Comparative effectiveness research
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The primary study objective is to conduct a prospective, randomized controlled clinical trial that compares the effectiveness of two approaches for delivering smoking cessation treatment for veterans with posttraumatic stress disorder (PTSD). An approach where smoking cessation treatment is integrated into mental health care for PTSD and delivered by mental health providers (experimental condition) will be compared to specialized smoking cessation clinic referral (VA's usual standard of care).

Secondary study objectives are to (a) compare the cost outcomes and cost-effectiveness of IC versus USC, (b) identify treatment process variables that explain (mediate) observed differences in smoking abstinence rates for the two study conditions, and (c) determine whether cessation from smoking is associated with worsening of symptoms of PTSD and/or depression.

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Journal Articles
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Clinical Trials
Authors
Mark W. Smith
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Background: Thrombolytic therapy is controversial in patients with submassive pulmonary embolism.

Methods: We performed a cost-effectiveness analysis to compare health effects and costs of treatment with alteplase plus heparin sodium vs heparin alone in hemodynamically stable patients with pulmonary embolism and right ventricular dysfunction by developing a Markov model and using data from clinical trials and administrative sources.

Results: Based on data from a recent randomized trial, we assumed that the risk of clinical deterioration requiring treatment escalation was almost 3 times higher in patients who received heparin alone (23.2% vs 7.6%) but that the risk of death was equal in the 2 cohorts (2.7%). Based on registry data, we assumed that the risk of intracranial hemorrhage was approximately 3 times higher in patients who received alteplase plus heparin (1.2% vs 0.4%). Under these and other assumptions, thrombolysis resulted in marginally higher total lifetime health care costs ($43,900 vs $43,300) and was slightly less effective (10.52 vs 10.57 quality-adjusted life-years) than treatment with heparin alone. Thrombolysis was more effective and cost less than $50,000 per quality-adjusted life-year gained when we assumed that the baseline risk of death in the heparin group was 3 times the base-case value (8.1%) and that alteplase reduced the relative risk of death by at least 10%.

Conclusions: Available data do not support the routine use of thrombolysis to treat patients with submassive pulmonary embolism. However, thrombolysis may prove to be cost-effective in selected subgroups of hemodynamically stable patients in whom the risk of death is higher.

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Archives of Internal Medicine
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Objective:

To assess the effectiveness and cost-effectiveness of treating HIV-infected injection drug users (IDUs) and non-IDUs in Russia with highly active antiretroviral therapy HAART.

Design and Methods:

A dynamic HIV epidemic model was developed for a population of IDUs and non-IDUs. The location for the study was St. Petersburg, Russia. The adult population aged 15 to 49 years was subdivided on the basis of injection drug use and HIV status. HIV treatment targeted to IDUs and non-IDUs, and untargeted treatment interventions were considered. Health care costs and quality-adjusted life years (QALYs) experienced in the population were measured, and HIV prevalence, HIV infections averted, and incremental cost-effectiveness ratios of different HAART strategies were calculated.

Results:

With no incremental HAART programs, HIV prevalence reached 64% among IDUs and 1.7% among non-IDUs after 20 years. If treatment were targeted to IDUs, over 40 000 infections would be prevented (75% among non-IDUs), adding 650 000 QALYs at a cost of USD 1501 per QALY gained. If treatment were targeted to non-IDUs, fewer than 10 000 infections would be prevented, adding 400 000 QALYs at a cost of USD 2572 per QALY gained. Untargeted strategies prevented the most infections, adding 950 000 QALYs at a cost of USD 1827 per QALY gained. Our results were sensitive to HIV transmission parameters.

Conclusions:

Expanded use of antiretroviral therapy in St. Petersburg, Russia would generate enormous population-wide health benefits and be economically efficient. Exclusively treating non-IDUs provided the least health benefit, and was the least economically efficient. Our findings highlight the urgency of initiating HAART for both IDUs and non-IDUs in Russia.

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Journal Articles
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AIDS
Authors
Margaret L. Brandeau
Douglas K. Owens
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Objectives:

To examine the cost-effectiveness of a quantitative D-dimer assay for the evaluation of patients with suspected pulmonary embolism (PE) in an urban emergency department (ED).

Methods:

The authors analyzed different diagnostic strategies over pretest risk categories on the basis of Wells criteria by using the performance profile of the ELISA D-dimer assay (over five cutoff values) and imaging strategies used in the ED for PE: compression ultrasound (CUS), ventilationperfusion (VQ) scan (over three cutoff values), CUS with VQ (over three cutoff values), computed tomography (CT) angiogram (CTA) with pulmonary portion (CTP) and lower-extremity venous portion, and CUS with CTP. Data used in the analysis were based on literature review. Incremental costs and quality-adjusted-life-years were the outcomes measured.

Results:

Computed tomography angiogram with pulmonary portion and lower-extremity venous portion without D-dimer was the preferred strategy. CUS-VQ scanning always was dominated by CT-based strategies. When CTA was infeasible, the dominant strategy was D-dimer with CUS-VQ in moderate- and high-Wells patients and was D-dimer with CUS for low-Wells patients. When CTP specificity falls below 80%, or if its overall performance is markedly degraded, preferred strategies include D-dimer testing. Sensitivity analyses suggest that pessimistic assessments of CTP accuracy alter the results only at extremes of parameter settings.

Conclusions:

In patients in whom PE is suspected, when CTA is available, even the most sensitive quantitative D-dimer assay is not likely to be cost-effective. When CTA is not available or if its performance is markedly degraded, use of the D-dimer assay has value in combination with CUS and a pulmonary imaging study. These conclusions may not hold for the larger domain of patients presenting to the ED with chest pain or shortness of breath in whom PE is one of many competing diagnoses.

