Predictors of Receipt of Clinical Preventive Services in Adolescents and Adults with Down Syndrome Accessing Medicaid.

BACKGROUND: Persons with Down syndrome (DS) require preventive care that addresses their age-/gender- and syndrome-specific needs. Yet, adolescents and adults with DS do not receive these preventive care services as recommended. OBJECTIVE/HYPOTHESIS: To identify factors that predict receipt of age-/gender- and syndrome-specific preventive healthcare among adolescents and adults with DS. We hypothesized that more healthcare encounters and greater medical complexity would increase receipt of preventive care due to more opportunities to complete these activities. METHODS: Using Medicaid claims (2006-2010) for California, Colorado, Michigan, and Pennsylvania, we conducted a retrospective cohort study of adolescents and adults with DS (≥12 years old). We modeled receipt of both ≥1 wellness examination and ≥1 thyroid function test (TFT) in 2009-2010 as a function of receipt of those same healthcare activities in 2006-08, adjusting for demographics, key comorbidities, and medical complexity using multivariable logistic regression. RESULTS: In this cohort of 3487 adolescents and adults with DS accessing Medicaid, 17% received both ≥1 wellness examination and ≥1 TFT in 2006-2008, 15% in 2009-2010, and only 7% during both time periods. Despite medical complexity and frequent healthcare interactions, the best predictor of future receipt of these activities was past receipt. State of residence variably impacted receipt of these preventive activities. CONCLUSIONS: Although past receipt of wellness examination and TFT was the best predictor of future receipt of these activities, overall rates were quite low in this cohort of adolescents and adults with DS. Further work is needed to improve preventive healthcare delivery to this vulnerable population.

Low Rates of Preventive Healthcare Service Utilization Among Adolescents and Adults With Down Syndrome.

INTRODUCTION: People with Down syndrome have health risks that require specific lifelong preventive health care. With increasing life expectancy, people with Down syndrome also face health conditions typical of their unaffected peers and thus need coordinated health care. The purpose of this study is to describe rates of age/sex- and Down syndrome-specific preventive healthcare activities among adolescents and adults with Down syndrome. METHODS: Using Medicaid claims (2006-2010) in California, Colorado, Michigan, and Pennsylvania, the cohort was defined as people with Down syndrome aged ≥12 years seen by primary care providers and enrolled in Medicaid for ≥45 of 60 months without dual Medicare enrollment (n=3,501). Age focus-consistent primary care providers were defined as having a focus concordant with a patient's age: 12-17 years, child or mixed-focus; ≥26 years, adult or mixed-focus; 18-25 years, any focus. Differences in healthcare activities were evaluated using Pearson's chi-square, Fisher's exact, and Kruskal-Wallis tests. Analyses were performed in 2015-2017. RESULTS: Of the cohort, 79% had an age focus-consistent primary care provider. However, 40% of adults aged ≥26 years received care from a child-focused primary care provider. Only 43% with an age focus-consistent provider had ≥1 well examination (age focus-inconsistent primary care provider: 35%, p<0.001). Most preventive activities had poor rates (<50%) regardless of age focus consistency between provider and patient age or whether they were age/sex- or Down syndrome-specific (well examinations; vaccinations; sleep apnea; hearing; and breast, cervical, and colon cancer screenings). Lipids, vision, and thyroid screenings reached moderate levels (50% to <80%). CONCLUSIONS: Rates of age/sex- and Down syndrome-specific preventive recommendations were low among adolescents and adults with Down syndrome, regardless of the age focus consistency of their primary care provider. This represents a significant opportunity to improve primary care in this vulnerable population.

Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response.

PURPOSE: Food and Drug Administration's (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge-attitudes-behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies. METHODS: A systematic literature review was conducted of US physician surveys (2000-2014) on pharmaceutical use (n = 75). Kruskal-Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson's chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks). RESULTS: Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%-68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items). CONCLUSIONS: Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.

How Measurement Variability Affects Reporting of a Single Readmission Metric.

