Background
Methods
Participants
Instrument development
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A questionnaire (Additional file 1: Table S1–2) using established measures to elicit basic demographic information, trust in health care providers and organizations, attitudes toward research, and general level of concern about health information privacy.
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Educational videos to convey basic information needed to support opinion formation. The first described EHRs, research use of clinical records and data, and oversight mechanisms and privacy protections employed in such research. The second introduced a hypothetical study (Table 1) as the basis for group discussion. In addition to using plain language principles [21] and attending to best practices for the verbal, visual, and textual display of information [22, 23], these narrated slide shows were reviewed by a multidisciplinary group of expert advisors and an endocrinologist to assess accuracy and neutrality. We then undertook several rounds of cognitive testing to improve comprehension and clarity.
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A moderator’s guide to explore participants’ opinions regarding several vignettes in which researchers conducting the hypothetical study might have reason to consider contact with patients. Participants’ reactions to vignettes involving the discovery of discrepant information (e.g., a potentially undiagnosed health condition) were reported elsewhere [24]; here we report reactions to a vignette about contact for the purpose of research recruitment.
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A worksheet for participants to record their individual responses to key closed-ended questions prior to full group discussion, with the goal of enhancing engagement and generating limited quantitative data for comparison [25].
Let’s pretend that researchers want to find ways to help people who are having trouble managing their diabetes to be more successful. They want to see whether people who receive a daily telephone call reminding them to check their blood sugar levels will do a better job of keeping their blood sugar at healthy levels. They want to conduct a study with patients who have diabetes and agree to be in the study to determine if the telephone reminders actually work. Half of the patients in the study would receive a daily phone call reminder to check their blood sugar. The other half of the patients would not receive the call. The researchers would keep track of all of the patients’ blood sugar levels over a 3 month period to see whether patients who got phone calls were managing their blood sugar better than patients who were not getting calls. In order to conduct the study, the researchers first need to identify people with diabetes who they can invite to be in the study. To find people with diabetes, the researchers use a computer program to search through thousands of EHRs. They create a search that tells the computer to pull EHRs based on diagnostic codes, lab results, and medications that may indicate that someone has diabetes. The computer runs the search, which provides the researchers with the EHRs of patients who likely have diabetes, and thus, might be eligible to be in the study. |
Data collection
Let’s say the researchers have reviewed all of the EHRs and have limited their list to people who definitely have diabetes and could participate in the research study. These are the people who the researchers want to invite to participate in the study. This study has been approved by the Institutional Review Board. There will be an informed consent process for the study, so people who are invited to participate can learn all about it and then decide whether they want to participate or not. a. Method of contact: There are two general ways that researchers could contact patients to invite them to participate in the study. • Direct contact: One way is to contact patients directly, for example by letter, phone, or email. The patient could then decide whether to be in the study. • Through physician: The other way would be to contact patients’ physicians, and ask them to let their patients know about the