Cost-effectiveness of CT screening in the National Lung Screening Trial.

BACKGROUND: The National Lung Screening Trial (NLST) showed that screening with low-dose computed tomography (CT) as compared with chest radiography reduced lung-cancer mortality. We examined the cost-effectiveness of screening with low-dose CT in the NLST. METHODS: We estimated mean life-years, quality-adjusted life-years (QALYs), costs per person, and incremental cost-effectiveness ratios (ICERs) for three alternative strategies: screening with low-dose CT, screening with radiography, and no screening. Estimations of life-years were based on the number of observed deaths that occurred during the trial and the projected survival of persons who were alive at the end of the trial. Quality adjustments were derived from a subgroup of participants who were selected to complete quality-of-life surveys. Costs were based on utilization rates and Medicare reimbursements. We also performed analyses of subgroups defined according to age, sex, smoking history, and risk of lung cancer and performed sensitivity analyses based on several assumptions. RESULTS: As compared with no screening, screening with low-dose CT cost an additional $1,631 per person (95% confidence interval [CI], 1,557 to 1,709) and provided an additional 0.0316 life-years per person (95% CI, 0.0154 to 0.0478) and 0.0201 QALYs per person (95% CI, 0.0088 to 0.0314). The corresponding ICERs were $52,000 per life-year gained (95% CI, 34,000 to 106,000) and $81,000 per QALY gained (95% CI, 52,000 to 186,000). However, the ICERs varied widely in subgroup and sensitivity analyses. CONCLUSIONS: We estimated that screening for lung cancer with low-dose CT would cost $81,000 per QALY gained, but we also determined that modest changes in our assumptions would greatly alter this figure. The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).

Waste in the U.S. Health care system: a conceptual framework.

CONTEXT: Health care costs in the United States are much higher than those in industrial countries with similar or better health system performance. Wasteful spending has many undesirable consequences that could be alleviated through waste reduction. This article proposes a conceptual framework to guide researchers and policymakers in evaluating waste, implementing waste-reduction strategies, and reducing the burden of unnecessary health care spending. METHODS: This article divides health care waste into administrative, operational, and clinical waste and provides an overview of each. It explains how researchers have used both high-level and sector- or procedure-specific comparisons to quantify such waste, and it discusses examples and challenges in both waste measurement and waste reduction. FINDINGS: Waste is caused by factors such as health insurance and medical uncertainties that encourage the production of inefficient and low-value services. Various efforts to reduce such waste have encountered challenges, such as the high costs of initial investment, unintended administrative complexities, and trade-offs among patients', payers', and providers' interests. While categorizing waste may help identify and measure general types and sources of waste, successful reduction strategies must integrate the administrative, operational, and clinical components of care, and proceed by identifying goals, changing systemic incentives, and making specific process improvements. CONCLUSIONS: Classifying, identifying, and measuring waste elucidate its causes, clarify systemic goals, and specify potential health care reforms that-by improving the market for health insurance and health care-will generate incentives for better efficiency and thus ultimately decrease waste in the U.S. health care system.

A model for a smallpox-vaccination policy.

BACKGROUND: The new reality of biologic terrorism and warfare has ignited a debate about whether to reintroduce smallpox vaccination. METHODS: We developed scenarios of smallpox attacks and built a stochastic model of outcomes under various control policies. We conducted a systematic literature review and estimated model parameters on the basis of European and North American outbreaks since World War II. We assessed the trade-offs between vaccine-related harms and benefits. RESULTS: Nations or terrorists possessing a smallpox weapon could feasibly mount attacks that vary with respect to tactical complexity and target size, and patterns of spread can be expected to vary according to whether index patients are hospitalized early. For acceptable results, vaccination of contacts must be accompanied by effective isolation. Vaccination of contacts plus isolation is expected to result in 7 deaths (from vaccine or smallpox) in a scenario involving the release of variola virus from a laboratory, 19 deaths in a human-vector scenario, 300 deaths in a building-attack scenario, 2735 deaths in a scenario involving a low-impact airport attack, and 54,729 deaths in a scenario involving a high-impact airport attack. Immediate vaccination of the public in an attacked region would provide little additional benefit. Prior vaccination of health care workers, who would be disproportionately affected, would save lives in large local or national attacks but would cause 25 deaths nationally. Prior vaccination of health care workers and the public would save lives in a national attack but would cause 482 deaths nationally. The expected net benefits of vaccination depend on the assessed probability of an attack. Prior vaccination of health care workers would be expected to save lives if the probability of a building attack exceeded 0.22 or if the probability of a high-impact airport attack exceeded 0.002. The probability would have to be much higher to make vaccination of the public life-saving. CONCLUSIONS: The analysis favors prior vaccination of health care workers unless the likelihood of any attack is very low, but it favors vaccination of the public only if the likelihood of a national attack or of multiple attacks is high.

