Reinventing Yourself After SCI Program: A Clinical Trial
Validation of the SCI-QoL BDS: Cross Cultural Comparisons and Clinical Outcomes
Studies At A Glance
Discussing neurogenic bladder after SCI: Tate and colleagues, Anton Emmauel MD from University College Hospital, London; Gianna M Rodriguez MD and Anne P Cameron MD from Michigan Medicine.
The Effect of Gentamicin Intravesical Instillations on Decrease Urinary Tract Infections (UTIs) in Patients with Neurogenic Bladder after SCI – National Institute on Disability, Independent Living and Rehabilitation Research. (IND 138946)
Clinical trial conducted with a collaboration of the Department of Urology (Cameron, Co-PI) and Physical Medicine and Rehabilitation (Tate, PI). Results showed a decrease in UTIs among participants who used bladder instillations with Gentamicin and an increase in quality of life. There were no changes in self-reported symptoms associated with bladder and bowel dysfunction. Lack of significance maybe associated with the small sample size of participants. A multisite trial is needed with larger number of participants to show treatment efficacy across sites.
Trial publications are underway. A Manual of Operations (MOP) has been created for conducting trials such as this one.
A survey on satisfaction with treatment results described participants’ comments as overwhelmingly positive: 90% described benefits such as fewer UTI related symptoms and infections, happiness, positive effects on life, no need for oral antibiotics and freedom to travel.
“My symptoms decreased drastically while using Gentamicin. I was happy with the results before the trial ended… Afterwards I got a prescription… and it does help prevent UTIs. I get them much less frequently.”
Related Publications and Presentations
Stalenhoef, J. E., van Nieuwkoop, C., Menken, P. H., Bernards, S. T., Elzevier, H. W., & van Dissel, J. T. (2019). Intravesical Gentamicin Treatment for Recurrent Urinary Tract Infections Caused by Multidrug Resistant Bacteria. The Journal of urology, 201(3), 549–555. https://doi.org/10.1016/j.juro.2018.10.004
Damm, T. L., Cameron, A.P. (2023). Antimicrobial Resistance in Urinary Tract Infections. Curr Bladder Dysfunct Rep. 18, 1–9. https://doi.org/10.1007/s11884-022-00674-3
Disability Network Washtenaw Monroe Livingston researchers, Tom Hoatlin and Clark Schuler, met with Tate’s team and provided critical input into project development and dissemination of findings to persons with SCI.
Patients Perspectives on the Use of Intravesical Gentamicin Instillations to Decrease Urinary Tract Infections after SCI – National Institute on Disability, Independent Living and Rehabilitation Research.
A prospective observational study to examine patients’ perspectives on their use of Gentamicin installation to prevent UTIs during the past year. The study includes two phases: a retrospective review of medical chart and patient databases to identify potential patients and information about their use of this medication; and second, prospective phone interviews with patients to discuss their impressions of the effectiveness of this medication, benefits, and barriers to using it. Study publications will be posted as available. Findings suggests that most participants were happy with the results of this treatment.
Related Publications and Presentations
Maymi-Castrodad P., Pines, C., Forchheimer, M., Tate, D. G., Cameron, A. P. (2023, March). Patients Experience and Satisfaction with Intravesical Gentamicin Irrigations [Conference presentation abstract]. American Urological Association Annual Meeting, Chicago, IL, United States.
Reinventing Research team at work: Tom Hoatlin (group facilitator, first to left), Sunny Roller (group facilitator, third to left) and others.
Reinventing Yourself After SCI Program: A Clinical Trial – National Institute on Disability Independent Living and Rehabilitation Research.
A multi-site parallel-arm randomized controlled trial of an intervention to improve outcomes after spinal cord injury comparing an interactive group format versus a no-intervention control. Craig Hospital lead this investigation in collaboration with Michigan Medicine and Kessler Rehabilitation. Participants included 81 individuals with SCI. Those randomized to treatment participated in six interactive learning sessions (2 hours each, one session per week) with structured and facilitated group interactions to improve self-efficacy.
A multi-site parallel-arm randomized controlled trial of an intervention to improve outcomes after spinal cord injury comparing an interactive group format versus a no-intervention control. Craig Hospital lead this investigation in collaboration with Michigan Medicine and Kessler Rehabilitation. Participants included 81 individuals with SCI. Those randomized to treatment participated in six interactive learning sessions (2 hours each, one session per week) with structured and facilitated group interactions to improve self-efficacy. While the Treatment group had greater increases in self-efficacy scores from baseline to immediately post-intervention (6 weeks) than the Control group, these differences did not remain significant after controlling for multiple comparisons.
