Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised cont
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《英国医生杂志》
1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands, 2 Department of Otorhinolaryngology, Wilhelmina Children's Hospital, University Medical Center Utrecht, PO Box 85090, 3508 AB Utrecht, Netherlands, 3 Department of Otorhinolaryngology, Head and Neck Surgery, University Medical Center Utrecht, 3584 CX Utrecht, Netherlands
Correspondence to: A G M Schilder A.Schilder@wkz.azu.nl
Abstract
Tonsillectomy, with or without adenoidectomy, is a common procedure in children in western countries, yet the indications for surgery remain uncertain, as reflected by the large variation in surgical rates across countries. In 1998, for example, 115 per 10 000 children underwent adenotonsillectomy in the Netherlands, 65 per 10 000 in England, and 50 per 10 000 in the United States.1
We previously reported that in the Netherlands 35% of children underwent adenotonsillectomy for frequent throat infections (seven or more a year) or obstructive sleep apnoea, and the remainder for less frequent throat infections, mild adenotonsillar hypertrophy, or indications such as upper respiratory tract infections.2 Although frequent throat infections and obstructive sleep apnoea are considered adequate indications for adenotonsillectomy in children,3-8 evidence for the benefits of surgery in children with milder symptoms is lacking.2 9-12 We carried out a randomised controlled trial to assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
Participants and methods
Between March 2000 and August 2002 we enrolled 300 children in our study; 151 were allocated to adenotonsillectomy and 149 to watchful waiting (fig 1). Characteristics at baseline were similar between the two groups (table 1). Overall, 43 children (18 from the adenotonsillectomy group) were lost to follow up. Reasons were non-medical (n = 36), serious comorbidity (n = 1), or unknown (n = 6). Fifty children allocated to watchful waiting underwent adenotonsillectomy and seven allocated to adenotonsillectomy did not undergo surgery. Median follow up was 22.0 months in the adenotonsillectomy group and 22.4 months in the watchful waiting group.
Fig 1 Flow of participants through trial
Table 1 Personal and clinical characteristics of 300 participants at baseline according to treatment allocation. Values are numbers (percentages) unless stated otherwise
Outcomes
Children in the adenotonsillectomy group had 0.21 fewer episodes of fever (95% confidence interval -0.12 to 0.54) per person year (table 2). During the first six months of follow up, the number of episodes was lower in children in the adenotonsillectomy group. From six to 24 months there was no difference between the groups.
Table 2 Incidence of fever, throat infections, sore throats, and upper respiratory tract infections per person year for children with mild symptoms of throat infections or adenotonsillar hypertrophy after adenotonsillectomy or watchful waiting
Compared with the watchful waiting group, children in the adenotonsillectomy group had, per person year, fewer throat infections (0.21, 95% confidence interval 0.06 to 0.36), fewer sore throats (0.60, 0.30 to 0.90), fewer days with sore throat (5.91, 5.24 to 6.57), and fewer upper respiratory tract infections (0.53, 0.08 to 0.97; see table 2).
Absence from day care or school due to upper tract respiratory infections was comparable between the groups (difference 0.09, -0.27 to 0.44).
At six months, small significant differences were found for some domains of the health related quality of life questionnaires, but these were not clinically relevant. We found no differences in other domains and at 24 months (figs 2 and 3).
Fig 2 Health related quality of life (preschool children quality of life questionnaire; TAPQoL) six and 24 months after adenotonsillectomy or watchful waiting for children aged 2-5 years
Fig 3 Health related quality of life (child health questionnaire parental form) six and 24 months after adenotonsillectomy or watchful waiting
At six months, Brouillette's scores were lower for children in the adenotonsillectomy group (fig 4). At 24 months there was no difference between the groups. Fewer children in the adenotonsillectomy group experienced snoring and difficulties in eating at six months, whereas there were no differences at 24 months (data not shown). Height and weight of children in both groups remained similar during follow up (data not shown).
Fig 4 Median Brouillette's obstructive sleep apnoea scores for children after adenotonsillectomy or watchful waiting
Subgroup analysis
The effects of adenotonsillectomy were more pronounced in children who had had three to six throat infections in the year before entry to the trial than in those with none to two throat infections: fever episodes (difference -1.07 (95% confidence interval -1.59 to -0.56) v 0.34 (-0.08 to 0.77), P = 0.01; table 3) and days with sore throat per person year (difference -11.33 (-12.48 to -10.17) v -2.38 (-3.19 to -1.60), P = 0.01). Age did not influence the effectiveness of adenotonsillectomy.
