TRAMS (Trials Research and Methodologies Unit), HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Health Services Research Unit, Health Sciences Building, Foresterhill, Aberdeen, United Kingdom.
PLoS One. 2022 May 24;17(5):e0268898. doi: 10.1371/journal.pone.0268898. eCollection 2022.
Complete and understandable information is vital for informed consent and this includes how and when potential participants can expect to receive trial results. Informing participants during informed consent about the sharing of trial results is important for addressing participants' needs, ensuring adherence to regulatory guidance, and in fulfilling a moral obligation.
Patient Information Leaflets (PILs) were collated from across the UK and Ireland. Trial characteristics and data on disseminating trial results was extracted. Analysis included descriptive statistics and a directed content analysis approach. The content analysis framework was informed by regulatory guidance on PIL content and existing research on dissemination of trial results. Results were analysed using descriptive statistics and presented as a narrative summary as appropriate.
238 PILs from 178 trials were analysed. Of the 238 PILs, 74% (n = 176) provided information on sharing results with participants, 70% (n = 123) of which described passive methods of disseminating results that require active engagement from the trial participants, i.e., effort required by the participant to seek the results. The majority (90%) of PILs included more than one proposed mode of dissemination that largely targeted healthcare professionals rather than participants. Only 8% of PILs specified a time period for when results could be expected, 47% did not specify a time period (e.g. at end of trial), and 45% included no information on when trial results would be available.
This study found that majority of the PILs included did include some information about dissemination of trial results. However, modes of dissemination tended to target researchers and clinicians rather than participants and information on when results would be available was often lacking. The findings highlight the need for further research that includes stakeholder input to identify what information on results summaries participants need at the point of making a decision about trial participation.
完整且易于理解的信息对于知情同意至关重要，这包括潜在参与者何时以及如何预期获得试验结果。在知情同意过程中告知参与者试验结果的分享情况对于满足参与者的需求、确保符合监管指导以及履行道德义务都非常重要。
从英国和爱尔兰各地收集了患者信息传单（PIL）。提取了试验特征和关于试验结果传播的数据。分析包括描述性统计和定向内容分析方法。内容分析框架以 PIL 内容的监管指导和关于试验结果传播的现有研究为依据。使用描述性统计对结果进行分析，并根据需要以叙述性摘要的形式呈现。
分析了来自 178 项试验的 238 份 PIL。在 238 份 PIL 中，74%（n=176）提供了与参与者分享结果的信息，其中 70%（n=123）描述了被动传播结果的方法，这需要试验参与者积极参与，即参与者寻求结果所需的努力。大多数（90%）PIL 包含了多种传播方式，主要针对医疗保健专业人员，而不是参与者。只有 8%的PIL 指定了可以预期结果的时间段，47%的PIL 没有指定时间段（例如在试验结束时），45%的PIL 没有包含关于何时可以获得试验结果的信息。
本研究发现，大多数包含的 PIL 确实包含了一些关于试验结果传播的信息。然而，传播方式往往针对研究人员和临床医生，而不是参与者，关于何时可以获得结果的信息往往缺乏。这些发现强调需要进一步研究，包括利益相关者的投入，以确定在做出参与试验的决策时，参与者需要关于结果摘要的哪些信息。
