiative for Asthma steps 4 and 5. Methods This was a before-vs-after retrospective cohort study of patients (12-75 years old) with asthma newly initiated to omalizumab, high-intensity corticosteroids (HICS; a1,000 μg/day of inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; a500 to \u3c1,000 μg/day of fluticasone equivalent) using 2002 to 2011 MarketScan data. Poisson regression was used to model HRU outcomes; Tobit regression was used to model medical expenditures. Results Of 19,227 patients, 856 initiated omalizumab, 6,926 initiated HICS, and 11,445 initiated HDICS. Use of β-agonist increased for the HDICS and HICS cohorts and decreased for the omalizumab cohort; acute care visits and oral corticosteroid use decreased during follow-up for the HDICS and omalizumab cohorts. Annual health care expenditures, polypharmacy burden, and outpatient visits were high for all cohorts and increased in the follow-up year (baseline to follow-up; general health care expenditures: omalizumab $14,071 to$34,887, HICS $12,030 to$15,557, HDICS $7,570 to$9,826; annual number of asthma prescriptions: omalizumab 11.74 to 19.46, HICS 7.8 to 12.44, HDICS 5.17 to 9.69; outpatient visits: omalizumab 26.79 to 34.06, HICS 18.78 to 21.37, HDICS 15.06 to 16.64). Conclusion Omalizumab use was associated with improvements in risk and control accompanied by large increases in expenditures per HRU. Patients on HDICS and HICS showed improvements in risk but worsening control and increased expenditures per HRU. Innovations in disease management and available treatment options are needed to more optimally achieve treatment goals

Association Between Pulmonary Function and Asthma Symptoms

Background: FEV1 as a percentage of predicted (FEV1%pred) is commonly measured in asthma clinical studies; however, reports vary on its association with asthma control instruments evaluating symptoms. Objective: Assess the association between FEV1%pred and Asthma Control Questionnaire (ACQ) scores in a managed-care population with persistent asthma. Methods: Retrospective analysis of survey responses and spirometry results of patients (aged ≥12 years) with persistent asthma from the Observational Study of Asthma Control and Outcomes was done. Eligible patients received 4 identical surveys including the 5-item ACQ (ACQ-5)/6-item ACQ (ACQ-6) and completed spirometry in parallel. Longitudinal analyses, comparisons of change over time, and fixed- and random-effects regression analyses were conducted, with/without adjustment for covariates. Results: There were 1748 survey responses with valid spirometry results. In unadjusted models, coefficients for ACQ-5/ACQ-6 scores were not statistically significant and coefficient of determination (R2) was low (0.03). When adjusted for covariates, ACQ-5 and ACQ-6 scores were significantly associated with FEV1%pred (P \u3c.001) and R2 increased to 0.11 and 0.12, respectively. In adjusted models, every 1-point increase in ACQ-5 and ACQ-6 scores was associated with a 1.7% and 1.9% decrease, respectively, in FEV1%pred. Change in FEV1%pred and change in ACQ-5/ACQ-6 scores were not significantly associated in regressions with/without covariates. Conclusions: The weak and statistically insignificant association between FEV1%pred and ACQ-5/ACQ-6 scores in unadjusted models suggests a high degree of unexplained variation between these measures. Results support the use of both symptoms and pulmonary function, rather than relying on one measure alone, to assess asthma control in clinical care and outcomes studies

Asthma in USA: Its impact on health-related quality of life

Objectives: Given the growing prevalence of asthma in USA, it is important to understand its national burden from the patient\u27s perspective. The objective of this research is to examine the national burden of asthma and poor asthma control on health function, health perception and preference-based health-related quality of life (HRQL). Methods: The Medical Expenditure Panel Survey (MEPS), a nationally representative survey, was used to estimate the impact of asthma and indicators of poor asthma control on health function, self-rated health perception and preference-based HRQL using multivariate regression methods controlling for socioeconomic, clinical and demographic characteristics. Two HRQL instruments were used: SF-12v2 Physical Component Scale (PCS-12) and Mental Component Scale (MCS-12); EQ-5D-3L index and visual analogue scale (VAS). Two multivariate regression methods were used, Censored Least Absolute Deviation [EQ-5D-3L and VAS (due to censoring)] and Ordinary Least Squares (OLS) (PCS-12 and MCS-12). Results: After controlling for covariates, asthma resulted in a statistically significant reduction in preference-based HRQL, health perception and physical and mental function (EQ-5D -0.023; VAS -2.21; PCS-12 -2.36; MCS-12 -0.96). Likewise, experiencing an exacerbation in the previous year and using more than three canisters of quick-relief medication in the previous 3 months were both associated with a statistically significant and clinically meaningful reduction in all four measures. Conclusions: Asthma itself and especially indicators of poor asthma control were associated with a deleterious effect on health function, preference-based HRQL and self-perceived health status. Given the prevalence of asthma, poorly controlled asthma constitutes a significant national burden in USA. © 2013 Informa Healthcare USA, Inc

Exploring asthma control cutoffs and economic outcomes using the Asthma Control Questionnaire

Background Understanding the effect of worsening asthma control on expenditures and health resource utilization (HRU) is important. Objective To explore the association of economic outcomes with asthma control cutoffs and longitudinal changes on the Asthma Control Questionnaire 5 (ACQ-5). Methods The Observational Study of Asthma Control and Outcomes was a survey of patients with persistent asthma who were patients of Kaiser Colorado, including claims-based HRU. Patients completed the ACQ-5 three times during 1 year between April 2011 and June 2012. The ACQ-5 cutoffs that indicated control were assessed in cross-sectional analyses. Longitudinal changes in control were explored: controlled (ACQ-5 score \u3c0.75), indeterminate (ACQ-5 score 0.75 to \u3c1.5), not well controlled (ACQ-5 score 1.5 to \u3c3.0), and very poorly controlled (ACQ-5 score ≥3.0). Analyses used generalized linear models with log link (expenditures) and negative binomial regression (HRU). Results There were 6,666 completed surveys (1,799 individuals completed all 3 survey waves). In the cross-sectional analyses, compared with an ACQ-5 score less than 0.5, individuals with ACQ-5 scores of 4 to 4.5 incurred 7.2 times the number of oral corticosteroid prescriptions, 4.3 times the number of emergency department visits, 6 times the number of inpatient visits, 10.4 times the number of asthma-specific emergency department visits, 4.58 times the number of asthma-specific inpatient visits, and $2,892 more in all-cause and$1,877 in asthma-specific expenditures during 4 months. In the longitudinal change analyses, individuals who improved from an ACQ-5 of 3.0 or greater to less than 0.75 incurred $6,023 less in asthma-specific expenditures during 4 months than those remaining at an ACQ-5 score of 3.0 or higher. Conclusion Results provide preliminary economic data on possible control cutoffs for the ACQ-5. Improving asthma control over time may result in significant savings that may justify financial investments designed to improve control