International Journal of Pediatric Otorhinolaryngology 79 (2015) 1
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Editorial
One size does not fit all!
A recent article [1] entitled ‘‘The rising rate of admissions for tonsillitis and neck space abscesses in England, 1991–2011’’ demonstrates the unexpected and deleterious effects of policymaking based upon the assumption that certain randomized control studies, mainly the Paradise et al. report of 1984 [2] can be applied to the entire population. The Lau article concludes: ‘‘Efforts to reduce the tonsillectomy rate are correlated with a significant rise in emergency admissions. The rise in the retro and parapharyngeal abscess rate is perhaps most alarming given the very high mortality of these conditions. Bed day data suggest that no net saving has been made despite the new measures.’’ [1] Lau et al. [1] found that during the 20 year period the overall rate of tonsillectomy decreased by 44% at the same time the admission rate for tonsillitis rose 310% and the peritonsillar abscess admissions rose by 31%. Other data for a lesser time period 1996–2011 found tonsillectomy rate decreasing by 41% with an increase of 39% of admissions for retro and parapharyngeal abscess. There appear to be many more children with a severe infection which could have been prevented by undergoing a tonsillectomy. The criteria were proposed by Paradise et al. [2] in 1984 that eligibility for the tonsillectomy trials should depend on fulfilling four domains of criteria which include that there had to be a documented occurrences of tonsilar pharyngitis of seven or more episodes in the preceding year, five or more in each of the two preceding years, or three or more in each of the three preceding years. These conclusions were based upon the eligibility of 187 from a population of 2043. Of these 187 potential subjects, 97 rejected randomization and 91 accepted randomization. Thus the whole study is based upon 91 self-selected children – surely not a population in which one could look at results for differences in more defined groups. The limited number of subjects did not allow for identifying complications which occur over time and/or which are not frequent. Thus with this limited sample one would not pick up the infrequent yet serious complications, nor is the possibility of looking at what happened after the study period taken into account. The overarching problem is that intervention is recommended only after the child has undergone significant morbidity. In retrospect it would have made more sense if resources had been focused on determining who would get sick before they got sick. The Paradise study [2] became the adopted standard in whole or in part of many clinical guidelines throughout the world [3–6]. The Lau study [1] shows that the reduction in the operative
intervention, at least the United Kingdom, has resulted in an increase in morbidity which should have been avoided. The analysis [7] of randomized controlled studies examining tonsillar pharyngitis has shown that they have severe limitations and at best are only applicable to narrowly defined and highly circumscribed populations. They cannot be generalized to the entire patient population because of their very limited external validity. We are now in the era of personalized medicine [8] when the clinician must consider the intrinsic and extrinsic characteristics of all patients in relation to their illness. One size does not fit all! References [1] A.S. Lau, N.S. Upile, M.D. Wilkie, S.C. Leong, A.C. Swift, The rising rate of admissions for tonsillitis and neck space abscesses in England, 1991–2011, Ann. R. Coll. Surg. Engl. 96 (4) (2014) 307–310. [2] J.L. Paradise, C.D. Bluestone, R.Z. Bachman, D.K. Colborn, B.S. Bernard, F.H. Taylor, 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. 310 (11) (1984) 674–683. [3] R.F. Baugh, S.M. Archer, R.B. Mitchell, R.M. Rosenfeld, R. Amin, J.J. Burns, et al., Clinical practice guideline: tonsillectomy in children, Otolaryngol. Head Neck Surg. 144 (1 Suppl.) (2011) S1–S30. [4] E. Lescanne, B. Chiron, I. Constant, V. Couloigner, B. Fauroux, Y. Hassani, et al., Pediatric tonsillectomy: clinical practice guidelines, Eur. Ann. Otorhinolaryngol. Head Neck Dis. 129 (5) (2012) 264–271. [5] K.P. Oomen, V.K. Modi, M.G. Stewart, Evidence-based practice: pediatric tonsillectomy, Otolaryngol. Clin. North Am. 45 (5) (2012) 1071–1081. [6] H.P. Verschuur, C.J. Raats, C.J. Rosenbrand, Practice guideline: adenoid and tonsil disorders in secondary care, Ned. Tijdschr. Geneeskd. 153 (2009) pB295. [7] R.J. Ruben, Randomized controlled studies and the treatment of middle-ear effusions and tonsillar pharyngitis: how random are the studies and what are their limitations? Otolaryngol. Head Neck Surg. 139 (3) (2008) 333–339. [8] R.J. Ruben, Otitis media: the application of personalized medicine, Otolaryngol. Head Neck Surg. 145 (5) (2011) 707–712.
Robert Ruben MD, FAAP, FACS Department of Otolaryngology, Montefiore Medical Center, New York, USA E-mail address: [email protected] (R. Ruben). Available online 18 November 2014
http://dx.doi.org/10.1016/j.ijporl.2014.11.013 0165-5876/ß 2014 The Author. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-SA license (http://creativecommons.org/licenses/by-ncsa/3.0/).
