Yashwant Sinha

Auditory integration training and other sound therapies for autism spectrum disorders: a systematic review

Objectives: To determine the effectiveness of auditory integration training (AIT) or other methods of sound therapy in people with autism spectrum disorders (ASD). Study design: A systematic review was carried out of randomised controlled trials (RCTs) of adults or children with ASD. Meta-analysis was attempted. Results: Six RCTs of AIT, including one crossover trial, were identified, with a total of 171 participants aged 3–39 years. 17 different outcome measures were used, with only two outcome measures used by three or more studies. Meta-analysis was not possible owing to very high heterogeneity or presentation of data in unusable forms. Three studies did not show any benefit of AIT over control conditions. Three studies reported improvements at 3 months in the AIT group for total mean scores of the Aberrant Behaviour Checklist (ABC), which is of questionable validity. Of these, one study also reported improvements at 3 months in the AIT group for ABC subgroup scores. No significant adverse effects of AIT were reported. Conclusion: At present there is not sufficient evidence to support its use.

How to use medicines in children: Principles of paediatric clinical pharmacology

Abstract:  Knowledge of drug administration in children and infants has significantly lagged behind that of adults. Despite several paediatric therapeutic mishaps that have been a catalyst for major regulatory reform, the majority of registered medicines do not have indications or dosing for children. This paper will briefly summarise key issues in paediatric pharmacology, including differences in prescribing for children, off‐label and unlicensed prescribing and conduct of paediatric clinical trials. A particular emphasis will placed on the situation in Australia.

Prescribing safely for children.

Abstract:  This paper is the second in a series of two and will attempt to highlight important issues in prescribing for children, including principles of safe prescribing, adverse drug reaction assessment and common drugs including paracetamol and ibuprofen. A list of drug information resources is included, which may be useful for clinicians.

The Pharmaceutical Benefits Scheme and implications for paediatric prescribing.

Aims:  To evaluate the impact of the Pharmaceutical Benefits Advisory Committee (PBAC) decisions on access to medicines listed on the Pharmaceutical Benefits Scheme (PBS) for children.

Drug approval processes in Australian Paediatric Hospitals

Objective To describe and evaluate the decision-making processes for drug approval in Australian paediatric hospitals. Design Multicentre descriptive study involving face-to-face interviews of drug and therapeutics committee chairs and secretaries, review of committee documents and drug submissions for all Australian paediatric hospital drug and therapeutics committees over a 1-year period. Setting All eight paediatric hospitals in Australia. Participants Eight committee chairs and seven secretaries or delegates. Main outcome measures Total drug expenditure, number of formulary submissions, individual-patient use approvals and approval rates for each hospital from 1 July 2006 to 30 June 2007, stratified by therapeutic class. Qualitative description of the approval processes. Results Total drug expenditure varied from

A national study of the processes and outcomes of paediatric formulary applications in Australia.

A1.7 million (US

Paediatric drug policy in Australia

1.5 million) to

Auditory integration training and other sound therapies for autism spectrum disorders (ASD)

A11.1million (US

Chelation therapy and autism

9.8 million) per hospital. The number of formulary submissions also varied, from 7 to 21, but approval rate was high (76%–100%) and not significantly different among hospitals (p=0.17). Several committees approved identical submissions for five drugs. The number of individual-patient use applications varied considerably, ranging from 10 to 456 per hospital. Where estimable, individual-patient use approval was 76%–100% and variable (p=0.03). Quality of evidence relating to safety and efficacy of drugs being considered was regarded as the most important factors influencing decision making, with the cost less important. Most committees had poor infrastructural support for approval processes. No committee formally included a pharmaco-economic evaluation. Conclusions Most drug submissions in tertiary paediatric hospitals are approved; however, workload, drug expenditure and individual-patient use schemes vary considerably. Duplication of effort occurs, and few committees are resourced sufficiently given their terms of reference.

Risk of Bias in Randomized Trials of Pharmacological Interventions in Children and Adults

Objective: To evaluate the processes by which pharmaceuticals are added to the formularies of Australian paediatric hospitals.