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

Cockayne 2005.

Study characteristics
Methods Parallel RCT, clusters randomised
Data UK, community setting.
Participants who were due to be sent a final follow‐up questionnaire
as part of the host trial.
Total n = 1038; mean age 76.4 (SD 4.6); 100% females.
Comparisons Intervention group participants were offered the results of the trial in a postal questionnaire.
Control group participants did not receive the offer of knowing the results of the trial.
Outcomes Return of final follow‐up questionnaire.
Notes Retention period: Three weeks. Those participants nor returning questionnaires within three weeks were sent up to two reminder letters, questionnaires and business reply envelopes, three and six weeks after the initial mailing.
Risk of bias
Item Authors' judgement Support for judgement
Allocation concealment? Unclear Not reported in the paper.
Adequate sequence generation? Yes An independent researcher from the York Trials Unit randomised eligible women in a 3:1 ratio in favour of offering the results of the trial, by computer
Blinding of participants and personnel? Yes Not clear if participants were blinded to effect of embedded trial intervention on retention but unblinding not likely to impact objective outcome.
Blinding of outcome assessment? Yes Statistical analysis was not undertaken blind to group allocation. However, objective outcome, participants blind (did not know there is a study) 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