Assessing the need for adenotonsillectomy for sleep-disordered

breathing in a community setting: A secondary outcome

measures analysis of a randomized controlled study
Chariton E. Papadakis, Konstantinos Chaidas, Theognosia S. Chimona, Maria Zisoglou, Alexander Ladias,
Efklidis K. Prolmos, Michael Miligkos, Athanasios G. Kaditis
Pediatric Pulmonology (2019); 54(10): 1527 - 1533

Presented by Aris Rahmanda, MD

Jakarta, 27th November 2020

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 Background
Numerous children globally undergo Adenotonsillectomy (AT) for Obstructive sleep-disordered
breathing (SDB)
Diagnosis based only on history and P.E findings without any objective testing
Childhood Adenotonsillectomy Trial Complex psychometric
Polysomnography
(CHAT) testing

Applied to demonstrate postoperative improvement in

respiratory disturbance and neurobehavioral morbidity
CHAT was not designed to identify patient subgroups who would improve postoperatively
A second RCT study demonstrated patient subgroups who improved after AT by using simple
tools like nocturnal oximetry and symptoms questionnaires
Aim
To assess whether children with SDB symptom severity above certain level measured by a validated
questionnaire improved after AT compared to no intervention

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 Methods
Prospective randomized controlled study.
Center: Chania General Hospital, Greece.

Inclusion criteria AT Group

 Presented to OPD ENT Clinic Evaluation immediately before AT
 Children aged 4 to 10 years and at 3 months postoperatively
 Simple randomization
History of snoring >3 nights /
(1:1 allocation ratio)
week at least 6 months Control group
 Tonsillar Hypertrophy (>2+) Evaluation at the initial visit and at
 Candidate for AT the end of the usual 3-month
 Were healthy* waiting period for surgery

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 Methods
Data collection: Baseline (0 month), Follow-up (3 months)

Study groups were

compared based on

PSQ-SRBD mESS Percents Participants Proportion Change in Change in Change in CRP

change change of proportion of subjects average morning serum
subjects of post-op with pulse rate systolic and concentration
with change in change in and diastolic BP
nocturnal body BMI z- frequency percentiles
enuresis weight z- score ≥0.5 of pulse
<1 score ≥0.5 rate rises
night/wk ≥6 bpm

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 Baseline characteristics of participants in the two study groups with
technically acceptable baseline.
AT group Control group
Variable
(n=68) (n=72)
Results Age, y.o 5.9 ± 1.6 6 ± 1.6
Sex, female (%) 33 (48.5) 34 (47.2)
Recruitment period:
Tonsillar size
June 2013 – April 2016 3+ (%) 61 (89,7) 65 (90,3)
4+ (%) 7 (10,3) 7 (9,7)
186 eligible children were
Weight z-score 0.3 ± 1.3 0.5 ± 1.4
randomized
Obesity (%) 0.3 ± 1.4 0.2 ± 1.6
140 children had two technically ODI3, per h 3.4 (1-5.7) 4.1 (1.5 - 9.3)
acceptable oximetries Subjects with ODI3 ≥ 3.5/h (%) 32 (47.1) 38 (52.8)
Subjects with PSQ-SRBD ≥ 0.33 (%) 48 (70.6) 51 (70.8)
Subjects with PSQ-SRBD ≥ 0.33 (%)
25 (36.8) 29 (40.3)
and ODI3 ≥ 3.5/h (%)
Subject with PSQ-SRBD <0.33 and
13 (19.1) 12 ( 16.7)
ODI3 <3.5/h (%)
Subjects with enuresis (%) 24 (35.3) 22 ( 30.36)

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Results
AT group Control group
Group no. (n=68) (n=72)
Outcome measures 0 mo Change between 3 0 mo Change between 3 Between-group P value
and 0 mo and 0 mo difference (95% CI)
PSQ-SRBD 0.44 ± 0.18 -0.32 ± 0.15 0.41 ± 0.16 -0.01 ± 0.009 -0.31 (-0.35 to -0.27) <.001a
mESS 5.51 ± 3.07 -2.75 ± 3.07 4.61 ± 3.82 0.01 ± 2.04 -2.76 (-36.3 to -1.90) <.001a
Cardiovascular outcomes
Average pulse rate,
bpm 84.5 (76.1 to 88.5) -0.1 (-6.3 to 5.2) 83.8 (78.4 to 90.4) -0.9 (-4.9 to 2.7) 0.547b
Average frequency of
pulse rate rises ≥6bpm, 9.7 (5.4 to 17.3) -1.2 (-7.6 to 1.1) 7.8 (4.8 to 14.6) -0.1 (-4.6 to 3.8) 0.062b
per h
Systolic BP percentile 90 (68 to 95) 0.5 (-8 to 10.8) 79.5 (68.3 to 93.8) -2 (-22 to 13) 0.208b
Diastolic BP percentile 79 (59.3 to 93.8) -1 (-22.3 to 14.5) 78 (60 to 90.5) -6 (-22 to 13) 0.585b
hs-CRP, mg/dL 0.1 (0.003 to 0.1) 0 (0 to 00.7) 0.1 (0.003 to 0.3) 0 (-0.17 to 0.07) 0.074b
No./ subgroup no.
No./ subgroup no. (%) (%) Risk ratio (95% CI) P value

Resolution of nocturnal enuresis 10/24 (41.7) 4/22 (18.2) 2.29 (0.84 to 6.25) 0.084c
Increase in weight z-score ≥ 0.5 23/68 (33.8) 21/72 (29.2) 1.16 (0.71 to 1.89) 0.553c
Increase in BMI z-score ≥0.5 22/68 (32.4) 13/72 (18) 1.79 (0.98 to 3.27) 0.057c

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Discussion
Significant Result
Significant improvement of PSQ-SRBD and mESS in AT group.

Non Significant Result

Frequency of enuresis.
Postoperative increase in body weight (z-score).
Changes in cardiovascular status.
CRP serum levels.

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Conclusion
Children with obstructive SDB and clinical indication for AT can be assessed by PSQ-
SRBD.
PSQ-SRBD can facilitate treatment decisions for children with obstructive SDB in
resource limited settings.
Strenghts Limitations
 Centralized computer randomization.  Small number of children with PSQ-SRBD
 Both study groups were comparable. score ≥0.33 who had ODI3 ≥3.5.
 Feasible to be applied in our  Observation period might not have been
community settings. long enough for some outcome
parameters.
 Single-blinded study.