Simes 1986.

Methods	Randomised controlled trial
Data	Setting: secondary care, Australia. 57 patients attending an oncology unit
Comparisons	Investigated the effect of different consent methods Individual approach to consent – patients given information about aims, expected results, potential toxicities of treatment; details of treatment left to discretion of consultant; patients given opportunity to ask questions, verbal consent obtained. This was compared to total disclosure approach – participants were fully informed about all trial aspects by consultant, with opportunity to ask questions and a consent form outlining the information; this was kept overnight, and written consent was obtained the following day.
Outcomes	Proportion recruited to trial
Notes
Risk of bias
Item	Authors' judgement	Description
Random Sequence generation ok?	Yes	Sealed envelopes using balanced randomisation
Allocation concealment?	Unclear	Unclear if envelopes were sequentially numbered
Blinding of participants and personnel ok?	Unclear	Participants were probably blinded. Clinicians were probably not blinded. It is not clear if it is the same clinicians provided information in to both groups.
Blinding of outcome assessment ok?	Yes	Objective outcome
Incomplete outcome data handled ok?	Yes	Adequate
Free of selective reporting?	Yes	Recruitment outcome presented, which is all the review needs
Was the study free of other bias?	Yes	No other biases apparent
Overall bias?	Unclear	Unclear risk of bias