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Grommets – Quality development Grommets – Quality development project in Region of Southern project in Region of Southern

DenmarkDenmark

A multi-center study

by

24

ENT-specialists

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24 participating doctors24 participating doctors

• Peter Vorre and Allan Suhr Olesen, Peter Vorre and Allan Suhr Olesen, SønderborgSønderborg • Axel Fogh, Tønder, Jan Nabe-Nielsen, Axel Fogh, Tønder, Jan Nabe-Nielsen, EsbjergEsbjerg• Poul Hertel, Poul Hertel, Haderslev Haderslev • Per Monrad, Susanne Haug, Jørgen Dyrmose, Per Monrad, Susanne Haug, Jørgen Dyrmose, VejleVejle • Preben Bjerregaard, Preben Bjerregaard, Askov Askov • Anette Kjær and Hans Henrik Fischer, Anette Kjær and Hans Henrik Fischer, FredericiaFredericia• Johnny Lunding, Johnny Lunding, MiddelfartMiddelfart • Mette Teilgaard Kristensen, Mette Teilgaard Kristensen, AssensAssens • Morten Johansen, Morten Johansen, FåborgFåborg • Berit Svendstrup and Jürg Zimmermann, Berit Svendstrup and Jürg Zimmermann, SvendborgSvendborg • Mogens Worsøe-Sørensen, Peer Karup, Ulf Schønsted-Madsen, Mogens Worsøe-Sørensen, Peer Karup, Ulf Schønsted-Madsen,

Pia Juul Andersen, Lotte Jung, Ole Larsen, Lars Gosvig, Mogens Pia Juul Andersen, Lotte Jung, Ole Larsen, Lars Gosvig, Mogens Fiellau-Nikolajsen, Fiellau-Nikolajsen, OdenseOdense

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Time schedule:Time schedule:

• Pilot project – summer, autumn 2007Pilot project – summer, autumn 2007• Introductory meeting – end of November 2007Introductory meeting – end of November 2007• Inclusion of patients – January till March 2008Inclusion of patients – January till March 2008• Second registration at the 3-month check-up – Second registration at the 3-month check-up –

April till June 2008April till June 2008• Follow-up meetings – autumn 2008 - spring Follow-up meetings – autumn 2008 - spring

20092009• Presentation at the spring meeting 2009 in the Presentation at the spring meeting 2009 in the

Danish College of Oto-laryngology – Head Danish College of Oto-laryngology – Head and Neck Surgery (DSOHH)and Neck Surgery (DSOHH)

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Treatment of children with serous otitis media Treatment of children with serous otitis media (SOM) and acute otitis media (AOM) is much (SOM) and acute otitis media (AOM) is much

debated. The aim of the study was to elucidate:debated. The aim of the study was to elucidate:

1.1. Are too many children being treated?Are too many children being treated?

2.2. Are the right children being treated? Are the right children being treated?

3.3. Are DSOHH’s recommended guidelines for first-time Are DSOHH’s recommended guidelines for first-time grommet treatment being followed?grommet treatment being followed?

4.4. How the parents judge the grommet treatment of their How the parents judge the grommet treatment of their childd based on softer quality values not normally childd based on softer quality values not normally measured upon?measured upon?

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HypothesesHypotheses

11. . The practising ENT specialist’s indication for grommet The practising ENT specialist’s indication for grommet insertion is in agreement with the general guidelines drawn up insertion is in agreement with the general guidelines drawn up by Danish specialistsby Danish specialists

Standard: 80% of the children are being treated within the Standard: 80% of the children are being treated within the guidelines guidelines

Indicator: Observation time of SOM prior to grommet insertionIndicator: Observation time of SOM prior to grommet insertion

22. . The children’s social functioning is improvedThe children’s social functioning is improvedThe child’s social functioning is assessed based on the results of a The child’s social functioning is assessed based on the results of a

questionnaire study to the parents prior to and 3 months after questionnaire study to the parents prior to and 3 months after grommet insertiongrommet insertion

3.3. An improvement in the child’s hearing before and after surgery An improvement in the child’s hearing before and after surgery

can be objectively measured can be objectively measured Middle ear pressure by means of tympanometry and oto-acoustic Middle ear pressure by means of tympanometry and oto-acoustic

emissions (OAE) is measured before and after grommet insertion.emissions (OAE) is measured before and after grommet insertion.

