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Resolving Clinical Trial Subject Disengagement in Socioeconomically Disadvantaged Subjects

Rhudy, James P. Jr; Lewis, Jonathan C.; Alexandrov, Andrei V.; Alexandrov, Anne W.

Journal of Neuroscience Nursing: August 2019 - Volume 51 - Issue 4 - p 164–168
doi: 10.1097/JNN.0000000000000449
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ABSTRACT BACKGROUND: Clinical trialists may be reluctant to enroll socioeconomically disadvantaged participants because of concerns for subject disengagement leading to noncompliance with longitudinal measures and high lost to follow-up (LTFU) rates. OBJECTIVES: We describe the LTFU problem associated with disadvantaged participants and propose strategies to reduce clinical trial disengagement. METHODS: Difficulties encountered in recruiting and retaining socioeconomically disadvantaged participants along with antecedents of disengagement are discussed. Data in the public domain were used to derive, symbolize, and map engagement by census tract. Exemplars of engaged and disengaged clinical trial participants are shared, and geospatial distribution of socio-spatial disengagement risk is presented. RESULTS: Subject disengagement can be visualized by geospatial informatics suggesting areas of low and high socio-spatial disengagement risk. By failing to enroll socioeconomically disadvantaged subjects, researchers may deliberately exclude those who may benefit the most because of significant health disparities. DISCUSSION: We propose a study of realistic LTFU rates for disadvantaged participants. Realistic clinical trial end points and methods may reduce disengagement among disadvantaged participants.

Questions or comments about this article may be directed to James P. Rhudy, Jr, PhD DNP APRN CCNS CCRN-CMC-CSC, at jrhudy1@uthsc.edu. He is a Research Assistant Professor of Neurology, Department of Neurology, University of Tennessee Health Science Center, Memphis, TN.

Jonathan C. Lewis, MDiv BCC, is Program Manager of UT and Conference Ministries, Faith and Health Division, Methodist Le Bonheur Healthcare, Memphis, TN.

Andrei V. Alexandrov, MD, is Professor and Semmes Murphy Chair of Neurology, University of Tennessee Health Science Center, Memphis, TN.

Anne W. Alexandrov, PhD RN AGACNP-BC ANVP-BC NVRN-BC CCRN FAAN, is Professor of Nursing and Neurology, University of Tennessee Health Science Center, Memphis, TN.

The authors declare no conflicts of interest.

Ethical Conduct of Research: All our active studies have current ethical approval.

Clinical Trial Registration: We do not specifically refer to any individual clinical trial.

Online date: June 7, 2019

© 2019 American Association of Neuroscience Nurses