Showing papers in "The American Journal of Managed Care in 2008"

Diabetes complications severity index and risk of mortality, hospitalization, and healthcare utilization.

Abstract: Among the 20 million Americans with diabetes, microvascular and macrovascular complications result in enormous morbidity, 1-4 disability,5 and mortality.6-8 Diabetes complications account for more than 35% of the estimated $91.8 billion in direct medical expenditures for this disease.9 Although much research has addressed individual complications, end-organ complications usually develop simultaneously or consecutively in a patient with diabetes rather than independently.10 Thus, an indicator that captures the severity or type of complications may be more powerful in predicting mortality and hospitalization than a simple count of complications. Few attempts have been made to quantify the overall severity of diabetes complications in a reproducible fashion for risk assessment, or for prediction of mortality or future treatment needs and costs.11 Risk equations have been developed to predict adverse cardiovascular outcomes12,13 and to identify high-risk patients to target for intervention.14 However, these risk models considered only cardiovascular disease risk factors and not the broader array of diabetes complications that can now be assessed in large populations enrolled in health plans with automated medical records. Because it is well established that diabetes contributes to increased morbidity and mortality in the general population,15-19 a logical next step is to use information relevant to the degree of progression of the disease to assess the level of risk for adverse outcomes, including hospitalization and mortality. Given that healthcare organizations have limited resources to invest in creating disease management interventions for high-risk patients with diabetes, it is important to develop models to predict which patients are at highest risk of adverse medical outcomes. In this study, we sought to develop a method of assessing the level of risk for diabetes adverse outcomes, including hospitalization and mortality, from automated medical record data on diabetes complications. To quantify the severity of complications and to potentially better predict the risk of adverse outcomes, we developed and employed the Diabetes Complications Severity Index (DCSI). The DCSI is a 13-point scale scored from automated diagnostic, pharmacy, and laboratory data. We compared the DCSI with a simple count of diabetes complications to assess whether a severity index of diabetes complications based on clinical diagnoses would improve the prediction of adverse diabetes outcomes.

Long-term cost effects of collaborative care for late-life depression.

Abstract: Objective To determine the long-term effects on total healthcare costs of the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) program for late-life depression compared with usual care.

Oral antidiabetic medication adherence and glycemic control in managed care

Abstract: Objective To evaluate adherence to oral diabetes medications (ODMs) in patients with type 2 diabetes and the impact of ODM adherence on glycemic control. Study design Retrospective observational study. Methods Medical and pharmacy claims from a managed care plan in Oregon were used to identify adults with diabetes who newly initiated ODM therapy (n = 2741); a subset of this cohort linked to electronic health records was used to evaluate the relationship between adherence and glycemic control (n = 249). Glycemic control was assessed based on most recent glycosylated hemoglobin (A1C) measurement within the study period. Results Mean cohort age was 54 years; 46% initiated therapy with metformin, 39% with a sulfonylurea, and 12% with a thiazolidinedione. Mean adherence overall was 81%, and 65% of subjects had good adherence (>80%). Increasing age and comorbidity burden were associated with higher medication adherence. In the patient subset with A1C measurements, mean baseline A1C was 8%. An inverse relationship existed between ODM adherence and A1C; controlling for baseline A1C and therapy regimen, each 10% increase in ODM adherence was associated with a 0.1% A1C decrease (P = .0004). Conclusion Although most patients were adherent to ODM therapy, adherent patients were more likely to achieve glycemic control than nonadherent patients. Greater efforts are needed to facilitate diabetes self-management behaviors to improve patient outcomes.

Parkinson's disease--Part 1: Pathophysiology, symptoms, burden, diagnosis, and assessment.

Abstract: Parkinson's disease (PD) is a chronic neurodegenerative disease associated with substantial morbidity, increased mortality, and high economic burden. Of importance to managed care is that the number of cases of PD are on the rise, paralleling the advancing age of the population, and misdiagnosis is common. Effective management of PD can minimize disability and potentially improve long-term outcomes, which would minimize long-term healthcare costs and medical resource utilization. This article provides a brief review of the epidemiology, pathophysiology, clinical course, and burden of PD.

Agreement between patient-reported symptoms and their documentation in the medical record

