Journal article
Multiply efficient trials: combining multiple trial arms and critical secondary questions increases trial efficiency
- Abstract:
- Designing explanatory trials to answer additional questions such as how and for whom treatments work should be a priority for improving trial efficiency. Multiple arm trials are also more efficient, as they provide more information about treatments over a shorter time span [1]. We studied the benefits of multiple trial arms and explanatory design using the Pacing, Graded Activity, and Cognitive Behaviour Therapy: A Randomised Evaluation (PACE) trial as an example. This trial studied three complex therapies and a specialised medical care comparison arm for the treatment of chronic fatigue syndrome. The study of how the treatments worked - mediation analysis - was built into the trial design. In terms of mediation, one interest was whether different treatments with some disparate components might vary in mechanism. In other words, might the effects of different treatments on a mediator (a paths or action theories) be associated with different mediator-outcome relationships (b paths or conceptual theories)?
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 3.9MB, Terms of use)
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- Publisher copy:
- 10.1186/s13063-017-1902-y
Authors
- Publisher:
- BioMed Central
- Journal:
- 4th International Clinical Trials Methodology Conference (ICTMC 2017) More from this journal
- Publication date:
- 2017-05-01
- Acceptance date:
- 2016-11-10
- DOI:
- ISSN:
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1745-6215
- Pubs id:
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pubs:734960
- UUID:
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uuid:ceac9018-35b2-4342-8527-2f963b18261a
- Local pid:
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pubs:734960
- Source identifiers:
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734960
- Deposit date:
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2017-11-01
- ARK identifier:
Terms of use
- Copyright holder:
- Sharpe et al
- Copyright date:
- 2017
- Notes:
- © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Licence:
- CC Attribution (CC BY)
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