Cost-effectiveness of a motivational interviewing obesity intervention versus usual care in pediatric primary care offices.

OBJECTIVE: This study aimed to assess the incremental cost-effectiveness ratio (ICER) of a 2-year motivational interviewing (MI) intervention versus usual primary care. METHODS: A national trial was implemented in the Pediatric Research in Office Settings (PROS) network of the American Academy of Pediatrics to evaluate MI versus usual care for children (2-8 years old; baseline BMI 85th-97th percentiles). Health care use, food costs, provider fees, and training costs were assessed, and sensitivity analyses were conducted. Primary outcome was the ICER, calculated as cost per unit change in BMI percentile for intervention versus usual care. RESULTS: At 2 years, 72% of enrolled parent/child dyads were retained; 312 children were included in the analysis. Mean BMI percentile point change was -4.9 and -1.8 for the intervention and control, respectively, yielding an incremental reduction of 3.1 BMI percentile points (95% CI: 1.2-5.0). The intervention cost $1051 per dyad ($658 for training DVD development). Incorporating health care and non-health care costs, the intervention ICER was $363 (range from sensitivity analyses: cost saving, $3159) per BMI percentile point decrease per participant over 2 years. CONCLUSIONS: Training pediatricians, nurse practitioners, and registered dietitians to deliver MI-based interventions for childhood obesity in primary care is clinically effective and acceptably cost-effective. Future work should explore this approach in broader dissemination.

The Future(s) of Pediatric Primary Care.

Pediatric primary care (PPC) arose in the early 20th century as the fusion of acute and chronic pediatric illness care with preventive elements borrowed from public and maternal and child health. Well-established and thriving by the 1930s, PPC saw major changes in childhood morbidity and mortality in the latter half of the 20th century with the recognition of the "new morbidity" of school, behavior, and social problems. At the same time, PPC experienced changes in its workforce, which became increasingly female and added nurse practitioners and physician assistants as practitioners. Independent practice, previously the dominant business model, decreased in prominence at the end of the 20th century as health systems bought practices and other sites morphed into federally qualified health centers. In the present century, electronic health records (EHRs) have brought profound changes in PPC workflows and practitioner experience. In addition, disruptive market competition such as retail clinics and corporate telemedicine providers coupled with changes in health insurance from fee-for-service to value-based payment further challenge the care model and economics of PPC. Finally, recognition of family social circumstances as major determinants of children's health presents another challenge to the status quo. As such, although one PPC future may resemble its present state, a more innovative future is likely to include clinics and practices more oriented toward and linked to communities and directed at the social determinants of health. In addition, the rise in physical, behavioral, and social problems in practice call for a growing focus on wellness, including sleep, nutrition, and activity, that promises to reorient the PPC future in productive new directions. The half-way technology of current EHR systems will ideally be spun into electronic hubs that facilitate teamwork between PPC, specialists, and community groups. Research and practice improvement strategies including involvement in "learning health systems" will be critical to making PPC effective in an evolving society. Although threatened by 21st century forces and hard-to-anticipate change, PPC is ideally positioned to build upon its core functions to create multidisciplinary teams that reach into the community, promoting a holistic wellness for children consistent with the broadest definition of health.

Caregiver and Clinician Perspectives on Missed Well-Child Visits.

PURPOSE: Despite the benefits of well-child care visits, up to one-half of these visits are missed. Little is known about why children miss them, so we undertook a qualitative study to elucidate these factors. METHODS: We interviewed 17 caregivers whose children had missed well-child visits and 6 clinicians, focusing on 3 areas: the value of well-child visits, barriers to attendance, and facilitators of attendance. Transcripts were analyzed with a grounded theory approach and thematic analysis. RESULTS: Caregivers and clinicians identified similar important aspects of well-child visits: immunizations, detection of disease, and monitoring of growth and development. Both groups identified similar barriers to attendance: transportation, difficulty taking time off from work, child care, and other social stressors. CONCLUSIONS: Further work to explore how addressing social determinants of health might improve attendance of well-child visits is needed.

Personalized Therapy: Immunoglobulin Replacement for Antibody Deficiency.

Immunoglobulin replacement therapy is the cornerstone of management for most primary immunodeficiency disease patients. The selection of a particular product, dose, and route of administration requires an understanding of the features of therapeutic immunoglobulin as well as patient-specific risk factors in order to maximize efficacy and tolerability and minimize risk. Individualizing therapy, taking into consideration the burdens of care, is necessary in order to optimize patient outcomes.