Perceived causes of disability added prognostic value beyond medical conditions and functional status.

OBJECTIVE: This study's objective was to determine the incremental benefit of respondent subjective attribution of functional decline beyond relying solely on disease burden in predicting survival. STUDY DESIGN AND SETTINGS: A total of 9447 older adults from the Second Longitudinal Study on Aging, a probability sample of community dwelling adults aged 70 or older, were evaluated. Survival was based on status at follow-up interview 3-4 years after baseline interview. Logistic regression was performed using demographic variables and coexisting diseases as a baseline, then adding functional status measures (ADL, IADL) and individual subjective attribution of functional limitation in subsequent models. RESULTS: The predictions improved significantly with the addition of functional status measures (P<0.001) and the individual subjective attribution of functional limitation (P<0.001). For example, the probability of mortality for individuals with cancer was 17.3%, but 28.8% of those with cancer and functional limitations died as did 50% of those with cancer who reported functional limitations attributable to cancer. CONCLUSION: Among persons who can make a specific attribution of their functional limitation, the attribution may have value as a marker of severity of disease and serve as a good predictive measure for mortality, especially in specific illnesses such as cancer.

Can a chronic care model collaborative reduce heart disease risk in patients with diabetes?

BACKGROUND: There is a need to identify effective practical interventions to decrease cardiovascular disease risk in patients with diabetes. OBJECTIVE: We examine the impact of participation in a collaborative implementing the chronic care model (CCM) on the reduction of cardiovascular disease risk in patients with diabetes. DESIGN: Controlled pre- and postintervention study. PATIENTS/PARTICIPANTS: Persons with diabetes receiving care at 13 health care organizations exposed to the CCM collaborative and controls receiving care in nonexposed sites. MEASUREMENTS AND MAIN RESULTS: Ten-year risk of cardiovascular disease; determined using a modified United Kingdom Prospective Diabetes Study risk engine score. A total number of 613 patients from CCM intervention sites and 557 patients from usual care control sites met the inclusion criteria. The baseline mean 10-year risk of cardiovascular disease was 31% for both the intervention group and the control group. Participants in both groups had improved blood pressure, lipid levels, and HbA1c levels during the observation period. Random intercept hierarchical regression models showed that the intervention group had a 2.1% (95% CI -3.7%, -0.5%) greater reduction in predicted risk for future cardiovascular events when compared to the control group. This would result in a reduced risk of one cardiovascular disease event for every 48 patients exposed to the intervention. CONCLUSIONS: Over a 1-year interval, this collaborative intervention using the CCM lowered the cardiovascular disease risk factors of patients with diabetes who were cared for in the participating organization's settings. Further work could enhance the impact of this promising multifactorial intervention on cardiovascular disease risk reduction.

Predicting outcomes of primary care patients with major depression: development of a depression prognosis index.

