appendix 1: interview guide

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APPENDIX 1: INTERVIEW GUIDE

Q1. On a scale of 1 to 5 with 1 being very important and 5 being not important at all, how important do you think it is to do medical research studies?

Very Important

Not at all important

Don’t know [DO NOT

READ]

Refused [DO NOT READ]

      

1 2 3 4 5 98 99

Q2a. We’re interviewing you today because you were included in a research study for people with Traumatic Brain Injury (TBI) called the PROTECT III study. From this point on in the interview, when I talk about

traumatic brain injury, I’ll just call it TBI for short.

Q2a_1. Can you tell me more about this research study?

Q2a_2. [IF NOT PROVIDED ABOVE] What do you think was being tested in this research study?

Q2a_3. How did you find out that you were included in this research study?

Q2b. You were included in a research study called the PROTECT III study. In this study, doctors are trying to figure out whether Progesterone, given through the vein immediately after TBI, helps to improve the

condition of patients with TBI. In this study, all patients like you receive standard medical treatment for TBI. In addition, patients are given either Progesterone or a fluid that looks like Progesterone but is not (It is a

placebo). The medication (either Progesterone or placebo) is given through an IV for 4 days, and whether a patient receives the Progesterone or the placebo is determined at random like by the flip of a coin. In other words, the doctors treating patients do not pick and choose who gets Progesterone and who gets placebo. In every other way, all patients receive standard treatment for TBI.

Do you have any questions about what I just described?

Can you describe this study in your own words for me?

[IF NECESSARY BASED ON PRIOR RESPONSE] This study is testing whether a new medicine (Progesterone) helps patients who have TBI. In addition to all regular care for TBI, patients in this study are treated with Progesterone or a fluid that looks like

Progesterone but is not really a medicine (a placebo). Which patients get treated with progesterone and which get treated with placebo is decided at random, like by the flip of a coin, and doctors don’t know who got which treatment.

Q2c. What do you think were the potential benefits to you of being included in this study?

Q2d. Do you remember being told about any risks associated with being included in this study?

Q2d_1. And what, specifically, are some of those risks?

Q2e. On a scale of 1 to 5 with 1 being strongly agree and 5 being strongly disagree, how does the following statement apply to you?

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Strongly Agree

Strongly Disagree

Don’t

know Refused

      

I am glad that I was included in

this research study ¹ ² ³ ⁴ ⁵ ⁹⁸ ⁹⁹

Q2e_1. Can you tell me why you chose that answer?

Q2f. On a scale of 1 to 5, where 1 means strongly agree and 5 means strongly disagree, please tell me how much you agree the following statement:

Strongly Agree

Strongly Disagree

READ]

Refused [DO NOT

READ]

      

It is important to do research to find out whether new treatments can improve care for patients with TBI.

1 2 3 4 5 98 99

VIEWS ON HAVING BEEN INCLUDED IN PROTECT

Q3a. [As I mentioned, the study you were included in is called the PROTECT III study, and it is testing whether Progesterone helps patients with TBI. Normally, people are only included in research studies after they or someone who makes decisions for them have agreed to be part of the study. But because you had suffered a brain injury, the study doctors couldn’t ask you for permission to be included in this study. When did you first find out that you had been included in the PROTECT III Study?

Q3b. When you first found out that you were included in this study without having been asked for permission (or consent), what were your reactions?

Q3c. Were you or someone else asked for permission to keep you in the PROTECT study at the time you found out about the study?

Q3c_2. [Did you or the person who was asked to decide for you agree to stay in the study?

Q3c_3. Can you tell me how you or that person made that decision?

Q3d. When researchers do studies to test treatments for emergencies like TBI, they can’t ask patients for their permission or consent at the time the patient is included in the study. This is because patients are very out of it or are unconscious. In addition, family members are not always around and decisions about how to treat people with these conditions have to be made very quickly.

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Does it make sense why researchers who do research like the PROTECT study sometimes have to include patients without asking them or their family members for consent or permission first?

[IF NECESSARY BASED ON PRIOR RESPONSE] When people have TBI, they aren’t able to be a part of decisions about treatment, because they’re often unconscious or really out of it. Also, family members or other people aren’t always around to help make treatment decisions for the patient. So doctors who want to do studies of TBI treatment sometimes have to include patients without asking for consent first.

Q3e. The rules that allow research in emergencies to happen without consent have some special

requirements. First, medical experts have to review and watch over the research to make sure it is safe for patients. Second, there has to be some chance that people may benefit from being in the study.

Third, researchers have to talk with community members in the areas where they would do the

research to ask for their opinions on the research study before the study is started. They also have to let the community know when the study is happening.

Do you have questions about these rules?

Q3f. Having heard about these rules of research and the reasons why sometimes research is done without patients’ consent if nobody is available to make decisions for a patient, I want to ask you now for your opinion about being included in the PROTECT III study. On a scale of 1 to 5 with 1 being strongly agree and 5 being strongly disagree, how would you rate the following statement?

