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

Sharp 2006.

Study characteristics
Methods 2 x 2 x 2 factorial parallel RCT, Individuals randomised
Data UK, secondary care setting.
Participants due to receive a host trial questionnaire were involved.
Total n = 930; mean age 34 (SD 10.4); 100% females; 96% White.
Comparisons Three trials were evaluated in this study:
Trial 1:
Intervention group received a TOMBOLA‐branded pen
Control group received no pen
Trial 2:
Intervention group questionnaire was dispatched by first class post
Control group questionnaire was dispatched by second class
Trial 3:
Intervention group received an enclosed pre‐addressed return envelope on which there was a second‐class postage stamp
Control group received Freepost business‐reply envelope.
This generated eight intervention groups:
1. standard (i.e. no pen, second class dispatch, Freepost return envelope)
2. pen
3. pen and first‐class dispatch
4. first‐class dispatch
5. stamp on the return envelope
6. stamp on the return envelope and pen
7. stamp on the return envelope and first‐class dispatch
stamp on the return envelope, pen and first‐class dispatch
Outcomes Questionnaire response rate
Notes Retention period: 12‐, 18‐, 24‐ and 30‐months questionnaires
Risk of bias
Item Authors' judgement Support for judgement
Allocation concealment? Unclear Not reported in the paper.
Adequate sequence generation? Yes Computer randomised by two authors using random numbers, to one of the eight intervention groups
Blinding of participants and personnel? Yes Not reported in the paper. Not clear if participants were blinded to effect of embedded trial intervention on retention and unblinding but likely to impact objective outcome.
Blinding of outcome assessment? Yes Staff not blind but they had no influence on a participant's decision to reply
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