S. Todd Callahan

ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults

BACKGROUND Adverse-event reports from North America have raised concern that the use of drugs for attention deficit-hyperactivity disorder (ADHD) increases the risk of serious cardiovascular events. METHODS We conducted a retrospective cohort study with automated data from four health plans (Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California, and OptumInsight Epidemiology), with 1,200,438 children and young adults between the ages of 2 and 24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs. We identified serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) from health-plan data and vital records, with end points validated by medical-record review. We estimated the relative risk of end points among current users, as compared with nonusers, with hazard ratios from Cox regression models. RESULTS Cohort members had 81 serious cardiovascular events (3.1 per 100,000 person-years). Current users of ADHD drugs were not at increased risk for serious cardiovascular events (adjusted hazard ratio, 0.75; 95% confidence interval [CI], 0.31 to 1.85). Risk was not increased for any of the individual end points, or for current users as compared with former users (adjusted hazard ratio, 0.70; 95% CI, 0.29 to 1.72). Alternative analyses addressing several study assumptions also showed no significant association between the use of an ADHD drug and the risk of a study end point. CONCLUSIONS This large study showed no evidence that current use of an ADHD drug was associated with an increased risk of serious cardiovascular events, although the upper limit of the 95% confidence interval indicated that a doubling of the risk could not be ruled out. However, the absolute magnitude of such an increased risk would be low. (Funded by the Agency for Healthcare Research and Quality and the Food and Drug Administration.).

Transition from pediatric to adult-oriented health care: a challenge for patients with chronic disease

Pediatric providers can expect that 1 of every 10 patients they see will have a chronic, activity-limiting health condition. Thanks to earlier diagnosis and improved therapies, most of these children will live well into adulthood. This means that eventually they will require care that focuses on adult health issues. Providers in the United States and around the world are recognizing the need for coordinated processes to transition adolescents and young adults with chronic conditions to adult health care. These models rely on the participation and input of the adolescent, his or her family, and pediatric and adult health professionals. This paper distinguishes medical transition from medical transfer; discusses potential barriers to transition; examines new initiatives to develop and study transition models; and reviews federal legislation influencing health care transitions.

Uninsurance and Health Care Access Among Young Adults in the United States

Objective. Young adults who are 19 to 24 years of age are the most likely age group to be uninsured in the United States, yet little is known about how uninsurance might affect health care access among young adults. The objective of this study was to describe the association between health insurance status and health care access among young adults while controlling for other determinants of access to care. Methods. We conducted a cross-sectional analysis of data from 11 866 19- to 24-year-old respondents who completed the National Health Interview Survey between 1998 and 2001. We present percentages and adjusted relative risk of young adults who in the previous year delayed or missed medical care because of cost, did not fill a prescription because of cost, had not spoken to a health professional, or identified no usual source of health care. Results. Among the young adults studied, 27% of women and 33% of men were uninsured. After potential confounders were adjusted for, the uninsured remained at significantly higher risk for reporting delayed or missed medical care (women: adjusted relative risk [95% confidence interval]: 3.24 [2.72–3.82]; men: 4.31 [3.44–5.34]), not filling a prescription because of cost (women: 3.27 [2.55–4.16]; men: 4.05 [2.78–5.81]), having no contact with a health professional (women: 2.54 [2.01–3.09]; men: 1.60 [1.43–1.77]), and having no usual source of health care (women: 3.45 [3.05–3.90]; men: 2.27 [2.06–2.48]) relative to privately insured peers. Women with Medicaid did not differ significantly from privately insured women in these measures. Conclusions. Uninsured young adults were significantly more likely than privately insured peers to report barriers to obtaining needed care, having no contact with a health professional, and identifying no usual source of health care. Given the high rates of uninsurance among young adults, additional study is needed to examine how these barriers affect the immediate and future health of the young adult.

