Costs and Impact of Disease in Adults with Sickle Cell Disease: A Pilot Study.

Limited data are available to characterize sickle cell disease (SCD) related disease burden and outcomes. We assessed the feasibility of collecting data to estimate illness burden in adults with SCD; investigated factors associated with health-related quality of life (HRQoL); and estimated societal burden. We recruited 32 adults with SCD. We collected data on fatigue, HRQoL and the Work Productivity and Activity Impairment via patient survey. Healthcare utilization was abstracted for the 12 months prior to enrollment using medical chart review. Mean (standard deviation) age was 36.7 (10.6) years, 84.4% had hemoglobin (Hb)SS/Sthal0 disease, and 81.3% reported chronic pain (experiencing pain on ≥3 days per week in the past 6 months). Mean EQ-5D-3L VAS was 63.4, index score was 0.79. The mean fatigue score was 57.9 (range 33.7-75.9). Higher fatigue score was correlated with lower EQ-5D index score (correlation coefficient r=-0.35, p=0.049), and ASCQ-Me scores, including pain (r=-0.47, p=0.006), sleep (r=-0.38, p=0.03), and emotion (r=-0.79, p<0.0001). The number of hospitalizations was negatively correlated with HRQoL (all p<0.05). Patients who reported chronic pain had significantly lower mean ASCQ-Me sleep scores (48.3 vs. 57.1, p=0.04) and EQ-5D index scores (0.72 vs. 0.89, p=0.002) than those without chronic pain. Mean estimated annual per-person costs were $51,779 (median: $36,366) for total costs, $7,619 ($0) for indirect costs (estimated from lost earnings of participants), and $44,160 ($31,873) for medical costs. Fatigue, SCD complications, hospitalization and chronic pain negatively impact HRQoL in this cohort. This sample experienced a high economic burden, largely from outpatient doctor visits.

Impact of mepolizumab in patients with high-burden severe asthma within a managed care population.

OBJECTIVE: To evaluate the real-world impact of mepolizumab on the incidence of asthma exacerbations, oral corticosteroid (OCS) use and asthma exacerbation-related costs in patients with high-burden severe asthma. METHODS: This was a retrospective study of the MarketScan Commercial and Medicare Databases in patients with high-burden severe asthma (≥80th percentile of total healthcare expenditure and/or significant comorbidity burden). Patients were ≥12 years of age upon mepolizumab initiation (index date November 1, 2015-December 31, 2018) and had ≥2 mepolizumab administrations during the 6 months post-index. Asthma exacerbation frequency (primary outcome), use of OCS (secondary outcome), and asthma exacerbation-related costs (exploratory outcome) were assessed during the 12 months pre-index (baseline) and post-index (follow-up). RESULTS: In total, 281 patients were analyzed. Mepolizumab significantly reduced the proportion of patients with any asthma exacerbation (P < 0.001) or exacerbations requiring hospitalization (P = 0.004) in the follow-up versus baseline period. The mean number of exacerbations decreased from 2.5 to 1.5 events/patient/year (relative reduction: 40.0%; P < 0.001). The proportion of patients with ≥1 OCS claim also decreased significantly from 94.0% to 81.9% (relative reduction: 12.9%; P < 0.001), corresponding to a decrease from 6.6 to 4.7 claims/person/year (P < 0.001). Of the 264 patients with ≥1 OCS claim during baseline, 191 (72.3%) showed a decrease in mean daily OCS use by ≥50% in 117 patients (61.3%). Total asthma exacerbation-related costs were significantly lower after mepolizumab was initiated (P < 0.001). CONCLUSIONS: Mepolizumab reduced exacerbation frequency, OCS use and asthma exacerbation-related costs in patients with high-cost severe asthma. Mepolizumab provides real-world benefits to patients, healthcare systems and payers.

Validation of a prospective mortality prediction score for hip fracture patients.