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Inclusion criteria:Inclusion criteria:

• First tympanic membrane grommet in First tympanic membrane grommet in children < 7 yearschildren < 7 years

• With/without siblings with/without With/without siblings with/without grommetsgrommets

• Relevant SOM, AOM rec. > 2/6 months or Relevant SOM, AOM rec. > 2/6 months or bothboth

• Suitable for outpatient grommet insertion Suitable for outpatient grommet insertion

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Age and sex of the child

19

99

21 2115

3 2

19

138

49

179 8

3

0

20

40

60

80

100

120

140

160

<1 year 1 year 2 years 3 years 4 years 5 years 6 years

Girl Boy

Antal (n=423)

Typical age. Overweight of boys.

8

1,4

10,7

44,1

35,9

15,9

22,4

67,4

67,1

34

0 10 20 30 40 50 60 70 80

None

Other

Fever episodes

Mood swings

Balance problems

Impeded hearing

Disturbed sleep

Earaches

Bad hearing

%

What problems has your child had prior to the operation (n=430)

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

Parents

9

Ved ikke1%

Nej87%

Ja12%

Has the child seen another health professional due to ear disease

If yes, who

25,5

51

17,6

5,9

0

10

20

30

40

50

60

Chiropractor Reflexologist Other Several

%

Parents

10

Who recommended you should contact the ear specialist?

32,9

44,5

4,2 5,67,5

5,2

0

5

10

15

20

25

30

35

40

45

50

I/ourselves GP Health visitor Insti./daycare Others Several ticks

% (n=425)

Questionnaire to parents before surgery

11

2,63,8

5,7

9

7,3

14,6

10,1

19,8

17,9

7,5

1,7

4,2

5,6

8,7

7,3

8,7

13,6

11,3

16,9

14,3

6,6

2,8

0

5

10

15

20

25

0 1 2 3 4 5 6 7 8 9 10

The child's daily life The family's daily life

%

How much do the ear problems affect . . .

Forældrene angav på en visuel skala problemernes størrelseParents

12

1,9

7,8

12,410,5

7,1

2,9

8,86,2

1,2

8,6

32,5

0

5

10

15

20

25

30

35

0 1 2 3 4 5 6

7-12

mon

ths

> 12

month

s

GP not o

bser

ved

Don't

know

%

For how long had the GP observed the childFilled in by the ear specialist

Parents

13

26,328,5

45,2

0

5

10

15

20

25

30

35

40

45

50

Yes No Don't know

%

Has the GP performed tympanometry?

Parents

14

Referred by GP

42,9

11,6

45,5

0

5

10

15

20

25

30

35

40

45

50

Yes, orally Yes, in writing No

% (n=422)

Questionnaire to the ear specialist prior to surgery

15

85,7

6,5 7,7

87,3

5,27,5

0

10

20

30

40

50

60

70

80

90

100

Yes No Not performed

%

Tympanogram: flat curve

ENT- specialist

16

How long was the total medical observation time before surgery

2,6

7,5

10,6

19

13,412,9

11,3

4,5 4,9

2,11,4 1,4

5,6

2,6

0

2

4

6

8

10

12

14

16

18

20

0 1 2 3 4 5 6 7 8 9 10 11 12 > 13

Number of months

% %

ENT- specialist

17

4,3

85,7

4,3 5,70,8

9,4

45,1

16,9

27,8

0

10

20

30

40

50

60

70

80

90

Deteriorated Unchanged Improved Don't know Not present

If bad hearing before (n=140) If not (n=266)

%

Parents’ assessment after surgeryBad hearing

18

8,5

36,5

17,1

36,7

1,2

56,5

6,1

23

13,2

1,2

0

10

20

30

40

50

60

pass refer Not possible Not measured No apparatus

Before 3 months after surgery

%

OAE- right ear

ENT- specialist

19

47,5

23,7

12,2

0,7

8,6 7,2

0

5

10

15

20

25

30

35

40

45

50

Imm

edia

tely

After a

few

day

s

After a

few

wee

ks

After a

few

month

s

Don't

know

No pro

blem

%

When did the effect show?Bad hearing (n=139)

Parents

20

1,14

84,8

3,26,9

0,8

9,2

42,3

10

37,7

0

10

20

30

40

50

60

70

80

90

Deteriorated Unchanged Improved Don't know Not present

If ear pain before If not

%

Parents’ assessment after surgeryEar pain

Parents

21

36,433,7

7,6

3,8

9,1 9,5

0

5

10

15

20

25

30

35

40

Imm

edia

tely

After a

few

day

s

After a

few

wee

ks

After a

few

month

s

Don't

know

Not a

pro

blem

%

When did the effect occur?Ear pain (n=264)

Parents

22

29,131

16,9

4,2

108,8

0

5

10

15

20

25

30

35

Imm

edia

tely

After a

few

day

s

After a

few

wee

ks

After a

few

month

s

Don't

know

Not a

pro

blem

%

When did the effect occur?Night’s sleep (n=261)

Parents

23

95,9

1,7 2,4

0

20

40

60

80

100

120

Yes No Don't know

%

Are you satisfied with your child having had grommets?

