Randomised controlled trialcited by the Tayebat archivefull text checked A-ORG-03 in-depth review
Trial: tonsil/adenoid surgery for children with sleep apnea
A randomized trial of adenotonsillectomy for childhood sleep apnea.
Overview
Marcus CL et al.. N Engl J Med 2013 · PMID 23692173 · DOI 10.1056/NEJMoa1215881
Surgery normalized sleep studies in 79% vs 46% with waiting and improved behaviour and quality of life.
Does the study support the specific claim? No · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
OSA treatment
- How was the study done?
RCT
- How many people, animals or samples were studied?
464
- What was actually found?
Symptom, QoL and sleep-study benefit; no cognitive benefit; 46% normalized with waiting
- How large was the observed effect?
79% vs 46%
- What do the results mean in everyday life?
Surgery helps children with sleep apnea
- What are the study's limitations?
7 months
- What does it say about Elawady's specific claim?
Contradicts blanket rejection of surgery, but supports watchful waiting as a valid option for many children
- Do the results apply to Germany and Europe?
Applicable
- What can explicitly not be concluded from this study?
Long-term cognition
Scientific in-depth review
1. Full reference
- Authors
- Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S, Childhood Adenotonsillectomy Trial (CHAT)
- Journal
- N Engl J Med
- Year
- 2013
- Identifier
- PMID 23692173 DOI 10.1056/NEJMoa1215881 · PMC3756808
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- full text
- Conflicts of interest and funding
NIH grants (HL083075, HL083129, UL1 RR024134, UL1 RR024989); no commercial support. Individual disclosures: equipment loans from Philips Respironics/Ventus Medical; consulting fees (Galleon, Arena, Procter & Gamble, others); one author with board roles, stock options and patents relevant to sleep-disorder diagnosis/treatment.
2. Research question
Early adenotonsillectomy vs watchful waiting for childhood OSA
3. Study design and population
- Study design
- Randomised controlled trial – Multicentre, single-blind randomized controlled trial (CHAT; NCT00560859) at seven academic sleep centres
- Population
Children 5-9 years with OSA (AHI >=2 or OAI >=1) without prolonged desaturation, suitable for surgery; 53% black, about 47% overweight/obese
- Country
USA
- Period
Randomization January 2008 - September 2011; follow-up 7 months
- Sample size
464 randomized; 400 (86%) followed up; 397 analysed for primary outcome (194 early adenotonsillectomy, 203 watchful waiting)
- Inclusion and exclusion criteria
Included: age 5-9, OSA by polysomnography, surgical candidates. Excluded: AHI >30, OAI >20, SpO2 <90% for >=2% of sleep time, recurrent tonsillitis, BMI z score >=3, ADHD medication
4. Methods and endpoints
- Exposure / intervention
Early adenotonsillectomy
- Comparator
Watchful waiting with supportive care (referral for allergy/asthma treatment as needed)
- Endpoints
Primary: change in NEPSY attention and executive-function score at 7 months. Secondary: Conners' and BRIEF behaviour (caregiver, teacher), PSQ-SRBD symptoms, Epworth, PedsQL, OSA-18, DAS, polysomnographic indexes
- Statistical methods
ANCOVA adjusted for stratification factors (age, race, weight status, site); intention-to-treat; multiple imputation sensitivity analysis; interaction tests (200 tests, 23 significant vs 10 expected by chance)
5. Actual results
- Results
Primary: NEPSY change 7.1+-13.9 (surgery) vs 5.1+-13.4 (waiting), effect size 0.15, P=0.16 (negative trial). Secondary favouring surgery: caregiver Conners' -2.9 vs -0.2 (ES 0.28, P=0.01), teacher Conners' -4.9 vs -1.5 (ES 0.29, P=0.04), caregiver BRIEF -3.3 vs 0.4 (P<0.001), teacher BRIEF n.s. (P=0.22), PSQ-SRBD -0.3 vs -0.0 (ES 1.50, P<0.001), PedsQL +5.9 vs +0.9 (ES 0.37, P<0.001), AHI median change -3.5 vs -1.6 (ES 0.57, P<0.001). PSG normalization 79% vs 46% (P<0.001); lower in black and obese children and those with higher baseline AHI in both groups. 15 serious adverse events (6 surgery, 9 waiting; 8 perioperative, incl. tonsillar haemorrhage in 4); 9 treatment failures, all in waiting group. Upper respiratory tract or ear illness events 67 (surgery) vs 90 (waiting) over 7 months.
