CAT: Tonsillectomy vs Watchful Waiting

Brief description of patient problem/setting

A 5 y/o female with medical history of Obstructive Sleep Apnea is brought in by mother to see a pediatric ENT for an acute tonsillitis for the fourth time this year. The pediatrician recommends tonsillectomy to help with both conditions, but patient’s mother is reluctant to agree to the surgery and wants to know if surgery outcomes can significantly improve her daughter’s life.

Search Question: Does tonsillectomy decrease number of episodes of sore throat per year and affect neurocognitive outcomes for pediatric patients with OSA and recurrent tonsillitis?

Question Type:

☐Prevalence                  ☐Screening          ☐Diagnosis

☒Prognosis                    ☒Treatment          ☐Harms

This is a “treatment” as well as “prognosis” question.

For “treatment” the level of evidence would be: Syst. Rev>RCT>Cohort>Case Control>Case series

For “prognosis” the level of evidence is: Cohort study>Case Control>Case Series

While Systematic reviews and Randomized Controlled Trials would contain the highest level of evidence for the “treatment” question, cohort studies are more accurate for monitoring outcomes. Therefore, I am going to include all of the above study designs in my research.

PICO search terms:

PICO
Pediatric population with recurrent throat infectionTonsillectomyWatchful waitingNeurocognitive outcomes: Improvement in global IQ, frequency of daytime naps
Pediatric population with mild OSATonsillectomy with adenoidectomy Diagnosed GAS infections
Pediatric population with recurrent throat infection and mild OSA  Recurrent tonsillitis
   Days with sore throat
   Episodes of sore throat
   Obstructive sleep apnea
   Medical care visits for pharyngitis/tonsillitis  
   URI rates

I will attempt to find studies focusing on my patient’s combination of conditions and age groups as closely as possible, but then if I need more evidence, I will expand my search to the pediatric population in general as well as patients with both disorders separately. Having access to data on each disorder separately will also aid in discussing desired outcomes during shared decision making as it might be useful to ask the patient whether she is considering surgery for recurrent tonsilitis, OSA or both.

Results found:

Pub Med :

  • Search words: tonsillectomy, adenotonsillectomy, streptococcal, pharyngitis, tonsillitis, sore throat, watchful waiting, pediatric population, IQ improvements
  • 8 results
  • Filter “Published within the past 5 years”
  • 5 results

TRIP:

  • Search words: tonsillectomy vs watchful waiting, adenotonsillectomy, streptococcal, pharyngitis, tonsillitis, sore throat, pediatric population, IQ improvements
  • 14 results

JAMA:

  • Search words: tonsillectomy vs watchful waiting, adenotonsillectomy, streptococcal, pharyngitis, tonsillitis, sore throat, pediatric population, IQ improvements
  • 14 results

Science Direct:

  • Search words: tonsillectomy vs watchful waiting, adenotonsillectomy, streptococcal, pharyngitis, tonsillitis, sore throat, pediatric population, IQ improvements
  • 70 results
  • 12 result after checking boxes “2021” and “2020”

Google Scholar:

  • Search words: tonsillectomy vs watchful waiting, adenotonsillectomy, streptococcal, pharyngitis, tonsillitis, sore throat, pediatric population, IQ improvements
  • 155 results
  • Filter “Since 2017” applied: 70 results
  • Filter “Since 2020” applied: 16 results

The topic has received a significant highlight in scientific community. I narrowed my choices by focusing on the most recent studies whose main objective is to determine the effectiveness of tonsillectomy/adenotonsillectomy in children with chronic/recurrent tonsillitis and OSA. I also selected articles that had large enough sample sizes and reliable inclusion/exclusion criteria in order to derive a conclusion with a high confidence level.

Article #1

NameTonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review
CitationMorad A, Sathe NA, Francis DO, McPheeters ML, Chinnadurai S. Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review. Pediatrics. 2017;139(2):e20163490. doi:10.1542/peds.2016-3490  
TypeSystematic review 2017
Hyperlinkhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5260157/  
AbstractCONTEXT: The effectiveness of tonsillectomy or adenotonsillectomy (“tonsillectomy”) for recurrent throat infection compared with watchful waiting is uncertain. OBJECTIVE: To compare sleep, cognitive, behavioral, and health outcomes of tonsillectomy versus watchful waiting in children with recurrent throat infections. DATA SOURCES: MEDLINE, Embase, and the Cochrane Library. STUDY SELECTION: Two investigators independently screened studies against predetermined criteria. DATA EXTRACTION: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE) and confidence in the estimate of effects. RESULTS: Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point. LIMITATIONS: Few studies fully categorized infection/sore throat severity; attrition was high.CONTEXT: The effectiveness of tonsillectomy or adenotonsillectomy (“tonsillectomy”) for recurrent throat infection compared with watchful waiting is uncertain. OBJECTIVE: To compare sleep, cognitive, behavioral, and health outcomes of tonsillectomy versus watchful waiting in children with recurrent throat infections. DATA SOURCES: MEDLINE, Embase, and the Cochrane Library. STUDY SELECTION: Two investigators independently screened studies against predetermined criteria. DATA EXTRACTION: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE) and confidence in the estimate of effects. RESULTS: Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point. LIMITATIONS: Few studies fully categorized infection/sore throat severity; attrition was high. CONCLUSIONS: Throat infections, utilization, and school absences improved in the first postsurgical year in tonsillectomized children versus children not receiving surgery. Benefits did not persist over time; longer-term outcomes are limited. SOE is moderate for reduction in short-term throat infections and insufficient for longer-term reduction. SOE is low for no difference in longer-term streptococcal infection reduction. SOE is low for utilization and missed school reduction in the short term, low for no difference in longer-term missed school, and low for no differences in quality of life. CONTEXT: The effectiveness of tonsillectomy or adenotonsillectomy (“tonsillectomy”) for recurrent throat infection compared with watchful waiting is uncertain. OBJECTIVE: To compare sleep, cognitive, behavioral, and health outcomes of tonsillectomy versus watchful waiting in children with recurrent throat infections. DATA SOURCES: MEDLINE, Embase, and the Cochrane Library. STUDY SELECTION: Two investigators independently screened studies against predetermined criteria. DATA EXTRACTION: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE) and confidence in the estimate of effects. RESULTS: Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point. LIMITATIONS: Few studies fully categorized infection/sore throat severity; attrition was high. CONCLUSIONS: Throat infections, utilization, and school absences improved in the first postsurgical year in tonsillectomized children versus children not receiving surgery. Benefits did not persist over time; longer-term outcomes are limited. SOE is moderate for reduction in short-term throat infections and insufficient for longer-term reduction. SOE is low for no difference in longer-term streptococcal infection reduction. SOE is low for utilization and missed school reduction in the short term, low for no difference in longer-term missed school, and low for no differences in quality of life.  
Key pointsThroat infections, utilization, and school absences improved in the first postsurgical year in tonsillectomized children versus children not receiving surgery. Benefits did not persist over time; longer-term outcomes are limited. SOE is moderate for reduction in short-term throat infections and insufficient for longer-term reduction. SOE is low for no difference in longer-term streptococcal infection reduction. SOE is low for utilization and missed school reduction in the short term, low for no difference in longer- term missed school, and low for no differences in quality of life.
Why I chose itThis systematic review is conducted by two independent investigators who kept each other’s data in check. After considering 9396 studies, only 241 were agreed on keeping. Strength of evidence was assigned to all analyzed data making the study clear and easy to follow.

