Evidence Report/Technology Assessment: Number 9, Supplement
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Under its Evidence-based Practice Program, the Agency for Healthcare Research and Quality (AHRQ) is developing scientific information for other agencies and organizations on which to base clinical guidelines, performance measures, and other quality improvement tools. Contractor institutions review all relevant scientific literature on assigned clinical care topics and produce evidence reports and technology assessments, conduct research on methodologies and the effectiveness of their implementation, and participate in technical assistance activities.
Background / Research Questions / Methodology / Results / Conclusion / Availability of Full Report
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.
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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?
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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 (Medical Subject Headings) 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. One hundred and thirty-eight 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. 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.
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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 were either 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 80.3 percent (303/377). Bacteriological data were too scanty and meaningless to combine, and reporting of safety data was erratic. Discontinuation of treatment due to 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 and 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 radiograph 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, non-clear irrigation fluid had no correlation with the presence of pathogenic microorganisms.
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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.
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Availability of the Full Report
The full evidence report from which this summary was taken was prepared for the Agency for Healthcare Research and Quality by the New England Medical Center, Boston, MA, under contract 290-97-0019. This Supplement is available online on the National Library of Medicine Bookshelf. The original report, Diagnosis and Treatment of Acute Bacterial Rhinosinusitis, which is focused on adults, is also available on the National Library of Medicine Bookshelf. Print copies of these publications are no longer available.
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AHCPR Publication Number 01-E007
Current as of October 2000