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Informing potential participants about research : observational study with an embedded randomized controlled trial
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Kirkby, Helen M., Calvert, Melanie, McManus, Richard J. and Draper, Heather (2013) Informing potential participants about research : observational study with an embedded randomized controlled trial. PLoS One, 8 (10). e76435. doi:10.1371/journal.pone.0076435 ISSN 1932-6203.
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Official URL: http://dx.doi.org/10.1371/journal.pone.0076435
Abstract
Objectives
To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant’s accessed; 3) to assess satisfaction and understanding.
Design
Observational study with an embedded randomised controlled trial.
Setting
Low risk intervention study based in primary care.
Participants
White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study.
Interventions
PDF copy of the standard paper participant information sheet (PDF-PIS) and an electronic Interactive Information Sheet (IIS) where participants could choose both the type and level of detail accessed.
Main Outcome Measures
1) Proportion of participants providing an email address and accessing electronic information 2) Willingness to participate in a recruitment clinic. 3) Type and depth of information accessed on the IIS. 4) Participant satisfaction and understanding.
Results
1160 participants were eligible for the study. Of these, 276 (24%) provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4). Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59%) who chose not to access any electronic information also booked an appointment.
| Item Type: | Journal Article | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
| Library of Congress Subject Headings (LCSH): | Informed consent (Medical law), Clinical trials, Medical care -- Patients | ||||||||
| Journal or Publication Title: | PLoS One | ||||||||
| Publisher: | Public Library of Science | ||||||||
| ISSN: | 1932-6203 | ||||||||
| Official Date: | 3 October 2013 | ||||||||
| Dates: |
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| Volume: | 8 | ||||||||
| Number: | 10 | ||||||||
| Article Number: | e76435 | ||||||||
| DOI: | 10.1371/journal.pone.0076435 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||
| Date of first compliant deposit: | 17 March 2017 | ||||||||
| Date of first compliant Open Access: | 17 March 2017 | ||||||||
| Funder: | Medical Research Council (Great Britain) (MRC), National Institute for Health Research (Great Britain) (NIHR) | ||||||||
| Grant number: | Grant ID G0800808 (MRC), PB-PG-1207-15042 (NIHR) | ||||||||
| Adapted As: |
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