S2 Table. – characteristics of included papers including outcomes used.
Study
Author (year)
Study Type
Duration of
Sample Participants
Number
Follow up
size
1.
Moller (1982) Retrospective
12 months70
Children
Cohort
4 years.
with CP
aged 12-156
months at
study entry
Interventions
CP with
bilateral VT,
Unilateral VT,
anterior
quadrant VT
Outcomes measured
(*primary outcome)
Incidence of otorrhoea
Method of measurement
Necessity to remove
VT
Middle ear ventilation
Necessity to remove VT
Tympanosclerosis
Middle ear ventilation
Necessity for new VT
OME*
2.
Potsic (1979)
Retrospective
Cohort
5 years
69
Children
with cleft
palate.
3.
Paradise and
Bluestone
(1974)
Case Series
32 Months
138
Children
with cleft
palate aged
<24months.
Pittsburgh
USA.
4.
Moller (1981)
Prospective
Cohort
36 Months
261
Children
with cleft
palate aged 1
month – 20
years (mean
7 years).
Western and
No treatment
vs VT when
needed vs VT
early insertion.
n/a
Hearing impairment*
Hearing impairment*
OME
Incidence of otorrhoea
Duration of otorrhoea
OME*
OME*
Perforation
tympanic membrane
on otoscopy
tympanic membrane on
otoscopy
28 bilateral
VT, 40
unilateral VT
Hearing impairment*
Middle ear pressure
OME
Scarring of the
tympanic membrane
Atelectasis of the
tympanic membrane
Tympanosclerosis of
Comments
Incidence of otorrhoea
within 1 year of VT
Position of tympanic
membrane (measure of
middle ear ventilation)
Tympanosclerosis
Retraction
Necessity for new VT
Otoscopic findings
(OME)
Pure tone audiometry
Speech audiometry
Otoscopic findings
Otorrhoea – 6 months
post op
Pneumatic otoscopy
Microscopy
Perforation
Fullness or bulging of
the tympanic membrane
Erythema or colour of t
the tympanic membrane
Pure tone audiometry
tympanometry
Otoscopic findings
Otoscopic findings
Otoscopic findings
Otoscopic findings
Hearing impairment
included as an outcome
with two methods of
assessment.
OME included as an
outcome with two
methods of assessment.
Northern
Norway.
5.
Smith et al.
(1994)
Case Series,
65 months
81
6.
Hormann et
al. (1991)
Prospective
Cohort
Age 8 and
16 years
184
7.
Broen et al.
(1995)
Prospective
cohort
3 monthly
follow up for
9-30 months
28 (CP)
29)
nonCP)
8.
9.
Frable et al.
(1985)
Sheahan et al.
(2002) (32)
Case series
Case series
6 monthly
follow up for
10 years.
Mean follow
up 6 years
and 11
36
104
Children
with cleft
palate, age
not stated.
North
Carolina,
USA.
-
Children
with cleft
palate.
Hamburg
Germany
(n=126) and
Ioqa, USA
(n=58)
children
with and
without CP.
Minnesota,
USA.
Grommets vs
early
grommets
Children
with cleft
palate
children
with cleft
palate.
Cleft vs non
cleft
the tympanic
membrane
Acute Otitis media
Chronic perforation
Stapedial reflex
Eustachian tube
dysfunction*
Number of VTs until
normal tympanometry
Average time to
extrusion of VT
Hearing
Perforation of the
tympanic membrane
Risk of otorrhoea
Middle ear status
Hearing impairment*
Hearing impairment*
Hearing impairment*
Middle ear function
Hearing screening
failures
Number of VTs
CP children
with bilateral
VTs placed
CP children
treated for
OME
Number of ventilation
tubes
tympanic membrane
atresia*
Chronic otitis media*
Incidence of acute
otitis media
Otitis media with
Effusion
Hearing Loss
chronic otitis media*
Cholesteatoma
Retraction
Otoscopic findings
Otoscopic findings
tympanometry
Tympanometry
Tympanometry/note
review
Note review
Pure Tone Audiometry
Otoscopy
Risk of otorrhoea
Unknown
Sound field audiometry
Visual reinforcement
audiometry
Pure Tone Audiometry
Tympanometry
Hearing impairment
included as an outcome
with three methods of
assessment.
