Abstract
Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. When the analysis of circulating cell free DNA (ccfDNA) became commercially available in 2011 through the Prenatal Diagnostic Laboratory at Women & Infants Hospital of Providence, Rhode Island to “high-risk” women, it provided an opportunity to examine how commercial laboratories informed potential consumers. We identified, via an internet search, four laboratories offering such testing in the United States and one in Europe. We evaluated patient educational materials (PEMs) from each using the Flesch Reading Ease method and a modified version of the Suitability Assessment of Materials (SAM) criteria. Pamphlets were also reviewed for their inclusion of content recommendations from the International Society for Prenatal Diagnosis, the National Society of Genetic Counselors, the American College of Obstetricians and Gynecologists jointly with the Society of Maternal Fetal Medicine, and the American College of Genetics and Genomics. Reading levels were typically high (10th–12th grade). None of the pamphlets met all SAM criteria evaluated nor did any pamphlet include all recommended content items. To comply with readability and content recommendations more closely, Women & Infants Hospital created a new pamphlet to which it applied the same criteria, and also subjected it to focus group assessment. These types of analyses can serve as a model for future evaluations of similar patient educational materials.
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Disclosure of financial support/funding
No commercial financial or other funding support was used in this study.
Conflict of interest
Paula Haddow declares that she has no conflict of interest.
Jacquelyn Halliday declares that she has no conflict of interest.
Edward Kloza, Barbara O’Brien, Geralyn Messerlian, and Glenn Palomaki are key personnel on an industry-sponsored grant from Natera, Inc. Women & Infants Hospital of Rhode Island served as the Coordinating Center for an international clinical validation study (clinicaltrials.gov - NCT00877292) of maternal plasma DNA testing for aneuploidy with Dr. Palomaki as a Co-Principal Investigator from 2008 through 2011 (funded by Sequenom, Inc, San Diego, CA). Edward Kloza and Geralyn Messerlian were also key personnel. The Prenatal Diagnosis Center at Women & Infants Hospital of Rhode Island served as an enrollment site for that study, with Barbara O’Brien as Site Investigator. Glenn Palomaki previously served on Sequenom’s Clinical Advisory Board between 2005 and 2007, and Barbara O'Brien serves as a Medical Science Liaison for Sequenom.
Human Studies and Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.
Animal Studies
No animal studies were carried out by the authors for this article.
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Kloza, E.M., Haddow, P.K., Halliday, J.V. et al. Evaluation of Patient Education Materials: The Example of Circulating cell free DNA Testing for Aneuploidy. J Genet Counsel 24, 259–266 (2015). https://doi.org/10.1007/s10897-014-9758-8
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DOI: https://doi.org/10.1007/s10897-014-9758-8