AMBER 2020.
Study characteristics | ||
Methods | Parallel RCT, individuals randomised | |
Data | UK, secondary care settings. Not all participants in the host trial that took part in this embedded trial. Only those who had yet to complete the study at the time of the SWAT set up. Total n = 64, age NR; sex NR. |
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Comparisons |
Intervention group received a tested a theoretically informed letter sent with the questionnaire Control group received a standard letter |
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Outcomes | Questionnaires returned | |
Notes | 6 months | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear | No information of the nested RCT was provided. |
Adequate sequence generation? | No | According to the authors, the randomisation list was generated and was not concealed. |
Blinding of participants and personnel? | Unclear | Participants were unaware if they were receiving a standard or theory‐based cover letter but may have noticed from earlier letters that it had a different “tone” |
Blinding of outcome assessment? | Unclear | No information of the nested RCT was provided. |
Incomplete outcome data addressed? All outcomes | Unclear | No concerns raised. |
Free of selective outcome reporting? | Unclear | No concerns raised. |
Other sources of bias | No | No further concerns raised. |
Overall Risk of Bias | Unclear | Unclear |