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) |
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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 |