| Study characteristics |
| Methods |
Cluster randomised trial |
| Participants |
373 women referred from participating GP practices to regional clinical genetics departments in south east Scotland participated in this study. Those who were symptomatic or had a breast/ovarian cancer diagnosis or those who had previously consulted another clinic about a family history of cancer were excluded from the trial. 31% of the sample were at low risk of cancer, 69% were at moderate/high risk |
| Interventions |
Novel (community‐based) service versus the standard regional service |
| Outcomes |
Subjective understanding (4‐point scale rating how well understand 4 issues relevant to breast cancer genetic risk to give composite score)
Objective understanding (true/false to 10 factual statements about breast cancer genetics ‐ give total scores for genetics understanding and mammography understanding)
Perceived risk of breast cancer (one item for analysis ‐ perceive risk to be high, moderate or low)
Psychological distress (2 measures: GHQ‐30 (Goldberg 1988); Cancer Worry Scale (Watson 1998))
Health behaviours (rate whether frequency of certain behaviours had changed since baseline) |
| Notes |
GP practices randomly assigned using a minimisation technique and was not possible to blind assignment status |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Practices were randomly assigned to either arm of the trial using a minimisation technique (Pocock 1983, pp 84‐86)" |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
All reasons/numbers for attrition stated. 373 participants were randomised. Main analyses were performed on data from 244 (65%) participants who completed all three follow‐up assessments. "Women who dropped out of the trial tended to be in the novel service arm of the trial or at low risk of breast cancer." Women who dropped out also had significantly higher baseline cancer worry scores |
| Selective reporting (reporting bias) |
Low risk |
All pre‐specified outcomes reported |
