Young 2006.
| Study characteristics | ||
| Methods | Randomised trial | |
| Participants | 90 women were randomised, of whom 3 were subsequently withdrawn. Women who were referred to the Tayside Familial Breast Cancer Service in Scotland, UK and whose risk of breast cancer was assessed as being at below the threshold for inclusion in a regular surveillance program were eligible for inclusion. All participants were therefore at low or average risk | |
| Interventions | Women were randomised to receive their genetic risk information in a personalised letter or to attend the genetics department for an interview with a genetics associate or nurse specialist. This gave the opportunity for questions to be asked and answered but did not include breast examination or mammography. The interview was followed up by a personal letter summarising the discussion | |
| Outcomes | Three months after the intervention, all participants were asked to complete a patient satisfaction questionnaire based on the instrument used in Brain 2000a. Breast cancer worry measured by the cancer worry scale (Lerman 1991a; Lerman 1991b). Understanding of breast cancer risk (11 questions: 5 about perceptions of own risk, 2 about perceptions of general population risk). Actions and experiences since receiving the risk assessment (12 items about possible adverse effects on behaviour, 10 items about possible positive effects on behaviour). Experiences of and satisfaction with the interview or written communication. General Health Questionnaire (Goldberg 1988) |
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| Notes | No baseline measures on any of the outcomes. Also no details of participant characteristics such as age and educational level | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomised by a genetics associate (using computer‐generated random numbers)" |
| Allocation concealment (selection bias) | Unclear risk | Allocation is likely to be concealed although this is not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 87 participants randomised after 3 exclusions. 81.6% completed 3‐month follow‐up. Reasons for exclusion and drop‐out reported. No data on differences between responders and non‐responders |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
RCT: randomised controlled trial
Due to the nature of the interventions, it would not always be possible for participants and treatment providers to be blind to assignment status once assigned therefore excluded from assessment of quality of allocation concealment