Readmissions are an important quality measure for public reporting, payment, and collaborative research. Lack of measure standardization may lead to inconsistent reporting of outcomes across study sites. In this study, we examined the impact of measurement variability on reporting of a single readmission metric, 30-day all-condition readmission rates (ARRs). We conducted a secondary database analysis of 2006-2008 Medicaid Analytic eXtract data merged from four states of children younger than 21 years. We calculated 30-day ARRs for this cohort using three previously described models varying in their inclusions and exclusions of index hospitalizations and readmissions. The 30-day ARR was highest for the model allowing each readmission to serve as an index admission for subsequent readmissions (ARR: 7%); intermediate for the model allowing one index admission and more than one readmissions in each 30-day period (ARR: 6.2%); and lowest for the model allowing only one readmission in each 30-day period (ARR: 5.6%). Similar variation was seen when stratifying patients by individual diagnostic groups. In conclusion, measurement variability impacts reported outcomes of a single readmission metric. To improve the value of readmission as a quality metric, stakeholders engaged in multisite quality improvement or research should ensure that definitions are standardized across sites.

Examining strategies for improving healthcare providers' communication about adolescent HPV vaccination: evaluation of secondary outcomes in a randomized controlled trial.

There is a critical need for campaigns and interventions to increase rates of human papillomavirus (HPV) vaccination among U.S. adolescents. Healthcare providers are key stakeholders in parents' HPV vaccine decision-making. The current study presents the evaluation of secondary outcomes in a multi-component communication-based intervention to improve healthcare providers' communication about HPV vaccination. Evaluation was conducted via surveys of providers participating in a 12-month randomized controlled trial. Findings suggest use of communication components (combined use of the presumptive approach [PA] with all patients, and motivational interviewing and a fact sheet with vaccine hesitant parents) contributed to providers in the intervention group reporting higher perceived levels of parental HPV vaccine acceptance than control providers, as well as increased vaccination rates in the intervention arm in the main RCT.

Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial.

Importance: The incidence of human papillomavirus (HPV)-related cancers is more than 35 000 cases in the United States each year. Effective HPV vaccines have been available in the United States for several years but are underused among adolescents, the target population for vaccination. Interventions to increase uptake are needed. Objective: To evaluate the effect of a 5-component health care professional HPV vaccine communication intervention on adolescent HPV vaccination. Design, Setting, and Participants: A cluster randomized clinical trial using covariate-constrained randomization to assign study arms and an intent-to-treat protocol was conducted in 16 primary care practices in the Denver, Colorado, metropolitan area. Participants included 188 medical professionals and 43 132 adolescents. Interventions: The 5 components of the intervention were an HPV fact sheet library to create customized information sheets relevant to each practice's patient population, a tailored parent education website, a set of HPV-related disease images, an HPV vaccine decision aid, and 2½ hours of communication training on using a presumptive vaccine recommendation, followed by motivational interviewing if parents were resistant to vaccination. Each practice participated in a series of 2 intervention development meetings over a 6-month period (August 1, 2014, to January 31, 2015) before the intervention. Main Outcomes and Measures: Differences between control and intervention changes over time (ie, difference in differences between the baseline and intervention period cohorts of patients) in HPV vaccine series initiation (≥1 dose) and completion (≥3 doses) among patients aged 11 to 17 years seen at the practices between February 1, 2015, and January 31, 2016. Vaccination data were obtained from the practices' records and augmented with state immunization information system data. Results: Sixteen practices and 43 132 patients (50.3% female; median age, 12.6 years [interquartile range, 10.8-14.7 years] at the beginning of the study period) participated in this trial. Adolescents in the intervention practices had significantly higher odds of HPV vaccine series initiation (adjusted odds ratio [aOR], 1.46; 95% CI, 1.31-1.62) and completion (aOR, 1.56; 95% CI, 1.27-1.92) than those in the control practices (a 9.5-absolute percentage point increase in HPV vaccine series initiation and a 4.4-absolute percentage point increase in HPV vaccine series completion in intervention practices). The intervention had a greater effect in pediatric practices compared with family medicine practices and in private practices compared with public ones. Health care professionals reported that communication training and the fact sheets were the most used and useful intervention components. Conclusions and Relevance: A health care professional communication intervention significantly improved HPV vaccine series initiation and completion among adolescent patients. Trial Registration: clinicaltrials.gov Identifier: NCT02456077.