Abstract: Physical symptoms account for half of all outpatient visits in the US1 and are commonly not diagnosed2. The verbal characterization of the symptoms conveyed by the patient, and recorded by care providers is central to the practice of clinical medicine, and increasing importance is attached to patient-centered clinical care3. With the increasing adoption of the electronic medical record, free text of the clinical history can now be subjected to automated analysis in ways which are impossible or uneconomic with paper based records4-6. A common, costly7 example of a symptomatic condition in which history taking is central to management is chronic stable angina pectoris8, the number one cause of death in the entire Western World9. In addition to its mortality burden, angina is associated with serious morbidity such as myocardial infarction and heart failure. Optimal methods of identifying stable angina patients remain unclear; many patients with typical symptoms are not diagnosed as angina10 and age, sex, and ethnicity may influence physician’s recommendations for diagnostic testing such as coronary angiography and the resulting ICD codes11-14. Our preliminary findings indicate that Natural Language Processing (NLP) of the free text of the EMR identifies patients with chronic angina pectoris15 and heart failure15 that were missed by traditional diagnostic coding approaches. NLP is a range of computational techniques aimed at extracting useful information from unstructured text. In the context of the EMR, NLP offers a promising method to automate the collection of a richer set of information for quality improvement and safety that would otherwise require manual chart abstraction. Early identification of patients at risk for myocardial infarction is critical to its prevention and improved prognosis16-18 and is possible using patient-reportable information19. Since the diagnosis of angina pectoris relies on the presentation of the symptoms that is conveyed by the patient to the physician20, the ambiguous nature of verbal communication as well as the nature of coronary artery disease presenting itself differently in patients of different race and gender can make the diagnosis challenging. These challenges can lead to inconsistency and incompleteness in both the diagnosis and the information recorded in the EMR21. Currently, the nature of the processes that lead to the creation of the EMR is poorly understood; however, prior research indicates that these processes have critical implications for clinical care and may have a significant impact on patient outcomes. The primary objective of the current study is to determine if there is disagreement between patient-reported symptoms of chest pain, dyspnea and cough and the documentation of these symptoms by care providers in the EMR. While in this study we focus on heart disease, which constitutes one of the top national health care priority areas22, our findings have significant implications for any condition whose diagnosis and treatment relies on verbal presentation of symptoms.

A Study on the Economic Impact of Bariatric Surgery

Abstract: Objective To evaluate the private third-party payer return on investment for bariatric surgery the United States. Study design Morbidly obese patients aged 18 years or older were identified in an employer claims database of more than 5 million beneficiaries (1999-2005) using International Classification of Diseases, Ninth Revision, Clinical Modification code 278.01. Each of 3651 patients who underwent bariatric surgery during this period was matched to a control subject who was morbidly obese and never underwent bariatric surgery. Bariatric surgery patients and controls were matched based on patient demographics, selected comorbidities, and costs. Methods Total healthcare costs for bariatric surgery patients and their controls were recorded for 6 months before surgery through the end their continuous enrollment. To account for potential differences in patient characteristics, we calculated the cost differential by estimating a Tobit model. A return on investment was estimated from the resulting coefficients. Costs were inflation adjusted to 2005 US dollars using the Consumer Price Index for Medical Care, and the cost savings were discounted by 3.07%, the month Treasury bill rate during the same period. Results The mean bariatric surgery investment ranged from approximately $17,000 to $26,000. After controlling for observable patient characteristics, we estimated all costs to have been recouped within 2 years for laparoscopic surgery patients and within 4 years for open surgery patients. Conclusions Downstream savings associated with bariatric surgery are estimated to offset the initial costs in 2 to 4 years. Randomized or quasiexperimental studies would be useful to confirm this conclusion, as unobserved characteristics may influence the decision to undergo surgery and cannot be controlled for in this analysis.

Prevalence, burden, and pharmacoeconomics of dry eye disease.

Abstract: Data from a large US managed care database suggest that the prevalence of clinically diagnosed dry eye disease (DED) is 0.4% to 0.5% overall, and is highest among women and the elderly. The burden of DED to the patient can be substantial, impacting visual function, daily activities, social and physical functioning, workplace productivity, and quality of life (QOL). Preliminary analysis suggests that DED also has a considerable economic impact in terms of both direct and indirect costs. A number of therapies have been shown to improve DED signs and symptoms, but few clinical trials have addressed QOL and economic issues. Limited data suggest that topical cyclosporine has the potential to reduce physician visits and use of other medications, including artificial tears; however, further research is needed to clarify its impact on both the direct and indirect costs of DED.

The cost of treating skeletal-related events in patients with prostate cancer

Abstract: Objectives To examine the economic burden of skeletal-related events (SREs) and to assess the frequency of different types of SREs in this population. Study design Retrospective claims analysis. Methods Data were obtained from i3's Lab Rx Database from May 1, 2000, through March 31, 2005. Patients included had at least 2 claims with a diagnosis of prostate cancer, at least 2 subsequent claims with a diagnosis of bone metastasis, and at least 1 SRE on or after the date of the initial diagnosis of bone metastasis. Descriptive statistics for 342 patients who fit all inclusion and exclusion criteria are provided, along with Kaplan-Meier curves, which were used to estimate annual costs, adjusting for the censoring of the data. Results Patients most frequently had radiation therapy (89%), followed by pathologic fracture (23%) and bone surgery (12%). Among patients diagnosed as having at least 1 SRE, 78% experienced 1 type of SRE, 17% had 2 types of SREs, and 5% had 3 or more distinct types of SREs. The mean costs associated with SREs in the year after the initial diagnosis of an SRE, adjusted for the censoring of the data, was $12,469, with the highest costs associated with radiation therapy ($5930), followed by pathologic fracture ($3179) and bone surgery ($2218). Conclusion This study of patients with prostate cancer and bone metastases revealed that the annual economic effect of medically treating SREs for these patients was $12,469.