Strongly Agree

Strongly Disagree

READ]

Refused [DO NOT

READ]

      

I think that it was ok for

researchers to include me in the PROTECT III research study without asking me for permission first.

1 2 3 4 5 98 99

Q3f_1. Can you tell me how you decided to give that question a [INSERT Q3f RATING]?

VIEWS ON ACCEPTABILITY OF THE USE OF EFIC IN RESEARCH (IN PROTECT AND IN GENERAL) Q4a. The last questions asked for your thoughts about having been included in the PROTECT study. Not

thinking specifically about your own situation, I now want to ask you about your thoughts, in general, about whether it was ok for researchers to do this study where people are included without being asked for permission first if nobody is available to make decisions for a patient. On a scale of 1 to 5 with 1 being strongly agree and 5 being strongly disagree, how would you rate the following statement?

[MULTIPLE RESPONSE – CODE 9 IN ADDITION TO OTHER RATING IF THEY ADD THAT THEY DON’T WANT TO SPEAK FOR OTHERS]

Strongly Agree

Strongly Disagree

Don’t want to speak

for

“everyone”

READ]

Refused [DO NOT

READ]

       

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I think that it was ok for researchers to include people in the PROTECT research study without asking them for permission first..

1 2 3 4 5 9 98 99

Q4a_1. [IF Q3f AND Q4a ARE DIFFERENT, ASK:] I noticed you gave the last question a

[INSERT Q4a RATING] and the previous one a [INSERT Q3f RATING]? Can you tell me why you felt differently about these two questions? [OPEN END]

Q4a_2. [IF Q4a=9] What do you think should be done instead given that we can’t usually know who would want to be in a study and who wouldn’t? [OPEN END]

VIEWS ON THE USE OF PLACEBOS

Q5a. As I mentioned earlier, in the PROTECT III study, all patients who were included received standard medical care. As part of the study, they were then treated with either progesterone or a placebo fluid, a fluid that looked like the progesterone but did not contain progesterone. Why do you think that

researchers used a placebo fluid like this for this study?

Q5b. Researchers use placebos in order to understand the effect of the treatment they are studying. By having a group of patients receive placebo and a group of patients receive progesterone, researchers doing the PROTECT study can do a direct comparison between the two groups of patients and learn whether Progesterone really helps patients with TBI and make sure it doesn’t cause any problems.

What were your reactions to finding out that you could have been treated with either Progesterone or placebo?

Q5c. On a scale of 1 to 5 with 1 being strongly agree and 5 being strongly disagree, how much do you agree with the following statement:

Strongly Agree

Strongly Disagree

READ]

Refused [DO NOT

READ]

      

I think that it was acceptable for researchers to give half of the patients in the PROTECT study placebo and half of the patients Progesterone.

1 2 3 4 5 98 99

Q5c_1. Can you tell me how you decided to rate this question a [INSERT Q5c RATING]?

VIEWS ON RANDOMIZATION

Q6a. Now I want to ask you a few questions about having treatments picked at random. As I mentioned earlier, in this study, doctors did not pick and choose which patients were treated with Progesterone and which patients were treated with placebo. This was decided at random, like by the flip of a coin.

Researchers decide treatments at random like this so they can tell whether one or the other treatment

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works better. If the doctors decided on their own which patients to treat with each of the 2 medicines, they might not give equal numbers of people each medicine or they might pick and choose certain types of patients to give one medicine or the other.

Does that make sense to you?

Q6b. On a scale of 1 to 5 with 1 being strongly agree and 5 being strongly disagree, how much do you agree with the following statement:

Strongly Agree

Strongly Disagree

READ]

Refused [DO NOT

READ]

      

I think that it was acceptable for researchers to assign treatments at random in this study

1 2 3 4 5 98 99

Q6b_1. Can you tell me a little bit more about why you gave an answer of [INSERT Q6b RATING]?

VIEWS ON CONVERSATIONS WITH INVESTIGATORS ABOUT THE STUDY

Q7a. Did someone from the research team talk to you about being included in the PROTECT study while you were being treated?

Q7a_1. How would you describe your conversation with that person about this study?

Q7a_2. Is there anything you would change about how you were told about the PROTECT study and having been included in it?

Q7a_2a. What, specifically, would you change about how you were told about the PROTECT study and having been included in it?

VIEWS ON THE COMMUNITY CONSULTATION PROCESS

Q8a. As I described earlier, when researchers want to do a study like this where people have to be included without being asked, the rules of research require researchers to ask members of the community before starting the study for their thoughts and opinions about the study. In other words, researchers asked community members for their input on the study. Does this seem like something important to do? [PROBE: In what way is this important/not important?]

Q8a_1. In the PROTECT study specifically, the one you were included in, are there particular people or groups of people that you think researchers should have talked to in trying to get the community’s thoughts on the study before starting the study?

