Open Access Research article

Effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy

Giovanni Motta, Sergio Motta, Pasquale Cassano, Salvatore Conticello, Massimo Ferretti, Bruno Galletti, Aldo Garozzo, Gennaro Larotonda, Nicola Mansi, Emilio Mevio, Gaetano Motta, Giuseppe Quaremba, Agostino Serra, Vincenzo Tarantino, Paolo Tavormina, Claudio Vicini, Maurizio Giovanni Vigili and Domenico Testa*

BMC Ear, Nose and Throat Disorders 2013, 13:1  doi:10.1186/1472-6815-13-1

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Guidelines: Tutelage of professional duties or of economic interests? An accurate revision of the guidelines requires fair criticism ( Motta G, Motta S, Testa D).

Domenico Testa   (2013-07-19 17:35)  University of Naples

We find it stimulating to answer the questions raised in the comment to our article (1) by some of the authors of the Italian guidelines, even because they recognize the need to revise the recommendations in their guidelines and constructively criticized by us in previous work (1-5). We will try to analytically evaluate their objections in order to improve the knowledge of issues of great importance from a clinical point of view.
1. As we stated in the paper, we first asked to what extent the guidelines were accepted by the specialists directly involved in the research. We understand the disappointment of the members of the Italian guidelines committee for the low degree of compliance with their recommendations, relative to the indications for intervention of (adeno) tonsillectomy, by the institutions enrolled in the study. In the survey we analytically explained the reasons for this. Briefly - though we encourage involved parties to fully read our contribution- it is likely that these recommendations have not been taken into account (or have been only modestly) as they are poorly adapted to clinical reality; in fact, the indication for (adeno) tonsillectomy, is generally based on the simultaneous presence of several clinical manifestations related to adeno-tonsillar disease, that is on a "comorbidity", and not on the incidence of a single symptom (as proposed in the guidelines).
We are well aware of the documents produced by the PNLG and SNLG and there is no need here to recall their inaccuracies and errors (2-5). It is enough to say that the reduction of tonsillectomies registered in Italy, to which the authors have referred to in their comment, a) refers to the same year of the publication of the first document (PNLG; April 2003), b) follows a decrease of 2002 and 3) precedes a further increase in 2004. Given these time references, it is really difficult to say, as our objectors instead do, that the reduction in the rate of tonsillectomy in 2003 is a sign of the impact of document PNLG "on a national level"!
It is superfluous to add that a reduction in the rate of tonsillectomy may be the result of several factors, first of all considering the improved socio-medical conditions of our country (regardless of latitude) as well as changes in the economic policy of the Italian national health system. These factors, totally independent from the recommendations of the guidelines, presumably have led to a downward trend in the rate of (adeno)-tonsillectomy over time, even before the publication of the 2003 document (PNLG) and, of course, of that of 2008 (SNLG)! Statistics on indexes that are projected on a larger time scale (8 years, 2003-2010) can hardly be related to a single factor (in our case to LG). Typically, this type of analysis should be conducted with multi-factorial techniques that take into account also latent factors (eg., improvement of hygienic and social conditions, changes in lifestyle, introduction of preventive treatments, etc.). Our investigation did not intend to provide representative data of an entire nation but, as made clear in the paper, it has tried to define the degree of acceptance of the recommendations included in guidelines by the specialists involved in the investigation, analyzing the causes of their possible refusal (not due to prejudices but to specific clinical factors).
The details, in terms of number of cases for each institution involved in the study, is known nationally and we strongly hope that this data is acknowledged by the members of the committee of guidelines. Contrarily, they can learn more about it in "Argomenti" , published by the Italian Society of Otolaryngology (5).
We do not believe that the reporting of a "particular type of bias" related to the name (i.e. last name) of some of the authors involved in the study deserves an answer, because - as far as the authors of the paper know - that bias is not contemplated scientifically (see also: Hartman JM, Forsen JW Jr, Wallace MS, Neely JG. Tutorials in clinical research: part IV: Recognizing and controlling bias. Laryngoscope 2002;112:23-31)!
6. The members of the committee who are signatories of the comment have unfortunately misinterpreted the sources mentioned by them, and this is particularly serious if we consider that this misrepresentation has concerned President Obama! The note of the President quoted by the committee, clearly addressing health and socio-economic problems of the United States of America, resulted in the rapid position taken by the American Academy of Otolaryngology, as reported in the article of the "Wall Street Journal "dated 26 July 2009,which suggested that; "in many cases tonsillectomy may be a more effective treatment, and less costly, than prolonged or repeated treatments for an infected throat.
7 Our survey is only in part dedicated to the problem of the reduction in the rate of surgical tonsillectomy in Italy. It is mainly aimed to analyze the problem of the correct surgical indications for this intervention. The authors of the commentary write that "there was a reduced variability of regional standardized rates, probably due to a decrease of inappropriate tonsillectomies mostly occurring in Northern Italy". If it is true that in northern Italy the recourse to (adeno)-tonsillectomy is "around five times higher than in Southern Italy", the reason for their criticism on the selection of institutes participating in our survey is incomprehensible (Most of the ENT Departments participating to the study are located in Southern Italy). Such recruitment indeed should have favourably contributed to confirm the data reported by the authors of the guidelines on the steady reduction of cases treated with tonsillectomy! However, we wish to point out that the only publication concerning the impact of the Italian guidelines (apart from the publications edited by the committee or by some of its members and quoted in the comment) has been published by this journal (6), mentioned in our paper and referring to a region of Northern Italy (Veneto region)! Region where, according to the committee of the Italian guidelines, "the most remarkable reduction of the rates ... after the publication of the Italian guidelines" would have taken place; thus, opposed to what was demonstrated in the research of Fedeli et al. (6) where there has been a rate stability in the interventions of adeno-tonsillectomy in the period between 2003 and 2006 (i.e. after the publication of the Italian Guidelines).
8. We partially agree with the comment of the committee: there are some ENT specialists and health professionals who are not inclined to scientific dialogue, (when it focuses on the correct clinical indications for adeno-tonsillectomy), perhaps because prejudicially unfavourable to the adoption of such surgery! We are not resistant to the guidelines as a matter of principle, but we believe that in order to revise and improve these documents, authors should learn from fair criticisms and not object to any scientific contradictory if not in line with their own personal beliefs!
9. Still, on a strictly scientific ground, we would like to properly quote some pioneering researches, as those published by Wennberg and Gittelsohn in 1973 (7), insensitive to the fashions and proving that not all deriving from the old times must necessarily be considered outdated. They suggest, even in a specialized ENT field (8) that purely economic reasons can influence the choice of medical activities. Shifting this concept to the present (or does someone want to restore the old times?), in which financial resources have been severely reduced - even for advanced health systems - the recommendations made in some guidelines seem to aim to the simple economic rationing of medical procedures, rather than to the rationalization of these procedures based on the principle of a better quality of care and a greater professional tutelage of the ENT specialist.

