Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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Dealing with parents' demand for surgery.
- Edoardo Cervoni (14 September 2004)
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adenotonsillectomy has major clinical benefits
- James C. Denning, Dr. Anne Schilder (15 September 2004)
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Usefulness of both EBM and Single Patient Based Medicine
- Sergio Stagnaro (17 September 2004)
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Watchful Waiting may not be appropriate in Children with Adenotonsillar Hypertrophy
- Simon C Langton Hewer, Claire Langton Hewer, Yvonne Pamula, James Martin, Declan Kennedy (20 September 2004)
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Pragmatic randomised controlled trial without pragmatic clinical indications: the case of adenotonsillectomy in healthy children
- Federico Marchetti, Marzia Lazzerini, Giorgio Longo (20 September 2004)
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Adenotonsillectomy in children with mild symptoms
- PJ Robb (21 September 2004)
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The appropriateness of adenotonsillectomy in children with mild symptoms.
- Ram P Moorthy, Hassan Khan (23 September 2004)
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Evidence gathering in childhood adenotonsillectomy
- Janet A Wilson (13 October 2004)
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No benefit from this study
- Narendra Babu Koyyalamudi (16 October 2004)
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T & A for mild symptoms
- Velayutham Sankar, Velayutham Sankar (1 June 2005)
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RCT is it valid to change our practice?
- Isam RUSTOM (19 September 2005)
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Edoardo Cervoni, ENT Specialist 19 Saunders Street, Southport PR9 0HP
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Sir, Birgit K van Staaij and coll. evaluated the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy in a 22-month follow-up study. They concluded that adenotonsillectomy has not major benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy. Still possibly remain some inevitable weaknesess of the study and possibly a slightly overall increase of incidence in of minor URTI problems with or without fever. As recognised by the Authors themselves, the study has some possible limitations such as the exclusion of children with frequent throat infections or OSA which were considered eligible for surgery and the fact that 34% children were changed from the watchful waiting group to surgery which may induce to underestimate the effect of treatment. I also wonder if those contribute to the slight increased incidence rate to the studied variables in the watchful waiting group and I do wonder if the occurrence of complications induced to go ahead with surgery in the 50 children initially allocated in the watchful waiting group. Apart from the accepted limitations, the study still offers valuable information and several interesting issues for discussion. Firstly, I do remark that among the 1226 children assessed for eligibility, 512 (41.8 %) were excluded from the study under parent's insistence. That's a really impressive percentage. Nothing new there maybe, but it does make me wonder from which kind of background moves such as pro-surgery approach of the parents which was anyway followed by the surgeons despite a preliminary knowledge that evidence of the benefits of adenotonsillectomy in children with milder symptoms is lacking. There is little doubt that an interventistic approach has been for very long time supported by ENT surgeons. The clinical reasons behind that approach have never been corroborated and, in fact, the major indications for tonsillectomy remained unchanged for at the least 4 decades. I found interesting a study from Wennberg JE and coll (1) on changes on tonsillectomy rates among 13 Vermont Hospital Service Areas after feedback and review. Tonsillectomy rates decreased over a five-year period. In 1969, the rates in seven areas exceeded the estimated United States national rate; by 1973, the average rate for all areas had declined 46% and only one area remained above the U.S. rate. Equally, within the same reading frame, I find always interesting the paper from Paradise JL and coll (2), who, as part of a prospective study of indications for tonsillectomy and adenoidectomy, have followed closely children with histories of recurrent throat infection that seemed impressive (at least seven episodes in one year, five in each of two consecutive years or three in each of three consecutive years), but lacked documentation. They concluded that undocumented histories of recurrent throat infection do not validly forecast subsequent experience and hence do not constitute an adequate basis for subjecting children to tonsillectomy. Overall, I believe that the message received from the parents (and patients) about tonsillectomy for a very long time has been: "tonsillectomy is good for sore throat". Consequently, tonsillectomy is an extremely popular surgery. And, where appropriate, it really does work. We can not forget that this fact may have had in itself an conditioning/educational role among