背景:在参与者信息传单(PILs)中共享有关试验干预潜在危害的信息的方式差异很大,并且可能导致主观的“nocebo”危害。这项研究旨在制定原则,以改善有关PIL中潜在的试验干预益处和危害的信息组成,从而减少变异性和可避免的危害。
方法:我们进行了两轮修改的在线Delphi调查,随后举行协商一致会议。对于第一轮调查,27个声明是根据以前的研究和英国的相关指导制定的,美国和世界卫生组织。与会者包括以下每个利益相关者团体的成员:患者和公众代表,研究伦理委员会成员,行业代表,医学法律专家,心理学家和审判经理。要求每个参与者以9分的李克特量表对每个陈述的同意或不同意程度进行评分。在第二轮中,参与者被邀请在审查第一轮的结果后重新评估他们的评级。最后,每个利益相关者小组的两名成员参加了一次会议,以确认达成一致的声明。
结果:150名参与者完成了第1轮,201名参与者完成了第2轮。在第一轮中,就16项声明达成了共识。在第二轮中,达成了另外三项声明的共识。协商一致会议确认了调查结果,并合并了声明。这个过程产生了七个原则:(1)应该列出给定干预的所有潜在危害,(2)所有潜在的危害应分为严重和不严重,(3)必须明确,并非所有潜在的危害都是已知的,(4)应列出所有潜在的利益,(5)所有潜在的好处和危害需要与如果参与者没有参加试验会发生什么进行比较,(6)适当时,应添加适当的视觉表示;(7)有关潜在利益和危害的信息不应分开一页或多页。
结论:我们改进的Delphi过程成功地产生了七个原则,这些原则可以并且应该被用于指导如何在关于潜在试验益处和危害的信息传单中向患者传达信息。
BACKGROUND: The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective \'nocebo\' harms. This study aimed to develop principles to improve the composition of information about potential trial intervention benefits and harms within PILs so that variability and avoidable harms are reduced.
METHODS: We conducted a two-round modified online Delphi survey, followed by a consensus meeting. For the first round of the survey, 27 statements were developed based on previous research and relevant guidance from the UK, the USA and the World Health Organization. Participants included members from each of the following stakeholder groups: patient and public representatives, research ethics committee members, industry representatives, medico-legal experts, psychologists and trial managers. Each participant was asked to rate their degree of agreement or disagreement with each statement on a 9-point Likert scale. In the second round, participants were invited to reappraise their ratings after reviewing the results of the first round. Finally, two members from each stakeholder group participated in a meeting to confirm those statements for which there was agreement.
RESULTS: Two hundred and fifty participants completed round 1, and 201 participants completed round 2. In round 1, consensus was reached for 16 statements. In round 2, consensus was reached for an additional three statements. The consensus meeting confirmed the survey results and consolidated the statements. This process resulted in seven principles: (1) all potential harms of a given intervention should be listed, (2) all potential harms should be separated into serious and less serious, (3) it must be made explicit that not all potential harms are known, (4) all potential benefits should be listed, (5) all potential benefits and harms need to be compared with what would happen if the participant did not take part in the trial, (6) suitable visual representations should be added where appropriate and (7) information regarding potential benefits and harms should not be presented apart by one or more pages.
CONCLUSIONS: Our modified Delphi process successfully generated seven principles that can and should be used to guide how information is conveyed to patients in information leaflets regarding potential trial benefits and harms.