Diagnosing Acute Bacterial Sinusitis in Children and Measuring Treatment Response

描述(由申请人提供)：鼻窦炎在美国最常见的诊断中排名第五，需要开抗菌药物处方。然而，关于哪些体征、症状或细菌学结果最能确定儿童鼻窦炎的诊断，几乎没有信息可用。在没有明确的临床诊断标准的情况下，医生很难区分急性细菌性鼻窦炎儿童和单纯感冒儿童。这项拟议的研究将检验临床和细菌学结果单独并结合成临床预测工具对急性细菌性鼻窦炎的诊断价值。这些标准的使用有可能减少这种多发疾病的不适当的抗菌药使用。此外，在鼻窦炎研究中还没有得到充分验证的测量治疗反应的方法。由于症状的缓解是抗菌治疗的一个重要目标，在临床试验中，症状评定表在逻辑上将是衡量结果的理想方法。开发有效的症状量表，这是该提案的第二个目标，将使研究人员能够比较各种治疗策略对儿童急性鼻窦炎的有效性。我们将登记260名2-12岁疑似鼻窦炎儿童的前瞻性队列。在基线阶段，我们将收集有关体征和症状的详细信息，以及鼻咽培养。所有儿童都将接受鼻窦X光检查；有鼻窦炎放射学证据的儿童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进行为期10天的随访。我们将使用这些信息来确定哪些发现最能识别阳性X线片所定义的急性鼻窦炎儿童，并验证用于未来试验的症状量表。这项初步工作将为评估儿童急性细菌性鼻窦炎抗菌治疗效果的多中心、随机、安慰剂对照研究奠定必要的基础。临床预测规则将为研究的纳入标准提供信息，症状评分将作为结果的主要结果衡量标准。公共卫生相关性：使用通过这项研究确定的标准，从业者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儿童急性细菌性鼻窦炎的疗效。

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.