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The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments.
To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the nation. The reports undergo peer review prior to their release.
AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality.
We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852.
| Douglas B. Kamerow, M.D. | John M. Eisenberg, M.D. |
| Director, Center for Practice and Technology Assessment | Director |
| Agency for Healthcare Research and Quality | Agency for Healthcare Research and Quality |
| The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Health Care Policy and Research or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service. |
Objectives. This report evaluates and analyzes the existing evidence for the diagnosis and treatment of acute uncomplicated sinusitis in children.
Search Strategy. Human studies of sinusitis were identified using MEDLINE (from 1966 to March 1999), technical experts, and bibliographies.
Selection Criteria. A systematic review and meta-analysis considered all pertinent studies that included at least 10 children younger than 18 years of age with symptoms of uncomplicated acute bacterial rhinosinusitis of less than 30 days duration. Only diagnostic studies that compared two or more tests were used. Both randomized and nonrandomized controlled trials were included to assess treatment efficacy.
Analysis. The analysis focused on clinical improvement rates for intervention studies of antibiotics or ancillary measures and the concordance of diagnostic tests, expressed as likelihood ratios.
Main Results. Of 1,857 citations reviewed, the authors identified 21 qualifying studies, compared with 450 reports on complications of acute sinusitis and 233 nonsystematic reviews of the subject, which did not qualify for inclusion. The qualifying studies included five randomized trials and eight case series on antibiotic therapy, three randomized trials on ancillary treatments, and eight studies with information on diagnostic tests (including three of the therapeutic trials). Definitions and inclusion criteria were heterogeneous across studies. The pooled clinical improvement rate with antibiotics was 87.6 percent (177/202) in randomized trials and 92.2 percent (318/345) in nonrandomized studies (p = 0.08). The respective improvement rates without antibiotics were 60 percent and 80 percent. Improvement rates were significantly higher in nonrandomized studies (odds ratio, 1.79; 95 percent confidence interval [CI], 1.05-3.04). Data on ancillary measures were sparse and heterogeneous. In studies with both clinical and plain film radiography, the pooled rate of abnormal radiographic findings against a clinical diagnosis of sinusitis was 73.2 percent (596/814; range 55.4 percent to 96 percent among studies). There was poor concordance between clinical criteria, plain film radiography, ultrasonography, computed tomography, and fluid on aspiration in all available paired assessments; all positive likelihood ratios were < 4.0, and all negative likelihood ratios were > 0.2.
Conclusions. High-quality evidence for acute uncomplicated sinusitis in children is very limited. Diagnostic modalities show poor concordance, and treatment options are based on inadequate data. More evidence is needed for this very common condition.
This document is in the public domain and may be used and reprinted without permission.
Suggested citation: Lau J, Ioannidis JP, Wald ER. Diagnosis and treatment of uncomplicated acute sinusitis in children. Evidence report/technology assessment no. 9, supplement (contract 290-97-0019 to New England Medical Center). AHRQ publication no. 01-E005. Rockville, MD: Agency for Healthcare Research and Quality. October 2000.
In March 1999, the Agency for Healthcare Research and Quality (previously the Agency for Health Care Policy and Research) published the original Evidence Report/Technology Assessment No. 9, Diagnosis and Treatment of Acute Bacterial Rhinosinusitis, which was prepared by the New England Medical Center Evidence-based Practice Center (EPC) under contract to the Agency. The original report used relevant, high-quality studies, but they dealt mostly with the diagnosis and treatment of acute rhinosinusitis in adults. In preparing that report, the EPC found only two randomized controlled trials that were devoted exclusively to the efficacy of using antibiotics to treat this condition in children.
This supplement was developed by the EPC to identify and analyze evidence from nonrandomized studies that pertains to the diagnosis and therapeutic management of acute sinusitis in children. Compared with adults, children have a different and constantly evolving sinus anatomy, and they probably have an increased incidence of upper respiratory tract infections.
This report deals with uncomplicated acute sinusitis, which is typically defined by symptoms that have persisted for less than 30 days. The following research questions were used to guide the analysis:
What is the evidence for the efficacy of various antibiotics in children with a diagnosis of acute sinusitis?
What is the evidence for the efficacy of various ancillary regimens that do not include antibiotics in the treatment of children with acute sinusitis?
