Randomised controlled trialindependent cross-checkabstract checked I-ORG-103 standard review

Waiting versus surgery in toddlers with mild sleep apnoea

Adenotonsillectomy vs Watchful Waiting in Pediatric Mild to Moderate Obstructive Sleep Apnea: The KATE Randomized Clinical Trial.

Overview

Sjölander I et al.. JAMA Otolaryngol Head Neck Surg 2025 · PMID 40965870 · DOI 10.1001/jamaoto.2025.2831

After 3 years, waiting was about as good as surgery on sleep tests, but 42% of the waiting group ended up having surgery.

Does the study support the specific claim? Partly · Methodological quality: low

Study explained simply

What did the researchers want to find out?: Compare surgery with waiting in 2-4-year-olds
How was the study done?: Small randomised trial with 3-year follow-up
How many people, animals or samples were studied?: 60 Swedish children
What was actually found?: No difference in sleep-study change; symptoms favoured surgery; 42% crossed over
How large was the observed effect?: Cohen d 0.05 for OAHI
What do the results mean in everyday life?: Mild cases with small tonsils can often wait
What are the study's limitations?: Very small, per-protocol analysis
What does it say about Elawady's specific claim?: Partly supports caution; does not support a 'never' rule
Do the results apply to Germany and Europe?: Directly applicable
What can explicitly not be concluded from this study?: Cannot show equivalence

Authors: Sjölander I et al.
Journal: JAMA Otolaryngol Head Neck Surg
Year: 2025
Identifier: PMID 40965870 DOI 10.1001/jamaoto.2025.2831
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: Not stated in abstract.

Is adenotonsillectomy more effective than watchful waiting after 3 years in otherwise healthy 2-4-year-olds with mild to moderate OSA?

Study design: Randomised controlled trial – Single-centre randomised clinical trial (KATE) with 3-year follow-up; per-protocol analysis
Population: Children aged 2-4 years with obstructive AHI 2 to < 10
Country: Sweden (Karolinska)
Period: 2014-2020, 3-year follow-up
Sample size: 60 randomised (29 ATE, 31 WW); 39 analysed per protocol
Inclusion and exclusion criteria: Otherwise healthy children, OAHI >= 2 and < 10

Results: No group difference in OAHI change (Cohen d 0.05, 95% CI -0.7 to 0.6); medium effect in OSA-18 favouring ATE (d 0.54, 95% CI -1.3 to 0.1). 13 of 31 (42%) in WW crossed over to surgery; crossovers had more moderate OSA, worse symptoms and larger tonsils.
Absolute risks: 42% of the watchful-waiting group needed surgery within 3 years.
Authors' conclusion: ATE was not more effective than WW in this small trial, but almost half of WW children had remaining OSA and underwent surgery; children with mild OSA and small tonsils could be recommended WW.

Orienting tool: RoB 2
Type of assessment: simplified assessment (abstract only)
Full formal assessment: no
Overall risk of bias: high
Rationale: Per-protocol analysis after excluding 42% crossovers from WW group introduces selection bias.

Underpowered; wide CIs; 'no difference' is not evidence of equivalence.

Addresses watchful waiting in the youngest children with OSA.

CHAT and Cochrane show benefit of surgery in established OSA.

Swedish trial, directly applicable.

Weak but supportive evidence for watchful waiting in mild OSA with small tonsils; nearly half still needed surgery.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	low
Risk of bias	high
Precision of results	low
Directness	direct
Reproducibility	partly replicated
Consistency with the overall evidence	mixed
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

Larger trials in under-5s.