Low bone mineral density risk factors and testing patterns in institutionalized adults with intellectual and developmental disabilities.

BACKGROUND: Adults with intellectual or developmental disability (ID/DD) have multiple risks for low bone mineral density (BMD) without formal guidelines to guide testing. We sought to identify risk factors and patterns of BMD testing among institutionalized adults with ID/DD. METHODS: We evaluated risk factors for low BMD (Z-/T-score < -1) and patterns of BMD testing among adults with ID/DD receiving care at a state-run residential facility. Kruskal-Wallis, Fisher's exact and Pearson's chi-squared tests were used as appropriate. RESULTS: Of the 140 eligible patients, only 44% ever had BMD testing of which 89% had low BMD. Median age at diagnosis was 42 years old. Individuals with low BMD were more likely to be older, non-weight bearing, Caucasian and have severe cognitive delay. CONCLUSIONS: Adults with ID/DD in this facility had a high prevalence of low BMD. Further studies are needed to better characterize risk factors and inform screening within this high-risk population.

Providers' time spent and tools used when discussing the HPV vaccine with parents of adolescents.

OBJECTIVES: Little is known about HPV vaccine communication tools currently used by primary care providers of adolescents, or how such tools impact the quality of HPV vaccine recommendations, which some have defined as using a "presumptive" communication style, continuing to offer vaccines despite resistance, and strongly recommending vaccines at the appropriate ages. We surveyed primary care providers to assess their current use of HPV vaccine communication tools, and how these related to their HPV vaccine recommendation quality. STUDY DESIGN: Cross sectional survey of 183 pediatrics and family medicine primary care providers in the Denver metro area. RESULTS: Response rate was 82% (n=150). Most (59%) providers used a presumptive vaccine recommendation >75% of the time, and 76% reported continuing to offer the HPV vaccine even after parent refusal. However, less than two-thirds of providers "strongly" recommended the vaccine to 11-12year olds (60% for females, 55% for males, p=0.02). The HPV vaccine information sheet from the Centers from Disease Control and Prevention was the most frequently used communication tool during clinical visits (64% used at least 75% of the time) and directing parents to preferred websites was the most frequently used between-visit communication tool (21% used >50% of visits). Use of tools was not associated with any measure of HPV vaccine recommendation quality but was associated with longer HPV vaccine discussion times. CONCLUSIONS: Providers use only limited types of adolescent HPV vaccine communication tools, and frequently do not use preferred vaccine communication strategies. Better engagement with existing HPV vaccine communication tools, and/or the creation of new tools may be needed to enhance providers' ability to provide high quality HPV vaccine recommendations.

Metabolic Testing for Adults in a State Medicaid Program Receiving Antipsychotics: Remaining Barriers to Achieving Population Health Prevention Goals.

IMPORTANCE: Medicaid quality indicators track diabetes mellitus and cardiovascular disease screening in adults receiving antipsychotics and/or those with serious mental illness. OBJECTIVE: To inform performance improvement interventions by evaluating the relative importance of patient, prescriber, and practice factors affecting metabolic testing. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was conducted using Missouri Medicaid administrative claims data (January 1, 2010, to December 31, 2012) linked with prescriber market data. The analysis included 9316 adults (age, 18-64 years) who were starting antipsychotic medication. Secondary analysis included the subset of adults (n = 1813) for whom prescriber knowledge, attitudes, and behavior survey data were available. Generalized estimating equations were performed to identify factors associated with failure to receive annual testing during antipsychotic treatment (adjusted odds ratio [OR], <1 favor testing). Data analysis was performed from October 1, 2014, to February 18, 2016. EXPOSURE: Oral second-generation antipsychotics. MAIN OUTCOMES AND MEASURES: A medical claim for glucose or lipid testing occurring within 180 days before and after the antipsychotic prescription claim. RESULTS: The 9317 patients (mean [SD] age, 37.6 [12.0] years) initiated antipsychotic medication in a variety of prescriber specialty-settings: 24.3%, community mental health center (CMHC); 27.6%, non-CMHC behavioral health; 24.3%, primary care practitioners; and 23.8%, other/unknown. Annual testing rates were 79.6% for glucose and 41.2% for lipids. Failure to test glucose and lipids was most strongly associated with patient factors and health care utilization. To illustrate by using findings from glucose modeling (reported as adjusted OR [95% CI]), lower failure to receive testing was associated with older age (40-49 vs 18-29 years; 0.64 [0.55-0.74]), diagnosis of schizophrenia or bipolar disorder (0.55 [0.44-0.67]), cardiometabolic comorbidity (dyslipidemia, 0.28 [0.22-0.37]), hypertension (0.59 [0.50-0.69]), and greater outpatient utilization (>6 encounters vs none; 0.33 [0.28-0.39]). Analysis incorporating prescriber practice information found lower failure to receive glucose testing if the patient received care at a CMHC (0.74 [0.64-0.85]) or if the initiating prescriber was a primary care practitioner (0.81 [0.66-1.00]). However, the initiating prescriber specialty-setting was not associated with lipid testing. CONCLUSIONS AND RELEVANCE: Compared with prior reports, progress has been made to improve diabetes screening, but lipid screening remains particularly underutilized. Medicaid performance improvement initiatives should target all prescriber settings and not just behavioral health.