Audiometry number of
ventilation tubes
Note review
Otoscopic findings
Otoscopic findings
Parent report
Otoscopic findings
Audiometry
Otoscopic findings
Otoscopic findings
Otoscopic findings
Cholesteatoma, retraction
and perforation have been
grouped in this paper and
months.
10.
Hubbard et al.
(1985)
Retrospective
study
60-132
months.
Dublin,
Ireland.
48
Children
with cleft
palate aged 3
months at
study entry.
Pittsburgh,
USA.
VT at 3
months v VT
30 months.
Perforation
Otitis Media with
Effusion
Hearing impairment
Scarring of the
tympanic membrane*
Hearing loss
Hearing loss
Middle ear pressure
Middle ear pressure
Otitis media with
effusion
Hypernasality of
speech
Consonant articulation
Social maturity
Social maturity
Self esteem
Behaviour
Nasal resonance
11.
12.
Gordon et al.
(1988)
Robson et al.
(1992)
Retrospective
study
Retrospective
Follow up
10-16 years
post
treatment.
30-60month
follow up
50
74
Children
with cleft
palate. New
Zealand
Children
with cleft
palate.
Bristol, UK.
Ventilation
tubes vs no
treatment
Ventilation
tubes vs no
treatment.
Perforation
Hearing impairment
Middle ear pressure
Tympanosclerosis *
Scarring of the
tympanic membrane *
Retraction
OME *
Otorrhoea *
Cholesteatoma *
Otorrhoea
Perforations of the
tympanic membrane
Tympanosclerosis
Episodes of otalgia
Middle ear pressure
Atelectasis of the
Otoscopic findings
Otoscopic findings
are considered to be signs
of chronic otitis media
Pure tone audiometry
Otoscopy
Pure Tone Audiometry
Speech reception
thresholds
Pneumatic otoscopy
tympanometry
Otoscopic findings
5 point scale completed
by speech and language
therapist
Test of articulation
Vineland Social
maturity scale
Wechsler intelligence
scale
Cooper smith selfesteem inventory
Child behaviour
checklist
Assessment by speech
and language therapist
Otoscopic findings
Pure tone audiometry
tympanometry
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
tympanometry
Otoscopy
Communication disorder
(verbal comprehension
and expression as an
outcome with four
methods of assessment.
tympanic membrane
Retraction of the
tympanic membrane
Velopharyngeal
insufficienty
OME
Hearing impairment
Educational
performance
Level of speech
therapy support
required
Behaviour
13.
Greig et al.
(1999)
Case Series
60 months.
36
Children
with cleft
palate.
London,
England.
CP children
with bilateral
VT tubes –
Communication
disorder (verbal
comprehension and
expression)*
Communication
disorder (verbal
comprehension and
expression)*
Communication
disorder (verbal
comprehension and
expression)*
Communication
disorder (verbal
comprehension and
expression)*
Hearing improvement
Change in otorrhea
Parental satisfaction
with VT treatment *
Speech improvement
Receptive language
Expressive language
Speech development
Global development
Hearing impairment
Nasal escape
Otoscopy
SLT assessment
Otoscopy
Pure tone audiogram
Parent questionnaire (is
child above/below
average)
Level of speech therapy
support required
Parent questionnaire (is
child above/below
average)
Cleft related articulation
at SLT assessment
Phonological problem
at SLT assessment
language difficulties at
SLT assessment
Learning difficulties at
SLT assessment
Parental questionnaire
Parental questionnaire
Parental questionnaire
Parental questionnaire
SLT assessment
SLT assessment
SLT assessment
Unclear
Audiometry (not details
given)
SLT assessment
Cleft Speech
Perforation
14.
15.
Shaw et al.
