- Email: [email protected]
Observation option toolkit for acute otitis media
International Journal of Pediatric Otorhinolaryngology 58 (2001) 1 – 8 www.elsevier.com/locate/ijporl
Observation option toolkit for acute otitis media Richard M. Rosenfeld * Department of Otolaryngology, State Uni6ersity of New York, Health Science Center at Brooklyn, 339 Hicks Street, Brooklyn, NY 11201, USA Received 31 October 2000; received in revised form 12 January 2001; accepted 13 January 2001
Abstract The observation option for acute otitis media (AOM) refers to deferring antibiotic treatment of selected children for up to 3 days, during which time management is limited to analgesics and symptomatic relief. With appropriate follow-up complications are not increased, and clinical outcomes compare favorably with routine initial antibiotic therapy. Although used commonly in the Netherlands and certain Scandinavian countries, this approach has not gained wide acceptance in Europe and the United States. This article describes an evidence-based toolkit developed by the New York Region Otitis Project for judicious use of the observation option. The toolkit is not intended to endorse the observation option as a preferred method of management, nor is it intended as a rigid practice guideline to supplant clinician judgement. Rather, it presents busy clinicians with the tools needed to implement the observation option in everyday patient care should they so desire. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Acute otitis media; Antibiotic therapy; Natural history; Practice guideline; Evidence-based medicine
1. Introduction Acute otitis media (AOM) is the most common illness for which children receive antibiotics, but such use may be associated with an alarming increase in multidrug-resistant bacteria. The observation option refers to deferring antibiotic treatment of selected children for up to 3 days, during which time management is limited to analgesics and symptomatic relief [1]. This practice is based on data from randomized trials that suggest most children improve from natural history alone, * Tel.: +1-718-7801498; fax: + 1-718-7802819. E-mail address: [email protected] (R.M. Rosenfeld).
with antibiotics providing only a marginal benefit [2,3]. Antibiotic therapy is begun, however, if symptoms persist or worsen during this initial period of observation. The observation option for AOM is an official policy in The Netherlands and Sweden (children aged 2 years or older), and an unofficial policy in Denmark and Norway. The Agency for Healthcare Research and Quality (AHRQ) recently concluded that suppurative complications are not increased with initial observation, provided that children are followed closely [4]. Only two out of 1211 children (0.17%) from eight randomized trials developed suppurative complications after initial observation, which did not differ from
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R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
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antibiotic-treated children [4]. Further, children who received placebo or no therapy for AOM had a pooled rate of clinical success at 1 – 7 days of 81%. Although the impact of antibiotics on clinical resolution was statistically significant, the magnitude was modest: about eight children with AOM would need initial therapy to avoid a single clinical failure. This report describes evidence-based materials developed by the New York Region Otitis Project to promote judicious antibiotic use in AOM. Our goal was to translate current best evidence regarding AOM therapy into practical guidelines that would allow interested clinicians to safely and efficiently incorporate the observation option into their everyday practice. No statements are made regarding choice of antibiotic, because the emphasis is placed on deciding whether initial therapy is necessary at all, and, if so, for what duration. When antibiotics are administered, choice of drug is left to clinician discretion, because no differences in clinical outcomes have been demonstrated based on drug selection [2,4,5].
2. Methods Early in 1999, the New York State Department of Health reached out to the New York region health plans and leading clinical and public health practitioners to collaboratively look at issues concerning the diagnosis and management of AOM in children. Clinician members of the resulting New York Region Otitis Project (see Acknowledgement) met bimonthly and organized an interactive educational intervention in March 2000 entitled ‘New Strategies for Judicious Antibiotic Use in Acute Otitis Media’. The conference included participants from the Netherlands, UK, AHRQ, and the Centers for Disease Control. A toolkit for implementing the observation option was presented at the conference, and later modified based on feedback from participants. The toolkit was developed according to the principles of evidence-based medicine, which blends current best research evidence with provider experience and patient preference [6]. Evidence on natural history and antibiotic benefit
Table 1 Consensus definition of AOM used in the AHRQ evidence reporta [4] AOM is defined asb 1.
presence of MEE as demonstrated by the actual presence of fluid in the middle ear as diagnosed by tympanocentesis or the physical presence of liquid in the external ear canal as a result of TM perforation or indicated by limited or absent mobility of the TM as diagnosed by pneumatic otoscopy, tympanogram, or acoustic reflectometry with or without the following: a. opacification, not including erythema b. a full or bulging TM c. hearing loss
And 2. Of 3.
