The extent of written trial information: preferences among potential and actual trial subjects.
OBJECTIVE
To investigate the preferred extent of written information in clinical trials among potential and actual trial participants.


METHODS
Questionnaire survey among citizens of Copenhagen County (PUB, N=508), patients attending an out-patient clinic (OPC, N=200), and finally among participants in two clinical trials (ROC, N=32; MRCRUC, N=47--see Abbreviations). Questions concerned attitudes to and preferences towards a relatively short ("short form") and a more detailed information form ("long form") about a hypothetical, but realistic trial.


RESULTS
Approximately 1/8 of the respondents in PUB were satisfied with the "short form", whereas this was the case for approximately 1/6 of outpatients and 1/5 of actual trial participants. Regarding the "long form" approximately three quarters of respondents in all groups were satisfied. Outpatients as a whole were satisfied to a larger extent that respondents from the PUB trial concerning the "short form" (p=0.04). The "long form" was preferred by a little less than 4/5 of respondents in all groups.


CONCLUSIONS
Written information to trial subjects should be detailed, as a majority of both potential and actual research participants prefers this, given the choice between two information forms of different extent on the same trial.
Madsen
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SM
Holm
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Riis
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D003142:Communication; D032962:Consent Forms / Q000592:standards*; D003718:Denmark; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000628:therapy; D017060:Patient Satisfaction; D011639:Public Opinion; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects / Q000523:psychology*; D011795:Surveys and Questionnaires