Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial
Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-015-0750-x
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发表时间：
2015-05-27
期刊：
影响因子：
2.5
通讯作者：
de Vries, Marieke
中科院分区：
文献类型：
--
作者：
Cuypers, Maarten;Lamers, Romy E. D.;de Vries, Marieke
背景：在早期阶段，前列腺癌患者通常有资格接受一种以上的治疗方案，或者可能选择推迟治愈性治疗。如果没有预先存在的更好的选择，病人必须权衡他的个人偏好和每个替代方案的风险和收益，以选择最合适的治疗。在此背景下，在前列腺癌的治疗决策中，特别适合遵循共享决策（shared decision-making， SDM）的原则，特别是在决策辅助（decision aids, DAs）等特定工具的支持下。虽然有几种替代方法，但目前的工具与常规临床实践不完全兼容。为了克服现有的障碍，并刺激DAs和SDM在临床实践中的结构性实施，开发了一个基于网络的前列腺癌治疗DA，以适应临床工作流程。遵循现有数据分析的结构，开发了荷兰语内容，并添加了值澄清方法（VCMs）。本研究的目的是调查这种DA对（共享）治疗选择和患者报告的结果的影响。方法/设计：19家荷兰医院被纳入一项实用的、集群随机对照试验，有干预和对照组。干预组将在诊断后提供DA，并总结患者的偏好，这些偏好与DA一致，可在随后的会诊中由患者和临床医生讨论。对照组患者将照常接受信息和决策支持。比较两组在决策冲突、治疗选择和参与决策过程的经验方面的结果。要求患者在治疗决策后、治疗开始前、6个月和12个月后填写问卷。这将使治疗满意度、决策后悔和生活质量的发展得到监测。来自两组的临床医生将评估他们的信息提供和决策支持的做法。讨论：本研究将描述一种基于网络的前列腺癌治疗DA与vcm。将评估该DA对决策过程和随后患者报告的结果的影响。
Background: At an early stage, prostate cancer patients are often eligible for more than one treatment option, or may choose to defer curative treatment. Without a pre-existing superior option, a patient has to weigh his personal preferences against the risks and benefits of each alternative to select the most appropriate treatment. Given this context, in prostate cancer treatment decision-making, it is particularly suitable to follow the principles of shared decision-making (SDM), especially with the support of specific instruments like decision aids (DAs). Although several alternatives are available, present tools are not sufficiently compatible with routine clinical practice. To overcome existing barriers and to stimulate structural implementation of DAs and SDM in clinical practice, a web-based prostate cancer treatment DA was developed to fit clinical workflow. Following the structure of an existing DA, Dutch content was developed, and values clarification methods (VCMs) were added. The aim of this study is to investigate the effect of this DA on (shared) treatment choice and patient-reported outcomes.Methods/design: Nineteen Dutch hospitals are included in a pragmatic, cluster randomized controlled trial, with an intervention and a control arm. In the intervention group, the DA will be offered after diagnosis, and a summary of the patients' preferences, which were identified with the DA, can be discussed by the patient and his clinician during later consultation. Patients in the control group will receive information and decisional support as usual. Results from both groups on decisional conflict, treatment choice and the experience with involvement in the decision-making process are compared. Patients are requested to fill in questionnaires after treatment decision-making but before treatment is started, and 6 and 12 months later. This will allow the development of treatment satisfaction, decisional regret, and quality of life to be monitored. Clinicians from both groups will evaluate their practice of information provision and decisional support.Discussion: This study will describe a web-based prostate cancer treatment DA with VCMs. The effect of this DA on the decision-making process and subsequent patient reported outcomes will be evaluated.