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 |