International Journal of Pediatric Otorhinolaryngology 78 (2014) 391–392
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Editorial
To give or not to give antibiotics in non-severe acute otitis media? The American Academy of Pediatrics Guidelines that do not guide
Acute otitis media (AOM) is the most frequent diagnosis in sick children visiting clinicians’ offices and the most common reason for administration of antibiotics [1–3]. Between 60 and 80 percent of children have at least one episode of AOM by one year of age, and 80 to 90 percent by two to three years [4–6]. The extremely high incidence of the disease (approximately 9 million children per year just in the USA) is associated with an a significant incremental health-care utilization burden on both patients and the health care system as it accounts for approximately three billion US dollars in added health care expense annually [7]. A significant part of these expenses involves antibiotics’ administration as otitis media is the most common condition for which antibacterial agents are prescribed for children in the United States [8]. Besides the enormous financial impact, there is also a very serious impact on microbe resistance making widely used antibiotics ineffective. From the early 1980s and 1990s several studies have appeared in the literature claiming acceptable outcome in children with AOM without prescribing antibiotics [9,10]. This has raised the fundamental question: could we just follow-up children with AOM without giving antibiotics? In other words, the Hamletian dilemma is: to give or not give antibiotics in AOM. However, and irrespective to the research studies, individual clinicians often feel insecure to leave their young patients ‘uncovered’ and seek evidence based guidelines in order to be persuaded and, in turn, to persuade parents just to follow-up the children. Moreover, these guidelines could be supportive evidence in case of medical legal issues if complications appeared. The most recent guidelines, the American Academy of Pediatrics, published in 2013 [11], attempted to clarify many issues related to AOM and their aim was to help physicians (general practitioners, pediatricians, and otorhinolaryngologists) to choose the best available treatment for their young patients. However, in the era of evidence based medicine all clinical practice guidelines are supposed to meet the requirements set by the GRADE system (Grading of Recommendations Assessment, Development, and Evaluation system of rating quality of evidence and grading strength of recommendations in systematic reviews, health technology assessments, and clinical practice guidelines) [12]. According to GRADE system, guidelines should ask explicit questions and the answers (the related evidence) should be summarized in a succinct and transparent way showing the quality of evidence and the magnitude of effects for each important outcome. In the particular fundamental question of whether physicians should prescribe antibiotics in non-severe pediatric 0165-5876/$ – see front matter ß 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijporl.2014.01.003
cases or follow a watchful waiting policy for 48-72 h the related guidelines are expected to assess all available evidence and take into account the high prevalence of the disease, the risk of increasing microbe resistance to antibiotics, the significant cost to health systems, the complications of antibiotics, and the complications or deterioration of the disease when no antibiotics are prescribed. In summary, the related guidelines should assess the available evidence and conclude if watchful waiting should be recommended. The question is a clear and explicit one requiring a clear answer. Of course, if the available evidence is poor or lacking, the recommendation can be type C or D (no recommendation). The clear answer to this question in the recent Korean AOM guidelines is: ‘watchful waiting as initial management for 48–72 h without use of antibacterial agents’ [13]. The recommendation grade is the impressive type A (the highest grade of recommendation). The other most recent AOM guidelines published in 2012 are those implemented by the Japanese Otological Society, the Japanese Society for Pediatric Otorhinolaryngology and the Japanese Society for Infectious Diseases in Otolaryngology [14]. Their answer is again clear and straightforward: watchful waiting for 3 days without use of antimicrobial agents in mild AOM. The strength of recommendation is again the highest (type A). In contrast to the above mentioned guidelines, the American Academy of Pediatrics (AAP) guidelines answer the