Table 3 Differences in incidence of fever, throat infections, upper respiratory tract infections, and days with sore throat in subgroups of children after adenotonsillectomy or watchful waiting for mild symptoms of throat infections or adenotonsillar hypertrophy
Complications of surgery
Of the 195 children who underwent adenotonsillectomy (145 in the adenotonsillectomy group and 50 in the watchful waiting group), 12 (6%) had complications related to surgery. Seven children (4%) had primary haemorrhage: two (1%) were managed surgically, five (3%) were managed non-surgically; and three (2%) were admitted for overnight observation. None of these children needed a blood transfusion. Five children (3%) had postoperative nausea, which was managed by antiemetics and intravenous hydration.
Discussion
Van den Akker EH, Hoes AW, Burton MJ, Schilder AGM. Large international differences in (adeno)tonsillectomy rates. Clin Otolaryngol 2004;29: 161-4.
Van den Akker EH, Schilder AG, Kemps YJ, van Balen FA, Hordijk GJ, Hoes AW. Current indications for (adeno)tonsillectomy in children: a survey in the Netherlands. Int J Pediatr Otorhinolaryngol 2003;67: 603-7.
Paradise JL, Bluestone CD, Bachman RZ, Colborn DK, Bernard BS, Taylor FH, et al. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials. N Engl J Med 1984;310: 674-83.
Nieminen P, Tolonen U, Lopponen H. Snoring and obstructive sleep apnea in children: a 6-month follow-up study. Arch Otolaryngol Head Neck Surg 2000;126: 481-6.
De Serres LM, Derkay C, Astley S, Deyo RA, Rosenfeld RM, Gates GA. Measuring quality of life in children with obstructive sleep disorders. Arch Otolaryngol Head Neck Surg 2000;126: 1423-9.
Flanary VA. Long-term effect of adenotonsillectomy on quality of life in pediatric patients. Laryngoscope 2003;113: 1639-44.
Scottish Intercollegiate Guidelines Network. 1999. www.sign.ac.uk/guidelines (accessed 20 May 2004).
American Academy of Otolaryngology-Head and Neck Surgery. 2000. Clinical indicators for otolaryngology—head and neck surgery. 2000. www.entlink.net/practice/products/indicators/tonsillectomy.html (accessed 17 Jun 2004).
Blair RL, McKerrow WS, Carter NW, Fenton A. The Scottish tonsillectomy audit. Audit Sub-Committee of the Scottish Otolaryngological Society. J Laryngol Otol 1996;110(suppl 20): 1-25.
Donnelly MJ, Quraishi MS, McShane DP. Indications for paediatric tonsillectomy: GP versus consultant perspective. J Laryngol Otol 1994;108: 131-4.
Capper R, Canter RJ. Is there agreement among general practitioners, paediatricians and otolaryngologists about the management of children with recurrent tonsillitis? Clin Otolaryngol 2001;26: 371-8.
Faulconbridge RV, Fowler S, Horrocks J, Topham JH. Comparative audit of tonsillectomy. Clin Otolaryngol 2000;25: 110-7.
Brouillette R, Hanson D, David R, Klemka L, Szatkowski A, Fernbach S, et al. A diagnostic approach to suspected obstructive sleep apnea in children. J Pediatr 1984;105: 10-4.
Fekkes M, Theunissen NC, Brugman E, Veen S, Verrips EG, Koopman HM, et al. Development and psychometric evaluation of the TAPQoL: a health-related quality of life instrument for 1-5-year-old children. Qual Life Res 2000;9: 961-72.
Raat H, Bonsel GJ, Essink-Bot ML, Landgraf JM, Gemke RJ. Reliability and validity of comprehensive health status measures in children: the child health questionnaire in relation to the health utilities index. J Clin Epidemiol 2002;55: 67-76.
Van Staaij BK, Rovers MM, Schilder AG, Hoes AW. Accuracy and feasibility of daily infrared tympanic membrane temperature measurements in the identification of fever in children. Int J Pediatr Otorhinolaryngol 2003;67: 1091-7.
