Braithwaite 2005.
| Study characteristics | ||
| Methods | Randomised trial | |
| Participants | 72 women over the age of 18 were randomised. Women had at least one first or second degree relative affected with breast cancer but no personal history of breast cancer. 35 (50.7%) participants were found to be at average risk, 16 (23.2%) at moderate risk and 18 (26.1%) at high risk. Participants were recruited from the Greater London area in the UK |
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| Interventions | A computerised tool to support stratification of breast cancer genetic risk assessment in the clinical environment (GRACE) versus risk counselling by a clinical nurse specialist. Intervention lasted for one session only | |
| Outcomes | Acceptability of the intervention (attitudes towards GRACE or consultation, perceived benefits, perceptions of risk information (credibility, trustworthiness, accuracy, clarity and helpfulness), satisfaction and risk communication preferences) Cognitive outcomes: comparative risk perception (measured with a single‐item on a 5‐point scale); risk accuracy (measured by assessing level of concordance between the women's perceived risk estimate and those provided by GRACE or nurse specialist) Emotional outcomes: Anxiety and depression scale (HADS); General anxiety (measured by the short version of the State‐Trait Anxiety Inventory STAI); Cancer worry scale [(Lerman 1991a) |
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| Notes | Women were relatively young (62% aged between 18‐34 years) and a majority reported being computer literate | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "...those found to be eligible were emailed further information about the study and randomized to one of the study conditions" Comment: Method of randomisation not reported |
| Allocation concealment (selection bias) | Unclear risk | "Both the clinical nurse specialist and the participants were blinded to the treatment arm until just prior to their appointment" Comment: Allocation concealment not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 72 participants randomised and provided data immediately post‐clinic. 54 women provided 3‐month follow‐up data. Reasons for attrition not reported. No comparison between respondents and non‐respondents in terms of risk perception or psychological variables |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |