1. 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

2. The National Institute of Clinical Excellence Clinical Guidelines òView arrived at after careful consideration of the available evidence òHealth professionals are expected to consider these when making a clinical judgement

3. The National Institute of Clinical Excellence Clinical Guidelines òdo 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’.

4. Previous Guidance: management of asthma in adults and children òBritish Thoracic Society (BTS) guideline issued in 1997 was the most commonly used in the UK òNot explicitly evidenced based òlargely considered the management of asthma in adults and older children

5. Previous Guidance: British Thoracic Society Guidance Contd. òPrinciples for selection of devices stated òRecommendations about specific devices not made

6. The Appraisal Process òExamination of the evidence on the clinical effectiveness and cost effectiveness of inhaler devices òStakeholder consultations

7. 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.

8. Randomised Controlled Trials òA 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.

9. Clinical effectiveness: Systematic Review òThe specificity of device and drug effect meant one drug in one device could not be compared to other drugs òLimited evidence found in relation to quantity and quality

10. Clinical effectiveness: Systematic Review òStudies claiming to demonstrate equivalence were unable to do so and some studies used inappropriate dose comparators òAvailable evidence therefore limited and poor

11. Delivery of bronchodilators- the evidence ò23 studies examined òSome used inappropriate dosing schedules, which may have biased their findings òSome included a high proportion of adults òSome were small or included few children

12. Delivery of anti-flammatory drugs- the evidence òA number of studies were examined òThe quality of the studies was variable either in relation to number of children or the use of the design òWell designed studies did not report on differences in effectiveness between devices

13. CFC- free devices - the evidence òNo evidence of difference in CFC containing or CFC free devices òAlthough some reports of higher deposition of cortico steroids in HFA inhalers

14. Other influences on effectiveness ò31 studies on ease of use, preference or compliance òquality generally poor, small numbers, some included adults òOnly 11 were RCTs

15. Other influences on effectiveness: Key finding òGood individual (verbal) instruction was the key to good inhaler technique òTwo studies found that above age 5 or 6 years this was so regardless of device

16. Cost effectiveness òNo robust cost effectiveness or utility studies examining the use of inhalers in children aged 5 - 15 years were identified in the systematic review

17. Consideration and Conclusions ò‘The available evidence failed to distinguish adequately between devices to suggest advantage in clinical effectiveness for one single delivery system’

18. Consideration and Conclusions òLimited 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.

19. Consideration and Conclusions òEconomic analysis suggests that no device should be excluded on grounds of cost effectiveness

20. Further research and implementation òIn view of the lack of robust evidence the need for further good quality research is identified òGood practice guidance is however provided to enable use of the limited evidence available.

21. 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