Wolfensberger M, Haury JA, Linder T. Parent satisfaction 1 year after adenotonsillectomy of their children. Int J Pediatr Otorhinolaryngol 2000;56: 199-205.
Conlon BJ, Donnelly MJ, McShane DP. Improvements in health and behaviour following childhood tonsillectomy: a parental perspective at 1 year. Int J Pediatr Otorhinolaryngol 1997;41: 155-61.
McKee WJE. A controlled study of the effects of tonsillectomy and adenoidectomy in children. Br J Prev Soc Med 1963;17: 49-69.
Mawson SR, Adlington P, Evans M. A controlled study evaluation of adenotonsillectomy in children. J Laryngol Otol 1967;81: 777-90.
Mawson SR, Adlington P, Evans M. A controlled study evaluation of adenotonsillectomy in children. Part II. J Laryngol Otol 1968;82: 963-79.
Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Rockette HE, Kurs-Lasky M. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Pediatrics 2003;110: 7-15.
Stewart MG, Friedman EM, Sulek M, deJong A, Hulka GF, Bautista MH, et al. Validation of an outcomes instrument for tonsil and adenoid disease. Arch Otolaryngol Head Neck Surg 2001;127: 29-35.
Van den Akker EH, Rovers MM, van Staaij BK, Hoes AW, Schilder AG. Representativeness of trial populations: an example from a trial of adenotonsillectomy in children. Acta Otolaryngol 2003;123: 297-301.
McKee WJE. The part played by adenoidectomy in the combined operation of tonsillectomy with adenoidectomy. Second part of a controlled study in children. Br J Prev Soc Med 1963;17: 133-40.
Van der Graaf Y. Clinical trials: study design and analysis. Eur J Radiol 1998;27: 108-15.
McLeod RS. Issues in surgical randomized controlled trials. World J Surg 1999;23: 1210-4.
Eskerud JR, Laerum E, Fagerthun H, Lunde PKM, Naess A. Fever in general practice. 1. Frequency and diagnoses. Fam Pract 1992;9: 263-9.
Soman M. Characteristics and management of febrile young children seen in a university family practice. J Fam Pract 1985;21: 117-22.(Birgit K van Staaij, gene)
Correspondence to: A G M Schilder A.Schilder@wkz.azu.nl
Abstract
Tonsillectomy, with or without adenoidectomy, is a common procedure in children in western countries, yet the indications for surgery remain uncertain, as reflected by the large variation in surgical rates across countries. In 1998, for example, 115 per 10 000 children underwent adenotonsillectomy in the Netherlands, 65 per 10 000 in England, and 50 per 10 000 in the United States.1
We previously reported that in the Netherlands 35% of children underwent adenotonsillectomy for frequent throat infections (seven or more a year) or obstructive sleep apnoea, and the remainder for less frequent throat infections, mild adenotonsillar hypertrophy, or indications such as upper respiratory tract infections.2 Although frequent throat infections and obstructive sleep apnoea are considered adequate indications for adenotonsillectomy in children,3-8 evidence for the benefits of surgery in children with milder symptoms is lacking.2 9-12 We carried out a randomised controlled trial to assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.
Participants and methods
Between March 2000 and August 2002 we enrolled 300 children in our study; 151 were allocated to adenotonsillectomy and 149 to watchful waiting (fig 1). Characteristics at baseline were similar between the two groups (table 1). Overall, 43 children (18 from the adenotonsillectomy group) were lost to follow up. Reasons were non-medical (n = 36), serious comorbidity (n = 1), or unknown (n = 6). Fifty children allocated to watchful waiting underwent adenotonsillectomy and seven allocated to adenotonsillectomy did not undergo surgery. Median follow up was 22.0 months in the adenotonsillectomy group and 22.4 months in the watchful waiting group.
Fig 1 Flow of participants through trial
Table 1 Personal and clinical characteristics of 300 participants at baseline according to treatment allocation. Values are numbers (percentages) unless stated otherwise
Outcomes
Children in the adenotonsillectomy group had 0.21 fewer episodes of fever (95% confidence interval -0.12 to 0.54) per person year (table 2). During the first six months of follow up, the number of episodes was lower in children in the adenotonsillectomy group. From six to 24 months there was no difference between the groups.
