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J Med Genet 2000;37:192-196 doi:10.1136/jmg.37.3.192
  • Original article

A model protocol evaluating the introduction of genetic assessment for women with a family history of breast cancer

  1. Jonathon Graya,
  2. Kate Braina,
  3. Paul Normanb,
  4. Cathy Anglima,
  5. Liz Francea,
  6. Garry Bartonc,
  7. Lucy Branstond,
  8. Evelyn Parsonsa,
  9. Angus Clarkea,
  10. Julian Sampsona,
  11. Elizabeth Robertsd,
  12. Robert Newcombee,
  13. David Cohenc,
  14. Cerilan Rogersd,
  15. Robert Manself,
  16. Peter Harpera
  1. aInstitute of Medical Genetics, University of Wales College of Medicine, Heath Park, Cardiff CF4 4XN, UK, bPsychology Department, Sheffield University, Sheffield, UK, cHealth Economics, University of Glamorgan, Glamorgan, UK, dBreast Test Wales, Cardiff, UK, eDepartment of Medical Computing and Statistics, University of Wales College of Medicine, Cardiff, UK, fDepartment of Surgery, University of Wales College of Medicine, Cardiff, UK
  1. Dr Gray
  • Revised 28 April 1999
  • Accepted 5 August 1999

Abstract

Randomised controlled trials allow comparisons to be made between different models of service delivery, but have not been used in the field of clinical genetics. With the advent of clinical governance, the evidence provided by such trials will be increasingly important in informing and shaping clinical genetics practice. The TRACE project (Trial of genetic assessment in breast cancer) is a randomised controlled trial of genetic assessment for women who are at increased risk of breast cancer because of their family history. The absence of cancer genetics service provision in Wales before this study gave a window of opportunity in which this important trial could be conducted. The present paper describes how TRACE will provide crucial evidence regarding the psychosocial as well as resource implications of adding individualised genetic assessment, genetic counselling, and (where appropriate) gene testing to typical advice and surveillance from a hospital breast clinic. In addition, it is anticipated that TRACE will represent a model for future trials of service delivery in the increasing number of complex genetic disorders where evidence on the economic implications of screening and management is currently limited.

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