What is the diagnostic accuracy and concordance of clinical symptoms, radiography and other imaging methods, and aspiration for the diagnosis of acute sinusitis in children?
Studies were included in this report-regardless of study design-if they were pertinent to the research questions, involved only patients younger than 18 years of age (or included subgroups of patients under age 18 that could be readily identified in the data), included at least 10 children, and involved only children who had been symptomatic for less than 30 days. Studies of chronic sinusitis were excluded, as were studies limited to complications (neurologic, local soft tissue, or other) of acute sinusitis.
To identify relevant studies, the authors of the report searched MEDLINE using a broad search strategy covering the period from 1966 to March 1999. The word "sinusitis" was used in the search as a text word and as a MeSH term. Search results were limited to English-language, human studies that included pediatric patients. The titles and abstracts of 1,857 citations were retrieved and screened; 1,719 articles were rejected immediately on the basis of their titles and abstracts. The remaining 138 articles not examined for the previous report were retrieved in full and examined. These articles included mostly nonrandomized studies and a few new randomized trials. A total of 21 studies ultimately qualified for inclusion in the supplement, including five randomized trials and eight nonrandomized studies on antibiotic therapy. These 13 studies were published between 1970 and 1997 and with two exceptions had been conducted at single centers by pediatricians or otolaryngologists. The largest case series had only 106 patients, and the largest randomized controlled trial had only 93 patients. Overall, 255 children were studied in the five randomized controlled trials, and 418 children were studied in the eight nonrandomized studies.
Eight of the 13 studies of antibiotic therapy did not specify the duration of symptoms, and therefore the diagnosis of "acute sinusitis" was not certain. Puncture for aspiration/irrigation was performed in selected children in six studies. Positive radiographic findings were required for the diagnosis of acute sinusitis in nine of the 13 studies, and no other imaging was performed. Clinical symptoms and signs typically were key factors in diagnosis, but there was substantial variation in the way sinusitis was diagnosed and in the prevalence of specific symptoms and signs.
A large array of antibiotics was tested. A placebo arm was present in two randomized controlled trials, and a "no antibiotic treatment group" was included in one of the case series. The duration of treatment varied from 3 to 28 days. The two shorter courses (3 and 5 days) were with azithromycin; all other studies involved at least 7 days of therapy. Decongestants either were reported to be routinely prescribed, or their use was not mentioned at all. One randomized controlled trial looked at whether lavage provided additional benefit.
Response to treatment was assessed typically after 7 to 14 days and, in some cases, later. With the limited data available, the clinical improvement rate with antibiotics was estimated at 87.6 percent (177/202) in randomized controlled trials and 92.2 percent (318/345) in nonrandomized studies. The rate of improvement without antibiotics was 66 percent (33/50). It was 60 percent (21/35) in one randomized trial and 80 percent (12/15) in one observational study.
Response data were available from five imaging (plain film radiography or ultrasound) studies, with an overall improvement rate of 80.4 percent (303/377). Bacteriological data were too scanty and meaningless to combine, and reporting of safety data was erratic. Discontinuation of treatment because of adverse effects was mentioned only in the two largest randomized trials and in three of the eight nonrandomized studies.
Three trials, with a total of 243 patients, studied the efficacy of ancillary measures in the treatment of acute sinusitis in children. One study enrolled children who had sinusitis on the basis of ultrasonography in the absence of any symptoms and addressed the value of lavage versus no lavage on top of background therapy with amoxicillin and phenylpropanolaminohydrochloride. The pertinence of this study to clinical practice is highly questionable. The other two trials evaluated in a double-blind fashion the efficacy of steroid or combination agents (nasal spray budesonide and a combination of nasal oxymetazoline in addition to oral brompheniramine or phenylpropanolamine, respectively) against placebo. None of the three studies used cure-improvement-failure categorization for clinical outcomes. No significant difference was found at any of the addressed time points, except for a superiority of budesonide over placebo at the end of 2 weeks in terms of the clinical score.
A total of eight studies provided some data on the performance of diagnostic tests. Five of these studies addressed the comparative diagnostic accuracy of at least two diagnostic procedures in acute sinusitis in children. Two of the randomized controlled trials on therapeutic measures provided data on percentage of abnormal radiographs among children with symptoms of sinusitis. One study compared ultrasound and radiography in a subgroup of children found incidentally to have sinusitis by occipitomental radiography when they were hospitalized for adenotonsillectomy or adenoidectomy. Typically, radiologists and/or otolaryngologists, rather than general pediatricians, authored the reports, and the study population usually was not adequately defined in terms of symptom duration.