Article #2

NameTonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis
CitationBurton MJ, Glasziou PP, Chong LY, Venekamp RP. Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis. Cochrane Database Syst Rev. 2014 Nov 19;2014(11):CD001802. doi: 10.1002/14651858.CD001802.pub3. PMID: 25407135; PMCID: PMC7075105.  
TypeSystematic review
Hyperlink  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075105/  
AbstractBackground: Surgical removal of the tonsils, with or without adenoidectomy (adeno-/tonsillectomy), is a common ENT operation, but the indications for surgery are controversial. This is an update of a Cochrane review first published in The Cochrane Library in Issue 3, 1999 and previously updated in 2009. Objectives: To assess the effectiveness of tonsillectomy (with and without adenoidectomy) in children and adults with chronic/recurrent acute tonsillitis in reducing the number and severity of episodes of tonsillitis or sore throat. Search methods: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 30 June 2014. Selection criteria: Randomised controlled trials comparing tonsillectomy (with or without adenoidectomy) with non-surgical treatment in adults and children with chronic/recurrent acute tonsillitis. Data collection and analysis: We used the standard methodological procedures expected by The Cochrane Collaboration. Main results: This review includes seven trials with low to moderate risk of bias: five undertaken in children (987 participants) and two in adults (156 participants). An eighth trial in adults (40 participants) was at high risk of bias and did not provide any data for analysis. Good information about the effectiveness of adeno-/tonsillectomy is only available for the first year following surgery in children and for a shorter period (five to six months) in adults. We combined data from five trials in children; these trials included children who were ‘severely affected’ (based on the specific ‘Paradise’ criteria) and less severely affected. Children who had an adeno-/tonsillectomy had an average of three episodes of sore throats (of any severity) in the first postoperative year, compared to 3.6 episodes in the control group; a difference of 0.6 episodes (95% confidence interval (CI) -1 to -0.1; moderate quality evidence). One of the three episodes in the surgical group was the ‘predictable’ one that occurred in the immediate postoperative period. When we analysed only episodes of moderate/severe sore throat, children who had been more severely affected and had adeno-/tonsillectomy had on average 1.1 episodes of sore throat in the first postoperative year, compared with 1.2 episodes in the control group (low quality evidence). This is not a significant difference but one episode in the surgical group was that occurring immediately after surgery. Less severely affected children had more episodes of moderate/severe sore throat after surgery (1.2 episodes) than in the control group (0.4 episodes: difference 0.8, 95% CI 0.7 to 0.9), but again one episode was the predictable postoperative episode (moderate quality evidence).Data on the number of sore throat days is only available for moderately affected children and is consistent with the data on episodes. In the first year after surgery children undergoing surgery had an average of 18 days of sore throat (of which some – between five and seven on average – will be in the immediate postoperative period), compared with 23 days in the control group (difference 5.1 days, 95% CI 2.2 to 8.1; moderate quality evidence).When we pooled the data from two studies in adults (156 participants), there were 3.6 fewer episodes (95% CI 7.9 fewer to 0.70 more; low quality evidence) in the group receiving surgery within six months post-surgery. However, statistical heterogeneity was significant. The pooled mean difference for number of days with sore throat in a follow-up period of about six months was 10.6 days fewer in favour of the group receiving surgery (95% CI 5.8 fewer to 15.8 fewer; low quality evidence). However, there was also significant statistical heterogeneity in this analysis and the number of days with postoperative pain (which appeared to be on average 13 to 17 days in the two trials) was not included. Given the short duration of follow-up and the differences between studies, we considered the evidence for adults to be of low quality. Two studies in children reported that there was “no statistically significant difference” in quality of life outcomes, but the data could not be pooled. One study reported no difference in analgesics consumption. We found no evidence for prescription of antibiotics.Limited data are available from the included studies to quantify the important risks of primary and secondary haemorrhage. Authors’ conclusions: Adeno-/tonsillectomy leads to a reduction in the number of episodes of sore throat and days with sore throat in children in the first year after surgery compared to (initial) non-surgical treatment. Children who were more severely affected were more likely to benefit as they had a small reduction in moderate/severe sore throat episodes. The size of the effect is very modest, but there may be a benefit to knowing the precise timing of one episode of pain lasting several days – it occurs immediately after surgery as a direct consequence of the procedure. It is clear that some children get better without any surgery, and that whilst removing the tonsils will always prevent ‘tonsillitis’, the impact of the procedure on ‘sore throats’ due to pharyngitis is much less predictable .Insufficient information is available on the effectiveness of adeno-/tonsillectomy versus non-surgical treatment in adults to draw a firm conclusion.The impact of surgery, as demonstrated in the included studies, is modest. Many participants in the non-surgical group improve spontaneously (although some people randomised to this group do in fact undergo surgery). The potential ‘benefit’ of surgery must be weighed against the risks of the procedure as adeno-/tonsillectomy is associated with a small but significant degree of morbidity in the form of primary and secondary haemorrhage and, even with good analgesia, is particularly uncomfortable for adults.    
Key pointsIn general children affected by recurrent acute tonsillitis may have a small benefit from adeno‐/tonsillectomy: this procedure will avoid 0.6 episodes of any type of sore throat in the first year after surgery compared to non‐surgical treatment. The children who had surgery had three episodes of sore throat on average compared to 3.6 episodes experienced by the other children. One of the three episodes is the episode of pain caused by surgery. When it comes to avoiding bad sore throats, children who have more severe or frequent tonsillitis may benefit more from surgery compared to less severely affected children. In less severely affected children the potential benefits of adeno‐/tonsillectomy are more uncertain. There are no good quality data for the effects of surgery in the second or later years after surgery. There was not enough evidence to draw firm conclusions on the effectiveness of tonsillectomy in adults with chronic/recurrent acute tonsillitis. Evidence is only available for the short term and is of low quality. The data are also difficult to interpret as the studies do not take into account the days of pain that always follow the operation. Based on the two small trials, tonsillectomy seems to result in fewer days of sore throat in the first six months after surgery. Two of the studies in children said that they could not find a difference in quality of life outcomes and one study could not find a difference in the amount of painkiller that children took to help with their sore throats. Bleeding immediately after tonsillectomy or in the two weeks following surgery is an important complication. The studies did not provide good information to allow us to assess accurately the risk of these complications  
Why I chose itEven though this study is from 2014, if offers an in detail assessment of a vast amount of data. The evidence is then assigned a level of quality. Secondary objectives were also sought to address the questions such as “what is the effectiveness of tonsillectomy/adenotonsillectomy in children with chronic/recurrent tonsillitis?”  