study. In this approach, it would be up to the physician to decide whether to let patients know about the study and, if so, which patients. If a patients’ physician agrees to allow the patient to hear about the study, it would still be up to the patient to make a final decision about whether to participate. b. Response requested: Let’s say that the way researchers plan to contact patients about the study is by letter. After describing a little bit about the study, there are two different things the letter could say: • Opt in: One thing the letter could say is: “If you would like to learn more about this study, please call the study’s 1–800 number.” In other words, you would need to take the step of calling if you wanted to find out more about the study – otherwise, researchers would not contact you further. • Opt out: The other thing the letter could say is: “We will give you a call next week to see if you would like to learn more about this study. If you would rather not hear from us, please call the study’s 1–800 number to let us know and we will take you off the list.” In other words, you would need to take the step of calling only if you want no further contact – otherwise, researchers would call to see if you wanted to find out more about the study. |
Data analysis
Results
Participant characteristics
TOTAL (15 groups) | Cabarrus (4 groups) | Durham (3 groups) | Mingo (3 groups) | Quitman (3 groups) | MURDOCK (2 groups) | p- value | |||||||
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Total participants | 110 | (100) | 31 | (28) | 28 | (25) | 15 | (14) | 16 | (15) | 20 | (18) | |
Gender | |||||||||||||
Men | 44 | (40) | 15 | (48) | 14 | (50) | 4 | (27) | 4 | (25) | 7 | (35) | 0.32 |
Women | 66 | (60) | 16 | (52) | 14 | (50) | 11 | (73) | 12 | (75) | 13 | (65) | |
Age group | |||||||||||||
18–35 | 16 | (15) | 5 | (16) | 2 | (7) | 1 | (7) | 2 | (13) | 6 | (30) | 0.52 |
36–64 | 65 | (59) | 18 | (58) | 20 | (71) | 10 | (67) | 9 | (56) | 8 | (40) | |
65+ | 29 | (26) | 8 | (26) | 6 | (21) | 4 | (27) | 5 | (31) | 6 | (30) | |
Education | |||||||||||||
Less than high school | 4 | (4) | 1 | (3) | 2 | (7) | 0 | (0) | 1 | (6) | 0 | (0) | 0.23 |
High school | 29 | (26) | 7 | (23) | 5 | (18) | 6 | (40) | 7 | (44) | 4 | (20) | |
Some college | 26 | (24) | 6 | (19) | 6 | (21) | 6 | (40) | 4 | (25) | 4 | (20) | |
Bachelor’s degree or higher | 51 | (46) | 17 | (55) | 15 | (54) | 3 | (20) | 4 | (25) | 12 | (60) | |
Race | |||||||||||||
Black | 40 | (36) | 7 | (23) | 14 | (50) | 4 | (27) | 12 | (75) | 3 | (15) | 0.00 |
White | 67 | (61) | 22 | (71) | 13 | (46) | 11 | (73) | 4 | (25) | 17 | (85) | |
Other | 3 | (3) | 2 | (6) | 1 | (4) | 0 | (0) | 0 | (0) | 0 | (0) | |
Health statusa | |||||||||||||
Poor | 3 | (3) | 0 | (0) | 1 | (4) | 1 | (7) | 1 | (6) | 0 | (0) | 0.41 |
Fair | 9 | (8) | 2 | (6) | 2 | (7) | 2 | (13) | 1 | (6) | 2 | (10) | |
Good | 41 | (37) | 14 | (45) | 10 | (36) | 6 | (40) | 6 | (38) | 5 | (25) | |
Very good | 38 | (35) | 12 | (39) | 11 | (39) | 5 | (33) | 4 | (25) | 6 | (30) | |
Excellent | 18 | (16) | 3 | (10) | 4 | (14) | 0 | (0) | 4 | (25) | 7 | (35) | |
Health care visits in past yearb | |||||||||||||
≤ 2 | 59 | (54) | 16 | (52) | 14 | (50) | 6 | (40) | 10 | (63) | 13 | (65) | 0.43 |
3–4 | 28 | (25) | 9 | (29) | 5 | (18) | 5 | (33) | 4 | (25) | 5 | (25) | |
5–9 | 15 | (14) | 2 | (6) | 8 | (29) | 2 | (13) | 1 | (6) | 2 | (10) | |
≥ 10 | 8 | (7) | 4 | (13) | 1 | (4) | 2 | (13) | 1 | (6) | 0 | (0) | |
Health care prohibited by cost?c | |||||||||||||
No | 86 | (78) | 24 | (77) | 20 | (71) | 13 | (87) | 13 | (81) | 16 | (80) | 0.87 |
Yes | 24 | (22) | 7 | (23) | 8 | (29) | 2 | (13) | 3 | (19) | 4 | (20) | |
Have regular healthcare provider?d | |||||||||||||
No | 11 | (10) | 1 | (3) | 4 | (14) | 2 | (13) | 4 | (25) | 0 | (0) | 0.03 |
Yes | 98 | (89) | 30 | (97) | 24 | (86) | 12 | (80) | 12 | (75) | 20 | (100) |
Initial contact with prospective participants: Cross-cutting themes
Trust and transparency
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CC1_P3: It’d be less intimidating if a doctor asked you to participate in [a study], as opposed to the researcher. ‘Cause you know the doctor and you trust him, most of what he says. The doctor knows more about you.