One study found good correlation between ultrasonographic findings and retrieval of fluid upon aspiration, but cultures of the aspirate from 59 sinuses yielded microbial pathogens in less than half (26/59) of the cases. The only study to compare ultrasonography with plain radiography and sinus fluid abnormalities in children with a clinical picture of sinusitis found very low concordance between these diagnostic techniques. Moreover, nonclear irrigation fluid had no correlation with the presence of pathogenic microorganisms.
This report examined the available evidence from randomized trials and nonrandomized studies on the diagnosis and management of acute sinusitis in children. The major conclusion is that, compared with the frequency of this very common condition, the amount of high-quality evidence is remarkably limited.
There is very little evidence on how to accurately diagnose acute sinusitis in childhood. Plain film radiography shows only modest concordance with clinical diagnosis, and the concordance depends largely on how a clinical diagnosis is defined. Other imaging modalities and irrigation have no clear role in the diagnostic management of the syndrome. There is no consensus on which clinical signs and symptoms are most useful for diagnosing this condition, and very limited attention has been given to this issue. Although one small trial found antibiotics to be superior to placebo, its applicability to settings in which sinusitis is defined by different criteria is uncertain. The available evidence also suggests that the various antibiotics used for pediatric sinusitis do not differ in their efficacy rates. In the absence of a gold standard for diagnosis, trials involving several hundred children would be needed to show such differences. Finally, there is no convincing evidence to support the use of ancillary treatment with decongestant-antihistamines and very limited evidence on the use of steroids.
This investigation clearly documents the paucity of the evidence and identifies important questions that need to be addressed in future studies. The paucity of primary data may be due to the difficulties when studying a pediatric population of applying the necessary rigorous methodologies that are needed to generate high-quality information. Obviously, more evidence-based research on this common infection is needed.
In March 1999, the Agency for Healthcare Research and Quality (previously the Agency for Health Care Policy and Research) published the original Evidence Report/Technology Assessment No. 9, Diagnosis and Treatment of Acute Bacterial Rhinosinusitis (Lau, Zucker, Engels, et al., 1999), which we at the New England Medical Center Evidence-based Practice Center (EPC) prepared under contract to the Agency. This original report dealt mostly with treatment of acute rhinosinusitis in adults. In preparing that report, our EPC found only two randomized controlled trials that were devoted exclusively to the efficacy of using antibiotics to treat this condition in children (Wald, Chiponis, and Ledesma-Medina, 1986; Wald, Reilly, Casselbrant, et al., 1984).
For this supplemental report, our objective was to identify and analyze evidence from nonrandomized studies that pertains to the diagnosis and therapeutic management of acute sinusitis in children. Compared with adults, children have a different and constantly evolving sinus anatomy, and they probably have an increased incidence of upper respiratory tract infections.
With these differences in mind, the main questions addressed in this report are as follows:
What is the evidence for the efficacy of various antibiotics in children with a diagnosis of acute sinusitis?
What is the evidence for the efficacy of various ancillary regimens that do not include antibiotics in the treatment of children with acute sinusitis?
What is the diagnostic accuracy and concordance of clinical symptoms, radiography and other imaging methods, and aspiration for the diagnosis of acute sinusitis in children?
As in the original evidence report, we focused on acute uncomplicated bacterial sinusitis. Inflammation of the paranasal sinuses may be accompanied by inflammation of the nasal passages. As such, the clinical condition termed "sinusitis" may in fact be rhinosinusitis. We excluded cases where clinically evident neurological, soft tissue, or other complications were present. Usually, these cases present as medical or surgical emergencies. Acute sinusitis is defined typically by symptoms that have persisted for less than 30 days. We did not attempt to separate bacterial from nonbacterial cases in the considered reports, as this would have been impossible. But, obviously, determining the effectiveness of antibiotic management is important for the treatment of cases with a bacterial etiology.