PURPOSE: Although mortality prediction tools are the subject of significant interest as components of comprehensive hip fracture protocols, few have been applied or validated to prospectively inform ongoing patient management. Five regional hospitals are currently generating real-time mortality risk scores for all adults at the time of admission using available laboratory and comorbidity data (Cowen et al. J Hosp Med 9(11):720-726, 2014). Although results for aggregated conditions have been published, the primary aim of this study is to determine how well prospectively calculated scores predict mortality for hip fracture patients specifically. METHODS: Using a five-hospital database, 1376 patients who were prospectively scored on admission were identified from January 2013 to April 2017, cross-referencing ICD9/10 diagnosis and procedure codes for AO/OTA 31A1 through 31B3 fractures. Prospective mortality scores have been previously divided into 5 risk categories to facilitate ease of clinical use. Vital status was determined from hospital data, Social Security and Michigan Death Indices. RESULTS: Prospective scores demonstrated good mortality prediction, with AUCs of 0.80, 0.73, 0.74 and 0.74 for in hospital, 30-, 60- and 90-day mortality, respectively. Patients in the top 2 mortality risk categories represented 30% (410/1376) of the cohort and accounted for 78% (25/32) of the inpatient and 59% (57/97) of the 30 day deaths. CONCLUSIONS: Implementation of this real-time mortality risk tool is feasible and valid for the prediction of short- to medium-term mortality risk for hip fracture patients, and potentially offers valuable information to guide ongoing patient management decisions such as admitting service or level of care.

Medication use patterns and predictors of nonpersistence and nonadherence with oral 5-aminosalicylic acid therapy in patients with ulcerative colitis.

BACKGROUND: 5-aminosalicylic acid (5-ASA) is the recommended first-line treatment for active mild-to-moderate ulcerative colitis (UC) and for maintenance of UC remission. However, persistence and adherence to prescribed 5-ASAs are often suboptimal. OBJECTIVE: To evaluate 5-ASA medication use patterns and assess risk factors associated with nonpersistence and nonadherence to oral 5-ASA medications in UC patients. METHODS: IMS LifeLink Health Plan claims data (January 2007 to June 2011) were analyzed. We identified adult patients (18 years or older) with at least 1 diagnosis of UC (ICD-9-CM code = 556.x [ulcerative colitis]) and at least 1 pharmacy claim for an oral 5-ASA (balsalazide disodium, sulfasalazine, mesalamine delayed-release, and Multi-Matrix System mesalamine) during the study period. Patients were required to have continuous eligibility on both health and pharmacy plans for 6 months pre- and 12 months post-initial pharmacy claim (index date). Medication use patterns (discontinuation, time to discontinuation [days], switch, and nonadherence) in the 12 months following the index date were evaluated. Nonpersistence or discontinuation with the index medication was defined as a treatment gap ≥ 60 days. Switch was identified as patients changing to another 5-ASA product after discontinuing the index medication. Nonadherence to index medication was determined by medication possession ratio (MPR) less than 0.8 for the index medication. Nonadherence to any 5-ASA treatment was determined by a proportion of days covered (PDC) less than 0.8 for any 5-ASA. A Cox model was used to assess the relative hazards associated with discontinuation. Multiple logistic regression models were used to assess risk factors associated with nonadherence to either the index or any 5-ASA medications. RESULTS: A total of 5,664 patients met selection criteria. The median time to discontinuation of index drug differed significantly across index medications (range, 98.5 days [sulfasalazine] to 177.5 days [Multi-Matrix System mesalamine], P less than 0.0001). Patients on Multi-Matrix System mesalamine were less likely to discontinue (63.3% vs. ≥ 68.6%, P = 0.001) and more likely to adhere to their medication (MPR ≥ 0.8; 23.1% vs. ≤ 17.4%, P less than 0.0001) than patients on other medications. Patients on mesalamine delayed-release (13.8%) or Multi-Matrix System mesalamine (14.3%) had lower switch rates than the patients on balsalazide (17.2%) or sulfasalazine (17.8%), P = 0.01. Significant predictors of nonpersistence included index medication versus Multi-Matrix System mesalamine (balsalazide disodium: HR = 1.21, 95% CI = 1.07-1.36; mesalamine delayed-release: HR = 1.21, CI = 1.11-1.32; sulfasalazine: HR = 1.40, CI = 1.25-1.57), female gender (HR = 1.16, CI = 1.09-1.23), never receiving specialist care (HR = 1.14, CI = 1.07-1.21), preferred provider organization (PPO) versus health maintenance organization (HR = 1.14, CI = 1.04-1.24), and Medicare fee for service or self-insured health plan versus commercial plan (HR = 1.29, CI = 1.10-1.52). Significant variables associated with nonadherence with 5-ASA treatment (PDC less than 0.8) included not switching medication (OR = 1.90, CI = 1.58-2.29), age less than 65 (OR = 1.90, CI = 1.56-2.31), index medication as compared with Multi-Matrix System mesalamine (balsalazide disodium: OR = 1.43, CI = 1.10-1.85; mesalamine delayed-release: OR = 1.41, CI = 1.19-1.68; sulfasalazine: OR = 1.66, CI = 1.30, 2.12), female gender (OR = 1.33, CI = 1.17-1.52), residing in different regions as compared with the Midwest region (the South [OR = 1.40, CI = 1.20-1.64] and Northeast [OR = 1.29, CI = 1.05-1.58]), no use of rectal forms during the post-index period (OR = 1.28, CI = 1.08-1.50), no use of immunosuppressive/biologic agents during the post-index period (OR = 1.70, CI = 1.35-2.14), never receiving specialist care (OR = 1.25, CI = 1.08-1.44), and Medicaid/Medicare versus commercial plan (OR = 1.48, CI = 1.03-2.13). CONCLUSIONS: Patients on once-daily dosed Multi-Matrix System mesalamine had the lowest risk of discontinuation and the highest adherence rate. Multiple factors were associated with either nonpersistence or nonadherence, including multiple-daily dosed index medication, younger age, female gender, residing in the South region, PPO plan, noncommercial payer, not using immunosuppressive/biologic agents, not using rectal 5-ASA, and never receiving specialist care.

