Bowen 2006.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 220 Ashkenazi Jewish women aged between 18 and 74 years were randomised. Participants had no personal history of breast or ovarian cancer and did not have a family history consistent with a BRCA1/2 mutation. The samples risk level was close to that of the general population lifetime risk. Participants living within 60 miles of Seattle were eligible to participate | |
| Interventions | Group psychosocial counselling versus individual genetic counselling compared with a delayed counselling control group. | |
| Outcomes | Perceived risk of breast cancer (personal estimate of lifetime risk on a continuous scale from 0% to 100%) Cancer worry (Cancer worry scale (Lerman 1991a)). General anxiety (measured with the 49‐item Brief Symptom Inventory (Derogatis 1983) on 5‐point Likert scales) Genetic testing beliefs (measured using three scales with 4‐point responses: fear of stigma; access to genetic testing; information flow about test results) Genetic testing awareness, interest and candidacy (measured with three single items) Jewish identity (measured using the 14‐item Multigroup Ethnic Identity Measure (Phinney 1992)) |
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| Notes | High‐risk patients not included in study. Blinding in the randomisation process was not possible. Two counselling protocols based on previous study (Bowen 2004) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Participants were randomly assigned to one of three study groups" Comment: Method of randomisation not reported |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 220 women randomised. Overall follow‐up rate 96% (77% returned 6‐month follow‐up questionnaire and 19% completed follow‐up telephone call). Reasons for attrition not reported. No differences among arms in follow‐up rates and no differences in baseline demographic data between women who did and did not provide follow‐up data. No data are available about the number of participants who provided follow‐up data from each group |
| Selective reporting (reporting bias) | Unclear risk | All pre‐specified outcomes reported except measure of general anxiety reported in methods section but not in results |