Cited by 184Statistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesEvaluation and Performance Assessment

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Adaptive Designs for Randomized Trials in Public Health

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Brown, C. Hendricks, Ten Have, Thomas R., Jo, Booil, Dagne, Getachew, Wyman, Peter A., Muthén, Bengt, Gibbons, Robert D.·2009·Annual Review of Public Health

DOI 10.1146/annurev.publhealth.031308.100223PMC PMC2778326

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Abstract

In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials.

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Additional file 2 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
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Additional file 7 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
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Additional file 8 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12494900
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Additional file 4 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
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Additional file 1 of Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial
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Additional file 7 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
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Additional file 1 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
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Additional file 4 of Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial
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Additional file 9 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12494909
Additional file 4 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
Smith, J. D., Li, D. H., & Rafferty, M. R. (2020) · Figshare · doi:10.6084/m9.figshare.13018056
Additional file 2 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
Smith, J. D., Li, D. H., & Rafferty, M. R. (2020) · Figshare · doi:10.6084/m9.figshare.13018050
Additional file 3 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
Smith, J. D., Li, D. H., & Rafferty, M. R. (2020) · Figshare · doi:10.6084/m9.figshare.13018053
Additional file 8 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
Smith, J. D., Li, D. H., & Rafferty, M. R. (2020) · Figshare · doi:10.6084/m9.figshare.13018068
Additional file 5 of The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects
Smith, J. D., Li, D. H., & Rafferty, M. R. (2020) · Figshare · doi:10.6084/m9.figshare.13018059
Additional file 2 of Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial
Cederström, N., Granér, S., Nilsson, G., Dahan, R., & Ageberg, E. (2021) · Figshare · doi:10.6084/m9.figshare.16851030
Additional file 3 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12494861
Additional file 6 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12494882
Additional file 1 of The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.12494849
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Authors: Brown, C. H., Ten Have, T. R., Jo, B., Dagne, G., Wyman, P. A., Muthén, B., & Gibbons, R. D.
Affiliations: University of South Florida (US)
Department of Biostatistics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, 19104
Stanford Medicine (US)
University of Rochester Medicine (US)
University of California, Los Angeles (US)
University of Illinois Chicago (US)
ORCID: Brown, C. Hendricks
Jo, Booil
Dagne, Getachew
Wyman, Peter A.
Muthén, Bengt
Gibbons, Robert D.
Venue: Annual Review of Public Health
Publisher: Annual Reviews
Published: 2009-04-01
Volume: 30
Issue: 1
Pages: 1-25
ISSN: 0163-7525 (ISSN-L)
1545-2093
DOI: 10.1146/annurev.publhealth.031308.100223
PMC: PMC2778326
OpenAlex: W2127297180
Cited by: 184
References: 153
Citations by year: 2026: 1 · 2025: 6 · 2024: 4 · 2023: 7 · 2022: 3 · 2021: 18 · 2020: 31 · 2019: 11 · 2018: 9 · 2017: 15 · 2016: 6 · 2015: 11 · 2014: 12 · 2013: 12 · 2012: 13
FWCI: 1.40
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Annual Review of Public Health (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health
Substance Abuse and Mental Health Services Administration
National Institute of Mental Health (P30MH068685, R01MH078016, R01MH40859, R34MH071189, R01MH076158, R01MH068423, P30MH074678, P20MH071897, R01MH06624, R01MH066319, R01MH069353, R01MH080122, R01MH040859)
National Institute on Drug Abuse (R01DA025192, P30DA023920)
National Institute of Neurological Disorders and Stroke (U54NS057405)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Social Sciences › Public Administration › Evaluation and Performance Assessment
Keywords: adaptive design, adaptive randomization, public health assessment, trial ethics, sequential decision making
MeSH terms: Decision Making, Financing, Government, Humans, National Institutes of Health (U.S.), Research Design, United States, Public Health Practice, Randomized Controlled Trials as Topic, Evidence-Based Practice

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Adaptive Designs for Randomized Trials in Public Health

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