Journal article
Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial
F O'Hare, S Spark, Z Flanagan, S Heritier, A Curtis, S Zoungas
Contemporary Clinical Trials Communications | ELSEVIER INC | Published : 2018
Open access
Abstract
Aims: To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF). Methods: This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version. Participants who attended a subsequent baseline screening visit were guided through ..
View full abstractGrants
Awarded by National Health and Medical Research Council
Funding Acknowledgements
This work (base trial) was supported by the National Health and Medical Research Council (NH&MRC) of Australia (APP1068146). The NH&MRC had no role in the writing of this paper.