(no subject)

[rivka]

Every time I start work on grantwriting, I think about how interesting it would be to document the steps of the process in my LJ, so that people can see how a vague research idea turns into a fully-formed proposal. Every time, it quickly becomes clear that just writing the grant is enough of a monumental energy drain, without adding writing about the grant to the mix. So nothing gets posted because the task just seems to large.

I'm in the middle of preparing an application to the National Institutes of Health, in response to a call for research on how people make decisions about treating a life-threatening illness. I'm proposing to study how people with HIV make decisions about starting anti-retroviral therapy. In particular, I want to combat the ridiculous tendency that medical decision-making research typically has of assuming that it's a purely logical process of weighing risks and threats against benefits. I think that irrational factors often play a critical role in medical decision-making.

One factor I want to examine is the extent to which people have a cynical, suspicious, mistrustful attitude towards HIV research and treatment, and the extent to which they buy into AIDS conspiracy theories. This morning, I've been working on developing a questionnaire to measure those attitudes. I thought I'd go ahead and post my working version of it, to give people a glimpse of what I'm doing. Comments and suggestions are very much welcome.

Respondents will be asked to rate the following statements on a 5-point scale from "disagree strongly" to "agree strongly." There's a little blurb at the top of the questionnaire explaining that people's opinions differ on these matters, that we are interested in hearing what they really think, and that we will not share their answers with their doctor or anyone else.

1. The U.S. government was involved in starting the HIV problem.


2. You can generally trust information about HIV that comes from official sources (doctors, newspapers, the government).


3. There is a cure for HIV, but only certain people are given access to it.


4. HIV doctors are unfairly experimenting on poor people and minorities.


5. HIV research makes patients safer and helps them live longer.


6. The Tuskegee study proves that people should be suspicious of doctors and medical researchers.


7. Drug companies aren’t interested in finding a cure for HIV, because there’s a lot more money to be made if people stay sick.


8. I can trust my doctor to make sure that I get the best possible treatment.


9. HIV was designed to get rid of people that American society doesn’t want, such as homosexuals and African-Americans.


10. In general, HIV medicines get enough testing before they release them to the public.


11. Doctors and medical researchers are more interested in making money than in helping people.


12. The real truth about HIV is hidden from patients.


13. When a cure for HIV is developed, everyone will be able to get it.


14. My doctor will do everything possible to keep me alive and well.


15. Doctors often use patients as “guinea pigs,” giving them experimental treatments without their knowledge.


16. It hasn’t really been proven that HIV actually causes AIDS.

Incidentally, pretty much every one of these items is taken verbatim from things clients and research participants have told me. I've switched some of them around so that there's a mix of positive and negative responses, because otherwise there's a danger that respondents will just fall into a response set (agree, agree, agree...) and stop thinking about the individual items. But I haven't exaggerated anything.

Comments

[eeyorerin]

One of my colleagues in the Psychology department is doing research on "irrational food beliefs" and their impact on people's decision-making with regard to making choices about changing eating habits, which seems similar to the kind of research you're doing. I can try and dig up his citations (we get email about recent faculty publications, and I know I saw his name in there) if that would be useful.

[rivka.livejournal.com]

It would, actually, if it's not too much trouble. Thanks!

[eeyorerin]

Here's his Web site, which has recent publications and also a link to the survey he used to develop the food beliefs scale.

[therealjae.livejournal.com]

Every time, it quickly becomes clear that just writing the grant is enough of a monumental energy drain, without adding writing about the grant to the mix.

Wow, I have been through EXACTLY the same thought process. I never write about writing it, either. It would be so useful, though--I would do a much better job at the grantwriting workshops my department keeps asking me to do if I had a better handle on my own process.

It sounds like an interesting research question!

-J

[telerib.livejournal.com]

If someone didn't know what the Tuskegee study was, how would they answer Question 6?

[rivka.livejournal.com]

If a member of our patient population didn't know what the Tuskegee study was, I would be astonished. I hear about it all the time - often a warped version in which the subjects were supposedly deliberately infected with syphillis. But yeah, I should probably include a parenthetical explanation.

[raincitygirl.livejournal.com]

It was that they were identified as having syphilis, but deliberately not treated so the progress of the disease could be studied, wasn't it? I'm not American, so it's not really part of my cultural consciousness, but it's the kind of thing that sticks in your brain once you've heard about it.

I never really got the point of Tuskegee (quite apart from the moral and ethical issues). I mean, in the days before modern medicine lots of people developed tertiary syphilis and died of it. You'd think after centuries they'd have a pretty damn good idea of how it worked when it wasn't treated with effective medicine.