Parents

24

0,2 0,7 0,7 1,2 0,7

53,4

13,5

20,721,6

32,2

0,21,2 1 1,4 1

8,27

11,3

18,1

20,5

30,1

0

5

10

15

20

25

30

35

0 1 2 3 4 5 6 7 8 9 10

The child's daily life The family's daily life

%

How much do you think the grommet insertion has meant to. . .

Parents

25

64,8

48

22,2

8,8

18,214,3

0

10

20

30

40

50

60

70

1 year 2 years 3 years 4 years 5 years 6 years

The child's age

%

Discharge from the ears after the operation

Parents

26

93,3

5,41,2

93,3

6,20,5

0

10

20

30

40

50

60

70

80

90

100

Yes No No grommets in this ear

Right ear Left ear

%

Grommets in place

93,3

4 2,7

92,1

5,72,2

0

10

20

30

40

50

60

70

80

90

100

Ja No No grommets in this ear

Right ear Left ear

%

Grommets functioning

3 months after surgery

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Grommet treatment to children with SOM og AOM. Grommet treatment to children with SOM og AOM. The study showed:The study showed:

Do too many children receive the treatment?Do too many children receive the treatment?Answer:Answer: NoNo

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).

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Grommet treatment to children with SOM and Grommet treatment to children with SOM and AOM. The study showedAOM. The study showed

Are the right children being treated? Are the right children being treated?

Answer: YesAnswer: Yes

The parents assess, that the insertion of grommets has a The parents assess, that the insertion of grommets has a markedly positive effect on the child’s and the family’s markedly positive effect on the child’s and the family’s wellbeing, and that the effect occurs immediately or after wellbeing, and that the effect occurs immediately or after a few daysa few days

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Grommet treatment to children with SOM og AOM. Grommet treatment to children with SOM og AOM. The study showedThe study showed

Have the guidelines from the Danish College of Have the guidelines from the Danish College of Otolaryngology – Head and Neck Surgery (DSOHH) Otolaryngology – Head and Neck Surgery (DSOHH) regarding first-time grommet treatment been followed? regarding first-time grommet treatment been followed? Answer: YesAnswer: Yes

The study shows that there are definite anamnetic and The study shows that there are definite anamnetic and objective findings as a basis for grommet insertion. There objective findings as a basis for grommet insertion. There is an observation time of at least 3 months.is an observation time of at least 3 months.

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Grommet treatment to children with SOM og AOM. Grommet treatment to children with SOM og AOM. The study showedThe study showed

How the parents assess the grommet treatment of How the parents assess the grommet treatment of their child based on a bit softer quality values their child based on a bit softer quality values than normally measured upon.than normally measured upon.

The parents assess that middle ear problems affect The parents assess that middle ear problems affect both the child’s and the family’s daily lives both the child’s and the family’s daily lives negatively to a great extent and that grommet negatively to a great extent and that grommet insertion has resulted in a considerable insertion has resulted in a considerable improvement.improvement.

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1.1. The practicing ENT specialist’s indication for grommet The practicing ENT specialist’s indication for grommet insertion is in agreement with the general guidelines issued by insertion is in agreement with the general guidelines issued by

Danish specialistsDanish specialistsStandard: 80% of the children are treated according to the Standard: 80% of the children are treated according to the

recommendations in the arbitrarily selected guidelines.recommendations in the arbitrarily selected guidelines. Indicator: SOM observation time prior to grommet insertion.Indicator: SOM observation time prior to grommet insertion.

22. . The children’s social functioningThe children’s social functioning The child’s social functioning is assessed based on results from The child’s social functioning is assessed based on results from a questionnaire study to parents before and 3 months after grommeta questionnaire study to parents before and 3 months after grommettreatment.treatment. 33. . An improvement in the child’s hearing can be objectively An improvement in the child’s hearing can be objectively

measured before and after surgerymeasured before and after surgeryMiddle ear pressure is measured by means of a tympanometer and oto-Middle ear pressure is measured by means of a tympanometer and oto-

acoustic emissions (OAE) if possible, before and after grommet acoustic emissions (OAE) if possible, before and after grommet treatment.treatment.

YES

YES

YES

Response to the hypothesesResponse to the hypotheses

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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

Project group

External consultant: Professor Karsten Jørgensen, DMedSci

Professor Jørgen Lous, DMedSci, recommends the project.

Dr. Anders Munck, GP, Head of Audit Project Odense, consultant and data processing

The project received financial support from FAS and Region Southern Denmark

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Questions and comments