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Self-directed multimedia process for delivering participant informed consent
Citation
Chapman, N and McWhirter, R and Armstrong, MK and Fonseca, R and Campbell, JA and Nelson, M and Schultz, MG and Sharman, JE, Self-directed multimedia process for delivering participant informed consent, BMJ Open, 10, (7) Article e036977. ISSN 2044-6055 (2020) [Refereed Article]
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Copyright Statement
© Author(s) (or their employer(s)) 2020. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/
DOI: doi:10.1136/bmjopen-2020-036977
Abstract
Design: It is a single-centre, randomised, prospective study to determine the efficacy, usability and acceptability of a self-directed multimedia consent process (intervention) compared with the traditional paper-based approach (control). The intervention was free of research staff, with computer-based finger-signed consent.
Setting: Pathology blood collection services in Tasmania, Australia.
Participants: 298 participants (63±8 years; 51% female individuals) referred from general practice were randomised to intervention (n=146) and control (n=152).
Outcome measures: Efficacy, usability and acceptability of the allocated consent process were assessed by a questionnaire.
Results: All participants successfully completed the allocated interventions. Efficacy parameters were higher among intervention participants, including a better understanding of study requirements compared with controls (p<0.05 all). Intervention participants were more likely to engage with the study information and spend more time on the consent process (p=<0.001 and p=0.006, respectively). Both groups reported similar levels of acceptability, although more control participants reported that the study information was too long (24% vs 14%; p=0.020).
Conclusion: A self-directed multimedia consent process is effective for achieving participant understanding and obtaining consent free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs and achieve informed consent in clinical research.
Item Details
Item Type: | Refereed Article |
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Keywords: | blood pressure, hypertension, public health |
Research Division: | Biomedical and Clinical Sciences |
Research Group: | Cardiovascular medicine and haematology |
Research Field: | Cardiology (incl. cardiovascular diseases) |
Objective Division: | Health |
Objective Group: | Clinical health |
Objective Field: | Clinical health not elsewhere classified |
UTAS Author: | Chapman, N (Dr Niamh Chapman) |
UTAS Author: | McWhirter, R (Dr Rebekah McWhirter) |
UTAS Author: | Armstrong, MK (Mr Matthew Armstrong) |
UTAS Author: | Fonseca, R (Mr Ricardo Fonseca Diaz) |
UTAS Author: | Campbell, JA (Dr Julie Campbell) |
UTAS Author: | Nelson, M (Professor Mark Nelson) |
UTAS Author: | Schultz, MG (Dr Martin Schultz) |
UTAS Author: | Sharman, JE (Professor James Sharman) |
ID Code: | 140110 |
Year Published: | 2020 |
Web of Science® Times Cited: | 1 |
Deposited By: | Menzies Institute for Medical Research |
Deposited On: | 2020-07-27 |
Last Modified: | 2020-08-07 |
Downloads: | 14 View Download Statistics |
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