Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children.

BackgroundStudies have noted variations in the cost-effectiveness of school-located influenza vaccination (SLIV), but little is known about how SLIV's cost-effectiveness may vary by targeted age group (e.g., elementary or secondary school students), or vaccine consent process (paper-based or web-based). Further, SLIV's cost-effectiveness may be impacted by its spillover effect on practice-based vaccination; prior studies have not addressed this issue.MethodsWe performed a cost-effectiveness analysis on two SLIV programs in upstate New York in 2015-2016: (a) elementary school SLIV using a stepped wedge design with schools as clusters (24 suburban and 18 urban schools) and (b) secondary school SLIV using a cluster randomized trial (16 suburban and 4 urban schools). The cost-per-additionally-vaccinated child (i.e., incremental cost-effectiveness ratio (ICER)) was estimated by dividing the incremental SLIV intervention cost by the incremental effectiveness (i.e., the additional number of vaccinated students in intervention schools compared to control schools). We performed deterministic analyses, one-way sensitivity analyses, and probabilistic analyses.ResultsThe overall effectiveness measure (proportion of children vaccinated) was 5.7 and 5.5 percentage points higher, respectively, in intervention elementary (52.8%) and secondary schools (48.2%) than grade-matched control schools. SLIV programs vaccinated a small proportion of children in intervention elementary (5.2%) and secondary schools (2.5%). In elementary and secondary schools, the ICER excluding vaccine purchase was $85.71 and$86.51 per-additionally-vaccinated-child, respectively. When additionally accounting for observed spillover impact on practice-based vaccination, the ICER decreased to $80.53 in elementary schools -- decreasing substantially in secondary schools. (to$53.40). These estimates were higher than the published practice-based vaccination cost (median = $25.50, mean =$45.48). Also, these estimates were higher than our 2009-2011 urban SLIV program mean costs ($65) due to additional costs for use of a new web-based consent system ($12.97 per-additionally-vaccinated-child) and higher project coordination costs in 2015-2016. One-way sensitivity analyses showed that ICER estimates were most sensitive to the SLIV effectiveness.ConclusionsSLIV raises vaccination rates and may increase practice-based vaccination in primary care practices. While these SLIV programs are effective, to be as cost-effective as practice-based vaccination our SLIV programs would need to vaccinate more students and/or lower the costs for consent systems and project coordination.Trial registrationClinicalTrials.gov NCT02227186 (August 25, 2014), updated NCT03137667 (May 2, 2017)

Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice

Abstract Background Most randomized controlled trials of interventions designed to promote cancer screening, particularly those targeting poor and minority patients, enroll selected patients. Relatively little is known about the benefits of these interventions among unselected patients. Methods/Design "Get Screened" is an American Cancer Society-sponsored randomized controlled trial designed to promote mammography and colorectal cancer screening in a primary care practice serving low-income patients. Eligible patients who are past due for mammography or colorectal cancer screening are entered into a tracking registry and randomly assigned to early or delayed intervention. This 6-month intervention is multimodal, involving patient prompts, clinician prompts, and outreach. At the time of the patient visit, eligible patients receive a low-literacy patient education tool. At the same time, clinicians receive a prompt to remind them to order the test and, when appropriate, a tool designed to simplify colorectal cancer screening decision-making. Patient outreach consists of personalized letters, automated telephone reminders, assistance with scheduling, and linkage of uninsured patients to the local National Breast and Cervical Cancer Early Detection program. Interventions are repeated for patients who fail to respond to early interventions. We will compare rates of screening between randomized groups, as well as planned secondary analyses of minority patients and uninsured patients. Data from the pilot phase show that this multimodal intervention triples rates of cancer screening (adjusted odds ratio 3.63; 95% CI 2.35 - 5.61). Discussion This study protocol is designed to assess a multimodal approach to promotion of breast and colorectal cancer screening among underserved patients. We hypothesize that a multimodal approach will significantly improve cancer screening rates. The trial was registered at Clinical Trials.gov NCT00818857http://deepblue.lib.umich.edu/bitstream/2027.42/78264/1/1472-6963-10-280.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78264/2/1472-6963-10-280.pdfPeer Reviewe