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QC2_P2: Might scare ‘em.
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QC2_P1: Might scare ‘em to death.
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Moderator: It might scare people?
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QC2_P1: Cause anxiety, you know. “I’m not sure I wanna be in this. Do you think it’s all right? Should I go talk to my doctor?” Some people are just nervous types and that would just give them something to think about, really. That might not be good for ‘em.
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CC1_P1: I’ve been involved in studies where I did not go through my physician. And depending on who’s doing the study, if they have a good track record, then I’m comfortable with it.
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MU1_P8: You could [send the letter] on behalf of the doctor, couldn’t you? “I’m [Name] from the Duke study, on behalf of Dr. Such-and-Such.” And then you have a connection.
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CC3_P1: I have a question about contacting patients directly. When you do that, do you let them know that you know they have diabetes? Or do you just send out a generic “If you have it…”, [so patients] don’t know that you know?
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CC3_P5: “Just a shot in the dark here: If you happen to have diabetes…”.
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CC3_P4: We’re in the South.
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CC3_P1: To be like, “We know you have it. Do you want to…” Or, you just happened to get something in the mail and be like, “Oh, okay. Yeah. I have that”—then you think everybody else got one too.
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CC3_P4: “What a coincidence. I do have diabetes.”
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MC3_P4: When you go calling [people] and [they have] no idea that anything’s going on and you’re like, “Oh, hey, I’ve been searching through your stuff,” everyone—almost everyone finds that offensive.
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DC2_P8: I guess if I know that the records are there and I know that researchers have access to them, then I’m okay with them contacting me directly for a study. Because that’s what researchers do. I would understand that.
Decision-making power
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MC1_P2: If I hear from my doctor … I’m gonna listen to him. ‘Cause that’s who I trust. It’s who I’ve been seeing for many years.
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CC1_P2: Well, he just knows your situation. And I think if he does, he’s gonna recommend you for that research.
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CC2_P2: The physician could possibly be able to know whether or not the research was a positive... Whether it was a research organization that was approved or recommended or etcetera.
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DC1_P3: I would think, from the researcher’s standpoint, that would not be good. Because it would be a subjective selection. It would be just who the doctors felt were—.
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DC1_P6: People who visit the doctors regularly.
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DC1_P3: ... or might have lifestyle choices …
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DC1_P2: The doctors … they know their patients, so they may guess how their patients would respond, and might have some bias in who they would invite or not invite because they would wanna affect the results, perhaps.
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QC2_P2: If y’all are offering monetary value to the person to be a part of the study, the physician’s gonna know who needs the money and who don’t.
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MC2_P2: The physician shouldn’t decide—if I want research done on this, my physician shouldn’t make my decision.
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MU2_P5: I just don’t think that it should be left in the hands of the doctor to decide, to exclude me from being a part of a study… To take away that right from me to be a part of something—I think that’s unacceptable.
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MC3_P4: I’m sure, for the people being researched, it’s much more respectful.
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MC3_P1: Well, the patient gets to decide instead of maybe the doctor deciding for them.
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MC3_P4: Exactly. You’re cutting out the middle man.
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MC3_P1: Letting the patient take responsibility for themself.
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QC3_P1: I think that should be your choice and not the doctor’s choice. Because you might learn something from this study. If he excludes you, you just might miss out on learning something.
Effect on research
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MU2_P9: The researcher isn’t having to go to the physician to ask for permission… And you’re also not waiting for the physician to ask the patients, and then waiting on that turnaround time from the patient.
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CC2_P5: The physician has other patients. I don’t think he’s really concerned about research. So he’s like, “Okay, I’ll get to it when I can.” If he ever gets to it.