the population. As yet, we are not sure about the long-term implications of this surgery, if any, especially in the youngest patients. A 2-year follow-up may be proven to be too a short time and the parameter we have been looking at may not be the most appropriate ones, despite so they would seem to be on the basis of our current knowledge. Thus, I find rather stimulating and welcome the works, also from Van Staaij and coll (3), aimed to identify the factors which may make a children more prone to develop tonsillitis. And, once again, it must be stressed that studies on the physiological role of palatine tonsils are still very much needed. Until then, I would suggest to assume that palatine tonsils should be provided with several innate defence mechanisms against microorganisms and to avoid surgery in absence of documented complications, or without a sound period of watchful waiting in presence of uncomplicated, well documented, recurring sore throats. This may implying seeing patients with recurring tonsillitis more often than what we may have been used to do in the past, and it could be also difficult convincing the parent already determined to go ahead with surgery, but, adopting the current knowledge and following the principle: “primum non nocere” , this seems to me being the most rational approach. Unfortunately, even if rarely, also tonsillectomy may have dramatic consequences. Sometime, we do not became aware of them until we do not discover the association, or possibility of an association, with other disease later on, such as CJD. Too a greater risk to take in absence of convincing criteria backing clinical benefit. 1. Paradise JL, Bluestone CD, Bachman RZ, Karantonis G, Smith IH, Saez CA, Colborn K, Bernard BS, Taylor FH, Schwarzbach RH, Felder H, Stool SE, Fitz AM, Rogers KD. History of recurrent sore throat as an indication for tonsillectomy. Predictive limitations of histories that are undocumented. N Engl J Med. 1978 Feb 23;298(8):409-13. 2. Wennberg JE, Blowers L, Parker R, Gittelsohn AM.Changes in tonsillectomy rates associated with feedback and review.Pediatrics. 1977 Jun;59(6):821-6. 3. Van Staaij BK, Van Den Akker EH, De Haas Van Dorsser EH, Fleer A, Hoes AW, Schilder AGDoes the tonsillar surface flora differ in children with and without tonsillar disease?Acta Otolaryngol.2003Sep;123(7):873-8. Competing interests: None declared |
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James C. Denning, president Sleep Disorders Info Inc. 11 Fern Rd. Holbrook ,Ma, Dr. Anne Schilder
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I live in America and my generation in the most part had their tonsils and adenoids removed in early childhood. Today we know better and consider it a useless procedure. Yet, we fail to look at the results. Visit any playground and Asthma inhalers abound. People are always complaining these kids are overweight. Adhd has become a national industry. Thinking about these problems we can't imagine what might be causing it. The writer of the article states "But from six to 24 months,there was no difference between the groups ." Perhaps we need to compare my generation to this new one? All the conditions stated above are related to Sleep Apnea. My generation is 40 before the symptoms of Apnea become apparent as opposed to the teens today. I have four kids, one had a T & A . It is no accident that one has no weight problem and the other three fight that battle the rest of their life. I would like to expand her test range to generations. If she does I think she will come to a different conclusion. Competing interests: None declared |
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Sergio Stagnaro, Specialist in Blood, Gastrointestinal, and Metabolic Diseases. Researcher in Biophysical Semeiotics. Via Erasmo Piaggio 23/8 16037 Riva Trigoso (Genova) Italy.
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Sirs, In assessing the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy, Single Patient Based Medicine (SPBM) helps doctors more efficaciously than EBM (2) (See web-site HONCode 233736, www.semeioticabiofisica.it: Constitutions. SPBM). In fact, although, the authors of an intriguing paper state that, studying large number of patients, no clinically relevant differences were found for health related quality of life, and adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none to two, not all young subjects with tonsillar infection are equal, as regards the presence of rheumatic constitutions, CAD real risk (3,4,5), kidney condition, a.s.o. Therefore, in my opinion, doctors must know both EBM and SPBM, which, in addition, provide physician with an efficacious objective therapeutic monitoring. 1) Van Staaij B.K., Van den Akker E.M. et al. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial BMJ 2004;329:651 (18 September), doi:10.1136/bmj.38210.827917.7C (published 10 September 2004) 2) Stagnaro Sergio, Stagnaro-Neri Marina. Introduzione alla Semeiotica Biofisica. Il Terreno oncologico”. Travel Factory SRL., Roma, 2004. http://www.travelfactory.it/semeiotica_biofisica.htm 3) Stagnaro S., Stagnaro-Neri M., Le Costituzioni Semeiotico- Biofisiche.Strumento clinico fondamentale per la prevenzione primaria e la definizione della Single Patient Based Medicine. Ediz. Travel Factory, Roma, (in press). 4) Stagnaro S. Pivotal role of Biophysical Semeiotic Constitutions in
