Pediatric Intervention Studies Research Articles

Considerations in pediatric intervention research: Lessons learned from two pediatric pilot studies

Background and purposePediatric populations represent a vulnerable research group. Careful thought must be given to many factors when designing and implementing pediatric intervention research studies. This article discusses methodological and implementation lessons learned from two pediatric intervention pilot studies and highlights facilitators and barriers encountered. Type of methodBoth studies used a pre/post with 6-week follow-up method and were adapted versions of an evidence-based program, Creating Opportunities for Personal Empowerment (COPE). Essential featuresCOPE is a 7-session, cognitive behavioral skills building intervention. COPE for Asthma was implemented in schools with small groups for elementary-aged children with asthma and symptoms of anxiety. Mindstrong to Combat Bullying was implemented individually in the outpatient mental health setting for adolescents who had experienced bullying with concurrent symptoms of depression/anxiety. Methodological applicationBoth intervention studies were successful in achieving their research aims, but more importantly the authors learned important lessons in how to successfully work with pediatric populations in research studies. Legal considerations, such as mandated reporting, suicide risk assessment and the inclusion of parents are reviewed. Other components, such as working with children vs. adolescents, integrating research into school-based settings vs. clinic-based settings, and completing intervention research in a group setting vs. individual setting are discussed. ConclusionsThe two pilot studies highlight important factors to consider when designing and implementing pediatric intervention studies. While challenges arise in working with this vulnerable population, research is ultimately needed to provide the best evidence-based care for our future generations. Clinical trial registrationThe COPE for Asthma study is registered at www.clinicaltrials.govNCT03481673.

Trial registration in pediatric surgery trials

BackgroundProspective clinical trial registration serves to increase transparency and to mitigate selective reporting bias. An assessment of adult surgical trials revealed poor trial registration practice with incomplete provision of information in registries and inconsistent information in the corresponding publication. The extent and completeness of pediatric surgical trial registration are unknown. We aimed to determine the proportion and adequacy of clinical trial registration in pediatric surgery trials published in 2014. MethodsUsing sensitive search strategies in MEDLINE, abstracts and full-texts of prospective pediatric intervention studies published in 2014 were screened in duplicate. Pediatric surgical trials were included. Clinical trial registration numbers obtained from publications were searched in trial registries. Data were extracted based on WHO 20-item minimum data set to determine the completeness of registration data. The proportion of registered trials was recorded and registration data were compared to reported data in the corresponding publication. ResultsOur search and abstract screening identified 3375 articles for full text review. Following coding, a total of 54 pediatric surgical trials were included and analyzed; 28% (15/54) of which published a registration number. In trials which reported a registration number, 40% (6/15) were retrospectively registered and 40% (6/15) had made changes to their registered primary and/or secondary outcome measures. One included published trial reported an incorrect registration number. ConclusionsAnalysis of pediatric surgery trials published in 2014 revealed a poor prospective trial registration rate and incomplete registration data. Our study supports future initiatives for improved registration behaviors in pediatric surgery trials to ensure high-quality, transparent, reproducible evidence is generated. Study typeTherapeutic (clinical trials), level II.

Estimation of effective dose for children in interventional cardiology

This study is devoted to the estimation of effective dose for children undergoing interventional cardiology examinations. The conversion coefficients (CC) from directly measured dose area product (DAP) value to effective dose (ED) were calculated within the approved effective dose assessment methodology (Guidelines 2.6.1. 2944-11). The CC, Ed K , [mSv / (Gy • cm 2 )] for newborn infants and children of 1, 5, 10 and 15 years old (main(range)) were calculated as 2.5 (1.8-3.2); 1.1 (0.8-1.3); 0.6 (0.4-0.7); 0.4 (0.3-0.5); and 0,22 (0,18-0,30) respectively. A special Finnish computer program PCXMC 2.0 was used for calculating the dose CC. The series of calculations were made for different values of the physical and geometrical parameters based on their real-existing range of values. The value of CC from DAP to ED were calculated for all pediatric age groups. This work included 153 pediatric interventional studies carried out in two hospitals of the city of St. Petersburg for the period of one year from the summer of 2015. The dose CC dependency from the patient’s age and parameters of the examinations were under the study. The dependence from the beam quality (filtration and tube voltage) and age of the patient were found. The younger is the patient, stronger is the filtration and higher is the voltage, the higher is the CC value. The CC in the younger (newborn) and older (15 years) age groups are different by the factor of 10. It was shown that the changes of the geometric parameters (in the scope of their real existing range) have small effect on the value of the effective dose, not exceed 30-50% allowable for radiation protection purpose. The real values of effective doses of children undergoing cardiac interventions were estimated. In severe cases, the values of ED can reach several tens of mSv.