(2003) (37)
Freeland et al.
(1981)
Retrospective
study
Retrospective
study
10 years
Followed 6
monthly for
48 months.
72
68
Children
with cleft
palate.
Liverpool,
UK.
Children
with cleft
palate.
Oxford, UK
Children
grouped into
LAHSAL cleft
classification
Speech – resonance *
Speech –articulation *
Number of grommets
SLT assessment
Recruited at
birth with
regular follow
up.
OME
Retraction*
Perforation *
Tympanosclerosis of
the tympanic
membrane
language development
Otoscopic findings
Otoscopic findings
Otoscopic findings
Otoscopic findings
16.
Zheng et al.
(2003)
Randomised
Control Trial
6 month post
op (VTs), 20
month post
op (control)
62
Children
with cleft
palate.
China.
Palatoplasty
(n=24) v
palatoplasty
+VT (n=38)
17.
Liu et al.
(2004)
Case Series
2weeks – 18
months post
operatively.
19
Children
with cleft
palate. China
unilateral VT
vs other ear as
control with
no VT
18.
19.
20.
Tanpowpong
and
Kittimanont
(2007)
Cohort
Civelek et al.
(2007)
Retrospective
Phua et al.
Retrospective
10 months
72 month
follow up.
Minimum 2
23
41
234
SLT assessment
Presume otoscopy
SLT assessment
6 children
with CP and
17 without
CP.
Bangcok.
Myringotomy
and VT
insertion
56 children
with cleft
palate, 15
children
without cleft
palate and
history of
VT
insertion.
Turkey.
Children
CP vs non-CP
with VTs
Vt (45) v no
Number of grommets
Presence of OME*
Reynell Developmental
Lanaguage Score
(RDLS)
Unknown
Hearing levels
Complications
Unknown
Unknown
Hearing loss*
Middle ear status
Hearing impairment*
Audiometry
Unknown
Pure Tone Audiometry
Middle Ear Pressure
Otorheaa
Time to extrusion of
VTs
Perforation*
Tympanometry
Otoscopy
Note review
Tympanosclerosis *
Cholesteatoma*
Retraction*
Hearing impairment*
Middle ear pressure
Velopharyngeal
insufficieny
Otoscopic findings
Otoscopic findings
Otoscopic findings
Pure Tone Audiometry
Tympanometry
Speech assessment
(method not specified)
Hearing Loss*
Pure Tone Audiogram
Otoscopic findings
Cholesteatoma, retraction
and perforation have been
grouped in this paper and
are considered to be signs
of chronic otitis media
(Sheahan 2002)
Article in Chinese.
Abstract and Ponduri
2009 review used.
Article in Chinese.
Abstract and Ponduri
2009 review used.
(2009) (24)
21
22
23
Reiter et al.
(2009)
Szabo et al.
(2010)
Hornigold et
al. (2008)
years,
maximum
15 years.
Retrospective
Retrospective
Long term
follow up data
of RCT
6 years
5 years
20 years post
VT insertion
in original
RCT.
with cleft
palate.
Auckland,
New
Zealand.
116
86
7
Children
with cleft
palate.
Germany.
Children
with cleft
palate.
Connecticut,
USA.
Children
with cleft
palate who
had
participated
in previous
RCT. United
Kingdom
treatment(189)
Divided age
and type of
cleft then +/VTs.