Cure, improvement, and treatment failure definitions are based on the original reports. Cures and failures were recorded as defined by the individual study. Cure generally meant resolution of all signs and symptoms, and failure generally signified no change or a worsening of signs and symptoms. Finally, in the absence of a gold standard for diagnosing "acute uncomplicated bacterial rhinosinusitis" (other than sinus aspiration and culture, which is very infrequently used), diagnostic parameters in the comparison of diagnostic methods should be interpreted as estimates of concordance between these diagnostic modalities rather than proof of diagnostic accuracy or lack thereof.
Studies qualified for inclusion in this report regardless of study design if they
Were pertinent to the questions identified above.
Studied only patients younger than 18 years of age (or included subgroups of patients under age 18 that could be readily identified in the presented data).
Included at least 10 children.
Included only patients who were symptomatic for less than 30 days.
Studies of chronic sinusitis were excluded. Subgroup data on acute sinusitis in studies with 10 or more patients in which both acute and chronic sinusitis or other infections were considered qualified for inclusion in this evidence report. Studies limited to complications (neurologic, local soft tissue, or other) of acute sinusitis were excluded.
We searched MEDLINE using a broad search strategy covering the period from 1966 to March 1999. The word "sinusitis" was used in the search as a text word and as a MeSH term. We then limited the search results to human studies and English-language studies that included pediatric patients using the terms "infant, newborn," "infant," "child, preschool," "child," and "adolescent." The titles and abstracts of the resulting 1,857 citations were retrieved and screened for articles that might have data on treatment of acute sinusitis in children. We immediately rejected 1,719 papers on the basis of their titles and abstracts. Notably, these included 450 articles on complications of acute sinusitis and 233 nonsystematic review articles without original data. The remaining 138 articles not previously examined in the earlier evidence report (Lau, Zucker, Engels, et al., 1999) were retrieved in full and examined. These articles included mostly nonrandomized studies and a few new randomized trials. A total of 21 studies ultimately qualified for inclusion in this supplemental report.
Given the paucity and heterogeneity of the data for specific questions, we did not attempt the application of formal meta-analytic techniques in most circumstances. When possible, rates were pooled across different studies, and heterogeneity was assessed with a chi-square statistic. Odds ratios for efficacy (clinical improvement) were also estimated by the Mantel-Haenszel formula stratified per antibiotic use.
For diagnostic modalities, we expressed concordance by using the positive likelihood ratio, which is calculated as
LR+ = sensitivity/(1-specificity)
and the negative likelihood ratio, which is calculated as
LR- = (1-sensitivity)/specificity
The positive likelihood ratio gives an estimate of how much more common a specific diagnostic finding is in the positive group versus the negative group as defined by a different diagnostic standard. The higher the positive likelihood ratio, the better the concordance of the two diagnostic modalities. A positive likelihood ratio of 1 shows there is no concordance. The positive likelihood ratio can take values up to infinity. There is no threshold value that characterizes a test of very good diagnostic performance, but values less than 5 probably are not sufficient. For example, a positive likelihood ratio of 5 corresponds to a sensitivity of 50 percent with specificity of 90 percent or a sensitivity of 90 percent with specificity of 82 percent. The inverse considerations hold true for the negative likelihood ratio, where good concordance is shown by diminishing values. A negative likelihood ratio of 1 also shows lack of concordance.
All reported p-values are two-tailed.
In 30 of the 68 randomized trials identified in the earlier report (Lau, Zucker, Engels, et al., 1999), the age range of the enrolled patients extended to less than 18 years, but no separate data on children under 18 years of age were available; most of the patients presumably were adults. Of these 30 trials, 23 had a lower age limit of between 12 and 17 years, and for another five it was 10 or 11 years. For all these 30 excluded studies, the upper age limit was 60 years or undefined, except for one study with an upper limit of 40 years. The remaining 38 randomized trials either included only adults or did not report any age data.
The 13 qualifying studies of antibiotic therapy had been published between 1970 and 1997 and with two exceptions had been conducted at single centers by pediatricians or otolaryngologists. Nine of the 13 reports, including six of the eight nonrandomized studies, originated outside the United States. Pharmaceutical sponsorship was clearly mentioned in four cases, but it is probable that most of these studies were funded by the pharmaceutical industry. The largest case series had only 106 patients, and the largest randomized controlled trial had only 93 patients. Overall, 255 children were studied in the five randomized controlled trials, and 418 children were studied in the eight nonrandomized studies. Eight of the 13 reports did not specify the duration of symptoms, and therefore we could not be certain of the diagnosis "acute sinusitis." Puncture for aspiration/irrigation was performed in selected children in six studies. Positive radiographic findings (typically combinations of air-fluid level, opacification, and/or mucous thickening criteria) were required for the diagnosis of acute sinusitis in nine of the 13 studies; no other imaging was performed in these studies. Clinical symptoms and signs typically were key factors in diagnosis, but there was substantial variation in the way sinusitis was diagnosed and in the prevalence of specific symptoms and signs.