1) Motta G, Motta S, Cassano P, et al. Effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy. BMC Ear, Nose and Throat Disorders 2013; 13: 1.
2) Motta, G., Esposito, E., Motta, S., Mansi, N., Cappello, V., Cassiano, B., Motta Jr., G. The treatment of acute recurrent pharyngotonsillitis. Acta otorhinolaryngol ital 2006; 26 (suppl. 84): 3-27.
3) Motta, G., Esposito, E., Motta, S., Mansi, N., Cappello, V., Cassiano, B., Motta Jr., G. Acute recurrent pharyngotonsillitis and otitis media. Acta otorhinolaryngol ital 2006; 26 (suppl. 84): 5-29.
4) Motta G, Esposito E, Motta S, Mansi N, Cappello V, Cassiano B, Motta G. Surgical treatment of acute recurrent throat infections in children. Auris Nasus Larynx 2011; 3: 356-61.
5) Motta G, Motta S, Cassano P, et al. A multi-centric study on guidelines and (adeno-)tonsillectomy. Argomenti Acta Otorhinolaryngologica Italica 2011; 5: 1-32.
6) Fedeli U, Marchesan M, Avossa F, Zambon F, Andretta M, Baussano I, Spolaore P. Variability of adenoidectomy/tonsillectomy rates among children of the Veneto Region, Italy. BMC Health Serv Res 2009,9:25.
7) Wennberg J, Gittelsohn A. Small area variations in health care delivery. Science 1973;14:1102-8.
8) Wennberg JE, Blowers L, Parker R, Gittelsohn A. Changes in tonsillectomy rates associated with feedback and review. AM.Pediatrics. 1977;59:821-6.

Competing interests

The authors have no competing interests.

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Impact of national guidelines on tonsillectomy in Italy

Enrico Materia   (2013-07-16 10:11)  Italian National System for Guidelines (SNLG) email

