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

OPAL 2020.

Study characteristics
Methods Parallel RCT, individuals randomised.
Data UK, secondary care settings.
not ALL participants in the trial that took part in the trial. Only those due to be receiving their 12‐ or 24‐month questionnaire at the time the trial was running.
Comparisons Intervention group received a tested theoretically informed letter sent with the questionnaire
Control group received a standard letter
Outcomes Questionnaires returned
Notes 12 or 24 months
Risk of bias
Item Authors' judgement Support for judgement
Allocation concealment? Unclear No information of the nested RCT was provided.
Adequate sequence generation? Yes The database would automatically produce the appropriate letter for each woman
Blinding of participants and personnel? Yes Women were unaware if they were receiving a standard or theory‐based cover letter but unblinding not likely to impact objective outcome
Blinding of outcome assessment? Yes No information of the nested RCT was provided.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