将 FDG PET/CT 意外研究结果退还给参与者:类风湿关节炎临床试验研究者调查。

IF 3.7 2区 医学 Q1 RHEUMATOLOGY
Jane S Kang, Howard F Andrews, Jon T Giles, Katherine P Liao, Daniel H Solomon, Joan M Bathon
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引用次数: 0

摘要

目的:关于研究人员对归还和管理全身 18F 氟脱氧葡萄糖正电子发射断层扫描/CT(FDG PET/CT)成像的偶然研究结果的态度和信念的数据有限:方法:对参与 "抗 RA 治疗及对 FDG PET/CT 的影响"(TARGET)试验的研究机构主要研究人员(PI)进行了调查:在符合研究条件的 28 个 TARGET 研究机构的首席研究员中,有 18 位同意参与研究(回复率:64%)。许多研究机构的首席研究员向参与者反馈了偶然发现(61%),最常见的发现是严重的(但不危及生命)和可治疗的(54.5%)。半数以上的研究人员认为,临床随访是否充分(58.8%)以及如果不披露附带发现的法律责任(55.6%)是退还全身 FDG PET/CT 附带研究发现的极其重要的因素。如果扫描发现了可治疗的高风险病症,所有调查人员都认为有很大责任退回附带研究结果。大多数研究人员认为非常有义务披露对健康有重要影响的附带研究结果(94.4%)、已被证实有预防或治疗干预措施的附带研究结果(77.8%)、能早期发现健康问题的附带研究结果(72.2%)、参与者要求提供附带研究结果的附带研究结果(72.2%)以及扫描结果对特定医疗状况有效的附带研究结果(61.1%):虽然建议研究人员报告和管理附带研究结果,但我们的数据显示,对于全身 FDG PET/CT 附带研究结果的回报内容、回报方式以及管理所需的随访程度,存在不同的观点和不确定性;这突出表明需要更具体和标准化的指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Returning Incidental Research Findings From 18F-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography to Participants: A Survey of Investigators From a Clinical Trial of Rheumatoid Arthritis.

Objective: There are limited data on researchers' attitudes and beliefs on returning and managing incidental research findings from whole body 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) imaging.

Methods: Site principal investigators (PIs) who enrolled participants for the Treatments Against Rheumatoid Arthritis and Effect on FDG PET/CT (TARGET) trial were surveyed.

Results: Of the 28 TARGET site PIs eligible for the study, 18 consented to participate (response rate: 64%). Many site PIs returned incidental findings to participants (61%), and the most common finding that was returned was serious (but not life-threatening) and treatable (54.5%). More than half of the investigators believed that adequacy of clinical follow up (58.8%) and legal liability if incidental findings are not disclosed (55.6%) were extremely important factors in returning incidental research findings from whole body FDG PET/CT. All investigators felt very obligated to return incidental research findings if scans revealed a treatable, high-risk medical condition. Most investigators felt very obligated to disclose incidental findings with important health implications (94.4%), for which proven preventive or therapeutic interventions exist (77.8%), that provide early detection of a health problem (72.2%), if participants ask for their incidental findings (72.2%), and if scans have established validity for a particular medical condition (61.1%).

Conclusion: Although it is recommended that researchers report and manage incidental research findings, our data show differing views and uncertainties on what and how to return, and the extent of follow up needed to manage, incidental findings from whole body FDG PET/CT; this highlights the need for more specific and standardized guidance.

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来源期刊
CiteScore
9.40
自引率
6.40%
发文量
368
审稿时长
3-6 weeks
期刊介绍: Arthritis Care & Research, an official journal of the American College of Rheumatology and the Association of Rheumatology Health Professionals (a division of the College), is a peer-reviewed publication that publishes original research, review articles, and editorials that promote excellence in the clinical practice of rheumatology. Relevant to the care of individuals with rheumatic diseases, major topics are evidence-based practice studies, clinical problems, practice guidelines, educational, social, and public health issues, health economics, health care policy, and future trends in rheumatology practice.
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