Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review
Considerable variability exists in the publication of clinical research study procedures related to study enrollment and participant exit from clinical trials. Despite recent efforts to encourage research data sharing and greater transparency regarding research outcomes, reporting of research proced...
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| Published in: | Frontiers in human neuroscience Vol. 14; p. 581090 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Switzerland
Frontiers Research Foundation
21-10-2020
Frontiers Media S.A |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Considerable variability exists in the publication of clinical research study procedures related to study enrollment and participant exit from clinical trials. Despite recent efforts to encourage research data sharing and greater transparency regarding research outcomes, reporting of research procedures remains inconsistent. Transparency about study procedures has important implications for the interpretation of study outcomes and the consistent implementation of best practices in clinical trial design and conduct. This review of publications from clinical trials of deep brain stimulation (DBS) using the MEDLINE database examines the frequency and consistency of publication of research procedures and data related to exit from DBS research. Related considerations, such as device explant or continued use, battery and other device hardware replacements, and post-trial follow-up care are also reviewed. This review finds significant variability in the publication and reporting of study exit procedures. Of the 47 clinical trials included in this review, 19% (9) disclosed procedures related to exit from research. Reporting of other exit-related data and study procedures examined in this review was identified in fewer than half of the included clinical trials. The rate of participant retention and duration of follow-up was reported more than any other category of data included in this review. Results inform efforts to improve consistency in research design, conduct, and publication of results from clinical trials in DBS and related areas of clinical research. |
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| Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Review-1 Specialty section: This article was submitted to Brain Imaging and Stimulation, a section of the journal Frontiers in Human Neuroscience Reviewed by: Ahmad El Kouzi, Southern Illinois University Carbondale, United States; Daniel Martinez-Ramirez, Tecnológico de Monterrey, Mexico Edited by: Adolfo Ramirez-Zamora, University of Florida Health, United States |
| ISSN: | 1662-5161 1662-5161 |
| DOI: | 10.3389/fnhum.2020.581090 |