Clinical Trials Transformation Initiative, Duke University School of Medicine, Durham, North Carolina.
Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina.
JAMA Netw Open. 2020 May 1;3(5):e205435. doi: 10.1001/jamanetworkopen.2020.5435.
Information to be included in advance informed consent forms for health care-associated pneumonia treatment trials remains to be determined.
To identify and determine how to describe information to be included in an advance informed consent form for an early-enrollment noninferiority hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) clinical trial.
DESIGN, SETTING, AND PARTICIPANTS: A Delphi consensus process with stakeholders in HABP/VABP clinical trials was conducted using qualitative semistructured telephone interviews from June to August 2016, followed by 2 online surveys, the first from April to May 2017, and the second from September to October 2017. All stakeholders who participated in the interview were invited to participate in the first survey. Stakeholders who participated in the first survey were invited to participate in the second survey. Stakeholders were patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators.
Description and consensus of information to be included in advance informed consent forms for early enrollment in noninferiority HABP/VABP clinical trials.
Suggestions from 52 stakeholders about what key informed consent concepts to include and how to explain them were used to create 3 categories to be included in an advance consent form: (1) reassurances on patient health and treatment, (2) rationale for advance consent and early enrollment, and (3) an explanation of noninferiority. At the end of the Delphi process, at least 80% consensus was reached among the 40 stakeholders who participated in the second online survey on each of the statements to include in the proposed consent text. Throughout the process, however, describing and reaching consensus on statements about noninferiority was more problematic than the other categories.
The stakeholders endorsed consent language to be used in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset. Data-driven consent language may help potential participants make informed decisions about their involvement in clinical research and improve enrollment rates, which are necessary to evaluate new treatments and improve patient care. The proposed consent language may be adapted for other trials using an early enrollment strategy and for noninferiority trials.
仍需确定包含在医疗相关性肺炎治疗试验的预先知情同意书中的信息。
确定并描述包含在早期入组非劣效性医院获得性和/或呼吸机相关性细菌性肺炎（HABP/VABP）临床试验的预先知情同意书中的信息。
设计、设置和参与者：采用德尔菲共识过程，对 HABP/VABP 临床试验的利益相关者进行定性半结构化电话访谈，时间为 2016 年 6 月至 8 月，随后进行了 2 次在线调查，第一次在 2017 年 4 月至 5 月进行，第二次在 2017 年 9 月至 10 月进行。所有参与访谈的利益相关者均被邀请参加第一次调查。参与第一次调查的利益相关者被邀请参加第二次调查。利益相关者包括肺炎风险患者、护理人员、机构审查委员会代表、研究者和研究协调员。
描述并达成共识，即包含在早期入组非劣效性 HABP/VABP 临床试验的预先知情同意书中的信息。
52 位利益相关者对包含哪些关键知情同意概念以及如何解释这些概念的建议，用于创建 3 个类别，以包含在预先同意书中：（1）对患者健康和治疗的保证，（2）提前同意和早期入组的理由，以及（3）非劣效性的解释。在德尔菲过程结束时，至少 40 位利益相关者中的 80% 对第二次在线调查中的每一个纳入提议同意书的陈述达成共识。然而，在整个过程中，与其他类别相比，描述和达成关于非劣效性的陈述的共识更具挑战性。
利益相关者认可将在结合一项策略的情况下使用同意书中的语言，该策略用于在感染发生之前招募感染肺炎风险最高的患者。数据驱动的同意语言可能有助于潜在参与者就参与临床研究做出明智的决策，并提高入组率，这对于评估新的治疗方法和改善患者护理是必要的。所提出的同意书可以适用于使用早期入组策略的其他试验和非劣效性试验。
