PEP.
Methods | Accrual: August 2007 to May 2008 Muticentre (breast screening units n = 7); UK‐based Parallel group randomised controlled trial using stratified block randomisation (block sizes of three, six and nine). Follow‐up: one month; one year |
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Participants | Women aged 67 to 70 attending for final routine appointment on the UK NHS Breast Screening programme. | |
Interventions |
Intervention group 1 (n = 287): received a booklet conveying key breast cancer awareness messages, given by a radiographer to each woman who had received her final routine mammogram, in addition to the usual care. Intervention group 2 (n = 294): received a 10‐min one‐to‐one verbal interaction with a radiographer or research psychologist plus booklet plus usual care. Control group (n = 286): received the usual care (women were informed that they were no longer eligible for routine screening, advised to continue to be screened every 3 years on request and given a card with contact details and a suggested date for contact). |
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Outcomes |
Primary Outcomes Knowledge of breast cancer symptoms, knowledge of age‐related risk, confidence to check breasts and overall breast cancer awareness. Breast cancer awareness Women’s breast cancer awareness measured using a breast cancer awareness score (a combination of responses to the three questions from the trial‐specific questionnaire on: knowledge of symptoms, knowledge of age‐related risk and reported breast checking). |
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Notes | Two‐year follow‐up reported by Forbes 2011a. Study funded by Cancer Research UK. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified block randomisation described. |
Allocation concealment (selection bias) | Low risk | Detail on randomisation provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Lack of blinding of personnel & participants. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Lack of blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detail on attrition provided. |
Selective reporting (reporting bias) | Low risk | All relevant outcomes detailed in Methods section were reported in Results section. |
Other bias | Low risk | No other potential sources of bias were identified. |