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CC1_P4: I could see [physicians], if they were in a hurry, just kinda starting at the top of the alphabet and going, “Let’s give ‘em ten people. Here.” They’re all As and Bs. You know, you didn’t really go through, because of time, and look at each patient individually to see who would qualify for the study.
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DC3_P6: [When] the physician becomes a gatekeeper, you narrow your roster of eligible patients. It could have an impact on the validity of the study. Because someone that’s not associated with the study is deciding who’s going to be in your study.
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DC3_P4: Despite what I said about the [advantage] being that the physician knew other things—whether it would be appropriate for an individual to be in the study—I still think if the physician is making the decision, it would skew the study.
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CC3_P4: [Physicians] may be able to filter it for you … to know what’s a best match for what you’re doing, the people most likely to accept, to kinda eliminate your turn-downs and stuff—to say, “These seven people will likely do it for you. Don’t bother calling the other three. I can’t even get them to come to the office” or something like that.
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MC3_P4: As a researcher, I’m sure you’d get more. I mean, I can imagine that the person who works at the physician’s office that already has the crappy job to begin with gets handed a list of 50 people that you want to participate in your research… I think your success rate would be much better with a person-to-person contact to the patient from the researcher.
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DC2_P7: If you got a call from your physician, it would appear to be his giving you his blessing or his opinion that this is more important that you do it. I think that it’d be harder to turn your doctor down than an anonymous researcher.
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DC2_P6: Yeah. I actually think you get a better response if the physician did ask the patient, because you’re gonna believe your doctor wouldn’t send you to something that wasn’t gonna be beneficial for your health.
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DC2_P4: True.
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DC2_P6: And your doctor knows you. Well, supposedly. I mean, if you have a good relationship with your primary care, you trust their opinion. And I would do it.
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MU2_P3: If you get emails, you might think it’s spam and just neglect it, and just toss it out.
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MU2_P6: I was kinda thinking the same thing. In today’s world, you have to be so leery about emails from your bank, from your Target credit card, everything you do, even medical records now… Seems like there’s just so many scams… So I just thought hearing it from your physician’s office would seem more legitimate to me as a patient than just getting a random letter or email or phone call.
Effect on patient care
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DC1_P7: I don’t wanna take any time away from my physician. I’m serious. We get 15 min. That’s it.
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CC2_P5: When the research is done, [researchers] can share information with the physicians and what they come up with, and this way it’s beneficial to the research and the physician.
Initial contact with prospective participants: Acceptability and most appropriate approach
TOTAL (15 groups) | Cabarrus (4 groups) | Durham (3 groups) | Mingo (3 groups) | Quitman (3 groups) | MURDOCK (2 groups) | p-value | |||||||
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Contact: Direct to patient | |||||||||||||
Unacceptable | 6 | (5) | 4 | (13) | 1 | (4) | 0 | (0) | 0 | (0) | 1 | (5) | 0.42 |
Acceptable | 104 | (95) | 27 | (87) | 27 | (96) | 15 | (100) | 16 | (100) | 19 | (95) | |
Contact: Through physician | |||||||||||||
Unacceptable | 27 | (25) | 7 | (23) | 7 | (25) | 5 | (33) | 6 | (38) | 2 | (10) | 0.33 |
Acceptable | 83 | (75) | 24 | (77) | 21 | (75) | 10 | (67) | 10 | (63) | 18 | (90) | |
Most appropriate approach | |||||||||||||
Direct to patient | 77 | (70) | 18 | (58) | 20 | (71) | 14 | (93) | 12 | (75) | 13 | (65) | 0.15 |
Through physician | 33 | (30) | 13 | (42) | 8 | (29) | 1 | (7) | 4 | (25) | 7 | (35) | |
Response: Opt in | |||||||||||||
Unacceptable | 7 | (6) | 2 | (6) | 1 | (4) | 3 | (20) | 1 | (6) | 0 | (0) | 0.20 |
Acceptable | 103 | (94) | 29 | (94) | 27 | (96) | 12 | (80) | 15 | (94) | 20 | (100) | |
Response: Opt out | |||||||||||||
Unacceptable | 19 | (17) | 6 | (19) | 8 | (29) | 0 | (0) | 5 | (31) | 0 | (0) | 0.01 |
Acceptable | 91 | (83) | 25 | (81) | 20 | (71) | 15 | (100) | 11 | (69) | 20 | (100) |
Modified approaches
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CC1_P1: If you took out the words that the doctor had the option to let people know about the study or not, [that] would be okay. I’m saying that the doctor has an obligation to his patients to let them know about the study once you contact him.