Benchmarking Physician Performance: Reliability of Individual and Composite Measures

Abstract: Measuring physician performance is becoming commonplace as health plans and purchasers look for ways to drive quality improvement and to increase physicians' accountability and rewards for achieving quality goals. A recent study1 reported that, among 89% of health maintenance organization plans using physician-oriented pay-for-performance programs, more than one-third measured and rewarded quality at the individual physician level. In addition, public and private purchasers are demanding more information about America's physicians and hospitals to aid in value-based purchasing and selection of health plans and providers.2 However, concerns remain regarding the validity and reliability of such physician performance profiles. Several factors are needed to support fair and accurate comparisons among physicians. These include evidence-based quality measures, complete and accurate data sources, and standardized methods of data collection. Physician-level reliability of a quality measure is another key consideration in this measurement. Physician-level reliability refers to the ability of a quality measure to distinguish an individual physician's performance from the performance of physicians overall. Good physician-level reliability requires the following 2 factors: (1) a sufficient number of patients eligible for a given quality measure and (2) performance variation across physicians on that quality measure.3-5 The greater the number of a physician's patients who are eligible for a quality measure, the more precise the estimate of the physician's performance. When performance variation for a given quality measure across physicians is limited, the likelihood that a physician's performance is statistically significantly different from that of his or her peers is also decreased. Hofer and colleagues6 showed that not controlling for a quality measure's physician-level reliability significantly misrepresented performance differences across physicians. However, adjusting performance profiles in such a manner is not commonplace across the healthcare industry. Ensuring that measurement results are valid and reliable is important when purchasers and plans (and potentially consumers) use the data to make decisions about which physicians get financial rewards or other benefits. The stakes are particularly high when profiling results are used for public reporting or eligibility for participation in a health plan network. Paying attention to the validity and reliability of data will help to ensure that these decisions are based on real differences in performance among physicians rather than any shortcomings of the measurement. Although performance results based on limited sample sizes could be adjusted for the reliability of individual measures,7-9 the creation of composite scores may also be a useful way to increase the reliability of physicians' performance scores.10 Little is known about the extent to which constructing composite scores mitigates the limitations of sample size and reliability, while continuing to provide useful and understandable information.11 To date, there have been few reports regarding the reliability of physician-level performance scores associated with commonly used practices and methods in the healthcare industry. To begin to address this deficiency, this study relied on a large data set that combined patient-level administrative data from 9 large health plans to compute performance for primary care physicians (PCPs) using 27 commonly measured quality indicators. This data set is typical of data sources often used by individual health plans to profile physician performance. Specifically, we examined for each quality measure and composite score the proportion of PCPs who could be evaluated given different minimum sample size criteria and the physician-level reliability under those minimum sample size criteria. Our primary research questions were the following: (1) What is the physician-level reliability of commonly used performance measures calculated exclusively based on administrative data? (2) Can more physicians be reliably evaluated using a composite score?

Dry eye disease: pathophysiology, classification, and diagnosis.

Abstract: Dry eye disease (DED) is a multifactorial disorder of the tear film and ocular surface that results in eye discomfort, visual disturbance, and often ocular surface damage. Although recent research has made progress in elucidating DED pathophysiology, currently there are no uniform diagnostic criteria. This article discusses the normal anatomy and physiology of the lacrimal functional unit and the tear film; the pathophysiology of DED; DED etiology, classification, and risk factors; and DED diagnosis, including symptom assessment and the roles of selected diagnostic tests.

Management of dry eye disease.

Abstract: The management of dry eye disease (DED) encompasses both pharmacologic and nonpharmacologic approaches, including avoidance of exacerbating factors, eyelid hygiene, tear supplementation, tear retention, tear stimulation, and anti-inflammatory agents. Artificial tears are the mainstay of DED therapy but, although they improve symptoms and objective findings, there is no evidence that they can resolve the underlying inflammation in DED. Topical corticosteroids are effective anti-inflammatory agents, but are not recommended for long-term use because of their adverse-effect profiles. Topical cyclosporine--currently the only pharmacologic treatment approved by the US Food and Drug Administration specifically for DED--is safe for long-term use and is disease-modifying rather than merely palliative. Treatment selection is guided primarily by DED severity. Recently published guidelines propose a severity classification based on clinical signs and symptoms, with treatment recommendations according to severity level.

Current management of glaucoma and the need for complete therapy.

Abstract: Glaucoma is a long-term ocular neuropathy defined by optic disc or retinal nerve fiber structural abnormalities and visual field abnormality. Primary open-angle glaucoma is the most common type of glaucoma. Currently available treatments, initiated in a stepwise process, focus on intraocular pressure (IOP) reduction, and initially include topical drug therapy (single then multidrug combinations), followed by laser then surgical treatment. Topical prostaglandin analogues or beta-adrenergic receptor blockers are first used, followed by alpha-agonists or topical carbonic anhydrase inhibitors, and infrequently, cholinergic agonists and oral therapy. Limitations to existing topical IOP-reducing medications include continued disease progression in glaucoma patients with normal IOP, treatment failure, and low rates of compliance and persistence. Therapeutic agents under investigation include neuroprotectants, which target the disease process manifested by death of retinal ganglion cells, axonal loss, and irreversible loss of vision. Neuroprotectants may be used alone or in combination with IOPreducing therapy (a treatment strategy called complete therapy). Memantine, an N-methyl-D-aspartate receptor blocker currently approved for dementia, is the neuroprotectant farthest along in the process seeking regulatory approval for glaucoma treatment and has a favorable safety profile because of its selective mechanism of action. Several other neuroprotectants are in early stage investigation. Complete therapy provides hope for improved outcomes by reducing the significant morbidity and economic consequences that occur as a result of neurodegeneration and disease progression.