The questions are very interesting, BTW.

[rivka.livejournal.com]

It was that they were identified as having syphilis, but deliberately not treated so the progress of the disease could be studied, wasn't it?

They were actually led to believe that they were getting treatment as part of the study. And it went further than that. The researchers went to great lengths to make sure that the men never received treatment from anyone else - for example, they helped them stay out of the draft for World War II, because they would've gotten treatment in the Army. And they also never told the men that they had an infectious disease which could be transmitted to their partners and children. They didn't use the word "syphillis" - they called it "bad blood," which has a local catch-all term for illness.

And yeah, part of what made the Tuskegee study so fucked up was that it became clear that the value of the scientific data was so poor as to be almost worthless... and yet they kept going.

[tchemgrrl.livejournal.com]

Having been involved, but not in charge of, the grant writing process (I'm still a grad student), I can completely see how writing about the grant while writing the grant would be really difficult. It's interesting to see the approaches of different fields, especially when in some ways we're writing the same grant (I think you mentioned you were going for an R01?)

One thing I was curious about in your list: is the Tuskegee syphilis study something that is common knowledge among your patients? I knew what you meant with the context of the question, but if you'd just said "Tuskegee" I don't think I'd've remembered it. Would you have a tickybox that said something like "I don't know" or "I've never heard of this idea"?

[rivka.livejournal.com]

I'm going for an R21. I don't have the status to apply for an R01 on my own.

The Tuskegee study is widely known and discussed in the population I work with. In many cases, it's probably the only research study they've ever really learned about.

[tchemgrrl.livejournal.com]

Ah, I've seen R21's in progress, too. Still stressful. :)

The Tuskegee study being so well-known and discussed is surprising to me, just because my own experience with my (white, largely working class) family is that it's generally harder to get them to *mistrust* a doctor, rather than the other way around. I suppose that still falls under "irrational factors".

[mjlayman.livejournal.com]

Rivka primarily sees black inner-city folks. The Tuskegee study looms large in the black community, rightfully.

[writingortyping.livejournal.com]

What about the flip side to #10? We have had people complain that there is too much testing -or at least, that the testing takes too long. There's a perception among certain people that potentially valuable agents (esp. for the treatment-resistant population) are kept in trials for too long.

[rivka.livejournal.com]

This is an interesting difference between populations. Complaints about insufficient access to experimental treatments typically come from white people, well-educated people, and people who are middle-class or higher. Those are three things that the population I'm studying are overwhelmingly not. There is a very high level of suspicion about experimental treatments, to the extent that clinical trials have a lot of trouble enrolling a representative sample of patients.

I should also note that, due to ACT UP activism in the 80s and early 90s, there are special rules in place for HIV drugs that give broader access more quickly. And access is even quicker for our patients because they're being seen in a major university clinic with strong research connections. I remember having patients on the now-popular HIV drug Kaletra back before it even had a generic name, let alone a brand name - it was called "Abbott 378." They weren't even part of the FDA studies for it - they were getting it through what's called an expanded-access program because they were out of other options.

[writingortyping.livejournal.com]

That is interesting.

I get inquiries from all over the world - people from South America and Asia also seem to feel that new drugs are coming out too slowly.

[perceval.livejournal.com]

Are you going to supplement the questionnaires with some focus groups or interviews? Just wondering because I've started doing this sort of qualitative work ...

[rivka.livejournal.com]

I will be doing a structured interview to go along with the questionnaires, but no qualitative stuff. Most of the existing research that's been done on antiretroviral therapy refusal has been qualitative, so I think it's time for a quantitative approach.

[perceval.livejournal.com]

If most existing work has been qualitative, then from my experience with putting together grant proposals, I would say:
- make sure that your questionnaire items are backed up very solidly by existing qualitative research
- check whether you will get reviewers who appreciate a quantitative approach
- argue very carefully that this field would definitely benefit from a mixed methods approach, and that you are supplying the quantitative part
- work in lots of checks and cross-checks of your questionnaire

I really hope I haven't been bringing coals to Newcastle here (or owls to Athens, for that matter!) Just speaking from my own bad experiences. I work in the field of speech technology for older people, and I had a well-designed psych experiment rejected because it wasn't real-world enough. (Yeah, right.) We suspect we managed to pee off an anthropologist.

[riarambles.livejournal.com]

*loves juicy research posts*

I had to read #13 twice to process that "it" refers to the cure and not to HIV, FWIW.