Characteristics of Avoidant/Restrictive Food Intake Disorder in Children and Adolescents: A “New Disorder” in DSM-5

PURPOSE To evaluate the DSM-5 diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID) in children and adolescents with poor eating not associated with body image concerns. METHODS A retrospective case-control study of 8-18-year-olds, using a diagnostic algorithm, compared all cases with ARFID presenting to seven adolescent-medicine eating disorder programs in 2010 to a randomly selected sample with anorexia nervosa (AN) and bulimia nervosa (BN). Demographic and clinical information were recorded. RESULTS Of 712 individuals studied, 98 (13.8%) met ARFID criteria. Patients with ARFID were younger than those with AN (n = 98) or BN (n = 66), (12.9 vs. 15.6 vs. 16.5 years), had longer durations of illness (33.3 vs. 14.5 vs. 23.5 months), were more likely to be male (29% vs. 15% vs. 6%), and had a percent median body weight intermediate between those with AN or BN (86.5 vs. 81.0 and 107.5). Patients with ARFID included those with selective (picky) eating since early childhood (28.7%); generalized anxiety (21.4%); gastrointestinal symptoms (19.4%); a history of vomiting/choking (13.2%); and food allergies (4.1%). Patients with ARFID were more likely to have a comorbid medical condition (55% vs. 10% vs. 11%) or anxiety disorder (58% vs. 35% vs. 33%) and were less likely to have a mood disorder (19% vs. 31% vs. 58%). CONCLUSIONS Patients with ARFID were demographically and clinically distinct from those with AN or BN. They were significantly underweight with a longer duration of illness and had a greater likelihood of comorbid medical and/or psychiatric symptoms.

Distribution of eating disorders in children and adolescents using the proposed DSM-5 criteria for feeding and eating disorders.

PURPOSE To determine the distribution of eating disorders (ED) in children and adolescents comparing the fourth edition of the Diagnostic and Statistical Manual (DSM) to the proposed fifth edition DSM criteria. METHODS A total of 215 consecutive patients (15.4 ± 3.3 years) presenting for initial ED evaluation to adolescent medicine physicians from six institutions were assigned ED diagnoses using current DSM-IV criteria as well as proposed DSM-5 criteria. RESULTS Diagnoses of anorexia nervosa and bulimia nervosa increased using the proposed DSM-5 criteria (from 30.0% to 40.0% and from 7.3% to 11.8%, p < .001). Approximately 14% of patients received the presumptive DSM-5 diagnosis of avoidant/restrictive food intake disorder. Cases of ED not otherwise specified decreased from 62.3% to 32.6% (p < .001). CONCLUSIONS Proposed DSM-5 criteria substantially decreased the frequency of ED not otherwise specified diagnoses and increased the number of cases of anorexia nervosa and bulimia nervosa in a population of young patients presenting for ED treatment. Avoidant/restrictive food intake disorder appears to be a significant diagnosis.

Changes in ambulatory health care use during the transition to young adulthood.

PURPOSE To identify changes in ambulatory health care use during the transition from adolescence to young adulthood. METHODS We analyzed data from health care encounters for adolescents (13-18 year olds) and young adults (19-24 year olds) in the National Ambulatory Medical Care Surveys or National Hospital Ambulatory Medical Care Surveys from 1997 through 2004. We present bivariate analysis of visit characteristics (including clinician specialty and health care setting, primary reason for the visit, and expected source of payment) for young adults as compared with those for adolescents, using weights provided by the National Center for Health Statistics to make national estimates. RESULTS Adolescents and young adults used similar number of health care visits annually; however, a greater proportion of ambulatory care for young adults was delivered in emergency departments as compared with adolescents (20% vs. 14%; p < .001), a smaller proportion was delivered to males (27% vs. 46%; p < .001), and a smaller proportion was covered by private health insurance (58% vs. 67%, respectively; p < .001). Among young adults, preventive care was listed as the reason for 40% of non-emergency department visits for females, whereas it accounted for only 10% of visits for males. CONCLUSIONS Significant changes in ambulatory health care use occur during young adulthood. Improving health care during the transition to adulthood will necessitate attention to health care research and delivery agendas that are relevant to the young adult population.

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.

BACKGROUND Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development. METHODS CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens. RESULTS 402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08. CONCLUSION The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.