Article #3

NameDoes tonsillectomy reduce medical care visits for pharyngitis/tonsillitis in children and adults? Retrospective cohort study from Sweden
CitationØstvoll E, Sunnergren O, Stalfors J. Does tonsillectomy reduce medical care visits for pharyngitis/tonsillitis in children and adults? Retrospective cohort study from Sweden. BMJ Open. 2019;9(11):e033817. Published 2019 Nov 11. doi:10.1136/bmjopen-2019-033817  
TypeRetrospective Cohort
Hyperlinkhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6858118/  
AbstractObjective To assess the effectiveness of tonsillectomy/adenotonsillectomy in reducing medical care visits for pharyngitis or tonsillitis in children and adults with chronic/recurrent tonsillitis.   Design Retrospective cohort study.   Setting Data were retrieved from the VEGA register, a comprehensive regional cohort in Sweden.   Participants 1044 children (<15 years) and 2244 adults.   Intervention Tonsillectomy/adenotonsillectomy compared with no surgical treatment.   Main outcome measures Changes in yearly mean rates of medical care visits due to pharyngitis/tonsillitis.   Results In children, there was a significant decrease in the yearly mean medical care visits rate from 1.93 (1.82 to 2.04) before surgery to 0.129 (0.099 to 0.165) after surgery, with a mean change of −1.80 (−1.90 to −1.69), p<0.0001. In patients who did not undergo surgery, the corresponding mean change was −1.51 (−1.61 to −1.41), resulting in a mean difference in the change in visit rates between the intervention and control groups of −0.283 (−0.436 to −0.135), p=0.0002. In adults, a significant decrease in the yearly mean medical care visit rate was observed from 1.45 (1.39 to 1.51) before surgery to 0.152 (0.132 to 0.173) after surgery, with a mean change of −1.30 (−1.36 to −1.24), p<0.0001, compared with −1.18 (−1.24 to −1.13) in the control group. The difference in the change in yearly mean visit rate between the surgical and non-surgical groups was −0.111 (−0.195 to −0.028), p=0.0097. The subgroup analysis showed a greater effect of surgery in children, in patients with a higher number of medical care visits before surgery and in the first year of follow-up.   Conclusion In this cohort of patients moderately or less affected with chronic/recurrent tonsillitis, the effectiveness of tonsillectomy/adenotonsillectomy in reducing medical care visits for pharyngitis and tonsillitis compared with no surgical treatment was low and of questionable clinical value.  
Key pointsIn this cohort of patients moderately or less affected with chronic/recurrent tonsillitis, the effectiveness of tonsillectomy/adenotonsillectomy in reducing medical care visits for pharyngitis and tonsillitis compared with no surgical treatment was low and of questionable clinical value.
Why I chose itThis is the first population-based cohort study comparing medical care visits for throat infections after tonsillectomy with medical care visits in a matched cohort of nonsurgically treated patients.This study supports the previous findings that (adeno)tonsillectomy has no major clinical benefit in reducing medical care visits over watchful waiting in children with fewer episodes of pharyngitis/tonsillitis.This is the first study of the long-term effect of tonsillectomy for chronic/recurrent throat infections in adults.

Article #4

NameCognition After Early Tonsillectomy for Mild OSA
CitationWaters KA, Chawla J, Harris MA, Heussler H, Black RJ, Cheng AT, Lushington K. Cognition After Early Tonsillectomy for Mild OSA. Pediatrics. 2020 Feb;145(2):e20191450. doi: 10.1542/peds.2019-1450. Epub 2020 Jan 9. PMID: 31919049.
TypeMulticenter Randomized Controlled Study
Hyperlinkhttps://pediatrics.aappublications.org/content/145/2/e20191450 https://pubmed.ncbi.nlm.nih.gov/31919049/
AbstractObjectives: It remains uncertain whether treatment with adenotonsillectomy for obstructive sleep apnea in children improves cognitive function. The Preschool Obstructive Sleep Apnea Tonsillectomy and Adenoidectomy study was a prospective randomized controlled study in which researchers evaluated outcomes 12 months after adenotonsillectomy compared with no surgery in preschool children symptomatic for obstructive sleep apnea. Methods: A total of 190 children (age 3-5 years) were randomly assigned to early adenotonsillectomy (within 2 months) or to routine wait lists (12-month wait, no adenotonsillectomy [NoAT]). Baseline and 12-month assessments included cognitive and behavioral testing, medical assessment, polysomnography, and audiology. The primary outcome was global IQ at 12-month follow-up, measured by the Woodcock Johnson III Brief Intellectual Ability (BIA). Questionnaires included the Pediatric Sleep Questionnaire, Parent Rating Scale of the Behavioral Assessment System for Children-II, and Behavior Rating Inventory of Executive Function, Preschool Version. Results: A total of 141 children (75.8%) attended baseline and 12-month assessments, and BIA was obtained at baseline and 12-month follow-up for 61 and 60 participants in the adenotonsillectomy versus NoAT groups, respectively. No cognitive gain was found after adenotonsillectomy compared with NoAT, adjusted for baseline; BIA scores at 12-month follow-up were as follows: adenotonsillectomy, 465.46 (17.9) versus NoAT, 463.12 (16.6) (mean [SD]). Improvements were seen for polysomnogram arousals and apnea indices and for parent reports of symptoms (Pediatric Sleep Questionnaire), behavior (Behavior Assessment System for Children behavioral symptoms, P = .04), overall health, and daytime napping. CONCLUSIONS: Structured testing showed no treatment-attributable improvement in cognitive functioning of preschool children 12 months after adenotonsillectomy compared with NoAT. Improvements were seen after adenotonsillectomy in sleep and behavior by using polysomnogram monitoring and parental questionnaires.  
Key PointsWhat’s Known on This Subject: Studies to evaluate changes in neurocognition after adenotonsillectomy for obstructive sleep apnea suggest that younger children may have potential for greater improvement. The previous study with a randomized design was in school-aged children. What This Study Adds: This randomized study of preschool children showed reduced frequency of day naps and confirmed polysomnographic and behavioral improvements after adenotonsillectomy compared with those still awaiting surgery, but our primary analysis showed no improvement in global IQ.
Why I chose itThis is nearly a year old study that was funded by government and philanthropic agencies with no commercial support which minimizes the bias. It covered in detail such aspects as neuropsychological states, polysomnography findings as well as executive function in everyday activities. Authors then used regression to determine strength of causality of intervention and outcomes. Overall this is a strong study to describe the efficacy of tonsillectomy on neurocognitive outcomes.