Table 2 Incidence of fever, throat infections, sore throats, and upper respiratory tract infections per person year for children with mild symptoms of throat infections or adenotonsillar hypertrophy after adenotonsillectomy or watchful waiting
Compared with the watchful waiting group, children in the adenotonsillectomy group had, per person year, fewer throat infections (0.21, 95% confidence interval 0.06 to 0.36), fewer sore throats (0.60, 0.30 to 0.90), fewer days with sore throat (5.91, 5.24 to 6.57), and fewer upper respiratory tract infections (0.53, 0.08 to 0.97; see table 2).
Absence from day care or school due to upper tract respiratory infections was comparable between the groups (difference 0.09, -0.27 to 0.44).
At six months, small significant differences were found for some domains of the health related quality of life questionnaires, but these were not clinically relevant. We found no differences in other domains and at 24 months (figs 2 and 3).
Fig 2 Health related quality of life (preschool children quality of life questionnaire; TAPQoL) six and 24 months after adenotonsillectomy or watchful waiting for children aged 2-5 years
Fig 3 Health related quality of life (child health questionnaire parental form) six and 24 months after adenotonsillectomy or watchful waiting
At six months, Brouillette's scores were lower for children in the adenotonsillectomy group (fig 4). At 24 months there was no difference between the groups. Fewer children in the adenotonsillectomy group experienced snoring and difficulties in eating at six months, whereas there were no differences at 24 months (data not shown). Height and weight of children in both groups remained similar during follow up (data not shown).
Fig 4 Median Brouillette's obstructive sleep apnoea scores for children after adenotonsillectomy or watchful waiting
Subgroup analysis
The effects of adenotonsillectomy were more pronounced in children who had had three to six throat infections in the year before entry to the trial than in those with none to two throat infections: fever episodes (difference -1.07 (95% confidence interval -1.59 to -0.56) v 0.34 (-0.08 to 0.77), P = 0.01; table 3) and days with sore throat per person year (difference -11.33 (-12.48 to -10.17) v -2.38 (-3.19 to -1.60), P = 0.01). Age did not influence the effectiveness of adenotonsillectomy.
Table 3 Differences in incidence of fever, throat infections, upper respiratory tract infections, and days with sore throat in subgroups of children after adenotonsillectomy or watchful waiting for mild symptoms of throat infections or adenotonsillar hypertrophy
Complications of surgery
Of the 195 children who underwent adenotonsillectomy (145 in the adenotonsillectomy group and 50 in the watchful waiting group), 12 (6%) had complications related to surgery. Seven children (4%) had primary haemorrhage: two (1%) were managed surgically, five (3%) were managed non-surgically; and three (2%) were admitted for overnight observation. None of these children needed a blood transfusion. Five children (3%) had postoperative nausea, which was managed by antiemetics and intravenous hydration.
Discussion
Van den Akker EH, Hoes AW, Burton MJ, Schilder AGM. Large international differences in (adeno)tonsillectomy rates. Clin Otolaryngol 2004;29: 161-4.
Van den Akker EH, Schilder AG, Kemps YJ, van Balen FA, Hordijk GJ, Hoes AW. Current indications for (adeno)tonsillectomy in children: a survey in the Netherlands. Int J Pediatr Otorhinolaryngol 2003;67: 603-7.
Paradise JL, Bluestone CD, Bachman RZ, Colborn DK, Bernard BS, Taylor FH, et al. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials. N Engl J Med 1984;310: 674-83.
Nieminen P, Tolonen U, Lopponen H. Snoring and obstructive sleep apnea in children: a 6-month follow-up study. Arch Otolaryngol Head Neck Surg 2000;126: 481-6.
De Serres LM, Derkay C, Astley S, Deyo RA, Rosenfeld RM, Gates GA. Measuring quality of life in children with obstructive sleep disorders. Arch Otolaryngol Head Neck Surg 2000;126: 1423-9.
Flanary VA. Long-term effect of adenotonsillectomy on quality of life in pediatric patients. Laryngoscope 2003;113: 1639-44.
Scottish Intercollegiate Guidelines Network. 1999. www.sign.ac.uk/guidelines (accessed 20 May 2004).
