Promoting emotional wellness in children with cystic fibrosis, Part I: Child and family resilience.

Attention should be given to individual and family well-being from a child's first interaction with the medical team and continuing throughout development, especially for families who experience chronic illnesses, such as cystic fibrosis (CF). While much attention has been given to the mental health of people with CF 12 years and older, this paper explores various areas for CF teams to assess and provide additional resources during the first 12 years of a child's life to promote child and family wellness. In this paper, we discuss parental mental health, social determinants of health, adherence/self-care, nutrition, attention to family lifestyle factors, engagement with school and peers, and modulator therapy for this age group of people with CF. This is the first of two companion papers which examines emotional wellness of children during the early years. The second paper examines mental health assessment and intervention for children under 12. Both encourage teams to strive to promote optimal child and family emotional health and wellness, emphasizing holistic health promotion and prevention, early identification, and intervention.

Promoting emotional wellness in children with CF, part II: Mental health assessment and intervention.

This is the second of two companion papers that examine the emotional wellness of children with cystic fibrosis (CF) during the early years of life, defined here as the period between birth and age 12. Both papers promote optimal mental health and well-being, with an emphasis on early identification and intervention. The first paper explores child and family resilience. Here, we discuss strategies for pediatric CF teams to provide routine, systematic mental health assessment, anticipatory guidance, brief intervention, and triage to evidence-based treatment when needed, while addressing barriers to accessing care. Many mental health conditions emerge before the age of 12, with the potential for lifelong effects on individuals, their families, and society. Living with a chronic illness such as CF can further increase the risk of mental health concerns and, in a bidirectional manner, their consequences for the quality of life, sustaining daily care, and health outcomes. There has been a significant focus in recent years on the mental health and wellness of adolescents and adults with CF, but less attention to specifics of depression and anxiety in younger children, or to other common pediatric comorbidities including trauma, developmental disorders such as attention-deficit/hyperactivity disorder or autism spectrum disorder, and oppositional behavior. Given the availability of psychometrically sound screening instruments and effective interventions, routinely addressing the mental health of children with CF and their families is feasible to integrate within multidisciplinary CF care, allowing for a personalized approach respecting individual needs, values, and goals.

The future of pediatric research.

The future of pediatric research will be enhanced by strengthening traditional biomedical approaches and embracing emerging opportunities. Biomedical discovery and translation of new knowledge, concepts, and devices into better diagnostic and therapeutic options will require more pediatric physician-scientists, rapid adoption of enabling technologies, increased funding for research and research training (including the creation of federally funded pediatric translational research centers), and a broader distribution of research activities across the academic pediatric community. Rapid improvement of child health outcomes also will be realized through robust health services research in pediatrics, including the application of rigorous quality improvement science that documents and disseminates successful interventions, leading to better access and effectiveness of care. Improving the value of pediatric care is a realistic goal. Achieving better outcomes through individually tailored (personalized) care for children should be tested experimentally. The future of pediatrics is bright, but will depend on the recognition of and response to a growing array of exciting opportunities.

Development and Testing of the Pediatric Respiratory Illness Measurement System (PRIMES) Quality Indicators.

OBJECTIVES: To develop and test quality indicators for assessing care in pediatric hospital settings for common respiratory illnesses. PATIENTS: A sample of 2796 children discharged from the emergency department or inpatient setting at 1 of the 3 participating hospitals with a primary diagnosis of asthma, bronchiolitis, croup, or community-acquired pneumonia (CAP) between January 1, 2010, and December 31, 2011. SETTING: Three tertiary care children's hospitals in the United States. METHODS: We developed evidence-based quality indicators for asthma, bronchiolitis, croup, and CAP. Expert panel-endorsed indicators were included in the Pediatric Respiratory Illness Measurement System (PRIMES). This new set of pediatric quality measures was tested to assess feasibility of implementation and sensitivity to variations in care. Medical records data were extracted by trained abstractors. Quality measure scores (0-100 scale) were calculated by dividing the number of times indicated care was received by the number of eligible cases. Score differences within and between hospitals were determined by using the Student's t-test or analysis of variance. RESULTS: CAP and croup condition-level PRIMES scores demonstrated significant between-hospital variations (P < .001). Asthma and bronchiolitis condition-level PRIMES scores demonstrated significant within-hospital variation with emergency department scores (means [SD] 82.2(6.1)-100.0 (14.4)] exceeding inpatient scores (means [SD] 71.1 (2.0)-90.8 (1.3); P < .001). CONCLUSIONS: PRIMES is a new set of measures available for assessing the quality of hospital-based care for common pediatric respiratory illnesses.