All cases VT
VT insertion v
control
Recurrent AOM
Persistent OME
Retraction
Perforation
Cholesteatoma
Subjective Hearing
Loss
Note review
Otoscopic findings
Otoscopic findings
Otoscopic findings
Otoscopic findings
Note review
Number of VTs
Cholesteatoma *
Hearing Loss
Middle ear pressure
Atelectasis of the
tympanic membrane*
Perforations of the
tympanic membrane *
Retraction of the
tympanic membrane *
OME
Hearing*
Note review
Otoscopic findings
Pure tone audiogram
Tympanometry
Otoscopic findings
Number of surgeries
Atelectasis of the
tympanic membrane
Perforations of the
tympanic membrane*
Retraction of the
tympanic membrane
Tympanosclerosis
Scarring of the
tympanic membrane
Hearing loss
Middle ear function
Mucosal COM
Cholesteatoma
(squamous COM)
Otorrhea *
Subjective hearing
loss*
Otoscopic findings
Otoscopic findings
Otoscopic findings
Newborn hearing
screening
Note review
Otoscopic findings
Otoscopic findings
Otoscopic findings
Otoscopic findings
Otoscopic findings
Pure Tone Audiometry
Tympanometry
Otoscopic findings
Otoscopic findings
Patient interview
Patient interview
In this study primary
outcomes (* and bold)
were grouped in the paper
as symptomatology
24
Merrick et al.
(2007)
Cohort study
Mean 8
years of age.
Follow up
post
palatoplasty.
100
50 children
with cleft
palate, 50
children
without cleft
palate.
United
Kingdom.
VT (50) v
control (50)
25
Curtin et al.
(2009)
Prospective
cohort
6 months
post palate
repair
33
Children
with cleft
palate.
Stanford,
USA.
VT at 9
months with a
6 month
follow up.
26
Mandel et al.
(1992)
RCT
4 weeks.
111
Children
without cleft
palate.
Pittsburgh,
USA.
Bi VT vs Bi
Myringotomy
vs no surgery
Otalgia*
Vertigo*
Tinnitus*
Need for further
surgery*
OME
Speech intelligibility*
Speech nasality*
Nasal air flow*
Consonant production
*
Cleft type
characteristics*
Incidence of otorrhea*
VT patency
Hearing impairment
Hearing impairment
Hearing impairment
Middle ear effusion *
Middle ear pressure
Recurrence of OME
following resolution
Incidence of acute
otitis media
Hearing impairment
Adverse events
27
Casselbrant et
al. (2009)
RCT
Up to 36
months
98
Children
without cleft
palate.
Pittsburgh,
USA.
myringotomy
+VT (32),
adenoids with
myringotomy
+ VT (32)
adenoidectom
y with
myringotomy
(34)
Percentage of time with
OME *
Percentage of time with
OME *
Percentage of time with
OME
Requirement for
further surgery
Incidence of acute
Patient interview
Patient interview
Patient interview
Patient interview
Otoscopy
Cleft palate speech
assessment audit form
assessment audit form
assessment audit form
assessment audit form
assessment audit form
Parent report
Tympanometry
Behavioural audiometry
Sound field audiometry
New-born infant hearing
screen
Pneumatic otoscopy
Tympanometry
Note review
Hearing impairment as an
outcome with three
methods of assessment.
Note review
Age appropriate hearing
test (procedures varied
according to age)
Incidence of
hyperactivity, increased
appetite, vomiting,
irritability, diarrhoea ,
abdominal discomfort,
rash.
Pneumatic otoscopy
Tympanometry
Otoscopy
Note review
Outpatient assessment
Percentage of time with
OME as an outcome with
three methods of
assessment.
28
29
30
Koivunen et
al. (2004)
Matilla et al.
(2003)
Paradise et al.
(1990)
RCT
RCT
RCT
Cohort
2 years
Follow up
until age 2,
mean follow
up 7 months.
3 years
180
137
99 in
RCT
Children
without cleft
palate. Oulu,
Finland
Children
without cleft
palate.