Therapies for treatment of osteoporosis in US women: cost-effectiveness and budget impact considerations.

Abstract: OBJECTIVE To evaluate the cost-effectiveness of osteoporosis treatments for women at high fracture risk and estimate the population-level impact of providing bisphosphonate therapy to all eligible high-risk US women. STUDY DESIGN Fractures, healthcare costs, and quality-adjusted life-years (QALYs) were estimated over 10 years using a Markov model. METHODS No therapy, risedronate, alendronate, ibandronate, and teriperatide (PTH) were compared among 4 risk groups. Sensitivity analyses examined the robustness of model results for 65-year-old women with low bone density and previous vertebral fracture. RESULTS Women treated with a bisphosphonate experienced fewer fractures and more QALYs compared with no therapy or PTH. Total costs were lowest for the untreated cohort, followed by risedronate, alendronate, ibandronate, and PTH in all risk groups except women aged 75 years with previous fracture. The incremental cost-effectiveness of risedronate compared with no therapy ranged from cost saving for the base case to $66,722 per QALY for women aged 65 years with no previous fracture. Ibandronate and PTH were dominated in all risk groups. (A dominated treatment has a higher cost and poorer outcome.) Treating all eligible women with a bisphosphonate would cost an estimated additional $5563 million (21% total increase) and would result in 390,049 fewer fractures (35% decrease). In the highest risk group, the additional cost of therapy was offset by other healthcare cost savings. CONCLUSIONS Osteoporosis treatment of high-risk women is cost-effective, with bisphosphonates providing the most benefit at lowest cost. For highest risk women, costs are offset by savings from fracture prevention.

Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis.

Abstract: Objective To perform a meta-analysis of randomized controlled trials (RCTs) and systematic reviews evaluating the efficacy of self-monitoring of blood glucose (SMBG) levels among patients with diabetes mellitus (DM). Study design Meta-analysis of RCTs among patients with DM not taking insulin comparing patients with SMBG versus those without SMBG and reporting results as change in glycosylated hemoglobin (A1C) values. Methods Prior systematic reviews and a PubMed search were used to identify studies. Data were extracted by trained physician reviewers working in duplicate. Trials were classified according to duration of the intervention, and random-effects meta-analysis was used to pool results. Results Three trials of SMBG of 3 months' duration were too heterogeneous to pool. Nine other trials were identified. Five trials of SMBG of 6 months' duration yielded a pooled effect estimate of a decrease in mean A1C values of -0.21% (95% confidence interval [CI], -0.38% to -0.04%). Four trials that reported outcomes of 1 year or longer yielded a pooled effect estimate of a decrease in mean A1C values of -0.16% (95% CI, -0.38% to 0.05%). Three trials reported hypoglycemic outcomes, which were increased in the patients using SMBG, although this mostly involved asymptomatic or mild episodes. Conclusions At most, SMBG produces a statistically significant but clinically modest effect in controlling blood glucose levels in patients with DM not taking insulin. It is of questionable value in helping meet target values of glucose control.

Medicare Part D's effects on elderly patients' drug costs and utilization.

Abstract: OBJECTIVE To analyze Medicare Part D's net effect on elderly patients' use of and out-of-pocket (OOP) costs for prescription drugs and to compare these with standardized results from prior studies. STUDY DESIGN Our dataset contains 1.4 billion prescriptions from Wolters Kluwer Health from December 2004 through December 2007 for patients whose age as of 2007 was more than 57 years. METHODS Days' supply per capita, OOP cost per day's supply, and number of individuals filling prescriptions were compared before and after January 2006 for those over age 66 years versus those age 58-64 years. Adjustment was made for under-reporting of pure cash prescriptions in the data. RESULTS Elderly patients' utilization in the first year of Part D increased compared with that of near-elderly patients by 8.1% for days' supply and 4.8% for the number of individuals filling prescriptions, and their OOP costs declined by 17.2%. Although elderly patients' OOP costs in the second year were reduced an additional 5.8%, days' supply increased by only an additional 1.0%. Correcting for the under-reporting of pure cash prescriptions yielded effects of 8.1% and -3.5% for days' supply and -15.6% and -7.2% for OOP costs in 2006 and 2007, respectively. A standardized comparison with previous estimates from Walgreens data showed that our utilization estimates were 2.6 times larger. CONCLUSION Part D lowered elderly patients' OOP costs and increased utilization, primarily during the first year of the program. Magnitudes vary substantially across studies because of differences in data and methods.

