Abstract

OBJECTIVE:

To evaluate the relationship between competition among fertility clinics and assisted reproductive technology (ART) treatment outcomes, particularly multiple births.

DESIGN:

Using clinic-level data from 1995 to 2001, we examined the relationship between competition and clinic-level ART outcomes and practice patterns.

SETTING:

National database registry.

PATIENT(S):

Clinics performing ART.

INTERVENTION(S):

The number of clinics within a 20-mile (32.19-km) radius of a given clinic.

MAIN OUTCOME MEASURE(S):

Clinic-level births, singleton births, and multiple births per ART cycle; multiple births per ART birth; average number of embryos transferred per cycle; and the proportion of cycles for women under age 35 years.

RESULT(S):

The number of competing clinics is not strongly associated with ART birth and multiple birth rates. Relative to clinics with no competitors, the rate of multiple births per cycle is lower (-0.03 percentage points) only for clinics with more than 15 competitors. Embryo transfer practices are not statistically significantly associated with the number of competitors. Clinic-level competition is strongly associated with patient mix. The proportion of cycles for patients under 35 years old is 6.4 percentage points lower for clinics with more than 15 competitors than for those with no competitors.

CONCLUSION(S):

Competition among fertility clinics does not appear to increase rates of multiple births from ART by promoting more aggressive embryo transfer decisions.

Abstract

To examine the relationship between state insurance mandate status and the number of embryos transferred in assisted reproductive technology cycles, we conducted a retrospective analysis of clinics reporting to the publicly available national Society for Assisted Reproductive Technology registry. We found that clinics in states with comprehensive mandates transferred between 0.210 and 0.288 fewer embryos per cycle depending upon patient age, and were more likely to transfer fewer embryos than recommended for older women; however, the relationship between state mandate status and clinic birth and multiple birth rates varied by age group.

Abstract

Background

Opioid prescribing for chronic pain is common and controversial, but recommended clinical practices are followed inconsistently in many clinical settings. Strategies for increasing adherence to clinical practice guideline recommendations are needed to increase effectiveness and reduce negative consequences of opioid prescribing in chronic pain patients.

Methods

Here we describe the process and outcomes of a project to operationalize the 2003 VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Non-Cancer Pain into a computerized decision support system (DSS) to encourage good opioid prescribing practices during primary care visits. We based the DSS on the existing ATHENA-DSS. We used an iterative process of design, testing, and revision of the DSS by a diverse team including guideline authors, medical informatics experts, clinical content experts, and end-users to convert the written clinical practice guideline into a computable algorithm to generate patient-specific recommendations for care based upon existing information in the electronic medical record (EMR), and a set of clinical tools.

Results

The iterative revision process identified numerous and varied problems with the initially designed system despite diverse expert participation in the design process. The process of operationalizing the guideline identified areas in which the guideline was vague, left decisions to clinical judgment, or required clarification of detail to insure safe clinical implementation. The revisions led to workable solutions to problems, defined the limits of the DSS and its utility in clinical practice, improved integration into clinical workflow, and improved the clarity and accuracy of system recommendations and tools.

Conclusions

Use of this iterative process led to development of a multifunctional DSS that met the approval of the clinical practice guideline authors, content experts, and clinicians involved in testing. The process and experiences described provide a model for development of other DSSs that translate written guidelines into actionable, real-time clinical recommendations.

Abstract

OBJECTIVE:

To assess the evidence for interventions designed to prevent or reduce overweight and obesity in children younger than 2 years.

DATA SOURCES:

MEDLINE, the Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, and references from relevant articles.

STUDY SELECTION:

Included were published studies that evaluated an intervention designed to prevent or reduce overweight or obesity in children younger than 2 years.

DATA EXTRACTION:

Extracted from eligible studies were measured outcomes, including changes in child weight status, dietary intake, and physical activity and parental attitudes and knowledge about nutrition. Studies were assessed for scientific quality using standard criteria, with an assigned quality score ranging from 0.00 to 2.00 (0.00-0.99 is poor, 1.00-1.49 is fair, and 1.50-2.00 is good).

DATA SYNTHESIS:

We retrieved 1557 citations; 38 articles were reviewed, and 12 articles representing 10 studies met study inclusion criteria. Eight studies used educational interventions to promote dietary behaviors, and 2 studies used a combination of nutrition education and physical activity. Study settings included home (n = 2), clinic (n = 3), classroom (n = 4), or a combination (n = 1). Intervention durations were generally less than 6 months and had modest success in affecting measures, such as dietary intake and parental attitudes and knowledge about nutrition. No intervention improved child weight status. Studies were of poor or fair quality (median quality score, 0.86; range, 0.28-1.43).

CONCLUSIONS:

Few published studies attempted to intervene among children younger than 2 years to prevent or reduce obesity. Limited evidence suggests that interventions may improve dietary intake and parental attitudes and knowledge about nutrition for children in this age group. For clinically important and sustainable effect, future research should focus on designing rigorous interventions that target young children and their families.