As shown in Evidence tables 1a--1e, a large array of antibiotics was tested. A placebo arm was present in two randomized controlled trials (Jeppesen and Illum, 1972; Wald, Chiponis, and Ledesma-Medina, 1986), and a "no antibiotic treatment group" was included in one of the case series (Aitken and Taylor, 1998). The duration of treatment varied between 3 and 28 days. The two shorter courses (3 and 5 days) were with azithromycin, which results in high drug levels for several days after its discontinuation. All other studies involved at least 7 days of therapy. Either decongestants were reported to be routinely prescribed, or their use was not mentioned at all. One randomized controlled trial looked at whether lavage provided additional benefit (Jeppesen and Illum, 1972).
Response data were available from five imaging (plain film radiography or ultrasound) studies (Helin, Andreasson, Jannert, et al., 1982; Herz and Gfeller, 1977; McLean, 1970; Revonta and Suonpaa, 1982; Wald, Reilly, Casselbrant, et al., 1984), yielding an overall improvement rate of 80.43 percent (303/377). Bacteriological data were too scanty and meaningless to combine. Reporting of safety data was erratic. Discontinuation of treatment because of adverse effects was mentioned only in the two largest randomized trials (Careddu, Bellosta, Tonelli, et al., 1993; Wald, Chiponis, and Ledesma-Medina, 1986) and in three of the eight nonrandomized studies (Gurses, Kalayci, Islek, et al., 1996; Hager, Bamberg, Dorn, et al., 1980; Herz and Gfeller, 1977).
Of the 12 randomized trials on ancillary measures identified as part of the previous report (Lau, Zucker, Engels, et al., 1999), only three trials (Barlan, Erkan, Bakir, et al., 1997; McCormick, John, Swischuk, et al., 1996; Revonta and Suonpaa, 1982) with a total of 243 patients studied the efficacy of ancillary measures in the treatment of acute sinusitis in children (Evidence tables 2a--2d). The age range of patients in the remaining nine trials extended to as low as 9 to 20 years (>12 years in seven trials). No separate data on children were provided, and most of the enrolled patients presumably were adults (upper age limit of 62 or undefined).
Of the three qualifying trials (Barlan, Erkan, Bakir, et al., 1997; McCormick, John, Swischuk, et al., 1996; Revonta and Suonpaa, 1982), one enrolled children who had sinusitis on the basis of ultrasonography in the absence of any symptoms and addressed the value of lavage versus no lavage on top of background therapy with amoxicillin and phenylpropanolaminohydrochloride (Revonta and Suonpaa, 1982). The pertinence of this study to clinical practice is highly questionable. The other two trials (Barlan, Erkan, Bakir, et al., 1997; McCormick, John, Swischuk, et al., 1996) evaluated in a double-blind fashion the efficacy of steroid or combination agents (nasal spray budenoside and a combination of nasal oxymetazoline in addition to oral brompheniramine or phenylpropanolamine, respectively) against placebo.
None of the three studies used cure-improvement-failure categorization for clinical outcomes. The study on lavage used strictly ultrasonographic criteria (Revonta and Suonpaa, 1982). The other two (Barlan, Erkan, Bakir, et al., 1997; McCormick, John, Swischuk, et al., 1996) used composite clinical and/or radiologic scores. No significant difference was found at any of the addressed time points, except for a superiority of budenoside over placebo at the end of 2 weeks in terms of the clinical score. In the Barlan, Erkan, Bakir, et al. study (1997), only 89 of the 151 enrolled patients received sufficient followup to be included in the analysis.
