Purpose. Mathematical and simulation models are increasingly used to plan for and evaluate health sector responses to disasters, yet no clear consensus exists regarding best practices for the design, conduct, and reporting of such models. The authors examined a large selection of published health sector disaster response models to generate a set of best practice guidelines for such models.

Methods. The authors reviewed a spectrum of published disaster response models addressing public health or health care delivery, focusing in particular on the type of disaster and response decisions considered, decision makers targeted, choice of outcomes evaluated, modeling methodology, and reporting format. They developed initial recommendations for best practices for creating and reporting such models and refined these guidelines after soliciting feedback from response modeling experts and from members of the Society for Medical Decision Making.

Results. The authors propose 6 recommendations for model construction and reporting, inspired by the most exemplary models: health sector disaster response models should address real-world problems, be designed for maximum usability by response planners, strike the appropriate balance between simplicity and complexity, include appropriate outcomes that extend beyond those considered in traditional cost-effectiveness analyses, and be designed to evaluate the many uncertainties inherent in disaster response. Finally, good model reporting is particularly critical for disaster response models.

Conclusions. Quantitative models are critical tools for planning effective health sector responses to disasters. The proposed recommendations can increase the applicability and interpretability of future models, thereby improving strategic, tactical, and operational aspects of preparedness planning and response.

Clinical research presents health care providers with information on the natural history and clinical presentations of disease as well as diagnostic and treatment options. Consumers, patients, and caregivers also require this information to decide how to evaluate and treat their conditions. All too often, the information necessary to inform these medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today lacking clear evidence of effectiveness.

Comparative effectiveness research (CER) identifies what works best for which patients under what circumstances. Congress, in the American Recovery and Reinvestment Act (ARRA) of 2009, tasked the Institute of Medicine (IOM) to recommend national priorities for research questions to be addressed by CER and supported by ARRA funds. In its 2009 report, Initial National Priorities for Comparative Effectiveness Research, the authoring committee establishes a working definition of CER, develops a priority list of research topics to be undertaken with ARRA funding using broad stakeholder input, and identifies the necessary requirements to support a robust and sustainable CER enterprise. The full list of priorities and recommendations can be found in the below report brief.

Background

Although the Accreditation Council for Graduate Medical Education (ACGME) limits the work hours of residents, concerns about fatigue persist. A new Institute of Medicine (IOM) report recommends, among other changes, improved adherence to the 2003 ACGME limits, naps during extended shifts, a 16-hour limit for shifts without naps, and reduced workloads.

Methods

We used published data to estimate labor costs associated with transferring excess work from residents to substitute providers, and we examined the effects of our assumptions in sensitivity analyses. Next, using a probability model to represent labor costs as well as mortality and costs associated with preventable adverse events, we determined the net costs to major teaching hospitals and cost-effectiveness across a range of hypothetical changes in the rate of preventable adverse events.

Results

Annual labor costs from implementing the IOM recommendations were estimated to be $1.6 billion (in 2006 U.S. dollars) across all ACGME-accredited programs ($1.1 billion to $2.5 billion in sensitivity analyses). From a 10% decrease to a 10% increase in preventable adverse events, net costs per admission ranged from $99 to $183 for major teaching hospitals and from $17 to $266 for society. With 2.5% to 11.3% decreases in preventable adverse events, costs to society per averted death ranged from $3.4 million to $0.

Conclusions

Implementing the four IOM recommendations would be costly, and their effectiveness is unknown. If highly effective, they could prevent patient harm at reduced or no cost from the societal perspective. However, net costs to teaching hospitals would remain high.

Background Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown.

Methods Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses.

Results Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs.

Conclusions About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards.