American Academy of Otolaryngology-Head and Neck Surgery. 2000. Clinical indicators for otolaryngology—head and neck surgery. 2000. www.entlink.net/practice/products/indicators/tonsillectomy.html (accessed 17 Jun 2004).
Blair RL, McKerrow WS, Carter NW, Fenton A. The Scottish tonsillectomy audit. Audit Sub-Committee of the Scottish Otolaryngological Society. J Laryngol Otol 1996;110(suppl 20): 1-25.
Donnelly MJ, Quraishi MS, McShane DP. Indications for paediatric tonsillectomy: GP versus consultant perspective. J Laryngol Otol 1994;108: 131-4.
Capper R, Canter RJ. Is there agreement among general practitioners, paediatricians and otolaryngologists about the management of children with recurrent tonsillitis? Clin Otolaryngol 2001;26: 371-8.
Faulconbridge RV, Fowler S, Horrocks J, Topham JH. Comparative audit of tonsillectomy. Clin Otolaryngol 2000;25: 110-7.
Brouillette R, Hanson D, David R, Klemka L, Szatkowski A, Fernbach S, et al. A diagnostic approach to suspected obstructive sleep apnea in children. J Pediatr 1984;105: 10-4.
Fekkes M, Theunissen NC, Brugman E, Veen S, Verrips EG, Koopman HM, et al. Development and psychometric evaluation of the TAPQoL: a health-related quality of life instrument for 1-5-year-old children. Qual Life Res 2000;9: 961-72.
Raat H, Bonsel GJ, Essink-Bot ML, Landgraf JM, Gemke RJ. Reliability and validity of comprehensive health status measures in children: the child health questionnaire in relation to the health utilities index. J Clin Epidemiol 2002;55: 67-76.
Van Staaij BK, Rovers MM, Schilder AG, Hoes AW. Accuracy and feasibility of daily infrared tympanic membrane temperature measurements in the identification of fever in children. Int J Pediatr Otorhinolaryngol 2003;67: 1091-7.
Wolfensberger M, Haury JA, Linder T. Parent satisfaction 1 year after adenotonsillectomy of their children. Int J Pediatr Otorhinolaryngol 2000;56: 199-205.
Conlon BJ, Donnelly MJ, McShane DP. Improvements in health and behaviour following childhood tonsillectomy: a parental perspective at 1 year. Int J Pediatr Otorhinolaryngol 1997;41: 155-61.
McKee WJE. A controlled study of the effects of tonsillectomy and adenoidectomy in children. Br J Prev Soc Med 1963;17: 49-69.
Mawson SR, Adlington P, Evans M. A controlled study evaluation of adenotonsillectomy in children. J Laryngol Otol 1967;81: 777-90.
Mawson SR, Adlington P, Evans M. A controlled study evaluation of adenotonsillectomy in children. Part II. J Laryngol Otol 1968;82: 963-79.
Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Rockette HE, Kurs-Lasky M. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Pediatrics 2003;110: 7-15.
Stewart MG, Friedman EM, Sulek M, deJong A, Hulka GF, Bautista MH, et al. Validation of an outcomes instrument for tonsil and adenoid disease. Arch Otolaryngol Head Neck Surg 2001;127: 29-35.
Van den Akker EH, Rovers MM, van Staaij BK, Hoes AW, Schilder AG. Representativeness of trial populations: an example from a trial of adenotonsillectomy in children. Acta Otolaryngol 2003;123: 297-301.
McKee WJE. The part played by adenoidectomy in the combined operation of tonsillectomy with adenoidectomy. Second part of a controlled study in children. Br J Prev Soc Med 1963;17: 133-40.
Van der Graaf Y. Clinical trials: study design and analysis. Eur J Radiol 1998;27: 108-15.
McLeod RS. Issues in surgical randomized controlled trials. World J Surg 1999;23: 1210-4.
Eskerud JR, Laerum E, Fagerthun H, Lunde PKM, Naess A. Fever in general practice. 1. Frequency and diagnoses. Fam Pract 1992;9: 263-9.
Soman M. Characteristics and management of febrile young children seen in a university family practice. J Fam Pract 1985;21: 117-22.(Birgit K van Staaij, gene)