- Absolute risks
PSG normalization 79% (surgery) vs 46% (watchful waiting); serious adverse events 6 vs 9; treatment failures 0 vs 9.
- Authors' conclusion
Early adenotonsillectomy did not improve attention/executive function on formal testing at 7 months but reduced symptoms and improved behaviour, quality of life and polysomnography; normalization in 46% of the watchful-waiting group indicates that medical management and reassessment after observation may be a valid option.
6. Strengths
- Large multicentre randomized trial with prespecified primary outcome
- Blinded psychometric testing and centralized polysomnography scoring
- 86% follow-up; multiple imputation sensitivity analysis
- Both caregiver and teacher behavioural ratings
- No commercial funding
7. Weaknesses
- Short follow-up (7 months)
- Primary outcome negative
- Caregivers unblinded; caregiver-rated outcomes susceptible to expectation bias (authors)
- Excluded children <5 years, severe hypoxaemia, ADHD medication, severe obesity
- Many exploratory interaction tests (23/200 significant)
- 24 children did not receive assigned treatment (8 declined surgery, 16 waiting group had early surgery)
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- structured assessment based on the full text by a single reviewer (no formal double review)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Low risk of bias for the primary outcome and polysomnography; some concerns for caregiver-reported secondary outcomes. Structured single-reviewer judgement from full text; a formal assessment would require two independent reviewers and the protocol.
| Domain | Judgement | Rationale |
|---|---|---|
| D1 randomisation process | low | Stratified randomization; baseline characteristics balanced. |
| D2 deviations from intended interventions | low | ITT analysis; per-protocol exclusion of 24 non-adherent children did not change results. |
| D3 missing outcome data | low | 86% follow-up, similar across groups; multiple imputation gave essentially identical results. |
| D4 measurement of the outcome | some concerns | Primary (psychometrist) and PSG (central scoring) outcomes blinded; caregiver-rated behaviour, symptom and QoL outcomes assessed by unblinded caregivers. |
| D5 selection of the reported result | low | Registered, protocol published; negative primary outcome reported as such. |
Full-text review (25 October 2026): Added eligibility criteria, sample flow (397 analysed), effect sizes and P values for all secondary outcomes, subgroup findings, adverse events and treatment failures, authors' statement that watchful waiting may be valid, funding/COI; RoB 2 domains added (D4 some concerns for caregiver outcomes), overall unchanged (low).
9. Assessment of the statistical interpretation
Negative for the cognitive primary outcome; moderate-to-large benefits on symptoms, QoL and polysomnography. Watchful waiting also normalized polysomnography in 46%, so conservative management with reassessment is a reasonable option for mild-moderate OSA in this age group.
10. Relevance to the specific claim
Contradicts C-ORG-01 for children with OSA.
11. Independent contrary findings
12. Transferability to Germany and Europe
Applicable.
13. Overall methodological judgement
High-quality evidence that adenotonsillectomy benefits symptoms, QoL and sleep in children with OSA; also shows that watchful waiting is a valid option for many children. Contradicts a blanket rule that tonsils/adenoids should never be removed, but does not support routine surgery for all.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Long-term cognitive outcomes; children <5 years or with severe OSA; long-term respiratory/immune effects.
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 contradicting or limiting the claim
- Childhood adenoidectomy or tonsillectomy doubles to triples the risk of upper respiratory disease later in life (Byars 2018, 1.19 million Danish children). – Studies contradicting or limiting the claim
- No working organ should be removed (e.g., a thyroid with nodules that still functions); one should stay away from the scalpel, and Elawady is 'against any operation, including caesarean section'. – Studies contradicting or limiting the claim
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in the archive bibliography only; the archive gives no specific interpretation.
- A. What was actually studied?
Adenotonsillectomy for OSA
- B. What did the authors find?
Benefits on symptoms, QoL, PSG; no cognitive benefit
- C. What conclusions do the authors themselves draw?
Beneficial effects
- D. What does the archive derive from it?
Not used in narrative.
- E. Is this derivation scientifically justified?
Not used; the trial supports surgery for documented OSA, which contradicts a blanket 'should not be removed'.
- Adequacy of the interpretation (by the archive)
- not applicable