The coverage, cost, and quality problems of the U.S. health care system are evident. Sustainable health care reform must go beyond financing expanded access to care to substantially changing the organization and delivery of care. The FRESH-Thinking Project held a series of workshops during which physicians, health policy experts, health insurance executives, business leaders, hospital administrators, economists, and others who represent diverse perspectives came together. This group agreed that the following 8 recommendations are fundamental to successful reform:

1. Replace the current fee-for-service payment system with a payment system that encourages and rewards innovation in the efficient delivery of quality care. The new payment system should invest in the development of outcome measures to guide payment.
2. Establish a securely funded, independent agency to sponsor and evaluate research on the comparative effectiveness of drugs, devices, and other medical interventions.
3. Simplify and rationalize federal and state laws and regulations to facilitate organizational innovation, support care coordination, and streamline financial and administrative functions.
4. Develop a health information technology infrastructure with national standards of interoperability to promote data exchange.
5. Create a national health database with the participation of all payers, delivery systems, and others who own health care data. Agree on methods to make deidentified information from this database on clinical interventions, patient outcomes, and costs available to researchers.
6. Identify revenue sources, including a cap on the tax exclusion of employer-based health insurance, to subsidize health care coverage with the goal of insuring all Americans.
7. Create state or regional insurance exchanges to pool risk, so that Americans without access to employer-based or other group insurance could obtain a standard benefits package through these exchanges. Employers should also be allowed to participate in these exchanges for their employees' coverage.
8. Create a health coverage board with broad stakeholder representation to determine and periodically update the affordable standard benefit package available through state or regional insurance exchanges.

Background: Induction of labor is on the rise in the U.S., increasing from 9.5 percent in 1990 to 22.1 percent in 2004. Although, it is not entirely clear what proportion of these inductions are elective (i.e. without a medical indication), the overall rate of induction of labor is rising faster than the rate of pregnancy complications that would lead to a medically indicated induction. However, the maternal and neonatal effects of induction of labor are unclear. Many studies compare women with induction of labor to those in spontaneous labor. This is problematic, because at any point in the management of the woman with a term gestation, the clinician has the choice between induction of labor and expectant management, not spontaneous labor. Expectant management of the pregnancy involves nonintervention at any particular point in time and allowing the pregnancy to progress to a future gestational age. Thus, women undergoing expectant management may go into spontaneous labor or may require indicated induction of labor at a future gestational age.

Objectives: The Stanford-UCSF Evidence-Based Practice Center examined the evidence regarding four Key Questions: 1) What evidence describes the maternal risks of elective induction versus expectant management? 2) What evidence describes the fetal/neonatal risks of elective induction versus expectant management? 3) What is the evidence that certain physical conditions/patient characteristics are predictive of a successful induction of labor? and 4) How is a failed induction defined?

Methods: We performed a systematic review to answer the Key Questions. We searched MEDLINE^® (1966-2007) and bibliographies of prior systematic reviews and the included studies for English language studies of maternal and fetal outcomes after elective induction of labor. We evaluated the quality of included studies. When possible, we synthesized study data using random effects models. We also evaluated the potential clinical outcomes and cost-effectiveness of elective induction of labor versus expectant management of pregnancy labor at 41, 40, and 39 weeks' gestation using decision-analytic models.

Results: Our searches identified 3,722 potentially relevant articles, of which 76 articles met inclusion criteria. Nine RCTs compared expectant management with elective induction of labor. We found that overall, expectant management of pregnancy was associated with an approximately 22 percent higher odds of cesarean delivery than elective induction of labor (OR 1.22, 95 percent CI 1.07–1.39; absolute risk difference 1.9, 95 percent CI: 0.2–3.7 percent). The majority of these studies were in women at or beyond 41 weeks of gestation (OR 1.21, 95 percent CI 1.01–1.46). In studies of women at or beyond 41 weeks of gestation, the evidence was rated as moderate because of the size and number of studies and consistency of the findings. Among women less than 41 weeks of gestation, there were three trials which reported no difference in risk of cesarean delivery among women who were induced as compared to expectant management (OR 1.73; 95 percent CI: 0.67–4.5, P=0.26), but all of these trials were small, non-U.S., older, and of poor quality. When we stratified the analysis by country, we found that the odds of cesarean delivery were higher in women who were expectantly managed compared to elective induction of labor in studies conducted outside the U.S. (OR 1.22; 95 percent CI 1.05–1.40) but were not statistically different in studies conducted in the U.S. (OR 1.28; 95 percent CI 0.65–2.49). Women who were expectantly managed were also more likely to have meconium-stained amniotic fluid than those who were electively induced (OR 2.04; 95 percent CI: 1.34–3.09). Observational studies reported a consistently lower risk of cesarean delivery among women who underwent spontaneous labor (6 percent) compared with women who had an elective induction of labor (8 percent) with a statistically significant decrease when combined (OR 0.63; 95 percent CI: 0.49–0.79), but again utilized the wrong control group and did not appropriately adjust for gestational age. We found moderate to high quality evidence that increased parity, a more favorable cervical status as assessed by a higher Bishop score, and decreased gestational age were associated with successful labor induction (58 percent of the included studies defined success as achieving a vaginal delivery anytime after the onset of the induction of labor; in these instances, induction was considered a failure when it led to a cesarean delivery).