Article #5

NameTonsillectomy for Obstructive Sleep-Disordered Breathing or Recurrent Throat Infection in Children
CitationFrancis DO, Chinnadurai S, Sathe NA, et al. Tonsillectomy for Obstructive Sleep-Disordered Breathing or Recurrent Throat Infection in Children [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Jan. (Comparative Effectiveness Reviews, No. 183.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK424048/  
typeSystematic Review with meta-analysis
Hyperlinkhttps://www.ncbi.nlm.nih.gov/books/NBK424048/
AbstractObjectives: To systematically review evidence addressing tonsillectomy in children with obstructive sleep-disordered breathing (OSDB) or recurrent throat infections.   Data sources: Multiple databases from January 1980 through June 2016.   Review methods: We included comparative studies of tonsillectomy, perioperative medications to improve outcomes, and postoperative medications for pain. We also included case series and database studies with ≥1,000 children to address harms. Two investigators independently screened studies and rated risk of bias. We extracted and summarized data qualitatively and quantitatively via Bayesian meta-analyses. We also assessed strength of the evidence (SOE).   Results: We identified 218 unique studies (141 randomized controlled trials [RCTs], 12 nonrandomized trials, 7 prospective and 5 retrospective cohort studies, and 53 database or registry studies or case series [67 low, 110 moderate, and 41 high risk of bias]). Populations; surgical approaches; anesthetic, analgesic, and antiemetic regimens varied across studies. For children with OSDB, most studies reported better sleep-related outcomes in those who had a tonsillectomy versus no surgery. For children with recurrent throat infections, tonsillectomy improved the number of infections, associated utilization (clinician visits), and work/school absences in the first postsurgical year. These benefits did not persist over time, however, and longer term outcomes are limited. Partial tonsillectomy was associated with faster return to normal diet or activity versus total tonsillectomy but also with a risk of tonsillar regrowth requiring reoperation. Commonly used “hot” techniques were generally associated with faster return to normal diet and activity than was cold dissection. In meta-analyses, frequency of post-tonsillectomy hemorrhage (PTH) was less than 4 percent, and frequency of bleeding-associated revisits or reoperations was less than 8 percent. Meta-analysis of nine RCTs reporting bleeding associated with perioperative dexamethasone compared with placebo did not indicate a significantly increased risk of bleeding with steroids, although confidence bounds were wide. Studies of perioperative medications were heterogeneous, but dexamethasone was consistently associated with less need for rescue analgesia than placebo. Preemptive perioperative 5-hydroxytryptamine (5-HT) antiemetics were associated with less need for postoperative antiemetics than placebo. Few studies of postoperative medications addressed the same agents or outcomes.
Key PointsTonsillectomy can produce short-term improvement in sleep outcomes compared with no surgery in children with OSDB (moderate SOE). In children with recurrent throat infections undergoing tonsillectomy, number of throat infections (moderate SOE) and associated health care utilization and work/school absences (low SOE) improved in the first postsurgical year. These benefits did not persist, and data on longer term results are lacking. Short-term improvements must be weighed against the risk of PTH (high SOE for low frequency of PTH). Surgical technique had little bearing on return to normal diet or activity (low SOE). Perioperative dexamethasone and pre-emptive 5-HT receptor antagonist antiemetics reduced the need for additional analgesics or antiemetics (low SOE). Dexamethasone did not increase risk of PTH compared with placebo, but estimates had wide confidence bounds (low SOE). Little evidence addressed the use of postoperative medications for pain-related outcomes (insufficient SOE).
Why I chose itThe current review addresses the comparative effectiveness and harms of tonsillectomy in children with the most common indications for the procedure, namely, OSDB and recurrent throat infections. It is targeted on these two key indications in order to maximize its utility for a broad population while maintaining a scope of work feasible for the systematic review. The review, nominated by the American Academy of Otolaryngology – Head & Neck Surgery Foundation, addresses key decisional dilemmas identified by stakeholders and through our preliminary scan of the literature in a comprehensive manner. The review also includes Key Questions (KQs) to improve understanding of outcomes in subgroups such as very young children (1-2 years old), children with Down syndrome, and those who are overweight or obese.

Article #6

NameEffectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial
CitationFehrm, Johan & Nerfeldt, Pia & Browaldh, Nanna & Friberg, Danielle. (2020). Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngology – Head and Neck Surgery. 146. 10.1001/jamaoto.2020.0869.
TypeRCT
Hyperlinkhttps://jamanetwork-com.york.ezproxy.cuny.edu/journals/jamaotolaryngology/fullarticle/2766471
AbstractImportance Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age. Objective To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.   Design, Setting, and Participants This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea–hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.   Main Outcomes and Measures The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea–18 (OSA– 18) questionnaire, and subgroup analyses. Polysomnography and the OSA–18 questionnaire were completed at baseline and after 6 months.   Results Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (−1.0; 95% CI, −2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA–18 questionnaire (eg, total OSA–18 score: −17; 95% CI, −24 to −10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (−3.1; 95% CI, −5.7 to −0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline. Conclusions and Relevance This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.
Key PointsQuestion:  Is adenotonsillectomy (ATE) more effective than watchful waiting for treating otherwise healthy children, between 2 and 4 years of age, with mild to moderate obstructive sleep apnea (OSA)? Findings:  In this randomized clinical trial including 60 children with OSA, there were only small differences between outcomes of ATE and watchful waiting, in favor of ATE, regarding changes in mean obstructive apnea–hypopnea index (OAHI), but there were large improvements in quality of life after ATE. Also, subgroup analyses showed that 11 children with moderate OSA who received ATE had a meaningful improvement in OAHI compared with 13 who received watchful waiting. Meaning:  Children with moderate OSA should be considered for early ATE, while children with mild OSA and mild effect on quality of life may benefit from a period of watchful waiting.
Why I chose itThis study is an update on a randomized trial by Marcus CL et al., 2013 that did not include children younger than 5 years. It is an up to date (2020) Randomized clinical Trial published in JAMA Otolaryngology covering specifically pediatric population 2 to 4 years of age with a reasonable male to female ratio (57% boys, 43% girls). Participants were randomized and then treated at the same facility. The statistical inference was performed with effect sizes and 95% CIs. Overall this study has a strong design and offers a reliable statistical analysis.

