Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial

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Abstract

Objective To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.

Design Open randomised controlled trial.

Setting 11 general hospitals and two academic centres.

Participants 111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy.

Intervention A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting.

Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months). Secondary outcome measures: days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life.

Results During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval −0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery.

Conclusion In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting.

Trial registration Dutch Trial Register NTR968: ISRCTN03720485.

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Most cited references 29

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PEDIATRICS

Jose Ceriani Cernadas (1979)

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Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children.

J Paradise, C D Bluestone, D Colborn … (2002)

In previous clinical trials involving children severely affected with recurrent throat infection (7 or more well-documented, clinically important, adequately treated episodes of throat infection in the preceding year, or 5 or more such episodes in each of the 2 preceding years, or 3 or more such episodes in each of the 3 preceding years), we found tonsillectomy efficacious in reducing the number and severity of subsequent episodes of throat infection for at least 2 years. The results seemed to warrant the election of tonsillectomy in children meeting the trials' stringent eligibility criteria but also provided support for nonsurgical management. We undertook the present trials to determine 1) whether tonsillectomy would afford equivalent benefit in children who were less severely affected than those in our earlier trials but who nonetheless had indications for tonsillectomy comparable to those in general use, and 2) whether, in such children, the addition of adenoidectomy would confer additional benefit. We conducted 2 parallel randomized, controlled trials in the Ambulatory Care Center of Children's Hospital of Pittsburgh. To be eligible, children were required to have had a history of recurrent episodes of throat infection that met standards slightly less stringent than the standards used in our earlier trials regarding either the frequency of previous episodes or their clinical features or their degree of documentation, but not regarding >1 of those parameters. These reduced standards were nonetheless more stringent than those in current official guidelines, which list "3 or more infections of tonsils and/or adenoids per year despite adequate medical therapy" as an indication for tonsillectomy or adenotonsillectomy. Of 2174 children referred by physicians or parents, 373 met the current trials' eligibility criteria and 328 were enrolled. Of these, 177 children without obstructing adenoids or recurrent or persistent otitis media were randomized to either a tonsillectomy group, an adenotonsillectomy group, or a control group (the 3-way trial), and 151 children who had 1 or more such conditions were randomized to either an adenotonsillectomy group or a control group (the 2-way trial). Outcome measures were the occurrence of episodes of throat infection during the 3 years of follow-up; other, indirect measures of morbidity; and complications of surgery. By various measures, the incidence of throat infection was significantly lower in surgical groups than in corresponding control groups during each of the 3 follow-up years. However, even among control children, mean rates of moderate or severe episodes were low, ranging from 0.16 to 0.43 per year. Adenotonsillectomy was no more efficacious than tonsillectomy alone. Of 203 children treated with surgery, 16 (7.9%) had surgery-related complications of varying types and severity. The modest benefit conferred by tonsillectomy or adenotonsillectomy in children moderately affected with recurrent throat infection seems not to justify the inherent risks, morbidity, and cost of the operations. We conclude that, under ordinary circumstances, neither eligibility criteria such as those used for the present trials nor the criterion for surgery in current official guidelines are sufficiently stringent for use in clinical practice.

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Quality of life for children with otitis media.

R Rosenfeld, L Tetlus, A Balzano … (1997)

To evaluate changes in health-related quality of life for children with otitis media. Cohort study using a 6-item quality-of-life survey (OM-6) representing the domains of physical suffering, hearing loss, speech impairment, emotional distress, activity limitations, and caregiver concerns. Hospital-based pediatric otolaryngology practice in a metropolitan area. One hundred eighty-six children aged 6 months to 12 years (median age, 3.4 years) with chronic otitis media with effusion or recurrent acute otitis media. The OM-6 was completed at entry by the child's caregiver and again at least 4 weeks after routine clinical care. Otoscopic findings, static admittance, tympanometric width, audiometric thresholds, and ear-related global quality of life (10-point visual scale) were recorded concurrently. Test-retest reliability, construct validity, and responsiveness to longitudinal change of the OM-6 survey score (mean value of the 6 items). Excellent test-retest reliability was obtained for the survey score (R=0.87) and individual survey items (R> or =0.71). The median survey score was 2.8 (95% confidence interval, 2.7-3.0) of a maximum 7.0, with higher values indicating poorer quality of life. Construct validity was shown by significant correlations between the survey score and global ear-related quality of life (R=-0.64), between physical suffering and physician visits in the past month (R=0.47), and between caregiver concerns and antibiotics consumed in the past month (R=0.26). The mean change in survey scores after tympanostomy tubes was 1.7, with a standardized response mean of 1.7 (95% confidence interval, 1.4-2.0), indicating large responsiveness to change. The change score was reliable (R=0.82) and correlated well with the degree of reported clinical change (R=0.66). The OM-6 is a valid, reliable, and responsive measure of quality of life for children with otitis media. The brevity and ease of administration make the OM-6 ideal for use in outcomes studies, clinical trials, and routine clinical care.

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Author and article information

Contributors

: Role: PhD student and registrar in otorhinolaryngology

: Role: PhD student and clinical epidemiologist

: Role: associate professor of clinical epidemiology

: Role: professor of clinical epidemiology and general practice

: Role: professor of paediatric otorhinolaryngology; ear, nose, and throat surgeon; and clinical epidemiologist

Journal

Journal ID (nlm-ta): BMJ

Journal ID (publisher-id): bmj

Title: BMJ : British Medical Journal

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1468-5833

Publication date Collection: 2011

Publication date (Print): 2011

Publication date (Electronic): 06 September 2011

Volume: 343

Electronic Location Identifier: d5154

Affiliations

[1 ]Department of Otorhinolaryngology, University Medical Centre Utrecht, Netherlands

[2 ]Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht

Author notes

Correspondence to: A G M Schilder, Department of Otorhinolaryngology, University Medical Centre Utrecht, Wilhelmina Children’s Hospital, HP KE 04.140.5, PO Box 85090, 3590 AB Utrecht, Netherlands A.Schilder@ 123456umcutrecht.nl

Article

Publisher ID: vanm848291

DOI: 10.1136/bmj.d5154

PMC ID: 3167877

PubMed ID: 21896611

SO-VID: b84647cd-4acc-4371-a974-b9bb2bfeda22

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial

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Most cited references 29

PEDIATRICS

Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children.

Quality of life for children with otitis media.

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