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

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.
Comparisons Intervention group received a tested a theoretically informed letter sent with the questionnaire
Control group
received a standard letter
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