OBJECTIVE: Depression research and practice focus increasingly on diverse patient populations with varying probabilities of response to clinical care. Prognostic indices use preexisting patient characteristics to estimate the probability of subsequent negative clinical outcomes and are useful tools for improving the study and care of diverse populations. Few such measures, however, have been developed for mental health conditions. This study developed and validated a depression prognosis measure for primary care patients with major depression. METHODS: Consecutive patients in 108 primary care practices were screened for depression, and 1,471 with major depression were enrolled. A Depression Prognosis Index (DPI) predicting persistent depression six months after baseline was developed for a random one-third subsample and validated with the remaining two-thirds. Models included prior treatment, demographic characteristics, comorbidities, and other physical, psychological, and social predictors. RESULTS: Sixty-four percent to 65% of patients classified by baseline DPI score as being in the sample quartile with the worst prognosis had probable major depression six months later, compared with 14% to 15% in the best-prognosis quartile. The DPI had an R2 of .40 in the development sample and .27 in the validation sample. Important predictors included severity of depression symptoms at baseline, social support, common physical symptoms, and having completed three months of antidepressants at sample entry. CONCLUSIONS: The ability of the DPI to predict six-month outcomes compares favorably to that of prognostic indices for general medical problems. These results validate the DPI and provide conceptual guidance for further development of depression risk stratification instruments for clinical and research use.

Development of an algorithm to identify fall-related injuries and costs in Medicare data.

BACKGROUND: Identifying fall-related injuries and costs using healthcare claims data is cost-effective and easier to implement than using medical records or patient self-report to track falls. We developed a comprehensive four-step algorithm for identifying episodes of care for fall-related injuries and associated costs, using fee-for-service Medicare and Medicare Advantage health plan claims data for 2,011 patients from 5 medical groups between 2005 and 2009. METHODS: First, as a preparatory step, we identified care received in acute inpatient and skilled nursing facility settings, in addition to emergency department visits. Second, based on diagnosis and procedure codes, we identified all fall-related claim records. Third, with these records, we identified six types of encounters for fall-related injuries, with different levels of injury and care. In the final step, we used these encounters to identify episodes of care for fall-related injuries. RESULTS: To illustrate the algorithm, we present a representative example of a fall episode and examine descriptive statistics of injuries and costs for such episodes. Altogether, we found that the results support the use of our algorithm for identifying episodes of care for fall-related injuries. When we decomposed an episode, we found that the details present a realistic and coherent story of fall-related injuries and healthcare services. Variation of episode characteristics across medical groups supported the use of a complex algorithm approach, and descriptive statistics on the proportion, duration, and cost of episodes by healthcare services and injuries verified that our results are consistent with other studies. CONCLUSIONS: This algorithm can be used to identify and analyze various types of fall-related outcomes including episodes of care, injuries, and associated costs. Furthermore, the algorithm can be applied and adopted in other fall-related studies with relative ease.

Is adjuvant therapy for older patients with node (-) early breast cancer cost-effective?

BACKGROUND: Node (-) breast cancer represents over 60% of cases in older women and currently there is a debate whether adjuvant therapy for these women is cost-effective. PURPOSE: Evaluate if adjuvant treatment for early-stage node (-) breast cancer with hormone therapy, chemotherapy, or combination therapy is cost-effective in older patients. DESIGN: Decision-analysis modeling using life tables integrated the cost of treatment in dollars and impact in length and quality of life. The primary data sources were meta-analysis from the Early Breast Cancer Trialists' Collaborative Group and the Red Book Average Wholesale Price for drugs. The incremental cost-effectiveness of different treatment strategies were then compared and mapped graphically. RESULTS: Adjuvant therapy is cost-effective in 65-year-old women with early breast cancer. In a 75-year-old estrogen receptor, ER (+) patient, hormone therapy, specifically tamoxifen, is cost-effective, 19,530 dollars/QALY. In a 75-year-old ER (-) the use of chemotherapy (AC or CMF) or 85-year-old ER (+) the use of hormone therapy was only marginally cost-effective, 54,000-76,000 dollars/QALY, only if efficacy was assumed to be age-insensitive (similar to a 65-year-old woman). CONCLUSION: Decision-analytic models can help policy makers who are faced with decisions about whether to support adjuvant therapy in older breast cancer patients and also outline the important parameters that need to be considered in such a decision.

The lifetime burden of chronic disease among the elderly.

The high costs of treating chronic diseases suggest that reducing their prevalence would improve Medicare's financial stability. In this paper we examine the impact of selected chronic diseases on the distribution of health spending and its variation over the course of disease. We also use a microsimulation model to estimate these conditions' impact on life expectancy and health spending from age sixty-five to death. A sixty-five-year-old with a serious chronic illness spends 1000-2000 dollars more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy.