The demands on emergency services have grown relentlessly, and the Institute of Medicine (IOM) has asserted the need for “regionalized, coordinated, and accountable emergency care systems throughout the country.” There are large gaps in the evidence base needed to fix the problem of how emergency care is organized and delivered, and science is urgently needed to define and measure success in the emerging network of emergency care. In 2010, Academic Emergency Medicine convened a consensus conference entitled “Beyond Regionalization: Integrated Networks of Emergency Care.” This article is a product of the conference breakout session on “Defining and Measuring Successful Networks”; it explores the concept of integrated emergency care delivery and prioritizes a research agenda for how to best define and measure successful networks of emergency care. The authors discuss five key areas: 1) the fundamental metrics that are needed to measure networks across time-sensitive and non–time-sensitive conditions; 2) how networks can be scalable and nimble and can be creative in terms of best practices; 3) the potential unintended consequences of networks of emergency care; 4) the development of large-scale, yet feasible, network data systems; and 5) the linkage of data systems across the disease course. These knowledge gaps must be filled to improve the quality and efficiency of emergency care and to fulfill the IOM’s vision of regionalized, coordinated, and accountable emergency care systems.

There used to be something called child health policy. It was focused on crafting a national agenda for child health and was explicit in distinguishing the special needs of children from those of the adult world. During earlier periods, child health policy was dedicated to translating the rapidly expanding science of child development and pediatrics into crucial programmatic priorities and implementation strategies.[1] and [2] The concern was as much for coherence as rigor and found concrete expression in the White House Conferences on Children and Youth that were held under the leadership of virtually every president from Theodore Roosevelt through Richard Nixon. There has been no such conference since 1971; recent bills to organize such a conference are currently languishing in Congress.

This report evaluates the level of evidence currently available to support the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications not approved by the U. S. Food and Drug Administration (FDA). rFVIIa is approved for a variety of uses in hemophilia patients who have developed antibody inhibitors that compromise the use of standard factor replacement. Use of this costly biologic product has expanded beyond these hemophilia-related indications to encompass a range of off-label uses, most of which are in-hospital uses. These uses differ substantially from the drug’s FDA approved label. The purpose of this report is two-fold: (1) To document the full range of clinical indications for which rFVIIa is being used and the types of studies available to evaluate these uses and (2) To provide a comparative effectiveness review of rFVIIa vs. usual care for several in-hospital clinical indications: intracranial hemorrhage, massive bleeding secondary to trauma, and the selected surgical procedures of cardiac surgery, liver transplantation, and prostatectomy.

Off-label drug use refers to any use of a medication that deviates from the product labeling approved and required by the FDA. The FDA drug approval process mandates randomized clinical trials that demonstrate efficacy and safety for specific indications prior to marketing. Once approval is given, however, the FDA does not regulate whether drugs are prescribed for off-label indications. In most instances, the data supporting off-label drug use falls short of the rigor that accompanies FDA review. This uncertainty may be acceptable, as when a drug’s use is infrequent. Nevertheless, concerns increase when off-label use is clinically distinct from approved indications, when off-label use becomes frequent, when a drug is costly, or when a drug is used in different clinical settings (e.g., shifts from outpatient to in-hospital use).

rFVIIa is a form of human factor VII produced by recombinant technology. This intravenously delivered product works as a potent procoagulant by effectively bypassing parts of the clotting process normally required for clotting. It can facilitate control of bleeding in situations where standard human blood product transfusions have failed. Novoseven® is the only form of rFVIIa available commercially. Developed in the late 1980s, rFVIIa was approved by the FDA in 1999 for use in patients with Hemophilia A and Hemophilia B with antibody inhibitors that lead to unresponsiveness to factor VIII or factor IX, respectively. Both of these X-linked genetic conditions are rare, and most hemophilia patients never require rFVIIa for treatment of bleeding episodes. While the hemophilia population has remained stable over the past decade, in-hospital, off-label use of rFVIIa has increased. 

Background: Sodium consumption raises blood pressure, increasing the risk for heart attack and stroke. Several countries, including the United States, are considering strategies to decrease population sodium intake.

Objective: To assess the cost-effectiveness of 2 population strategies to reduce sodium intake: government collaboration with food manufacturers to voluntarily cut sodium in processed foods, modeled on the United Kingdom experience, and a sodium tax.

Design: A Markov model was constructed with 4 health states: well, acute myocardial infarction (MI), acute stroke, and history of MI or stroke.

Data Sources: Medical Panel Expenditure Survey (2006), Framingham Heart Study (1980 to 2003), Dietary Approaches to Stop Hypertension trial, and other published data.

Target Population: U.S. adults aged 40 to 85 years.

Time Horizon: Lifetime.

Perspective: Societal.

Outcome Measures: Incremental costs (2008 U.S. dollars), quality-adjusted life-years (QALYs), and MIs and strokes averted.

Results of Base-case Analysis: Collaboration with industry that decreases mean population sodium intake by 9.5% averts 513 885 strokes and 480 358 MIs over the lifetime of adults aged 40 to 85 years who are alive today compared with the status quo, increasing QALYs by 2.1 million and saving $32.1 billion in medical costs. A tax on sodium that decreases population sodium intake by 6% increases QALYs by 1.3 million and saves $22.4 billion over the same period.

Results of Sensitivity Analysis: Results are sensitive to the assumption that consumers have no disutility with modest reductions in sodium intake.

Limitation: Efforts to reduce population sodium intake could result in other dietary changes that are difficult to predict.

Conclusion: Strategies to reduce sodium intake on a population level in the United States are likely to substantially reduce stroke and MI incidence, which would save billions of dollars in medical expenses.

Primary Funding Source: Department of Veterans Affairs, Stanford University, and the National Science Foundation.