RCT to evaluate guidelines for acute rhinosinusitis

评估急性鼻窦炎指南的随机对照试验

• 批准号: 7233235
• 负责人: Jane M Garbutt
• 金额: $ 33.96万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-01 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7233235
• 关键词: Acute; Adult; Amoxicillin; Analgesics; Antibiotic Therapy; Antibiotics; Bacterial Infections; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Communities; Decision Making; Decongestants; Diagnosis; Diagnostic; Direct Costs; Disease; Effectiveness; Enrollment; Facial Pain; Future; Guidelines; Knowledge; Maxilla; Measures; Morbidity - disease rate; Multivariate Analysis; Nose; Oral; Outcome; Outcome Measure; Patient Care; Patients; Pharmaceutical Preparations; Placebos; Primary Health Care; Productivity; Public Health; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recommendation; Recurrence; Research; Research Design; Series; Sinus; Sinusitis; Site; Symptoms; Telephone Interviews; Testing; Treatment Effectiveness; Treatment Protocols; United States National Institutes of Health; acute rhinosinusitis; cost; day; functional status; improved; inclusion criteria; instrument; prognostic; randomized placebo controlled trial; rhinosinusitis; satisfaction; treatment effect

DESCRIPTION (provided by applicant): Sinusitis is a common problem associated with significant patient morbidity, lost productivity and cost. Accurate diagnosis of bacterial disease is not possible in the ambulatory setting, and antibiotics are overused. There are few studies that assess the effectiveness of antibiotic therapy, and study inclusion criteria severely limit the generalizability of their findings to inform primary care management. To reduce the excessive use of antibiotics, the Centers for Disease Control and Prevention (CDC) and an expert panel recommended that 1) antibiotic treatment be reserved for patients with moderate or severe symptoms that persist for at least seven days and include maxillary or facial pain and purulent nasal secretions, and 2) initial antibiotic treatment be a narrow-spectrum drug. The effectiveness of these treatment recommendations has not been evaluated. The objective of this study is to determine the incremental benefit of amoxicillin added to a regimen of symptomatic treatments in patients diagnosed with acute bacterial rhinosinusitis using clinical criteria. We will conduct a.double-blinded, randomized, placebo-controlled trial in the primary care setting. Two hundred adult patients who meet the CDC recommended diagnostic criteria for acute bacterial rhinosinusitis will be randomized to receive a 10-day course of either amoxicillin or placebo. In addition, all patients will receive symptomatic treatments including an analgesic, an oral decongestant and an anti-tussive agent. Patient outcomes will be assessed by telephone interview at 3, 7, 10 and 28 days. The primary outcome measures will be the effect of treatment on the disease-specific quality of life, measured with a validated evaluative instrument, the Sino-Nasal Outcome Test-16 (SNOT-16). Secondary outcomes will include the effect of treatment on change in functional status and symptoms, disease recurrence, satisfaction with care and the direct costs of treatment. We propose the current study as the first in a series of studies designed to determine the most effective primary care management of patients with acute rhinosinusitis. We will evaluate symptomatic treatments in future studies. The relevance of this research to public health is that it will provide knowledge about how to best care for patients with acute sinusitis, a common problem that is cared for in the community. In addition, knowledge gained from this research could be used to decrease the inappropriate use of antibiotics.

描述（由申请人提供）：鼻窦炎是一个常见的问题，与严重的患者发病率，生产力失去和成本相关。在门诊环境中，无法准确诊断细菌疾病，并且抗生素被过度使用。很少有研究评估抗生素疗法的有效性，并且研究纳入标准严重限制了其发现的普遍性以告知初级保健管理。为了减少过度使用抗生素，疾病控制与预防中心（CDC）和专家小组建议1）为中度或重度症状的患者保留抗生素治疗，至少持续7天，并包括上颌或面部疼痛和脓性鼻痛和脓性鼻痛，以及2）初始抗生素治疗是一种狭窄的药物。这些治疗建议的有效性尚未评估。这项研究的目的是确定使用临床标准诊断出患有急性细菌性鼻炎的患者，在有症状治疗方案中添加了阿莫西林的增量益处。我们将在初级保健环境中进行A.双盲，随机，安慰剂对照试验。符合CDC的200名成年患者建议针对急性细菌性鼻炎的诊断标准随机分配，以接受10天的阿莫西林或安慰剂。此外，所有患者都将接受症状治疗，包括镇痛药，口服缺乏症和抗刺激药。将在3、7、10和28天通过电话访谈评估患者的结果。主要结果指标将是治疗对特定疾病特定生活质量的影响，该疾病特定的生活质量，通过经过验证的评估仪器，中鼻鼻结果测试16（SNOT-16）。次要结果将包括治疗对功能状况和症状变化的影响，疾病复发，对护理的满意度和直接治疗成本。我们将当前的研究作为一系列研究中的第一项研究，旨在确定急性鼻炎患者最有效的初级保健管理。我们将在以后的研究中评估症状治疗。这项研究与公共卫生的相关性是，它将提供有关如何为急性鼻窦炎的患者最好的护理的知识，这是社区中照顾的一个常见问题。此外，从这项研究中获得的知识可用于减少抗生素的不当使用。