The study included facilitators who conducted the intervention at each site. Download a PDF transcript of an interview with A. Sunny Roller, who facilitated this intervention in Michigan.
Colleagues from the Rocky Mountain Regional Spinal Cord Injury System at Craig Hospital, Drs. Susie Charlifue and Jennifer Coker, Co-PIs of the Reinventing Yourself Project.
Related Publications and Presentations
Coker, J., Charlifue, S., Botticello, A., Tate, D. G., Philippus, A., Strober, L., Forchheimer, M., & Monden, K. R. (2022). A Study Protocol for a Multisite Randomized Controlled Trial of an Intervention to Improve Outcomes After Spinal Cord Injury. Topics in spinal cord injury rehabilitation, 28(4), 44–55. https://doi.org/10.46292/sci22-00013
Coker, J, Charlifue, S, Chase, T., Monden, K. (2023 October). Delivering an Intervention to Improve Psychological Outcomes for People with SCI: ReInventing Yourself after Spinal Cord Injury. [Conference presentation]. International Spinal Cord Injury (ISCoS) Annual Scientific Meeting, Edinburgh, Scotland.
Advisory board members included Michael Harris, Executive Director of Michigan Paralyzed Veterans of America, meet to discuss project progress.
Neurogenic Bowel and Bladder Management After Spinal Cord Injury: Examining Factors Involved in Successful Decision-Making Processes – US Department of Defense.
Living with SCI requires the ability to make extensive and complex decisions to address the many associated health issues and complications. Persons with SCI make daily decisions about their care that directly and indirectly impact the management of their condition, especially in relation to neurogenic bladder and bowel (NBB) dysfunction. This study examined veterans and civilians NBB management decisions and resulting outcomes. It identified the factors influencing the decision-making process and potential changes across time considering age and time since injury while assessing participants’ abilities and coping styles in carrying out NBB management decisions and the outcomes of these decisions on their health and wellbeing, overall satisfaction, and quality of life. Participants included veterans and civilians. Results showed that significant associations were found between styles of decision making, self-efficacy, participation in social roles and activities suggesting the importance of these elements in the decision-making process. Confidence in decision making was related to increased participation among both veterans and civilians with SCI.
A series of newsletters describing results were developed for persons with SCI is available on this website.
Related Publications and Presentations
Tate, D. G., Forchheimer, M., Rodriguez, G., Chiodo, A., Cameron, A. P., Meade, M., & Krassioukov, A. (2016). Risk Factors Associated With Neurogenic Bowel Complications and Dysfunction in Spinal Cord Injury. Archives of physical medicine and rehabilitation, 97(10), 1679–1686. https://doi.org/10.1016/j.apmr.2016.03.019
Nevedal, A., Kratz, A. L., & Tate, D. G. (2016). Women's experiences of living with neurogenic bladder and bowel after spinal cord injury: life controlled by bladder and bowel. Disability and rehabilitation, 38(6), 573–581. https://doi.org/10.3109/09638288.2015.1049378
Tate D.G. (2017, May). Complications of Neurogenic Bladder and Bowel After Spinal Cord Injury: The Military Veteran's Perspective [Conference presentation]. International Society of Phys. Rehab. Med., Buenos Aires, Argentina.
Dr. Tate with colleagues, Drs. Allen Heinemann, Director of the Center for Rehabilitation Outcomes and Professor at Feinberg School of Medicine and Naomi Lynn Gerber, former head of RMD at the NIH and Professor, George Mason University.
Tate, D. G., Forchheimer, M., Rodriguez, G., Chiodo, A., Cameron, A. P., Meade, M., & Krassioukov, A. (2016). Risk Factors Associated With Neurogenic Bowel Complications and Dysfunction in Spinal Cord Injury. Archives of physical medicine and rehabilitation, 97(10), 1679–1686. https://doi.org/10.1016/j.apmr.2016.03.019
Nevedal, A., Kratz, A. L., & Tate, D. G. (2016). Women's experiences of living with neurogenic bladder and bowel after spinal cord injury: life controlled by bladder and bowel. Disability and rehabilitation, 38(6), 573–581. https://doi.org/10.3109/09638288.2015.1049378
Tate D,G. (2017, May). Complications of Neurogenic Bladder and Bowel After Spinal Cord Injury: The Military Veteran's Perspective [Conference presentation]. International Society of Phys. Rehab. Med., Buenos Aires, Argentina.