Helsinki,
Finland.
children
without cleft
adenoidectom
y (60)
chemoprohpyl
axis (60)
placebo (60)
Bilateral VTs
(63) vs Bi
lateral VTs
+adenoidecto
my (74)
adenoidectom
y (99) vs
otitis media
Incidence of otorrhea
VT functional status
Perforation of the
tympanic membrane
Intervention failure*
Incidence of acute
otitis media
Necessity to visit
doctor
Requirement for
antibiotics
Days with rhinitis
Days with earache
Days with fever
Incidence of adverse
events
Rate of acute otitis
media *
Rate of acute otitis
media *
Rate of otits media
episodes caused by S
pnemoniae
Rate of otits media
episodes caused by H
influenzae
Rate of otits media
episodes caused by M
catarrhalis
Middle ear pressure
Number of days with
otorrhea
Proportion of time with
otitis media
Outpatient assessment
Tympanometry
Otoscopy
2 acute episodes in 2
months or 3 in 6 months
based on symptom diary
Or
Middle ear effusion for
at least 2 months as
assessed by study
otolaryngologist using
pneumatic otoscope
Symptom diary
Necessity to visit doctor –
definition of doctor not
specified in paper, would
assume that the outcome
describes unplanned visits
to the GP and not planned
study visits to the
consultant
Symptom diary
Symptom diary
Symptom diary
Symptom diary
Symptom diary
Symptom diary
Otoscopy
Symptomology
Culture
Culture
culture
Tympanometry
Follow up card
Interpolation of visit
data. Pneumatic
Rate of AOM as an
outcome with two
methods of assessment.
114 in
cohort
31
32
33
34
Paradise et al.
(1999)
Rynnel-Dagoo
et al. (1978)
Gates et al.
(1989)
HammarenMalmi et al.
RCT
Prospective
controlled
study
RCT
RCT
Up to 3
years
24 months
24 months
12 months
461
(304 in
3 way
trial
and
157 in
2 way
trial)
76
491
217
palate.
Pittsburgh,
USA.
children
without cleft
palate.
Pittsburgh,
USA.
Children
without cleft
palate.
Sweden.
Children
without cleft
palate.
Texas, USA.
Children
without cleft
control (114)
Number of VT
insertions
Number of days when
experienced otalgia
Number of days
receiving antibiotics
adenoidectom
y (n=100) vs
adenotonsillec
tomy (n=180)
vs control
(n=181)
adenoidectom
y (37) control
(39)
bilateral
myringotomy
(107) vs
Bilateral VTs
(129), vs
adenoidectom
y (130) vs
adenoidectom
y and bilateral
VTs (125)
adenoidectom
y +bilateral
Number of episodes of
acute otitis media*
Proportion of time with
otitis media
Number of VT
insertions
Number of days when
experienced otalgia
Number of
myringotomies
Number of days
receiving antibiotics
Change in frequency of
common cold
Change in frequency of
purulent otitis media
Change in frequency of
serious otitis media
Change in frequency of
nasal obstruction
Time with hearing loss
Time with OME
Time to recurrence of
OME
Requirement for
further VT insertion.
Number of acute otitis
media episodes in 12
otoscopy and bi weekly
enquiries by nurse
Case note review
Biweekly enquiries by
nurse
Biweekly enquiries by
nurse
Not specified
Interpolation of visit
data. Pneumatic
otoscopy and bi weekly
enquiries by nurse
Case note review
Biweekly enquiries by
nurse
Not specified
Biweekly enquiries by
nurse
unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Patient diary and review
by GP (primary care
IB and NH agreed only
one outcome in paper
, (2005) (51)
35
36
Roydhouse,
(1980)
Black et al.
(1990)
RCT
RCT
36 months
2 years
169
149
37
Dempster et al
(1993) (45)
RCT
12 months
78
38
Maw et al
(1999)
RCT
18 months
182
39
Rach et al.
(1991)
RCT
6 months
43
palate.
Helsinki,
Finland.
Children
without cleft
palate.
Auckland,
New
Zealand.
Children
without cleft
palate.
Oxford,
United
Kingdom.
children
without cleft
palate.
Glasgow,
United
Kingdom.
Children
without cleft
palate.
Bristol,
United
Kingdom.
Children
without cleft
palate.
VTs (109) vs
bilateral VTs
only (108)
Bilateral VT +
adenoids (50),
bilat VT no
adenoids (50),
control (69)
months*
doctor)
Presence of OME
Requirement for
repeated grommets
Number of relapses
Unknown
Unknown
Adenoidectom
y,
myringotomy
and VTs (37)
vs
adenoidectom
y and VT, (38)
vs
myringotomy
and VTs (37)
vs VTs (37).