Gaps in Well-Child Care Attendance Among Primary Care Clinics Serving Low-Income Families.

BACKGROUND AND OBJECTIVES: It is unclear which specific well-child visits (WCVs) are most frequently missed and whether age-specific patterns of attendance differ by race or insurance type. METHODS: We conducted a retrospective cohort study of children 0 to 6 years old between 2011 and 2016 within 2 health networks spanning 20 states. WCVs were identified by using International Classification of Diseases, Ninth and 10th Revisions and Current Procedural Terminology codes. We calculated adherence to the 13 American Academy of Pediatrics-recommended WCVs from birth to age 6 years. To address data completeness, we made 2 adherence calculations after a child's last recorded WCV: 1 in which we assumed all subsequent WCVs were attended outside the network and 1 in which we assumed none were. RESULTS: We included 152 418 children in our analysis. Most children were either publicly insured (77%) or uninsured (14%). The 2-, 4-, and 6-month visits were the most frequently attended (63% [assuming no outside care after the last recorded WCV] to 90% [assuming outside care]), whereas the 15- and 18-months visits (41%-75%) and 4-year visit (19%-49%) were the least frequently attended. Patients who were publicly insured and uninsured (versus privately insured) had higher odds of missing WCVs. Hispanic and Asian American (versus non-Hispanic white) patients had higher odds of attending WCVs. DISCUSSION: The 15- and 18-month WCVs as well as the 4-year WCV are the least frequently attended WCVs. The former represent opportunities to identify developmental delays, and the latter represents an opportunity to assess school readiness.

Correction to: Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials.

The article Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials, written by Mark Ballow, Richard L. Wasserman, Stephen Jolles, Helen Chapel, Mel Berger, Siraj A. Misbah, was originally published Online First without open access.

The Nuts and Bolts of Immunoglobulin Treatment for Antibody Deficiency.

Immunoglobulin therapy is a key element in the management of most patients with primary immunodeficiency disease. Allergist/immunologists should be familiar with the appropriate evaluation of candidates for immunoglobulin, the characteristics of immunoglobulin products, and how to use them to provide the best care to their patients. Available immunoglobulin products appear to be equally efficacious, but they are not interchangeable. Minimizing the risk of serious adverse events and controlling minor side effects is important to ideal patient care. Immunoglobulin may be administered intravenously or subcutaneously. Individualizing the choice of immunoglobulin product, mode of administration, and site of care can optimize the clinical outcome and minimize the burden of care.

Overcoming challenges in the changing environment of practice-based research.

PURPOSE: Conducting studies in national practice-based research networks presents logistic and methodologic challenges. Pediatric Research in Office Settings (PROS) has learned valuable lessons in implementing new strategies and adapting to challenges. We describe practical challenges and results of novel applied strategies in implementing and testing the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention as part of a national-level cluster-randomized controlled trial. METHODS: In the trial, 20 PROS practices were randomized to either a CEASE intervention arm or a control arm. Parents of children seen in the office who indicated smoking in the past 7 days were asked to complete a postvisit enrollment interview and telephone interviews 3 and 12 months later. Identified challenges included (1) recruiting 20 practices serving a high percentage of parent smokers; (2) screening all parents bringing children for visits and enrolling eligible parents who smoked; and (3) achieving an acceptable 12-month telephone response rate. RESULTS: A total of 47 interested practices completed the Practice Population Survey, of which 20 practices in 16 states completed parent enrollment. Thirty-two research assistants screened 18,607 parents and enrolled 1,980 of them. The initial telephone interview response rate was 56% at 12 months, with incorrect and disconnected numbers accounting for nearly 60% of nonresponses. The response rate rose to 67% after practices supplied 532 new contact numbers and 754 text messages were sent, with 389 parents completing interviews. CONCLUSION: The strategies we used to overcome methodologic barriers in conducting a national intervention trial allowed data collection to be completed in the office setting and increased the telephone interview response rate.

Imputing Missing Race/Ethnicity in Pediatric Electronic Health Records: Reducing Bias with Use of U.S. Census Location and Surname Data.