Summary of the Evidence:

Author (Date)Level of EvidenceSample/Setting (# of subjects/ studies, cohort definition etc. )Outcome(s) studiedKey FindingsLimitations and Biases
Morad et al., 2017Systematic ReviewAfter considering 9396 studies conducted from 1980 to 2016 and written in English, only 241 were agreed on keeping. Article focused on RCTs, prospective and retrospective cohort studies. Studies with high risk of bias were excluded. Out of 241 studies, 7 addressed recurrent throat infection were analyzed. Out of them 4 were RCTs, 2 Retrospective Cohorts and one nonrandomized trial. Due to including a Retrospective cohort with an impressive N = 13,872, total N of participants analyzed in this study is 15,394.  Sore throat days before and after study entryGAS infections  Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point.  Few studies fully categorized infection/sore throat severity; attrition was high.   Some studies were limited by a strong preference for surgery among parents of children with more severe symptoms, thus affecting the generalizability of the patients who were randomized  
Burton MJ et al., 2014Systematic ReviewRandomised controlled trials (RCTs) conducted from 1999 to 2014, with no restrictions on publication status or language of publication. This review includes seven trials with low to moderate risk of bias: five undertaken in children (987 participants) and two in adults (156 participants).    Primary outcomes: Number and severity of episodes of tonsillitis or sore throatNumber of days with sore throatMorbidity and mortality of surgery (measures of morbidity include complications of surgery and number of days with postoperative pain)   Secondary outcomes: Consumption of antibioticsConsumption of analgesicsAbsence or time off work or schoolQuality of lifeIn general children affected by recurrent acute tonsillitis may have a small benefit from adeno‐/tonsillectomy: this procedure will avoid 0.6 episodes of any type of sore throat in the first year after surgery compared to non‐surgical treatment. The children who had surgery had three episodes of sore throat on average compared to 3.6 episodes experienced by the other children. One of the three episodes is the episode of pain caused by surgery.The outcome definitions and methods of data collection were different between studies, introducing some clinical heterogeneity. However, the study did standardise the definition of key outcomes such as (refraining from) including the number of days and episodes of sore throat post-surgery in the meta-analyses. There was also a concern about potential skewness from the use of count data for episodes of sore throat.
Østvoll E, et al., 2019Retrospective CohortData were retrieved from the VEGA register, a comprehensive regional cohort in Sweden.   Participants: 1044 children (<15 years) and 2244 adults.Changes in yearly mean rates of medical care visits due to pharyngitis/tonsillitis.In this cohort of patients moderately or less affected with chronic/recurrent tonsillitis, the effectiveness of tonsillectomy/adenotonsillectomy in reducing medical care visits for pharyngitis and tonsillitis compared with no surgical treatment was low and of questionable clinical value.The study design, a retrospective cohort study, does not allow control of the circumstances leading to a tonsillectomy decision, and it is possible that patients who underwent surgery had ‘more severe’ disease compared to patients that did not undergo surgery.   No specific code for recurrent tonsillitis exists in the International Classification of Diseases 10th Revision coding system (ICD-10); hence, differentiation between chronic and recurrent tonsillitis as indication for surgery was not possible.
Waters KA et al., 2020Multicenter Randomized Controlled StudyA total of 190 children (age 3-5 years) were randomly assigned to early adenotonsillectomy (within 2 months) or to routine wait lists (12-month wait, no adenotonsillectomy [NoAT]). Baseline and 12-month assessments included cognitive and behavioral testing, medical assessment, polysomnography, and audiology. A total of 141 children (75.8%) attended baseline and 12-month assessments, and BIA was obtained at baseline and 12-month follow-up for 61 and 60 participants in the adenotonsillectomy versus NoAT groups, respectively.The primary outcome was global IQ at 12-month follow-up, measured by the Woodcock Johnson III Brief Intellectual Ability (BIA). Questionnaires included the Pediatric Sleep Questionnaire, Parent Rating Scale of the Behavioral Assessment System for Children-II, and Behavior Rating Inventory of Executive Function, Preschool Version.No cognitive gain was found after adenotonsillectomy compared with NoAT, adjusted for baseline; BIA scores at 12-month follow-up were as follows: adenotonsillectomy, 465.46 (17.9) versus NoAT, 463.12 (16.6) (mean [SD]). Improvements were seen for polysomnogram arousals and apnea indices and for parent reports of symptoms (Pediatric Sleep Questionnaire), behavior (Behavior Assessment System for Children behavioral symptoms, P = .04), overall health, and daytime napping.Difficulties with recruitment and retention of subjects in a study that can be demanding of families with young children, creating an inherent loss of data across time. Although reliance on intention to treat gives more “real world” results, it can cause loss of power because of subject attrition. Together, these factors combine to increase the risk for a type II error.   Disruption to the protocol also occurred when one hospital move to new facilities.
Francis DO et al., 2017Systematic Review with meta analysisStudy included comparative studies of tonsillectomy, perioperative medications to improve outcomes, and postoperative medications for pain. It also included case series and database studies with ≥1,000 children to address harms. Two investigators independently screened studies and rated risk of bias. Then they extracted and summarized data qualitatively and quantitatively via Bayesian meta-analyses. Study  also assessed strength of the evidence (SOE). Investigators identified 218 unique studies (141 randomized controlled trials [RCTs], 12 nonrandomized trials, 7 prospective and 5 retrospective cohort studies, and 53 database or registry studies or case series [67 low, 110 moderate, and 41 high risk of bias]  Sleep related outcomesBehavioral outcomesNumber of throat infectionsNumber of clinical visits due to throat infectionsWork/school absences in the first postsurgical yearFrequency of post-tonsillectomy hemorrhageBleeding associated revisits and reoperationsQuality of life (physical suffering, sleep disturbances, speech issues, or caregiver concerns)  Tonsillectomy can produce short-term improvement in sleep outcomes compared with no surgery in children with OSDB (moderate SOE). In children with recurrent throat infections undergoing tonsillectomy, number of throat infections (moderate SOE) and associated health care utilization and work/school absences (low SOE) improved in the first postsurgical year. These benefits did not persist, and data on longer term results are lacking.Most available studies provided little to no clinical outcome data, focusing instead on intermediate outcomes and harms. In addition, few studies addressed questions about the need for tonsillectomy compared with a nonsurgical treatment. Patient populations were generally poorly characterized, and little information was available on first-line treatment attempts before surgery.  
Fehrm et al., 2020RCTThis randomized clinical trial was conducted from Dec 2014 to Dec 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea–hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea–18 (OSA– 18) questionnaire, and subgroup analyses. Polysomnography and the OSA–18 questionnaire were completed at baseline and after 6 months.This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.This trial had a small study sample (n = 60), and it included only otherwise healthy children, making the generalizability limited and therefore not applicable to children with comorbidities or severe OSA. There were only 4 children with obesity who completed the study, and therefore it was not possible to evaluate the effect in patients with obesity. However, excluding these patients did not affect the primary result. Also, QoL is a subjective measure, and the children and caregivers were not blinded to treatment allocation. Therefore, there is a possibility that larger improvements in QoL after ATE could be explained by a surgical placebo effect.  

