Diagnosing Acute Bacterial Sinusitis in Children and Measuring Treatment Response

描述（由申请人提供）：鼻窦炎是美国第五大最常见的抗菌处方诊断。然而，关于哪些体征、症状或细菌学结果最好地定义儿童鼻窦炎诊断的信息很少。由于缺乏明确的临床诊断标准，医生很难区分急性细菌性鼻窦炎患儿和单纯感冒患儿。建议的研究将检查临床和细菌学结果的诊断价值，单独和结合成临床预测工具，对急性细菌性鼻窦炎。使用这些标准有可能减少对这种经常发生的情况不适当使用抗微生物药物。此外，在鼻窦炎研究中，没有足够有效的方法来衡量治疗反应。由于症状的缓解是抗菌药物治疗的一个重要目标，因此在临床试验中，症状量表是一种衡量结果的理想方法。开发有效的症状量表，这是本提案的第二个目标，将使研究人员能够比较急性鼻窦炎儿童各种治疗策略的有效性。我们将招募260名疑似鼻窦炎的2-12岁儿童作为前瞻性队列。在基线时，我们将收集有关体征和症状的详细信息，并进行鼻咽培养。所有儿童都将接受鼻窦x线摄影；有鼻窦炎放射学证据的患者将接受大剂量阿莫西林-克拉维酸治疗，并使用初步症状量表随访10天。我们将利用这些信息来确定哪些发现可以最好地识别由x线片阳性定义的急性鼻窦炎儿童，并验证症状量表，以便在未来的试验中使用。这项初步工作将为一项明确的多中心随机安慰剂对照研究奠定必要的基础，以评估抗菌治疗对急性细菌性鼻窦炎儿童的疗效。临床预测规则将为本研究的纳入标准提供依据，症状量表将作为评价结果的主要指标。公共卫生相关性：使用本研究确定的标准，从业人员将能够更准确地区分需要抗生素的急性鼻窦炎儿童和不需要抗生素的感冒儿童。此外，我们还将开发一种症状量表，使研究人员能够比较不同治疗策略对急性细菌性鼻窦炎儿童的有效性。

DESCRIPTION (provided by applicant): Sinusitis is the 5th most common diagnosis warranting an antimicrobial prescription in the US. However, little information is available regarding which signs, symptoms, or bacteriologic findings best define a diagnosis of sinusitis in children. Without clear clinical diagnostic criteria, practitioners have had difficulty differentiating children with acute bacterial sinusitis from children with simple colds. The proposed research will examine the diagnostic value of clinical and bacteriologic findings, individually and combined into a clinical prediction tool, for acute bacterial sinusitis. Use of these criteria has the potential to reduce inappropriate antimicrobial use for this frequently occurring condition. Furthermore, there are no adequately validated methods of measuring treatment response in sinusitis studies. Since resolution of symptoms is an important goal of antimicrobial therapy, a symptom scale would logically be a desirable method of measuring outcome in clinical trials. Development of a valid symptom scale, which is the second aim of this proposal, will allow researchers to compare the effectiveness of various treatment strategies in children with acute sinusitis. We will enroll a prospective cohort of 260 children aged 2-12 years with suspected sinusitis. At baseline, we will collect detailed information regarding signs and symptoms, along with a culture from the nasopharynx. All children will undergo sinus radiography; those with radiographic evidence of sinusitis will be treated with high- dose amoxicillin-clavulanate and followed for 10 days using a preliminary symptom scale. We will use this information to determine which findings best identify children with acute sinusitis as defined by positive radiographs and to validate a symptom scale for use in future trials. This preliminary work will lay the necessary groundwork for a definitive multicenter randomized placebo- controlled study evaluating the efficacy of antimicrobial therapy in children with acute bacterial sinusitis. The clinical prediction rule will inform the inclusion criteria for the study and the symptom scale will be used as the primary outcome measure of outcome. PUBLIC HEALTH RELEVANCE: Using criteria identified through this study, practitioners will be able to more accurately separate children with acute sinusitis who need antibiotics from children with colds who do not. In addition, we will also develop a symptom scale which will allow researchers to compare the effectiveness of different treatment strategies for children with acute bacterial sinusitis.