Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial.
Fleur O'Hare, Simone Spark, Zachary Flanagan, Stephane Heritier, Andrea Curtis, Sophia Zoungas, undefined STAREE Investigator Group
Contemp Clin Trials Commun | Published : 2018
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 abstract