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

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

Gender, class, employment status and social mobility following spinal cord injury in Denmark, the Netherlands, Norway and Switzerland

STUDY DESIGN: Cross sectional survey of 1055 persons with spinal cord injury (SCI) in Denmark, the Netherlands, Norway and Switzerland. OBJECTIVES: (1) To analyse the employment levels of people of working age with SCI, including possible gender differences. (2) To study the relevance of occupational class before SCI and its impact on employment and occupational class after SCI. SETTING: Members of national SCI consumer associations. METHODS: Employment status and social mobility after SCI was regressed on occupational class before SCI, using multinomial and binary logistic regression analysis of employment, while controlling for other explanatory variables to employment after SCI and demographic characteristics. RESULTS: Employment levels after injury were similar for men and women in each of the four nations, but Dutch women had significantly lower scores on predicted employment than Dutch men. Employment and social mobility trajectories were heavily in favour of middle-class occupations. Gender differences in employment status at the time of study primarily occurred among those in working-class occupations before SCI, with men less likely than women of being non-employed. Working-class men were significantly more likely than working-class women to retain a working-class occupation at the time of study, and although non-significant, to attain a middle-class occupation after SCI. CONCLUSION: There was little variation in employment by gender within and across countries but significant differences between working-class and middle-class occupations before and after injury. The results suggest that targeted employment measures should be particularly invested in the rehabilitation of women in working-class occupations