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QC2_P1: If somebody got upset about getting a letter or an email or something, they’d probably go to the doctor anyway and say, “What is this all about? Do you know?”
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MC3_P4: Personally, I think that that needs to be “Contact patients directly, after letting the physician know of the study.” I think that’s probably a much more acceptable… I think that the best results would be contacting the patient after you’d contacted the physician to let them know that it’s going on.
The nature of the study
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CC3_P9: If it were like something like taking a medication, my opinion would probably be different. But just to participate in [this] study? I don’t think that that needs to go through a physician. But obviously if it’s something that’s going to impact their health like taking a medication or doing something that will actually affect their individual health, then I would think they would need to go through the physician.
Response requested to initial contact
Opt-in
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QC1_P3: You save time, you save money, everything. Because only the ones that’s gonna want to do it is gonna call… If they don’t want to, they’re gonna toss it in the garbage or just forget that it was ever there. You save time and money both.
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MU2_P10: Lifestyles are so filled with … so many distractions. Something that you’re just getting in the mail, it’s so easy to put it down. And once you don’t think about it, then it’s gone; it’s done. So they’ve gotta be getting their mail at the moment that they’re in the mood to look at it—so your response rate’s just gonna be so low.
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QC2_P4: Well, to call the 800 number it would be on my time. I may not be at home if you call me, or I may be in an area that my phone didn’t pick up, if the researchers were doing the call.
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QC2_P1: And that way you’d be kinda volunteering to find out more.
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QC2_P2: Right.
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QC2_P1: [With opt-out], you were just waiting to be called, and if you don’t wanna be called, you still have to call them. This way’s a lot less phone time.
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QC1_P5: I think that when you get that information in the mail and you read it, and you have an option then to say yea or nay, basically that’s how people answer. That’s how they operate. They got their mind made up … if they intend to deal with it, they will. If not, in the garbage it go.
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CC1_P8: If somebody really wanted to participate in it … they gonna take out the time to call the number. And have real desire to do it.
Opt-out
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DC2_P3: I kinda hate to go back to dollars and cents all the time, but if you do the opt-out, you’ve gotta have somebody that’s gonna pick up the phone and call everybody on your list. And that’s gonna cost you money.
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QC3_P1: If it’s a number that’s not programmed and a name gonna come up with it, I don’t answer it.
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MC1_P3: I would take opt-out, because most of the time if we get something that we are to call an 800 number, I’m never gonna call it… But I’ve been made aware of the study; I’ve had a week to think about it; I’ve become familiar with it. So I would be more than likely to accept the phone call and talk to the person.
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MU1_P8: Opt-out, you have the chance to change their mind too if you call ‘em. They might get the letter and be like, “I ain’t doing that.” But then [the researcher] gets them on the phone and she could change their mind… It’s more personal than a letter. So if you’re that type of person, it might change your mind.
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MU1_P7: With the opt-out you’re gonna have a lotta people that are not interested but they for some reason don’t have time to call in… And they’ll just be irritated by the phone call. If somebody’s really interested, they’ll call.
Response requested to initial contact: Acceptable approaches
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DC1_P8: I just think they’re both—they’ve got their pros and cons, and none of them seem very problematic to me.
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CC2_P3: I think it’s whichever way the people doing the research decide they wanna go.
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Moderator: Okay. So whatever the researchers think is the best, you’re okay with.
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CC2_P3: Yeah. And I’ll make the decision whether I wanna be involved in it.