A Cost-Effectiveness Analysis of Population-Level Dental Caries Prevention Strategies in US Children.

OBJECTIVE: To improve oral health disparities and outcomes among US children impacted by dental caries, there is a need to understand the cost-effectiveness of a targeted, risk-based versus universal-based approach for caries prevention. METHODS: Health and economic outcomes were simulated in a cohort of 50,000 US children aged 1-18 years, comparing current practice (CP) to risk-based-prevention (RBP) and prevention-for-all (PFA) strategies using health care sector and limited societal perspectives. Prevention included biannual oral health exams and fluoride varnish application, and one-time dental sealant placement. The primary outcome is the cost-effectiveness ratio (ICER), defined as the additional cost per quality-adjusted life year (QALY) gained when comparing each strategy to the next least costly one. RESULTS: For RBP compared to CP, the ICER was US$83,000/QALY from the health care sector perspective; for PFA compared to RBP the ICER was US$154,000/QALY. Using a limited societal perspective that includes caregiver time spent attending dental or medical setting visits, RBP compared to CP yielded a ratio of $119,000/QALY and PFA compared to RBP was $235,000/QALY. Results were most sensitive to changes in the probability of pain from an episode of dental caries, costs for prevention and restoration, and the loss in health-related quality of life due to dental caries pain. Scenario analyses evaluating a reduced intensity of prevention services yielded lower ICERs. CONCLUSION: Using a risk-based approach that identifies and targets children at increased risk for dental caries to guide the delivery of prevention services represents an economic value similar to other pediatric prevention programs.

Cost-effectiveness of routine annual influenza vaccination by age and risk status.

BACKGROUND: The epidemiology of circulating seasonal influenza strains changed following the 2009 pandemic influenza A(H1N1). A universal influenza vaccination recommendation has been implemented and new vaccine types have become available post-2009. The objective of this study was to evaluate the cost-effectiveness of routine annual influenza vaccination in the context of this new evidence. METHODS: A state transition simulation model was constructed to estimate the health and economic outcomes of influenza vaccination compared to no vaccination for hypothetical US cohorts stratified by age and risk status. Model input parameters were derived from multiple sources, including post-2009 vaccine effectiveness data from the US Flu Vaccine Effectiveness Network. The analysis used societal and healthcare sector perspectives and a one-year time horizon, except permanent outcomes were also included. The primary outcome was the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life years (QALYs) gained. RESULTS: Compared to no vaccination, vaccination yielded ICERs lower than $95,000/QALY for all age and risk groups, except for non-high-risk adults 18-49 years ($194,000/QALY). Vaccination was cost-saving for adults ≥50 years at higher risk for influenza-related complications. Results were most sensitive to changes in the probability of influenza illness. Performing the analysis from the healthcare sector perspective, excluding vaccination time costs, delivering vaccinations in lower-cost settings, and including productivity losses improved the cost-effectiveness of vaccination. Sensitivity analysis revealed that vaccination remains below $100,000/QALY for older persons ≥65 years at vaccine effectiveness estimates as low as 4 %. CONCLUSIONS: Cost-effectiveness of influenza vaccination varied by age and risk status and was less than $95,000/QALY for all subgroups, except for non-high-risk working-age adults. Results were sensitive to the probability of influenza illness and vaccination was more favorable under certain scenarios. Vaccination for higher risk subgroups resulted in ICERs below $100,000/QALY even at low levels of vaccine effectiveness or circulating virus.

Quantification of Mucosal Activity from Colonoscopy Reports via the Simplified Endoscopic Mucosal Assessment for Crohn's Disease.

