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PCORI stands for the Patient Centered Outcomes Research Institute - http://www.pcori.org. It was funded by congress in 2010 and meant to support research that has a patient centered approach. In the past, medical research has concentrated on physician or disease defined outcomes, such as whether a cancer was cured, or did the patients require less pain medication. The outcomes in patient centered research are things like, the patient’s report of their quality of life after a cancer surgery, satisfaction with their care, and health perceptions on different medication regimens. More and more in medical research it is these outcomes that are becoming important, especially as we are able to effectively treat advanced conditions that are not necessarily cured by medical science.
At Universities of Utah, Michigan, and Minnesota there are a lot of people with spinal cord injury. The urologists at these universities decided to submit a grant to PCORI in 2014 entitled “Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury.” This grant was a good match for PCORI as quality of life is understudied in people with spinal cord injury and almost all of our studies involve physician defined outcomes not patient defined outcomes. Our grant began in August of 2015, and we plan to start enrolling participants in January 2016.
A very unique part of PCORI grants is that patients or participants also help in the research. These individuals are called “stakeholders” and help with many aspects of research. Engagement is the concept of getting help in guiding research by those that are most involved in the problem. For instance, in our grant, we have several people that have spinal cord injury helping design the questions that we will be asking about quality of life and what types of things affect bladder management decisions. We also have a spectrum of professional researchers and clinicians working with us. They are urologists, nurses, physical medicine and rehabilitation physicians, and epidemiologists that designed the questionnaires we plan on using for the study. By assembling a diverse research group, the research produced does not have significant holes and has the greatest chance of helping people living with spinal cord injury make decisions about or understand their bladder care. Part of the engagement process, in PCORI grants, is a meeting with patients to discuss a research plan, as well as a separate meeting of the research team. These meetings are called the patient advisory group and the study kick-off meeting.
We are hoping to gain insight into what factors affect a person’s quality of life when they use different methods of managing their bladder after a spinal cord injury or problem. There are several different choices that people with spinal cord problems have in bladder management. These choices span everything from reconstructive surgery to reliance on a simple catheter that stays in the bladder all the time. Through the research we hope to be able to find out for which groups each method of bladder management works the best. For instance, the research might reveal that indwelling catheters work well for people that have poor hand function until they experience a certain number of urinary infections and then their quality of life begins to suffer, or intermittent catheterization is an excellent option for people with paraplegia until they leak a certain amount in between catheterizations and then quality of life begins to be affected. Ultimately this information is meant to help people with spinal cord injury make decisions with their physicians about the best choices for their bladder management.
The study will run from January 2016 – January 2018. The criteria for entering the study is outlined below.
The study enrollment period is from January 2016 – January 2017. Participants will be followed for a total of a year, or as long as they are willing to answer questionnaires. The last questionnaires will be sent to participants January 2018. View the timeline You can get a visual of how the study works from this flow of participants.
The primary reason to participate in the study is to help other people with spinal cord problems make decisions that will lead to the best quality of life. We will pay 100 dollars for your time for participating in the study. Fifty dollars will be paid at the beginning of the study and fifty dollars at the end of the study at 1 year. This is not as much as your time is worth, but is at least little compensation for your efforts.
Follow this link and you will be asked several simple questions about your spinal cord injury or problem. We will then contact you over email or the phone, depending upon your preference, to send you a consent document for you to review, in order to participate in the study, as well as arrange for a phone interview with a study coordinator. After you complete the interview a link to quality of life questionnaires will be sent to you. You will then receive fifty dollars for participating. In the next year these questionnaires will be sent every 3 months and if you fill them all out you will receive another fifty dollars at the end of the year. There will be another shorter interview with the study coordinator at the end of the year.