Information disclosure, subject understanding, and informed consent in psychiatric research. Evaluating the benefits of a patient information video during the informed consent process. Improving informed consent: a comparison of four consent tools.
nan The study objective was to evaluate the effect of a patient information video during the informed consent process of a perinatal trial. Ninety women, between 19 and 33 weeks gestation, were randomised to receive written information about this perinatal trial and watch an information video or to receive written information only. Participants completed a questionnaire immediately after entry and 2-4 weeks later assessing knowledge of; feelings about the worth of; and willingness for future participation in the perinatal trial. When initially asked, more women who watched the video thought they would consent to the study (chi 2 = 6.3; df = 1; P = 0.01). No differences in knowledge about the perinatal trial were found initially, but 2-4 weeks later more knowledge had been retained by women who had watched the video (chi 2 = 6.7; df = 1; P = 0.01). These results suggest that a patient information video combined with an information sheet may result in greater participation in a research trial and may increase women's knowledge of a specific health problem and related research trial. nan
The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. 
Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.