The following are recommended as indications for consideration of tonsillectomy for recurrent acute sore throat in both children and adults:

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1 DOI: / X Tonsillectomy: an exceptional treatment? N Kara StR in Otolaryngology A Lawley SHO in Otolaryngology V Veer StR in Otolaryngology S Carrie Consultant Otolaryngologist Newcastle upon Tyne Hospitals NHS Foundation Trust Tonsillectomy is a well established procedure in ear, nose and throat (ENT) practice, with around 46,000 of these being performed in England alone in It is most commonly indicated for the treatment of recurrent acute tonsillitis and is often an operation that is performed by junior trainees as it allows for the development of basic surgical skills that are required to progress as an ENT surgeon. While the decision to operate has always been based on a balance of benefits and risks, more recently the indications and effectiveness of tonsillectomy have been called into question. Ann R Coll Surg Engl (Suppl) 2015; 95: XX XX The Scottish Intercollegiate Guidelines Network (SIGN) guidance with regards to tonsillectomy has been available for many years. 2 This has become a gold standard reference that many clinicians cite when considering a patient for tonsillectomy. The SIGN guidelines state: The following are recommended as indications for consideration of tonsillectomy for recurrent acute sore throat in both children and adults: > > sore throats are due to acute tonsillitis > > the episodes of sore throat are disabling and prevent normal functioning > > seven or more well documented, clinically significant, adequately treated sore throats in the preceding year or > > five or more such episodes in each of the preceding two years or > > three or more such episodes in each of the preceding three years. 2 In the wake of ongoing healthcare reforms and current fiscal austerity measures, primary care trusts (PCTs) have been set the task to identify and implement efficiency savings. In 2006 Croydon PCT presented a list of 34 procedures that it believed were of limited clinical value. When analysed further, the London Health Observatory found that this economic exercise had the potential of generating an annual saving of million if applied to the whole of London alone. The Croydon list has been adopted by an increasing number of PCTs across the NHS and many services have been subject to re-evaluation. Controversially, the driving force behind this is based on economic analyses of potential cost savings rather than on a robust review of clinical evidence. This list includes grommet insertion and tonsillectomy. ENT surgeons have been faced with the task of reappraising 40,000 operations a year that, on paper, have limited clinical evidence. There has been much discussion regarding the evidence base and clinical effectiveness of tonsillectomy, which has been earmarked by many as a non-essential procedure. Consequently, many PCTs have developed regulations surrounding this procedure, only agreeing to fund them if they comply with the agreed criteria. NHS North of Tyne is a commissioning consortium, created to represent three neighbouring primary care organisations. Its remit being to strengthen commissioning and financial management arrangements, it developed an individual exceptional treatment (IET) request policy in (most recently revised in 2012), which sets out their stance on a number of procedures and criteria that must be fulfilled in order to justify the procedure. Regarding tonsillectomy, it differs considerably from the SIGN guidelines. It states: There is no high quality evidence in adults for the effectiveness of tonsillectomy. Any benefits from tonsillectomy may be outweighed by the morbidity associated with surgery in children who are not severely affected by tonsillitis Insufficient evidence of clinical effectiveness of tonsillectomy indicates that it may only be funded in accordance with the guidance specified Patients (both adult* and children) should meet all of the following criteria for consideration of tonsillectomy: 1

2 1. sore throats are due to tonsillitis; 2. five or more episodes of sore throat per year; 3. symptoms for at least a year; 4. the episodes of sore throat are disabling and prevent normal functioning. Figure 1 Presence of documentation indicating diagnosis of tonsillitis and severity of symptoms *Consensus statement (NSAG ENT surgeons): a fixed numerical number of attacks may not be appropriate for adults with particularly severe episodes [of] tonsillitis causing severe morbidity. So that particular criterion (No. 2) should not apply to adults. 