What does the RAND Health Insurance Experiment tell us about the impact of patient cost sharing on health outcomes

Abstract: A s healthcare spending has risen, patients have been required to pay more when they seek care. This trend is exemplified by increases in deductibles, copayments, and coinsurance rates, as well as by increased enrollment in high-deductible health plans such as health reimbursement arrangements or health savings accounts. It is widely accepted, based on considerable evidence accumulated over decades of study, that higher cost sharing will lead to reduced healthcare expenditures. The gold standard of evidence supporting this conclusion is the RAND Health Insurance Experiment (HIE), which was a randomized trial of higher cost sharing conducted in the 1970s. Estimates from the HIE suggest that when patients were required to pay for 95% of their care (up to an out-of-pocket maximum that was based on their income) they reduced spending by about 30%.1 Less dramatic levels of cost sharing suggested that a 10% increase in cost sharing would result in about a 2% reduction in spending. Numerous resulting academic publications and research reports based on the HIE have examined the impact of cost sharing on a wide range of spending categories and subpopulations.2 The impact of cost sharing on health status has been much more controversial. The HIE found that, on average, there were minimal or no adverse health consequences associated with higher cost sharing. The estimates were not only statistically insignificant, but the associated confidence intervals indicated that any true effect was clinically small. Yet both the HIE and considerable current work report that greater cost sharing is associated with reductions in use of clinically important services. For example, recent research has documented that relatively modest increases in cost sharing reduce utilization of important medications for managing chronic disease.3-9 Goldman and colleagues reported that a doubling of copayments reduced use of antidiabetes medications by patients with diabetes by 23% and reduced use of antihypertension medications by patients with hypertension by 10%.5 Huskamp and colleagues reported that when an employer increased cost-sharing requirements by about $10 to $20 per prescription (depending on the exact medication), 21% of patients stopped taking their medication for high cholesterol (compared with 11% in a control group).6 Hsu et al reported that higher cost sharing for prescription drugs resulted in worse physiologic outcomes (eg, blood pressure), more visits to the emergency department, and even greater mortality.10 Similarly, Chandra et al reported that high cost sharing can lead to worse compliance with important healthcare services and, in turn, result in more hospital admissions and other poor health outcomes.11 Reducing copayment rates seems to have the opposite effect. Evidence suggests that reduction in copayments of about $10 per prescription increased patient adherence to treatment regimens for chronic disease.12 Recent reviews of the literature confirmed these conclusions.4,13 Similarly, recent research suggests that higher cost sharing will reduce use of preventive or screening services that are typically used to measure quality. For example, Trivedi et al documented reduced use of mammography after increases in copayment rates.14 How can these results be reconciled with the overall findings of the HIE? The reconciliation begins with a return to the results of the HIE. The RAND HIE was consistent with other research in that it found that patients reduced utilization of services deemed clinically appropriate by the same amount as they reduced the us of services deemed clinically inappropriate.15 The lack of a relationship between cost sharing and health outcomes in the HIE was not due to patients choosing only to forego services with limited clinical value. Instead RAND researchers interpreted the failure to find an effect of cost sharing on health status as reflecting a beneficial reduction in use of harmful medical services that offset the negative consequences associated with a reduced use of beneficial services. Specifically, some of the services foregone because of higher cost sharing might have led to worse health outcomes, suggesting a benefit from charging patients What Does the RAND Health Insurance Experiment Tell Us About the Impact of Patient Cost Sharing on Health Outcomes?

Impact of bipolar disorder in employed populations.

Abstract: Objective To review literature on the impact of bipolar disorder on the workplace, with respect to costs to employers, workplace productivity and functioning, and any employer-initiated programs implemented with the aim of improving work attendance and performance. Study design Systematic literature review. Methods Original studies relating to bipolar disorder in the workplace were identified from PubMed and EMBASE using a reproducible, systematic search strategy in July 2007. There were no constraints on publication dates. Results were first evaluated by title and/or abstract. Full manuscripts of potentially relevant papers then were obtained and assessed for inclusion. Productivity data were extracted in terms of absenteeism, short-term disability, presenteeism, and any associated cost burden to US employers. Results Seventeen studies met search criteria and were included in this review. The data indicate that bipolar disorder imposes a significant financial burden on employers, costing more than twice as much as depression per affected employee. A large proportion of the total cost of bipolar disorder is attributable to indirect costs from lost productivity, arising from absenteeism and presenteeism. The presence of comorbid conditions and stigma in the workplace may lead to delays in accurate diagnosis and effective management of bipolar disorder. Conclusion Bipolar disorder among the working population can have a significant, negative effect on work relationships, attendance, and functioning, which can lead to substantial costs to US employers arising from lost productivity. There is a need for workplace initiatives to address the health and cost consequences of bipolar disorder within an employed population.

History of Neuroprotection and Rationale as a Therapy for Glaucoma

Abstract: Neuroprotection is any therapy that prevents, retards, or reverses apoptosis-associated neuronal cell death resulting from primary neuronal lesions. Although more than 500 products have been investigated for neuroprotective effects, there has been a low rate of success in human trials. Reasons include failure of the animal model to simulate human disease, human disease variability, brain size and development differences, variations in the ratio of axonal to neuronal damage, and lack of efficacy of the compound under study. Other reasons include narrow drug therapeutic index, drug molecular size, the small treatment window after cellular injury, multiple comorbidities of test subjects causing recruitment and statistical challenges, and insufficiently valid and reliable end points. Glaucoma is a neurodegenerative disease for which the neuropathic pathology has been studied since 1972. There have been recent significant advances in understanding the mechanisms for death of retinal neurons, and numerous agents are under development. Memantine, currently approved for Alzheimer's disease and in phase 3 trials for glaucoma progression, is one of the most studied neuroprotectants in glaucoma. Therapies that prevent death of the retinal ganglion cell (neuroprotection), its axon (axoprotection), or both, theoretically should be useful in treating glaucoma.

