Enhancing informed consent in cancer clinical trials;development and evaluation o

描述（由申请人提供）：关于临床试验的医患沟通存在问题。增加患者参与咨询与更好的患者结局相关。在帮助医生与患者沟通方面已经证明有重要前景的一种方法是问题提示列表（QPL）。QPL由一系列分为内容类别的书面问题样本组成。这些简单的患者干预措施尚未在肿瘤临床试验中进行测试。问题因肿瘤学背景而异。使用特定情境QPL的研究结果表明，它们受到患者的欢迎，并增加了特定类型的问题。本研究中提出的试点研究将开发和评价肿瘤学临床试验特定QPL的可接受性。将在临床环境中使用一种新的测量方法（问题匹配率）评估这种新QPL的效用。本探索性研究的具体目的是：1）制定临床试验的目标问题提示列表，并评价其对癌症患者的可接受性; 2）探索临床试验QPL在肿瘤学咨询中的效用，包括I、II或III期临床试验的讨论。在拟议研究的第1阶段，（i）肺癌、乳腺癌和前列腺癌患者及其护理人员和（ii）医疗保健专业人员将参加单独的焦点小组，以帮助制定和探索临床试验QPL问题列表的可接受性。定性分析专家将分析这些数据。该分析将为QPL的最终版本提供信息。该项目的第二阶段包括在肺癌、前列腺癌和乳腺癌患者样本中对QPL进行试点测试，以探索问题清单的效用和患者对咨询的满意度。在他们的临床试验之前，患者将被要求通过圈出他们想问的问题来使用QPL。他们将完成咨询前的信息和参与偏好量表以及咨询后的参与偏好和满意度量表。将对磋商进行录音、转录和编码，并使用一种新的衡量标准-问题匹配率-对这些数据进行分析。将该比率与患者满意度和偏好数据进行比较，以确定QPL的效用。预计这些数据将用于确定QPL在肿瘤学临床试验背景下的可接受性和实用性，并为QPL的拟议随机临床试验提供证据基础。患者与医生之间的沟通往往存在问题，因为患者通常会误解试验信息，并且无法实现他们参与决策的偏好。通过创建专门用于讨论临床试验的问题提示列表，患者将更好地了解临床试验过程，因此对应计过程感到更舒适。这可以改善应计率以及医生和患者之间的沟通。

DESCRIPTION (provided by applicant): Doctor patient communication about clinical trials is problematic. Increasing patient participation in consultations is associated with better patient outcomes. One method that has demonstrated significant promise in aiding doctor-patient communication are Question Prompt Lists (QPLs). QPLs consist of a list of sample written questions separated into content categories. These simple patient interventions have not been tested in the oncology clinical trial setting. Questions vary across oncology contexts. The results of studies using context-specific QPLs suggest that they are well received by patients and increase specific types of questions asked. The pilot research proposed in this study will develop and evaluate the acceptability of a QPL specific to oncology clinical trials. The utility of this new QPL will be assessed in the clinical setting using a novel measure, the question match ratio. The specific aims of this exploratory study are to; 1) develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients and 2) explore the utility of the QPL for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial. In stage 1 of the proposed study, (i) lung, breast and prostate cancer patients and their carers and (ii) health care professionals, will participate in separate focus groups to help develop and explore the acceptability of a QPL for Clinical Trials Question list. A qualitative analysis expert will analyze these data. This analysis will inform a final version of the QPL. Stage 2 of the project involves pilot testing the QPL in a sample of lung, prostate and breast cancer patients to explore the utility of the question list and patient satisfaction with the consultation. Prior to their clinical trial, patients will be asked to use the QPL by circling questions they would like to ask. They will complete pre- consultation information and involvement preference scales and post consultation achievement of involvement preferences and satisfaction with the consultation scale. The consultations will be audiotaped, transcribed and coded and these data analyzed using a new measure, the Question Match Ratio. This ratio will be compared with patient satisfaction and preference data to determine the utility of the QPL. It is anticipated that these data will be used to establish the acceptability and utility of the QPL in oncology clinical trial context and providing an evidence base for a proposed randomized clinical trial of the QPL. Patient-doctor communication is often problematic as patients commonly misunderstand trial information and do not achieve their preferences for decision involvement. By creating a question prompt list specifically for discussions concerning clinical trials, patients will gain a better understanding of the clinical trial process and therefore feel more comfortable with the accrual process. This could improve accrual rates as well as communication between doctors and patients.