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. 2021 Mar 6;2021(3):MR000032. doi: 10.1002/14651858.MR000032.pub3

Bell 2016.

Study characteristics
Methods Parallel RCT, individuals randomised
Data UK, primary care setting.
All host trial participants, as a source of the retention trial sample. Host trial participants from 5 centres were followed up using postal questionnaires at the fifth year of follow‐up.
Total n = 7,655; range age 70‐85 years; 100% females.
Comparisons Intervention group received trial‐branded pen with the 60‐month follow‐up questionnaire.
Control group 60‐month follow‐up questionnaire alone.
Outcomes Questionnaire return.
Notes Retention period: 60 months follow‐up.
Risk of bias
Item Authors' judgement Support for judgement
Allocation concealment? Unclear Not reported in the paper.
Adequate sequence generation? Yes A computer‐randomisation package was used to allocate all eligible participants
Blinding of participants and personnel? Yes Not reported in the paper but unblinding not likely to impact objective outcome
Blinding of outcome assessment? Yes Not reported in the paper. However, objective outcome, staff have no plausible additional opportunity to influence postal response rate once questionnaires sent.
Incomplete outcome data addressed?
All outcomes Yes No concerns raised.
Free of selective outcome reporting? Yes No concerns raised.
Other sources of bias Yes No further concerns raised.
Overall Risk of Bias Unclear Unclear