Brain 2000a.

Study characteristics
Methods	Prospective RCT
Participants	735 women aged between 19 and 73 were randomised. The final sample consisted of 545 women in Brain 2000a. In Brain 2002, 653 participants were compared at baseline and follow‐up immediately after attending clinic. Patients with a family history of breast cancer, who had no personal history of breast cancer, no prior counselling and were resident in Wales were eligible to participate. The data reported in Brain 2002 state that of the 653 women who received risk information and completed the immediate follow‐up questionnaire, 107 were at low risk of cancer, 447 were at moderate risk and 99 were at high risk. A four‐way randomisation was carried out to control for differences between two venues (Breast Test Wales Screening Centre and the Family History Clinic at the University Hospital of Wales)
Interventions	Surgical consultation with genetic assessment versus the standard surgical consultation without genetic assessment
Outcomes	Primary outcomes: Emotional well‐being (2 measures: general anxiety measured by the State‐Trait Anxiety Inventory STAI (Spielberger 1983); breast cancer worry measured by the Breast Cancer Worries Scale (Lerman 1991a; Lerman 1991b)) Perceived risk of breast cancer (2 items derived from previous research (Lerman 1991a; Lerman 1993; Champion 1984)) Secondary outcomes: Knowledge of familial breast cancer (4 true / false items to make knowledge score) Patient satisfaction (12‐Item Satisfaction with Genetic Counseling Questionnaire (Shiloh 1990)) Costs were also compared with current service provision
Notes	Secondary analyses of the data are presented in Brain 2002. The 2 study groups are compared at baseline and follow‐up immediately after attending the clinic of 653 participants stratified into low, moderate or high‐risk categories on the following outcomes: anxiety; worry; perceived risk; satisfaction
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The randomization procedure was based on a computer‐generated sequence of random numbers"
Allocation concealment (selection bias)	Unclear risk	Randomisation is likely to have been concealed although this is not stated
Incomplete outcome data (attrition bias) All outcomes	High risk	26.35% of randomised participants were withdrawn from the trial; five participants were excluded due to non‐attendance in the surgical aspect of the multidisciplinary trial clinic and 190 (87 control group, 103 intervention group) were lost to follow‐up. "Those who dropped out at baseline reported statistically significantly higher trait and state anxiety and lower personal risk than participants." At the first assessment and at 9‐month assessment, drop‐outs were significantly younger and reported higher baseline cancer worry. Those in the control group were less likely to return the questionnaire immediately after the clinic. "Participants who did not complete both follow‐up questionnaires were not included in the main comparative analyses."
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported