Dosage form preference consultation study in children and young adults:paving the way for patient-centred and patient-informed dosage form development

Objectives: The current study aims to evaluate dosage form preferences in children and young adults together with identifying the key pragmatic dosage form characteristics that would enable appropriate formulation of orally disintegrating tablets (ODTs). Methods: International, multisite, cross-sectional questionnaire of children and young adults aged from 6 to 18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications. The study was carried out at three locations: the UK, Saudi Arabia and Jordan. The questionnaire instrument was designed for participant self-completion under supervision of the study team.Results 104 questionnaires were completed by the study cohort (n=120, response rate 87%). Results: showed that ODTs were the most preferred oral dosage forms (58%) followed by liquids (20%), tablets (12%) and capsules (11%). The preferred colours were pink or white while the preferred size was small (<8 mm) with a round shape. With regard to flavour, strawberry was the most preferred (30.8%), while orange was the least preferred (5.8%). The results also showed that the most important physical characteristics of ODTs were disintegration time followed by taste, size and flavour, respectively. Conclusions: The results of our study support the WHO's claim for a shift of paradigm from liquid towards ODTs dosage forms for drug administration to young children older than 6 years. Data from this study will also equip formulators to prioritise development of key physical/performance attributes within the delivery system.

Balance ability of 7 and 10 year old children in the population:results from a large UK birth cohort study

OBJECTIVE: The literature contains many reports of balance function in children, but these are often on atypical samples taken from hospital-based clinics and may not be generalisable to the population as a whole. The purpose of the present study is to describe balance test results from a large UK-based birth cohort study. METHODS: Data from the Avon Longitudinal Study of Parents and Children (ALSPAC) were analysed. A total of 5402 children completed the heel-to-toe walking test at age 7 years. At age 10 years, 6915 children underwent clinical tests of balance including beam-walking, standing heel-to-toe on a beam and standing on one leg. A proportion of the children returned to the clinic for retesting within 3 months allowing test-retest agreement to be measured. RESULTS: Frequency distributions for each of the balance tests are given. Correlations between measures of dynamic balance at ages 7 and 10 years were weak. The static balance of 10 year old children was found to be poorer with eyes closed than with eyes open, and poorer in boys than in girls for all measures. Balance on one leg was poorer than heel-to-toe balance on a beam. A significant learning effect was found when first and second attempts of the tests were compared. Measures of static and dynamic balance appeared independent. Consistent with previous reports in the literature, test-retest reliability was found to be low. CONCLUSIONS: This study provides information about the balance ability of children aged 7 and 10 years and provides clinicians with reference data for balance tests commonly used in the paediatric clinic.

A telephone survey to determine the experiences of children and their parents/carers, following the initiation of a new medicine

Objective: To determine what issues are experienced during the first few weeks of therapy by patients, and their parents/carers, when a child/young person has been prescribed a new medicine. Method: One hundred patients aged ≤18 years of age prescribed a new medicine for ≥6 weeks were recruited from a single UK National Health Service specialist paediatric hospital outpatient pharmacy. Six weeks after the first dispensing of their new medicine the patient or their parent/carer received telephone follow-up by a researcher and verbally completed a questionnaire containing both open and closed questions. Patient or parent/carer experiences were identified and analysed using thematic analysis and descriptive statistics. Results: Eighty-six participants were available for telephone follow-up. Six (7%) had not started their medicine. Paediatric patients and their parents/carers experienced a range of issues during the first few weeks after starting a new medicine. These included additional concerns/questions (24/80, 30%), administration issues (21/80, 26.3%), adverse effects (29/80, 36.3%) and obtaining repeat supplies (12/80, 15%). The Morisky Medication Adherence Scale indicated that 34/78 (43.6%) participants had a high adherence rating, 35/78 (44.9%) medium and 9/78 (11.5%) a low rating. Conclusions: Paediatric patients and their parents/carers experience a range of issues during the first few weeks after starting a new medicine. Further research is required to determine the type of interventions that may further support medicines use in this group of patients.

The Gilles de la Tourette Syndrome-Quality of Life Scale for children and adolescents (C&A-GTS-QOL):development and validation of the Italian version

BACKGROUND: Gilles de la Tourette syndrome (GTS) is a chronic childhood-onset neuropsychiatric disorder with a significant impact on patients' health-related quality of life (HR-QOL). Cavanna et al. (Neurology 2008; 71: 1410-1416) developed and validated the first disease-specific HR-QOL assessment tool for adults with GTS (Gilles de la Tourette Syndrome-Quality of Life Scale, GTS-QOL). This paper presents the translation, adaptation and validation of the GTS-QOL for young Italian patients with GTS. METHODS: A three-stage process involving 75 patients with GTS recruited through three Departments of Child and Adolescent Neuropsychiatry in Italy led to the development of a 27-item instrument (Gilles de la Tourette Syndrome-Quality of Life Scale in children and adolescents, C&A-GTS-QOL) for the assessment of HR-QOL through a clinician-rated interview for 6-12 year-olds and a self-report questionnaire for 13-18 year-olds. RESULTS: The C&A-GTS-QOL demonstrated satisfactory scaling assumptions and acceptability. Internal consistency reliability was high (Cronbach's alpha > 0.7) and validity was supported by interscale correlations (range 0.4-0.7), principal-component factor analysis and correlations with other rating scales and clinical variables. CONCLUSIONS: The present version of the C&A-GTS-QOL is the first disease-specific HR-QOL tool for Italian young patients with GTS, satisfying criteria for acceptability, reliability and validity. © 2013 - IOS Press and the authors. All rights reserved.