Conclusion(s):

1 – (Morad et al., 2017) – A systematic review finds that tonsillectomy provides some short-term benefits over watchful waiting for children with mild to moderate throat infections, but it’s not clear if the benefits persist.

2 – (Burton MJ et al., 2014) – On average surgical patients had 3 episodes of sore throat vs non-surgical – 3,6. Even given that one of the episodes for those who underwent tonsillectomy was immediately after the surgery itself, if patient has 3 or less episodes of sore throat/tonsillitis a year, this statistical difference is not significant enough to create clinical value, especially given that a sore throat is not a life-threatening condition. However, if the patient experiences more than three episodes of sore throat a year, thus, migrating to the “more severely affected” group – the statistical significance becomes more evident thus creating grounds for consideration of surgery in that situation.

3 – (Ostwol et al., 2019) – Results suggest that the threshold for surgical intervention in both children and adults moderately or less affected by chronic or recurrent throat infections needs to be further studied and discussed as most patients seem to improve spontaneously within a year without surgery. Another interpretation of this would be that the watchful waiting period before a final decision for surgery should last no longer than a year.

4 – (Waters KA et al., 2020) – Study demonstrated improvements in polysomnography parameters, sleep quality, parent- reported symptoms, and aspects of behavior in preschool children with mild to moderate OSA undergoing early adenotonsillectomy compared with those awaiting surgery on routine waitlists. No difference in the global cognitive measures was attributable to study intervention at a 12-month follow-up.

5 – (Francis DO et al., 2017). – Tonsillectomy can produce short-term improvement in sleep outcomes compared with no surgery in children with OSDB (moderate SOE). In children with recurrent throat infections undergoing tonsillectomy, number of throat infections (moderate SOE) and associated health care utilization and work/school absences (low SOE) improved in the first postsurgical year. These benefits did not persist, and data on longer term results are lacking. Short-term improvements must be weighed against the risk of PTH (high SOE for low frequency of PTH).

6 – (Johan Fehrm MD et al., 2020)- In this randomized clinical trial including 60 children with OSA, there were only small differences between outcomes of ATE and watchful waiting, in favor of ATE, regarding changes in mean obstructive apnea–hypopnea index (OAHI), but there were large improvements in quality of life after ATE. Also, subgroup analyses showed that 11 children with moderate OSA who received ATE had a meaningful improvement in OAHI compared with 13 who received watchful waiting.

Overarching Conclusion

    Tonsillectomy provides some short-term benefits over watchful waiting for children with mild to moderate throat infections, but it’s not clear if the benefits persist (Morad et al., 2017). Francis DO et. Al., 2017, further supported the notion of lack of evidence to underwrite benefits of ATE lasting longer than a year post surgery. Children that are more likely to benefit from the surgery are those “severely affected” meaning 6 or more recurrencies of throat infections per year (Burton MJ et al., 2014). As per cognitive outcomes, a multicenter randomized controlled study following 129 children by Waters KA et. Al., 2020 pointed out improvements in polysomnography parameters, sleep quality, parent- reported symptoms, and aspects of behavior in children who underwent surgery in comparison to those who have not. No difference in the global cognitive measures was noted.

    Another small RCT by Fehrm MD et al., 2020 including 60 children, found only small differences in mean obstructive apnea–hypopnea index favoring the adenotonsillectomy (ATE), but reported large improvements of quality of life after ATE. However, QOL is a subjective measure and, given that participants were not blinded to treatment allocation, it is difficult to assign it a true clinical value.

    A retrospective cohort study by Østvoll E et al., 2019, following 1044 children < 15 years and 2244 adults moderately or less affected with chronic/recurrent tonsillitis, found ATE effectiveness being low and of questionable clinical value for reducing medical care visits for pharyngitis and tonsillitis.

    To summarize, the existing evidence points towards potential small improvements in quality of life of sleep apnea patients and a possible, although not lasting, decrease of number of episodes of sore throat per year for those with recurrent tonsillitis, but it does not come at no price. The most significant complication of tonsil surgery is postoperative hemorrhage, which can result in urgent readmission to the hospital, return to the OR and in rare instances, death. The procedure is also associated with several days of postoperative pain, and even with the standard use of postoperative analgesics, many patients report significant pain and discomfort. Therefore, an in-depth shared decision-making conversation about goals, benefits and risks of surgery must take place.

Clinical Bottom Line:

–  Weight of the Evidence

For answering my clinical question, the level of evidence would go in order

Meta-analysis → RCT → Retrospective cohort

Other important factors to include would be N number of participants, the population studied and how closely it relates to my specific patient.

