Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA.
Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):e13-9. doi: 10.1016/j.ijrobp.2011.11.072. Epub 2012 Feb 28.
To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa).
We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale.
Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either "definitely" or "probably" participate. Seventeen percent (8 of 46) stated they would "definitely not" or "probably not" enroll, most of whom (6 of 8) preferred PBT before their physician visit.
A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.
调查患者参与一项比较前列腺癌调强放疗（IMRT）和质子束放疗（PBT）的随机对照试验（RCT）的意愿（WTP）。
我们进行了一项定性研究，前瞻性地招募了患有临床局限性前列腺癌的患者。我们采用了目的性抽样，以确保根据年龄、种族、旅行距离和医生的不同，样本具有多样性。患者参加了半结构化访谈，他们在访谈中查看了一个假设性 RCT 的描述，被问及关于参与的动机和顾虑的开放性和针对性后续问题，并完成了一份评估人口统计学特征和对 IMRT 或 PBT 了解程度等特征的问卷。患者的 WTP 是使用 6 分李克特量表评估的。
从 8 位医生的诊所共招募了 46 名符合条件的患者（33 名白人，13 名黑人）。我们确定了 21 个影响患者 WTP 的因素，这些因素主要集中在五个主要主题上：利他主义/比较治疗的愿望、随机化、对医生意见的尊重、经济激励和时间需求/安排。大多数患者（46 名中的 27 名，59%）表示他们“肯定”或“可能”会参与。17%（46 名中的 8 名）表示他们“肯定不会”或“可能不会”参与，其中大多数（8 名中的 6 名）在就诊前更喜欢 PBT。
相当一部分患者表示愿意参与比较前列腺癌 IMRT 和 PBT 的 RCT。
