Background Equitable access to research studies needs to be increased for all patients. There is debate about which is the best approach to use to discuss participation in research in real-world clinical settings. Objective We aimed to determine the feasibility of asking all clinical staff within one hospital Trust (an organisation that provides secondary health services within the English and Welsh National Health Service) to use a newly created form on the Trust’s electronic patient records system, as a means of asking patients to consent to discuss participation in research (the opt-in approach). We also aimed to collect feedback from patients and clinicians about their views of the opt-in approach. Methods Four pilot sites were selected in the Trust: two memory clinics, an adult mental health team and an acute adult ward. Data were collected in three phases: (1) for 6 months, pilot site staff were asked to complete a consent to discuss participation in research form with patients; (2) staff feedback on the form was collected through an online survey; and (3) patient feedback was collected through focus groups. Findings Of 1779 patients attending services during the pilot period, 197 (11%) had a form completed by staff and 143 (8%) opted-in to finding out about research. Staff cited limited time, low priority and poor user experience of the electronic patient records system as reasons for low uptake of the form. Patients generally approved of the approach but offered suggestions for improvement. Conclusions There were mixed results for adopting an opt-in approach; uptake was very low, limiting its value as an effective strategy for improving access to research. Clinical implications Alternative strategies to the opt-in approach, such as transparent opt out approaches, warrant consideration to maximise access to research within routine clinical care.

中文翻译：

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同意讨论参与研究：试点研究。

背景技术需要增加所有患者的平等参与研究的机会。关于哪种方法是讨论在实际临床环境中参与研究的最佳方法，存在争议。目的我们旨在确定是否可以要求一个医院信托基金（该组织在英语和威尔士国家卫生服务部门内提供二级医疗服务的组织）中的所有临床人员使用信托基金电子病历系统上新创建的表格作为一种手段征求患者同意以讨论参与研究的方式（选择加入方式）。我们还旨在收集患者和临床医生对他们选择采用治疗方法的意见的反馈。方法在Trust中选择四个试点：两个记忆诊所，一个成人心理健康小组和一个急性成人病房。数据分三个阶段收集：（1）为期6个月，要求试验现场工作人员完成同意，与患者讨论参加研究表格的同意；（2）通过在线调查收集了员工对表格的反馈；（3）通过焦点小组收集患者反馈。调查结果在试点期间参加服务的1779名患者中，有197名（11％）填写了由工作人员填写的表格，而143名（8％）选择了查找有关研究的信息。工作人员将时间有限，优先级低和电子病历系统用户体验差的原因归咎于表格使用率低。患者普遍认可该方法，但提出了改善建议。结论采用选择加入方法的结果不一。吸收率非常低，限制了其作为改善研究获取的有效策略的价值。