Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening.
Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening.
复制标题
改进重病老年人不良事件的定义、分类、报告和监测方法：多方利益相关者会议的建议。
DOI：
10.1007/s11606-022-07646-7
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发表时间：
2023
影响因子：
5.7
通讯作者：
Siu,Albert
中科院分区：
文献类型：
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作者：
Baim-Lance,Abigail;Ferreira,KatelynB;Cohen,HarveyJay;Ellenberg,SusanS;Kuchel,GeorgeA;Ritchie,Christine;Sachs,GregA;Kitzman,Dalane;Morrison,RSean;Siu,Albert
背景需要临床试验来研究与患有严重疾病的老年人相关的主题。在这一人群中进行临床试验的研究人员面临的挑战是如何适当地定义、分类、报告和监测严重和非严重不良事件(SAE/AE)，因为一些传统上报告的不良事件(压疮、精神错乱)和SAE(死亡、住院)在严重疾病患者中很常见，可能与他们的护理目标一致。目标一个多利益相关者小组召开会议，以更好地阐明这一关键问题和解决这一关键问题的新方法。参与者32名研究调查人员、监管机构和赞助机构的成员以及患者利益相关者参加了这项研究。接近该小组召开了几乎四次会议，并使用协作方法进行了调查、选择访谈和新方法结果SAE/AE挑战分为两个领域：(1)定义和分类，包括(A)不可信的关系，(B)与以患者为中心的护理目标不一致，(C)知名协会，以及(2)报告和监测，包括(A)有限的指导，(B)监管机构之间不一致的标准，以及(C)数据安全监测委员会(DSMB)成员的知识差距。问题在很大程度上反映了惯例规范，而不是已经支持具体情况和综合报告的监管要求。可以通过采用以下原则来改进方法：更好地将应对不良事件的策略与正在测试的干预类型相结合，支持常规和汇总而不是快速报告，并确定SAE/AE与以患者为中心的护理目标的优先顺序。报告计划和决定应遵循以这些原则为基础的算法。结论采用建议的方法，并通过教育支持它，并更好地与监管指南和程序保持一致，可以提高涉及患有严重疾病的老年人和其他脆弱人群的临床试验安全性的质量和效率。
BackgroundClinical trials are needed to study topics relevant to older adults with serious illness. Investigators conducting clinical trials with this population are challenged by how to appropriately define, classify, report, and monitor serious and non-serious adverse events (SAEs/AEs), given that some traditionally reported AEs (pressure ulcers, delirium) and SAEs (death, hospitalization) are common in persons with serious illness, and may be consistent with their goals of care.ObjectivesA multi-stakeholder group convened to establish greater clarity on and new approaches to address this critical issue.ParticipantsThirty-two study investigators, members of regulatory and sponsor agencies, and patient stakeholders took part.ApproachThe group met virtually four times and, using a collaborative approach, conducted a survey, select interviews, and reviewed regulatory guidance to collectively define the problem and identify a new approach.ResultsSAE/AE challenges fell into two areas: (1) definitions and classifications, including (a) implausible relationships, (b) misalignment with patient-centered care goals, and (c) well-known associations, and (2) reporting and monitoring, including (a) limited guidance, (b) inconsistent standards across regulators, and (c) Data Safety Monitoring Board (DSMB) member knowledge gaps. Problems largely reflected practice norms rather than regulatory requirements that already support context-specific and aggregate reporting. Approaches can be improved by adopting principles that better align strategies for addressing adverse events with the type of intervention being tested, favoring routine and aggregate over expedited reporting, and prioritizing how SAE/AEs relate to patient-centered care goals. Reporting plans and decisions should follow an algorithm underpinned by these principles.ConclusionsAdoption of the proposed approach—and supporting it with education and better alignment with regulatory guidance and procedures—could improve the quality and efficiency of clinical trials’ safety involving older adults with serious illness and other vulnerable populations.