PMC:3925439 / 7827-9508 JSONTXT

{"project":"2_test","denotations":[{"id":"24524676-10979117-142841349","span":{"begin":301,"end":303},"obj":"10979117"},{"id":"24524676-3060211-142841350","span":{"begin":475,"end":477},"obj":"3060211"},{"id":"24524676-17701403-142841351","span":{"begin":833,"end":835},"obj":"17701403"},{"id":"24524676-17701403-142841352","span":{"begin":934,"end":936},"obj":"17701403"}],"text":"n-of-1 trials\nn-of-1 trials are multiple-cycle, double-blind, placebo-controlled cross-over trials using standardised measures of effect, with randomisation order independently generated for each patient. They provide the strongest evidence possible about treatment efficacy in an individual patient [20]. This may be particularly important in the ABI population, as there may be positive effects for some individuals ('responders’) as opposed to others ('non-responders’); [11,13,16].\nThe number of children available for many trials is generally smaller than for adult RCTs, making it difficult to achieve a sample with adequate power when undertaking conventional parallel arm RCTs. Aggregated n-of-1 trials are ideally suited to paediatric populations, as the sample size required to achieve adequate power is considerably less [21]. Additionally, individual responses are available for feedback to participants and their carers [21]. As no previous n-of-1 trials have been conducted in this area, this reported series of n-of-1 trials significantly enhances paediatric community rehabilitation knowledge and practice.\nObjectives were 1) to determine the efficacy of central nervous system stimulants for children with traumatic brain injury and 2) to determine the effect size using the Conners’ 3 Parent Rating Scales Score as the primary endpoint in this pilot study. This would later be used to calculate the sample size for a larger trial. The main hypothesis was that stimulant therapy compared to placebo would significantly improve attention and concentration, and executive dysfunction including disorders of behavioural and emotional regulation, in children with TBI."}

{"project":"NEUROSES","denotations":[{"id":"T179","span":{"begin":631,"end":636},"obj":"PATO_0001024"},{"id":"T180","span":{"begin":805,"end":810},"obj":"PATO_0001024"},{"id":"T181","span":{"begin":686,"end":696},"obj":"PATO_0001629"},{"id":"T182","span":{"begin":771,"end":775},"obj":"PATO_0000117"},{"id":"T183","span":{"begin":1277,"end":1281},"obj":"PATO_0000117"},{"id":"T184","span":{"begin":1424,"end":1428},"obj":"PATO_0000117"},{"id":"T185","span":{"begin":996,"end":1000},"obj":"PATO_0001323"},{"id":"T186","span":{"begin":1558,"end":1571},"obj":"PATO_0000033"},{"id":"T187","span":{"begin":1587,"end":1598},"obj":"PATO_0001624"},{"id":"T188","span":{"begin":1648,"end":1658},"obj":"PATO_0000076"},{"id":"T170","span":{"begin":2,"end":5},"obj":"CHEBI_30241"},{"id":"T171","span":{"begin":16,"end":19},"obj":"CHEBI_30241"},{"id":"T172","span":{"begin":699,"end":702},"obj":"CHEBI_30241"},{"id":"T173","span":{"begin":956,"end":959},"obj":"CHEBI_30241"},{"id":"T174","span":{"begin":1028,"end":1031},"obj":"CHEBI_30241"},{"id":"T175","span":{"begin":32,"end":40},"obj":"PATO_0002118"},{"id":"T176","span":{"begin":55,"end":60},"obj":"PATO_0001177"},{"id":"T177","span":{"begin":622,"end":630},"obj":"PATO_0001627"},{"id":"T178","span":{"begin":796,"end":804},"obj":"PATO_0001627"}],"text":"n-of-1 trials\nn-of-1 trials are multiple-cycle, double-blind, placebo-controlled cross-over trials using standardised measures of effect, with randomisation order independently generated for each patient. They provide the strongest evidence possible about treatment efficacy in an individual patient [20]. This may be particularly important in the ABI population, as there may be positive effects for some individuals ('responders’) as opposed to others ('non-responders’); [11,13,16].\nThe number of children available for many trials is generally smaller than for adult RCTs, making it difficult to achieve a sample with adequate power when undertaking conventional parallel arm RCTs. Aggregated n-of-1 trials are ideally suited to paediatric populations, as the sample size required to achieve adequate power is considerably less [21]. Additionally, individual responses are available for feedback to participants and their carers [21]. As no previous n-of-1 trials have been conducted in this area, this reported series of n-of-1 trials significantly enhances paediatric community rehabilitation knowledge and practice.\nObjectives were 1) to determine the efficacy of central nervous system stimulants for children with traumatic brain injury and 2) to determine the effect size using the Conners’ 3 Parent Rating Scales Score as the primary endpoint in this pilot study. This would later be used to calculate the sample size for a larger trial. The main hypothesis was that stimulant therapy compared to placebo would significantly improve attention and concentration, and executive dysfunction including disorders of behavioural and emotional regulation, in children with TBI."}