Development of a complex intervention improved randomization and informed consent in a randomized controlled trial
Development of a complex intervention improved randomization and informed consent in a randomized controlled trial
Objective
Multicenter randomized trials are required for pragmatic evaluations of health care interventions, but recruitment is difficult. Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to increase levels of randomization and informed consent.
Study Design and Setting
The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring for men aged 50–69 years with localized prostate cancer. The intervention was developed using qualitative research methods (content, thematic and conversation analysis). Rates of randomization and immediate acceptance of allocation were measured every 6 months to evaluate the impact of the intervention.
Results
The complex intervention comprised reviews of centers falling below study targets, training programmes, documents and individually tailored feedback. Over 65% of eligible participants consented to randomization. Trial participants became increasingly well informed as immediate acceptance of allocation rose from 65% to 81% between 2001 and 2005.
Conclusion
This complex intervention resulted in high levels of randomization and informed consent in a difficult trial. The generic aspects of the intervention could be applied to other trials to maximize randomization and informed consent, and allow the mounting of trials previously considered too difficult.
randomized controlled trial, randomization, qualitative research methods, prostate cancer, recruitment, ProtecT study
29-36
Donovan, Jenny L.
b7031316-92f5-44cf-899c-9eadbca136fb
Athene, L.J.
b424dd97-7088-4c96-bc17-4cd52b29d439
Peters, Tim J.
b3ab1e07-326f-41c2-9813-f00f3b75bcf0
Brindle, Lucy
17158264-2a99-4786-afc0-30990240436c
Salter, Elizabeth
dd90c848-078f-43d1-b36f-6385be7f5af6
Gilliatt, David
edd9b9cd-49c0-41fb-a125-f60c41b37b18
Powell, Philip
62026bbd-183d-4d2a-8a73-15cb92807dfc
Bollina, Prasad
c1aa6642-0089-4abf-ad67-d35959b4ff90
Neal, David E.
4d30d841-cc46-46a8-a69e-4016478db74a
Hamdy, Freddie C.
b4c01384-52e7-432e-816a-57f2bc50215d
January 2009
Donovan, Jenny L.
b7031316-92f5-44cf-899c-9eadbca136fb
Athene, L.J.
b424dd97-7088-4c96-bc17-4cd52b29d439
Peters, Tim J.
b3ab1e07-326f-41c2-9813-f00f3b75bcf0
Brindle, Lucy
17158264-2a99-4786-afc0-30990240436c
Salter, Elizabeth
dd90c848-078f-43d1-b36f-6385be7f5af6
Gilliatt, David
edd9b9cd-49c0-41fb-a125-f60c41b37b18
Powell, Philip
62026bbd-183d-4d2a-8a73-15cb92807dfc
Bollina, Prasad
c1aa6642-0089-4abf-ad67-d35959b4ff90
Neal, David E.
4d30d841-cc46-46a8-a69e-4016478db74a
Hamdy, Freddie C.
b4c01384-52e7-432e-816a-57f2bc50215d
Donovan, Jenny L., Athene, L.J., Peters, Tim J., Brindle, Lucy, Salter, Elizabeth, Gilliatt, David, Powell, Philip, Bollina, Prasad, Neal, David E. and Hamdy, Freddie C.
(2009)
Development of a complex intervention improved randomization and informed consent in a randomized controlled trial.
Journal of Clinical Epidemiology, 62 (1), .
(doi:10.1016/j.jclinepi.2008.02.010).
(PMID:18619811)
Abstract
Objective
Multicenter randomized trials are required for pragmatic evaluations of health care interventions, but recruitment is difficult. Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to increase levels of randomization and informed consent.
Study Design and Setting
The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring for men aged 50–69 years with localized prostate cancer. The intervention was developed using qualitative research methods (content, thematic and conversation analysis). Rates of randomization and immediate acceptance of allocation were measured every 6 months to evaluate the impact of the intervention.
Results
The complex intervention comprised reviews of centers falling below study targets, training programmes, documents and individually tailored feedback. Over 65% of eligible participants consented to randomization. Trial participants became increasingly well informed as immediate acceptance of allocation rose from 65% to 81% between 2001 and 2005.
Conclusion
This complex intervention resulted in high levels of randomization and informed consent in a difficult trial. The generic aspects of the intervention could be applied to other trials to maximize randomization and informed consent, and allow the mounting of trials previously considered too difficult.
This record has no associated files available for download.
More information
e-pub ahead of print date: 10 July 2008
Published date: January 2009
Keywords:
randomized controlled trial, randomization, qualitative research methods, prostate cancer, recruitment, ProtecT study
Organisations:
Health Sciences
Identifiers
Local EPrints ID: 145071
URI: http://eprints.soton.ac.uk/id/eprint/145071
ISSN: 0895-4356
PURE UUID: d9a8bf60-158b-4442-a579-c288e8295152
Catalogue record
Date deposited: 15 Apr 2010 15:46
Last modified: 14 Mar 2024 02:51
Export record
Altmetrics
Contributors
Author:
Jenny L. Donovan
Author:
L.J. Athene
Author:
Tim J. Peters
Author:
Elizabeth Salter
Author:
David Gilliatt
Author:
Philip Powell
Author:
Prasad Bollina
Author:
David E. Neal
Author:
Freddie C. Hamdy
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics
