The Influence of Gender on Symptom Characteristics During Acute Coronary Syndrome

描述（由申请人提供）：预计2009年将有超过140万美国人经历急性冠状动脉综合征（ACS）发作。对ACS症状的评估很重要，因为症状决定了患者何时或是否寻求护理。最近的研究已经确定了ACS症状的性别差异，然而回顾性设计，从病历中提取症状，以及评估表格的变化使得难以确定性别差异的临床意义或是否需要性别特异性健康信息。因此，本前瞻性研究的目的是：1）在调整年龄、诊断、合并症和功能状态后，评估14种ACS症状的发生、严重程度和痛苦的性别差异，2）建立症状作为女性和男性ACS指标的敏感性、特异性和预测值，3）探索症状群，包括性别、年龄、诊断、合并症和功能状态，以及4）确定功能状态、主要心血管事件、住院、急诊室就诊和死亡率的纵向（30天和6个月）结果是否存在性别差异。一个探索性的目的是确定选择的生物标志物和女性和男性ACS症状之间是否存在关系。将使用一种新的方法，即在急诊室记录症状。样本将包括630例因ACS症状入院的患者：522例确诊ACS患者和108例排除ACS的患者。参与者将从伊利诺斯州和俄勒冈州的四个医疗中心招募。14项ACS症状检查表将在提交给急诊科时填写。当患者稳定时，将测量合并症、活动状态和患者变量。试验数据表明，这些程序是可行和安全的。将使用协方差分析来检验症状存在性别差异的假设。将使用凝聚聚类分析检查症状群，并使用线性混合方法评价结局。研究结果将有助于建立ACS症状的临床意义。 公共卫生相关性：这项研究将解决现有研究的局限性，包括缺乏前瞻性设计，系统的方法，标准化的评估表格，以及对症状的敏感性和特异性的评估，特别重要的是，因为症状会引发就医行为。鉴于持续长时间的患者决策延迟，对潜在危及生命的疾病的症状进行综合评估变得更加紧迫。

DESCRIPTION (provided by applicant): More than 1.4 million Americans are expected to experience an episode of acute coronary syndromes (ACS) in 2009. Evaluation of the symptoms of ACS is important since symptoms determine when, or if, patients seek care. Recent studies have identified gender differences in symptoms of ACS, however retrospective designs, abstraction of symptoms from medical records, and variations in assessment forms make it difficult to determine the clinical significance of gender differences or if gender specific health messages are warranted. Therefore, the aims of this prospective study are to: 1) evaluate for gender differences in the occurrence, severity, and distress of 14 ACS symptoms after adjusting for age, diagnosis, comorbidities, and functional status, 2) establish the sensitivity, specificity, and predictive value of symptoms as an indicator of ACS for women and men, 3) explore symptom clusters including characteristics of gender, age, diagnosis, comorbidities, and functional status, and 4) determine if there are gender differences in the longitudinal (30 days and 6 months) outcomes of functional status, major cardiovascular events, hospital admissions, emergency department visits, and mortality. An exploratory aim is to determine if a relationship exists between selected biomarkers and symptoms of ACS for women and men. A novel approach, in which symptoms are recorded in the emergency department as they are occurring, will be used. The sample will be comprised of 630 patients admitted to the emergency department with symptoms suggestive of ACS: 522 patients with confirmed ACS and 108 patients ruled out for ACS. Participants will be recruited from four medical centers in Illinois and Oregon. The 14-item ACS Symptom Checklist will be completed on presentation to the emergency department. Comorbidities, activity status, and patient variables will be measured when the patient is stable. Pilot data indicate that the procedures are feasible and safe. Analysis of covariance will be used to test the hypothesis that there are gender differences in symptoms. Symptom clusters will be examined using agglomerative cluster analysis, and outcomes will be evaluated using linear mixed methods. Findings will aid in establishing the clinical significance of ACS symptoms. PUBLIC HEALTH RELEVANCE: This study will address limitations of prior research including lack of prospective designs, systematic methods, standardized assessment forms, and evaluation of sensitivity and specificity of symptoms, particularly important since symptoms trigger health seeking behaviors. Given persistently long patient decision-delay, comprehensive evaluation of symptoms for a potential life-threatening illness take on added urgency.