IMPACT OF PUBLIC DISCLOSURE

Q9a. These researchers also tried to inform communities about the PROTECT study so that they would know it was going on. Were you aware of the PROTECT study before you were injured and brought to the hospital?

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Q9a_1. [ASK IF PREVIOUSLY AWARE Q9a=1] How did you hear about the study?

Q9a_1a. [ASK IF PREVIOUSLY AWARE Q9a=1] Were you aware of any ways to let researchers know that you did not want to be included in this study if you had a TBI?

Q9a_1b. [ASK IF AWARE OF WAYS Q9a_1a=1] What were some of the ways you were aware of? [

Q9a_1c. [ASK IF AWARE OF WAYS Q9a_1a=1] Did you call about the study? Why or why not?

Q9b. [ASK IF NOT PREVIOUSLY AWARE] People who heard about the study could call in and get a wrist band that would let people know that they didn’t want to be included in this study if they had a TBI and were treated at a hospital participating in this study. They also could have their name put on a list of people who wouldn’t want to be in the study that doctors could check before putting someone into the study. Is this something you would have done if you had known about the study and knew it was an option?

Q9b_1. Why would you/would you have not done either of these things? [ TRUST IN RESEARCHERS AND CLINICAL RESEARCH

Q10a. I want to ask you some questions now about your thoughts about doctors and researchers. On a scale of 1 to 5 with 1 meaning you strongly agree and 5 meaning you strongly disagree, how much would you say you agree with the following statements?

Strongly Agree

Strongly Disagree

READ]

Refused [DO NOT

READ]

[RANDOMIZE VARIABLES]       

Q10a_1. Doctors who do medical research care only about what is best for each patient

1 2 3 4 5 98 99

Q10_a_2. Doctors tell their patients everything they need to know about being in a research study

1 2 3 4 5 98 99

Q10a_3. I completely trust

doctors who do medical research ¹ ² ³ ⁴ ⁵ ⁹⁸ ⁹⁹

Q10a_4. Medical researchers

treat people like “guinea pigs” ¹ ² ³ ⁴ ⁵ ⁹⁸ ⁹⁹

Q10b. [IF Q10a_1=3, 4 or 5] Can you tell me why you gave a rating of [INSERT Q10a_1 RATING] for the statement “Doctors who do medical research care only about what is best for each patient?”

Q10c. [IF Q10a_2=3, 4 or 5] Can you tell me why you gave a rating of [INSERT Q10a_2 RATING] for the statement “Doctors tell their patients everything they need to know about being in a research study?”

Q10d. [IF Q10a_3=3, 4 or 5] Can you tell me why you gave a rating of [INSERT Q10a_3 RATING] for the statement “I completely trust doctors who do medical research?”

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Q10e. [IF Q10a_4=1, 2 or 3] Can you tell me why you gave a rating of [INSERT Q10a_4 RATING] for the statement “Medical researchers treat people like ‘guinea pigs?’”

DEMOGRAPHICS [ASK ALL]

D1. Is the respondent male or female? [RECORD FROM OBSERVATION]

Male 1

Female 2

D2. In what year were you born? [RECORD 4 DIGIT YEAR OF BIRTH]

Don’t know [DO NOT READ] 98

Refused [DO NOT READ] 99

D3. Which of the following best describes your marital status?

Single 1

Married 2

Divorced or separated 3

Unmarried living with partner 4

Widow or widower 5

D4. Do you consider yourself to be Hispanic or Latino?

Yes [GO TO D6] 1

No [CONTINUE] 2

Refused [DO NOT READ] [CONTINUE] 99 D5. Which of the following best describes you? Are you . . .

Asian, Hawaiian, or Pacific Islander 1

Black or African American 2

Native American/Aboriginal 3

White 4

Some other race [RECORD VERBATIM] 97

D6. What is the last grade or year you completed in school?

Less than high school 1

Some high school 2

High school graduate or GED 3

Some college 4

College graduate 5

Some post-graduate 6

Post-graduate or Professional degree 7

Other [RECORD VERBATIM] 97

D7. Which of the following best describes your employment or student status? Are you employed . . .

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Employed full-time 1

Employed part-time 2

Retired 3

Not employed 4

Disabled 5

Student 6

D8. Which category best describes your combined family income in the last year (before taxes)? Was it . . .

< $5,000 1

$5,000 - $19,999 2

$20,000 - $39,999 3

$40,000 - $59,999 4

$60,000 - $79,999 5

> $80,000 6

Don't know [DO NOT READ] 98

D9. Do you currently have medical insurance coverage of any sort?

Yes 1

No 2

D18. Did you have any side effects or problems as a result of being in the PROTECT study?

Yes [CONTINUE] 1

No [END SURVEY] 2

Don’t know [DO NOT READ] [END SURVEY] 98 Refused [DO NOT READ] [END SURVEY] 99

D18a. What were the side effects? [OPEN END]

Gave response [DO NOT READ] 1