[rivka.livejournal.com]

Oops! That sounds like something I'd want to fix, doesn't it?
How about, "When a cure for HIV is developed, it will be made available to everyone who needs it."

[riarambles.livejournal.com]

I think that wording is much clearer.

[hobbitbabe.livejournal.com]

Your work sounds so exactly in line with the call for proposals, which must help.

How on earth do you help people make good choices, when some of the reasons for their mistrust have kernels of truth?

[(Anonymous)]

How about just plain old "dont like going to Doctors"? Usually due to bad experiences that could fit under #8 or maybe #14. And with GLBT folks, there's a lot of experience with Drs who don't like dealing with them and it comes through loud and clear.

Not to mention a variation in #11: insurance companies. For those fortunate enough to have it that is and find a Dr they like who will accept it, not tack on extra charges to deal with it.

I dont know if any of that fits into what you're looking for as you're after HIV care issues and the experiences I and my GF have had are unrelated to HIV entirely.

For something directly related to HIV, how about drug side effects and the effort required for a treatment regiment? I know the early day drugs were nasty in both respects and I think people have an awareness of that. I dont know if newer treatments have improved that much or not. Maybe its a factor..??

Certainly affordability will be a factor....

[rivka.livejournal.com]

In other sections of the study protocol I will be asking questions about perceived barriers to treatment: side effects, toxicities, complicated regimens, etc.

In early days the treatments were unbelievably toxic, and the regimens were hard to follow. These days, it's most common for people to just be taking a few pills a day - anywhere from 1 to 6 - and there are enough options that people can usually find a regimen that they tolerate pretty well. But of course people remember what it used to be like - some of them are long-term survivors, and most have known other people with HIV or are familiar with the general reputation of the medicines. So I think that kind of thing probably does play a role.

I'm also planning to look at the quality of the doctor-patient relationship - how much the participants trust their doctor and so forth - and at the degree to which the participants think of health problems as something that is primarily their own job to fix, primarily something that doctors should take control of, or primarily due to luck/the will of God.

Virtually none of our patients have private insurance, and none of them assume the costs of their own health care. It's all government-funded.

[epi-lj.livejournal.com]

I have to admit that I buy into #7 a lot. I don't have any actual evidence for it, so it's certainly something that could be characterized by superstition, but I have this strong feeling about the idea that most companies, especially public companies, answer to their stockholders first and foremost and will do *anything* to maximize profitability. That's probably misplaced, but I'd be lying if I didn't say that it influences my decision process somewhat.

[rivka.livejournal.com]

I can certainly see that, but I also think that coming up with a cure for HIV would be UNBELIEVABLY profitable.

[epi-lj.livejournal.com]

Yeah. But... more profitable than lifelong medication that could control it? It's tough to say. I realize on some level that it's probably a tad irrational, especially because curing AIDS would be insanely good press for a drug company, but I always have a hard time shaking that feeling.

[mjlayman.livejournal.com]

I think sometimes unusual decisions about life-threatening illnesses aren't because of bad experiences or mistrust, but because the patient has had enough. The neurologist just told me I'm having brain seizures and my front parietal lobes are slow so I've started phenobarb -- one more restricted med. I've been thinking for some time that I might not have dialysis when the doctor wants me to. My life is limited enough, I don't think I can give three days a week to a tube in my arm. I've been in stage three renal failure for 16 years, which is unusually long so maybe I'll die before I need dialysis, but the doctor doesn't think so.

I read in the WashPost recently that a study showed that black folks are more likely than white folks to want every last little bit of possible treatment, even if it's futile.

[tassie-gal.livejournal.com]

What sort of ethics clearance would something like this need? And what sort of process would you have to go through to get it?
How is the population being sourced?
(Sorry those are the questions I am trying to get my head around for my PhD in ethics....feel free to ignore).

[rivka.livejournal.com]

What sort of ethics clearance would something like this need?

It will go under ethical review three times: First by the scientists NIH asks to review the proposal to decide whether or not it's good enough to fund, then by the Institutional Review Board at my university, and finally by a different set of people at NIH, when I apply for something called a Certificate of Confidentiality.

In the proposal itself, I have to include a lengthy section describing the fairness of my participant selection process, the potential risks of participation, potential benefits to participants and to society, and the various steps I intend to take to minimize risks to participants. I have to provide extensive justification that the potential benefits of the study outweigh any risks to participants. A project that is ethically problematic probably won't get funded - at least, not without changes being made.