In the decision analytic model, we utilized a baseline assumption of no difference in cesarean delivery between the two arms as there was no statistically significant difference in the U.S. studies or in women prior to 41 0/7 weeks of gestation. In each of the models, women who were electively induced had better overall outcomes among both mothers and neonates as estimated by total quality-adjusted life years (QALYs) as well as by reduction in specific perinatal outcomes such as shoulder dystocia, meconium aspiration syndrome, and preeclampsia. Additionally, induction of labor was cost-effective at $10,789 per QALY with elective induction of labor at 41 weeks of gestation, $9,932 per QALY at 40 weeks of gestation, and $20,222 per QALY at 39 weeks of gestation utilizing a cost-effectiveness threshold of $50,000 per QALY. At 41 weeks of gestation, these results were generally robust to variations in the assumed ranges in univariate and multi-way sensitivity analyses. However, the findings of cost-effectiveness at 40 and 39 weeks of gestation were not robust to the ranges of the assumptions. In addition, the strength of evidence for some model inputs was low, therefore our analyses are exploratory rather than definitive.

Conclusions: Randomized controlled trials suggest that elective induction of labor at 41 weeks of gestation and beyond may be associated with a decrease in both the risk of cesarean delivery and of meconium-stained amniotic fluid. The evidence regarding elective induction of labor prior to 41 weeks of gestation is insufficient to draw any conclusion. There is a paucity of information from prospective RCTs examining other maternal or neonatal outcomes in the setting of elective induction of labor. Observational studies found higher rates of cesarean delivery with elective induction of labor, but compared women undergoing induction of labor to women in spontaneous labor and were subject to potential confounding bias, particularly from gestational age. Such studies do not inform the question of how elective induction of labor affects maternal or neonatal outcomes. Elective induction of labor at 41 weeks of gestation and potentially earlier also appears to be a cost-effective intervention, but because of the need for further data to populate these models our analyses are not definitive. Despite the evidence from the prospective, RCTs reported above, there are concerns about the translation of such findings into actual practice, thus, there is a great need for studying the translation of such research into settings where the majority of obstetric care is provided.

Russia has one of the world's fastest growing HIV epidemics, and HIV screening has been widespread. Whether such screening is an effective use of resources is unclear. We used epidemiologic and economic data from Russia to develop a Markov model to estimate costs, quality of life and survival associated with a voluntary HIV screening programme compared with no screening in Russia. We measured discounted lifetime health-care costs and quality-adjusted life years (QALYs) gained. We varied our inputs in sensitivity analysis. Early identification of HIV through screening provided a substantial benefit to persons with HIV, increasing life expectancy by 2.1 years and 1.7 QALYs. At a base-case prevalence of 1.2%, once-per-lifetime screening cost $13,396 per QALY gained, exclusive of benefit from reduced transmission. Cost-effectiveness of screening remained favourable until prevalence dropped below 0.04%. When HIV-transmission-related costs and benefits were included, once-per-lifetime screening cost $6910 per QALY gained and screening every two years cost $27,696 per QALY gained. An important determinant of the cost-effectiveness of screening was effectiveness of counselling about risk reduction. Early identification of HIV infection through screening in Russia is effective and cost-effective in all but the lowest prevalence groups.

