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. 2018 Feb 22;2018(2):MR000013. doi: 10.1002/14651858.MR000013.pub6

Myles 1999.

Methods Randomised controlled trial
Data Setting: secondary care, Australia. 769 inpatients aged 18 or over, scheduled for elective surgery
Comparisons Investigated the effect of different consent methods
Intervention A: pre‐randomised to experimental drug and asked to provide consent; if no consent, standard treatment given
 
 Intervention B: pre‐randomised to standard drug and asked to provide consent; if no consent, experimental treatment given
 
 Intervention C: told that the physician thinks experimental drug superior, if consent given, has 70% chance of receiving this; if no consent, standard treatment given
 
 Intervention D: allowed to increase or decrease their chance of receiving the experimental drug if consent given, and if no preference, 50% chance of receiving it; if no consent, standard treatment given
 
 Compared to standard randomisation method (equal chance of experimental or standard drug)
Outcomes Proportion recruited to hypothetical trial
Notes  
Risk of bias
Item Authors' judgement Description
Random Sequence generation ok? Unclear Mentions randomisation but no details given
Allocation concealment? Unclear See above
Blinding of participants and personnel ok? Unclear Patient is blinded (they are not told the exact details of the study in the patient information). Researchers (probably) knew the allocation.
Blinding of outcome assessment ok? Unclear Outcome was subjective and unclear what potential researchers had to influence this while participants answered questions about intentions
Incomplete outcome data handled ok? Yes Adequate
Free of selective reporting? Yes Willingness to take part outcome presented, which is all the review needs
Was the study free of other bias? No Hypothetical trial
Overall bias? Yes High risk of bias