If the project is funded, I then provide much the same information to the university's IRB, which includes scientists from several different departments as well as patient representatives. They have the power to forbid me to do the study or to require me to make changes to give additional protections to the participants. They also need to approve the precise wording of the consent form, which outlines the risks and benefits of the study for patients and provides an explanation of their rights as research subjects.

The IRB will want me to get a Certificate of Confidentiality (http://grants.nih.gov/grants/policy/coc/index.htm) from the federal government, so that will be the last ethics hoop I have to jump through. Certificates of Confidentiality provide extremely strong protection of participant privacy - they would even allow me to defy a subpoena of my research data. They're especially important in cases like this, where even disclosing the fact that someone is in my study would be an invasion of their privacy that could have serious negative consequences. The C of C application is the final ethics review before getting started.

The project would then be reviewed by the IRB on an annual basis. They'd be looking for any kind of problems with the protocol, any evidence that participants were unhappy or harmed, and any new information that might change the risk:benefit ratio.

This study would be considered a minimal-risk protocol. The only real danger is that participants' confidentiality would be breached, and we'll have a zillion safeguards against that.

How is the population being sourced?

We have an established research and clinical relationship with the clinic where we'll be recruiting participants. Participants will come from three places: (1) they will recognize me as a researcher and ask if I have anything they can enter, (2) a staff member of the clinic (a research recruiter or a medical provider, most likely) will send them in my direction, or (3) I will pull their name from a list of patients who have agreed to have their information shared with researchers who might have studies they are eligible for.

[tassie-gal.livejournal.com]

Thanks for this - it helps me get my head around some of the processes and how they differ from Australia and the Uk. It also points out something I didnt know exsisted, and now have to go and explore further to see if its 1. relevent, 2. comparable to anything in either Australia or the UK.

[rivka.livejournal.com]

The Certificate of Confidentiality, I assume?

I should point out that the Certificate adds an extra layer of confidentiality to research; it's not the case that there's open season on research participants' personal information unless a certificate has been obtained. Typically researchers are expected to go to great lengths to ensure the privacy and confidentiality of their subjects.

But this adds extra protection for people who would be in higher levels of danger if their confidentiality is breached, because of stigma (in the case of my research, in which a breach could reveal that someone has HIV) or because of actual negative consequences - say, in research where people are asked about illegal drug use.

It protects my participants from big threats like subpoenas, but also from small everyday threats - like having to receive their compensation for participating in the form of a check properly issued by the university and marked with their Social Security number (which would identify them as a participant in HIV research to any number of university financial people). I get to pay them in untraceable cash.

[tassie-gal.livejournal.com]

Yup - how do you think knowing that you have a CoC affects your participation rate? Do you think its higher than if you just had the usual ethical approvals? Sorry for all the questions, but your post came at the same time I am re-editing a 16 page and growing missive entitled "Comparision of Bioethics in Australia and other countries from a Statutory point of View" which will eventually be a chapter in my PhD thesis tentitavely titled "The Ethics - They Are A Changing. Ethical Dimensions to
Epidemiological Research with a Particular Focus on
Tasmanina Iodine Research."
So to ask questions of someone undergoing the process helps me make sure I understand it correctly!

[mjlayman.livejournal.com]

A minor suggestion -- the phrasing is usually "A'Changin'".

[tassie-gal.livejournal.com]

LOL! See this is why I waffle about my research - so people can pick things like that up...neither my supervisor nor I had THOUGHT of that!

[aloha-moira.livejournal.com]

Sounds like a fascinating study. I'll do my best to summon the funding faeries for you! ;)

[lydy.livejournal.com]

This structure of your questionairre always leaves me feeling a bit lost when I run into a question I know nothing about. I don't have a feeling, other than "I have no fucking idea." My usual choice is to choose 3, neither agree nor disagree, but I've always been unsatisfied with that option. Having a neutral opinion does not seem the same to me as having no opinion. Which doesn't mean there's a flaw, there are lots of questionairres designed like that. I just want to know what circle to fill in. :-)

[nancymcc.livejournal.com]

I may be stating the obvious to people in your field, because my field is user interface design (which gets me reading about cognitive issues).

I was struck by how extremely pro-conspiracy the first question is. I believe there's a lot of research that says answers to questionnaires are highly influenced by how the questions are asked. My guess would be that you'd get less-biased results starting off with closer-to-neutral questions (ones where you'd predict a 50-50 response). Of course, if that IS a 50-50 question in your population, I've just learned a lot!

[rivka.livejournal.com]

If memory serves, about 70% of our clinic population endorse that one. Scary, huh?