Hearing impairment *
Developmental
progress
Pure tone audiometry
Parental opinion of
Adenoidectom
y + VTs (37),
vs VTs only
VT(35)
adenoidectom
y (47) vs
adenoidectom
y and
tonsilectomy
(47) vs control
(56)
VTs v no
surgery
Presence of an
abnormal
tympanogram
Adverse side effects of
treatment
Requirement for
further surgery
Parents opinion on
treatment
Presence of OME *
Presence of OME *
Hearing*
Tympanosclerosis
Perforation
Retraction
Hearing loss
Expressive language*
Verbal
comprehension*
Mental development
Middle ear pressure
Presence of OME
Requirement for
further VTs
Language development
– Verbal expression *
Language development
Unknown
child’s progress
Impedance
tympanometry
Parental opinion
(favourable, uncertain or
unfavourable)
Note review
3 point scale.
Otoscopy
Tympanometry
Pure tone audiometry
Otoscopy
Otoscopy
Otoscopy
Age appropriate hearing
test
Reynell test at 9 and 18
months
Reynell test at 9 and 18
months
Griffiths mental
development scales
Tympanometry
Otoscopy
Note review
Reynell test
Reynell test
Presence of OME likely
to be primary outcome
but paper states two
primary outcomes,
presence of OME and
hearing
Expressive language,
Verbal comprehension
(grouped as language
development)
Netherlands.
40.
41.
42.
Rovers et al.
(2000)
Johnston et al.
(2004)
Paradise et al.
(2001)
RCT
Screening
followed by
RCT
RCT
12 months
Follow up to
age 3 years.
Follow up to
age 3 years.
187
429
429
Children
without cleft
palate.
Netherlands.
VT (93) v No
surgery (94)
Children
without cleft
palate.
Pittsburg,
USA.
VT (216) vs
Delayed VT
(213)
Children
without cleft
palate.
Pittsburg,
USA.
VT (216) vs
Delayed VT
(213
– Verbal
comprehension *
Middle ear pressure
Duration of VT tube in
situ
Presence of OME
Expressive language*
Expressive language*
Comprehensive
language*
Hearing loss
IQ
OME
OME
Tympanoscerosis*
Fibrosis*
Atrophy*
Retraction pocket*
Perforation *
Hearing impairment
Cholesteatoma*
Cognition*
Hearing loss*
Behaviour*
Receptive language*
expressive language*
expressive language*
expressive language*
Parental distress*
Duration of OME
Tympanometry
Tympanometry
Tympanometry
Schlichting test
Lexi test
Reynell yest
Visual reinforcement
audiometry
Bayleys
Otoscopy
Tympanometry
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Otoscopy
Pure tone audiometry
Otoscopy
General cognitive index
of McCarthy scales of
children’s abilities
Age appropriate hearing
tests
child behaviour
checklist
Peabody-revised picture
vocabulary test
Number of different
words
Percentage of
consonants correct revised
Mean length of
utterance in morphemes
Parental stress index,
short form
Pneumatic otoscopy
Primary outcometympanic membrane
abnormalities which
includes –
tympanosclerosis,
fibrosis, atrophy,
retraction pocket,
perforation and
cholesteatoma
43.
Maw (1983)
RCT
12 months
222
44.
Zielhus et al.
(1989)
Screening
followed by
RCT
Up to age 4
years
43
RCT
6 months
postoperativ
elt
45.
46.
47.
FiellauNikolajsen et
al. (1980)
Nguyen et al.
(2004)
Paradise et al.
(2007)
RCT
RCT
Minimum 12
months
Follow up at
age 9 10 11
years.
42
63
429 in
original
study.
391 in
follow
up.
Children
without cleft
palate.
Bristol,
United
Kingdom.
Children
without cleft
palate.