a
rapid onset (over the course of 48 h)c one or more of the following signs or symptoms: a. otalgia (or pulling of ear in an infant) b. otorrhea c. irritability in the infant or toddlerd d. fever with or without anorexia, nausea, or vomiting
AOM, acute otitis media; MEE, middle-ear effusion; TM, tympanic membrane. Abbreviated definition: AOM is the presence of MEE in conjunction with the rapid onset of one or more signs or symptoms of inflammation of the middle ear. c Rapid onset is defined as 548 h from the onset of acute signs or symptoms first noted by the parent or guardian to contact with the health system. d Irritability in the infant or toddler and fever must be associated with either otalgia or otorrhea to fulfil criterion 3. b
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8 Table 2 Scope of the AOM observation option toolkita Aspect
Definition
Disease entity
Initial presentation of uncomplicated AOM (as defined in Table 1) Excludes AOM treatment failures or relapses (within 30 days), AOM with sinusitis or streptococcal pharyngitis, and children with syndromes, immune deficiency, or craniofacial anomalies Age 2 months to 18 years
Patient population Setting Interventions
Influencing factors
Outcome measures
a
All types of providers and practice settings Initial observation (observation option) Initial short-course antibiotics (5 days) Initial full-course antibiotics (7–10 days) Diagnostic certainty for AOM Age under 2 years versus 2 years or older Illness severity Follow-up availability and reliability Patient or caregiver preference Clinical success defined as resolution or improvement of all presenting AOM signs and symptoms, excluding MEE Observation failure defined as worsening or persistence of initial AOM signs and symptoms by 72 h
AOM, acute otitis media; MEE, middle-ear effusion.
was derived from three systematic reviews [2,3,7], and nine randomized trials [8 – 16] of antibiotic vs. placebo or no drug for initial management of AOM. Clinical outcomes were abstracted from the AHRQ evidence report on AOM [4] for which the author (RMR) was a technical expert representing the American Academy of Otolaryngology — Head and Neck Surgery. Evidence concerning the impact of child age [13,16,19] illness severity [15] and duration of antibiotic therapy [20 –24] on AOM outcomes was identified. Provider experience was incorporated into the decision-making process regarding the certainty of AOM diagnosis and degree of illness of severity. Last, patient preference was incorporated by providing a patient information sheet.
3
3. Results AOM was defined as the presence of middle-ear effusion (MEE) in conjunction with the rapid onset of one or more signs or symptoms of inflammation of the middle ear. Specific diagnostic criteria (Table 1) were based on the consensus definition recommended by the AHRQ in the AOM Evidence Report [4]. The scope of the toolkit is described in Table 2. The recommendations are intended for otherwise healthy children with new onset of uncomplicated AOM, for which the clinician is contemplating a choice between initial observation, short-course antibiotics (5 days or less), or traditional full-course antibiotics (7–10 days). Although the patient population extends to age 18 years, we recognize that most AOM occurs in the preschool years and that children over age 12 years were infrequent participants in the randomized trials used as primary evidence. Guidelines for judicious use of antibiotics in treating AOM are described in Table 3, which is the focal point of the toolkit. Note that, in conTable 3 Guidelines for judicious use of antibiotics in treating AOMa Child age
Certain AOM diagnosis
Uncertain AOM diagnosis
Under 6 month 6 month to 2 years
Antibioticsb Antibioticsb
2 years or older
Antibioticsc if severee illness Observed if non-severeeillness
Antibioticsb Antibioticsb if severee illness Observed if non-severee illness Observed
a
AOM, acute otitis media. Children under age 2 years receive full-course antibiotics. c Children aged 2 years or older may receive short-course antibiotics or full-course antibiotics based on clinician judgement and parental preference. d Observation is appropriate only when follow-up can be assured (by telephone or office visit) and antibiotics started if symptoms worsen or persist by 72 h. e Non-severe illness is mild otalgia and fever B39°C orally (102 F) or B39.5°C rectally in the past 24 h; severe illness is moderate to severe otalgia or higher fever or clinician judgement that child is toxic or severely ill. b
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
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Table 4 Expected AOM clinical outcomes based on published evidencea Clinical success at 24 h will occur for 55–65% of children, but may be lower for children under age 2 years Clinical success at 24 h will not be affected by initial antibiotic therapy Clinical success at 2–7 days will occur for 85–95% of children; roughly 5–15% of this results from antibiotic use, but the impact may be greater in children under age 2 years On average, approximately eight children will need initial antibiotic therapy to avoid a single case of clinical failure at 2–7 days (number needed to treat of 8) Mastoiditis and other suppurative complications will not be greater with initial observation, provided that children are followed closely and observation failures receive antibiotics Asymptomatic fluid (MEE) will persist in 35–45% of children after 1 month, decreasing to 10–25% by 3 months; additional antibiotics will not hasten MEE resolution Antibiotics given for 7–10 days will increase resolution at 10–14 days by 8% over shorter courses, but the effect will be larger (12–20%) in children under age 2 years
1.
2. 3.
4.
5.
6.
