麻豆传媒

For children with habitual snoring and mild sleep apnea, early adenotonsillectomy did not improve executive function or attention compared with watchful waiting, a randomized clinical trial showed.

Average improvement in executive function score over 12 months came out statistically similar between 233 children randomized to adenotonsillectomy and 227 randomized to watchful waiting. The between-group difference was 0.96 points (P=0.27) on the Global Executive Composite T score scale, measuring behavioral regulation and metacognition with a population mean score of 50.

Improvement in attention scores was also not statistically significant between the two groups (P=0.68), Susan Redline, MD, MPH, of Brigham and Women's Hospital in Boston, and colleagues .

However, improvement in secondary outcomes, such as behavioral problems, quality of life, and blood pressure levels, was greater in the early intervention group.

"For the past 7 years, I have been awaiting the results of this study to further clarify the management of children with mild SDB [sleep-disordered breathing]," Norman Friedman, MD, of the University of Colorado School of Medicine in Aurora, wrote in an published in JAMA Otolaryngology–Head & Neck Surgery. "Unfortunately, the management is still nuanced, which may be frustrating for some families who want clear guidance."

The trial "provides high-quality data to support the role of adenotonsillectomy in patients with SDB, although it does not provide a specific pathway to identify patients who may benefit from surgery compared with medical treatment or watchful waiting," Dana Thompson, MD, MS, MBA, of the Ann and Robert H. Lurie Children's Hospital of Chicago, and colleagues agreed in an accompanying the study in JAMA.

They pointed to the importance of shared decision-making with patients and families when deciding to proceed with surgery. "The effect of symptom burden on QOL [quality of life] should be balanced with the potential morbidity of adenotonsillectomy, the possible beneficial effects of medical management, and the unique characteristics of each patient."

The findings are "reassuring" for sleep laboratories, though, Friedman added: "If the secondary outcome measures had shown no improvement in quality of life or behavior, clinicians would be obligated to request more preoperative PSGs [polysomnograms] to confirm the presence of at least moderate OSA. These needs could overwhelm pediatric sleep laboratories and be a barrier to care."

Redline and colleagues enrolled children ages 3 to 12 years treated at seven U.S. academic sleep centers from June 29, 2016, to Feb. 1, 2021, for snoring and an obstructive apnea-hypopnea index (AHI) less than 3.

Among the secondary endpoint findings at 12 months, significant improvements were seen with adenotonsillectomy over watchful waiting for the following:

• Systolic and diastolic blood pressure percentiles (−9.02 and −6.52, respectively)
• Behavioral problems (Childhood Behavior Checklist total problems score −3.09 and internalizing subscale −3.05)
• SDB symptoms (−0.16 on the 1-point Pediatric Sleep Questionnaire–Sleep-Related Breathing Disorder scale)
• Sleepiness (−1.18 on the 24-point Epworth Sleepiness Scale modified for children)
• Disease-specific quality of life (−9.75 on the Obstructive Sleep Apnea 18 assessment tool with a range from 18 to 126 points)
• Overall quality of life (4.76 points on the 100-point Pediatric Quality of Life Inventory scale)

At 12 month follow-up, AHI exceeded the study's upper entry criteria of 3 for 1.3% of kids in the adenotonsillectomy group compared with 13.2% of children in the watchful waiting group. AHI levels progressed to moderate sleep apnea (≥5) in 7.2% of children in the watchful waiting group but none in the adenotonsillectomy group.

Approximately 30% of children included in the study were less than 5 years of age, and about 30% were from households with an annual income below $30,000. Just under 27% were Black or African American children, and about 16% were of Hispanic ethnicity.

Nearly 37% of kids were overweight or obese, around a quarter had a history of asthma, and about two-thirds had tonsils that occupied more than 50% of the oropharyngeal width. About 72% of kids had an AHI of less than 1.

Six serious adverse events occurred related to perioperative complications (secondary hemorrhage requiring intervention), with one occurring in a child randomized to watchful waiting who crossed over to surgery.

No long-term consequences of early intervention were observed. And risk of having an adverse event, whether related to the study group assignment or not, did not differ between the two groups.

Limitations included that caregivers could not be masked to the intervention, which might have influenced several outcome assessments, and that learning and memory were not assessed.