same clear and explicit question with an unclear and non-explicit action statement: in non-severe AOM the clinicians should either prescribe antibiotics or offer a close follow-up without antibiotics for 48–72 h. If the evidence found, according to the AAP assessment, was suspicious or no clear advantage of prescribing antibiotics could be found, then the recommendation should have been type C (option) according to the accepted guideline definitions for evidence based statements. However, the ambiguous recommendation was type B. It seems that this recommendation is in reality a vicious circle as AAP guidelines avoid to take any side and do not even categorize the answer as an option. It is quite astonishing that both Korean and Japanese guidelines recommend watchful waiting in non-severe AOM with strength of recommendation type A and the American Academy of Pediatrics guidelines recommend either antibiotics or watchful waiting with strength of recommendation type B. On the other hand, the same AAP guidelines give a clear and explicit answer in the question of prophylactic antibiotic administration in recurrent AOM (no prophylactic antibiotics with strength of recommendation type B). Finally, a rather surprising question and related statement in the AAP guidelines is the administration of painkillers if pain is
392
Editorial / International Journal of Pediatric Otorhinolaryngology 78 (2014) 391–392
present (strong recommendation). If one follows this kind of thinking, then one should investigate the administration of water in order to avoid dehydration or food to avoid starving!!! Both the Korean and Japanese guidelines do not find necessary to investigate such questions and do not assess the evidence behind their recommendation of providing the necessary painkillers. It is well known to the first year students of medical statistics that any statistical conclusions and evidence based medicine analyses that do not make any sense in medicine or are self evident, are useless or misleading. In conclusion, it seems that the American Academy of Pediatrics guidelines have failed to answer the most important question on non-severe AOM treatment: to give or not to give antibiotics. References [1] A.C. Nyquist, R. Gonzales, J.F. Steiner, M.A. Sande, Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis, JAMA 279 (1998) 875. [2] T.R. Coker, L.S. Chan, S.J. Newberry, M.A. Limbos, M.J. Suttorp, P.G. Shekelle, G.S. Takata, Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review, JAMA 304 (19) (2010) 2161–2169. [3] A. Soni, Ear Infections (Otitis Media) in Children (0–17): Use and Expenditures, 2006. Statistical Brief No. 228, Agency for Healthcare Research and Quality Website, 2008 http://www.meps.ahrq.gov/mepsweb/data_files/publications/ st228/stat228.pdf. [4] D.W. Teele, J.O. Klein, B. Rosner, Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study, J. Infect. Dis. 160 (1989) 83. [5] J.L. Paradise, H.E. Rockette, D.K. Colborn, B.S. Bernard, C.G. Smith, M. Kurs-Lasky, J.E. Janosky, Otitis media in 2253 Pittsburgh-area infants: prevalence and risk factors during the first two years of life, Pediatrics 99 (3) (1997) 318–333.
[6] F. Ladomenou, A. Kafatos, Y. Tselentis, E. Galanakis, Predisposing factors for acute otitis media in infancy, J. Infect. 61 (2010) 49. [7] S. Ahmed, N.L. Shapiro, N. Bhattacharyya, Incremental health care utilization and costs for acute otitis media in children, Laryngoscope (2013), http://dx.doi.org/ 10.1002/lary.24190. [8] C.G. Grijalva, J.P. Nuorti, M.R. Griffin, Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings, JAMA 302 (7) (2009) 758–766. [9] N. Mygind, K.I. Meistrup-Larsen, J. Thomsen, V.F. Thomsen, K. Josefsson, H. Sørensen, Penicillin in acute otitis media: a double-blind placebo-controlled trial, Clin. Otolaryngol. Allied Sci. 6 (1) (1981) 5–13. [10] T. Lehnert, Acute otitis media in children. Role of antibiotic therapy, Can. Fam. Physician 39 (1993) 2157–2162. [11] A.S. Lieberthal, A.E. Carroll, T. Chonmaitree, T.G. Ganiats, A. Hoberman, M.A. Jackson, et al., The diagnosis and management of acute otitis media, Pediatrics 131 (3) (2013) e964–e999. [12] G. Guyatt, A.D. Oxman, E.A. Akl, R. Kunz, G. Vist, J. Brozek, et al., GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables, J Clin Epidemiol. 64 (4) (2011) 383–394. [13] H.J. Lee, S.K. Park, K.Y. Choi, S.E. Park, Y.M. Chun, K.S. Kim, et al., Korean clinical practice guidelines: otitis media in children, J Korean Med Sci 27 (8) (2012) 835– 848. [14] Clinical practice guidelines for the diagnosis and management of acute otitis media in children in Japan, Auris Nasus Larynx 39 (2012) 1–8.