Glucose Testing for Adults Receiving Medicaid and Antipsychotics: A Population-Based Prescriber Survey on Behaviors, Attitudes, and Barriers.

OBJECTIVE: This study aimed to assess provider attitudes about glucose testing for adults prescribed second-generation antipsychotic medication. METHODS: Missouri Medicaid prescribers of antipsychotics in 2011 were surveyed (N=924, 25% response rate). Pearson's chi square test was used to compare responses between prescriber specialty setting. Multivariable log-binomial regression evaluated the association of factors hypothesized as barriers to screening. RESULTS: Prescribers in community mental health centers were more likely than primary care providers to report that they would definitely order baseline testing (57% versus 39%, p<.001) and were greater promoters of screening to colleagues (76% versus 49%, p<.001). The strongest predictor of screening intent was disagreeing strongly that "metabolic screening is not a priority for me or my organization" (94% more likely to screen at drug initiation and 74% more likely at annual evaluation, both p<.001). CONCLUSIONS: Establishing organizational priority across all treatment settings is important for achieving population-based diabetes screening goals for all Medicaid patients receiving antipsychotics.

Concomitant Fundoplication With Gastrostomy: A Two-State Comparison Showing Continued Use of Reflux Medications.

OBJECTIVES: We sought to determine whether practice differences for fundoplication exist between 2 geographically distinct states, and to determine the reflux medication use pattern associated with concomitant fundoplication. METHODS: A retrospective observational cohort study of children in Colorado (CO) and North Carolina (NC) insured by Medicaid from 2006 to 2008. Children who received a surgical gastrostomy during the study period were included, and our primary outcome measure was the performance of a concomitant gastric fundoplication. Thirty-day prescription fills for reflux medications were examined before and after gastrostomy procedure. RESULTS: We examined 969 surgical gastrostomy admission in both states over the 3-year study period (CO, n = 341 and NC, n = 628). Patients in each state had similar age (median age, 6 months, P = 0.97). Use of pH probe (CO: 15%, NC: 11%) and diagnosis of reflux (CO: 84%, NC: 72%) differed in each state. Concomitant fundoplication was performed in 60% of patients in CO and 43% in NC (P < 0.01). Age less than 6 months was associated with an increased adjusted odds of fundoplication in CO (OR 9.77, CI, 3.91, 24.43), but less so in NC (OR 2.73, CI, 1.48, 5.04). Among patients undergoing gastrostomy, the proportion of patients on reflux medication 4 to 6 months post-discharge did not differ between those receiving fundoplication and those that did not in either state. CONCLUSIONS: Rates of concomitant fundoplication varied in the 2 states despite patients having similar demographic and clinical characteristics. Antireflux surgery was not associated with a reduction in reflux medications in either state.

Validation and Impact of Caregivers' Oral Health Knowledge and Behavior on Children's Oral Health Status.

