Matloff 2006.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 64 participants randomised, of whom 48 completed both questionnaires and received the intervention. Women were aged 40 years or over, had at least one first degree relative with breast cancer, had gone through natural menopause and were not currently taking menopausal therapy. Women were excluded if they had a personal cancer history, were a known BRCA1/2 mutation or had heart disease. Trial setting in Connecticut, USA | |
| Interventions | Two 60‐minute genetic counselling sessions and risk assessment with a certified genetic counsellor. Individuals' risk for breast and endometrial cancer, heart disease, and osteoporosis were calculated based on family history and personal health data and were presented to the participant at the second visit, which was held 3‐4 weeks after the first session. Control participants were offered the counselling intervention after the trial data collection finished | |
| Outcomes | Perceived lifetime risk of breast cancer, heart disease and osteoporosis (scale 0% to 100%), estimates of the lifetime risk of an average woman (scale 0% to 100%). Worry about breast cancer in past month measured with a single item (1 = not at all, 4 = almost all of the time). Decisional conflict regarding menopausal therapy decision making assessed with the Decisional Conflict Scale (5‐point scale). Satisfaction with counselling intervention in terms of information received, support received, amount of time involved and convenience of counselling session. Accuracy of knowledge about menopause assessed using a 30‐item true/false questionnaire |
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| Notes | High‐risk patients not included in study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "randomized to either an intervention or control arm upon recruitment (every other patient)" Comment: Quasi‐randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 64 participants randomised. 57 completed baseline questionnaire and received the intervention (n = 29) or in control group (n = 28). "Analyses are confined to the 48 participants who completed assessments at all three time points (23 in the intervention group and 25 in the control group). "Participants were excluded from the analyses for which they had missing data, and no imputations were conducted." No reasons for attrition reported |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |