Stakeholder perspectives regarding pragmatic clinical trial collateral findings.
Stakeholder perspectives regarding pragmatic clinical trial collateral findings.
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利益相关者有关实用临床试验结果结果的观点。
DOI：
10.1002/lrh2.10245
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发表时间：
2021-10
影响因子：
3.1
通讯作者：
Sugarman J
中科院分区：
文献类型：
--
作者：
Morain SR;Mathews DJH;Weinfurt K;May E;Bollinger JM;Geller G;Sugarman J
实用临床试验（PCT）因其相对便宜且为医疗保健决策提供重要益处而变得越来越普遍，但也可能带来实际、伦理和法律方面的挑战。其中一项挑战涉及管理“实用临床试验附带结果”(PCT-CF)，或 PCT 中出现的与主要研究问题无关的信息，但可能对收集数据的个体患者、临床医生或医疗保健系统产生影响。 PCT 的扩展使得医疗保健系统可能会越来越多地遇到 PCT-CF，但关于其适当管理的指导却很少。我们对具有 PCT 实施或监督经验的主要利益相关者以及卫生系统领导者进行了半结构化访谈。访谈探讨了受访者对 PCT 和 PCT-CF 的体验，以及对 PCT-CF 管理的实际或假设反应。我们使用标准的定性分析方法来确定关键主题。四十一个利益相关者参加了会议。出现了四个关键主题。首先，PCT-CF 的讨论因与 PCT 本身的性质以及由此产生的意外结果相关的层层模糊性而变得复杂。其次，PCT-CF 的管理是针对具体情况的，不适合“一刀切”的方法。第三，对于 PCT 中研究者的责任范围存在着广泛的不同态度。第四，受访者之前通常没有考虑过 PCT-CF，但人们普遍相信前瞻性规划以预测未来 PCT 中的此类问题的重要性。 PCT-CF 可能会增加，但负责 PCT-CF 决策及其披露的人员不太可能有处理这些问题的经验。需要进一步审议有关 PCT-CF 的道德义务和实施流程。为了提高制定合理政策和实践的可能性，此类审议应包括 PCT 主要利益相关者的意见和观点，包括专业人员、政策制定者和患者。
Pragmatic clinical trials (PCTs), which are becoming widespread since they are relatively inexpensive and offer important benefits for healthcare decision‐making, can also present practical, ethical, and legal challenges. One such challenge involves managing “pragmatic clinical trial collateral findings” (PCT‐CFs), or information emerging in a PCT that is unrelated to the primary research question(s), yet may have implications for individual patients, clinicians, or health care systems from whom or within which data were collected. The expansion of PCTs makes it likely healthcare systems will increasingly encounter PCT‐CFs, yet little guidance exists regarding their appropriate management. We conducted semi‐structured interviews with key stakeholders experienced in the conduct or oversight of PCTs and those in health system leadership. Interviews explored respondents' experience with PCTs and PCT‐CFs, and actual or hypothetical reactions to PCT‐CF management. We used standard methods of qualitative analysis to identify key themes. Forty‐one stakeholders participated. Four key themes emerged. First, discussions of PCT‐CFs are complicated by layers of ambiguity related to both the nature of PCTs themselves, and unanticipated results that emanate from them. Second, management of PCT‐CFs is context‐specific, and not amenable to a “one‐size‐fits‐all” approach. Third, there was a wide diversity of attitudes regarding the scope of researcher responsibilities in PCTs. Fourth, PCT‐CFs had generally not been previously considered by respondents, but there was widespread belief in the importance of prospective planning to anticipate such issues in future PCTs. PCT‐CFs are likely to increase, yet those charged with PCT‐CF decision‐making and their disclosure are unlikely to have experience with these issues. Further deliberation about the ethical obligations and implementation processes regarding PCT‐CFs is needed. To enhance the likelihood of developing sound policies and practices, such deliberations should include the input and perspectives of key stakeholders in PCTs, including professionals, policy makers, and patients.
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DOI：
10.1038/gim.2013.73
发表时间：
2013-07
期刊：
Genetics in medicine : official journal of the American College of Medical Genetics
影响因子：
--
作者：
通讯作者：
--
影响因子：
3.3
作者：
Sabin, James E.;Cocoros, Noelle M.;Platt, Richard
通讯作者：
Platt, Richard
影响因子：
4
作者：
Nielson, Carrie M.;Petrik, Amanda F.;Coronado, Gloria D.
通讯作者：
Coronado, Gloria D.
影响因子：
4
作者：
Weinfurt, Kevin P.;Hernandez, Adrian F.;Curtis, Lesley H.
通讯作者：
Curtis, Lesley H.
影响因子：
2.1
作者：
Richardson, Henry S.
通讯作者：
Richardson, Henry S.