Assessing the implementation of the chronic care model in quality improvement collaboratives.

OBJECTIVE: To measure organizations' implementation of Chronic Care Model (CCM) interventions for chronic care quality improvement (QI). DATA SOURCES/STUDY SETTING: Monthly reports submitted by 42 organizations participating in three QI collaboratives to improve care for congestive heart failure, diabetes, depression, and asthma, and telephone interviews with key informants in the organizations. STUDY DESIGN: We qualitatively analyzed the implementation activities of intervention organizations as part of a larger effectiveness evaluation of yearlong collaboratives. Key study variables included measures of implementation intensity (quantity and depth of implementation activities) as well as fidelity to the CCM. DATA COLLECTION/EXTRACTION METHODS: We developed a CCM-based scheme to code sites' intervention activities and criteria to rate their depth or likelihood of impact. PRINCIPAL FINDINGS: The sites averaged more than 30 different change efforts each to implement the CCM. The depth ratings for these changes, however, were more modest, ranging from 17 percent to 76 percent of the highest rating possible. The participating organizations significantly differed in the intensity of their implementation efforts (p<.001 in both quantity and depth ratings). Fidelity to the CCM was high. CONCLUSIONS: Collaborative participants were able, with some important variation, to implement large numbers of diverse QI change strategies, with high CCM fidelity and modest depth of implementation. QI collaboratives are a useful method to foster change in real world settings.

Options for handling missing data in the Health Utilities Index Mark 3.

BACKGROUND: The Health Utilities Index Mark 3 (HUI3) is a tool composed of 41 questions, covering 8 attributes: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Responses to these questions can define more than 972,000 health situations. This tool allows respondents to answer "Don't Know," for which there is no scoring instruction, to any given question. This situation creates a break in the scoring algorithm and leads to considerable amounts of missing data. The goal of this study is to develop strategies to deal with HUI3 scores for participants who have missing data. METHODS: The authors used data from 248 individuals enrolled in the Cataract Management Trial, focusing on the HUI3 vision and ambulation attributes, which had 19% and 10% of attribute levels missing, respectively. Inspection and deduction were used to fill in values independent of the value of the missing data, then alternative analytic techniques were compared, including mean substitution, model scoring, hot deck, multiple imputation, and regression imputation. RESULTS: Inspection and logical deduction reduced the percentage of missing information in the HUI3 by 49% to 87%. A comparison of analytic techniques used for the remaining HUI3 vision data missing demonstrated the value of building models based on internal response patterns and that simple analytic techniques fare as well as more complicated ones when the number of missing cases is small. CONCLUSION: Analyzing the pattern of responses in cases where the attribute level score is missing reduces the amount of missing data and can simplify the analytic process for the remaining missing data.

A meta-analysis of interventions to improve care for chronic illnesses.

OBJECTIVE: To use empirical data from previously published literature to address 2 research questions: (1) Do interventions that incorporate at least 1 element of the Chronic Care Model (CCM) result in improved outcomes for specific chronic illnesses? (2) Are any elements essential for improved outcomes? STUDY DESIGN: Meta-analysis. METHODS: Articles were identified from narrative literature reviews and quantitative meta-analyses, each of which covered multiple bibliographic databases from inception to March 2003. We supplemented this strategy by searching the MEDLINE database (1998-2003) and by consulting experts. We included randomized and nonrandomized controlled trials of interventions that contained 1 or more elements of the CCM for asthma, congestive heart failure (CHF), depression, and diabetes. We extracted data on clinical outcomes, quality of life, and processes of care. We then used random-effects modeling to compute pooled standardized effect sizes and risk ratios. RESULTS: Of 1345 abstracts screened, 112 studies contributed data to the meta-analysis: asthma, 27 studies; CHF, 21 studies; depression, 33 studies; and diabetes, 31 studies. Interventions with at least 1 CCM element had consistently beneficial effects on clinical outcomes and processes of care across all conditions studied. The effects on quality of life were mixed, with only the CHF and depression studies showing benefit. Publication bias was noted for the CHF studies and a subset of the asthma studies. CONCLUSIONS: Interventions that contain at least 1 CCM element improve clinical outcomes and processes of care--and to a lesser extent, quality of life--for patients with chronic illnesses.