BACKGROUND: Endoscopic mucosal healing is the gold standard for evaluating Crohn's disease (CD) treatment efficacy. Standard endoscopic indices are not routinely used in clinical practice, limiting the quality of retrospective research. A method for retrospectively quantifying mucosal activity from documentation is needed. We evaluated the simplified endoscopic mucosal assessment for CD (SEMA-CD) to determine if it can accurately quantify mucosal severity recorded in colonoscopy reports. METHODS: Pediatric patients with CD underwent colonoscopy that was video recorded and evaluated via Simple Endoscopic Score for CD (SES-CD) and SEMA-CD by central readers. Corresponding colonoscopy reports were de-identified. Central readers blinded to clinical history and video scoring were randomly assigned colonoscopy reports with and without images. The SEMA-CD was scored for each report. Correlation with video SES-CD and SEMA-CD were assessed with Spearman rho, inter-rater, and intrarater reliability with kappa statistics. RESULTS: Fifty-seven colonoscopy reports were read a total of 347 times. The simplified endoscopic mucosal assessment for CD without images correlated with both SES-CD and SEMA-CD from videos (rho = 0.82, P < .0001 for each). The addition of images provided similar correlation. Inter-rater and intrarater reliability were 0.93 and 0.92, respectively. CONCLUSIONS: The SEMA-CD applied to retrospective evaluation of colonoscopy reports accurately and reproducibly correlates with SES-CD and SEMA-CD of colonoscopy videos. The SEMA-CD for evaluating colonoscopy reports will enable quantifying mucosal healing in retrospective research. Having objective outcome data will enable higher-quality research to be conducted across multicenter collaboratives and in clinical registries. External validation is needed.

Development and Testing of a New Simplified Endoscopic Mucosal Assessment for Crohn's Disease: The SEMA-CD.

OBJECTIVES: Endoscopic mucosal improvement is the gold standard for assessing treatment efficacy in clinical trials of Crohn's disease. Current endoscopic indices are not routinely used in clinical practice. The lack of endoscopic information in large clinical registries limits their use for research. A quick, easy, and accurate method is needed for assessing mucosal improvement for clinicians in real-world practice. We developed and tested a novel simplified endoscopic mucosal assessment for Crohn's disease (SEMA-CD). METHODS: We developed a 5-point scale for ranking endoscopic severity of ileum and colon based on Simple Endoscopic Score for Crohn's disease (SES-CD). Central readers were trained to perform SES-CD and SEMA-CD. Pediatric patients with Crohn's disease undergoing colonoscopy were enrolled. Video recordings of colonoscopies were de-identified and randomly assigned to blinded central readers. The SES-CD and SEMA-CD were scored for each video. The SES-CD was considered the validated standard for comparison. Correlation was assessed with Spearman rho, inter- and intrarater reliability with kappa statistics. RESULTS: Fifty-seven colonoscopies were read a total of 212 times. Correlation between SEMA-CD and SES-CD was strong (rho = 0.98, P < 0.0001). Inter-rater reliability for SEMA-CD was 0.80, and intrarater reliability was 0.83. Central readers rated SEMA-CD as easier than SES-CD. CONCLUSION: The SEMA-CD accurately and reproducibly correlates with the standard SES-CD. Central readers viewed SEMA-CD as easier than SES-CD. Use of SEMA-CD in practice should enable collecting mucosal improvement information in large populations of patients. This will improve the quality of research that can be conducted in clinical registries. External validation is needed.

Validation of EpiTRAQ, a transition readiness assessment tool for adolescents and young adults with epilepsy.

OBJECTIVE: To design and validate a transition readiness assessment tool for adolescents and young adults with epilepsy and without intellectual disability. METHODS: We adapted a general transition readiness assessment tool (TRAQ) to add epilepsy-relevant items based on concepts in current epilepsy quality measures. The adapted tool, EpiTRAQ, maintained the original structure and scoring system. Concurrent with clinical implementation in pediatric and adult epilepsy clinics at an academic medical center, we assessed the validity and reliability of this adapted tool for patients 16-26 years of age. This process included initial validation with 302 patients who completed EpiTRAQ between October 2017 and May 2018; repeat validation with 381 patients who completed EpiTRAQ between June 2018 and September 2019; and retest reliability among 153 patients with more than one completed EpiTRAQ. RESULTS: Mean scores were comparable between initial and repeat validation populations (absolute value differences between 0.05 and 0.1); internal consistency ranged from good to high. For both the initial and repeat validation, mean scores and internal consistency demonstrated high comparability to the original TRAQ validation results. Upon retest, few patients rated themselves with a lower score, while the majority rated themselves with higher scores. SIGNIFICANCE: EpiTRAQ is a valid and reliable tool for assessing transition readiness in adolescents and young adults with epilepsy and without intellectual disability.