Eight studies provided some data on the performance of diagnostic tests. Five studies (Glasier, Mallory, and Steele, 1989; Jannert, Andreasson, Helin, et al., 1982; Kogutt and Swischuk, 1973; van Buchem, Peeters, and Knottnerus, 1992; Watt-Boolsen and Karle, 1977) addressed the comparative diagnostic accuracy of at least two diagnostic procedures in acute sinusitis in children (Evidence tables 3a--3d). In addition, two of the randomized controlled trials on therapeutic measures (Barlan, Erkan, Bakir, et al., 1997; Wald, Chiponis, and Ledesma-Medina, 1986) provided data on percentage of abnormal radiographs among children with symptoms of sinusitis. One study (Revonta and Suonpaa, 1982) compared ultrasound and radiography in a subgroup of children found incidentally to have sinusitis by occipitomental radiography when they were hospitalized for adenotonsillectomy or adenoidectomy. These studies were very heterogeneous. Five studies (Barlan, Erkan, Bakir, et al., 1997; Jannert, Andreasson, Helin, et al., 1982; Revonta and Suonpaa, 1982; van Buchem, Peeters, and Knottnerus, 1992; Watt-Boolsen and Karle, 1977) originated outside the United States. Typically, radiologists and/or otolaryngologists, rather than general pediatricians, authored the reports. The study population usually was not adequately defined in terms of symptom duration.
Similar rates of abnormal radiographs were also seen in the two randomized controlled trials that used strict clinical criteria for the diagnosis of acute sinusitis. Wald, Chiponis, and Ledesma-Medina (1986) defined sinusitis by the presence of any nasal discharge and/or cough that was not improving for 10--30 days. Barlan, Erkan, Bakir, et al. (1997) defined sinusitis by the presence of at least two of three major criteria (purulent nasal discharge, pharyngeal discharge, cough) or one of these plus two of nine minor criteria with a duration of at least 7 days. In these two randomized controlled trials, abnormal radiographs were seen in 136/171 (79.5 percent) and 69/89 (77.5 percent) of children with a clinical diagnosis, respectively. The other three studies that present data on radiography and clinical diagnosis do not specify a priori explicit criteria for the clinical diagnosis of acute sinusitis (Kogutt and Swischuk, 1973; van Buchem, Peeters, and Knottnerus, 1992; Watt-Boolsen and Karle, 1977). One study simply lists the percentage of various symptoms (Kogutt and Swischuk, 1973), while another (Watt-Boolsen and Karle, 1977) does not give any clinical information on signs and symptoms. The third study (van Buchem, Peeters, and Knottnerus, 1992) states that the distinction between "sinusitis" and "rhinitis" was based on the impression of the clinician. Interestingly, the "rhinitis" group did not differ from the "sinusitis" group in the prevalence of fever, purulent secretion, sinus tenderness, or headache. The only differences between the two groups were in cough (54/68 [79.4 percent] vs. 39/79 [49.4 percent]) and prolonged runny nose (72 percent vs. 36 percent), but these differences were not impressive.
This report examined the available evidence from randomized trials and nonrandomized studies on the diagnosis and management of acute sinusitis in children. The major conclusion is that, considering the frequency of this very common condition, the amount of high-quality evidence is remarkably limited. It is important to note that most randomized data on adolescents may have been inextricably merged with data on adults in previous studies, and it is unclear whether adolescents should differ from adults in the diagnosis and management of acute sinusitis. However, for the purely pediatric population, evidence is sparse.
There is very little evidence on how to accurately diagnose acute sinusitis in childhood. Plain film radiography shows only modest concordance with clinical diagnosis, and the concordance depends largely on how a clinical diagnosis is defined. Other imaging modalities and irrigation have no clear role in the diagnostic management of the syndrome. There is no consensus on which clinical signs and symptoms are most useful for diagnosing this condition, and very limited attention has been given to this issue. Although one small trial has shown the superiority of antibiotics over placebo, its applicability to settings where sinusitis is defined by different criteria is uncertain. The available evidence also suggests that the various antibiotics used for pediatric sinusitis do not differ in their efficacy rates. Nevertheless, given the sparse evidence, modest differences could have been missed. In the absence of a gold standard for diagnosis, trials involving several hundred children would be needed to show such differences. There is no convincing evidence to support the use of ancillary treatment with decongestant-antihistamines and very limited evidence on the use of steroids.