Cost effectiveness analysis of Year 2 of an elementary school-located influenza vaccination program–Results from a randomized controlled trial

BACKGROUND: School-located vaccination against influenza (SLV-I) has the potential to improve current suboptimal influenza immunization coverage for U.S. school-aged children. However, little is known about SLV-I’s cost-effectiveness. The objective of this study is to establish the cost-effectiveness of SLV-I based on a two-year community-based randomized controlled trial (Year 1: 2009–2010 vaccination season, an unusual H1N1 pandemic influenza season, and Year 2: 2010–2011, a more typical influenza season). METHODS: We performed a cost-effectiveness analysis on a two-year randomized controlled trial of a Western New York SLV-I program. SLV-I clinics were offered in 21 intervention elementary schools (Year 1 n = 9,027; Year 2 n = 9,145 children) with standard-of-care (no SLV-I) in control schools (Year 1 n = 4,534 (10 schools); Year 2 n = 4,796 children (11 schools)). We estimated the cost-per-vaccinated child, by dividing the incremental cost of the intervention by the incremental effectiveness (i.e., the number of additionally vaccinated students in intervention schools compared to control schools). RESULTS: In Years 1 and 2, respectively, the effectiveness measure (proportion of children vaccinated) was 11.2 and 12.0 percentage points higher in intervention (40.7 % and 40.4 %) than control schools. In year 2, the cost-per-vaccinated child excluding vaccine purchase ($59.88 in 2010 US$) consisted of three component costs: (A) the school costs ($8.25); (B) the project coordination costs ($32.33); and (C) the vendor costs excluding vaccine purchase ($16.68), summed through Monte Carlo simulation. Compared to Year 1, the two component costs (A) and (C) decreased, while the component cost (B) increased in Year 2. The cost-per-vaccinated child, excluding vaccine purchase, was$59.73 (Year 1) and $59.88 (Year 2, statistically indistinguishable from Year 1), higher than the published cost of providing influenza vaccination in medical practices ($39.54). However, taking indirect costs (e.g., averted parental costs to visit medical practices) into account, vaccination was less costly in SLV-I ($23.96 in Year 1,$24.07 in Year 2) than in medical practices. CONCLUSIONS: Our two-year trial’s findings reinforced the evidence to support SLV-I as a potentially favorable system to increase childhood influenza vaccination rates in a cost-efficient way. Increased efficiencies in SLV-I are needed for a sustainable and scalable SLV-I program

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

Crime And Criminal Justice: Applied Research From Routine Monitoring To Evidence-Based Practices

Applied research has been at, and remains at, the heart of the fields of criminology and criminal justice since the days of the moral statisticians. This article examines some of the history of applied research in these fields, and the roles of government, university-based, and nonuniversity-based researchers. The impact of different sources of funding and the challenges that funding produce to the integrity of applied research are canvassed. Particular attention is paid to applied research in the areas of prevention, intervention, and evaluation studies. The development of evidence-based practices, implementation research, and translational research is also covered as part of the evolution of applied research in criminal justice and criminology. Exemplars in the areas of corrections and policing are offered to highlight the continuing development of this important aspect of the application of social science research to applied problems

Reducing Geographic, Racial, and Ethnic Disparities in Childhood Immunization Rates by Using Reminder/Recall Interventions in Urban Primary Care Practices