Cost-effectiveness of Prostate Health Index for prostate cancer detection.

OBJECTIVE: • To evaluate the cost-effectiveness of early prostate cancer detection with the Beckman Coulter Prostate Health Index (phi) (not currently available in the USA) adding to the serum prostate-specific antigen (PSA) test compared with the PSA test alone from the US societal perspective. PATIENTS AND METHODS: • Phi was developed as a combination of PSA, free PSA, and a PSA precursor form [-2]proPSA to calculate the probability of prostate cancer and was used as an aid in distinguishing prostate cancer from benign prostatic conditions for men with a borderline PSA test (e.g. PSA 2-10 ng/mL or 4-10 ng/mL) and non-suspicious digital rectal examination. • We constructed a Markov model with probabilistic sensitivity analysis to estimate expected costs and utilities of prostate cancer detection and consequent treatment for the annual prostate cancer screening in the male population aged 50-75 years old. • The transition probabilities, health state utilities and prostate cancer treatment costs were derived from the published literature. The diagnostic performance of phi was obtained from a multi-centre study. Diagnostic related costs were obtained from the 2009 Medicare Fee Schedule. • Cost-effectiveness was compared between the strategies of PSA test alone and PSA plus phi under two PSA thresholds (≥2 ng/mL and ≥4 ng/mL) to recommend a prostate biopsy. RESULTS: • Over 25 annual screening cycles, the strategy of PSA plus phi dominated the PSA-only strategy using both thresholds of PSA ≥2 ng/mL and PSA ≥4 ng/mL, and was estimated to save $1199 or $443, with an expected gain of 0.08 or 0.03 quality adjusted life years, respectively. • The probabilities of PSA plus phi being cost effective were approximately 77-70% or 78-71% at a range of $0-$200,000 willingness to pay using PSA thresholds ≥2 ng/mL and ≥4 ng/mL, respectively. CONCLUSION: • The strategy PSA plus phi may be an important strategy for prostate cancer detection at both thresholds of PSA ≥2 ng/mL and PSA ≥4 ng/mL to recommend a prostate biopsy compared with using PSA alone.

Nonadherence to clinical practice guidelines and medications for multiple chronic conditions in a California Medicaid population.

OBJECTIVES: To assess and profile quality of care in California Medicaid beneficiaries with chronic conditions. DESIGN: Retrospective cohort study. SETTING: California from 2002 to 2004. PATIENTS: 1,123,577 beneficiaries. INTERVENTION: Eligibility and claims data (2002-2004) were used to identify beneficiaries with dyslipidemia, hypertension, coronary artery disease (CAD), heart failure, or diabetes. MAIN OUTCOME MEASURES: Quality of care was based on nonadherence with clinical practice guidelines including recommended medications. Chi-square was used to evaluate nonadherence and patient characteristics. RESULTS: The proportion of patients without a prescription fill for recommended medications varied by disease (43% hypertension, 40% dyslipidemia and CAD, and 25% diabetes and heart failure). For Medicaid-only beneficiaries with diabetes, 78% lacked glycosylated hemoglobin tests, 62% lacked low-density lipoprotein cholesterol tests, and 50% lacked eye exams. Medication nonadherence was high (69% hypertension, 64% CAD, 57% heart failure, 48% dyslipidemia, 41% diabetes). Overall, younger age, Medicaid-only status, and black/other race were associated with poorer rates. CONCLUSION: Quality of care was suboptimal, with nonadherence varying by condition. Programs targeting both patients and providers and addressing patient-related characteristics (e.g., age, race) and policy reform addressing alterable factors (e.g., insurance eligibility) should be developed to improve guideline adherence.