On the basis of the current evidence, it is difficult to specify the prime clinical criteria for diagnosing acute sinusitis in children and which diagnostic tests are warranted. Many traditional clinical criteria seem to have no discriminating ability between sinusitis and rhinitis. It is possible that these entities are very difficult, if not impossible, to separate and that they may co-exist to some extent in most cases. The term "acute rhinosinusitis" thus may be more appropriate and may need to replace the term "acute sinusitis." Radiographs appear to be abnormal in approximately 80 percent of cases where strict clinical criteria have been applied (Barlan, Erkan, Bakir, et al., 1997; Jannert, Andreasson, Helin, et al., 1982; Wald, Chiponis, and Ledesma-Medina, 1986), but the rates of abnormal plain film radiographsy are substantially lower when clinical criteria are less strict. However, there is insufficient evidence regarding any of the imaging modalities, CT is considered expensive for routine use, and sinus aspiration is invasive and cumbersome. Concordance of the different diagnostic modalities seems to be very low, but additional data are warranted. In the absence of a true "gold standard," even diagnostic concordance would not be equivalent to diagnostic accuracy, and the role of any diagnostic tests, including plain film radiography, in the management of acute uncomplicated rhinosinusitis is uncertain. A decision analysis in our original evidence report (Lau, Zucker, Engels, et al., 1999) suggests that imaging studies may not be cost effective at any level of suspected acute bacterial rhinosinusitis. It is possible the condition may be overdiagnosed and overtreated currently in some community settings (Aitken and Taylor, 1998). On the other hand, in the absence of clear "gold standard" diagnostic criteria, it also conceivably could be underdiagnosed and undertreated in other settings.
The therapeutic management of acute uncomplicated sinusitis is even more controversial. Given the very high rates of spontaneous resolution, there is no evidence to support the use of antibiotic therapy in children with a low likelihood of acute bacterial sinusitis. Antibiotics showed superiority to placebo in a population defined by nasal discharge or cough that were not improving for at least 10 days and had positive radiographs. Perhaps obtaining a radiograph is not necessary if these clinical criteria exist for more than 10 days, since almost 80 percent of these children would have a positive radiograph. Empirical treatment with antibiotics may be warranted in such cases. However, it is unlikely that the use of antibiotics can be supported by the data in other groups of children, such as those without nasal discharge or cough, those with shorter duration of symptoms, and those with improving symptoms. Spontaneous recovery rates in these groups are likely to be too high for antibiotics to offer any meaningful benefit.
In addition, if antibiotic treatment is prescribed, limited evidence supports the use of amoxicillin initially, unless there is a history of allergy to beta-lactams. There is no evidence currently that newer broad-spectrum antibiotics offer any advantage over amoxicillin, and convincing data from studies of adults show the equivalence of amoxicillin to such antibiotics for the treatment of acute sinusitis. Nevertheless, the applicability of the adult findings to children and the clinical relevance, if any, of increasing resistance rates among common pathogens need to be documented in properly designed studies.
Finally, the current evidence does not offer any clear indication for the use of ancillary measures. Although antihistamines and decongestants are routinely used, there is no strong randomized evidence to justify their use in children. Randomized evidence for the use of steroids comes from a single small trial (Barlan, Erkan, Bakir, et al., 1997). Clearly, more evidence is needed to clarify the appropriate use of these agents.
The strongest message conveyed in this report is the paucity of the evidence. In addition, we identify several important questions that need to be addressed in future studies. We were surprised to find that despite the presence of an extensive bibliography on sinusitis in children, actual evidence on the diagnosis and management of acute uncomplicated sinusitis in children is very limited. We encountered over 450 reports on complications of sinusitis, mostly case reports or case series. While it is important to know about the rare complications of this disease, it is questionable whether all these case reports and small case series give us really useful information, when in comparison only a few studies deal with common, uncomplicated forms of the infection. We also were surprised at the number of reviews we encountered in our search: a total of 233 nonsystematic review articles, compared with 21 primary studies with analyzable original data. The paucity of primary data may be dueresult from to the difficulties encountered when studying a pediatric population of applying the necessary rigorous methodologies that are needed to generate high-quality information. Obviously, more evidence-based research on this common infection is needed.
amox= amoxicillin
ct= computed tomography
cl= clinical
d= day
dis= discharge
dx= diagnosis
ent= ear, nose, and throat
gp= general practice
hx= history
ped= pediatric
pharm= pharmaceutical
pn= postnasal
rad= radiology
rct= randomized controlled trial
rx= medication
sx= symptoms
urti= upper respiratory tract infection
us= ultrasound
