Randomised controlled trialindependent cross-checkabstract checked★ key study I-ORG-102 in-depth review
Tonsil surgery for children who snore but have only mild apnoea
Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial.
Overview
Redline S et al.. JAMA 2023 · PMID 38051326 · DOI 10.1001/jama.2023.22114
Surgery did not improve thinking or attention after a year but did improve behaviour, symptoms and quality of life.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test early surgery versus waiting in children with mild sleep-disordered breathing
- How was the study done?
Randomised trial, 12 months
- How many people, animals or samples were studied?
459 children aged 3-12 in the USA
- What was actually found?
No cognitive benefit; better symptoms, QoL and blood pressure with surgery
- How large was the observed effect?
AHI progression 1.3% vs 13.2%
- What do the results mean in everyday life?
Waiting is reasonable for mild cases, surgery helps symptoms
- What are the study's limitations?
Unblinded subjective outcomes; short follow-up
- What does it say about Elawady's specific claim?
Partly supports caution; does not support 'never operate' or diet as treatment
- Do the results apply to Germany and Europe?
Directly applicable
- What can explicitly not be concluded from this study?
Nothing about diet
Scientific in-depth review
1. Full reference
- Authors
- Redline S et al.
- Journal
- JAMA
- Year
- 2023
- Identifier
- PMID 38051326 DOI 10.1001/jama.2023.22114
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
NIH-funded (PubMed publication type: Research Support, N.I.H., Extramural); individual disclosures not read.
2. Research question
Does early adenotonsillectomy improve neurodevelopmental, behavioural, health and PSG outcomes compared with watchful waiting in children with snoring and mild sleep-disordered breathing (AHI < 3)?
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre randomised clinical trial (PATS), 1:1, 12-month follow-up
- Population
Children 3-12.9 years with habitual snoring and obstructive AHI < 3
- Country
USA (7 academic sleep centres)
- Period
June 2016 - February 2021, 12-month follow-up
- Sample size
459 randomised (231 AT, 228 watchful waiting); 394 (86%) completed 12 months
- Inclusion and exclusion criteria
Snoring with AHI < 3; details in trial registration NCT02562040
4. Methods and endpoints
- Exposure / intervention
Early adenotonsillectomy
- Comparator
Watchful waiting with supportive care
- Endpoints
Primary: BRIEF GEC (executive function) and Go/No-go attention score at 12 months; 22 secondary outcomes
- Statistical methods
Differences in change from baseline with 95%/97% CIs
5. Actual results
- Results
Executive function: difference -0.96 (95% CI -2.66 to 0.74); attention: 0.05 (-0.18 to 0.27) - no significant differences. Behaviour, sleepiness, symptoms and quality of life improved more with AT. Systolic/diastolic BP percentile changes -9.02 (97% CI -15.49 to -2.54) and -6.52 (-11.59 to -1.45). Progression to AHI > 3: 1.3% vs 13.2% (difference -11.2%, 97% CI -17.5 to -4.9). Serious adverse events related to AT in 6 children (2.7%).
- Absolute risks
Progression to AHI > 3: 1.3% vs 13.2%; serious adverse events 2.7% after AT.
- Authors' conclusion
In mild SDB, adenotonsillectomy did not improve executive function or attention at 12 months but improved behaviour, symptoms, quality of life and blood pressure.
6. Strengths
- Large multicentre RCT
- Pre-registered primary outcomes
- Diverse sample
7. Weaknesses
- Unblinded caregivers for subjective outcomes
- 14% loss to follow-up
- 12 months only
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Randomised and registered; subjective secondary outcomes rated by unblinded caregivers.
9. Assessment of the statistical interpretation
Negative on both primary outcomes; positive secondary outcomes need cautious interpretation because of multiplicity and unblinded reporting. NNT about 8 to prevent one progression to AHI > 3 within 12 months.
10. Relevance to the specific claim
Directly addresses whether surgery is needed in the large group of children with snoring but only mild apnoea.
11. Independent contrary findings
CHAT (A-ORG-03) and Cochrane (I-ORG-101) show larger benefit in established OSA.
12. Transferability to Germany and Europe
High.
13. Overall methodological judgement
Shows that cognition does not suffer with watchful waiting in mild disease, while surgery still improves symptoms. Supports shared decision-making, not a blanket rule either way.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Long-term outcomes beyond 12 months.
15. Linked fact checks
- Adenoids, tonsils and the gallbladder are organs that should not be removed; correcting the diet should be the foundation of treatment. – Studies with mixed or unclear results