TY - JOUR
T1 - Facilitators and barriers to spinal cord injury clinical trial participation
T2 - Multi-national perspective of people living with spinal cord injury
AU - Anderson, Kim D.
AU - Cowan, Rachel E.
AU - Horsewell, Jane
N1 - Publisher Copyright:
© Mary Ann Liebert, Inc. 2016.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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.
AB - 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.
KW - barrier
KW - clinical trial
KW - facilitator
KW - participation
KW - spinal cord injury
UR - http://www.scopus.com/inward/record.url?scp=84959219696&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84959219696&partnerID=8YFLogxK
U2 - 10.1089/neu.2015.4064
DO - 10.1089/neu.2015.4064
M3 - Article
C2 - 26414175
AN - SCOPUS:84959219696
VL - 33
SP - 493
EP - 499
JO - Central Nervous System Trauma
JF - Central Nervous System Trauma
SN - 0897-7151
IS - 5
ER -