PURPOSE: To validate oral health knowledge and behavior measures from the Basic Research Factors Questionnaire, developed to capture specific themes contributing to children's oral health outcomes and the influence of caregivers. METHODS: Data were collected as part of a randomized clinical trial (n equals 992) aimed at reducing dental caries in young children. Participants were American Indian/Alaska Native caregivers with a three- to five-year-old child enrolled in a Navajo Nation Head Start Center. Caregivers completed the questionnaire at enrollment with concomitant evaluation of children for decayed, missing, and filled tooth surfaces (dmfs). Oral health knowledge and behavior outcomes were compared with convergent measures (participant sociodemographic characteristics, oral health attitudes, and indicators of oral health status). RESULTS: Caregiver oral health knowledge was significantly associated with education, income, oral health behavior, and all but one of the oral health attitude measures. Behavior was significantly associated with several measures of oral health attitudes and all but one measure of oral health status. As the behavior score improved, dmfs scores declined, child/caregiver overall oral health status improved, and pediatric oral health quality of life improved. CONCLUSIONS: Questionnaire measures were valid for predicting specific caregiver factors potentially contributing to children's oral health status.

The Role of Clinical Setting and Management Approach in Metabolic Testing Among Youths and Adults Treated With Antipsychotics.

OBJECTIVE: This study compared metabolic screening among patients who received antipsychotic treatment at community mental health centers (CMHCs), with or without case management, and patients treated elsewhere. METHODS: Rates of glucose and lipid testing among youths and adults in Missouri Medicaid (N=9,473) who received antipsychotic treatment at CMHCs, with and without case management, were evaluated. Multivariable logistic regressions determined which characteristics were independently associated with metabolic testing. RESULTS: A total of 37.0% and 17.3% of youths and 68.7% and 34.9% of adults had glucose and lipid testing, respectively. Compared with treatment elsewhere, treatment at CMHCs, with or without case management, respectively, was associated with higher odds of glucose testing (youths, adjusted odds ratio [AOR]=1.68 and 1.89; adults, AOR=1.43 and 1.44) and lipid testing (youths, AOR=2.40 and 2.35; adults, AOR=1.97 and 1.48). CONCLUSIONS: CMHCs had higher rates of metabolic testing, possibly reflecting Missouri's efforts to promote testing in these settings.

Outpatient follow-up visits and readmission in medically complex children enrolled in Medicaid.

OBJECTIVE: To examine the association between postdischarge outpatient follow-up and 30-day readmissions in Medicaid enrolled children with complex, chronic conditions. STUDY DESIGN: This was a retrospective cohort analysis of Colorado Medicaid recipients with complex, chronic conditions who were discharged from the hospital between 2006 and 2008. The primary outcome was readmission between 4 and 30 days after index hospital discharge. Using multivariable logistic regression, we examined the association between early postdischarge outpatient visits (≤ 3 days postdischarge) and readmission. We secondarily analyzed the relationship between any outpatient visit from 4 to 29 days of index discharge and readmission. RESULTS: For the 2415 patients with complex, chronic conditions included in the analysis, the 4- to 30-day readmission rate was 6.3%. The odds of readmission was significantly greater for patients with ≥ 1 outpatient visit ≤ 3 days after discharge compared with patients without a visit ≤ 3 days after discharge (aOR 1.7 [1.1-2.4]). The odds of readmission were significantly lower for patients with ≥ 1 outpatient visit from 4 to 29 days after discharge compared with patients without such visits (aOR 0.5 [0.3-0.7]). Other factors associated with readmission included index hospital length of stay and number of complex, chronic conditions. CONCLUSIONS: In medically complex children, there is a positive association between early postdischarge outpatient follow-up and readmission. There is an inverse association between later postdischarge outpatient follow-up and readmission. Outpatient follow-up occurring within 4-29 days after discharge may help to prevent 30-day readmissions. Additional research is needed to inform guidelines regarding longer term postdischarge outpatient follow-up in these children.

Comparative effectiveness of injectable paliperidone palmitate versus oral atypical antipsychotics: early postmarketing evidence.