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Academic Emergency Medicine
Authors
Ross D. Shachter
Margaret L. Brandeau
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Abstract

The authors introduce economic evaluation with particular attention to cost-effectiveness analysis. They begin by establishing why health care decisions should be guided by economics. They then explore different types of economic evaluations. To illustrate how to conduct and evaluate a cost-effectiveness analysis, a hypothetical study about the treatment of posttraumatic stress disorder with psychotherapy versus pharmacotherapy is considered. The authors conclude with recommendations for increasing the strength and relevance of economic evaluations.

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Journal of Traumatic Stress
Authors
Mark W. Smith
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We investigated the determinants of inpatient rehabilitation costs in the Department of Veterans Affairs (VA) and examined the relationship between length of stay (LOS) and discharge costs using data from VA and community rehabilitation hospitals. We estimated regression models to identify patient characteristics associated with specialized inpatient rehabilitation costs. VA data included 3,535 patients discharged from 63 facilities in fiscal year 2001. We compared VA costs to community rehabilitation hospitals using a sample from the Uniform Data System for Medical Rehabilitation of 190,112 patients discharged in 1999 from 697 facilities. LOS was a strong predictor of cost for VA and non-VA hospitals. Functional status, measured by Functional Independence Measure (FIM) scores at admission, was statistically significant but added little explanatory value after controlling for LOS. Although FIM scores were associated with LOS, FIM scores accounted for little variance in cost after controlling for LOS. These results are most applicable to researchers conducting cost-effectiveness analyses.

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Journal of Rehabilitation Research and Development
Authors
Mark W. Smith
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In late September, the federal Centers for Disease Control and Prevention announced new guidelines recommending that all Americans ages 13 to 64 be voluntarily screened for HIV infection. That's a significant change from the previous guidelines, which recommended testing only for high-risk individuals, such as injection drug users or those with multiple sex partners.

The new guidelines were influenced by a study published last year in the New England Journal of Medicine, led by Douglas K. Owens, a CHP/PCOR core faculty member and an investigator at the VA Palo Alto. Owens and his colleagues -- including CHP/PCOR researchers Gillian D. Sanders, Vandana Sundaram, Kristof Neukermans and Laura Lazzeroni -- found that expanding HIV screening would be a cost-effective way to increase life expectancy and decrease the transmission of HIV. Below, Owens discusses the research and the CDC's new screening guidelines.

Q. Why does this new policy matter, and whom will it help?

Owens: The policy is a profound change because it advises that all individuals ages 13 to 64 be screened for HIV. It matters because it will identify people who have HIV but don't know it. These people will benefit because they'll have access to life-prolonging drugs that they otherwise might not have received until very late in the course of HIV disease. The rest of the community will also benefit, through reduced transmission of HIV.

Q. How did your findings contribute to the CDC adopting the new guidelines?

Owens: First, we found that widespread screening provides a substantial health benefit to HIV-positive people who are identified through screening and receive anti-retroviral treatment earlier than they would have otherwise. Early treatment added about a year and a half of life expectancy for these people. Second, we found a substantial potential benefit to the community because of reduced transmission of HIV. Transmission is reduced because many people cut down on risky behaviors (such as having unprotected sex) when they're identified as having HIV, and because anti-retroviral treatment makes a person less infectious. Our key finding was that routine screening is cost-effective even if only 1 in 2,000 people who are screened have HIV. This means HIV screening is cost-effective in a much broader group than recognized previously.

Q. How and why did the CDC revise its previous guidelines? What role did you and your colleagues play in the decision-making?

Owens: CDC officials made this change because they saw mounting evidence that the prior approach to screening -- focusing on those with identifiable risk factors -- simply wasn't working. If you test people based on risk behavior, you miss many people who have HIV. Even among people who had easily identified risk behaviors, many of them weren't being tested. We also know that most people who have HIV are diagnosed very late in the disease, when they can't get the full benefit from anti-retroviral therapy.

Our involvement in the decision-making was to help assess the prevalence of HIV at which routine screening would be recommended. Through several conference calls with CDC officials, we presented our work and explained the issues related to cost-effectiveness and prevalence. Based on those results and the results of a similar study from Yale, the agency went in the direction of lowering the threshold for screening quite substantially -- to 1 in 1,000 from a prior threshold of 1 percent.

Q. Will most physicians follow the new guidelines? What can be done to make sure they do?

Owens: That's the big question. The CDC's previous screening guidelines were not widely adopted. The new recommendations are much easier to adopt, because they don't depend on clinicians determining the prevalence of HIV in their patient population. Still, it will take a lot of follow-up to make sure physicians implement the guidelines. One key obstacle will be getting payers to reimburse for HIV testing. That's a critical issue, which the CDC is well aware of.

Q. Some HIV/AIDS advocates object to the new guidelines because they recommend removing two requirements that some states now have: mandatory signed consent forms and counseling before testing. Does removing these requirements pose a big problem?

Owens: It's important to emphasize that the new guidelines say people should always be informed before testing and should be able to decline. Informed consent and pretest counseling had become significant barriers that were preventing people from being tested who should have been tested. Everyone agrees that no one should be tested without their knowledge, but that doesn't mean you need a separate consent form. Of course, the confidentiality of the test results should continue to be carefully protected. I would point out that some states have laws requiring informed consent, but whether they will now change those laws isn't clear.

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