An assessment of child passenger safety levels of service in Michigan.

Objective: The purpose of this article was to assess the match between child passenger safety resources (child passenger safety technicians [CPSTs], car seat checks, and child restraint system [CRS] distribution programs) and the child population in Michigan by utilizing geographic information systems approaches and to analyze the impact of Michigan's CPSTs on child passenger safety behaviors on departure from a seat check. Methods: Data were collected from administrative sources and a survey of CPSTs to determine the number and location of child passenger safety resources and children in Michigan. The main analyses used data from 2014. The child population ≤4 years old per county and per traffic safety region was determined from census data. CPST and car seat check locations were determined from a list from the Michigan Office of Highway Safety Planning (Mi-OHSP) and a survey of CPSTs who coordinate seat checks. Summary sheets from Mi-OHSP served as the data source for CRSs distributed through their occupant protection program. Data from child passenger safety checklists completed with seat checks were obtained from Safe Kids Michigan. Addresses were geocoded using Google Maps Geocoding API and then mapped at the county level using ArcGIS Desktop 10.3.1. Descriptive statistics were calculated and levels of service were determined at the county and regional levels. Results: In 2014, there were 570,929 children ≤4 years old in Michigan and 979 CPSTs who worked at 209 known seat check locations. An average of 6,854 seats was checked per year through Safe Kids Michigan Coalitions. All but 3 regions met an intermediate service level for seat check locations by offering one or more per 5,000 children ≤4 years old. There was at least one CPST in 80 of 83 counties (median 5; interquartile range, 2, 10.5). Assuming that an average Michigan CPST provides 10 h of service each year, all but 2 regions reached an intermediate service level of at least one technician hour per 90 children ≤4 years old. Fewer regions reached a basic level of service for the number of seat checks. Almost half (49.5%) of Safe Kids Michigan seat checks resulted in a change in child passenger safety behaviors. Conclusions: Child passenger safety resources in Michigan are not evenly distributed yet most regions and counties meet intermediate levels of service. Reallocating resources to areas that are providing basic levels of service could help reduce disparities in child passenger safety behaviors.

A Cost-Effectiveness Analysis of Vaccination for Prevention of Herpes Zoster and Related Complications: Input for National Recommendations.

Background: The U.S. Advisory Committee on Immunization Practices recently developed recommendations for use of a new recombinant zoster vaccine (RZV). Objective: To evaluate the cost-effectiveness of vaccination with RZV compared with zoster vaccine live (ZVL) and no vaccination, the cost-effectiveness of vaccination with RZV for persons who have previously received ZVL, and the cost-effectiveness of preferential vaccination with RZV over ZVL. Design: Simulation (state-transition) model using U.S. epidemiologic, clinical, and cost data. Data Sources: Published data. Target Population: Hypothetical cohort of immunocompetent U.S. adults aged 50 years or older. Time Horizon: Lifetime. Perspective: Societal and health care sector. Intervention: Vaccination with RZV (recommended 2-dose regimen), vaccination with ZVL, and no vaccination. Outcome Measures: The primary outcome measure was the incremental cost-effectiveness ratio (ICER). Results of Base-Case Analysis: For vaccination with RZV compared with no vaccination, ICERs ranged by age from $10 000 to $47 000 per quality-adjusted life-year (QALY), using a societal perspective and assuming 100% completion of the 2-dose RZV regimen. For persons aged 60 years or older, ICERs were less than $60 000 per QALY. Vaccination with ZVL was dominated by vaccination with RZV for all age groups 60 years or older. Results of Sensitivity Analysis: Results were most sensitive to changes in vaccine effectiveness, duration of protection, herpes zoster incidence, and probability of postherpetic neuralgia. Vaccination with RZV after previous administration of ZVL yielded an ICER of less than $60 000 per QALY for persons aged 60 years or older. In probabilistic sensitivity analyses, RZV remained the preferred strategy in at least 95% of simulations, including those with 50% completion of the second dose. Limitation: Few data were available on risk for serious adverse events, adherence to the recommended 2-dose regimen, and probability of recurrent zoster. Conclusion: Vaccination with RZV yields cost-effectiveness ratios lower than those for many recommended adult vaccines, including ZVL. Results are robust over a wide range of plausible values. Primary Funding Source: Centers for Disease Control and Prevention.