AIM: To provide comparative effectiveness evidence for long-acting injectable paliperidone palmitate versus oral atypical antipsychotics. PATIENTS & METHODS: We performed a retrospective, observational cohort study using patient claims data from Missouri Medicaid to compare the likelihood of emergency department (ED) visits and hospitalizations in the year following drug initiation using multivariable logistic regression. RESULTS: Adjusted odds ratios (AOR) for ED visits (AOR: 0.63; 95% CI: 0.47-0.85) and hospitalizations (AOR: 0.85; 95% CI: 0.64-1.13) were lower in paliperidone palmitate patients, although hospitalizations did not achieve statistical significance. Sensitivity analyses examining mental health-related outcomes and using different analytic strategies for patient selection bias showed directionally similar beneficial effects but were not statistically significant. CONCLUSION: Early evidence for paliperidone palmitate under real-world conditions is encouraging. However, caution should be taken until additional research substantiates the findings with greater certainty.

Adjusting for geographic variation in observational comparative effectiveness studies: a case study of antipsychotics using state Medicaid data.

BACKGROUND: Area-level variation in treatment and outcomes may be a potential source of confounding bias in observational comparative effectiveness studies. This paper demonstrates how to use exploratory spatial data analysis (ESDA) and spatial statistical methods to investigate and control for these potential biases. The case presented compares the effectiveness of two antipsychotic treatment strategies: oral second-generation antipsychotics (SGAs) vs. long-acting paliperiodone palmitate (PP). METHODS: A new-start cohort study was conducted analyzing patient-level administrative claims data (8/1/2008-4/30/2011) from Missouri Medicaid. ESDA techniques were used to examine spatial patterns of antipsychotic prescriptions and outcomes (hospitalization and emergency department (ED) visits). Likelihood of mental health-related outcomes were compared between patients starting PP (N = 295) and oral SGAs (N = 8,626) using multilevel logistic regression models adjusting for patient composition (demographic and clinical factors) and geographic region. RESULTS: ESDA indicated significant spatial variation in antipsychotic prescription patterns and moderate variation in hospitalization and ED visits thereby indicating possible confounding by geography. In the multilevel models for this antipsychotic case example, patient composition represented a stronger source of confounding than geographic context. CONCLUSION: Because geographic variation in health care delivery is ubiquitous, it could be a comparative effectiveness research (CER) best practice to test for possible geographic confounding in observational data. Though the magnitude of the area-level geography effects were small in this case, they were still statistically significant and should therefore be examined as part of this observational CER study. More research is needed to better estimate the range of confounding due to geography across different types of observational comparative effectiveness studies and healthcare utilization outcomes.

Parent attitudes about adolescent school-located vaccination and billing.

PURPOSE: School-located vaccination programs may need to bill health insurance to be sustainable. This mixed methods study assessed parent attitudes about school-located vaccination and billing. METHODS: Seven public schools in Denver, Colorado, participated in a school-located adolescent vaccination program that billed students' insurance. From April through June 2010, a survey was administered to parents of 1,000 randomly selected sixth to eighth grade students in these schools. In March and April 2011, focus groups were conducted with a sample of parents of adolescents attending these schools to further explore and help explain patterns emergent in the survey data. RESULTS: Survey response rate was 66%. Among survey respondents, 56% strongly supported and 29% somewhat supported school-located vaccination. Forty-two percent reported concern about receiving a bill if their child participated in a school-located vaccination program that billed insurance, and 23% did not want to provide insurance information to the school. Four focus groups were conducted with English-speaking (n = 17) and Spanish-speaking (n = 14) parents. Focus group participants indicated strong support for school-located vaccination, emphasizing the convenience of the program for both parents and adolescents. These parents also appreciated the affordability of the program and reported feeling comfortable with in-school vaccination delivery. Very few participants indicated concerns about providing health insurance information to the school, but some expressed concern about potential record scatter. CONCLUSIONS: Although some parents expressed concerns about billing health insurance for school-located vaccination, most parents indicated strong support for school-located vaccination.

National trends and outcomes of pediatric gastrostomy tube placement.