7.
a
AOM, acute otitis media; MEE, middle-ear effusion.
trast to the Dutch AOM guideline, diagnostic certainty for AOM is a primary influencing factor. A certain diagnosis is a clinical picture suggesting AOM (Table 1) with a high probability of MEE. An uncertain diagnosis is suspected AOM with anything less than a high probability of MEE as a result of obstructing cerumen, child apprehension, or other factors that impair visibility of the tymTable 5 Observation option poem for acute otitis media Less drugs … means safer bugs If the child is young and sick, then antibiotics will do the trick. For older children or diagnosis uncertain, observe up to three days unless really hurtin’. But the observation option is best ignored, when timely follow-up cannot be assured. And in the quest to create safer bugs, remember most cures come from nature, not drugs.
panic membrane or adequate performance of pneumatic otoscopy. We recommend initial antibiotic therapy (Table 3) for all children under 2 years of age with a certain diagnosis of AOM because of a poorer natural history [16 –19] and greater absolute benefit from full-course antibiotics than older children [20 –24]. Young children cared for outside the home during the day derive even greater benefit from full-course therapy [22,24]. In contrast, older children are the best candidates for initial observation or short-course therapy, [25] particularly when the illness is non-severe [15] or the AOM diagnosis is uncertain. Short-course therapy offers the dual benefits of easier administration and reduced incidence of resistant pneumococci after therapy. We recommend liberal use of analgesics for 24 h after diagnosis, because about one-third of all children — and nearly two-thirds of children under age 2 years — will remain symptomatic regardless of whether they have been observed or treated (Table 4) [3,4,7,16]. Clinical success rises dramatically within several days, but persistent asymptomatic MEE may persist up to several months. Parents should be counseled that persistent MEE may cause a transient hearing loss or sensation of fullness, but that additional antibiotics will not hasten resolution [2–4]. The complete Observation Option Toolkit consists of five single-page documents to help busy clinicians implement the observation option for AOM with a minimum of time and effort. Toolkit components include: (1) Overview of treatment guidelines; (2) Health care provider information sheet; (3) Parent or caregiver information sheet (Figure); (4) Annotated bibliography; and (5) the Observation Option Poem (Table 5). All parents are given an information sheet (Fig. 1), because they are unlikely to embrace or participate in a process of observation unless they fully understand the favorable natural history of AOM and the limited, incremental benefit of antibiotic therapy [26,27]. Copies of the complete Observation Option Toolkit can be obtained from the author by sending a forwarding mailing or e-mail address.
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
4. Discussion Although antibiotics are prescribed in the
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United States for nearly all cases of AOM [28], strong evidence suggests a role for observation alone in selected cases [1]. Mounting concerns
Fig. 1. Information sheet distributed to the child’s parent or caregiver whenever the observation option is suggested.
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R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
about the adverse effects of antibiotic therapy, especially accelerated bacterial resistance, mandate that United States physicians reconsider the Dutch observation option. Our experience has been that many clinicians and parents are willing to consider initial observation, but lack the methodology for safe and rational implementation. The toolkit described in this article attempts to fill this void, with simple guidelines (Table 3) and evidence-based educational handouts. Several aspects of the summary guideline in Table 3 deserve emphasis. First, observation is appropriate for initial management of AOM only when follow-up can be assured, and antibiotics can be started if the child fails to improve within 72 h. Selected parents can receive a ‘deferred’ antibiotic, by providing a prescription but requesting that they do not fill it unless initial observation fails [26]. Second, some degree of uncertainty nearly always exists when diagnosing AOM because of the difficulties in detecting MEE. Rather than ignore or deny this uncertainty, we suggest using it to prioritize initial management decisions as outlined in Table 3. In contrast to the Dutch AOM guidelines, we do not recommend the observation option for children aged 6 months to 2 years with a certain diagnosis of AOM (Table 3). Initial observation of this age group may become more acceptable as clinicians begin to immunize of all children 23 months and younger with the heptavalent pneumococcal conjugate vaccine, as recommended by the American Academy of Pediatrics and the Advisory Committee for Immunization Practices [29]. Although the vaccine prevents only 6 – 7% of all AOM, it reduces the incidence of pneumococcal AOM by 34% and vaccine-type AOM by 57% [30,31]. This may eventually shift AOM bacteriology away from Streptococcus pneumoniae towards organisms with better spontaneous resolution and reduced potential for suppurative complications. The guidelines proposed in Table 3 are options, not mandates. To be consistent with the principles of evidence-based medicine, provider experience and patient preference must be a part
of the decision-making process. Provider experience and judgement are needed to assess diagnostic certainty, illness severity, and the ultimate suitability of any particular child for observation or short-course antibiotics. Similarly, patients must be involved through educational handouts (Fig. 1) and by involvement in the discussion of treatment choices. We hope that the Observation Option Toolkit will promote artful care of children with AOM by facilitating an evidencebased dialogue among all involved parties.