CONTEXT: An overarching national health goal of Healthy People 2010 is to eliminate disparities in leading health care indicators including immunizations. Disparities in US childhood immunization rates persist, with inner-city, black, and Hispanic children having lower rates. Although practice or clinic-based interventions, such as patient reminder/recall systems, have been found to improve immunization rates in specific settings, there is little evidence that those site-based interventions can reduce disparities in immunization rates at the community level. OBJECTIVE: To assess the effect of a community-wide reminder, recall, and outreach (RRO) system for childhood immunizations on known disparities in immunization rates between inner-city versus suburban populations and among white, black, and Hispanic children within an entire county. SETTING: Monroe County, New York (birth cohort: 10 000, total population: 750 000), which includes the city of Rochester. Three geographic regions within the county were compared: the inner city of Rochester, which contains the greatest concentration of poverty (among 2-year-old children, 64% have Medicaid); the rest of the city of Rochester (38% have Medicaid); and the suburbs of the county (8% have Medicaid). INTERVENTIONS: An RRO system was implemented in 8 city practices in 1995 (covering 64% of inner-city children) and was expanded to 10 city practices by 1999 (covering 74% of inner-city children, 61% of rest-of-city children, and 9% of suburban children). The RRO intervention involved lay community-based outreach workers who were assigned to city practices to track immunization rates of all 0- to 2-year-olds, and to provide a staged intervention with increasing intensity depending on the degree to which children were behind in immunizations (tracking for all children, mail, or telephone reminders for most children, assistance with transportation or scheduling for some children, and home visits for 5% of children who were most behind in immunizations and who faced complex barriers). STUDY PARTICIPANTS: Three separate cohorts of 0- to 2-year-old children were assessed-those residing in the county in 1993, 1996, and 1999. STUDY DESIGN: Immunization rates were measured for each geographic region in Monroe County at 3 time periods: before the implementation of a systematic RRO system (1993), during early phases of implementation of the RRO system (1996), and after implementation of the RRO system in 10 city practices (1999). Immunization rates were compared for children living in the 3 geographic regions, and for white, black, and Hispanic children. Immunization rates were measured by the same methodology in each of the 3 time periods. A denominator of children was obtained by merging patient lists from the practice files of most pediatric and family medicine practices in the county (covering 85% to 89% of county children). A random sample of children (>500 from the suburbs and >1200 from the city for each sampling period) was then selected for medical chart review at practices to determine demographic characteristics (including race and ethnicity) and immunization rates. City children were oversampled to allow detection of effects by geographic region and race. Rates for the 3 geographic regions and for the entire county were determined using Stata to adjust for the clustered sampling. MAIN OUTCOME MEASURES: Immunization rates at 12 and 24 months for recommended vaccines (4 diphtheria-tetanus-pertussis:3 polio:1 measles-mumps-rubella: > or =1 Haemophilus influenzae type b on or after 12 months of age). RESULTS: DISPARITIES BY GEOGRAPHIC REGION: Baseline immunization rates (1993) for 24-month-olds were as follows: inner city (55%), rest of city (64%), and suburbs (73%), with an 18% difference in rates between the inner city and suburbs. By 1996, immunization rates rose faster in the inner city (+21% points) than in the suburbs (+14% points) so that the difference in rates between the inner city and suburbs had narrowed to 11%. In 1999, rates were similar across geographic regions: inner city (84%), rest of city (81%), and suburbs (88%), with a 4% difference between the inner city and suburbs. DISPARITIES BY RACE AND ETHNICITY: Immunization rates were available in 1996 and 1999 by race and ethnicity. Twenty-four-month immunization rates in 1996 showed disparities: white (89%), black (76%), and Hispanic (74%), with a 13% difference between rates for white and black children and a 15% difference between white and Hispanic children. In 1999, rates were similar across the groups: white (88%), black (81%), and Hispanic (87%), with a 7% difference between rates for white and black children, and a 1% difference between white and Hispanic children. CONCLUSIONS: A community-wide intervention of patient RRO raised childhood immunization rates in the inner city of Rochester and was associated with marked reductions in disparities in immunization rates between inner-city and suburban children and among racial and ethnic minority populations. By targeting a relatively manageable number of primary care practices that serve city children and using an effective strategy to increase immunization rates in each practice, it is possible to eliminate disparities in immunizations for vulnerable children