Netherlands.
adenoidectom
y (36) vs no
surgery (33)
vs
adenotonsillec
tomy (34)
VT (22) vs no
treatment (21)
Children
without cleft
palate.
Aarhus,
Denmark.
myringtomy
with adenoids
(20)
myringotomy
only (22)
Children
without cleft
palate.
Quebec,
Canada
VTs and
adenoidectom
y (23) VTs
only (40)
children
without cleft
palate
VTs (216) v
Delayed
treatment
(213)
Duration of OME
Presence OME*
tympanometry
Pneumatic otoscopy
Presence OME
OME
Verbal comprehension
*
Verbal expression *
tympanometry
Otoscopy
Middle ear pressure*
Presence of OME
Duration of OME
Hearing impairment
Presence of middle ear
reflexes
Middle ear pressure*
Recurrence Acute
Otitis Media *
Recurrence of OME
over 3 months *
Re-insertion of
Ventilation Tubes *
Literacy
Literacy
Literacy
Phonological
awareness
Auditory processing
ability
Attention, impulsivity
Reynell’s test
Reynell’s test
Tympanometry
otoscopy
otoscopy (repeated over
time)
Pure tone audiometry
Impedance audiometry
Tympanometry
Patient questionnaire
Patient questionnaire
Patient questionnaire
Woodcock reading
mastery tests
Oral fluency -The
number of words in a
grade level passage read
correctly
Spelling and writing
samples subtests of the
Woodcock Johnson III
tests of achievement
Ellison and Rapid Letter
Naming subtests of the
comprehensive tests of
phonological processing
Children’s version of the
hearing in noise test
Disruptive behaviours
Although other
methodologies listed
these were to confirm
OME as part of patient
screening and were not
used as an outcome.
Verbal comprehension
and verbal expression
grouped as language
development
Presence of middle ear
reflexes was measured
but not discussed in the
paper
Primary outcome
included in paper as
“treatment failure“ as
defined by the three
outcomes listed.
Multilple methods of
assessment for outcomes
listed in paper.
Follow up of 2003 and
2005 paper
and psychological
functioning
Attention, impulsivity
and psychological
functioning
Attention, impulsivity
and psychological
functioning
Attention, impulsivity
and psychological
functioning
Intelligence and
academic achievement
Intelligence and
academic achievement
48.
Paradise et al.
(2005)
RCT
Follow up at
age 6
429
Children
without cleft
palate.
Pittsburg,
USA
VT (216) v
Delayed
treatment
(213)
Attention, impulsivity
and psychological
functioning
Attention, impulsivity
and psychological
functioning
Intelligence and
academic achievement
Receptive vocabulary
Behaviour
Phonologic memory
Auditory processing
and language
Vocabulary diversity
disorders rating scale
children behaviour
checklist
impairment rating scales
Social skills scale of the
social skills rating
system .
Wechsler abbreviated
scale of intelligence
Calculation subtest of
the Woodcock Johnson
II test of achievement
Continuous performance
test – Visual
Continuous performance
test – auditory
Wechsler abbreviated
scale of intelligence
Peabody picture
vocabulary test
Parent reported
inventories - Child
behaviour checklist
Non word repetition
task
SCAN Test
Conversational sample –
number of different
words
Sentence length and
grammatical
complexity
Conversational sample –
length of utterances in
morphemes
Speech sound
production
Conversational sample –
Percentage of
consonants correct
Parent reported
Parent-child stress
Follow up of 2003 paper
49.
Paradise et al.
(2003)
RCT
Follow up at
age 4 years.
429
Children
without cleft
palate.
Pittsburg,
USA
VT (216) v
Delayed
treatment
(213)
Cognition
Receptive language
Phonological memory
Expressive language
Expressive language
Expressive language
Parental-child stress
Behaviour
inventories - Parental
stress index
McCarthys scales of
children’s abilities
PPVT-R
Non word repetition test
Word diversity (NDW)
Sentence length and
grammatical complexity
(MLUm)
Speech sound
production (PCC-R)
Parental stress index
Child behaviour
checklist