  1. Tonsillectomy for Obstructive Sleep-Disordered Breathing or Recurrent Throat Infection in Children Francis DO et al., 2017). – Meta analysis – Investigators identified 218 unique studies (141 randomized controlled trials [RCTs], 12 nonrandomized trials, 7 prospective and 5 retrospective cohort studies, and 53 database or registry studies or case series [67 low, 110 moderate, and 41 high risk of bias]. The study does not mention total N of participants specifically, but this meta-analysis undoubtedly includes the highest N of all studied included in this work. This study covers in depth both main outcomes of tonsillectomy investigated in my work – recurrent throat infections and Obstructive Sleep-Disordered breathing thus granting it the highest level of evidence to answer my question.
  2. Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review (Morad et al., 2017) 7 studies. 4 RCTs, 2 Retrospective Cohorts and one non-randomized trial. Due to including a Retrospective cohort with an impressive N = 13,872, total N of participants analyzed in this study is 15,394.
  3. Does tonsillectomy reduce medical care visits for pharyngitis/tonsillitis in children and adults? Retrospective cohort study from Sweden (Ostwol et al., 2019) – retrospective cohort; N = 1044 children (<15 years) and 2244 adults.
  4. Cognition After Early Tonsillectomy for Mild OSA (Waters KA et al., 2020) – multicenter RCT; N = 141 children 3 to 5 years of age.
  5. Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial (Johan Fehrm MD et al., 2020)

RCT. N = 60 children 2 to 4 years of age.

  • Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis (Burton MJ et al., 2014) – syst review of Randomized controlled trials only. It included 7 trials, with a total N of 987 children and 156 adults. “Adults” were identified as those 15 years of age and older and only one included study specified the age for children – 4 to 15 years old. Even though this study has a higher N than Waters KA et al., 2020 and Johan Fehrm MD et al., 2020, I assign it lower level of evidence due to the lack of clarity on age of participating children.

–  Magnitude of any effects –

1 – (Morad et al., 2017) – Long-term effects are limited in the literature base, particularly regarding outcomes that include growth and development and quality- of-life outcomes. Exploration of demographics of patient populations more likely to be refractory to initial management strategies is also limited. It appears clear that throat infections decline in children over time regardless of treatment group, but with high loss to follow-up, the relative contribution of this decline on apparent effectiveness

is unknown. Definitions of severity have been assigned somewhat arbitrarily, based on best evidence or consensus approach, and until there is a robust literature surrounding natural history of throat infections

in childhood, it may be difficult to achieve consistency in this description.

2 – (Burton MJ et al.,2014) – The impact of surgery, as demonstrated in the included studies, is modest. Many participants in the non-surgical group improve spontaneously (although some people randomized to this group do in fact undergo surgery). The potential ‘benefit’ of surgery must be weighed against the risks of the procedure as adeno-/tonsillectomy is associated with a small but significant degree of morbidity in the form of primary and secondary hemorrhage and, even with good analgesia, is particularly uncomfortable.

3 – (Ostwol et al., 2019) – In the decision for tonsillectomy, the potential gain must be weighed against the risks of complications. The most significant complication of tonsil surgery is postoperative hemorrhage, which can result in urgent readmission to the hospital, return to the theatre and in rare instances, death.18–20 The procedure is also associated with several days of postoperative pain, and even with the standard use of postoperative analgesics, many patients report significant pain and discomfort.21 The small differences in mean visit rates between the patients who underwent surgery compared with those who did not, together with the low incidence rates of medical care visits in the patients who did not undergo surgery during the follow-up period, imply that the gain of tonsillectomy in the studied population may be questioned. Our results suggest that the threshold for surgical intervention in both children and adults moderately or less affected by chronic or recurrent throat infections needs to be further studied and discussed as most patients seem to improve spontaneously within a year without surgery.

4 – (Waters KA et al., 2020) – Study primary analysis rejects the hypothesis that younger (preschool) children have improved global IQ after earlier intervention with adenotonsillectomy, nor were there improvements in BRIEF scores (parent-reported executive function). However, improvements in polysomnography parameters, sleep quality, parent-reported symptoms, and aspects of behavior in preschool children with mild to moderate OSA undergoing early adenotonsillectomy compared with those awaiting surgery on routine waitlists was reported. With that said, an in depth shared decision-making discussion must take place in order to determine if the revealed improvements overweigh the risks of surgery such as hemorrhage, sepsis and overall discomfort.

5 – (Francis DO et al., 2017) – Despite substantial research, the literature is largely silent on the natural history of OSDB or throat infections that would provide a basis for the need for tonsillectomy in the long term. Many young patients may outgrow the need for intervention, but more data are needed to describe the potential to outgrow these indications to parents and to describe population factors that may predict resolution. Indeed, in many studies, outcomes for children in nonsurgical groups also improved, though improvements were generally greater in children receiving tonsillectomy. Long-term data are needed in order to enable caregivers to weigh the benefits of surgery versus the reality of managing their child’s condition as they wait for it to resolve; obtaining longer-term data, however, is difficult, as evidenced by the high rate of attrition in most studies with more than 6 months follow-up included in this review.

6 – (Johan Fehrm MD et al., 2020) – main limitation of this study is that it had a small study sample (n = 60), and it included only otherwise healthy children, making the generalizability limited and therefore not applicable to children with comorbidities or severe OSA. There were only 4 children with obesity who completed the study, and therefore it was not possible to evaluate the effect in patients with obesity. However, excluding these patients did not affect the primary result. Also, QoL is a subjective measure, and the children and caregivers were not blinded to treatment allocation. Therefore, there is a possibility that larger improvements in QoL after ATE could be explained by a surgical placebo effect. Even so, it is important to not only focus on PSG (polysomnography) parameters; additional outcomes measuring symptoms and behavior would have been of value to this study. Also, it is difficult to separate children with mild and moderate OSA, based on the clinical presentation, and PSG is seldom used in clinical practice.

– Clinical significance –

1 – (Morad et al., 2017) – The authors reported a greater decrease in the number of throat infections, clinician contacts, diagnosis of infection by group A streptococcus (GAS) and school absences in the short term in patients treated with TE. These differences, while statistically significant, seem scarcely relevant from a clinical standpoint. This is a moderate effect that, furthermore, does not persist and is only observed in the first year, which may overlap with the natural decrease in episodes of tonsillitis as years go by. In one of the studies with the lowest risks of bias, the TE group had 1.74 episodes of throat pain or infection in the first year post surgery, (95% confidence interval [95 CI]: 1.54 to 2) compared to 2.93 episodes in the control group (95 CI: 2.69 to 3.22).3 There are previous studies that have not found a reduction in the number of respiratory infections following TE4 or have found only a modest decrease in recurrent pharyngitis. A study of the cost-effectiveness of TE compared to medical treatment in reducing the frequency of tonsillitis in school aged children concluded that TE can reduce the overall number of episodes of tonsillitis in the two years following the procedure (95 CI: 0.61 to 5.2) at a reasonable cost (with a reduction of £261 [95 CI: 161 to 586] per prevented episode of “tonsillitis” [throat involvement]). Furthermore, we must take into account that the risks of severe complications of TE could exceed the risks of rheumatic fever or local suppurative complications in conservative treatment1.