Abstract

Objective: Inadequate adherence to highly active antiretroviral therapy (HAART) may lead to poor health outcomes and the development of HIV strains that are resistant to HAART. The authors developed a model to evaluate the cost-effectiveness of counseling interventions to improve adherence to HAART among men who have sex with men (MSM). Methods. The authors developed a dynamic compartmental model that incorporates HIV treatment, adherence to treatment, and infection transmission and progression. All data estimates were obtained from secondary sources. The authors evaluated a counseling intervention given prior to initiation of HAART and before all changes in drug regimens, combined with phone-in support while on HAART. They considered a moderate-prevalence and a high-prevalence population of MSM. Results. If the impact of HIV transmission is ignored, the counseling intervention has a cost-effectiveness ratio of $25,500 per quality-adjusted life year (QALY) gained. When HIV transmission is included, the cost-effectiveness ratio is much lower: $7400 and $8700 per QALY gained in the moderate- and high-prevalence populations, respectively. When the intervention is twice as costly per counseling session and half as effective as estimated in the base case (in terms of the number of individuals who become highly adherent, and who remain highly adherent), then the intervention costs $17,100 and $19,600 per QALY gained in the 2 populations, respectively. Conclusions. Counseling to improve adherence to HAART increased length of life, modestly reduced HIV transmission, and cost substantially less than $50,000 per QALY gained over a wide range of assumptions but did not reduce the proportion of drug-resistant strains. Such counseling provides only modest benefit as a tool for HIV prevention but can provide significant benefit for individual patients at an affordable cost.

Although HIV infection is more prevalent in people younger than age 45 years, a substantial number of infections occur in older persons. Recent guidelines recommend HIV screening in patients age 13 to 64 years. The cost-effectiveness of HIV screening in patients age 55 to 75 years is uncertain. OBJECTIVE: To examine the costs and benefits of HIV screening in patients age 55 to 75 years. DESIGN: Markov model. DATA SOURCES: Derived from the literature. TARGET POPULATION: Patients age 55 to 75 years with unknown HIV status. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: HIV screening program for patients age 55 to 75 years compared with current practice. OUTCOME MEASURES: Life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: For a 65-year-old patient, HIV screening using traditional counseling costs $55,440 per QALY compared with current practice when the prevalence of HIV was 0.5% and the patient did not have a sexual partner at risk. In sexually active patients, the incremental cost-effectiveness ratio was $30,020 per QALY. At a prevalence of 0.1%, HIV screening cost less than $60,000 per QALY for patients younger than age 75 years with a partner at risk if less costly streamlined counseling is used. RESULTS OF SENSITIVITY ANALYSIS: Cost-effectiveness of HIV screening depended on HIV prevalence, age of the patient, counseling costs, and whether the patient was sexually active. Sensitivity analyses with other variables did not change the results substantially. LIMITATIONS: The effects of age on the toxicity and efficacy of highly active antiretroviral therapy and death from AIDS were uncertain. Sensitivity analyses exploring these variables did not qualitatively affect the results. CONCLUSION: If the tested population has an HIV prevalence of 0.1% or greater, HIV screening in persons from age 55 to 75 years reaches conventional levels of cost-effectiveness when counseling is streamlined and if the screened patient has a partner at risk. Screening patients with advanced age for HIV is economically attractive in many circumstances.

OBJECTIVE: To use unweighted counts of dependencies in activities of daily living (ADLs) to assess the impact of functional impairment requires an assumption of equal preferences for each ADL dependency. To test this assumption, we analyzed standard gamble (SG) utilities of single and combination ADL dependencies among older adults. STUDY DESIGN AND SETTING: Four hundred older adults used multimedia software (FLAIR1) to report SG utilities for their current health and hypothetical health states of dependency in each of 7 ADLs and 8 of 30 combinations of ADL dependencies. RESULTS: Utilities for health states of multiple ADL dependencies were often greater than for states of single ADL dependencies. Dependence in eating, which is the ADL dependency with the lowest utility rating of the single ADL dependencies, ranked lower than 7 combination states. Similarly, some combination states with fewer ADL dependencies had lower utilities than those with more ADL dependencies. These findings were consistent across groups by gender, age, and education. CONCLUSION: Our results suggest that the count of ADL dependencies does not adequately represent the utility for a health state. Cost-effectiveness analyses and other evaluations of programs that prevent or treat functional dependency should apply utility weights rather than relying on simple ADL counts.