Acknowledgements This project would not have been possible without input and feedback from clinician members of the New York Region Otitis Project, including (in alphabetical order): Ellis Arnstein, MD, Pediatrics, New York Floating Hospital; Andrea Berne, CPNP, MPH, Pediatric nurse practitioner, New York private practice; Philip Bonaparte, MD, Robert Wood Johnson University Hospital at Hamilton; Thomas Fischer, MD, Emergency medicine, University Hospital at Stony Brook; Gary Krigsman, MD, New York City Department of Health, School Health Program; Winston Price, MD, Aetna U.S. Health Care, New York; Richard Propp, MD, New York State Department of Health, Office of Medicaid Management; Richard Rosenfeld, MD, MPH, Pediatric Otolaryngology, SUNY Downstate Medical Center; Robert Ruben, MD, Pediatric otolaryngology, Albert Einstein College of Medicine; Bella Sandhaus, R-PAC, Pediatric physician assistant, Brooklyn private practice; Robert Schiller, MD, Family medicine, Beth Israel Medical Center; Paul Shurin, MD, Pediatric infectious disease, Montefiore Medical Center; Denise Spor, RN, New York State Department of Health, Office of Medicaid Management; Michael Tunik, MD, Pediatric emergency medicine, NYU School of Medicine; Denia Varrasso, MD, Community Access to Child Health, District II Facilitator, American Academy of Pediatrics; Lutgarda Vasquez, MD, New York State Department of Health, Hospital Program, MARO.
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
References [1] L. Culpepper, J. Froom, Routine antimicrobial treatment of acute otitis media. Is it necessary?, J. Am. Med. Assoc. 278 (1997) 1643– 1645. [2] R.M. Rosenfeld, J.E. Vertrees, J. Carr, et al., Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials, J. Pediatr. 124 (1994) 355–367. [3] C. Del Mar, P. Glasziou, M. Hayem, Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis, Br. Med. J. 314 (1997) 1526– 1529. [4] Management of Acute Otitis Media. Summary, Evidence Report/technology Assessment: Number 15, June 2000. Agency for Healthcare Quality and Research, Rockville, MD. http://www.ahrq.gov/clinic/otitisum.htm. [5] S. Berman, P.J. Byrns, J. Bondy, et al., Otitis media-related antibiotic prescribing patterns, outcomes, and expenditures in a pediatric Medicaid population, Pediatrics 100 (1997) 585– 592. [6] D.L. Sackett, W.M. Rosenberg, J.A.M. Gray, R.B. Haynes, W.S. Richardson, Evidence based medicine: what it is and what it isn’t, Br. Med. J. 312 (1996) 71–72. [7] R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media. BC Decker, Hamilton, Ontario, 1999. [8] C. Halsted, M.L. Lepow, N. Balassanian, et al., Otitis media: clinical observations, microbiology, and evaluation of therapy, Am. J. Dis. Control 115 (1968) 542–551. [9] O.E. Laxdal, J. Merida, R.H. Trefor Jones, Treatment of acute otitis media: a controlled study of 142 children, Can. Med. Assoc. J. 102 (1970) 263–268. [10] F.L. van Buchem, J.H.M. Dunk, M.A. van’t Hof, Therapy of acute otitis media: myringotomy, antibiotics, or neither: a double-blind study in children, Lancet 2 (1981) 883– 887. [11] N. Mygind, K.I. Meistrup-Larsen, J. Thomsen, et al., Penicillin in acute otitis media: a double-blind, placebocontrolled trial, Clin. Otolaryngol. 6 (1981) 5–13. [12] A. Thalin, O. Densert, A. Larsson et al. Is penicillin necessary in the treatment of acute otitis media? Proceedings of the International Conference on Acute and Secretory Otitis Media, Part 1, Jerusalem, Israel, 17–22 November 1985. Kugler Publications, Amsterdam, 1985, pp. 441– 446. [13] C.L.M. Appelman, J.Q.P.J. Claessen, F.W.M.M. TouwbOtten, et al., Coamoxiclav in recurrent acute otitis media: placebo-controlled study, Br. Med. J. 303 (1991) 1450– 1452. [14] P. Burke, J. Bain, D. Robinson, J. Dunleavey, Acute red ear in children: controlled trial of nonantibiotic treatment in general practice, Br. Med. J. 303 (1991) 558–562. [15] P.H. kaleida, M.L. Casselbrant, H.E. Rockette, et al., Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial, Pediatrics 87 (1991) 466– 474.