OBJECTIVE: To assess the utility of imputing race/ethnicity using U.S. Census race/ethnicity, residential address, and surname information compared to standard missing data methods in a pediatric cohort. DATA SOURCES/STUDY SETTING: Electronic health record data from 30 pediatric practices with known race/ethnicity. STUDY DESIGN: In a simulation experiment, we constructed dichotomous and continuous outcomes with pre-specified associations with known race/ethnicity. Bias was introduced by nonrandomly setting race/ethnicity to missing. We compared typical methods for handling missing race/ethnicity (multiple imputation alone with clinical factors, complete case analysis, indicator variables) to multiple imputation incorporating surname and address information. PRINCIPAL FINDINGS: Imputation using U.S. Census information reduced bias for both continuous and dichotomous outcomes. CONCLUSIONS: The new method reduces bias when race/ethnicity is partially, nonrandomly missing.

Antipsychotic medication prescribing in children enrolled in Medicaid.

BACKGROUND: Although the increase in treatment of children and adolescents with antipsychotic medications has been well documented, much less is known about the factors related to the use of these agents and how closely the treatment follows best practice recommendations. METHODS: Prescribers of each antipsychotic medication prescription issued for a Medicaid-insured child in Vermont aged <18 years were sent a prior authorization survey that assessed several domains including the clinical indication, other treatments, metabolic monitoring, prescriber specialty, and prescription origin. These variables were combined to categorize prescriptions as following indications approved by the US Food and Drug Administration (FDA) and best practice guidelines. RESULTS: The response rate of the survey was 80%, with 677 surveys from 147 prescribers available for analysis; more than one-half of the respondents were primary care clinicians. Overall, the clinical indication for an antipsychotic prescription followed best practice guidelines 91.7% of the time, with overall best practice guidelines followed at a rate of 50.1%. An FDA indication was followed in 27.2% of cases. Psychiatrists were significantly more likely to follow best practice guidelines than nonpsychiatrists. Antipsychotic medications were typically used only after other pharmacologic and nonpharmacologic treatments were ineffective, although previous treatment with cognitive-behavioral therapy was uncommon (15.5%). Metabolic monitoring that included serial laboratory tests was reported in 57.2% of cases. CONCLUSIONS: Current prescribing patterns of antipsychotic medications for children and adolescents follow best practice guidelines approximately one-half of the time, with nonadherence often related to lack of metabolic monitoring.

Racial differences in antibiotic prescribing by primary care pediatricians.

OBJECTIVE: To determine whether racial differences exist in antibiotic prescribing among children treated by the same clinician. METHODS: Retrospective cohort study of 1,296,517 encounters by 208,015 children to 222 clinicians in 25 practices in 2009. Clinical, antibiotic prescribing, and demographic data were obtained from a shared electronic health record. We estimated within-clinician associations between patient race (black versus nonblack) and (1) antibiotic prescribing or (2) acute respiratory tract infection diagnosis after adjusting for potential patient-level confounders. RESULTS: Black children were less likely to receive an antibiotic prescription from the same clinician per acute visit (23.5% vs 29.0%, odds ratio [OR] 0.75; 95% confidence interval [CI]: 0.72-0.77) or per population (0.43 vs 0.67 prescriptions/child/year, incidence rate ratio 0.64; 95% CI 0.63-0.66), despite adjustment for age, gender, comorbid conditions, insurance, and stratification by practice. Black children were also less likely to receive diagnoses that justified antibiotic treatment, including acute otitis media (8.7% vs 10.7%, OR 0.79; 95% CI 0.75-0.82), acute sinusitis (3.6% vs 4.4%, OR 0.79; 95% CI 0.73-0.86), and group A streptococcal pharyngitis (2.3% vs 3.7%, OR 0.60; 95% CI 0.55-0.66). When an antibiotic was prescribed, black children were less likely to receive broad-spectrum antibiotics at any visit (34.0% vs 36.9%, OR 0.88; 95% CI 0.82-0.93) and for acute otitis media (31.7% vs 37.8%, OR 0.75; 95% CI 0.68-0.83). CONCLUSIONS: When treated by the same clinician, black children received fewer antibiotic prescriptions, fewer acute respiratory tract infection diagnoses, and a lower proportion of broad-spectrum antibiotic prescriptions than nonblack children. Reasons for these differences warrant further study.

Pediatric clinical research networks: current status, common challenges, and potential solutions.