Impact of the Italian guidelines on tonsillectomy

Sir,
On behalf of the panel that developed the Italian guidelines on tonsillectomy and adenoidectomy 1,2, we would like to provide some comments to the paper recently published by Motta et al. on BMC Ear, Nose and Throat Disorders 3.
The Italian guidelines that are criticized by Motta et al, were drafted according to the standard methodology of Italian national program for guidelines (PNLG/SNLG) by a multidisciplinary panel. Although the panellists agree that some of the recommendations may deserve an update as they were formulated more than five years ago, the impact of the guidelines on the clinical practice in Italy was remarkable and supported by evidence.
The aim of the study of Motta et al. was to verify what influence the guidelines have had on clinical practice regarding (adeno)tonsillectomy in Italy 3 . Unfortunately, the sample of ENT Departments which produced the data analysed in the study is not representative at all of the national context. Therefore it is not possible to infer results of this study to a larger scale. In addition, contributions in terms of number of cases from individual Department is not reported, whereas more than one Author, not contributing to acquisition of data but only to conception, design and interpretation of data, has the same name of the principal one: this fact may represent a particular type of bias.
Most of the ENT Departments participating to the study are located in Southern Italy and only four are located in Northern Italy. As a matter of fact, in Northern Italy the rates of tonsillectomy and adenoidectomy are highest (around five times higher than in Southern Italy) 4 and right there the most remarkable reduction of the rates took place after the publication of the Italian guidelines.
We documented that the first document on the appropriateness of (adeno)tonsillectomy published in 2003 5,6 had a notable impact on surgery rates on a national level. The amount of hospitalization for tonsillectomy was stable around 60,000 interventions from 1998 until 2002, and it showed a sharp 16% decrease in 2003
the index year when the document was implemented evoking a wide resonance on the media. The tonsillectomy rates decreased from 10.5-10.9 per 10,000 in the period 1998-2002 to 9.1 in 2003 and 9.4 in 2004 5,6. In addition, there was a reduced variability of regional standardized rates, probably due to a decrease of inappropriate tonsillectomies mostly occurring in Northern Italy.
After the publication of the 2008 guideline, the rate of tonsillectomy in Italy reported by the Ministry of Health fell to 7.1 per 10,000 in 2010, representing a overall reduction of 30% compared to year 2002 7.
The acceptance of the guidelines was good among the medical community, as we could verify at several national ENT and Paediatrics symposia. Nevertheless, a few Italian ENT specialists and professionals appeared poorly keen to interdisciplinary dialogue and refractory to discuss the inappropriateness of tonsillectomy.
It is worthwhile to remember that the Italian guideline is quoted in the Clinical Practice Guideline on Tonsillectomy in Children of the American Academy for Otholaringology 8, where its recommendations are compared with the American as well as the SIGN guidelines.
As President Obama recently spoke out 9, guidelines are important to avoid unnecessary tonsillectomy: a procedure well known to be highly discretionary since when Wennberg and Gittelsohn pointed out it in a seminal paper four decades ago 8. Do Prof. Motta and his colleagues like to restore the old times?

Enrico Materia, MD, MsPH, ASL RMA, Rome, Italy.
Paola Marchisio, MD, Pediatric Clinic 1, Department of Pathophysiology and Transplantation, University of Milan and Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan, Italy.
Angelo Camaioni, MD, President Italian Society of Otorhinolaryngology; Department of Otorhinolaryngology, AO. S. Giovanni Addolorata, Rome, Italy.
Eugenio Pallestrini, MD, University of Genoa, Past Pesident of Italian Society of Pediatric Otorhinolaringology.
Luisa M. Bellussi MD, ChD, Honorary President of the Italian Society of Pediatric Otorhinolaryngology. Department of Human Pathology and Oncology, O.R.L. Division University of Siena, Italy



1. Programma Nazionale Linee Guida. The clinical and organisational appropriateness of tonsillectomy and adenoidectomy. Policy Document; 2003. www.pnlg.it
2. Sistema Nazionale Linee Guida. Appropriateness and safety of tonsillectomy and/or adenoidectomy. 2008. www.snlg-iss.it.
3. Motta G et al. effects of guidelines on adeno-tonsillar surgery on the clinical behaviour of otorhinolaryngologists in Italy. BMB Ear, Nose and Throat Disorders 2013; 131.
4. Materia E et al. Epidemiology of tonsillectomy and/or adenoidectomy in Italy. Med Surg Ped 2004; 26:179-186.
5. Materia E et al. Impatto del documento PNLG sugli interventi di adeno-tonsillectomia. Rapporto Osservasalute 2007; 510-4.
6. Materia E et al. Impact evaluation of guideline on tonsillectomy in Italy. Proceedings IV International Conference on Guidelines, Toronto 23-27 August 2007.
7. Ministero della Salute. Rapporto Annuale sullattivita di ricovero ospedaliero. Dati SDO 2010. Ottobre 2011.
8. R. Wald, et al. Clinical Practice Guideline: Tonsillectomy in Children. Otolaryngology - Head and Neck Surgery 2011; 144: S1.
9. Dr. Obama's Tonsillectomy. Do Americans want a federal board deciding if their kids need surgery? The Wall Street Journal, July 26, 2009. http://online.wsj.com/article/SB10001424052970204886304574308472181248330.htm
10. Wennberg J. Small Area Variations in Health Care Delivery. Science, 1973; 182: 1102-8.

Competing interests

The Authors have been members of the panel that developed the Italian national guidelines on tonsillectomy

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