Thomas P. Nikolopoulos MD, DM, PhD* *Tel.: +30 6973956979 E-mail address: [email protected] (T.P. Nikolopoulos). 3 January 2014 Available online 11 January 2014
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Editorial
To give or not to give antibiotics in non-severe acute otitis media? The American Academy of Pediatrics Guidelines that do not guide
Acute otitis media (AOM) is the most frequent diagnosis in sick children visiting clinicians’ offices and the most common reason for administration of antibiotics [1–3]. Between 60 and 80 percent of children have at least one episode of AOM by one year of age, and 80 to 90 percent by two to three years [4–6]. The extremely high incidence of the disease (approximately 9 million children per year just in the USA) is associated with an a significant incremental health-care utilization burden on both patients and the health care system as it accounts for approximately three billion US dollars in added health care expense annually [7]. A significant part of these expenses involves antibiotics’ administration as otitis media is the most common condition for which antibacterial agents are prescribed for children in the United States [8]. Besides the enormous financial impact, there is also a very serious impact on microbe resistance making widely used antibiotics ineffective. From the early 1980s and 1990s several studies have appeared in the literature claiming acceptable outcome in children with AOM without prescribing antibiotics [9,10]. This has raised the fundamental question: could we just follow-up children with AOM without giving antibiotics? In other words, the Hamletian dilemma is: to give or not give antibiotics in AOM. However, and irrespective to the research studies, individual clinicians often feel insecure to leave their young patients ‘uncovered’ and seek evidence based guidelines in order to be persuaded and, in turn, to persuade parents just to follow-up the children. Moreover, these guidelines could be supportive evidence in case of medical legal issues if complications appeared. The most recent guidelines, the American Academy of Pediatrics, published in 2013 [11], attempted to clarify many issues related to AOM and their aim was to help physicians (general practitioners, pediatricians, and otorhinolaryngologists) to choose the best available treatment for their young patients. However, in the era of evidence based medicine all clinical practice guidelines are supposed to meet the requirements set by the GRADE system (Grading of Recommendations Assessment, Development, and Evaluation system of rating quality of evidence and grading strength of recommendations in systematic reviews, health technology assessments, and clinical practice guidelines) [12]. According to GRADE system, guidelines should ask explicit questions and the answers (the related evidence) should be summarized in a succinct and transparent way showing the quality of evidence and the magnitude of effects for each important outcome. In the particular fundamental question of whether physicians should prescribe antibiotics in non-severe pediatric 0165-5876/$ – see front matter ß 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijporl.2014.01.003
cases or follow a watchful waiting policy for 48-72 h the related guidelines are expected to assess all available evidence and take into account the high prevalence of the disease, the risk of increasing microbe resistance to antibiotics, the significant cost to health systems, the complications of antibiotics, and the complications or deterioration of the disease when no antibiotics are prescribed. In summary, the related guidelines should assess the available evidence and conclude if watchful waiting should be recommended. The question is a clear and explicit one requiring a clear answer. Of course, if the available evidence is poor or lacking, the recommendation can be type C or D (no recommendation). The clear answer to this question in the recent Korean AOM guidelines is: ‘watchful waiting as initial management for 48–72 h without use of antibacterial agents’ [13]. The recommendation grade is the impressive type A (the highest grade of recommendation). The other most recent AOM guidelines published in 2012 are those implemented by the Japanese Otological Society, the Japanese Society for Pediatric Otorhinolaryngology and the Japanese Society for Infectious Diseases in Otolaryngology [14]. Their answer is again clear and straightforward: watchful waiting for 3 days without use of antimicrobial agents in mild AOM. The strength of recommendation is again the highest (type A). In contrast to the above mentioned guidelines, the American Academy of Pediatrics (AAP) guidelines answer the same clear and explicit question with an unclear and