PT - JOURNAL ARTICLE AU - Gray, Jonathon AU - Brain, Kate AU - Norman, Paul AU - Anglim, Cathy AU - France, Liz AU - Barton, Garry AU - Branston, Lucy AU - Parsons, Evelyn AU - Clarke, Angus AU - Sampson, Julian AU - Roberts, Elizabeth AU - Newcombe, Robert AU - Cohen, David AU - Rogers, Cerilan AU - Mansel, Robert AU - Harper, Peter TI - A model protocol evaluating the introduction of genetic assessment for women with a family history of breast cancer AID - 10.1136/jmg.37.3.192 DP - 2000 Mar 01 TA - Journal of Medical Genetics PG - 192--196 VI - 37 IP - 3 4099 - http://jmg.bmj.com/content/37/3/192.short 4100 - http://jmg.bmj.com/content/37/3/192.full SO - J Med Genet2000 Mar 01; 37 AB - 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.