Longitudinal changes in visual acuity and health-related quality of life: the Los Angeles Latino Eye study.

PURPOSE: To examine the association between longitudinal changes in visual acuity (VA) and health-related quality of life (HRQOL) in a population-based sample of adult Latinos. DESIGN: A population-based cohort study of eye disease in Latinos. PARTICIPANTS: We included 3169 adult Latino participants who live in the city of La Puente, California. METHODS: Data for these analyses were collected for the Los Angeles Latino Eye Study (LALES). Distance VA was measured during a detailed ophthalmologic examination using the standard Early Treatment Diabetic Retinopathy Study protocol at baseline and a 4-year follow-up examination. We assessed HRQOL by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the Medical Outcomes Study 12-Item Short-Form Health Survey version 1 (SF-12). MAIN OUTCOME MEASURES: Mean differences in HRQOL composite and subscale scores between baseline and follow-up were calculated for 3169 participants with complete clinical examination and HRQOL data at both time points. Mean differences and effect sizes (ES) for NEI-VFQ and SF-12 scores were calculated for 3 categories of VA change over the 4-year follow-up period (VA improved ≥ 2 lines, no change in VA or -2 < VA < 2, VA loss ≥ 2 lines). RESULTS: For participants with a 2-line loss in VA, we noted an approximate 5-point loss in the NEI-VFQ-25 composite score, with the greatest score changes found for the driving difficulties, vision-related mental health, and vision-related dependency subscales (-12.7, -11.5, and -11.3, respectively). For participants with a 2-line improvement in VA, we also noted an approximate 5-point gain in the NEI-VFQ-25 composite score. The greatest change (ES = 0.80) was observed for the driving difficulties subscale. No measurable differences in HRQOL were observed for individuals without change in VA from baseline to follow-up. CONCLUSIONS: Clinically important, longitudinal changes in VA (≥ 2-line changes) were associated with significant changes in self-reported visual function and well-being. Both the size and direction of VA change influenced change in HRQOL scores.

The increased cost of medical services for people diagnosed with primary open-angle glaucoma: a decision analytic approach.

PURPOSE: Glaucoma accounts for more than 11% of all cases of blindness in the United States, but there have been few studies of economic impact. We examine incremental cost of primary open-angle glaucoma considering both visual and nonvisual medical costs over a lifetime of glaucoma. DESIGN: A decision analytic approach taking the payor's perspective with microsimulation estimation. METHODS: We constructed a Markov model to replicate health events over the remaining lifetime of someone newly diagnosed with glaucoma. Costs of this group were compared with those estimated for a control group without glaucoma. The cost of management of glaucoma (including medications) before the onset of visual impairment was not considered. The model was populated with probability data estimated from Medicare claims data (1999 through 2005). Cost of nonocular medications and nursing home use was estimated from California Medicare claims, and all other costs were estimated from Medicare claims data. RESULTS: We found modest differences in the incidence of comorbid conditions and health service use between people with glaucoma and the control group. Over their expected lifetime, the cost of care for people with primary open-angle glaucoma was higher than that of people without primary open-angle glaucoma by $1688 or approximately $137 per year. CONCLUSIONS: Among Medicare beneficiaries, glaucoma diagnosis not found to be associated with significant risk of comorbidities before development of visual impairment. Further study is necessary to consider the impact of glaucoma on quality of life, as well as aspects of physical and visual function not captured in this claims-based analysis.

Integration of acupuncture into family medicine teaching clinics.

OBJECTIVES: As growing numbers of patients use complementary and alternative medicine (CAM), improvement is needed in communication between providers of CAM and allopathic medicine. This study describes collaborative acupuncture clinics (CACs) run by providers from Oregon Health and Science University (OHSU) and the Oregon College of Oriental Medicine (OCOM) in the setting of family medicine teaching clinics. It examines patient demographics, quality of education for medical learners, referral practices of primary care physicians (PCPs), and quality of communication between acupuncturists and PCPs at these clinics. DESIGN: Demographic data were abstracted from electronic medical records of patients treated at least three times in the CACs between 2006 and 2007. A survey on quality of education at the CACs was given to acupuncture interns, medical students, and acupuncture supervisors. A separate survey collected information from PCPs at the family medicine clinics regarding referral practices to acupuncture and quality of communication between PCPs and acupuncturists. RESULTS: Of the 96 patients seen at the clinics, 74% were female, 76% were European-American, and the mean age was 45.9 years. Sixty-one percent (61%) of patients were insured through private insurance, 31.3% had Medicare or Medicaid, and 7.3% did not have insurance. Most of the 51 acupuncture providers who responded were satisfied with the quality of education at the CACs. Eighty percent of responding PCPs had referred at least one patient to the CACs. The majority of referrals was for a pain condition. Most PCPs would find a summary of the acupuncture visit helpful. Referral practices to different modalities were most influenced by patient interest and physician's belief in whether or not the modality would help. CONCLUSIONS: Demographics of patients at the CACs were comparable to those of patients seen in other acupuncture clinics. The collaborative structure of the CACs allowed for a unique learning experience and improved communication between providers of CAM and conventional medicine.