Cost-effectiveness of telephonic disease management in heart failure.

Abstract: Objective To evaluate the cost-effectiveness of a telephonic disease management (DM) intervention in heart failure (HF). Study design Randomized controlled trial of telephonic DM among 1069 community-dwelling patients with systolic HF (SHF) and diastolic HF performed between 1999 and 2003. The enrollment period was 18 months per subject. Methods Bootstrap-resampled incremental cost-effectiveness ratios (ICERs) were computed and compared across groups. Direct medical costs were obtained from a medical record review that collected records from 92% of patients; 66% of records requested were obtained. Results Disease management produced statistically significant survival advantages among all patients (17.4 days, P = .04), among patients with New York Heart Association (NYHA) class III/IV symptoms (47.7 days, P = .02), and among patients with SHF (24.2 days, P = .01). Analyses of direct medical and intervention costs showed no cost savings associated with the intervention. For all patients and considering all-cause medical care, the ICER was $146 870 per quality-adjusted life-year (QALY) gained, while for patients with NYHA class III/IV symptoms and patients with SHF, the ICERs were $67 784 and $95 721 per QALY gained, respectively. Costs per QALY gained were $101 120 for all patients, $72 501 for patients with SHF, and $41 348 for patients with NYHA class III/IV symptoms. Conclusions The intervention was effective but costly to implement and did not reduce utilization. It may not be cost-effective in other broadly representative samples of patients. However, with program cost reductions and proper targeting, this program may produce life-span increases at costs that are less than $100 000 per QALY gained.

Adherence With Statins Over 8 Years in a Usual Care Setting

Abstract: OBJECTIVE To describe adherence with statin treatment in a usual practice setting and to investigate potential determinants of better adherence. STUDY DESIGN Retrospective cohort study using administrative claims data. METHODS Study patients were 47,680 individuals enrolled in the Central District of Clalit Health Services HMO in Israel who filled at least 1 prescription for statins between January 1, 1999, and December 31, 2006. Data were retrieved on patients' sex, year of birth and immigration, socioeconomic status, and whether they had diabetes mellitus, hypertension, and other cardiovascular diseases. RESULTS Mean age at the beginning of treatment was 61.3 +/- 11.8 years; 53.3% of the study patients were women. The proportion with at least 1 chronic disease before starting statins was 40.1%; and 38.9%, 21.8%, and 9.6% of the patients were continuously adherent after 1, 3, and 6 years, respectively. Risk of discontinuation was highest among new immigrants (hazard ratio [HR] = 1.20; 95% confidence interval [CI] = 1.14, 1.27). Adherence was higher in patients having a chronic disease before starting statins (HR = 0.88; 95% CI = 0.84, 0.94) or after starting statins (HR = 0.90; 95% CI = 0.86, 0.95). Patients age 79 years had lower adherence rates. Low socioeconomic state did not affect adherence. CONCLUSIONS Adherence with statin therapy was poor, though adherence rates were better in patients with accompanying chronic diseases. Of particular concern was the low level of adherence in new immigrants. Intervention programs are needed and should target all patient groups.

Do diabetes group visits lead to lower medical care charges

Abstract: OBJECTIVE To evaluate whether attending diabetes group visits (GVs) leads to lower medical care charges for inadequately insured patients with type 2 diabetes mellitus (DM). STUDY DESIGN Randomized controlled clinical trial. METHODS Data were abstracted from financial records for 186 patients with uncontrolled type 2 DM randomized to receive care in GVs or usual care for 12 months. Mann-Whitney tests for differences of means for outpatient visits (primary and specialty care), emergency department (ED) visits, and inpatient stays were performed. Separate charge models were developed for primary and specialty outpatient visits. Because GV adherence is potentially dependent on unobserved patient characteristics, treatment effect models of outpatient charges and specialty care visits were estimated using maximum likelihood methods. RESULTS Mann-Whitney test results indicated that GV patients had reduced ED and total charges but more outpatient charges than usual care patients. Ordinary least squares estimations confirmed that GVs increased outpatient visit charges; however, controlling for endogeneity by estimating a treatment effect model of outpatient visit charges showed that GVs statistically significantly reduced outpatient charges (P <.001). Estimation of a separate treatment effect model of specialty care visits confirmed that GV effects on outpatient visit charges occurred via a reduction in specialty care visits. CONCLUSIONS After controlling for endogeneity via estimation of a treatment effect model, GVs statistically significantly reduced outpatient visit charges. Estimation of a separate treatment effect model of specialty care visits indicated that GVs likely substitute for more expensive specialty care visits.

Parkinson's disease--Part 3: Neuropsychiatric symptoms.

Abstract: The nonmotor neuropsychiatric symptoms of Parkinson's disease, particularly depression, psychosis, and cognitive impairment/dementia, are major contributors to disability and a decline in quality of life. Their effect on patients may be more disabling than motor symptoms. Increasing awareness of the importance of recognizing and treating neuropsychiatric symptoms of this disease in the medical community is a focus of specialists and organizations. This article looks at useful screening measures to help clinicians recognize neuropsychiatric symptoms and offers suggestions for their effective treatment.

Practice systems are associated with high-quality care for diabetes.