3 Our aim was to retrospectively review the patients who underwent tonsillectomies in the ENT department at Freeman Hospital in Newcastle and assess their suitability in accordance with the IET criteria, to feed back this information to the ENT department with a view to ensuring all clinicians were aware of the new policies and the criteria required to be fulfilled, and to re-evaluate our practice by reviewing patients who were subsequently listed for tonsillectomy. Methods All patients who underwent a tonsillectomy during September 2010 were identified. Their referral letters, case notes and clinic letters were examined, and patients who underwent the procedure for a reason other than recurrent tonsillitis/sore throats were excluded from the study. The cases were assessed with regards to adherence to both SIGN and IET criteria. An assessment was also made of the relevant documentation. The results were disseminated by and presented at our departmental clinical governance meeting. The importance of adhering to the guidelines was emphasised as well as documenting the relevant criteria in detail. This dissemination of information formed the basis of the audit s intervention, comparing the cases to both SIGN and IET guidelines, and using the latter as the gold standard. A further cohort of patients was then selected. This consisted of patients who were listed following the dissemination and who underwent a tonsillectomy between April and May The same exclusion criteria were applied and the same data were collated for this group. Both groups were compared, looking for a change in practice and an increased adherence to the guidelines. This study was registered with the clinical governance department and ethical approval was not deemed necessary. Results During the first cycle, a total of 45 tonsillectomy procedures were performed. Ten of these were immediately excluded as they were performed for reasons other than recurrent tonsillitis (sleep apnoea/ breathing difficulties: n=9, recurrent peritonsillar abscess: n=1). The age range was 3 56 years, with a mean and median of 21 years. Eleven patients (31%) were aged 16 years or younger. A total of 37 tonsillectomy procedures were performed in the second cycle. Similar to the first cohort, ten of these were excluded from the study (sleep apnoea: n=3, dysphagia: n=1, recurrent peritonsillar abscess: n=5, suspected malignancy: n=1). The age range was 3 26 years, with a mean and median of 13 years. Seventeen patients (63%) were aged 16 years or younger. On reviewing the patient notes and letters, the term tonsillitis was documented in 91% of cases (32/35) in the initial cohort and this increased to 100% for the second cohort (Fig 1). The guidelines state that the symptoms should be disabling, preventing normal functioning, and the presence of documented evidence supporting this was also noted. The presence of the term disabling or similar increased from 60% (21/35) in the first round to 82% (22/27) in the second round (Figure 1). Using the SIGN guidelines, 66% of cases met the recommended annual recurrence rate, 11% fell below and 23% of patients had inadequate documentation to determine this. These figures improved considerably and in the second round, 89% had documentation of a recurrence rate comparable with the criteria while only 4% fell below and only 7% lacked adequate documentation (Figure 2). Nevertheless, although the new local guidelines bear some resemblance to those of SIGN, there are some important differences and the data were therefore also analysed to compare both groups with these criteria. IET criteria 2 and 3 define the recurrence rate and required symptom duration for listing for a tonsillectomy. However, it is noted that using a fixed number of attacks may not be appropriate in adults with severe functional impairment resulting from their symptoms. For the purposes of this audit, patients under 16 years of age were determined to have met these criteria if they had experienced the requisite number of recurrences over a period of at least 12 months. Patients aged over 16 were determined to have met these criteria if they had symptoms for at least 12 months alongside the required recurrence rate or clearly documented evidence of disabling symptoms. On comparison with IET guidelines on frequency/severity, 80% met the required criteria, 6% did not and 14% lacked the 2

3 Figure 2 Criteria for frequency as per Scottish Intercollegiate Guidelines Network 2 less of a marked improvement in those less affected. The Cochrane review also commented that there was no evidence from randomised controlled trials (RCTs) to guide clinicians in their decision making process. 11 This was conducted in 2009 and since then, a large RCT has been published. 12 However, despite its findings, its limitations suggest it is unlikely to alter the current review. It demonstrates both clinical benefits and improvements in quality of life scores, which tend to be more marked in the second year following the procedure. appropriate documentation to determine this. Again, there was an improvement and in the second round, 89% met the required criteria while only 4% fell below and only 7% lacked adequate documentation (Fig 3). It was also noted that while 9% (3/35) of documentation in the first round made specific reference to criteria and guidelines, this increased to 37% (10/27) in the second round. Discussion The tonsillectomy procedure has a rich history with the first reports of this procedure being performed dating back to Hindu medicine around 3,000 years ago. Celsus (AD10) gave the first clear description of the operation, which involved a finger dissection followed by scalpel separation if this was not possible. 