Engaging with a world outside of ourselves:vistas of flatness, children's work and the urban informal economy

This paper considers the work and labour of children living on the streets of Accra, Ghana. It does so in two distinctive ways. First, it considers how the children's photographs of a day or two in their working lives, and the dialogues that go on in, through and around them, may contribute to the making of strong sociological arguments about children's work. In so doing, this paper elaborates the connections between visual sociology and realist traditions of photography, and argues that photographs can contribute distinctive and novel sources of insight into working children's lives and a powerful, humanising media of dissemination. Second, these arguments are then deployed to examine street children's experiences of work. Conceptualised in terms of its 'flatness', the paper explores the informal means of regulation through which the children are locked into types of working that prove difficult to escape. © Sociological Research Online, 1996-2012.

Adherence to treatment in children and adolescents with cystic fibrosis:a cross-sectional, multi-method study investigating the influence of beliefs about treatment and parental depressive symptoms

Background: Adherence to treatment is often reported to be low in children with cystic fibrosis. Adherence in cystic fibrosis is an important research area and more research is needed to better understand family barriers to adherence in order for clinicians to provide appropriate intervention. The aim of this study was to evaluate adherence to enzyme supplements, vitamins and chest physiotherapy in children with cystic fibrosis and to determine if any modifiable risk factors are associated with adherence. Methods: A sample of 100 children (≤18 years) with cystic fibrosis (44 male; median [range] 10.1 [0.2-18.6] years) and their parents were recruited to the study from the Northern Ireland Paediatric Cystic Fibrosis Centre. Adherence to enzyme supplements, vitamins and chest physiotherapy was assessed using a multi-method approach including; Medication Adherence Report Scale, pharmacy prescription refill data and general practitioner prescription issue data. Beliefs about treatments were assessed using refined versions of the Beliefs about Medicines Questionnaire-specific. Parental depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale. Results: Using the multi-method approach 72% of children were classified as low-adherers to enzyme supplements, 59% low-adherers to vitamins and 49% low-adherers to chest physiotherapy. Variations in adherence were observed between measurement methods, treatments and respondents. Parental necessity beliefs and child age were significant independent predictors of child adherence to enzyme supplements and chest physiotherapy, but parental depressive symptoms were not found to be predictive of adherence. Conclusions: Child age and parental beliefs about treatments should be taken into account by clinicians when addressing adherence at routine clinic appointments. Low adherence is more likely to occur in older children, whereas, better adherence to cystic fibrosis therapies is more likely in children whose parents strongly believe the treatments are necessary. The necessity of treatments should be reinforced regularly to both parents and children.

Early predictors of phonological and morphological awareness and the link with reading:evidence from children with different patterns of early deficit

This study examines the contribution of early phonological processing (PP) and language skills on later phonological awareness (PA) and morphological awareness (MA), as well as the links among PA, MA, and reading. Children 4-6 years of age with poor PP at the start of school showed weaker PA and MA 3 years later (age 7-9), regardless of their language skills. PA and phonological and morphological strategies predict reading accuracy, whereas MA predicts reading comprehension. Our findings suggest that children with poor early PP are more at risk of developing deficits in MA and PA than children with poor language. They also suggest that there is a direct link between PA and reading accuracy and between MA and reading comprehension that cannot be accounted for by strategy use at the word level.

Eating behaviours of preadolescent children over time:stability, continuity and the moderating role of perceived parental feeding practices

The links between childhood eating behaviours and parental feeding practices are well-established in younger children, but there is a lack of research examining these variables in a preadolescent age group, particularly from the child's perspective, and longitudinally. This study firstly aimed to examine the continuity and stability of preadolescent perceptions of their parents' controlling feeding practices (pressure to eat and restriction) over a 12 month period. The second aim was to explore if perceptions of parental feeding practices moderated the relationship between preadolescents' eating behaviours longitudinally. Two hundred and twenty nine preadolescents (mean age at recruitment 8.73 years) completed questionnaires assessing their eating behaviours and their perceptions of parental feeding practices at two time points, 12 months apart (T1 and T2). Preadolescents' perceptions of their parental feeding practices remained stable. Perceptions of restriction and pressure to eat were continuous. Perceptions of parental pressure to eat and restriction significantly moderated the relationships between eating behaviours at T1 and T2. The findings from this study suggest that in a preadolescent population, perceptions of parental pressure to eat and restriction of food may exacerbate the development of problematic eating behaviours.

