Sikorskii Alla, Given Charles W, You Mei, Jeon Sangchoon, Given Barbara A
Michigan State University, Department of Statistics and Probability, College of Natural Science, A423 Wells Halls, East Lansing, MI 48824, USA.
J Clin Epidemiol. 2009 Jul;62(7):716-24. doi: 10.1016/j.jclinepi.2008.09.007. Epub 2009 Jan 4.
To describe the methodology of evaluating the response of cancer patients to interventions directed at lowering severity of multiple symptoms, and to compare two arms of a symptom management trial to determine factors associated with response and time to response.
Randomized trial comparing a nurse-assisted symptom management (NASM) cognitive-behavioral intervention with an automated telephone symptom management (ATSM). Patients in both arms received six intervention contacts over 8 weeks. Analyses of the intervention contact data for 190 patients in NASM arm and 164 patients in the ATSM arm were conducted. Severities of 15 cancer-related symptoms were assessed at each intervention contact, and an anchor-based definition of response was adopted. Analyses were carried out using generalized estimating equations and Cox marginal proportional hazard models.
When compared with patients in the NASM, patients in the ATSM had better response to manage anxiety, depression, poor appetite, cough, and fatigue. NASM was more successful in managing cancer pain. Response and time to response were associated with several patient and disease characteristics.
The approach described here presents an analytic and clinical improvement over methods that examine each symptom separately or use summed scores of severity.
描述评估癌症患者对旨在降低多种症状严重程度的干预措施反应的方法，并比较一项症状管理试验的两个组，以确定与反应及反应时间相关的因素。
一项随机试验，比较护士辅助症状管理（NASM）认知行为干预与自动电话症状管理（ATSM）。两组患者在8周内均接受6次干预接触。对NASM组的190名患者和ATSM组的164名患者的干预接触数据进行了分析。在每次干预接触时评估15种癌症相关症状的严重程度，并采用基于锚定的反应定义。使用广义估计方程和Cox边际比例风险模型进行分析。
与NASM组患者相比，ATSM组患者在管理焦虑、抑郁、食欲不佳、咳嗽和疲劳方面有更好的反应。NASM在管理癌症疼痛方面更成功。反应及反应时间与若干患者和疾病特征相关。
本文所述方法相较于单独检查每种症状或使用严重程度总分的方法，在分析和临床方面有所改进。