Dr. Tate meets an Argentinian painter with spinal cord injury in the streets of Buenos Aires. His paintings were exhibited in the district of La Boca.
We shared our project findings at professional meetings.
The University of Michigan Transportation and Research Institute (UMTRI) showed us their research on crashes using dummies in wheelchairs as models.
Tate, D., Rohn E., Forchheimer M., Pelletier-Cameron A., Rodriguez G., Routin R., DiPonio L. (2018 September 13-15). Patient decision-making in relation to managing neurogenic bowel and bladder after spinal cord injury. [Poster presentation]. 58th International Spinal Cord Injury Society (ISCoS) Annual Scientific Meeting. Sydney, Australia.
Tate D., Rohn E., Forchheimer M., Walsh S., Routin R. (2018 July 8-12). Decision-making in Relation to Neurogenic Bowel and Bladder Management. [Poster presentation]. 12th International Society of Physical Medicine and Rehabilitation (ISPMR) World Congress. Paris, France.
Tate, D. G., Cameron, A. P., Rodriguez, G., DiPonio, L., Forchheimer, M., Rohn, E., Walsh, S. (2018 November 5). Pee or Poop: Battling Neurogenic Bladder and Bowel Dysfunction from a Spinal Cord Injury Patient’s Perspective, [Plenary presentation]. 58th International Spinal Cord Society (ISCoS) Meeting, Nice, France.
Tate, D., Rohn, E., Walsh, S., Forchheimer, M., DiPonio, L., Rodriguez, G. and Cameron, A. (2020 September). Factors related to Decision Making About Surgery after Neurogenic Bowel and Bladder (NBB) Following Spinal Cord Injury (SCI). [Conference presentation]. 59th International Spinal Cord Society Annual Scientific Meeting.
Rohn, E.J., Nevedal, A.L. & Tate, D.G. Narratives of long-term resilience: two cases of women aging with spinal cord injury. Spinal Cord Ser Cases 6, 23 (2020). https://doi.org/10.1038/s41394-020-0267-8
Tate D.G. (2021 May). Speaker) Decision making about living with spinal cord injury complications: postCOVID-19: Clinical and Research Implications. [Keynote speaker]. 9th European Spinal Psychologists Association (ESPA) European Conference Spinal Cord Injury.
Tate, D. G., Rohn, E. J., Forchheimer, M., Walsh, S., DiPonio, L., Rodriguez, G. M., & Cameron, A. P. (2023). Factors influencing decisions about neurogenic bladder and bowel surgeries among veterans and civilians with spinal cord injury. The journal of spinal cord medicine, 46(2), 215–230. https://doi.org/10.1080/10790268.2021.1970897
Meeting the Brazilian research team working on the validation project at the University of Sao Paulo: Drs. Julia Greve, Angelica Castilho Alonso e Alexandra Christofi.
Validation of the SCI-QoL BDS: Cross Cultural Comparisons and Clinical Outcomes- Craig H Neilsen Foundation
Quality of life (QoL) for persons with spinal cord injury or disease (SCI/D) can vary across countries as issues such as access to health care, housing and employment may not be available for all. Measuring QoL is critical for the overall wellbeing of persons with SCI/D. Yet, QoL can mean many things to many people. Finding a measure that could be used equally across borders is thus a priority to compare results and establish policies to improve the lives of its citizens accordingly. This is a prospective international validation of the SCI-QoLBDS, a quality-of-life dataset developed to be used across countries, utilizing a diverse sample of participants collected from 2 US centers (Colorado and Michigan) and 3 internationals rehabilitation clinical sites (Australia, Brazil, and Netherlands). The goal was to determine if the SCI-QoLBDS is a psychometrically sound measure of QoL to use with persons with SCI/D. Results showed the SCI-QoLBDS to be a conceptually sound measure to be used across international borders for basic screening purposes. These results are described throughout a series of publications and presentations made by this team of investigators.
Related Publications and Presentations
Tate, D.G., Post, M.W., Charlifue, S., Forchheimer, M., Greve, J. M, New P. W. (2017). Towards a Common Measure of Quality of Life for SCI Clinical Trials. [Conference presentation]. International Society of Physical Medicine and Rehabilitation (ISPMR) 11th Annual Meeting, Buenos Aires, Argentina.