OBJECTIVES: The goals were (1) to describe and to characterize pediatric clinical research networks (PCRNs) in the United States and Canada, (2) to identify PCRN strengths and weaknesses, (3) to evaluate the potential for collaboration among PCRNs, and (4) to assess untapped potential interest in PCRN participation. METHODS: Data collection included (1) initial identification of PCRNs through an Internet search and word of mouth, (2) follow-up surveys of PCRN leaders, (3) telephone interviews with 21 PCRN leaders, and (4) a survey of 43 American Academy of Pediatrics specialty leaders regarding untapped interest in network research. RESULTS: Seventy exclusively pediatric networks were identified. Of those, specialty care networks constituted the largest proportion (50%), followed by primary care (28.6%) and disease-specific (21.4%) networks. A network profile survey (response rate: 74.3%) revealed that ∼90% held infrastructure funding. Nearly 75% of respondents viewed cross-network collaborations positively. In-depth telephone interviews corroborated the survey data, with cross-network collaboration mentioned consistently as a theme. American Academy of Pediatrics specialty leaders indicated that up to 30% of current nonparticipants might be interested in research involvement. CONCLUSIONS: Pediatric networks exist across the care continuum. Significant numbers of uninvolved practitioners may be interested in joining PCRNs. A strong majority of network leaders cited potential benefits from network collaboration.

Real-world assessment of a metered-dose inhaler with integrated dose counter.

Currently available metered dose inhalers (MDIs) do not track the remaining number of doses, indicating the need for a device that accurately monitors medication use. In an open-label study at 37 outpatient centers, patients > or =4 years old with asthma or chronic obstructive pulmonary disease requiring short-acting 32-agonists received two actuations of albuterol hydrofluoroalkane (HFA) [Ventolin HFA: GlaxoSmithKline], 90 microg twice daily, via a novel MDI with an integrated dose counter until all 200 actuations were completed. Concordance between counter readings, diary card-recorded actuations, and canister weights were measured in patients who completed > or =90% of the labeled actuations (n = 224). Adverse events and patient satisfaction were assessed in the intent-to-treat population (n = 268). In 43,865 recorded actuations, 333 counter versus diary discrepancies occurred (discrepancy rate of 0.76%), and 88% of discrepancies were by one to two actuations. Forty-seven percent of patients had no discrepancies. Incidence of the device firing without changes in counter readings was very low (0.09%). Mean expected actuations based on canister weights (184) were slightly lower than mean counter and diary-reported actuations (200 each). At baseline, 62% of patients reported anxiety about not knowing the quantity of medication remaining in their inhaler. On study completion, 92% expressed satisfaction with the dose counter and 92% agreed it would help prevent them from running out of medication. The adverse event profile showed that albuterol HFA was well tolerated. Integrated MDI counters are a useful and reliable tool for tracking a patient's medication supply.

Patient visits to a national practice-based research network: comparing pediatric research in office settings with the National Ambulatory Medical Care Survey.

OBJECTIVE: Our objective with this study was to assess the extent to which patients who are seen by practitioners in Pediatric Research in Office Settings, a national primary care practice-based research network, are representative of those who are seen in ambulatory office-based pediatric primary care in the United States. METHODS: Pediatric Research in Office Settings patient data were collected from the offices of 57 randomly selected network practitioners as part of an Agency for Healthcare Research and Quality-funded effort to describe primary care visits and replicate the National Ambulatory Medical Care Survey in primary care practice-based research networks. These data were from 1706 randomly selected pediatric patient visits that occurred between March and June 2002. National comparison data were 948 randomly selected pediatric patient visits that occurred between March and June 2000 in the offices of the 33 primary care pediatric practitioners who had participated in the National Ambulatory Medical Care Survey. The groups were compared on patient demographics (age, gender, race, ethnicity, and socioeconomic status, as represented by Medicaid status), visit characteristics (percentages of patients referred, practitioner designation of visit as acute versus nonacute, and continuity of care), the top patient/parent-articulated reasons for visit, and the top practitioner diagnoses. RESULTS: Comparisons revealed substantial similarities between Pediatric Research in Office Settings and national data, including gender, ethnicity, socioeconomic status, and visit characteristics. Differences were noted for age and race, with Pediatric Research in Office Settings children approximately 1 year older and comprising a significantly lower proportion of black patients than their National Ambulatory Medical Care Survey counterparts. Although the top 6 reasons that were articulated by parents for outpatient visits in the 2 groups were remarkably similar in rank order and proportions, there were overall differences, mostly attributable to a larger number of the "other" category in the Pediatric Research in Office Settings cases. There were no significant differences among the top 5 practitioner visit diagnoses between the Pediatric Research in Office Settings and National Ambulatory Medical Care Survey data. CONCLUSIONS: The Pediatric Research in Office Settings patient population is reasonably representative of patients who are seen in US ambulatory office-based pediatric primary care practices; therefore, the Pediatric Research in Office Settings is an appropriate laboratory for studies of care in such settings.