Abstract
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.
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Author Contributions Section
Meng Li, Caroline S. Bennette, David L. Veenstra and Donald L. Patrick contributed to the design of the work, analysis and interpretation of data, and drafting and revising the manuscript, approved the final version to be published, and agreed to be accountable for all aspects of the work.
Laura M. Amendola, M. Ragan Hart, Patrick Heagerty, Bryan Comstock, Peter Tarczy-Hornoch, Stephanie M. Fullerton, Dean A Regier, Wylie Burke, Susan B. Trinidad and Gail P. Jarvik contributed to the acquisition of data and critical revisions of the manuscript, approved the final version to be published, and agreed to be accountable for all aspects of the work.
Funding
This research received funding from the National Human Genome Research Institute and National Cancer Institute (grant numbers: U01HG0006507 and U01HG007307).
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Authors Meng Li, Caroline S. Bennette, Laura M. Amendola, M. Ragan Hart, Patrick Heagerty, Bryan Comstock, Peter Tarczy-Hornoch, Stephanie M. Fullerton, Dean A Regier, Wylie Burke, Susan B. Trinidad, Gail P. Jarvik, David L. Veenstra, and Donald L. Patrick declare that they have no conflict of interest.
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This study was approved by the University of Washington Institutional Review Board. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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Li, M., Bennette, C.S., Amendola, L.M. et al. The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation. J Genet Counsel (2018). https://doi.org/10.1007/s10897-018-0286-9
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DOI: https://doi.org/10.1007/s10897-018-0286-9