OBJECTIVES: National outcomes data regarding surgical gastrostomy tube (G-tube) and percutaneous endoscopic gastrostomy (PEG) tube procedures are lacking. Our objectives were to describe trends in G-tube and PEG procedures, examine regional variation, and compare outcomes. METHODS: This was a retrospective study using pediatric admissions during 1997, 2000, 2003, 2006, and 2009 from the Kids' Inpatient Database. Length of stay and cost were adjusted for demographics, complexity, setting, year, and infection or surgical complication. RESULTS: G-tubes were placed during 64,412 admissions, increasing from 16.6 procedures/100,000 US children in 1997 to 18.5 in 2009. Surgical gastrostomy rates increased by 19% (0.17 procedures/100,000/year, P < 0.002) and, among children <1 year, they increased by 32% (2.56 procedures/100,000/year, P < 0.01). PEG rates did not increase (0.02 procedures/100,000/year, P = 0.47) in the study years. The West had an 18% higher rate than the national average for surgical G-tubes and a 10% higher rate for PEGs. When the sole procedure during the admission was gastrostomy, the G-tube was associated with a 19% (confidence interval 9.7-57.5) longer length of stay, and a 25% higher cost (confidence interval 16.4-34.5) compared with PEG. CONCLUSIONS: Surgical gastrostomy insertion rates have increased whereas PEG rates have not, despite evidence of better severity-adjusted outcome measures for PEG tubes. Surgical gastrostomy insertion in children <1 year of age yielded the greatest increase, which may relate to a changing patient population; however, regional variation suggests that provider preference also plays a role. Our data underline the need for more robust collection and analysis of surgical outcomes to guide decision making.

Methodological considerations in estimating adherence and persistence for a long-acting injectable medication.

BACKGROUND: Measures of medication adherence and persistence are important for researchers and policymakers to assess quality of care. Lack of adherence has been associated with adverse outcomes and higher costs of care. Long-acting medication formulations, including injectable forms, have been proposed as interventions to increase adherence and in turn improve health outcomes and costs. Standard measures of adherence/persistence were developed for orally administered medications. Methods for assessing adherence/persistence of long-acting injectable dose forms are understudied. OBJECTIVE: To compare the consistency between standard measures of adherence/persistence versus proposed variations that consider the data quality and injectable administration method for a long-acting injectable second-generation antipsychotic (SGA) using an orally administered SGA as the reference. METHODS: Standard adherence/persistence measures were designed for oral tablet formulations, in particular accounting for accumulation of pills caused by early refills. To address this limitation and the accuracy of the days supply field for long-acting injectable SGAs in pharmacy claims, 2 alternatives are proposed. The first approach calculates days supply using the labeled dosing schedule for the given injectable. The second approach builds on the first and sets days supply to the minimum of the time between injections and the time frame according to the labeled dosing schedule. Administrative health care claims data from the Missouri Medicaid system were analyzed to compare adherence/persistence measures between formulations. Common adherence/persistence measures, including medication possession ratio (MPR) and proportion of days covered (PDC), were evaluated in this study. The analysis cohorts comprised 195 adult patients with schizophrenia who initiated a long-acting injectable SGA (LA-SGA) and 369 patients initiating an oral SGA (O-SGA) from August 1, 2009, through April 30, 2010. Chi-squared tests, the Kruskal-Wallis test, and Kaplan-Meier curves were used to compare adherence/persistence measures between cohorts. RESULTS: Days supply was most frequently recorded as 30 days for O-SGA and 28 days for LA-SGA. Time between claim fills was most commonly 28 days for both cohorts. Using the LA-SGA pharmacy claims data, MPR was 0.91 and did not vary significantly from MPR of O-SGA (0.90; test statistic = 0.29, P = 0.590). When applying the labeled dosing schedule to compute days supply, the LA-SGA MPR rose to 0.97 and varied significantly from MPR of O-SGA (test statistic = 9.60, P = 0.002). Additionally controlling for the inability for excess medication accumulation, MPR for LA-SGA dropped to 0.86, which varied significantly from MPR of O-SGA (test statistic = 4.01, P = 0.045). PDC varied from 0.55 to 0.61 for LA-SGA but was consistently significantly different from the 0.37 PDC value of O-SGA (P less than 0.05 for each comparison). CONCLUSIONS: Standard medication adherence/persistence measures yielded different conclusions when comparing a LA-SGA and an O-SGA, depending on the measure and underlying assumption for days supply. Adherence/persistence measures that address pharmacological differences in terms of formulation and duration of therapeutic drug levels between medications may be necessary and are particularly important as more injectable antipsychotic medications are approved in the United States. Therefore, payers and investigators should consider sensitivity analysis using different adherence/persistence definitions when making product comparisons to ensure confidence in conclusions.