Transition probabilities and predictors of adherence in a California Medicaid population using antihypertensive and lipid-lowering medications.

OBJECTIVES: To determine adherence rates, transition probabilities, and factors associated with transition from higher to lower adherence in antihypertensive (AH) and lipid-lowering (LL) medications. METHODS: California Medicaid data (1995-2003) were used to identify hypertensive patients with prescriptions for both AH and LL medications. Proportion of days covered (PDC) was used to define three adherence classifications: fully adherent (FA, PDC >or= 0.8), partially adherent (PA, 0.2

Noncompliance with vision care guidelines in Latinos with type 2 diabetes mellitus: the Los Angeles Latino Eye Study.

OBJECTIVE: To determine the prevalence of and personal factors associated with noncompliance with American Diabetes Association (ADA) guidelines for vision care in a population-based sample of adult Latinos with type 2 diabetes mellitus (T2DM). DESIGN: Population-based cross-sectional study. PARTICIPANTS: Eight hundred twenty-one Los Angeles Latino Eye Study (LALES) participants with a history of T2DM and a history of treatment for T2DM. METHODS: Detailed interviews, physical examinations, and dilated eye examinations were performed on all participants. Interviews assessed sociodemographic factors, history of diabetes and eye disease, and utilization of health and eye care services. All participants with a self-reported history and treatment of diabetes were asked about health and vision care utilization and diabetes self-care. MAIN OUTCOME MEASURE: Compliance with ADA guidelines for vision care. Noncompliance was defined as having had no dilated eye examination in the previous 12 months. Logistic regression analyses were used to identify personal factors associated with noncompliance. RESULTS: Of 821 individuals who self-reported having T2DM and being on treatment for T2DM, 535 (65%) had not complied with ADA vision guidelines for persons with T2DM. When compared with those with T2DM who complied with ADA guidelines, noncompliers were more likely to be less educated (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.1-2.2), to lack health insurance (OR, 2.5; 95% CI, 1.7-3.7), to have had no routine physical examination in the 12 months before the LALES examination (OR, 1.8; 95% CI, 1.3-2.5), and to have a glycosylated hemoglobin level > or = 9.0% (OR, 1.7; 95% CI, 1.1-2.6). CONCLUSIONS: Because timely and appropriate vision care can delay the onset of ocular morbidity, visual impairment, and blindness associated with diabetic retinopathy, our data suggest the need to evaluate intervention programs aimed at a targeted group of Latinos with T2DM--those who have less than a high school education, lack health insurance, have had no routine physical examination in the previous year, and have poorly controlled T2DM.

Mapping the SF-12 to the HUI3 and VAS in a managed care population.

BACKGROUND: Transforming generic health-related quality of life (HRQOL) instruments to a summary utility index is useful for deriving quality-adjusted life years (QALY) in any cost/QALY analysis. OBJECTIVE: The purpose of this study was to investigate the role of the SF-12 in predicting utility scores derived from Health Utility Index (HUI3) and Visual Analog Scale (VAS). METHOD: Data were obtained from a survey of 6923 managed care patients in the United States, aged 18 to 93 years, selected by strata of medication usage (at least 1 medication in target year, 5 or more medications, target medications, and both). The SF-12 was used to assess self-reported HRQOL. Utility was measured by the HUI3 and a VAS. The SF-12 items were used to predict HUI3 and VAS scores using ordinary least square regressions, with sociodemographic covariates. A second model entered each SF-12 item as categorized responses. A third model used the Physical Composite and Mental Composite scores to predict HUI3 and VAS scores. RESULTS: The SF-12 items and sociodemographic covariates accounted for 35% to 55% of the variations in HUI3 and VAS scores, respectively. Age and most SF-12 items were significantly (P < 0.0001) associated with both utility scores in all 3 models. CONCLUSIONS: This research provides support that an algorithm can be derived from the SF-12 to estimate utility scores based on the HUI3 and VAS for studies in populations where utility has not or cannot be measured directly.