Primary Prevention. Cardiovascular Diabetology.2003, 2:1,
5) Stagnaro S. A clinical efficacious maneouvre, reliable in bed-side diagnosing coronary artery disease, even initial or silent, as well as “heart coronary risk”. 3rd TCVC Argentine Congress of Cardiology, September 2003 . http://www.fac.org.ar/tcvc/marcoesp/marcos.htm Competing interests: None declared |
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Simon C Langton Hewer, Consultant Respiratory Paediatrician Flinders University, South Australia SA 5042, Claire Langton Hewer, Yvonne Pamula, James Martin, Declan Kennedy
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Sir, We read with interest and with concern the paper of van Staaij and colleagues.1 The authors have conducted a large study that has examined the effectiveness of adenotonsillectomy in children with mild symptoms of throat infection or adenotonsillar hypertrophy. Their conclusion is that adenotonsillectomy confers no major clinical benefits over watchful waiting. We are concerned that the conclusion may lead the reader into a false sense of security over the safety of watchful waiting. The paper states that children with suspected obstructive sleep apnoea have been excluded because they scored more than 3.5 on Brouillette’s obstructive sleep apnoea score.2 A more recent publication from Brouillette has indicated that, whilst a score of greater than 3.5 is suggestive of OSA, a score of less than this does not distinguish OSA from primary snoring.3 Children with OSA are therefore unlikely to have been excluded from the cohort described in the paper by van Staaij. Several authors have demonstrated improvement in neurocognitive outcome in children with OSA following adenotonsillectomy4-6 and we are concerned that this important outcome measure was not included in the van Staaij paper and was not recognised as a limitation of the study in their discussion. The result of watchful waiting in children with adenotonsillar hypertrophy and OSA may deny these children potential for behavioural and neurocognitive improvement. 1. Van Staaij BK, Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. Bmj 2004. 2. Brouilette 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(1):10-4. 3. Brouillette RT, Morielli A, Leimanis A, Waters KA, Luciano R, Ducharme FM. Nocturnal pulse oximetry as an abbreviated testing modality for pediatric obstructive sleep apnea. Pediatrics 2000;105(2):405-12. 4. Blunden S, Lushington K, Kennedy D, Martin J, Dawson D. Behavior and neurocognitive performance in children aged 5-10 years who snore compared to controls. J Clin Exp Neuropsychol 2000;22(5):554-68. 5. Goldstein NA, Fatima M, Campbell TF, Rosenfeld RM. Child behavior and quality of life before and after tonsillectomy and adenoidectomy. Arch Otolaryngol Head Neck Surg 2002;128(7):770-5. 6. Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A, Friger M, Tarasiuk A, et al. Adenotonsillectomy improves neurocognitive function in children with obstructive sleep apnea syndrome. Sleep 2003;26(8):999-1005. Competing interests: None declared |
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Federico Marchetti, consultant paediatrician Clinica Pediatrica, IRCCS Burlo Garofolo, Università di Trieste, Marzia Lazzerini, Giorgio Longo
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Sir, Van Staaij BK et al (1) reported the inefficacy and the risk of the intervention of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy. However, the need to perform a pragmatic randomised controlled trial (RCT) without pragmatic clinical indications is questionable. We agree that frequent throat infections and obstructive sleep apnoea are adequate indications for adenotonsillectomy. Anyway, the summary of evidences based on RCT on the effectiveness of tonsillectomy comparing with non surgical management in children with "severe" recurrent tonsillitis show controversial results and gaps in the evidence, because no RCT found improvement in major outcomes, as general wellbeing, development or behaviour (2). Moreover, there is evidence of the inefficacy of adenotonsillectomy in children with milder symptoms. A previous RCT by Paradise J et al (3), concluded that "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”. So, on the basis of previous evidences, the choice of design a RCT to study children with mild symptoms of throat infections is not pertinent and ethically doubtful, given also the risk related to the surgical procedures and the cost for the whole health system. Many studies showed a lack of agreement among general practitioners, paediatricians and otolaryngologists about the management of children with recurrent tonsillitis (4). In Netherlands for example, during 1998 115 per 10,000 children underwent adenotonsillectomy, 65% was performed without clear evidence of efficacy (1). In Italy tonsillectomy rate during 2000 was 94.3 per 10,000 among children aged 4-9 years, with a large variation across regions (5). National guidelines have recently been agreed (5). The wide variation in attitude toward tonsillectomy will probably continue until the decision-making process of doctors involved in the treatment of children with recurrent tonsillitis is better understood. Implementation of evidence-based guidelines is a long time process and need major commitment. Federico Marchetti, consultant paediatrician