Reviewing the evidence base for the Children and Young People Safety Thermometer (CYPST):a mixed studies review

The objective was to identify evidence to support use of specific harms for the development of a children and young people's safety thermometer (CYPST). We searched PubMed, Web of Knowledge, and Cochrane Library post-1999 for studies in pediatric settings about pain, skin integrity, extravasation injury, and use of pediatric early warning scores (PEWS). Following screening, nine relevant articles were included. Convergent synthesis methods were used drawing on thematic analysis to combine findings from studies using a range of methods (qualitative, quantitative, and mixed methods). A review of PEWS was identified so other studies on this issue were excluded. No relevant studies about extravasation injury were identified. The synthesized results therefore focused on pain and skin integrity. Measurement and perception of pain were complex and not always carried out according to best practice. Skin abrasions were common and mostly associated with device related injuries. The findings demonstrate a need for further work on perceptions of pain and effective communication of concerns about pain between parents and nursing staff. Strategies for reducing device-related injuries warrant further research focusing on prevention. Together with the review of PEWS, these synthesized findings support the inclusion of pain, skin integrity, and PEWS in the CYPST.

'Their tummys don't really suit that food':children and young teenagers understanding of food allergy

Background: Food allergy (FA) is aunique chronic condition as sufferers aregenerally well unless they accidentally ingest an allergen, whereupon symptoms can be life threatening. A good under-standing of the condition is essential forsuccessful self-management, however little is known about children and young teenagers' understanding. This study aimed toexplore understanding of FA in childrenwith and without FA and whether under-standing changes as children get older.Method: Participants aged 6–14 years (53with FA; 89 without), recruited from loc evidence of a prospective associationbetween maternal, perinatal or infant VDIand subsequent IgE-mediated FA schools and allergy clinics took part insemi-structured interviews; data were analysed using thematic analysis.Results: Three themes were identified fromthe data across the different age groups andallergy statuses: food allergy as a sickness, food allergy as an illness and food allergy asintolerance to food. Children aged 6–8 years described FA as a sickness; you were not allowed the food because it makes youpoorly. Children aged 9–11 years also talked about FA as something that makesyou poorly, but many also described it as anillness and understood that symptoms were caused by food. Children aged 12–14 yearsdescribed it as an intolerance or that FA was your body's response to a particularfood. These age-related differences wereseen in children with and without FA. Conclusion: Although sophistication ofknowledge of FA increases with age, it is still a little understood condition by chil-dren and young teenagers. Clear, age-re-lated information about food allergy andhow it should be managed is needed forthose with and without allergy, to avoidmisunderstanding, and aid awareness andbetter self-management of the condition

Association of SNPs in LCP1 and CTIF with hearing in 11 year old children:findings from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort and the G-EAR consortium

BACKGROUND: The genetic basis of hearing loss in humans is relatively poorly understood. In recent years, experimental approaches including laboratory studies of early onset hearing loss in inbred mouse strains, or proteomic analyses of hair cells or hair bundles, have suggested new candidate molecules involved in hearing function. However, the relevance of these genes/gene products to hearing function in humans remains unknown. We investigated whether single nucleotide polymorphisms (SNPs) in the human orthologues of genes of interest arising from the above-mentioned studies correlate with hearing function in children. METHODS: 577 SNPs from 13 genes were each analysed by linear regression against averaged high (3, 4 and 8 kHz) or low frequency (0.5, 1 and 2 kHz) audiometry data from 4970 children in the Avon Longitudinal Study of Parents and Children (ALSPAC) birth-cohort at age eleven years. Genes found to contain SNPs with low p-values were then investigated in 3417 adults in the G-EAR study of hearing. RESULTS: Genotypic data were available in ALSPAC for a total of 577 SNPs from 13 genes of interest. Two SNPs approached sample-wide significance (pre-specified at p = 0.00014): rs12959910 in CBP80/20-dependent translation initiation factor (CTIF) for averaged high frequency hearing (p = 0.00079, β = 0.61 dB per minor allele); and rs10492452 in L-plastin (LCP1) for averaged low frequency hearing (p = 0.00056, β = 0.45 dB). For low frequencies, rs9567638 in LCP1 also enhanced hearing in females (p = 0.0011, β = -1.76 dB; males p = 0.23, β = 0.61 dB, likelihood-ratio test p = 0.006). SNPs in LCP1 and CTIF were then examined against low and high frequency hearing data for adults in G-EAR. Although the ALSPAC results were not replicated, a SNP in LCP1, rs17601960, is in strong LD with rs9967638, and was associated with enhanced low frequency hearing in adult females in G-EAR (p = 0.00084). CONCLUSIONS: There was evidence to suggest that multiple SNPs in CTIF may contribute a small detrimental effect to hearing, and that a sex-specific locus in LCP1 is protective of hearing. No individual SNPs reached sample-wide significance in both ALSPAC and G-EAR. This is the first report of a possible association between LCP1 and hearing function.