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Editorial
One size does not fit all!
A recent article [1] entitled ‘‘The rising rate of admissions for tonsillitis and neck space abscesses in England, 1991–2011’’ demonstrates the unexpected and deleterious effects of policymaking based upon the assumption that certain randomized control studies, mainly the Paradise et al. report of 1984 [2] can be applied to the entire population. The Lau article concludes: ‘‘Efforts to reduce the tonsillectomy rate are correlated with a significant rise in emergency admissions. The rise in the retro and parapharyngeal abscess rate is perhaps most alarming given the very high mortality of these conditions. Bed day data suggest that no net saving has been made despite the new measures.’’ [1] Lau et al. [1] found that during the 20 year period the overall rate of tonsillectomy decreased by 44% at the same time the admission rate for tonsillitis rose 310% and the peritonsillar abscess admissions rose by 31%. Other data for a lesser time period 1996–2011 found tonsillectomy rate decreasing by 41% with an increase of 39% of admissions for retro and parapharyngeal abscess. There appear to be many more children with a severe infection which could have been prevented by undergoing a tonsillectomy. The criteria were proposed by Paradise et al. [2] in 1984 that eligibility for the tonsillectomy trials should depend on fulfilling four domains of criteria which include that there had to be a documented occurrences of tonsilar pharyngitis of seven or more episodes in the preceding year, five or more in each of the two preceding years, or three or more in each of the three preceding years. These conclusions were based upon the eligibility of 187 from a population of 2043. Of these 187 potential subjects, 97 rejected randomization and 91 accepted randomization. Thus the whole study is based upon 91 self-selected children – surely not a population in which one could look at results for differences in more defined groups. The limited number of subjects did not allow for identifying complications which occur over time and/or which are not frequent. Thus with this limited sample one would not pick up the infrequent yet serious complications, nor is the possibility of looking at what happened after the study period taken into account. The overarching problem is that intervention is recommended only after the child has undergone significant morbidity. In retrospect it would have made more sense if resources had been focused on determining who would get sick before they got sick. The Paradise study [2] became the adopted standard in whole or in part of many clinical guidelines throughout the world [3–6]. The Lau study [1] shows that the reduction in the operative
intervention, at least the United Kingdom, has resulted in an increase in morbidity which should have been avoided. The analysis [7] of randomized controlled studies examining tonsillar pharyngitis has shown that they have severe limitations and at best are only applicable to narrowly defined and highly circumscribed populations. They cannot be generalized to the entire patient population because of their very limited external validity. We are now in the era of personalized medicine [8] when the clinician must consider the intrinsic and extrinsic characteristics of all patients in relation to their illness. One size does not fit all! References [1] A.S. Lau, N.S. Upile, M.D. Wilkie, S.C. Leong, A.C. Swift, The rising rate of admissions for tonsillitis and neck space abscesses in England, 1991–2011, Ann. R. Coll. Surg. Engl. 96 (4) (2014) 307–310. [2] J.L. Paradise, C.D. Bluestone, R.Z. Bachman, D.K. Colborn, B.S. Bernard, F.H. Taylor, 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. 310 (11) (1984) 674–683. [3] R.F. Baugh, S.M. Archer, R.B. Mitchell, R.M. Rosenfeld, R. Amin, J.J. Burns, et al., Clinical practice guideline: tonsillectomy in children, Otolaryngol. Head Neck Surg. 144 (1 Suppl.) (2011) S1–S30. [4] E. Lescanne, B. Chiron, I. Constant, V. Couloigner, B. Fauroux, Y. Hassani, et al., Pediatric tonsillectomy: clinical practice guidelines, Eur. Ann. Otorhinolaryngol. Head Neck Dis. 129 (5) (2012) 264–271. [5] K.P. Oomen, V.K. Modi, M.G. Stewart, Evidence-based practice: pediatric tonsillectomy, Otolaryngol. Clin. North Am. 45 (5) (2012) 1071–1081. [6] H.P. Verschuur, C.J. Raats, C.J. Rosenbrand, Practice guideline: adenoid and tonsil disorders in secondary care, Ned. Tijdschr. Geneeskd. 153 (2009) pB295. [7] R.J. Ruben, Randomized controlled studies and the treatment of middle-ear effusions and tonsillar pharyngitis: how random are the studies and what are their limitations? Otolaryngol. Head Neck Surg. 139 (3) (2008) 333–339. [8] R.J. Ruben, Otitis media: the application of personalized medicine, Otolaryngol. Head Neck Surg. 145 (5) (2011) 707–712.
Robert Ruben MD, FAAP, FACS Department of Otolaryngology, Montefiore Medical Center, New York, USA E-mail address: [email protected] (R. Ruben). Available online 18 November 2014
http://dx.doi.org/10.1016/j.ijporl.2014.11.013 0165-5876/ß 2014 The Author. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-SA license (http://creativecommons.org/licenses/by-ncsa/3.0/).
