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

Ives 2001.

Methods Randomised controlled trial
Data Setting: secondary care, UK. 50 patients attending an HIV hospital clinic
Comparisons Investigated the effect of different trial information methods
Standard trial information plus booklet entitled, 'Clinical Trials in HIV and AIDS: Information for people who are thinking about joining a trial'. This was compared to standard trial information (information sheet specific to proposed trial, plus discussion with trial doctor and research nurse)
Outcomes Proportion recruited to trial
Notes  
Risk of bias
Item Authors' judgement Description
Random Sequence generation ok? Yes Randomisation done sequence of numbered envelopes
Allocation concealment? Yes See above
Blinding of participants and personnel ok? Yes Patients and investigators not blinded. Not clear if interviewers were the investigators and therefore blind or unblinded. Unlikely to have affected outcome
Blinding of outcome assessment ok? Yes Partial (see above) but objective outcome
Incomplete outcome data handled ok? Unclear 50 were randomised but outcome data available for only 31, most of whom had joined a trial. There were some difference between those who provide only baseline data and those who provided follow‐up data. Not clear if there were differences between groups
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