title: Access to personalized medicine: factors influencing the use and value of gene expression profiling in breast cancer treatment.
abstract: Genomic information is increasingly being used to personalize health care. One example is gene expression profiling (gep) tests, which estimate recurrence risk to inform chemotherapy decisions in breast cancer. Recently, gep tests were publicly funded in Ontario. We explored the perceived utility of gep tests, focusing on the factors influencing their use and value in treatment decision-making by patients and oncologists.
  
  
  METHODS
  We conducted interviews with oncologists (n = 14) and interviews and a focus group with early-stage breast cancer patients (n = 28) who underwent gep testing. Both groups were recruited through oncology clinics in Ontario. Data were analyzed using the content analysis and constant comparison techniques.
  
  
  RESULTS
  Narratives from patients and oncologists provided insights into various factors facilitating and restricting access to gep. First, oncologists are positioned as gatekeepers of gep, providing access in medically appropriate cases. However, varying perceptions of appropriateness led to perceived inequities in access and negative impacts on the doctor-patient relationship. Second, media attention facilitated patient awareness of gep, but also complicated gatekeeping. Third, the dedicated administration attached to gep was burdensome and led to long waits for results and also to increased patient anxiety and delayed treatment. Collectively, because of barriers to access, those factors inadvertently heightened the perceived value of gep for patients relative to other prognostic indicators.
  
  
  CONCLUSIONS
  Our study delineates the factors facilitating and restricting access to gep, and highlights the roles of media and organization of services in the perceived value and utilization of gep. The results identify a need for administrative changes and practice guidelines to support streamlined and standardized use of gep tests.
authors.affiliation: University of Toronto, Toronto, ON. ; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, ON.
authors.forename: Y
authors.initials: Y
authors.lastname: Bombard
authors.affiliation: Independent qualitative researcher.
authors.forename: L
authors.initials: L
authors.lastname: Rozmovits
authors.affiliation: University of Toronto, Toronto, ON. ; Sunnybrook Health Sciences Centre, Toronto, ON.
authors.forename: M
authors.initials: M
authors.lastname: Trudeau
authors.affiliation: University of Toronto, Toronto, ON. ; Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON.
authors.forename: N B
authors.initials: NB
authors.lastname: Leighl
authors.affiliation: McMaster University, DeGroote School of Business, Hamilton, ON.
authors.forename: K
authors.initials: K
authors.lastname: Deal
authors.affiliation: McMaster University, Department of Clinical Epidemiology and Biostatistics, and St. Joseph's Healthcare, Hamilton, ON; and Department of Community Health Sciences, University of Calgary, Calgary, AB.
authors.forename: D A
authors.initials: DA
authors.lastname: Marshall
keywords: Gene expression profiling; access; breast cancer; decision-making; genomics; health care providers; patient perceptions; personalized medicine; perspectives; risk recurrence