Marzia Lazzerini, specialist registrar in paediatrics Giorgio Longo, consultant paediatrician Clinica Pediatrica, IRCCS Burlo Garofolo, Università di Trieste, Via dell'Istria 65/1, 34100 Trieste, Italy Competing interests: None declared 1.Van Staaij BK, van den Akker, EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AGM. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. BMJ 2004;329:651-0 2.McKerrow W. Recurrent Tonsillitis. In: Clinical Evidence 7, June 2002, pp477-80. London: BMJ Publishing Group, 2002 3.Paradise J, Bluestone C, Colborn D, Bernard B, Rockette H, Kurs-Lasky M. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Pediatrics 2002;110:7-15 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(5):371-8. 5.Italian Ministry of Health, National Institute of Health, Agency of Public Health Lazio Region, LINCO Project. The clinical and organisational appropriateness of tonsillectomy and adenoidectomy http://www.pnlg.it/LG/007tonsille/tonsillectomy.pdf Competing interests: None declared |
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PJ Robb, Consultant ENT Surgeon Epsom & St Helier University Hospitals NHS Trust Epsom KT18 7EG
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The well presented paper by van Staaij et al highlights the need for clincians to carefully consider the effectiveness of surgical intervention in children with mild symptoms of adenotonsillar disease. In the abridged article, however, the very important information regarding intervention rates is ommitted. In England, the intervention rate is approximately 50% of the rate in the Netherlands. Interestingly, the rate in Northern Ireland approximates the very high Dutch rate of surgical intervention. For the UK readership of the hard copy, this vital information is missing, and the Dutch practice, may incorrectly be preceived as current practice in England. Many ENT surgeons, GP's and paediatricians use guidelines such as those from SIGN, (Scottish Intercollegiate Guidelines Network), to inform decision making when discussing with parents surgical treatment versus watchful waiting. It is also disappointing that adenotonsillectomy has been considered as a single intervention: for many years, in the UK, these have been considered operations for different indications, that are however, sometimes indicated together in the same age group. The more interesting and important question is surely why there is such variation in surgical rates in different parts of the UK and in the Netherlands in comaprison to the rest of Europe? Competing interests: None declared |
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Ram P Moorthy, Specialist Registrar in ENT New Cross Hospital, Wolverhampton, WV10, Hassan Khan
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Sir, We read with interest the large study by van Staaij BK et al (1) and the commentary by Little P (2). This large open, multi-centre randomised controlled trial was carried out in the Netherlands. The paper states that all the patients randomised had been send and assessed as appropriate according to current medical practice. The paper itself makes no mention of the fact that these practices vary from country to country. In the UK most ENT departments would use the SIGN guidelines (3), which acknowledge that there is a paucity of high quality evidence fro surgical intervention. Following the SIGN guidelines, however, would mean that many of the children in the randomised group would have been placed on a “watch and wait” policy. This would appear to have been confirmed by the 34% in the watchful waiting group who underwent adenotonsillectomy. Tonsillectomy itself is of benefit in preventing sore throats due to tonsillitis. Recurrent upper respiratory, infection, the commonest cause of a fever in that age group, is not an indication for adenoidectomy and therefore we are unsure as to how much information is added by the primary outcome of a fever alone. We agree with the authors that watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy is appropriate. 1. Van Staaij BK, Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. BMJ 2004; 329: 651-654 2. Little P. Commentary: Watchful waiting is useful for children with recurrent throat infections. BMJ 2004; 329: 654 3. Scottish Intercollegiate Guidelines Network. 1999. www.sign.ac.uk Competing interests: None declared |
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Janet A Wilson, Prof Otolaryngology Head and Neck Surgery, University of Newcastle Dept of Otolaryngology, Freeman Hospital, Newcastle upon Tyne NE7 7DN