An Assessment of Public Preferences for Newborn Screening Using Best-Worst Scaling.

OBJECTIVE: To identify and quantify public preferences for attributes of newborn screening conditions. STUDY DESIGN: We conducted an online national survey of the public (n = 502) to evaluate preferences for attributes of candidate newborn screening conditions. Respondents were presented with hypothetical condition profiles that were defined using 10 attributes with 2-6 levels per attribute. Participants indicated whether they would recommend screening for a condition and which condition attributes were most and least important when making this decision (best-worst scaling). Difference scores were calculated and stratified by condition recommendation (recommend or not recommend for screening). Regression analyses were used to evaluate the effect of attributes on choice to screen or not screen. RESULTS: The number of babies diagnosed was important to those who would recommend newborn screening for a profile, and age at which the treatment would start was important to those who would not recommend newborn screening. Cost was considered to be a key attribute, and treatment effectiveness and impact of making the diagnosis through newborn screening were of low importance for both groups. CONCLUSION: Public preferences identified through survey methods that provide an adequate baseline understanding of newborn screening can be used to inform newborn screening decisions.

Insurance Among Young Adults With Inflammatory Bowel Disease: Changes Under the Affordable Care Act Dependent Provision.

BACKGROUND: A total of 20% to 30% of patients with inflammatory bowel disease (IBD) present before age 18 years, eventually requiring transfer to adult care. Vulnerability during transfer may be exacerbated by loss of insurance. A provision of the Affordable Care Act (ACA) allows young adults (YAs) to remain on parental private insurance through age 25 years. There has been a decrease in uninsured YAs since its implementation in 2010. Little is known about whether insurance coverage of YAs with IBD has been affected. OBJECTIVE: The aim of the present study was to determine whether the proportion of uninsured YAs with IBD has changed following the implementation of extended dependent eligibility under the ACA. METHODS: We conducted a cross-sectional analysis of hospitalized patients with IBD, identified in the Nationwide Inpatient Sample (NIS) using diagnostic codes, to estimate proportions of insurance coverage during the years 2006-2013. We compared 19 to 25 year olds to 2 to 18 and 26 to 35 year olds, unaffected by the provision, to account for underlying trends. RESULTS: From 2006 to 2010, 19 to 25 year olds had the highest proportion of uninsured, peaking at 14.1% in 2010. In 2011, the proportion decreased to 10.1%, below the proportion of uninsured 26 to 35 year olds (13.1%), remaining in this range through 2013. Private coverage increased in 2011 for 19 to 25 year olds, remaining stable for 26 to 35 year olds. DISCUSSION: Previous research cited 5% uninsured among all hospitalized patients with IBD. Our study indicates a higher proportion for YAs, decreasing after the ACA. Lack of insurance increases vulnerability during transfer but may be modifiable through policy change. Furthermore, research should analyze the effects of Medicaid expansion and health care exchanges.

Measuring family HRQoL spillover effects using direct health utility assessment.

