The Influence of Gender on Symptom Characteristics During Acute Coronary Syndrome

描述（由申请人提供）：2009年预计将有超过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治疗。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、从医疗记录中提取症状以及评估形式的变化使得难以确定性别差异的临床意义或是否有必要提供针对性别的健康信息。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、严重程度和痛苦程度的性别差异；2)建立症状作为ACS女性和男性指标的敏感性、特异性和预测价值；3)探索包括性别、年龄、诊断、合并症和功能状态特征在内的症状群。4)确定功能状态、主要心血管事件、住院率、急诊科就诊率和死亡率的纵向（30天和6个月）结局是否存在性别差异。探索性目的是确定所选生物标志物与女性和男性ACS症状之间是否存在关系。将采用一种新颖的方法，在急诊科记录症状，因为它们正在发生。样本将包括630名急诊科有ACS症状的患者：522名确诊ACS患者和108名排除ACS的患者。参与者将从伊利诺伊州和俄勒冈州的四个医疗中心招募。14项ACS症状清单将在提交给急诊科时完成。当患者病情稳定时，将测量合并症、活动状态和患者变量。试验数据表明，该程序是可行和安全的。协方差分析将用于检验症状存在性别差异的假设。症状聚类将使用聚类分析进行检查，结果将使用线性混合方法进行评估。研究结果将有助于确定ACS症状的临床意义。

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.