title: Patient feedback and early outcome data with a novel tiered-binned model for multiplex breast cancer susceptibility testing.
abstract: OBJECTIVE
  The risks, benefits, and utilities of multiplex panels for breast cancer susceptibility are unknown, and new counseling and informed consent models are needed. We sought to obtain patient feedback and early outcome data with a novel tiered-binned model for multiplex testing.
  
  
  METHODS
  BRCA1/2-negative and untested patients completed pre- and posttest counseling and surveys evaluating testing experiences and cognitive and affective responses to multiplex testing.
  
  
  RESULTS
  Of 73 patients, 49 (67%) completed pretest counseling. BRCA1/2-negative patients were more likely to proceed with multiplex testing (86%) than those untested for BRCA1/2 (43%; P < 0.01). Many patients declining testing reported concern for uncertainty and distress. Most patients would not change anything about their pre- (76%) or posttest (89%) counseling sessions. Thirty-three patients (72%) were classified as making an informed choice, including 81% of those who proceeded with multiplex testing. Knowledge increased significantly. Anxiety, depression, uncertainty, and cancer worry did not significantly increase with multiplex testing.
  
  
  CONCLUSIONS
  Some patients, particularly those without prior BRCA1/2 testing, decline multiplex testing. Most patients who proceeded with testing did not experience negative psychological responses, but larger studies are needed. The tiered-binned approach is an innovative genetic counseling and informed consent model for further study in the era of multiplex testing.Genet Med 18 1, 25-33.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Angela R
authors.initials: AR
authors.lastname: Bradbury
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA.|Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Linda J
authors.identifier: http://orcid.org/0000-0003-4315-8687
authors.initials: LJ
authors.lastname: Patrick-Miller
authors.affiliation: Fox Chase Cancer Center, Temple University Health System, Biostatistics and Bioinformatics Facility, Philadelphia, Pennsylvania, USA.
authors.forename: Brian L
authors.initials: BL
authors.lastname: Egleston
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: DiGiovanni
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jamie
authors.initials: J
authors.lastname: Brower
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Diana
authors.initials: D
authors.lastname: Harris
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Evelyn M
authors.initials: EM
authors.lastname: Stevens
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Kara N
authors.initials: KN
authors.lastname: Maxwell
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Abha
authors.initials: A
authors.lastname: Kulkarni
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Tyler
authors.initials: T
authors.lastname: Chavez
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Brandt
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jessica M
authors.identifier: http://orcid.org/0000-0003-0382-7890
authors.initials: JM
authors.lastname: Long
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jacquelyn
authors.initials: J
authors.lastname: Powers
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jill E
authors.initials: JE
authors.lastname: Stopfer
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Division of Translational Medicine and Human Genetics, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Basser Research Center, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Nathanson
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.|Basser Research Center, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Domchek
mesh_terms: D019313:BRCA1 Protein / Q000235:genetics; D024682:BRCA2 Protein / Q000235:genetics; D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000523:psychology; D003376:Counseling; D003657:Decision Making; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005817:Genetic Counseling; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing / Q000379:methods; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D035501:Uncertainty
chemical_list: D019313:BRCA1 Protein; C492913:BRCA1 protein, human; D024682:BRCA2 Protein; C551750:BRCA2 protein, human
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