TY - JOUR
T1 - Overcoming Challenges in Multisite Trials
AU - Smith, Laureen
AU - Tan, Alai
AU - Stephens, Janna D.
AU - Hibler, David
AU - Duffy, Sonia A.
N1 - Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Background: Conducting multisite studies has many challenges, including determining the geographic distance between sites, ensuring effective communication, monitoring intervention and data integrity, handling institutional policy variations, seeking institutional review board approval with unique site needs or complex subcontracts, and planning for additional costs. Objectives: This article discusses common challenges in conducting multisite studies and identifies strategies to overcome these challenges using real-world examples from the literature, the authors' research studies, and their personal experiences. Methods: A summary of articles on multisite trials conducted within the past 10 years was explored to uncover common challenges in conducting multisite trials. To enrich the context, exemplars from authors' works are included. Based on literature and experience, strategies to combat challenges are summarized. Results: Unique issues related to multisite studies include site selection, use of epicenters/coordinating centers, hiring/managing staff, fidelity monitoring, institutional review board approval, statistical considerations, and approaches to authorship. Conclusion: Addressing challenges a priori can improve scientific rigor, reproducibility, and evidence from multisite studies. Given the benefits to scientific rigor, reproducibility, and design, findings from multisite studies are more likely to provide evidence to transform clinical practice and influence policy.
AB - Background: Conducting multisite studies has many challenges, including determining the geographic distance between sites, ensuring effective communication, monitoring intervention and data integrity, handling institutional policy variations, seeking institutional review board approval with unique site needs or complex subcontracts, and planning for additional costs. Objectives: This article discusses common challenges in conducting multisite studies and identifies strategies to overcome these challenges using real-world examples from the literature, the authors' research studies, and their personal experiences. Methods: A summary of articles on multisite trials conducted within the past 10 years was explored to uncover common challenges in conducting multisite trials. To enrich the context, exemplars from authors' works are included. Based on literature and experience, strategies to combat challenges are summarized. Results: Unique issues related to multisite studies include site selection, use of epicenters/coordinating centers, hiring/managing staff, fidelity monitoring, institutional review board approval, statistical considerations, and approaches to authorship. Conclusion: Addressing challenges a priori can improve scientific rigor, reproducibility, and evidence from multisite studies. Given the benefits to scientific rigor, reproducibility, and design, findings from multisite studies are more likely to provide evidence to transform clinical practice and influence policy.
KW - coordinating centers
KW - fidelity
KW - institutional review board
KW - multisite study
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U2 - 10.1097/NNR.0000000000000324
DO - 10.1097/NNR.0000000000000324
M3 - Article
C2 - 31033866
AN - SCOPUS:85065432249
SN - 0029-6562
VL - 68
SP - 227
EP - 236
JO - Nursing research
JF - Nursing research
IS - 3
ER -