Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision
Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision
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DOI：
10.1200/jco.2004.01.187
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发表时间：
2004-11-01
影响因子：
45.3
通讯作者：
Levine, MN
中科院分区：
文献类型：
--
作者：
Wright, JR;Whelan, TJ;Levine, MN
目的 很少有干预措施被设计和测试来改善肿瘤学临床试验的招募。影响患者决策的多种因素使得特定干预措施的优先顺序变得具有挑战性。本研究旨在确定癌症患者决定参加随机临床试验的独立预测因素。方法通过一系列涉及癌症患者、医生和临床研究助理 (CRA) 的焦点小组，扩充了医学文献中的一系列因素。我们根据这些因素制定了一系列调查问卷，并在患者决定参加试验后同时向 189 名癌症患者、他们的医生和 CRA 进行调查。使用与进入临床试验的决定显着相关（通过单变量分析）的项目进行正向逻辑回归模型。结果许多项目与患者的决定显着相关。在多变量逻辑回归模型中，患者对个人利益的感知最为重要，优势比（OR）为3.08（P
Purpose Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial.Methods A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial.Results A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P