BACKGROUND: Applications of cost-effectiveness analysis do not typically incorporate effects on caregiver quality of life despite increasing evidence that these effects are measurable. METHODS: Using a national sample of US adults, we conducted 2 cross-sectional surveys during December 2011 and January 2012. One version asked respondents to value their own experience as the family member of a person with a chronic illness (experienced sample), and the other version asked respondents to value hypothetical scenarios describing the experience of having a family member with a chronic illness (community sample). Conditions included Alzheimer's disease/dementia, arthritis, cancer, and depression. Using standard gamble questions, respondents were asked to value the spillover effects of a family member's illness. We used regression analysis to evaluate the disutility (loss in health-related quality of life) of having a family member with a chronic illness by condition and relationship type, controlling for the respondent's own conditions and sociodemographic characteristics. RESULTS: For the experienced sample (n = 1389), regression analyses suggested that greater spillover was associated with certain conditions (arthritis, depression) compared with other conditions (Alzheimer's disease, cancer). For the community sample (n = 1205), regression analyses indicated that lower spillover was associated with condition (cancer) but not the type of relationship with the ill family member (parent, child, spouse). CONCLUSIONS: The effects of illness extend beyond the individual patient to include effects on caregivers of patients, parents of ill children, spouses, and other close family and household members. Cost-effectiveness analyses should consider the inclusion of health-related quality of life spillover effects in addition to caregiving time costs incurred by family members of ill individuals.

False-positive newborn screening result and future health care use in a state Medicaid cohort.

OBJECTIVE: To compare health care visit rates between infants with false-positive and those with normal newborn screening (NBS) results. PATIENTS AND METHODS: We analyzed administrative claims of Medicaid-enrolled infants born in Michigan in 2006 and calculated the average number of outpatient, emergency department, and hospital visits for infants aged 3 to 12 months according to NBS results. We calculated an adjusted incidence rate ratio for each visit category, adjusting for covariates and accounting for interaction effects. RESULTS: Of the 49,959 infants in the analysis, 818 had a false-positive NBS result. We noted a significant interaction between gestational age and NBS results. We found that preterm, but not term, infants with false-positive results had more acute outpatient visits than their counterparts with normal NBS results. We found no difference in adjusted rates of other visit types (emergency department, inpatient, outpatient well) between infants with false-positive and normal NBS results, regardless of gestational age. CONCLUSIONS: Increased rates of acute outpatient visits among preterm infants with false-positive NBS screening results may be attributable to underlying chronic illness or parental anxiety. The absence of increased health care utilization among term infants may be unique to this Medicaid population or a subgroup phenomenon that was not detectable in this analysis.

Age and sex differences in hospitalizations associated with diabetes.

AIM: To evaluate national trends in hospitalizations and hospital charges associated with diabetes over a recent 14-year period. METHODS: We evaluated hospital discharges with a primary or secondary diagnosis of diabetes (250.xx)in the Nationwide Inpatient Sample (1993-2006). Outcomes included population-adjusted estimates of hospital discharges and hospital charges (2006 $U.S.). RESULTS: Overall, discharges associated with diabetes increased 65.3% (1,384/100,000 in 1993, 2,288/100,000 in 2006) over the 14-year period (p < 0.001 test for trend). The largest increase in hospitalizations occurred among adults 30-39 years of age, representing a 102% increase. Among young adults, increases among women were ∼1.3 times greater compared with men, for the 20-29 year (63% vs. 46%) and 30-39 year (118% vs. 85%) age groups, even after excluding pregnancy-related hospitalizations. Overall, women had higher rates of hospitalizations associated with diabetes compared with men, but there was evidence of an age by sex interaction, with higher rates of hospitalizations among women in the younger age groups and among men in the older age groups. Annual inflation-adjusted total charges for hospitalizations with diabetes increased 220% over the period. CONCLUSIONS: Large increases in diabetes hospitalizations occurring among adults aged 30-39 years and young women signal a shift in the hospital burden of diabetes.