title: Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.
abstract: OBJECTIVE
  Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies.
  
  
  METHODS
  Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing.
  
  
  RESULTS
  In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing.
  
  
  CONCLUSIONS
  A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.
authors.affiliation: 1] Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA [2] Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania, USA [3] Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Angela R
authors.initials: AR
authors.lastname: Bradbury
authors.affiliation: 1] Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA [2] Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Patrick-Miller
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jessica
authors.initials: J
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: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Stopfer
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Andrea
authors.identifier: 0000000347828908
authors.initials: A
authors.lastname: Forman
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Rybak
authors.affiliation: Department of Hematology/Oncology, MD Anderson Cancer Center at Cooper, Camden, New Jersey, USA.
authors.forename: Kristin
authors.identifier: 0000000163893158
authors.initials: K
authors.lastname: Mattie
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, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Rachelle
authors.identifier: 0000000194447169
authors.initials: R
authors.lastname: Chambers
authors.affiliation: 1] Department of Pediatrics, Columbia University Medical Center, New York, New York, USA [2] Department of Medicine, Columbia University Medical Center, New York, New York, USA.
authors.forename: Wendy K
authors.identifier: 0000000334506926
authors.initials: WK
authors.lastname: Chung
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Churpek
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Mary B
authors.initials: MB
authors.lastname: Daly
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Digiovanni
authors.affiliation: Department of Hematology/Oncology, MD Anderson Cancer Center at Cooper, Camden, New Jersey, USA.
authors.forename: Dana
authors.initials: D
authors.lastname: Farengo-Clark
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Dominique
authors.initials: D
authors.lastname: Fetzer
authors.affiliation: Department of Internal Medicine, John H. Stroger, Jr. Hospital, Chicago, Illinois, USA.
authors.forename: Pamela
authors.identifier: 0000000250384132
authors.initials: P
authors.lastname: Ganschow
authors.affiliation: Department of Hematology/Oncology, MD Anderson Cancer Center at Cooper, Camden, New Jersey, USA.
authors.forename: Generosa
authors.initials: G
authors.lastname: Grana
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Cassandra
authors.initials: C
authors.lastname: Gulden
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Hall
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Lynne
authors.initials: L
authors.lastname: Kohler
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Kara
authors.initials: K
authors.lastname: Maxwell
authors.affiliation: Department of Translational Medicine and Human Genetics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Shana
authors.initials: S
authors.lastname: Merrill
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Montgomery
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Mueller
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Nielsen
authors.affiliation: 1] Division of Hematology-Oncology, Department of Medicine, The University of Chicago, Chicago, Illinois, USA [2] Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, Illinois, USA.
authors.forename: Olufunmilayo
authors.initials: O
authors.lastname: Olopade
authors.affiliation: Department of Clinical Genetics, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Rainey
authors.affiliation: Department of Internal Medicine, John H. Stroger, Jr. Hospital, Chicago, Illinois, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Seelaus
authors.affiliation: 1] Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA [2] Department of Translational Medicine and Human Genetics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Katherine L
authors.identifier: 0000000303827890
authors.initials: KL
authors.lastname: Nathanson
authors.affiliation: 1] Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA [2] Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Domchek
mesh_terms: D005817:Genetic Counseling; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing / Q000941:ethics / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D008962:Models, Theoretical; D009369:Neoplasms / Q000175:diagnosis* / Q000235:genetics*