Abstract

In an era of limited healthcare budgets, mathematical models can be useful tools to identify cost-effective programs and to support policymakers in informed decision making. This paper reports results of our work carried out over several years with the Asian Liver Center at Stanford University, a nonprofit outreach and advocacy organization that is an international leader in the fight against hepatitis B and liver cancer. Hepatitis B is a vaccine-preventable viral disease that, if untreated, can lead to death from cirrhosis and liver cancer. Infection with hepatitis B is a major public health problem, particularly in Asian populations. We used new combinations of decision analysis and Markov models to analyze the cost-effectiveness of several interventions to combat hepatitis B in the United States and China. The results of our OR-based analyses have helped change United States public health policy on hepatitis B screening for millions of people and have helped encourage policymakers in China to enact legislation to provide free catch-up vaccination for hundreds of millions of children. These policies are an important step in eliminating health disparities, reducing discrimination, and ensuring that millions of people who need it can now receive hepatitis B vaccination or lifesaving treatment.

Abstract

We estimated the effectiveness and cost-effectiveness of changes in concurrent sexual partnerships in reducing the spread of HIV in sub-Saharan Africa. Using data from Swaziland, Tanzania, Uganda and Zambia, we estimated country-specific concurrency behaviour from sexual behaviour survey data on the number of partners in the past 12 months, and we developed a network model to compare the impact of three behaviour changes on the HIV epidemic: (1) changes in concurrent partnership patterns to strict monogamy; (2) partnership reduction among those with the greatest number of partners; and (3) partnership reduction among all individuals. We estimated the number of new HIV infections over 10 years and the cost per infection averted. Given our assumptions and model structure, we find that reducing concurrency among high-risk individuals averts the most infections and increasing monogamy the least (11.7% versus 8.7% reduction in new infections, on average, for a 10% reduction in concurrent partnerships). A campaign that costs US$1 per person annually is likely cost-saving if it reduces concurrency by 9% on average, given our baseline estimates of concurrency. In sensitivity analysis, the rank ordering of behaviour change scenarios was unaffected by potential over-estimation of concurrency, though the number of infections averted decreased and the cost per HIV infection averted increased. Concurrency reduction programmes may be effective and cost-effective in reducing HIV incidence in sub-Saharan Africa if they can achieve even modest impacts at similar costs to past mass media campaigns in the region. Reduced concurrency among high-risk individuals appears to be most effective in reducing HIV incidence, but concurrency reduction in other risk groups may yield nearly as much benefit.

Abstract

BACKGROUND:

To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.

METHODS:

Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.

RESULTS:

The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.

CONCLUSIONS:

Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00237692.

Abstract

BACKGROUND- The majority of current implantable cardioverter-defibrillator (ICD) recipients are significantly older than those in the ICD trials. Data on periprocedural complications among the elderly are insufficient. We evaluated the influence of age on perioperative complications among primary prevention ICD recipients in the United States. METHODS AND RESULTS- Using the National Cardiovascular Data's ICD Registry, we identified 150 264 primary prevention patients who received ICDs from January 2006 to December 2008. The primary end point was any adverse event or in-hospital mortality. Secondary end points included major adverse events, minor adverse events, and length of stay. Of 150 264 patients, 61% (n=91 863) were 65 years and older. A higher proportion of patients ≥65 years had diabetes, congestive heart failure, atrial fibrillation, renal disease, and coronary artery disease. Approximately 3.4% of the entire cohort had any complication, including death, after ICD implant. Any adverse event or death occurred in 2.8% of patients under 65 years old; 3.1% of 65- to 69-year-olds; 3.5% of 70- to 74-year-olds; 3.9% of 75- to 79-year-olds, 4.5% of 80- to 84-year-olds; and 4.5% of patients 85 years and older. After adjustment for clinical covariates, multivariate analysis found an increased odds of any adverse event or death among 75- to 79-year-olds (1.14 [95% confidence interval, 1.03 to 1.25], 80-to 84-year-olds (1.22 [95% confidence interval, 1.10 to 1.36], and patients 85 years and older (1.15 [95% confidence interval, 1.01 to 1.32], compared with patients under 65 years old. CONCLUSIONS- Older patients had a modestly increased-but acceptably safe-risk of periprocedural complications and in-hospital mortality, driven mostly by increased comorbidity.

