Cunningham‐Burley 2020.
Study characteristics | ||
Methods | Parallel RCT, individuals randomised | |
Data | UK, secondary care setting. Participants in the host trial who were due to be sent their 14‐week postal questionnaire. Total n = 1466, mean age 43.0 (SD 11.3) years, sex 86.1%. |
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Comparisons |
Intervention group received a branded pen with their questionnaire. Control group did not receive a pen. |
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Outcomes | Proportion of participants who return the questionnaire. | |
Notes | Retention period: 14‐week questionnaire | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear | Not discussed in the paper |
Adequate sequence generation? | Yes | Participants were allocated to either the intervention (pen) or control (no pen) group using simple randomisation in a 1:1 ratio. The allocation sequence was generated by the host trial statistician, who was not involved in sending out the questionnaires. |
Blinding of participants and personnel? | Yes | Participants were not aware of their involvement in this SWAT, but due to the nature of the intervention participants and study team members could not be blinded to group allocation.Unblinding not likely to impact objective outcome |
Blinding of outcome assessment? | Yes | Not discussed 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 |