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Plymouth Health Community NICE Guidance Implementation Group. Asthma inhalers for routine treatment of chronic asthma in older children (aged 5 - 15 years) Miss Faye Doris University of Plymouth. The National Institute of Clinical Excellence Clinical Guidelines.
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Plymouth Health CommunityNICE Guidance Implementation Group Asthma inhalers for routine treatment of chronic asthma in older children (aged 5 - 15 years) Miss Faye Doris University of Plymouth
The National Institute of Clinical ExcellenceClinical Guidelines • View arrived at after careful consideration of the available evidence • Health professionals are expected to consider these when making a clinical judgement
The National Institute of Clinical ExcellenceClinical Guidelines • do not ‘override the individual responsibility of health professionals, to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and or their guardian or carer’.
Previous Guidance: management of asthma in adults and children • British Thoracic Society (BTS) guideline issued in 1997 was the most commonly used in the UK • Not explicitly evidenced based • largely considered the management of asthma in adults and older children
Previous Guidance: British Thoracic Society Guidance Contd. • Principles for selection of devices stated • Recommendations about specific devices not made
The Appraisal Process • Examination of the evidence on the clinical effectiveness and cost effectiveness of inhaler devices • Stakeholder consultations
The Appraisal Process: Systematic Reviews A review of research-based evidence on a topic in which the evidence has been systematically identified, appraised and summarised according to pre determined criteria.
Randomised Controlled Trials • A trial in which subjects are randomly assigned to either a group receiving an intervention that is being tested or control group receiving an alternative or no intervention. The results compare the results of different groups.
Clinical effectiveness: Systematic Review • The specificity of device and drug effect meant one drug in one device could not be compared to other drugs • Limited evidence found in relation to quantity and quality
Clinical effectiveness: Systematic Review • Studies claiming to demonstrate equivalence were unable to do so and some studies used inappropriate dose comparators • Available evidence therefore limited and poor
Delivery of bronchodilators- the evidence • 23 studies examined • Some used inappropriate dosing schedules, which may have biased their findings • Some included a high proportion of adults • Some were small or included few children
Delivery of anti-flammatory drugs- the evidence • A number of studies were examined • The quality of the studies was variable either in relation to number of children or the use of the design • Well designed studies did not report on differences in effectiveness between devices
CFC- free devices - the evidence • No evidence of difference in CFC containing or CFC free devices • Although some reports of higher deposition of cortico steroids in HFA inhalers
Other influences on effectiveness • 31 studies on ease of use, preference or compliance • quality generally poor, small numbers, some included adults • Only 11 were RCTs
Other influences on effectiveness: Key finding • Good individual (verbal) instruction was the key to good inhaler technique • Two studies found that above age 5 or 6 years this was so regardless of device
Cost effectiveness • No robust cost effectiveness or utility studies examining the use of inhalers in children aged 5 - 15 years were identified in the systematic review
Consideration and Conclusions • ‘The available evidence failed to distinguish adequately between devices to suggest advantage in clinical effectiveness for one single delivery system’
Consideration and Conclusions • Limited evidence supports the use of press and breathe pMDIs with large volume spacers compared to press and breathe devices alone in the delivery of bronchodilators.
Consideration and Conclusions • Economic analysis suggests that no device should be excluded on grounds of cost effectiveness
Further research and implementation • In view of the lack of robust evidence the need for further good quality research is identified • Good practice guidance is however provided to enable use of the limited evidence available.
Plymouth Health CommunityNICE Guidance Implementation Group Asthma inhalers for routine treatment of chronic asthma in older children (aged 5 - 15 years) Miss Faye Doris University of Plymouth