Abstract

Despite the recent advances made in the care of children with sickle cell disease (SCD), premature mortality, especially among older children and young adults, remains a hallmark of this disease. The lack of survival gains highlights the translational gap of implementing innovations found efficacious in the controlled trial setting into routine clinical practice. Health services research (HSR) examines the most effective ways to finance, organize, and deliver high quality care in an equitable manner. To date, HSR has been underutilized as a means to improve the outcomes for children with SCD. Emerging national priorities in health care delivery, new sources of funding, and evolving electronic data collection systems for patients with SCD have provided a unique opportunity to overcome the translational gap in pediatric SCD. The purpose of this article is to provide a comprehensive HSR agenda to create patient-specific evidence of clinical effectiveness for interventions used in the routine care setting, understand the barriers faced by clinicians to providing high quality care, assess and improve the interactions of patients with the health care system, and measure the quality of care delivered to increase survival for all children and young adults with SCD.

Abstract

The diabetic Charcot foot syndrome is a serious and potentially limb-threatening lower-extremity complication of diabetes. First described in 1883, this enigmatic condition continues to challenge even the most experienced practitioners. Now considered an inflammatory syndrome, the diabetic Charcot foot is characterized by varying degrees of bone and joint disorganization secondary to underlying neuropathy, trauma, and perturbations of bone metabolism. An international task force of experts was convened by the American Diabetes Association and the American Podiatric Medical Association in January 2011 to summarize available evidence on the pathophysiology, natural history, presentations, and treatment recommendations for this entity.

Clinical practice guidelines aim to help providers make decisions that optimize patient care (1). Both developers and users of guidelines understand that guidelines could be improved by tailoring the recommendations to the specific circumstances of an individual patient. Tailored guideline recommendations may improve health outcomes when a group of patients can be divided into subgroups in which the tailored recommendations would increase benefits, reduce harms, or save costs relative to more generic recommendations. For example, a guideline for hypertension may recommend antihypertensive treatment in patients whose blood pressure is higher than 140/90 mm Hg. However, patients with diabetes or high cardiovascular risk may benefit from receiving treatment at lower blood pressures, whereas other patients may benefit from less aggressive treatment.

However, for both guideline developers and clinicians, tailoring recommendations is easier said than done. Developers of guidelines face a difficult tradeoff: Issue simplified, easy-to-follow guidelines or, instead, guidelines targeted more precisely to each patient, at the cost of greater complexity and more challenging implementation. In addition, little evidence may exist to guide how to tailor recommendations, because trials may exclude patients who have the comorbid conditions and other factors that would warrant tailoring a recommendation.

Clinicians also may have far more information about an individual patient than even complex guidelines can accommodate. Should a patient with atrial fibrillation receive guideline-concordant anticoagulation therapy even if he or she is at increased risk for falls? Such …

BACKGROUND:

The effect of adherence, treatment failure, and comorbidities on the cost of HIV care is not well understood.

OBJECTIVE:

To characterize the cost of HIV care including combination antiretroviral treatment (ART).

RESEARCH DESIGN:

Observational study of administrative data.

SUBJECTS:

Total 1896 randomly selected HIV-infected patients and 288 trial participants with multidrug-resistant HIV seen at the US Veterans Health Administration (VHA).

MEASURES:

Comorbidities, cost, pharmacy, and laboratory data.