4 While ancient indications were somewhat varied, the common current indications include recurrent acute tonsillitis, peritonsillar abscess, obstructive sleep apnoea, snoring, dysphagia and suspected malignancy. In the 1930s as many as 200,000 tonsillectomies were being performed annually in the UK. 5 This has seen a steady decline to around quarter of that figure in recent years. 1 To a large extent, this is a result of the introduction of penicillin, prior to which tonsillectomy was frequently performed prophylactically to prevent post-streptococcal complications such as rheumatic fever and glomerulonephritis. However, evidence in favour of the procedure was considered scanty and its necessity was being questioned constantly. This viewpoint was best summed up by the Medical Research Council, who described the procedure as a routine prophylactic ritual for no particular reason and with no particular result. 5 As with any surgical intervention, there should exist a robust scientific evidence base supporting a role for surgery in the management of the condition, and the benefits of the procedure must clearly outweigh the potential risks and complications that the procedure poses. Obstructive sleep apnoea is part of the sleep disordered breathing spectrum and affects % of children. 6 In addition to the short-term effects of sleep deprivation, it can result in longterm sequelae including neurobehavioural and cardiorespiratory consequences. In conjunction with adenoidectomy, tonsillectomy is the most commonly performed intervention for children with sleep apnoea. 7 It is considered an acceptable and recognised treatment for children with clinical features suggestive of obstructive sleep apnoea, 7 and has been shown to result in an improvement in symptoms and quality of life in children with sleep disordered breathing (regardless of a definitive diagnosis of sleep apnoea). 8,9 With regard to tonsillectomy for recurrent tonsillitis, the evidence does depict a statistically significant improvement in symptoms in those patients who are severely affected 10,11 but Severe unremitting recurrent tonsillitis that disables a patient s life is a clear indication for tonsillectomy if this situation were to continue indefinitely. Nevertheless, the reality is that while some patients may have a year or two of severe recurring episodes that then burn out, 13,14 others will continue to have lifelong problems. This seemingly random natural history is the main impasse when deciding whether tonsillectomy is warranted in these patients. It has caused immense controversy as measuring the effectiveness of such a treatment is almost impossible. This has led to attempts at producing guidelines to assist in selecting those patients who are likely to benefit from a tonsillectomy. In 1983 Paradise et al defined recurrent tonsillitis warranting surgery by the attack frequency standard as [s]even or more in a year, five or more per year for two years, or three or more per year for three years. 15 The 2000 guidelines of the American Academy of Otolaryngology Head and Neck Surgery stated intriguingly that tonsillectomy is indicated if a patient contracts three or more attacks of sore throat per year despite adequate medical therapy. 16 However, its more recently published clinical practice guidelines on tonsillectomy in children 17 bear more of a resemblance to the original criteria of Paradise et al. 15 Similar criteria have been adopted by SIGN, who first published its guidelines relating to the management of sore throats and indications for tonsillectomy in 1999, revised and published again in April Acknowledging that there is a lack of good quality clinical studies, the SIGN guidelines are based only on level 4 evidence. Nevertheless, are the guidelines followed by most UK practising 3

4 ENT surgeons? It is therefore interesting to note that on comparison of statistics from all the local authority areas in England (n=380), there is up to a sevenfold unexplained variation in tonsillectomy rates across the geographical regions. 