2 – (Burton MJ et al.,2014) – Good information about the effectiveness of adeno-/tonsillectomy is only available for the first year following surgery in children and a shorter period (five to six months following surgery) in adults. For more severely affected children (those who fulfil the ‘Paradise criteria’), those who have an adeno-/tonsillectomy will have a significant, but predictable episode of sore throat immediately following surgery and then two other episodes in the first postoperative year (1 predictable + 2 unpredictable = 3 in total) compared with 3.6 unpredictable episodes in the control group. The difference is 0.6 episodes, but with a confidence interval of -1 to -0.1; in other words, the real difference may be one episode or almost none. In practical terms, this difference is modest.

Less severely affected children who have adeno-/tonsillectomy may never have had another moderate/severe sore throat anyway; the chance of them so doing is modestly reduced by adeno-/ tonsillectomy. For them, surgery will mean having an average of 1.2 moderate/severe sore throats (1 predictable + 0.2 unpredictable = 1.2 in total) rather than 0.4 unpredictable episodes experienced by the control group. If the postoperative episode is set aside (and this may not be a reasonable thing to do), there is no difference in the number of unpredictable episodes of moderate/severe sore throat. The children who have surgery will have 18 rather than 23 sore throat days but something between five to seven (on average) of these 18 days will be in the immediate postoperative period.

The very modest benefits that have been identified should be carefully weighed against the possible harms of surgery, as the procedure is associated with a small but significant degree of morbidity in the form of primary and secondary hemorrhage and, even with good analgesia, is particularly uncomfortable.

3 – (Ostwol et al., 2019) – Both patients who underwent tonsillectomy and patients who did not had statistically fewer medical care visits after surgery/fictitious surgery. A significantly greater decrease in medical care visits was observed for patients who underwent surgery compared with patients who did not. The NNTs were unexpectedly high, indicating that tonsillectomy was not very effective in reducing medical care visits in children and adults with chronic/recurrent tonsillitis in this cohort. The improvement compared with no surgical treatment was small and of questionable clinical value considering the few medical care visits observed in the patients who did not undergo tonsillectomy. The study design did not allow control of the actual circumstances leading to a tonsillectomy decision in the operated group, and therefore all possible causal relationships between intervention and outcome should be interpreted with caution.

4 – (Waters KA et al., 2020) –  Randomized design of the study is helpful in answering the question, especially with a 12-month delay to follow-up. Although the trajectory of overall IQ change appeared improved in the adenotonsillectomy group, it was not clinically significant. Among subscales, long-term retrieval (memory) improved in the adenotonsillectomy group, and this is 1 area of neurocognition

identified both as impaired and showing improvement after therapy in adult OSA. Possible explanations for improved neurocognition over time include improvements with age and/or effects of development and a learning effect, although the 12-month recommended retesting interval, included in our design, minimizes any learning effect. It may also be important that study excluded children with hearing loss from the baseline assessments, a factor not routinely considered in studies of OSA and IQ, despite its demonstrable association with executive function in OSA. Nonetheless, study primary analysis rejects the hypothesis that younger (preschool) children have improved global IQ after earlier intervention with adenotonsillectomy, nor were there improvements in BRIEF scores (parent-reported executive function). However, improvements in polysomnography parameters, sleep quality, parent-reported symptoms, and aspects of behavior in preschool children with mild to moderate OSA undergoing early adenotonsillectomy compared with those awaiting surgery on routine waitlists was reported.

5 – (Francis DO et al., 2017) – Investigators combined three studies reporting AHI (Apnea Hypopnea Index) outcomes in a fixed effects meta-analysis. They found a mean effect size of -4.81 (95% credible interval: -6.5 to -3.1), indicating an approximately 5-point improvement in obstructive symptoms in children receiving tonsillectomy compared with those not undergoing surgery. The clinical significance of this improvement is likely influenced by baseline disease severity and may be most obvious in children with mild or moderate OSDB (i.e., AHI scores of 1 to 10). Two RCTs, one nonrandomized trial, and one retrospective cohort (all with moderate risk of bias) used several different parent-reported quality measures to assess sleep quality outcomes, limiting the ability to compare effectiveness directly across studies, although better outcomes were consistently associated with tonsillectomy. In one RCT and one prospective and one retrospective cohort study (moderate risk of bias) evaluating behavioral outcomes (emotional lability, attention, aggression) again using different measures, outcomes were consistently better among children receiving tonsillectomy; in all studies reporting baseline data, scores on behavioral measures were not indicative of clinical concern. While children’s behaviors improved in these studies, the clinical significance and magnitude of the improvement is not clear. Executive function measures did not differ among children receiving tonsillectomy or no surgery in one RCT and one prospective cohort study, both with moderate risk of bias. In studies reporting baseline scores, sleep quality and behavioral outcomes for children in the no surgery groups also moderately improved from baseline, with greater improvement in children who had tonsillectomy. Studies rarely reported other outcomes (e.g., cognitive outcomes).

6 – (Johan Fehrm MD et al., 2020) – In this RCT there were small differences between ATE and watchful waiting in favor of ATE regarding changes in mean OAHI (obstructive apnea–hypopnea index) scores in otherwise healthy children without obesity who have mild to moderate OSA. However, children undergoing ATE had greater improvements in QoL, and ATE was more effective in children with moderate OSA regarding change in mean OAHI score. These results suggest that otherwise healthy children with moderate OSA benefit from early ATE and that watchful waiting could be an alternative for mild OSA. Nonetheless, QoL should also be taken into consideration when deciding to perform surgery. Therefore, even though the study demonstrated relative statistical significance, since Quality of Life is a very subjective outcome, it is difficult to assign these results a clinical significance with a high confidence.

Other Considerations –

Bleeding immediately after tonsillectomy or in the two weeks following surgery is an important complication. Of all identified studies, only one (Francis DO et al., 2017) covered post tonsillectomy hemorrhage as an outcome. Other studies evaluating effectiveness of surgery should have retrieved and analyzed this data more precisely.

When evaluating neurocognitive outcomes, exclusion criteria did not cover a history of TBI or previous anesthesia which could largely affect participant’s memory and cognition improvement rates. Larger RCT with a more thorough exclusion criteria are needed.

Additional Sources:

1 – https://evidenciasenpediatria.es/files/41-13247-RUTA/AVC_52_ENG.pdf

Citation: Perdikidis Olivieri L. Tonsillectomy reduces moderately the frequency of tonsillitis, but it must be evaluated case by case.

Evid Ped. 2017;13:52.

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