title: American BRCA Outcomes and Utilization of Testing (ABOUT) study: a pragmatic research model that incorporates personalized medicine/patient-centered outcomes in a real world setting.
abstract: Research to date regarding identification and management of hereditary breast and ovarian cancer syndrome (HBOC) in the U.S. has been confined primarily to academic center-based studies with limited patient engagement. To begin to understand and address the current gaps and disparities in delivery of services for the appropriate identification and optimal risk management of individuals with HBOC, we designed and have initiated the American BRCA Outcomes and Utilization of Testing (ABOUT) Study. ABOUT relies on a collaborative patient advocacy, academic and industry partnership to recruit and engage U.S. individuals who are at increased risk for HBOC and investigate their experiences, decisions and outcomes. It utilizes an extensive research infrastructure, including an interactive web-based data system and electronic interfaces for secure online participation and automated data exchange. We describe the novel recruitment approach that was designed for collaboration with a national commercial health plan partner to identify all individuals for whom a healthcare provider orders a BRCA test and mail to each individual an invitation to participate and study packet. The study packet contains detailed information about the study, a baseline questionnaire and informed consent for participation in the study, for release of relevant medical and health plan records and for ongoing research engagement. This approach employs patient-reported, laboratory-reported and health plan-reported outcomes and facilitates longitudinal engagement. We believe that the type of innovative methodology and collaborative framework we have developed for ABOUT is an ideal foundation for a patient-powered research network. This approach can make substantial contributions to identifying current and best practices in HBOC, leading to improved strategies for clinical care and optimal health outcomes among individuals with high inherited risk for cancer.
authors.affiliation: Women's Health, Aetna, Hartford, CT, USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Armstrong
authors.forename: Michele
authors.initials: M
authors.lastname: Toscano
authors.forename: Nancy
authors.initials: N
authors.lastname: Kotchko
authors.forename: Sue
authors.initials: S
authors.lastname: Friedman
authors.forename: Marc D
authors.initials: MD
authors.lastname: Schwartz
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Virgo
authors.forename: Kristian
authors.initials: K
authors.lastname: Lynch
authors.forename: James E
authors.initials: JE
authors.lastname: Andrews
authors.forename: Claudia X
authors.initials: CX
authors.lastname: Aguado Loi
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bauer
authors.forename: Carolina
authors.initials: C
authors.lastname: Casares
authors.forename: Rachel Threet
authors.initials: RT
authors.lastname: Teten
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Kondoff
authors.forename: Ashley D
authors.initials: AD
authors.lastname: Molina
authors.forename: Mehrnaz
authors.initials: M
authors.lastname: Abdollahian
authors.forename: Lana
authors.initials: L
authors.lastname: Brand
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Walker
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sutphen
mesh_terms: D000328:Adult; D003299:Cooperative Behavior; D019317:Evidence-Based Medicine / Q000458:organization & administration; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005817:Genetic Counseling / Q000592:standards*; D061325:Hereditary Breast and Ovarian Cancer Syndrome / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care / Q000458:organization & administration*; D018802:Patient-Centered Care / Q000592:standards*; D057285:Precision Medicine / Q000592:standards*; D058996:Quality Improvement / Q000458:organization & administration; D014481:United States