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[16] R.A. Damoiseaux, F.A. van Balen, A.W. Hoes et al., Primary care based randomised, double blind trial of amoxicillin vs. placebo for acute otitis media in children aged under 2 years. [17] G. Harsten, K. Prellner, J. Heldrup, et al., Treatment failure in acute otitis media: a clinical study of children during their first three years of life, Acta Otolaryngol. 108 (1989) 253– 258. [18] S.A. Carlin, C.D. Marchant, P.A. Shurin, et al., Host factors and early therapeutic response in acute otitis media, J. Pediatr. 118 (1991) 178– 183. [19] S.A. Schutzman, S. Petrycki, G.R. Fleisher, Bacteremia with otitis media, Pediatric 87 (1991) 48 – 53. [20] J.L. Paradise, Short-course antimicrobial treatment for acute otitis media: not best for infants and young children, J. Am. Med. Assoc. 278 (1997) 1640– 1642. [21] A. Hoberman, J.L. Paradise, D.J. Burch, et al., Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentin) for treatment of acute otitis media in children, Pediatr. Infect. Dis. J. 16 (1997) 463– 470. [22] R. Cohen, C. Levy, M. Boucherat, J. Langue, F. de La Rocque, A multicenter, randomized, double-blind trial of 5 versus 10 days of antibiotic therapy for acute otitis media in young children, J. Pediatr. 133 (1998) 634– 639. [23] A.L. Korzyrskyj, G.E. Hildes-Ripstein, S.E.A. Longstaffe, et al., Treatment of acute otitis media with shortened course of antibiotics: a meta-analysis, J. Am. Med. Assoc. 279 (1998) 1736– 1742. [24] R.C. Cohen, C. Levy, M. Boucherat, et al., Five vs. ten days of antibiotic therapy for acute otitis media in young children, Pediatr. Infect. Dis. J. 19 (2000) 458– 463. [25] D. Guillemot, C. Carbon, B. Balkau, et al., Low dosage and long treatment duration of beta-lactams: risk factors for carriage of penicillin-resistant Streptococcus pneumoniae, J. Am. Med. Assoc. 279 (1998) 365– 370. [26] C. Cates, An evidence based approach to reducing antibiotic use in children with acute otitis media: controlled before and after study, Br. Med. J. 318 (1999) 715– 716. [27] H. Bauchner, L. Simpson, Specific issues related to developing, disseminating, and implementing pediatric practice guidelines for physicians, patients, families, and other stakeholders, Health Services Res. 33 (1998) 1161– 1177. [28] S.F. Dowell, S.M. Marcy, W.R. Phillips, et al., Otitis media: principles of judicious use of antimicrobial agents, Pediatrics 101 (1998) 165– 171. [29] Committee on Infectious Diseases, American Academy of Pediatrics. Policy statement: recommendations for the prevention of pneumococcal infections, including the use of pneumococcal conjugate vaccine (Prevnar), pneumococcal polysaccharide vaccine, and antibiotic prophylaxis. Pediatrics 106 (2000) 362– 366. [30] S. Black, H. Shinefield, B. Fireman, et al., Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children: Northern California Kaiser Permanente Vaccine Study Center Group, Pediatr. Infect. Dis. J. 19 (2000) 187– 195.
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[31] J. Eskola, T. Kilpi, Efficacy of a heptavalent pneumococcal conjugate vaccine (PncCRM) against serotype-specific, culture-confirmed pneumococcal acute otitis media in in-
fants and children. Presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. September 26 – 29, 1999. Abstract LB-13, San Francisco, CA.
.
Observation option toolkit for acute otitis media Richard M. Rosenfeld * Department of Otolaryngology, State Uni6ersity of New York, Health Science Center at Brooklyn, 339 Hicks Street, Brooklyn, NY 11201, USA Received 31 October 2000; received in revised form 12 January 2001; accepted 13 January 2001
Abstract The observation option for acute otitis media (AOM) refers to deferring antibiotic treatment of selected children for up to 3 days, during which time management is limited to analgesics and symptomatic relief. With appropriate follow-up complications are not increased, and clinical outcomes compare favorably with routine initial antibiotic therapy. Although used commonly in the Netherlands and certain Scandinavian countries, this approach has not gained wide acceptance in Europe and the United States. This article describes an evidence-based toolkit developed by the New York Region Otitis Project for judicious use of the observation option. The toolkit is not intended to endorse the observation option as a preferred method of management, nor is it intended as a rigid practice guideline to supplant clinician judgement. Rather, it presents busy clinicians with the tools needed to implement the observation option in everyday patient care should they so desire. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Acute otitis media; Antibiotic therapy; Natural history; Practice guideline; Evidence-based medicine
1. Introduction Acute otitis media (AOM) is the most common illness for which children receive antibiotics, but such use may be associated with an alarming increase in multidrug-resistant bacteria. The observation option refers to deferring antibiotic treatment of selected children for up to 3 days, during which time management is limited to analgesics and symptomatic relief [1]. This practice is based on data from randomized trials that suggest most children improve from natural history alone, * Tel.: +1-718-7801498; fax: + 1-718-7802819. E-mail address: [email protected] (R.M. Rosenfeld).
