Grommets – Quality development project in Region of Southern Denmark

1. Grommets – Qualitydevelopmentproject in Region of Southern Denmark A multi-center study by 24 ENT-specialists

2. 24 participatingdoctors Peter Vorre and Allan Suhr Olesen, Sønderborg Axel Fogh, Tønder, Jan Nabe-Nielsen, Esbjerg Poul Hertel, Haderslev Per Monrad, Susanne Haug, Jørgen Dyrmose, Vejle Preben Bjerregaard, Askov Anette Kjær and Hans Henrik Fischer, Fredericia Johnny Lunding, Middelfart Mette Teilgaard Kristensen, Assens Morten Johansen, Fåborg Berit Svendstrup and JürgZimmermann, Svendborg Mogens Worsøe-Sørensen, Peer Karup, Ulf Schønsted-Madsen, Pia Juul Andersen, Lotte Jung, Ole Larsen, Lars Gosvig, Mogens Fiellau-Nikolajsen, Odense

3. Time schedule: Pilot project – summer, autumn 2007 Introductory meeting – end of November 2007 Inclusion of patients – Januarytill March 2008 Secondregistration at the 3-month check-up – April till June 2008 Follow-up meetings – autumn 2008 - spring 2009 Presentation at the spring meeting 2009 in the Danish College of Oto-laryngology – Head and NeckSurgery (DSOHH)

4. Treatment of childrenwithserousotitis media (SOM) and acuteotitis media (AOM) is muchdebated. The aim of the studywas to elucidate: Are too many children being treated? Are the right children being treated? Are DSOHH’s recommended guidelines for first-time grommet treatment being followed? How the parents judge the grommet treatment of their childd based on softer quality values not normally measured upon?

5. Hypotheses 1. The practising ENT specialist’sindication for grommetinsertion is in agreement with the general guidelines drawn up by Danish specialists Standard: 80% of the childrenarebeingtreatedwithin the guidelines Indicator: Observation time of SOM prior to grommetinsertion 2. The children’s social functioning is improved The child’s social functioning is assessedbasedon the results of a questionnairestudy to the parents prior to and 3 monthsaftergrommetinsertion An improvement in the child’shearingbefore and aftersurgerycanbeobjectivelymeasured Middleearpressure by means of tympanometry and oto-acoustic emissions (OAE) is measuredbefore and aftergrommetinsertion.

6. Inclusioncriteria: Firsttympanicmembranegrommet in children < 7 years With/withoutsiblingswith/withoutgrommets Relevant SOM, AOM rec. > 2/6 monthsorboth Suitable for outpatientgrommetinsertion

7. Typical age. Overweight of boys.

8. Parents 77% AF BØRNENE KOM FRA E.L. ELLER PÅ FORÆLDRENES EGET INITIATIV

9. Parents

10. Questionnaire to parents before surgery

11. Parents Forældrene angav på en visuel skala problemernes størrelse

12. Parents

13. Parents

14. Questionnaire to the ear specialist prior to surgery

15. ENT- specialist

16. ENT- specialist

18. ENT- specialist

19. Parents

20. Parents

21. Parents

22. Parents

23. Parents

24. Parents

25. Parents

26. 3 months after surgery

27. Grommet treatment to children with SOM og AOM. The study showed: Do too many children receive the treatment? Answer:No The study shows that there are definite objective findings as basis for grommet insertion and that an observation period of more than 3 months is complied with - as recommended by Dansk Selskab for Oto-laryngologi-Hoved og Halskirurgi (DSOHH).

28. Grommettreatment to childrenwith SOM and AOM. The studyshowed Are the right children being treated? Answer: Yes The parents assess, that the insertion of grommets has a markedly positive effect on the child’s and the family’s wellbeing, and that the effect occurs immediately or after a few days

29. Grommettreatment to childrenwith SOM og AOM. The studyshowed Have the guidelines from the Danish College of Otolaryngology – Head and Neck Surgery (DSOHH) regarding first-time grommet treatment been followed? Answer: Yes The study shows that there are definite anamnetic and objective findings as a basis for grommet insertion. There is an observation time of at least 3 months.

30. Grommettreatment to childrenwith SOM og AOM. The studyshowed How the parents assess the grommet treatment of their child based on a bit softer quality values than normally measured upon. The parents assess that middle ear problems affect both the child’s and the family’s daily lives negatively to a great extent and that grommet insertion has resulted in a considerable improvement.

31. The practicing ENT specialist’s indication for grommet insertion is in agreement with the general guidelines issued by Danish specialists Standard: 80% of the children are treated according to the recommendations in the arbitrarily selected guidelines. Indicator: SOM observation time prior to grommet insertion. 2. The children’s social functioning The child’s social functioning is assessed based on results from a questionnaire study to parents before and 3 months after grommet treatment. 3. An improvement in the child’s hearing can be objectively measured before and after surgery Middle ear pressure is measured by means of a tympanometer and oto-acoustic emissions (OAE) if possible, before and after grommet treatment. Response to the hypotheses YES YES YES

32. Project group Head of project, ENT specialist, associate professor Ulf Schønsted-Madsen Nørregade 16 3.th ,5000 Odense C, ENT specialist Lotte Jung, PhD Fisketorvet 4-6, 5. sal 5000 Odense C ENT specialist Berit Svendstrup. Voldgade 9, 2. sal 5700 Svendborg Dr. Anders Munck, GP, Head of Audit Project Odense, consultant and data processing External consultant: Professor Karsten Jørgensen, DMedSci Professor Jørgen Lous, DMedSci, recommends the project. The project received financial support from FAS and Region Southern Denmark

33. Questions and comments