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J Neurotrauma. 2016 Mar 1;33(5):493-9. doi: 10.1089/neu.2015.4064. Epub 2015 Dec 2.

Facilitators and Barriers to Spinal Cord Injury Clinical Trial Participation: Multi-National Perspective of People Living with Spinal Cord Injury.

Author information

1
1 Department of Neurological Surgery, Miami Project to Cure Paralysis, University of Miami Leonard M. Miller School of Medicine , Miami, Florida.
2
2 The European Spinal Cord Injury Federation, Nottwil, Switzerland .

Abstract

These are exciting times for the translation of promising interventions for spinal cord injury (SCI) into testing with clinical trials. These interventions include acute surgical decompression, neuroprotection, neural repair, cell replacement, activity-based rehabilitation, and medical devices, including devices requiring surgical implantation. By nature, clinical trials can have strict inclusion and exclusion criteria, which narrow down the pool of potential participants. Meeting enrollment numbers for properly powered trials is a daunting task. Therefore, it is important that trials are designed in a manner that facilitates participation. The purpose of this research study was to learn more about the factors that encourage or interfere with the decision to participate in clinical trials from the perspective of people living with SCI. A multi-national survey was conducted, primarily online, in which 802 participants with SCI ranked 32 factors as facilitators or barriers, using a Likert-type scale. There were 13 universal facilitators, five universal barriers, and three universally neutral factors. The number one facilitator was possible improvement in functionality and the number one barrier was possible decline in functionality--as may be expected. However, many unexpected facilitators and barriers were identified. There also were certain factors that were strong barriers or facilitators to certain sub-groups of people living with SCI. All of these factors should be taken into careful consideration when designing clinical trials so as to promote enrollment and enable adherence to different protocols.

KEYWORDS:

barrier; clinical trial; facilitator; participation; spinal cord injury

PMID:
26414175
DOI:
10.1089/neu.2015.4064
[Indexed for MEDLINE]

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