Paediatrics (RCH) - Research Publications
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ItemEfficacy of two once-daily methylphenidate formulations compared across dose levels at different times of the day: Preliminary indications from a secondary analysis of the COMACS study data(BMC, 2004)BACKGROUND: Methylphenidate (MPH) is commonly prescribed in the treatment of Attention-Deficit/Hyperactivity Disorder or ADHD. Concerta and Metadate CD are once-daily formulations of MPH using different delivery mechanisms resulting in different pharmacokinetic profiles. A recent study (COMACS) showed that for near-milligram (mg) equivalent daily doses, Metadate CD provides greater symptom control in the morning (1.5 through 4.5 hours post-dose), while Concerta provides greater control in the early evening (12 hours post-dose). Non-inferential comparison of effects for different dose levels of the two formulations suggested that equivalent levels of morning symptom control could be obtained with lower daily doses of Metadate CD than Concerta; the situation being reversed in the evening. The current paper presents a secondary analysis that provides a statistical test of these observations. METHOD: The COMACS study was a multi-center, double-blind crossover study of Metadate CD, Concerta and placebo with each treatment administered for 1 week. Children were assigned on the basis of their pre-trial dosage to either high (Metadate CD 60 mg; Concerta 54 mg), medium (Metadate CD 40 mg; Concerta 36 mg) or low doses (Metadate CD 20 mg; Concerta 18 mg) of MPH, and attended a laboratory school on the 7th day for assessment at 7 sessions across the day. For the post-hoc comparisons across dose levels presented here, total SKAMP scores with the active treatments (adjusted for placebo response) were analyzed using an analysis of covariance, with a combined measure modeling placebo response across all time period as the covariate. RESULTS: Symptom control from 1.5 through 6.0 hours post-dose was as good with lower doses of Metadate CD (20 and 40 mg) as with higher doses of Concerta (36 and 54 mg, respectively). Lower daily doses of Concerta (18 and 36 mg) and higher doses of Metadate CD (40 and 60 mg, respectively) gave equivalent control at 7.5 and 12 hours with Metadate CD giving better control from1.5 through 6.0 hours post-dose. CONCLUSIONS: Different delivery profiles of Metadate CD and Concerta can be exploited to limit total daily exposure to MPH while at the same targeting a specific, especially clinically significant, period of the day. These results need to be confirmed in a study in which children are randomly allocated to different dose levels of the two formulations and plasma MPH concentrations are assessed simultaneously.
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ItemImpact of attention-deficit/hyperactivity disorder on the patient and family: results from a European survey.(Springer Science and Business Media LLC, 2008-10-28)BACKGROUND: Children with attention-deficit/hyperactivity disorder (ADHD) often experience problems with education, interaction with others and emotional disturbances. Families of ADHD children also suffer a significant burden, in terms of strain on relationships and reduced work productivity. This parent survey assessed daily life for children with ADHD and their families. METHOD: This pan-European survey involved the completion of an on-line questionnaire by parents of children (6-18 years) with ADHD (ADHD sample) and without ADHD (normative population sample). Parents were questioned about the impact of their child's ADHD on everyday activities, general behaviour and family relationships. RESULTS: The ADHD sample comprised 910 parents and the normative population sample 995 parents. 62% of ADHD children were not currently receiving medication; 15% were receiving 6-8 hour stimulant medication and 23% 12-hour stimulant medication. Compared with the normative population sample, parents reported that ADHD children consistently displayed more demanding, noisy, disruptive, disorganised and impulsive behaviour. Significantly more parents reported that ADHD children experienced challenges throughout the day, from morning until bedtime, compared with the normative population sample. Parents reported that children with ADHD receiving 12-hour stimulant medication experienced fewer challenges during early afternoon and late afternoon/early evening than children receiving 6-8 hour stimulant medication; by late evening and bedtime however, this difference was not apparent. ADHD was reported to impact most significantly on activities such as homework, family routines and playing with other children. All relationships between ADHD children and others were also negatively affected, especially those between parent and child (72% of respondents). Parents reported that more children with ADHD experienced a personal injury in the preceding 12 months, including those requiring the attention of healthcare professionals. Although 68% of parents were satisfied with their child's current treatment, 35-40% stated that their child's ADHD symptoms needed to be more effectively treated during the afternoon and evening. CONCLUSION: This parent survey highlights the breadth of problems experienced by ADHD children and the impact throughout the day on both activities and relationships. Therefore, there is a need for treatment approaches that take into account the 24-hour impact of the disorder and include all-day coverage with effective medication.
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ItemThe validity, reliability and normative scores of the parent, teacher and self report versions of the Strengths and Difficulties Questionnaire in China.(Springer Science and Business Media LLC, 2008-04-29)BACKGROUND: The Strengths and Difficulties Questionnaire (SDQ) has become one of the most widely used measurement tools in child and adolescent mental health work across the globe. The SDQ was originally developed and validated within the UK and whilst its reliability and validity have been replicated in several countries important cross cultural issues have been raised. We describe normative data, reliability and validity of the Chinese translation of the SDQ (parent, teacher and self report versions) in a large group of children from Shanghai. METHODS: The SDQ was administered to the parents and teachers of students from 12 of Shanghai's 19 districts, aged between 3 and 17 years old, and to those young people aged between 11 and 17 years. Retest data was collected from parents and teachers for 45 students six weeks later. Data was analysed to describe normative scores, bandings and cut-offs for normal, borderline and abnormal scores. Reliability was assessed from analyses of internal consistency, inter-rater agreement, and temporal stability. Structural validity, convergent and discriminant validity were assessed. RESULTS: Full parent and teacher data was available for 1965 subjects and self report data for 690 subjects. Normative data for this Chinese urban population with bandings and cut-offs for borderline and abnormal scores are described. Principle components analysis indicates partial agreement with the original five factored subscale structure however this appears to hold more strongly for the Prosocial Behaviour, Hyperactivity - Inattention and Emotional Symptoms subscales than for Conduct Problems and Peer Problems. Internal consistency as measured by Cronbach's alpha coefficient were generally low ranging between 0.30 and 0.83 with only parent and teacher Hyperactivity - Inattention and teacher Prosocial Behaviour subscales having alpha > 0.7. Inter-rater correlations were similar to those reported previously (range 0.23 - 0.49) whilst test retest reliability was generally lower than would be expected (range 0.40 - 0.79). Convergent and discriminant validity are supported. CONCLUSION: We report mixed findings with respect the psychometric properties of the Chinese translation of the SDQ. Reliability is a particular concern particularly for Peer Problems and self ratings by adolescents. There is good support for convergent validity but only partial support for structural validity. It may be possible to resolve some of these issues by carefully examining the wording and meaning of some of the current questions.