Elisa Gordon at Northwestern wants to develop a protocol for better living donor informed consent. And you can help.
Traditional research usually starts with a researcher devising a question (“Do dogs prefer beef-flavored or chicken-flavored dog treats?”) or theory (Dogs prefer chunky peanut butter over creamy), and running a study to measure those research-defined variables (beef vs chicken, chunky vs smooth). But the Patient-Centered Outcomes Research Institute (PCORI), where Elisa is applying, requires that the ‘patient group’ (in this case, living donors and those affected by living donation), help develop the variables to be measured.
Elisa has come up with a series of questions about different aspects of informed consent, but she needs YOU to tell her which are important enough to include in her research study.
The questions, and Elisa’s explanation, are below, as well as in a word document at the link. Email your answers back to Elisa at at e-gordon[at]northwestern[dot]edu (<- spambot avoidance technique) with “living donor informed consent research” in the subject line.
If you have any questions, feel free to comment, email me or Elisa. Oh, and pass this on!
More about Elisa: She was the editor on the “Narrative in Bioethics” issue about living donation, and she serves on OPTN’s ethics committee. She is an ally for improved living donor protections and treatment.
I am a social scientist preparing to write a grant to the Patient-Centered Outcomes Research Institute (PCORI) on helping living donors prepare for living donation. PCORI grants are designed to be patient-centered. I am asking living donors (both potential donors and those who already donated) on this listserv for information to help me prepare this grant. I am not doing research.
Specifically, informed consent is a legal and ethical requirement for living donors. Studies show that many living donors are not satisfied with the education and informed consent process, do not feel that clinicians disclose enough information, or that donors do not fully comprehend that information. My goal is to improve the education and informed consent process to make sure that donors are optimally informed and prepared to donate. I am writing to ask your help to learn what is important to you. Your feedback will be very much appreciated! I have 3 sets of questions:
1. What surprised you about being a living donor? What weren’t you aware of?
2. How would you like to change the education and informed consent process?
3. What do you wish you were told that you learned after donating?
4. How would you like your health care professionals to communicate information to you?
5. How would you change the delivery of information to potential donors?
a. There are lots of ways to communicate information to potential donors e.g., through face to face discussions, pamphlets, booklets, videos, websites, web-based games and quizzes, smart phone mobile apps, etc. Which way would you think would be helpful to you or preferred by potential donors?
6. How helpful would it be to have a web-based learning tool that uses videos and games to educate potential donors?
a. Would you prefer web-based learning with or without quizzes that test whether donors fully understand what they are getting into?
7. Living donors who are cleared to donate still have health risks. Would you be interested in having a method to calculate your specific risks compared to other donors e.g., your risk of developing hypertension after donating (“donor risk calculator”)?
8. All transplant programs have an education process for donors. I’m interested in your general attitude toward obtaining health information. In looking back at your experience, would you have liked to have learned a minimal amount, a moderate amount, or every possible detail about what could happen to living donors?
9. Do you have any further comments about informed consent or about your experience you would like to share?
What are the 3 most important living donor outcomes of being educated about living donation that should be measured? In other words, what living donor factors might be affected in the short-term or long-term by being educated and/or prepared about living donation and should be studied? Please check the three most important outcomes that you think should be considered when educating potential living donors.” Please write in others that you think should be added.
___ Comprehension of living donor risks, benefits, alternatives to donating
___ Preparedness to care for one self after donation
___ Psychosocial health e.g., anxiety, quality of life
___ Satisfaction with donation experience
___ Length of hospital stay
___ Pain management (what it’s like to feel afterward)
___ Expected outcome of recipient
___ Ability to return to normal activities
___ Finances of donation and complications
___ Lifestyle changes
___ Other (please specify): ___________________________________________
1. What kinds of subgroups of living donors would be most important to study? Please check the top 3 groups that you think are important.
___ Directed donors
___ Nondirected donors
___ Non-English speaking donors
___ Liver donors
___ Kidney donors
___ Donors with risk factors: e.g., ethnic/racial minority donors, borderline hypertensive,
___ Adult to adult
___ Adult to child
___ Extended & Standard
___ Family relationships vs. distant relationships & friends
___ Paired donation
___ Donors whose recipient had psychological and physical complications within the first
___ Donors without recipient complications
___ Donors who are satisfied with their experience, e.g., they did not experience
___ Donors who are not satisfied with their experience e.g., they
___ Recipients of living donor kidneys or liver lobes
___ Older donors (over age 50 to 60)
___ Other (please specify): _________________________________
I look forward to hearing your thoughts. Feel free to email me directly at e-gordon[at]northwestern[dot]edu
Word document: EGordon-LD-informed-consent-research