Jane S Kang, Howard F Andrews, Jon T Giles, Katherine P Liao, Daniel H Solomon, Joan M Bathon
{"title":"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。","authors":"Jane S Kang, Howard F Andrews, Jon T Giles, Katherine P Liao, Daniel H Solomon, Joan M Bathon","doi":"10.1002/acr.25424","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>There are limited data on researchers' attitudes and beliefs on returning and managing incidental research findings from whole body <sup>18</sup>F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) imaging.</p><p><strong>Methods: </strong>Site principal investigators (PIs) who enrolled participants for the Treatments Against Rheumatoid Arthritis and Effect on FDG PET/CT (TARGET) trial were surveyed.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":8406,"journal":{"name":"Arthritis Care & Research","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Returning Incidental Research Findings From <sup>18</sup>F-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography to Participants: A Survey of Investigators From a Clinical Trial of Rheumatoid Arthritis.\",\"authors\":\"Jane S Kang, Howard F Andrews, Jon T Giles, Katherine P Liao, Daniel H Solomon, Joan M Bathon\",\"doi\":\"10.1002/acr.25424\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>There are limited data on researchers' attitudes and beliefs on returning and managing incidental research findings from whole body <sup>18</sup>F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) imaging.</p><p><strong>Methods: </strong>Site principal investigators (PIs) who enrolled participants for the Treatments Against Rheumatoid Arthritis and Effect on FDG PET/CT (TARGET) trial were surveyed.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":8406,\"journal\":{\"name\":\"Arthritis Care & Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-09-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Arthritis Care & Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/acr.25424\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Arthritis Care & Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/acr.25424","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
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.
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.