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Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of participatory and informed consent (PIC)

机译：随机对照试验中的知情同意：参与和知情同意（PIC）措施的开发和初步评估

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Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding.Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above.DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to complete) with good levels of stability (i.e. test-retest reliability) and inter-rater reliability maintained.The DevPICv2 provides a measure for application to trial recruitment appointments to evaluate quality of recruiter information provision and evidence of patient understanding and participation during IC discussions. Initial evaluation shows promising feasibility, validity, reliability and ability to discriminate across a range of recruiter practice and evidence of participant understanding. More validation work is needed in new clinical trials to evaluate and refine the measure further.
机译：知情同意（IC）是参加试验的道德和法律先决条件，但是当前评估参与者在招募期间对IC理解的方法缺乏一致性。还没有确定经过验证的措施可以根据参与者互动过程中的贡献来评估参与者对IC的理解。本文概述了参与式和知情同意（PIC）措施的发展和形成性评估，该措施适用于记录的招聘任命。 PIC允许评估招聘人员的信息提供和参与者理解的证据。对发布的IC指南进行了审查，以识别可能包含的项目。审查了来自三个不同试验的17个有目的抽样的试验招募约会，以确认是否存在与IC相关的项目。起草了该措施的开发版本（DevPICv1），并将其应用于来自另外三个不同试验的六个补充招募任命中，以评估可行性，有效性，稳定性和评估者间的可靠性。调查结果指导对方法（DevPICv2）进行修订，该方法已应用于上述六个进一步的招聘任命.DevPICv1评估了招聘人员的信息提供（分别评估了细节和清晰度）和参与者谈话（分别评估了细节和理解）超过20个参数（或23个参数）三臂试验）。这项措施最初用于六个不同的征聘任命，证明了前景可观的稳定性和评估者之间的可靠性，但需要简化措施以缩短完成时间。修订后的衡量标准（DevPICv2）将招聘人员信息的详细程度和清晰度以及参与者理解的详细程度和证据的评估合并为两个单一的量表，适用于22个参数或25个参数用于三臂试验。将DevPICv2应用到另外六个不同的招聘任命中，显示出可行性（例如完成时间）方面的显着改善，并具有良好的稳定性（即重测可靠性）和评估者间可靠性。DevPICv2提供了一种适用于试用招聘任命的措施评估招聘人员信息提供的质量以及在IC讨论期间患者理解和参与的证据。初步评估显示出有希望的可行性，有效性，可靠性和区别征兵实践的能力以及参与者理解的证据。在新的临床试验中，需要更多的验证工作来进一步评估和完善该措施。

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