Promoting translational research in academic health centers: navigating the "roadmap".

The translation of hypothesis-driven research laboratory findings about basic disease mechanisms into clinically useful tests or therapies, particularly in pediatric diseases, is time-consuming, expensive, and not well supported by traditional research grant mechanisms. Accordingly, the development of new drugs and clinical assays has typically been largely the domain of the pharmaceutical industry. Aside from partnering with for-profit companies, academic health centers are challenged to find ways to actively engage in biomedical research to bridge the gap between basic and clinical research. The Translational Research Initiative (TRI) at Cincinnati Children's Hospital Medical Center was launched in 2001 with the mission to build an institutional infrastructure for promoting and facilitating the clinical implementation of investigator-initiated basic research. The TRI's goals are to provide grant support for proposals that are translational in nature and that address serious diagnostic or therapeutic deficiencies in pediatric illnesses; to create and support specialized research cores and a specialized office that provides support for research protocol development and regulatory affairs; and to organize educational opportunities focused on bridging communication between basic and clinical scientists and encouraging multidisciplinary interactions. The authors describe the program structure and provide an interim outcome report as measured by extramural funding obtained, Investigational New Drug applications filed, manuscripts published, clinical trials launched, and educational initiatives created. The broad success of this program suggests that it might serve as a model for other academic health centers in promoting and conducting translational research.

Pediatric faculty members' attitudes about part-time faculty positions and policies to support part-time faculty: a study at one medical center.

PURPOSE: To examine pediatric faculty members' attitudes about part-time faculty positions and policies to support part-time faculty. METHOD: In 2001, an anonymous 26-item questionnaire assessing attitudes about part-time faculty was mailed to all 441 faculty members of Cincinnati Children's Hospital Medical Center. Multivariable analyses were used to determine faculty characteristics associated with specific attitudes, and qualitative methods were used to analyze responses to an open-ended item assessing beliefs about facilitating part-time careers. RESULTS: Three hundred (68%) faculty members completed questionnaires. Twenty-nine (10%) worked part-time and an additional 88 (33%) had considered part-time work, primarily because of dependent children. Although 177 (59%) believed that part-time faculty were perceived as being less committed to their careers and the institution, 207 (69%) believed part-time faculty should be eligible for all academic tracks and 219 (73%) that they should be allowed extension of time to obtain tenure. Most reported that policy changes to support part-time faculty would enhance diversity (N = 234, 78%) and improve recruitment, retention, and promotion of female faculty. Multivariable analysis demonstrated that women and respondents with dependent children were more likely to be concerned about perceived commitment and more likely to endorse policies to support part-time faculty. Participants suggested that part-time careers for faculty would be facilitated by clarifying productivity expectations, expanding resources, and modifying existing policies. CONCLUSIONS: Although women and respondents with dependent children were concerned about perceived commitment of part-time faculty and were most supportive of policies that would support part-time faculty, pediatric faculty generally supported such policies.

IOM Review of FDA--approved biologics labeled or studied for pediatric use.

BACKGROUND: Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologics. This analysis examines the extent to which biologics are labeled for pediatric use or have been studied in children. METHODS: The analysis covers the 96 biologics (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologics. A separate analysis examined labeling and studies for 55 vaccines. RESULTS: For ∼60% of the 96 biologics, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologics have ≥1 registered pediatric trial completed, underway, or planned. Overall, ∼90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%. CONCLUSIONS: A majority of biologics approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority of these products.