Determination of Appropriate Dosing of Influenza Drugs in Pediatric Patients

Dose-finding studies of influenza antiviral drugs are challenging because it is difficult to enroll subjects in pediatric interventional studies and also because of the lack of concentration (or toxicity)–response relationships, the short duration of antiviral therapy, and the continually developing metabolic profiles of infants and young children. The evaluation of influenza antiviral agents in premature infants adds even more complexity. Recent advances in exposure-targeted study designs and modeling and simulations have aided in addressing some of these challenges.

Psychosocial Considerations for Children and Young Adolescents with Implantable Cardioverter Defibrillators: An Update

The extension of the life-saving benefits of the implantable cardioverter-defibrillator (ICD) to prevent sudden cardiac arrest in children and young adults represents a key clinical development. The psychosocial adjustment in young ICD patients has not been as well-studied as in adults and remains an area of needed research. The current paper reviews the quantitative research regarding ICD patient psychosocial outcomes in the adult and pediatric literature, and highlights existing intervention research on adult ICD patients and its implications for young ICD patients. Literature review indicates that anxiety may be the most problematic psychosocial reaction for young ICD patients, similar to adult patients. Since young ICD patients appear to be more likely to experience shocks than adults; shock-related anxiety is suspected to be particularly common. Interventions in adults have shown a reduction in anxiety but no pediatric intervention studies are currently available in the literature. Additional research and clinical attention is warranted to further assist young ICD patients to achieve desirable quality of life outcomes.

A Review of Music-based Intervention Reporting in Pediatrics

Determining how music-based interventions have been described in published literature is an important first step in evaluating whether guidelines for reporting music-based interventions need to be developed. Twenty-two pediatric intervention studies that met specified inclusion criteria were reviewed for content in 11 areas. This review revealed significant gaps in intervention reporting. Problems were particularly pronounced in eight areas: music qualities, intervention materials, intervention components, intervention delivery schedule, interventionist, treatment fidelity, setting and music delivery method. Development of reporting guidelines for music-based interventions is needed to improve reporting and advance evidence-based practice.

CAN CHILDHOOD SPORT PREVENT ADULT OSTEOPOROSIS? - LESSONS FROM SPORT & INTERVENTION STUDIES

2100 The symposium permits active pediatric bone researchers to present the most current results from longitudinal physical activity studies. Dr Vuori's introduction will emphasis the importance of peak bone mass as a determinant of adult bone mineral density, and thus, risk of osteoporotic fracture. Dr Bailey will summarise outcomes of the University of Saskatchewan Pediatric Bone Mineral Accrual Study, a 7-yr longitudinal study of normal children that identified the tempo & timing of peak bone mineral content velocity and examined the association between physical activity & bone mineral accrual in normally active children. Dr Haapasalo, from the Bone Research Group at the UKK Institute, will outline the strengths of the tennis model for bone research, illustrate the role of pubertal stage in modulating the effect of loading on bone accrual, and discuss results of detraining studies that suggest pediatric bone gain may provide long-standing benefits. Dr McKay will review the few pediatric intervention studies and report results of the University of British Columbia's School-based Exercise Intervention Study - a 9 month randomized control trial in a mixed ethnic group of prepubertal children - that intervened with an increased loading curriculum within existing physical education classes.