Fureman 1997.
Methods | Randomised controlled trial | |
Data | Setting: university, USA. 188 participants in the Risk Assessment Project (injection drug users) | |
Comparisons | Investigated the effect of different trial information methods Enhanced video on an HIV vaccine trial plus 1‐hour pamphlet presentation (5 minutes pre‐test, 26 minutes of video, 10 minutes to review pamphlet, research assistant initiated question and answer session, post‐test questionnaire, survey at 1 month. This was compared to standard half‐hour pamphlet‐only presentation (5 minutes pre‐test, 10 minutes to review trial information pamphlet; research assistant initiated question and answer session, post‐test questionnaire, survey at 1 month |
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Outcomes | Willingness to take part in hypothetical trial (expressed as a score on a willingness scale) | |
Notes | ||
Risk of bias | ||
Item | Authors' judgement | Description |
Random Sequence generation ok? | Unclear | Randomisation mentioned but no details |
Allocation concealment? | Unclear | See above |
Blinding of participants and personnel ok? | Unclear | Not clear how much participants were told before the study, not clear what the research assistant running sessions knew about randomisation; probably knew that video was the intervention. Assistant could in principle influence post‐test questionnaire responses of participants because these were done during the session |
Blinding of outcome assessment ok? | Unclear | Outcome not objective and not clear what influence lack of blinding might have had on this |
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 |