Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia
Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care-Associated Pneumonia
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DOI：
10.1001/jamanetworkopen.2018.5816
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发表时间：
2018-12-01
影响因子：
13.8
通讯作者：
Holland, Thomas L.
中科院分区：
文献类型：
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作者：
Corneli, Amy;Perry, Brian;Holland, Thomas L.
重要性 对于危及生命的感染，包括医疗相关肺炎，需要更好的治疗选择。在诊断前让患者参加抗菌临床试验可能会规避现有的入组时间限制。然而，使用事先同意的早期入组策略的可接受性尚不清楚。 目的 评估在肺炎诊断前将患者纳入抗菌临床试验的早期入组策略的可接受性。 设计、设置和参与者 这项定性、描述性研究使用半结构化电话访谈。在计划的非劣效性肺炎抗生素试验的框架内，描述了早期入组策略并评估了看法。使用这种策略，患者在出现肺炎之前同意加入，由研究人员进行监测，并在出现肺炎时随机分配一种研究抗生素。所有访谈均进行录音、逐字转录，并使用应用主题分析进行分析。 2016 年 6 月 20 日至 8 月 19 日，对来自美国各地的 52 名主要利益相关者进行了访谈，其中包括 18 名有肺炎风险的患者、12 名护理人员、10 名机构审查委员会代表、7 名研究者和 5 名研究协调员。 主要结果和措施 早期入组策略的可接受性。 结果 接受采访的 52 名利益相关者（年龄 29-75 岁； 14 名女性）、患者和护理人员对于在患上肺炎之前就接触患者参与活动表示不担心；然而，一些患者在了解自己患肺炎的风险后可能会感到焦虑。没有对研究人员访问患者医疗记录表示担忧。同意信息的清晰度对于理解研究非常重要，而不是对病情进行调查。患者、护理人员和机构审查委员会代表对于选择退出和先例自主程序的偏好各不相同。几乎所有患者都愿意使用早期入组策略参加试验，并且护理人员愿意提供代理同意书。机构审查委员会代表支持该战略，并就研究方案提出建议，主要围绕知情同意。研究人员和研究协调员认为该策略不会造成负担，并提出建议以确保其可行性。结论和相关性研究结果表明早期入组策略是可以接受的。未来的研究应评估该策略是否可以提高登记性肺炎试验以及入组窗口狭窄和/或短暂决策无能力患者的其他急性感染综合征试验的入组率。
IMPORTANCE Better treatment options are needed in life-threatening infections, including health care-associated pneumonia. Enrolling patients in antibacterial clinical trials before diagnosis may circumvent existing time-to-enrollment constraints. However, the acceptability of an early enrollment strategy using advance consent is unknown.OBJECTIVE To assess the perceived acceptability of an early enrollment strategy for enrolling patients in an antibacterial clinical trial before a pneumonia diagnosis.DESIGN, SETTING, AND PARTICIPANTS This qualitative, descriptive study used semistructured telephone interviews. Framed within a planned noninferiority pneumonia antibiotic trial, an early enrollment strategy was described and perceptions were assessed. Using this strategy, patients give consent to enroll before developing pneumonia, to be monitored by study staff, and to be randomly assigned a study antibiotic if pneumonia develops. All interviews were audiorecorded, transcribed verbatim, and analyzed using applied thematic analysis. Fifty-two key stakeholders from across the United States, including 18 patients at risk of pneumonia, 12 caregivers, 10 representatives of institutional review boards, 7 investigators, and 5 study coordinators, were interviewed from June 20 to August 19, 2016.MAIN OUTCOMES AND MEASURES Perceived acceptability of the early enrollment strategy.RESULTS Among the 52 stakeholders interviewed (ages 29-75 years; 14 women), patients and caregivers expressed no concerns about patients being approached about participation before developing pneumonia; however, some patients may experience anxiety on learning about their risk for pneumonia. No concerns with study staff accessing patients' medical records were expressed. The clarity of consent information was important for understanding the study rather than having the condition under investigation. Among patients, caregivers, and institutional review board representatives, preferences varied regarding opt-out and precedent autonomy procedures. Nearly all patients would be willing to join a trial using the early enrollment strategy and caregivers would be willing to provide proxy consent. Institutional review board representatives were supportive of the strategy and made recommendations for the study protocol, primarily around informed consent. Investigators and study coordinators believed the strategy would not be burdensome and offered suggestions to ensure its feasibility.CONCLUSION AND RELEVANCE Results of the study suggest that the early enrollment strategy is acceptable. Future research should evaluate whether the strategy improves enrollment rates in registrational pneumonia trials and in trials of other acute infection syndromes with narrow enrollment windows and/or patients with transient decisional incapacity.