18 Figure 3 Criteria for frequency/severity as per individual exceptional treatment guidelines 3 As a result of Department of Health initiatives, recent changes in healthcare commissioning have brought about significant changes and this has occurred on a national scale in England. Our PCT has devised the IET policy 3 and many trusts throughout the country have devised similar documentation. Available to view online by conducting a simple internet search, these can vary considerably to each other in their content, all being very individual to that specific trust. Sadly, we now appear to be lacking a national consensus guideline, resulting in a contentious postcode lottery situation. In addition, it appears that these are not so much guidelines as a list of prerequisites. While the wording in each document varies somewhat, the message is consistent that patients must fulfil all the criteria in order to qualify for funding for a tonsillectomy. In the current financial climate where specialist services are under constant scrutiny from the fund holders, it is important that we are not only seen to be providing value for money but also to be acting in accordance with agreed guidelines and protocols. Despite this, there is evidence to suggest that even when local guidelines are in place, surgeons may have a tendency to break guidelines more often in favour of performing rather than withholding surgery. 19 It is important to note, of course, that this caveat only applies to recurrent tonsillitis and not to any of the other indications for tonsillectomy. That decision is still left to the clinical discretion of the surgeon who assesses the patient. Nevertheless, the main dilemma clinicians face is in making the actual diagnosis of tonsillitis. Most patients will present directly to their GP, who will have the benefit of examining them in order to make the diagnosis before treating them accordingly. They will have a record of the frequency of attendance and how often it was managed as tonsillitis (or not). When the patient attends the ENT outpatient clinic, clinicians are faced with a clinically well patient, and have to make management decisions based only on the patient history and the referral letter. This can be a difficult decision to make, with evidence suggesting that seemingly impressive histories may not truly represent the real clinical picture and undocumented histories should be regarded with caution. 20 Additionally, it is suggested that patients whose episodes are less severe or who lack good documentation pertaining to the episodes do not gain sufficient benefit from the procedure. 21 Evidence supports that parental opinions also play an important role in the incidence of tonsillectomy, with many parents exhibiting strong preferences for the surgical management of their symptoms and a willingness to pay for the procedure if necessary. 12,22 Often there will be a family history of tonsillitis, the parents or older siblings having had a tonsillectomy. Tonsillitis also carries a significant economic burden. In the UK, it is responsible for 35 million days lost every year from school or work and 60 million are spent annually on GP consultations for sore throats. 23 Analysis of an RCT published in 2012 suggests that once patients meet the criteria over a twoyear period, then early intervention with a tonsillectomy can save around eight sore throats per year ( 261 per sore throat). 24 A Belgian study calculated that the economic impact of lost productivity relating to a tonsillectomy procedure was less than that resulting from an episode of acute tonsillitis and the general costs associated with the procedure were offset by just over three acute episodes. 25 The results from our study confirm that in the majority of cases, the decision to offer a tonsillectomy for recurrent tonsillitis is appropriate within the local guidance and, given certain current opinion on tonsillectomies, 26 it is a reassuring finding indeed. In the remaining cases, however, the documentation to substantiate this is lacking. Simple communication to the department and raising awareness of the new guidelines were all that were needed to increase our compliance dramatically. Other ways of improving documentation could be used, such as a standardised checklist or proforma, and this has been adopted by many practices as part of a standardised referral letter for consideration for a tonsillectomy. In the current financial climate of healthcare commissioning, specialist services are required to provide their specialist input and management but, for a large part, to only act within the agreed guidance although it is difficult to prove that this has been adhered to without a high standard of accurate and appropriate documentation. Being under constant scrutiny from the fund holders, it is important that we are not only seen to be providing value for money 4