Cost effectiveness of nonoperative management versus laparoscopic appendectomy for acute uncomplicated appendicitis.

BACKGROUND: Appendectomy remains the gold standard in the treatment of acute, uncomplicated appendicitis in the United States. Nonetheless, there is growing evidence that nonoperative management is safe and efficacious. METHODS: We constructed a decision tree to compare nonoperative management of appendicitis with laparoscopic appendectomy in otherwise healthy adults. Model variables were abstracted from a literature review, data from the Healthcare Cost and Utilization Project data, the Medicare Physician Fee schedule, and the American College of Surgeons Surgical Risk Calculator. Uncertainty surrounding parameters of the model was assessed via 1-way and probabilistic sensitivity analyses. RESULTS: Operative management cost $12,213 per patient. Nonoperative management without interval appendectomy (IA) was the dominant strategy, costing $1,865 less and producing 0.03 more quality-adjusted life-years (QALYs). Nonoperative management with IA cost $4,271 more than operative management, but yielded only 0.01 additional QALY. One-way sensitivity analysis suggested operative management would become the preferred strategy if the recurrence rate was >40.5% or the total cost of appendectomy was decreased to <$5,468. Probabilistic sensitivity analysis confirmed nonoperative management without IA was the preferred strategy in 95.6% of cases. CONCLUSION: Nonoperative management without IA is the least costly, most effective treatment for acute, uncomplicated appendicitis and warrants further evaluation in a disease thought to be definitively surgical.

Effect of a falls quality improvement program on serious fall-related injuries.

OBJECTIVES: To determine whether a program that improves the quality of care for falls reduces the number of episodes of care for serious fall-related injuries. DESIGN: Nonrandomized controlled trial. SETTING: Four community-based primary care practices. PARTICIPANTS: Individuals aged 75 and older who screened positive for fall risk. INTERVENTION: A multicomponent quality improvement program (Assessing Care of Vulnerable Elders Practice Redesign for Improved Medical Care for Elders) involving face-to-face clinician education about falls and decision support to prompt primary care providers to implement appropriate care, including referral to appropriate community resources, in response to individuals screening positive for fall risk. MEASUREMENTS: Episodes of care for selected fall-related injuries, based on healthcare claims. RESULTS: Of 1,791 individuals with data available for analysis, 1,187 were in the intervention group, and 604 were in the control group. Mean age was 83, and more than two-thirds of the sample were women. After adjusting for potential confounders, there were no statistically significant differences between intervention and control groups in episodes of care for fall-related injuries during the 12-month (incidence rate ratio (IRR) 1.27, 95% confidence interval (CI) = 0.93-1.73) or 24-month (IRR 1.18, 95% CI = 0.93-1.49) period after initiation of the intervention. CONCLUSION: Despite improving the care of falls, this quality improvement initiative did not result in a change in the number of episodes of care for serious fall-related injuries. Future work in community-based settings should test higher-intensity interventions to reduce fall-related injuries.

An evaluation of collaborative interventions to improve chronic illness care. Framework and study design.

The author's dual-purpose evaluation assesses the effectiveness of formal collaboratives in stimulating organizational changes to improve chronic illness care (the chronic care model or CCM). Intervention and comparison sites are compared before and after introduction of the CCM. Multiple data sources are used to measure the degree of implementation, patient-level processes and outcomes, and organizational and team factors associated with success. Despite challenges in timely recruitment of sites and patients, data collection on 37 participating organizations, 22 control sites, and more than 4,000 patients with diabetes, congestive heart failure, asthma, or depression is nearing completion. When analyzed, these data will shed new light on the effectiveness of collaborative improvement methods and the CCM.

The value of health information technology: filling the knowledge gap.

