6 Month Outcome Visit Key Points and FAQs Prepared for the ProTECT Investigator Meeting

1. 6 Month Outcome Visit Key Points and FAQs Prepared for the ProTECT Investigator Meeting November 13, 2012 Angela Caveney, Ph.D. University of Michigan Felicia Goldstein, Ph.D. Emory University

2. General Q: How does certification expiration work? A: Certifications expire on the static dates of May 1st and November 1stof each year. You must conduct 2 tests (whether with a mock patient or real Study Participant) over the previous 6 months to stay active. Q: Can I let my (GOSE, NP) certification expire if I will not be doing any testing or Training of new staff at my site? A: Yes, but you must be certified again to train or test in the future.

3. General Q: If a Study Participant’s GOAT is <75, do I ask a family member to complete the FRSBE? A: No. Only do the: • GOSE • DRS • NOS-TBI • 6 Month Follow Up Form

4. General Q: We have a Study Participant who no longer lives in our area. What do we do? A: Contact Bethany Lane as soon as you become aware of this situation to determine the best course of action. • There are many possible options including (but not limited to) flying your Examiner out to do testing or hiring another ProTECT site to do the evaluation.

5. GOSE Q: Can I use other information (like the Npsych testing or NOS-TBI information) to help me score the GOSE? A: Yes. You can use any information available to you to help get the most accurate evaluation possible.

6. GOSE TIPS

7. Don’t Be Afraid to ask too many questions • Knowing we will be watched/reviewed, there is a natural tendency to do “less”, rather than “more.” • It is OK to ask the same question repeatedly in different ways

8. Study Participant vs. Other • Conduct separate interviews • It is very common for people with head injury to be unaware of or minimize their difficulties • Do not start each question by telling the 2nd person what the other one said • though you might need to in order to clarify • Complete a final version of the GOSE form based on your best understanding from all sources

9. Ask Hypothetical Questions • If it were not for your (insert physical injury), could you….. • I understand you have not gone back to work, but do you think you COULD? • Could you work to the same level as before in terms of productivity, number of hours etc…? • Could you do ANY type of work at this time?

10. GOSE Question #7 (Personality Change) • Preface this question by saying something like: “Many people say that after a TBI, they notice changes to behavior or personality. Some may become calmer while others may become more irritable, or more easily angered. Have you noticed any changes in your personality?”

11. GOSE vs. DRS • GOSE – Isolate what problems are due to the brain injury versus all other causes. • DRS – All reasons for the difficulty should be considered (e.g., brain injury, physical, social, emotional). • Similar items (e.g., work) may not be consistent between the GOSE and DRS. • Someone not working ONLY because of a physical impairment.

12. GOAT Q: Can I give full credit for recall of any event before or after the injury, no matter how far it is from the injury? A: YES

13. GOAT Q: On the date of injury item, can I give full credit if someone accurately refers to the date without being able to provide the actual date (e.g., Thanksgiving) A: YES

14. 6 Month Follow Up Form Q: Do I score what I know – or what the Study Participant says? A: Score what you know/believe to be the truth on each item. If this contradicts the video, be sure to also add a comment regarding this.

15. 6 Month Follow Up Form Q: Is ADHD considered a learning disability for purposes of filling out the 6 Month Follow Up Form? A: No. However, be sure to further question about LD as they are often comorbid.

16. 6 Month Follow Up Form Q: Can I score the education level as “Associates” if a Study Participant has attended “trade school” for 2 or more years? A: Yes. Education that would be roughly equivalent to an Associate’s Degree can be considered here. This education would typically result in some kind of certificate or license for a particular profession or skill.

17. NOS-TBI Q: When do I use “Untestable”? A: Use the worst score (not UN) for items when you cannot tell what the score would be due to severe impairment. • Using “UN” essentially removes this item from the total score, causing Study Participants who are very impaired to have artificially low (unimpaired) scores. • Only use “UN” when a Study Participant is truly only untestable due to a physical barrier or disability, such as a Study Participant who probably could speak if it were not for being intubated or in the case of amputation.

18. Gentle Reminders • Please don’t record a patient’s face. • Leave identifying information off the forms you mail to us. • Put Patient ID# on every form (Trails). • Fill in all blanks on source documents. • (_ _ _: 0 0 3 vs _ _ 3) • Check your DVD before shipping! • When in doubt…call Angi or Felicia to help you sort out scoring. This is what we are here for!

19. Questions? Angela Caveney angif@umich.edu Felicia Goldstein fgoldst@emory.edu