Abstract: OBJECTIVE To determine whether a questionnaire that assesses the presence of practice systems is associated with clinical performance rates for diabetes care. STUDY DESIGN Cross-sectional study of the relation between a survey-based measure of practice systems within 5 of the domains of the chronic care model (CCM) and high-quality care for diabetes during 2005 among 40 medical groups in Minnesota. METHODS Correlations were calculated between (1) practice systems as measured by the Physician Practice Connections-Readiness Survey (PPC-RS) questionnaire and (2) process and outcome measures of diabetes quality from a standardized system managed by Minnesota Community Measurement. RESULTS Most process and outcome measures were correlated at 0.31 to 0.52 (P <.05) with the PPC-RS total score as well as with several of the CCM domains. Only yearly eye exams and blood pressure control lacked correlation with any CCM domain, but delivery system redesign and self-management support lacked correlation with quality measures. CONCLUSIONS As measured by the PPC-RS questionnaire, the presence of practice systems overall and within several domains of the CCM was associated with high-quality care for diabetes. The PPC-RS may be a useful and relatively simple tool for evaluating and guiding improvement of practice systems for diabetes care quality.

Second-line and Third-line Chemotherapy for Lung Cancer: Use and Cost

Abstract: Objectives To identify commonly prescribed first-, second-, and third-line chemotherapy regimens for persons with lung cancer and to evaluate the utilization patterns and costs of care associated with receiving these regimens. Study design Retrospective data analysis. Methods Using health insurance claims from January 1, 2002, through December 31, 2006, patients with lung cancer were identified by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. An algorithm was developed to identify first-, second-, and third-line chemotherapy. Patients were stratified by the number of discrete regimens received or by their specific chemotherapy agent or combination of agents. Data were analyzed for up to 2 years from the date of the initial first-line regimen and for 1 year from the second and third lines. Patient costs were based on total reimbursements for each group during the observation period. Results Of patients receiving first-line chemotherapy, 25% and 10% received second-line and third-line chemotherapy, respectively. Docetaxel, gefitinib, and erlotinib hydrochloride were the most commonly prescribed second-line regimens; gefitinib and docetaxel were the most commonly prescribed third-line regimens. The most commonly prescribed second- and third-line agents changed substantially over time. Total costs and costs per patient per month increased as the number of lines of chemotherapy prescribed increased. Conclusions Second- and third-line chemotherapy is prescribed infrequently, and patterns of prescribing are changing over time. Direct medical care costs increase substantially with additional lines of therapy.

Self-monitoring of blood glucose in type 2 diabetes: cost-effectiveness in the united states.

Abstract: Objective This study was designed to model the cost-effectiveness of self-monitoring of blood glucose (SMBG) at frequencies of 1 or 3 times per day for patients with type 2 diabetes mellitus (T2DM) who are treated with oral antidiabetic (OAD) medications within the United States. Study design Based on a Kaiser Permanente study showing glycosylated hemoglobin (HbA1C) improvements related to SMBG frequency, a validated model was used to project 40-year clinical and economic outcomes for SMBG at 1 or 3 times per day vs no SMBG. Methods Baseline mean HbA1C (8.6%), age, and sex of the simulated cohort came from the Kaiser analysis of new SMBG users of OAD agents for T2DM. Other cohort characteristics, transition probabilities, utilities, and direct costs (from a US public payer perspective) were derived from relevant literature. Outcomes were discounted at 3% per annum, with sensitivity analyses performed on discount rates and time horizons. Results Compared with no SMBG, quality-adjusted life expectancy increased with SMBG frequency. Increases were 0.103 and 0.327 quality-adjusted life-years (QALYs) for SMBG at 1 and 3 times per day, respectively. Corresponding incremental cost-effective ratios (ICERs) were $7856 and $6601 per QALY gained. Results indicate that SMBG at both 1 and 3 times per day in this cohort of patients with T2DM taking OADs would represent good value for money in the United States, with ICERs being most sensitive to the time horizon. Conclusions Longer time horizons generally led to greater SMBG cost-effectiveness. The ICER for SMBG 3 times per day was $518 per QALY over a 10-year time horizon, indicating very good value.

Stroke and TIA: epidemiology, risk factors, and the need for early intervention.

Abstract: The risk of recurrent stroke in patients who have suffered a prior stroke or transient ischemic attack (TIA) is significant. It is imperative that individuals who report symptoms of a cerebrovascular event receive immediate medical attention--preferably at a hospital--to help determine its origin and impact. Many researchers recommend that any evaluation include neuroimaging studies to target those patients who would benefit most from secondary prevention, such as antithrombotic therapy. This article defines the 2 main types of stroke and their respective subtypes and discusses the debate over how to define stroke versus TIA. Additionally, the article talks about the incidence of stroke, related morbidity and mortality rates, and several risk factors that predispose an individual to stroke and recurrent stroke. Several systems have been established to help determine the likelihood of stroke for patients with concurrent risk factors. Measures for secondary prevention can be initiated to address many of these risk factors. The importance of early intervention cannot be underestimated. Rapid treatment following a stroke or TIA can minimize cerebrovascular damage and prevent recurrence; addressing modifiable risk factors can reduce the risk of subsequent cardiovascular and cerebrovascular events. Facilitating the initiation of effective secondary preventive therapy must become a priority in managed care.

Comprehension and choice of a consumer-directed health plan: an experimental study.

