Bowen 2004.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 354 women aged between 18 and 74 were randomised. Patients with a family history of breast cancer but with no personal history of breast/ovarian cancer or BRCA1/2 mutation. The Gail lifetime score for the sample as a whole was 12%, which is close to population lifetime risk of breast cancer. Women living within a 60‐mile radius of the research centre were eligible to participate | |
| Interventions | Individual genetic counselling versus group psychosocial counselling compared with a no‐counselling comparison group | |
| Outcomes | Perceived risk (4 items developed by research team measuring beliefs about perceived personal breast cancer risk: personal estimate of lifetime risk on scale from 0% to 100%; personal estimate of risk relative to average woman rated on 8‐point scale; personal estimate of risk relative to own age group rated on 8‐point scale; personal risk without referrant using categories of 'very high', 'high', 'low', and 'very low' ) Actual breast cancer risk information (patients provided information on their family history of breast cancer, current age and reproductive and breast health risk factors. Risk estimates were calculated) Emotional reactions (measured in two ways: brief symptom inventory measuring general anxiety and depression ‐ shortened version of Hopkins symptom checklist ‐ 49 items on 5‐point Likert scales; Cancer worry scale (Lerman 1991a) Reactions to counselling (brief survey focusing on use of written educational materials, enjoyment and perceived usefulness of counselling, perceived support from counsellor, comfort of talking during counselling) | |
| Notes | Parts of methodology not fully explained but explained in earlier papers (Bowen 1999; Bowen 2002). High‐risk patients not included in study. Blinding in the randomisation process was not possible. Bowen 1999 was not excluded from the study however, it is the data from Bowen 2004 which are presented as the main trial paper. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomization was conducted by assigning a randomization number to each participant in a blinded fashion. Each randomization number was pre‐assigned to one of three study conditions without bias" Comment: Method of randomisation not reported |
| Allocation concealment (selection bias) | High risk | "Those women who completed the baseline were randomized into the study and informed of their randomized study arm over the telephone" Comment: No allocation concealment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 354 participants randomised. 346 (98%) completed the 6‐month follow‐up. Final analyses performed on those who completed follow‐up and baseline assessment (n = 348). |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |