Other Stakeholders

Form Approved

OMB No. 0990-XXXX

Exp. Date XX/XX/20XX

KidneyX Evaluation

Attachment F

KidneyX Interview Guide: Other Stakeholders

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Thank you for participating in this discussion. My name is [Interviewer Name]. I work for RTI, a research organization contracted by HHS to evaluate the Kidney Innovation Accelerator (KidneyX). The evaluation will assess the effects of KidneyX in terms of spurring innovative solutions to address kidney disease and improve outcomes for patients. The evaluation assesses participation in the prize competitions and potential longer-term outcomes related to commercialization of innovations.

The purpose of this interview is to get your perspectives as ...

Before we begin, I’d like to review a few key points about today’s discussion:

• Your participation is voluntary, and you can decide not to respond to a question or to stop participating in the discussion at any time.

• This conversation is one of several we will have to help inform the KidneyX evaluation.

• The RTI Institutional Review Board did not need to approve this study because our conversations will inform the program and it is not designed as a research effort.

• You were selected as a key informant because you ….

• We have reserved 45 minutes for today’s discussion. So, I may have to interject at times to help us stay on topic, or to introduce a new topic. This will help us get through all the questions within the allotted time. We are happy to follow up with you on a later date if there are any topics we don’t get to today.

• [Note taker], also from RTI, is on the line and will be taking high level notes. We would like to record the session so that we can have a full record of our conversation and accurate transcript. The recording and transcript will be stored on RTI’s secure project drive.

Do we have your permission to record?

• Yes; If there is any point during the discussion that anyone would like for us to pause the recording, please just let us know.

• No

Do you have any questions before we begin?

INTRODUCTIONS

1. To start, can you please tell me a little bit about the nature of your involvement in the field of kidney health?

   • How long have you been involved in this field?

   • What are some of your or your organization’s contributions in this field?

MAIN QUESTIONS

Now I’d like to hear about your organizations experiences with KidneyX.

2. Can you describe your organization’s role and involvement in KidneyX?

   • When and how did your organization first get involved with Kidney X?

   • How has your organization’s involvement in KidneyX changed over time?

3. In what ways has your organization had an influence on KidneyX?

   • To what extent have you had the influence you anticipated or wanted?

4. Overall, how satisfied are you with your organization’s involvement with and influence on KidneyX?

   • What are you most/ and least satisfied with?

   • In what ways, if any, would you like your organization’s involvement to change?

Now I’d like to hear your thoughts about other organizations that are or might be involved with KidneyX.

5. What organizations/ entities/ groups do you consider to be key stakeholders in KidneyX?

6. Are there any potentially important groups or communities that are not involved in KidneyX?

   • (If yes) Who are they, and why are they not involved?

7. Which organizations currently engaged in KidneyX do you feel are most critical to the success of KidneyX? Why?

8. What strategies have been more/less effective in attracting and engaging specific stakeholder groups?

9. How could KidneyX do a better job of attracting and engaging stakeholders?

10. To what extent do you feel you that other stakeholder groups are satisfied with their involvement in KidneyX?

    • What gives you that impression?

Now I’d like to ask for your thoughts on KidneyX overall.

11. KidneyX describes its mission as accelerating innovation in the prevention, diagnosis, and treatment of kidney disease and improving the quality of life of kidney patients. From your perspective, to what extent has KidneyX been successful in this mission?

    • What are the greatest successes?

    • Where has it not yet achieved expected success?

    • What else could KidneyX do to achieve its mission?

12. Has your organization had any interaction with KidneyX applicants?

    • If so, what was the nature of that interaction?

    • What questions, if any, have applicants posed to your organization?

13. What is your view of the qualifications of the KidneyX applicants?

14. To your knowledge, are the ideas submitted to KidneyX particularly innovative?

    • Can you share some examples?

15. To what extent do you feel you that KidneyX is doing sufficient outreach to communities that have ideas that can accelerate innovation in the field of kidney health?

16. Have you seen an increase in the number of new firms competing in the domain of kidney health?

    • What information have you seen that might support your observation?

17. In your view, are the small firms awarded a KidneyX prize likely to find financing?

18. What are examples of actual or potential changes in regulatory processes or policy in response to the efforts of KidneyX, if any?

19. Do you see any evidence that new firms or investors are funding innovative products or solutions in the kidney health domain since the start of KidneyX?

    • If so, to what degree do you think that new interest is attributable to KidneyX activities?

Now I’d like to hear your thoughts on engagement of patients and care-partners in KidneyX.

20. To what extent do you feel you feel that patients/patient advocacy organizations are playing a meaningful role in how KidneyX functions?

21. Can you name examples of KidneyX prize winners that reflect especially strong appreciation for and understanding of patient needs and preferences?

SUMMARY AND WRAP UP

22. Do you have any closing thoughts to share about the topics we discussed?

23. Do you have any recommendations for KidneyX based on your experiences?

Thank you for your time and valuable feedback. Your input will help to inform the KidneyX evaluation.