RESULTS:

Many HIV-infected patients (24.5%) of the random sample did not receive ART. Outpatient pharmacy accounted for 62.8% of the costs of patients highly adherent with ART, 32.2% of the cost of those with lower adherence, and 6.2% of the cost of those not receiving ART. Compared with patients not receiving ART, high adherence was associated with lower hospital cost, but no greater total cost. Individuals with a low CD4 count (500. Most patients had medical, psychiatric, or substance abuse comorbidities. These conditions were associated with greater cost. Trial participants were less likely to have psychiatric and substance abuse comorbidities than the random sample of VHA patients with HIV.

CONCLUSIONS:

Patients receiving combination ART had higher medication costs but lower acute hospital cost. Poor control of HIV was associated with higher cost. The cost of psychiatric, substance abuse, rehabilitation, and long-term care and medications other than ART, often overlooked in HIV studies, was substantial.

OBJECTIVE:

Acute HIV infection often causes influenza-like illness (ILI) and is associated with high infectivity. We estimated the effectiveness and cost-effectiveness of strategies to identify and treat acute HIV infection in men who have sex with men (MSM) in the USA.

DESIGN:

Dynamic model of HIV transmission and progression.

INTERVENTIONS:

We evaluated three testing approaches: viral load testing for individuals with ILI, expanded screening with antibody testing, and expanded screening with antibody and viral load testing. We included treatment with antiretroviral therapy for individuals identified as acutely infected.

MAIN OUTCOME MEASURES:

New HIV infections, discounted quality-adjusted life years (QALYs) and costs, and incremental cost-effectiveness ratios.

RESULTS:

At the present rate of HIV-antibody testing, we estimated that 538,000 new infections will occur among MSM over the next 20 years. Expanding antibody screening coverage to 90% of MSM annually reduces new infections by 2.8% and costs US$ 12,582 per QALY gained. Symptom-based viral load testing with ILI is more expensive than expanded antibody screening, but is more effective and costs US$ 22,786 per QALY gained. Combining expanded antibody screening with symptom-based viral load testing prevents twice as many infections compared to expanded antibody screening alone, and costs US$ 29,923 per QALY gained. Adding viral load testing to all annual HIV tests costs more than US$ 100,000 per QALY gained.

CONCLUSION:

Use of HIV viral load testing in MSM with ILI prevents more infections than does expanded annual antibody screening alone and is inexpensive relative to other screening interventions. Clinicians should consider symptom-based viral load testing in MSM, in addition to encouraging annual antibody screening.

BACKGROUND:

The prime-boost HIV vaccine regimen used in the recent RV144 trial resulted in modest efficacy of 31% over 3.5 years, but was substantially higher in the first year post-vaccination. We sought to explore the potential impact of a vaccine with rapidly waning efficacy in a South African population.

METHODS:

We explored two strategies using a dynamic compartmental epidemic model for heterosexual transmission of HIV: [1] vaccination of a single cohort (30%, 60% or 90% of the initial population), with exponentially waning efficacy, but booster vaccinations at 5- or 2-year intervals, and [2] continuous vaccination of the unvaccinated population at the same coverage levels (30%, 60% or 90%) but with a constant efficacy vaccine of short duration. We also examined potential changes in post-vaccination condom use.

RESULTS:

The single cohort vaccination strategies did not have a substantial impact on HIV prevalence, although without boosters they still prevented 2-6% of the expected infections at 20 years, depending on the population coverage. The 5-year and 2-year booster strategies prevented 8-24% and 17-45% of the expected infections, respectively. Continuous vaccination to maintain population coverage levels resulted in more substantial reductions in population HIV prevalence and greater numbers of infections prevented: HIV prevalence at 20 years was reduced from 23% to 8-14% and the number of expected infections was decreased by 34-59%, depending on the population coverage level. Moderate changes in post-vaccination condom use did not substantially affect these outcomes.

CONCLUSIONS:

An HIV vaccine with partial efficacy and declining protection similar to the RV144 vaccine could prevent a substantial proportion of HIV infections if booster vaccinations were effective and available. Our estimates of the population impact of vaccination would be improved by further understanding of the duration of protection, the effectiveness of booster vaccination, and whether the vaccine efficacy varies between subpopulations at higher and lower risk of exposure.