Tate, D. G., Post, M. W., Charlifue, S., Forchheimer, M. B., Greve, J. M., New, P. W. (2017 October). Associations between Secondary Health Conditions and Quality of Life: Use of the International SCI QoLBasic Dataset (SCI-QoLBDS) in Clinical Practice. [Conference presentation]. International Spinal Cord Society (ISCoS) 56th Annual Scientific Meeting, Dublin, Ireland.
Post, M. W. et al. (2019 March). Cross-cultural validation of the International Quality of Life Data Set: Patient’s understanding of concepts and test-retest reliability results. [Conference presentation]. Bi-annual meeting of the European Spinal Psychologists Association (ESPA), Zurich, Switzerland.
Post, M.W.M., Forchheimer, M.B., Charlifue, S. et al. Reproducibility of the international spinal cord injury quality of life basic data set: an international psychometric study. Spinal Cord 57, 992–998 (2019). https://doi.org/10.1038/s41393-019-0302-4
Post, M. W., Forchheimer, M. B., Charlifue, S., New, P., Greve, J. M., Tate, D. G. (2019 November). Reproducibility of the International Spinal Cord Injury Quality of Life Basic Dataset: An International Psychometric Study. [Conference presentation]. International Spinal Cord Society (ISCoS) 58th Annual Scientific Meeting, Nice, France.
Coker J,, Tate, D., Post, M., Charlifue, S., Noonan, V., New, P. W., Greve, J., Forchheimer, M. (2019 November). Evaluation of a self-report method to obtain ASIA impairment scale score in people with traumatic SCI who reside in the community. [Conference presentation]. International Spinal Cord Society (ISCoS) 58th Annual Scientific Meeting, Nice, France.
Coker, J., Tate, D., Post, M,, Charlifue, S., Noonan, V., New, P., Greve, J., Forchheimer, M., Sevigny, M. (2020 October). Evaluation of a self-report method to obtain ASIA impairment Scale in people with SCI who reside in the community. [Conference presentation]. American Spinal Injury Association (ASIA) Annual Meeting, Online.
Coker, J., (2020 October). Mulcahey Award for Research in Outcomes Measurement: Evaluation of a self-report method to obtain ASIA Impairment Scale in people with SCI who reside in the community. [Conference presentation]. American Spinal Injury Association (ASIA) Annual Meeting, Online.
Rohn, E. J., Hakbijl-van der Wind, A. J., Post, M. W. M., Forchheimer, M., Charlifue, S., New, P. W., Greve, J. M. D., & Tate, D. G. (2022). A cross-cultural mixed methods validation study of the spinal cord injury quality of life basic dataset (SCI QoL-BDS). Spinal cord, 60(2), 177–186. https://doi.org/10.1038/s41393-021-00742-1
Post, M. W. M., Fellinghauer, C. S., Charlifue, S., New, P. W., Forchheimer, M. B., & Tate, D. G. (2022). Rasch Analysis of the International Quality of Life Basic Data Set Version 2.0. Archives of physical medicine and rehabilitation, 103(11), 2120–2130. https://doi.org/10.1016/j.apmr.2022.02.018
Coker, J., Tate, D., Post, M., Rohn, E.. (2021 October). Measuring quality of life after SCI: Key findings from a validation study of the International Spinal Cord Injury Quality of Life Basic Dataset (SCI-QoLBDS). [Conference workshop]. International Spinal Cord Society (ISCoS) Annual Scientific Meeting, Online.
Christofi, A. A. S. N., Tate, D. G., Witter, C., Alonso, A. C., & Greve, J. M. D. (2023). Predictors of quality of life of individuals living in Brazil with spinal cord injury/disease. Spinal cord, 61(4), 253–259. https://doi.org/10.1038/s41393-023-00881-7
Post, M. W. M., Forchheimer, M., Charlifue, S., D'Andréa Greve, J., New, P., & Tate, D. G. (2023). Responsiveness of the International Spinal Cord Injury Quality of Life Basic Data Set V2.0: An international longitudinal study. The journal of spinal cord medicine, 46(5), 760–768. https://doi.org/10.1080/10790268.2023.2197820
Hakbijl-van der Wind, A. J., Rohn, E. J., Tate, D. G., van Leeuwen, C. M. C., Forchheimer, M., Stolwijk-Swüste, J. M., Charlifue, S., Greve, J. M. D., New, P. W., & Post, M. W. M. (2024). The social dimension of quality of life following spinal cord injury or disease: an international ICF-linking study. Spinal cord, 62(3), 104–109. https://doi.org/10.1038/s41393-023-00954-7
