Verheggen F W, Nieman F, Jonkers R
University Hospital Maastricht, The Netherlands.
Patient Educ Couns. 1998 Oct;35(2):111-25. doi: 10.1016/s0738-3991(98)00060-3.
In a survey on 26 clinical trials we have studied the reasons why some patients choose to participate in clinical trials while others decline. Interviews were held with 198 adult patients, just after they had been asked by the trial-clinician to participate. We interviewed patients who were asked to participate in a clinical trial, including those who decided not to participate. The theoretical guidelines to explain participation were based on an extended form of the Health Belief Model. Patients being asked to participate in a clinical trial decide by making a personal balance account. This comprises the physical and emotional added value patients hope to gain from the trial treatment compared to the non-trial treatment, minus the risks they expect in the trial and minus the extra time they expect the trial will take. The extent they feel physically threatened by their illness will also influence their decision. Furthermore, this personal balance account was found to depend on patient opinion about medical care and care-givers in general and on how patients regard their illness. Relatively long-term patients show a slightly different motivation to participate in a clinical trial than short-term patients. In line with the Health Belief Model, motivational beliefs on the relevance to reducing the threat to the patient's health condition ('values') and the evaluations of the clinical trial the patient is approached for ('expectancy'), are relevant in explaining patient behavior. Moreover, specific evaluative frames of reference are relevant in patients faced with the choice to participate or not. Suggestions are made to improve insight into patient motivation during the informed consent procedure of clinical trials.
在一项针对26项临床试验的调查中，我们研究了一些患者选择参与临床试验而另一些患者拒绝的原因。在198名成年患者刚被试验临床医生邀请参与试验后，我们对他们进行了访谈。我们访谈了那些被邀请参与临床试验的患者，包括那些决定不参与的患者。用于解释参与情况的理论指导方针基于健康信念模型的扩展形式。被邀请参与临床试验的患者通过进行个人平衡计算来做出决定。这包括患者希望从试验治疗中获得的与非试验治疗相比的身体和情感附加值，减去他们预计在试验中会遇到的风险，再减去他们预计试验会花费的额外时间。他们感受到疾病对身体威胁的程度也会影响他们的决定。此外，发现这种个人平衡计算取决于患者对一般医疗护理和护理人员的看法，以及患者对自身疾病的看法。与短期患者相比，长期患者参与临床试验的动机略有不同。与健康信念模型一致，关于降低对患者健康状况威胁的相关性的动机信念（“价值观”）以及患者对所参与临床试验的评估（“预期”），在解释患者行为方面具有相关性。此外，特定的评估参照框架对于面临是否参与选择的患者具有相关性。文中提出了一些建议，以在临床试验的知情同意程序中提高对患者动机的了解。