with antibiotics providing only a marginal benefit [2,3]. Antibiotic therapy is begun, however, if symptoms persist or worsen during this initial period of observation. The observation option for AOM is an official policy in The Netherlands and Sweden (children aged 2 years or older), and an unofficial policy in Denmark and Norway. The Agency for Healthcare Research and Quality (AHRQ) recently concluded that suppurative complications are not increased with initial observation, provided that children are followed closely [4]. Only two out of 1211 children (0.17%) from eight randomized trials developed suppurative complications after initial observation, which did not differ from
0165-5876/01/$ - see front matter © 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 5 - 5 8 7 6 ( 0 1 ) 0 0 4 2 1 - 9
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8
2
antibiotic-treated children [4]. Further, children who received placebo or no therapy for AOM had a pooled rate of clinical success at 1 – 7 days of 81%. Although the impact of antibiotics on clinical resolution was statistically significant, the magnitude was modest: about eight children with AOM would need initial therapy to avoid a single clinical failure. This report describes evidence-based materials developed by the New York Region Otitis Project to promote judicious antibiotic use in AOM. Our goal was to translate current best evidence regarding AOM therapy into practical guidelines that would allow interested clinicians to safely and efficiently incorporate the observation option into their everyday practice. No statements are made regarding choice of antibiotic, because the emphasis is placed on deciding whether initial therapy is necessary at all, and, if so, for what duration. When antibiotics are administered, choice of drug is left to clinician discretion, because no differences in clinical outcomes have been demonstrated based on drug selection [2,4,5].
2. Methods Early in 1999, the New York State Department of Health reached out to the New York region health plans and leading clinical and public health practitioners to collaboratively look at issues concerning the diagnosis and management of AOM in children. Clinician members of the resulting New York Region Otitis Project (see Acknowledgement) met bimonthly and organized an interactive educational intervention in March 2000 entitled ‘New Strategies for Judicious Antibiotic Use in Acute Otitis Media’. The conference included participants from the Netherlands, UK, AHRQ, and the Centers for Disease Control. A toolkit for implementing the observation option was presented at the conference, and later modified based on feedback from participants. The toolkit was developed according to the principles of evidence-based medicine, which blends current best research evidence with provider experience and patient preference [6]. Evidence on natural history and antibiotic benefit
Table 1 Consensus definition of AOM used in the AHRQ evidence reporta [4] AOM is defined asb 1.
presence of MEE as demonstrated by the actual presence of fluid in the middle ear as diagnosed by tympanocentesis or the physical presence of liquid in the external ear canal as a result of TM perforation or indicated by limited or absent mobility of the TM as diagnosed by pneumatic otoscopy, tympanogram, or acoustic reflectometry with or without the following: a. opacification, not including erythema b. a full or bulging TM c. hearing loss
And 2. Of 3.
a
rapid onset (over the course of 48 h)c one or more of the following signs or symptoms: a. otalgia (or pulling of ear in an infant) b. otorrhea c. irritability in the infant or toddlerd d. fever with or without anorexia, nausea, or vomiting
AOM, acute otitis media; MEE, middle-ear effusion; TM, tympanic membrane. Abbreviated definition: AOM is the presence of MEE in conjunction with the rapid onset of one or more signs or symptoms of inflammation of the middle ear. c Rapid onset is defined as 548 h from the onset of acute signs or symptoms first noted by the parent or guardian to contact with the health system. d Irritability in the infant or toddler and fever must be associated with either otalgia or otorrhea to fulfil criterion 3. b
R.M. Rosenfeld / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 1–8 Table 2 Scope of the AOM observation option toolkita Aspect
Definition
Disease entity
Initial presentation of uncomplicated AOM (as defined in Table 1) Excludes AOM treatment failures or relapses (within 30 days), AOM with sinusitis or streptococcal pharyngitis, and children with syndromes, immune deficiency, or craniofacial anomalies Age 2 months to 18 years
Patient population Setting Interventions
Influencing factors
Outcome measures
a
All types of providers and practice settings Initial observation (observation option) Initial short-course antibiotics (5 days) Initial full-course antibiotics (7–10 days) Diagnostic certainty for AOM Age under 2 years versus 2 years or older Illness severity Follow-up availability and reliability Patient or caregiver preference Clinical success defined as resolution or improvement of all presenting AOM signs and symptoms, excluding MEE Observation failure defined as worsening or persistence of initial AOM signs and symptoms by 72 h
AOM, acute otitis media; MEE, middle-ear effusion.
was derived from three systematic reviews [2,3,7], and nine randomized trials [8 – 16] of antibiotic vs. placebo or no drug for initial management of AOM. Clinical outcomes were abstracted from the AHRQ evidence report on AOM [4] for which the author (RMR) was a technical expert representing the American Academy of Otolaryngology — Head and Neck Surgery. Evidence concerning the impact of child age [13,16,19] illness severity [15] and duration of antibiotic therapy [20 –24] on AOM outcomes was identified. Provider experience was incorporated into the decision-making process regarding the certainty of AOM diagnosis and degree of illness of severity. Last, patient preference was incorporated by providing a patient information sheet.