Predictors of Outcome at 1 Year in Adolescents With DSM-5 Restrictive Eating Disorders: Report of the National Eating Disorders Quality Improvement Collaborative

PURPOSE The National Eating Disorders Quality Improvement Collaborative evaluated data of patients with restrictive eating disorders to analyze demographics of diagnostic categories and predictors of weight restoration at 1 year. METHODS Fourteen Adolescent Medicine eating disorder programs participated in a retrospective review of 700 adolescents aged 9-21 years with three visits, with DSM-5 categories of restrictive eating disorders including anorexia nervosa (AN), atypical AN, and avoidant/restrictive food intake disorder (ARFID). Data including demographics, weight and height at intake and follow-up, treatment before intake, and treatment during the year of follow-up were analyzed. RESULTS At intake, 53.6% met criteria for AN, 33.9% for atypical AN, and 12.4% for ARFID. Adolescents with ARFID were more likely to be male, younger, and had a longer duration of illness before presentation. All sites had a positive change in mean percentage median body mass index (%MBMI) for their population at 1-year follow-up. Controlling for age, gender, duration of illness, diagnosis, and prior higher level of care, only %MBMI at intake was a significant predictor of weight recovery. In the model, there was a 12.7% change in %MBMI (interquartile range, 6.5-19.3). Type of treatment was not predictive, and there were no significant differences between programs in terms of weight restoration. CONCLUSIONS The National Eating Disorders Quality Improvement Collaborative provides a description of the patient population presenting to a national cross-section of 14 Adolescent Medicine eating disorder programs and categorized by DSM-5. Treatment modalities need to be further evaluated to assess for more global aspects of recovery.

Continuity of health insurance coverage among young adults with disabilities.

OBJECTIVES. Although considered critical to facilitate the successful transition from pediatric to adult health care, the continuity of insurance coverage for young adults with disabilities as they make the transition to adulthood has not been well characterized. The purpose of this work was to compare the continuity of insurance coverage reported by a nationally representative sample of young adults 16 to 25 years old with and without disabilities during a consecutive 36-month period. METHODS. We performed secondary analysis of data from the 2001 Survey of Income Program and Participation. Data for the survey were collected at 4-month intervals from February 2001 through January 2004 for 5170 young adults. Subjects with disabilities were those who reported limitations in activities of daily living or work, used assistive devices, and/or had learning disabilities, mental retardation, or other mental disorders. The primary outcome was uninsurance defined for each study month in which there was no coverage by private, public, or military programs. We present bivariate analyses of the months of uninsurance according to disability status using longitudinal weights and design-effect adjustments to account for the complex sample design. RESULTS. The sample consisted of 599 subjects with and 4571 without reported disabilities, representing 3970000 and 30800000 young adults in the United States, respectively. At study entry, 22% of the young adults with disabilities were uninsured. During the 36-month follow-up period, 56% of the young adults with disability reported gaps in insurance coverage with a mean of 15 months of uninsurance. The proportion of uninsured subjects did not significantly differ by disability status. CONCLUSIONS. The majority of young adults with disabilities reported gaps in insurance coverage, and many were uninsured for a substantial portion of the study period. As an increasing number of children with special health care needs make the transition to adulthood, improving the continuity of health insurance coverage for this population warrants specific attention.

Seroprevalence of Cytomegalovirus (CMV) and Risk Factors for Infection in Adolescent Males

BACKGROUND Congenital cytomegalovirus (CMV) is a leading cause of disability, including sensorineural hearing loss, developmental delay, and mental retardation. Although the seroprevalence of CMV and associated exposure and behavioral risk factors have been reported in adolescent females, few data exist about males. METHODS Serum samples were obtained from males aged 12-17 years from June 2006 through July 2007 in Cincinnati, Ohio; Galveston, Texas; and Nashville, Tennessee. The samples were tested for CMV immunoglobulin G antibody with a commercial assay. Participants completed a computer-assisted screening interview to assess 7 risk categories. RESULTS A total of 397 adolescent males were screened, and 165 (47%) were seropositive. African American race, older age, and exposure to children ≤ 3 years of age in the home were significant predictors of CMV infection in the univariate analysis. Hispanic ethnicity, group living situations, saliva-sharing behaviors, and intimate sexual contact were not associated with CMV infection. However, among those with a history of sexual contact, the number of life-time partners was associated with CMV. In the final multivariate model, CMV seroprevalence was significantly higher in African American subjects (odds ratio [OR], 1.93; 95% confidence interval [CI], 1.27-2.95) and subjects ≥ 14 years of age (OR, 1.1; 95% CI, 1.0-1.28). With each additional risk factor, males had a 1.6 times increased risk of CMV. CONCLUSIONS CMV infections are common in adolescent males and are associated with African American race and increasing age. Further study is needed to understand these risk factors in preparation for a CMV vaccine targeted at both adolescent males and females.