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. |
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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 |
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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 |