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Anne Schilder and her Dutch colleagues are to be congratulated on the successful completion of what remains a rare clinical research achievement - an randomised controlled trial of surgical intervention. In the UK, the Health Technology Assessment funded NESSTAC study (North-East England and Scotland Study of Tonsillectomy and Adenotonsillectomy in Childhood) is well under way, and now recruiting in five sites: Newcastle upon Tyne, Liverpool, Manchester, Bradford and Glasgow. As lead clinical investigator, I am encouraged by the Dutch findings that we are addressing a worthwhile question on the cost- effectiveness of what remains one of the commonest inpatient surgical procedures in childhood. The UK tonsil and adenoid practice is undoubtedly different from that in the Netherlands. The NESSTAC study reflects these differences, with an inclusion age range from four to 15 years of age. The Dutch study recruited children aged 2 to 8 years: in the UK, tonsillectomy for reasons other than obstructive symptoms is very uncommon under that age of 4 years. The NESSTAC entry threshold is 4 attacks in two consecutive years, or more than 6 in one year - it is not surprising, therefore to a UK otolaryngologist that surgery confers little benefit in children with two or fewer sore throats preoperatively. Finally, adenoidectomy is performed in most UK centres for separate indications - such as severe nasal block, not merely as an adjunct to tonsillectomy in the management of recurrent sore throat. Thus, while it is encouraging that the Dutch group have successfully completed a surgical trial in childhood, the results of the NESSTAC study will address a different population of children and deliver results across a broad range of clinical, health related quality of life and socioeconomic domains. Competing interests: None declared |
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Narendra Babu Koyyalamudi, Locum Consultant ENT surgeon Tyrone County Hospital,Omagh,BT790AP
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At present adenotonsillectomy is not carried out if children are having mild symptoms unless there is some other general condition warranting tonsillectomy. It has been the practice for many decades. I am surprised that adenotonsillectomy is carried out for mild symptoms. How can this be justified? Is it ethical?I do not see any benefit in carrying out the above study. I feel the energy and resources could have been used towards a useful study. I am surprised that this has been accepted for publication. Competing interests: None declared |
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Velayutham Sankar, Doctor Royal Bolton Hospital,Bolton, BL4 0JR, Velayutham Sankar
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Rapid response Effectiveness of adenotonsillectomy in Children(1) opens up more discussion. It reiterates the Paradise criteria(2) for tonsillectomy. Currently the guidelines vary in different units for listing the patients for tonsillectomy regarding the frequency of tonsillitis and adenotonsillectomy may be undertaken for less number of attacks. The study also shows that there was no difference between the surgical vs conservative management after 6 months upto 24 months. The fact that sleep and eating patterns initially improved but no difference after 24 months calls for the need for a multicentered randomised trial to be undertaken. The study could have included throat swab being taken while child is having fever to differentiate between viral and bacterial tonsillitis or any other upper respiratory tract infection. This may help to reduce unwanted antibiotics usage in the community for presumed tonsillitis. It also opens up further questions regarding the indications of tonsillectomy and perhaps whether some children are exposed to unnecseeary surgery and complications from it in some parts of the world where the indications are not rigidly adhered to. There is a limitation in the current study as about 50 children out of 149 (3) allocated for watchful waiting group underwent adenotonsillectomy also need to be taken into account while interpreting the results. References 1.Birgit K van staaji,emma H Van den Akker, Maroeska M Rovers, Gerrit Jan Hordijk, arno W Hoes, Anne G M Schilder. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsilar hypertrophy: open, randomised controlled trial.Bmj 2004:329;651-654. 2.ParadiseJ, Bluestone C, Bachman R etal-Efficacy of tonsillectomy for recurrent throat infection in severely affected children:results of parallel randomised and nonrandomised control trials.N Eng J Med 1984:310:674-83. 3.Little P.Commentary: Watchful waiting is useful for children with recurrent throat infection.BMJ 2004:329: 654. Competing interests: None declared |
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Isam RUSTOM, Senior SHO in Otolarayngology York Hospital YO31 8HE
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It is very interesting to have a randomised controlled trial of this number of participants with a surgical intervention. The study added no benefit to E.N.T. practice in the UK. The common practice in the UK decided on the criteria for Tonsillectomy and Adenoidectomy years ago. The methodology of this study raises some questions. It is not clear how the randomisation has been conducted?. Was there any definition for adenotonsillar hypertrophy which was the question of the study?. Having a recorded stored data in a thermometer is unique for this study, but is it valid and specific for throat infection or tonsillitis in an eight year old child? The study conducted the results depending on questionnaires. How reliable are these questionnaires? Do they really reflect on the child’s health? This study needs to answer many questions before it can be considered a transformer of our practice. Competing interests: None declared |
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