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Lessons learned from two randomized controlled trials: CITIES and STOP-DKD

BACKGROUND: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease...

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Autores principales: Zullig, Leah L., Oakes, Megan M., McCant, Felicia, Bosworth, Hayden B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7358179/
https://www.ncbi.nlm.nih.gov/pubmed/32685766
http://dx.doi.org/10.1016/j.conctc.2020.100612
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author Zullig, Leah L.
Oakes, Megan M.
McCant, Felicia
Bosworth, Hayden B.
author_facet Zullig, Leah L.
Oakes, Megan M.
McCant, Felicia
Bosworth, Hayden B.
author_sort Zullig, Leah L.
collection PubMed
description BACKGROUND: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. OBJECTIVES: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. METHODS: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. CONCLUSIONS: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. TRIAL REGISTRATION: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.
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spelling pubmed-73581792020-07-17 Lessons learned from two randomized controlled trials: CITIES and STOP-DKD Zullig, Leah L. Oakes, Megan M. McCant, Felicia Bosworth, Hayden B. Contemp Clin Trials Commun Article BACKGROUND: Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings. OBJECTIVES: Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials. METHODS: These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina. CONCLUSIONS: We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens. TRIAL REGISTRATION: Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908. Elsevier 2020-07-08 /pmc/articles/PMC7358179/ /pubmed/32685766 http://dx.doi.org/10.1016/j.conctc.2020.100612 Text en © 2020 Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Zullig, Leah L.
Oakes, Megan M.
McCant, Felicia
Bosworth, Hayden B.
Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title_full Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title_fullStr Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title_full_unstemmed Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title_short Lessons learned from two randomized controlled trials: CITIES and STOP-DKD
title_sort lessons learned from two randomized controlled trials: cities and stop-dkd
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7358179/
https://www.ncbi.nlm.nih.gov/pubmed/32685766
http://dx.doi.org/10.1016/j.conctc.2020.100612
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