non-explicit action statement: in non-severe AOM the clinicians should either prescribe antibiotics or offer a close follow-up without antibiotics for 48–72 h. If the evidence found, according to the AAP assessment, was suspicious or no clear advantage of prescribing antibiotics could be found, then the recommendation should have been type C (option) according to the accepted guideline definitions for evidence based statements. However, the ambiguous recommendation was type B. It seems that this recommendation is in reality a vicious circle as AAP guidelines avoid to take any side and do not even categorize the answer as an option. It is quite astonishing that both Korean and Japanese guidelines recommend watchful waiting in non-severe AOM with strength of recommendation type A and the American Academy of Pediatrics guidelines recommend either antibiotics or watchful waiting with strength of recommendation type B. On the other hand, the same AAP guidelines give a clear and explicit answer in the question of prophylactic antibiotic administration in recurrent AOM (no prophylactic antibiotics with strength of recommendation type B). Finally, a rather surprising question and related statement in the AAP guidelines is the administration of painkillers if pain is
392
Editorial / International Journal of Pediatric Otorhinolaryngology 78 (2014) 391–392
present (strong recommendation). If one follows this kind of thinking, then one should investigate the administration of water in order to avoid dehydration or food to avoid starving!!! Both the Korean and Japanese guidelines do not find necessary to investigate such questions and do not assess the evidence behind their recommendation of providing the necessary painkillers. It is well known to the first year students of medical statistics that any statistical conclusions and evidence based medicine analyses that do not make any sense in medicine or are self evident, are useless or misleading. In conclusion, it seems that the American Academy of Pediatrics guidelines have failed to answer the most important question on non-severe AOM treatment: to give or not to give antibiotics. References [1] A.C. Nyquist, R. Gonzales, J.F. Steiner, M.A. Sande, Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis, JAMA 279 (1998) 875. [2] T.R. Coker, L.S. Chan, S.J. Newberry, M.A. Limbos, M.J. Suttorp, P.G. Shekelle, G.S. Takata, Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review, JAMA 304 (19) (2010) 2161–2169. [3] A. Soni, Ear Infections (Otitis Media) in Children (0–17): Use and Expenditures, 2006. Statistical Brief No. 228, Agency for Healthcare Research and Quality Website, 2008 http://www.meps.ahrq.gov/mepsweb/data_files/publications/ st228/stat228.pdf. [4] D.W. Teele, J.O. Klein, B. Rosner, Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study, J. Infect. Dis. 160 (1989) 83. [5] J.L. Paradise, H.E. Rockette, D.K. Colborn, B.S. Bernard, C.G. Smith, M. Kurs-Lasky, J.E. Janosky, Otitis media in 2253 Pittsburgh-area infants: prevalence and risk factors during the first two years of life, Pediatrics 99 (3) (1997) 318–333.
[6] F. Ladomenou, A. Kafatos, Y. Tselentis, E. Galanakis, Predisposing factors for acute otitis media in infancy, J. Infect. 61 (2010) 49. [7] S. Ahmed, N.L. Shapiro, N. Bhattacharyya, Incremental health care utilization and costs for acute otitis media in children, Laryngoscope (2013), http://dx.doi.org/ 10.1002/lary.24190. [8] C.G. Grijalva, J.P. Nuorti, M.R. Griffin, Antibiotic prescription rates for acute respiratory tract infections in US ambulatory settings, JAMA 302 (7) (2009) 758–766. [9] N. Mygind, K.I. Meistrup-Larsen, J. Thomsen, V.F. Thomsen, K. Josefsson, H. Sørensen, Penicillin in acute otitis media: a double-blind placebo-controlled trial, Clin. Otolaryngol. Allied Sci. 6 (1) (1981) 5–13. [10] T. Lehnert, Acute otitis media in children. Role of antibiotic therapy, Can. Fam. Physician 39 (1993) 2157–2162. [11] A.S. Lieberthal, A.E. Carroll, T. Chonmaitree, T.G. Ganiats, A. Hoberman, M.A. Jackson, et al., The diagnosis and management of acute otitis media, Pediatrics 131 (3) (2013) e964–e999. [12] G. Guyatt, A.D. Oxman, E.A. Akl, R. Kunz, G. Vist, J. Brozek, et al., GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables, J Clin Epidemiol. 64 (4) (2011) 383–394. [13] H.J. Lee, S.K. Park, K.Y. Choi, S.E. Park, Y.M. Chun, K.S. Kim, et al., Korean clinical practice guidelines: otitis media in children, J Korean Med Sci 27 (8) (2012) 835– 848. [14] Clinical practice guidelines for the diagnosis and management of acute otitis media in children in Japan, Auris Nasus Larynx 39 (2012) 1–8.
Thomas P. Nikolopoulos MD, DM, PhD* *Tel.: +30 6973956979 E-mail address: [email protected] (T.P. Nikolopoulos). 3 January 2014 Available online 11 January 2014
