The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation

The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation
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DOI:
10.1007/s10897-018-0286-9
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发表时间:
2019-04-01
影响因子:
1.9
通讯作者:
Patrick, Donald L.
Patrick, Donald L.
中科院分区:
医学4区
文献类型:
--
作者:
Li, Meng;Bennette, Caroline S.;Patrick, Donald L.

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本研究的目的是开发一种简短的工具,即基因组测试结果的感受 (FACToR),以衡量在研究和临床实践中将基因组结果返回给患者的心理社会影响。为了创建 FACToR,我们根据文献综述、两个焦点小组 (N=12) 和认知访谈 (N=6) 的结果修改和增强了癌症风险评估的多维影响 (MICRA) 调查问卷。我们评估了来自 (NEXT) 医学研究中的新外显子组技术评估遗传性结直肠癌或息肉病的 122 名参与者的数据,这是一项外显子组测序与常规护理的随机对照试验。我们评估了每个项目的下限和上限效应,进行主成分分析以确定子量表,并评估每个子量表的内部一致性、重测信度和结构效度。在排除不明确或表现出下限或上限效应的项目后,保留了构成四个不同子量表的 12 个项目以供进一步分析:负面情绪、积极感受、不确定性和隐私问题。所有四个都表现出良好的内部一致性(0.66-0.78)和重测可靠性(0.65-0.91)。积极情绪和不确定性分量表证明了已知群体的有效性。具有四个子量表的 12 项 FACToR 在有限样本中的初步评估中显示出有希望的心理测量特性,并且需要在其他人群中进行评估。
The purpose of this study was to develop a brief instrument, the Feelings About genomiC Testing Results (FACToR), to measure the psychosocial impact of returning genomic findings to patients in research and clinical practice. To create the FACToR, we modified and augmented the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire based on findings from a literature review, two focus groups (N=12), and cognitive interviews (N=6). We evaluated data from 122 participants referred for evaluation for inherited colorectal cancer or polyposis from the New EXome Technology in (NEXT) Medicine Study, an RCT of exome sequencing versus usual care. We assessed floor and ceiling effects of each item, conducted principal component analysis to identify subscales, and evaluated each subscale's internal consistency, test-retest reliability, and construct validity. After excluding items that were ambiguous or demonstrated floor or ceiling effects, 12 items forming four distinct subscales were retained for further analysis: negative emotions, positive feelings, uncertainty, and privacy concerns. All four showed good internal consistency (0.66-0.78) and test-retest reliability (0.65-0.91). The positive feelings and the uncertainty subscales demonstrated known-group validity. The 12-item FACToR with four subscales shows promising psychometric properties on preliminary evaluation in a limited sample and needs to be evaluated in other populations.