Abstract: OBJECTIVES To examine the extent to which numeracy predicts consumer-directed health plan (CDHP) comprehension and health plan choice. Also, to test whether comprehension can be improved using different presentation approaches. STUDY DESIGN We conducted an experimental laboratory study in which 303 adults viewed information about a hypothetical CDHP and a hypothetical preferred provider organization (PPO) presented in several different ways. Participants were randomized to view plan comparisons in a side-by-side or a common/unique format, and whether or not to view a framework. METHODS Participants completed a survey that included comprehension items, numeracy and literacy assessments, and sociodemographics. Multivariate regression models were developed to examine the independent effects of numeracy and presentation approach on CDHP comprehension and choice. Interactions between numeracy and presentation approaches were tested. RESULTS Although less numerate consumers understood less about CDHPs, they were substantially more likely to select the CDHP. Providing an overarching framework to highlight the differences between the CDHP and PPO boosted comprehension on items related to the framework message. However, it reduced comprehension on items that were not related to the framework, particularly among the less numerate. Participants reported that the common/unique presentation of comparative information was easier to understand, yet there was a trend toward less comprehension using that presentation approach. CONCLUSIONS This study highlights the difficulty many consumers have in understanding comparative plan information and in making informed healthcare choices. Findings also indicate that some presentation strategies may help the less skilled understand choices better.

Care Coordination to Increase Referrals to Smoking Cessation Telephone Counseling: A Demonstration Project

Abstract: Objective To test the effectiveness of a care coordination program for telephone counseling in raising referral and treatment rates for smoking cessation. Study design A demonstration project implementing a smoking cessation care coordination program offering telephone counseling and medication management to patients referred from primary care. Methods The study was performed at 18 Veterans Health Administration (VA) sites in California. Participants were VA patients receiving primary care. We randomly allocated 10 of 18 sites to receive the Telephone Care Coordination Program, which included simple 2-click referral, proactive care coordination, medication management, and 5 follow-up telephone calls. Each patient received a 30- to 45-minute counseling session from the California Smokers' Helpline. Patients at control sites received usual care. Results During 10 months, we received 2965 referrals. We were unable to reach 1156 patients (39%), despite at least 3 attempts. We excluded 73 patients (3%), and 391 patients (13%) were not interested. We connected the remaining 1345 patients (45%) to the Helpline. At 6-month followup, 335 patients (11% of all referrals and 25% of participating patients) were abstinent. Providers at intervention sites reported referring many more patients to telephone counseling than providers at control sites (15.6 vs 0.7 in the prior month). Conclusions The program generated a large number of referrals; almost half of the patients referred were connected with the Helpline. Long-term abstinence was excellent. These results suggest that managed care organizations may be able to improve tobacco control by implementing a similar system of care coordination.

A health economic model of breakthrough pain.

Abstract: Although the literature adequately addresses the biologic basis, epidemiology, and management of breakthrough pain (BTP), it does not yet describe the full impact of this troubling, widespread phenomenon. The risks of a scanty understanding of BTP impact are failure to take preventive measures, underdiagnosis, undertreatment, and inappropriate management. Studies to date of the impact of BTP have followed pharmacoeconomic approaches. Building on prior efforts, this paper develops a more comprehensive health economic model that encompasses the full spectrum of costs, outcomes, risks and benefits associated with BTP and its management. The authors provide a rubric within which stakeholders--including providers, institutional leaders, administrators, and policymakers--can systematically balance the myriad potential effects of different treatment scenarios to guide decision-making. The paper then extends this model to the population level, providing a template for health economic analysis of alternate strategies for managing BTP, and delineating steps for accomplishing the analysis.

Adherence to Inhaled Corticosteroid Use and Local Adverse Events in Persistent Asthma

Abstract: Objectives: To measure adherence to inhaled corticosteroid (ICS) therapy using prescription claims and a patient survey, to identify local adverse events (LAEs) from the patient perspective and from medical records, and to evaluate the association between LAEs and adherence to ICS therapy. Study Design: Survey administration and claims-based and medical record-abstracted data. Methods: Patients aged 6 to 64 years with persistent asthma (defined using an established algorithm) and at least 2 ICS prescriptions were selected from a claims database (1999-2006) of a central Massachusetts medical group practice. Prescription claims were used to calculate the ICS medication possession ratio (MPR). A survey obtained information about patient-reported adherence to ICSs using the Morisky scale and a visual analog scale (VASE and about LAEs using the validated Inhaled Corticosteroid Questionnaire. Medical records of survey respondents were abstracted for LAEs. Results: Among 372 survey respondents, 2.7% met the claims-based measure of good adherence (MPR, >= 80%). Patient-reported adherence was much higher; 20.7% of patients were highly adherent based on the Morisky scale (score, 0) and 55.4% based on the VAS (score, 80%). Medical record review identified 27.2% of patients having at least 1 LAE within 1 year after the ICS index date, but 47.3% of patients reported being bothered at least "quite a lot" by LAEs. Multivariate analysis indicated that unpleasant taste was significantly related to lower adherence based on the Morisky scale (P = .02). Conclusions: Patient-reported adherence and LAEs were higher than those measured from claims or medical records. Unpleasant taste seems to be associated with lower adherence based on the Morisky scale.