Despite rapid growth in the rate of adoption of health information technology (HIT), and in the volume of evaluation studies, the existing knowledge base for the value of HIT is not advancing at a similar rate. Most evaluation articles are limited in that they use incomplete measures of value and fail to report the important contextual and implementation characteristics that would allow for an adequate understanding of how the study results were achieved. To address these deficiencies, we present a conceptual framework for measuring HIT value and we propose a checklist of characteristics that should be considered in HIT evaluation studies. The framework consists of 3 key principles: 1) value includes both costs and benefits; 2) value accrues over time; and 3) value depends on which stakeholder's perspective is used. Through examples, we show how these principles can be used to guide and improve HIT evaluation studies. The checklist includes a list of contextual and implementation characteristics that are important for interpretation of results. These improvements will make future studies more useful for policy makers and more relevant to the current needs of the healthcare system.

Redirecting Innovation in U.S. Health Care: Options to Decrease Spending and Increase Value.

New medical technologies are a leading driver of U.S. health care spending. This article identifies promising policy options to change which medical technologies are created, with two related policy goals: (1) Reduce total health care spending with the smallest possible loss of health benefits, and (2) ensure that new medical products that increase spending are accompanied by health benefits that are worth the spending increases. The analysis synthesized information from peer-reviewed and other literature, a panel of technical advisors convened for the project, and 50 one-on-one expert interviews. The authors also conducted case studies of eight medical products. The following features of the U.S. health care environment tend to increase spending without also conferring major health benefits: lack of basic scientific knowledge about some disease processes, costs and risks of U.S. Food and Drug Administration (FDA) approval, limited rewards for medical products that could lower spending, treatment creep, and the medical arms race. The authors identified ten policy options that would help advance the two policy goals. Five would do so by reducing the costs and/or risks of invention and obtaining FDA approval: (1) Enable more creativity in funding basic science, (2) offer prizes for inventions, (3) buy out patents, (4) establish a public-interest investment fund, and (5) expedite FDA reviews and approvals. The other five options would do so by increasing market rewards for products: (1) Reform Medicare payment policies, (2) reform Medicare coverage policies, (3) coordinate FDA approval and Centers for Medicare & Medicaid Services coverage processes, (4) increase demand for technologies that decrease spending, and (5) produce more and more-timely technology assessments.

A cost-effectiveness analysis of a proposed national falls prevention program.

Falls are a major health concern for elderly people and cause substantial health care costs. The authors used meta-analytic findings on the effectiveness of fall prevention interventions to determine cost-effectiveness of a proposed Medicare fall prevention program for people who experience a recent fall. Using published clinical trial data, the authors constructed a population-based economic model and estimated that, in the base case, the program could prevent a half million people from falling again within a year. From the model, under most circumstances the cost-effectiveness ratio is less than $1500 per person prevented from experiencing a recurrent fall. Paying for a fall prevention program to increase the use of evidence-based interventions would be a cost-effective use of Medicare dollars.

Health information technology and physicians' knowledge of drug costs.

OBJECTIVE: To examine whether physicians' use of information technology (IT) was associated with better knowledge of drug costs. STUDY DESIGN/METHODS: A 2007 statewide survey of 247 primary care physicians in Hawaii regarding IT use and self-reported knowledge of formularies, copayments, and retail prices. RESULTS: Approximately 8 in 10 physicians regularly used IT in clinical care: 60% Internet, 54% e-prescribing, 43% electronic health records (EHRs), and 37% personal digital assistants (PDAs). However, fewer than 1 in 5 often knew drug costs when prescribing, and more than 90% said lack of knowledge of formularies and copayments remained a barrier to considering drug costs for patients. In multivariate analyses adjusting for sex, practice size, years in practice, number of formularies, and use of clinical resources (eg, pharmacists), use of the Internet -- but not e-prescribing, EHRs, or PDAs -- was associated with physicians reporting slightly better knowledge of copayments (adjusted predicted percentage of 23% vs 11%; P = .04). No type of IT was associated with better knowledge of formularies or retail prices. CONCLUSIONS: Despite high rates of IT use, there was only a modest association between physicians' use of IT and better knowledge of drug costs. Future investments in health IT should consider how IT design can be improved to make it easier for physicians to access cost information at the point of care.