3
3. Results AOM was defined as the presence of middle-ear effusion (MEE) in conjunction with the rapid onset of one or more signs or symptoms of inflammation of the middle ear. Specific diagnostic criteria (Table 1) were based on the consensus definition recommended by the AHRQ in the AOM Evidence Report [4]. The scope of the toolkit is described in Table 2. The recommendations are intended for otherwise healthy children with new onset of uncomplicated AOM, for which the clinician is contemplating a choice between initial observation, short-course antibiotics (5 days or less), or traditional full-course antibiotics (7–10 days). Although the patient population extends to age 18 years, we recognize that most AOM occurs in the preschool years and that children over age 12 years were infrequent participants in the randomized trials used as primary evidence. Guidelines for judicious use of antibiotics in treating AOM are described in Table 3, which is the focal point of the toolkit. Note that, in conTable 3 Guidelines for judicious use of antibiotics in treating AOMa Child age
Certain AOM diagnosis
Uncertain AOM diagnosis
Under 6 month 6 month to 2 years
Antibioticsb Antibioticsb
2 years or older
Antibioticsc if severee illness Observed if non-severeeillness
Antibioticsb Antibioticsb if severee illness Observed if non-severee illness Observed
a
AOM, acute otitis media. Children under age 2 years receive full-course antibiotics. c Children aged 2 years or older may receive short-course antibiotics or full-course antibiotics based on clinician judgement and parental preference. d Observation is appropriate only when follow-up can be assured (by telephone or office visit) and antibiotics started if symptoms worsen or persist by 72 h. e Non-severe illness is mild otalgia and fever B39°C orally (102 F) or B39.5°C rectally in the past 24 h; severe illness is moderate to severe otalgia or higher fever or clinician judgement that child is toxic or severely ill. b
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Table 4 Expected AOM clinical outcomes based on published evidencea Clinical success at 24 h will occur for 55–65% of children, but may be lower for children under age 2 years Clinical success at 24 h will not be affected by initial antibiotic therapy Clinical success at 2–7 days will occur for 85–95% of children; roughly 5–15% of this results from antibiotic use, but the impact may be greater in children under age 2 years On average, approximately eight children will need initial antibiotic therapy to avoid a single case of clinical failure at 2–7 days (number needed to treat of 8) Mastoiditis and other suppurative complications will not be greater with initial observation, provided that children are followed closely and observation failures receive antibiotics Asymptomatic fluid (MEE) will persist in 35–45% of children after 1 month, decreasing to 10–25% by 3 months; additional antibiotics will not hasten MEE resolution Antibiotics given for 7–10 days will increase resolution at 10–14 days by 8% over shorter courses, but the effect will be larger (12–20%) in children under age 2 years
1.
2. 3.
4.
5.
6.
7.
a
AOM, acute otitis media; MEE, middle-ear effusion.
trast to the Dutch AOM guideline, diagnostic certainty for AOM is a primary influencing factor. A certain diagnosis is a clinical picture suggesting AOM (Table 1) with a high probability of MEE. An uncertain diagnosis is suspected AOM with anything less than a high probability of MEE as a result of obstructing cerumen, child apprehension, or other factors that impair visibility of the tymTable 5 Observation option poem for acute otitis media Less drugs … means safer bugs If the child is young and sick, then antibiotics will do the trick. For older children or diagnosis uncertain, observe up to three days unless really hurtin’. But the observation option is best ignored, when timely follow-up cannot be assured. And in the quest to create safer bugs, remember most cures come from nature, not drugs.