5 but also to be acting in accordance with agreed guidelines and protocols. As the service purchasers, commissioners often undertake clinical notes audits to sanction payments and have the ability to withdraw payment if they are not satisfied. Providers should bear this in mind as it may only be a matter of time before they are required to defend their actions retrospectively. Conclusions Medicine is an art that is built on the science of evidence and this is the principle that ensures good medical practice. It is important to review practice constantly in light of emerging evidence to ensure that we provide patients with the best possible care. However, to withhold effective treatment from patients purely due to financial constraints is inherently contradictory to our deeply ingrained ethos. Appropriate documentation is paramount as it not only provides an accurate timeline and history of recurring illnesses but also acts as evidence to back up clinical decisions. This holds true both for GPs and specialists. If PCTs are only willing to fund procedures that adhere to specific criteria, then it should be ensured that patients who meet these criteria have it documented clearly in their notes and that decisions to operate are visibly based on this. Specialists should be aware that the absence of this would only lead to contention over the relevant funding. Regardless of how individuals feel about this practice, significant changes are occurring in how healthcare is commissioned, and in order to remain a clinically effective and financially viable service, we need to adapt our practice accordingly. References 1. Main Procedures and Interventions: 3 Character. Hospital Episode Statistics. uk/ease/servlet/contentserver?siteid=1937&category ID=205 (cited October 2012). 2. Scottish Intercollegiate Guidelines Network. Management of Sore Throat and Indications for Tonsillectomy. Edinburgh: SIGN; NHS North of Tyne. Policy No: NoT MD04 Individual Exceptional Treatment Requests Version 3. Newcastle: NHS North of Tyne; McNeill RA. A history of tonsillectomy: two millenia of trauma, haemorrhage and controversy. Ulster Med J 1960; 29: Glover JA. The incidence of tonsillectomy in school children. Proc R Soc Med 1938; 31: 1, Powell S, Kubba H, O Brien C, Tremlett M. Paediatric obstructive sleep apnoea. BMJ 2010; 340: c Robb PJ, Bew S, Kubba H et al. Tonsillectomy and adenoidectomy in children with sleep related breathing disorders: consensus statement of a UK multidisciplinary working party. Clin Otolaryngol 2009; 34: Avior G, Fishman G, Leor A et al. The effect of tonsillectomy and adenoidectomy on inattention and impulsivity as measured by the Test of Variables of Attention (TOVA) in children with obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg 2004; 131: Owens J, Opipari L, Nobile C, Spirito A. Sleep and daytime behavior in children with obstructive sleep apnea and behavioral sleep disorders. Pediatrics 1998; 102: 1, Van Staaij BK, van den Akker EH, Rovers MM et al. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. BMJ 2004; 329: Burton MJ, Glasziou PP. Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis. Cochrane Database Syst Rev 2009; 1: CD Lock C, Wilson J, Steen N et al. North of England and Scotland Study of Tonsillectomy and Adenotonsillectomy in Children (NESSTAC): a pragmatic randomised controlled trial with a parallel nonrandomised preference study. Health Technol Assess 2010; 14: Woolford TJ, Ahmed A, Willatt DJ, Rothera MP. Spontaneous resolution of tonsillitis in children on the waiting list for tonsillectomy. Clin Otolaryngol Allied Sci 2000; 25: Prim MP, de Diego JI, Larrauri M et al. Spontaneous resolution of recurrent tonsillitis in pediatric patients on the surgical waiting list. Int J Pediatr Otorhinolaryngol 2002; 65: Paradise JL, Bluestone CD, Bachman RZ et al. Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials. N Engl J Med 1984; 310: American Academy of Otolaryngology Head and Neck Surgery. Clinical Indicators: Tonsillectomy, Adenoidectomy, Adenotonillectomy. Alexandria, VA: AAO HNS; Baugh RF, Archer SM, Mitchell RB et al. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg 2011; 144: S1 S Suleman M, Clark MP, Goldacre M, Burton M. Exploring the variation in paediatric tonsillectomy rates between English regions: a 5-year NHS and independent sector data analysis. Clin Otolaryngol 2010; 35: Donaldson L, Hayes JH, Barton AG, Howel D. The Development and Evaluation of Best Practice Guidelines: Tonsillectomy with or without Adenoidectomy. Report to the Department of Health. Newcastle: University of Newcastle upon Tyne; Paradise JL, Bluestone CD, Bachman RZ et al. History of recurrent sore throat as an indication for tonsillectomy. Predictive limitations of histories that are undocumented. N Engl J Med 1978; 298: Paradise JL, Bluestone CD, Colborn DK et al. Tonsillectomy and adenotonsillectomy for recurrent throat infection in moderately affected children. Pediatrics 2002; 110: Fried D. On tonsillectomy: mom s personal experience. Lancet 1995; 346: ENT UK. Indications for Tonsillectomy Position Paper, ENT UK London: ENT UK; Wilson JA, Steen IN, Lock CA et al. Tonsillectomy: a cost-effective option for childhood sore throat? Further analysis of a randomized controlled trial. Otolaryngol Head Neck Surg 2012; 146: Hox V, Schrooten W, Indesteege F et al. Cost-effectiveness of childhood tonsillectomy compared to watchful waiting: impact of economic productivity loss caused by parents work absenteeism. Presented at: Meeting of the Royal Belgian Society for ENT and Head and Neck Surgery; March 2010; Brussels. 26. Spence D. Bad medicine: paediatric ear, nose, and throat surgery. BMJ 2010; 341: c