Information presentation and decisions to enter clinical trials: a hypothetical trial of hormone replacement therapy.

We examined recruitment to an imaginary trial of hormone replacement therapy (HRT) following two different styles of information about HRT. We predicted that for treatments which, like HRT, are available outside a trial, people offered the facts as currently known would be less likely to remain unsure about the relative costs and benefits, and so less likely to agree to enter a randomised trial. In contrast, when the information provided reflected the current state of uncertainty which justified the trial, we predicted that people would be less likely to form a preference for one treatment arm over the other, and so more likely to agree to enter a trial. One hundred women aged 25-40 years were informed about HRT via a video and an information leaflet. For half the participants the information was framed in a way which emphasised the current state of uncertainty about the relative costs and benefits of HRT, and in that respect it reflected the justification for a trial. This version was considered to be similar in style to information commonly provided to potential trial participants. For half the participants the same information was framed in a way which offered explicit numerical detail about currently known facts, and in that respect it was considered to be similar in style to information commonly available to doctors prior to a trial. Women learned as much about HRT in the two conditions, but women given the explicit versions were more likely (i) to hold a stronger view about whether or not they would take HRT (ratings were not elicited from the first 30 participants in this condition. N = 20, p < 0.05 1 tailed) and (ii) to refuse entry to the trial (N = 50, p < 0.05 2 tailed). Those who, given the explicit version, agreed rather than refused to enter the trial, scored higher on believing that others control their health (p < 0.01 2 tailed).

RCT Entities:   Population Interventions Outcomes