panic membrane or adequate performance of pneumatic otoscopy. We recommend initial antibiotic therapy (Table 3) for all children under 2 years of age with a certain diagnosis of AOM because of a poorer natural history [16 –19] and greater absolute benefit from full-course antibiotics than older children [20 –24]. Young children cared for outside the home during the day derive even greater benefit from full-course therapy [22,24]. In contrast, older children are the best candidates for initial observation or short-course therapy, [25] particularly when the illness is non-severe [15] or the AOM diagnosis is uncertain. Short-course therapy offers the dual benefits of easier administration and reduced incidence of resistant pneumococci after therapy. We recommend liberal use of analgesics for 24 h after diagnosis, because about one-third of all children — and nearly two-thirds of children under age 2 years — will remain symptomatic regardless of whether they have been observed or treated (Table 4) [3,4,7,16]. Clinical success rises dramatically within several days, but persistent asymptomatic MEE may persist up to several months. Parents should be counseled that persistent MEE may cause a transient hearing loss or sensation of fullness, but that additional antibiotics will not hasten resolution [2–4]. The complete Observation Option Toolkit consists of five single-page documents to help busy clinicians implement the observation option for AOM with a minimum of time and effort. Toolkit components include: (1) Overview of treatment guidelines; (2) Health care provider information sheet; (3) Parent or caregiver information sheet (Figure); (4) Annotated bibliography; and (5) the Observation Option Poem (Table 5). All parents are given an information sheet (Fig. 1), because they are unlikely to embrace or participate in a process of observation unless they fully understand the favorable natural history of AOM and the limited, incremental benefit of antibiotic therapy [26,27]. Copies of the complete Observation Option Toolkit can be obtained from the author by sending a forwarding mailing or e-mail address.
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4. Discussion Although antibiotics are prescribed in the
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United States for nearly all cases of AOM [28], strong evidence suggests a role for observation alone in selected cases [1]. Mounting concerns
Fig. 1. Information sheet distributed to the child’s parent or caregiver whenever the observation option is suggested.
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about the adverse effects of antibiotic therapy, especially accelerated bacterial resistance, mandate that United States physicians reconsider the Dutch observation option. Our experience has been that many clinicians and parents are willing to consider initial observation, but lack the methodology for safe and rational implementation. The toolkit described in this article attempts to fill this void, with simple guidelines (Table 3) and evidence-based educational handouts. Several aspects of the summary guideline in Table 3 deserve emphasis. First, observation is appropriate for initial management of AOM only when follow-up can be assured, and antibiotics can be started if the child fails to improve within 72 h. Selected parents can receive a ‘deferred’ antibiotic, by providing a prescription but requesting that they do not fill it unless initial observation fails [26]. Second, some degree of uncertainty nearly always exists when diagnosing AOM because of the difficulties in detecting MEE. Rather than ignore or deny this uncertainty, we suggest using it to prioritize initial management decisions as outlined in Table 3. In contrast to the Dutch AOM guidelines, we do not recommend the observation option for children aged 6 months to 2 years with a certain diagnosis of AOM (Table 3). Initial observation of this age group may become more acceptable as clinicians begin to immunize of all children 23 months and younger with the heptavalent pneumococcal conjugate vaccine, as recommended by the American Academy of Pediatrics and the Advisory Committee for Immunization Practices [29]. Although the vaccine prevents only 6 – 7% of all AOM, it reduces the incidence of pneumococcal AOM by 34% and vaccine-type AOM by 57% [30,31]. This may eventually shift AOM bacteriology away from Streptococcus pneumoniae towards organisms with better spontaneous resolution and reduced potential for suppurative complications. The guidelines proposed in Table 3 are options, not mandates. To be consistent with the principles of evidence-based medicine, provider experience and patient preference must be a part
of the decision-making process. Provider experience and judgement are needed to assess diagnostic certainty, illness severity, and the ultimate suitability of any particular child for observation or short-course antibiotics. Similarly, patients must be involved through educational handouts (Fig. 1) and by involvement in the discussion of treatment choices. We hope that the Observation Option Toolkit will promote artful care of children with AOM by facilitating an evidencebased dialogue among all involved parties.
Acknowledgements This project would not have been possible without input and feedback from clinician members of the New York Region Otitis Project, including (in alphabetical order): Ellis Arnstein, MD, Pediatrics, New York Floating Hospital; Andrea Berne, CPNP, MPH, Pediatric nurse practitioner, New York private practice; Philip Bonaparte, MD, Robert Wood Johnson University Hospital at Hamilton; Thomas Fischer, MD, Emergency medicine, University Hospital at Stony Brook; Gary Krigsman, MD, New York City Department of Health, School Health Program; Winston Price, MD, Aetna U.S. Health Care, New York; Richard Propp, MD, New York State Department of Health, Office of Medicaid Management; Richard Rosenfeld, MD, MPH, Pediatric Otolaryngology, SUNY Downstate Medical Center; Robert Ruben, MD, Pediatric otolaryngology, Albert Einstein College of Medicine; Bella Sandhaus, R-PAC, Pediatric physician assistant, Brooklyn private practice; Robert Schiller, MD, Family medicine, Beth Israel Medical Center; Paul Shurin, MD, Pediatric infectious disease, Montefiore Medical Center; Denise Spor, RN, New York State Department of Health, Office of Medicaid Management; Michael Tunik, MD, Pediatric emergency medicine, NYU School of Medicine; Denia Varrasso, MD, Community Access to Child Health, District II Facilitator, American Academy of Pediatrics; Lutgarda Vasquez, MD, New York State Department of Health, Hospital Program, MARO.
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