Ethics of CT scans for medical research study

[zxcvbob]

I've just been diagnosed with Obstructive Sleep Apnea.  Gonna get a CPAP machine and all that.  (it'll be nice to actually get a restful night's sleep, which I haven't had in about 6 months.

One of the doc's colleagues has a research grant from NIH to study the the effects of OSA on vascular... something.  (high blood pressure, etc)  They've been having trouble finding volunteers that fit the study, and I'm a perfect match because I have been diagnosed with OSA will begin CPAP treatment soon, and do not have diabeetus, high cholesterol, hypertension (but my BP is getting close to "pre-hypertension"), don't smoke, etc, etc.

We won't talk about my delaying treatment for a few days to be part of the study.

Part of the study data is to take three CT scan "slices" of my abdomen and one of my thighs.  I asked what kind of radiation that was and he just glossed over how safe they are.  Well, I've been reading...  X-rays at much higher dosage than normal X-ray imaging.

From the hospital's own FAQ about CT scans: (not the only source that I looked up)
"CT scans may slightly increase your risk of developing cancer, although at the low doses used with CT, the risk is very small — so small that it's difficult to prove that any risk actually exists. Because of the possible risk, the American College of Radiology advises that no imaging exam be done unless there is a clear medical benefit that outweighs any associated risk. [emphasis added]
When your doctor believes that a CT scan will help answer an important medical question, the potential benefits to your health can greatly outweigh any small potential risk from radiation."

In a research study, there is no medical benefit to the volunteer (clear or otherwise), yet the volunteer assumes all the risk.

I asked if their ethics committee had reviewed the study, and also asked why they are not using magnetic resonance imaging.

Am I way off base?  I get that way sometimes.  I haven't said "no" to the study yet, but consent needs to be informed and I wasn't until I looked up the info myself, even when I asked about it in the interview.  In the doctor's defense, radiology is not his specialty -- but it should be somebody's specialty on the study panel.

[MillCreek]

Any research study like this has been approved by an IRB: institutional review board that provides ethical oversight for medical research.  I suspect the risk from the x-ray exposure to the CT scans is essentially nil, assuming that you have not had extensive previous exposure to radiation.

[SADShooter]

1) They shouldn't be enrolling patients if the IRB hasn't reviewed and approved the research, so I'm guessing the were approved.

2) You should have been provided an offer to discuss the consent form, which could include an explanation of the purpose/risks of the diagnostics. If that wasn't satisfactory, you could complain to the IRB. There should be a complaint contact on the consent form. This could result in anything from an order to retrain the consenting staff to suspension of the study. Likely the risks were deemed minimal by the IRB.

...and the house Risk Manager beats me to the trigger.

[zxcvbob]

So I'm overreacting again.  Thanks.    I'm going to talk do the doctor tomorrow (not the director of the study, just the doctor who recruited me); I would like to know why they need a CT instead of an MRI -- it didn't sound like the higher resolution would be necessary, but maybe it is.  Curiosity at this point rather than concern.

This at least got me looking critically at whether I should participate in the study.  I think I'm going to decline -- even tho' I'd like to do it.  Not because of the CT, but:

• it would delay me starting to use the CPAP machine until I'm actually on a once-in-a-lifetime Hawiian vacation with Wife (so I won't be have access to the Sleep Medicine nurse-coaches.)  Starting a few days earlier makes a *lot* more sense in case I have problems w/ it
• One of the things they do is a fat biopsy (maybe 2) and I talked with someone who's had that done.  Not something to do the day before starting a vacation; he was on restricted activity for several days and hurt for a week.  He was taking Plavix at the time and I'm not, but just the same I don't want to risk ruining the vacation.

[Hawkmoon]

I don't think you are over-reacting. MRIs are more accurate and less physically intrusive than CAT scans.The argument of the people promoting your study is that somebody else might benefit from the infomation YOUR scan provides. Great. As you so astutely noted, there is no upside for you. The risk of the downside may be small, but it is not zero.

[Brad Johnson]

1. It's no appreciable risk to you.
2. It might truly help someone else.
3. Do it.

You'll likely suffer more.radiation exposure during your vacation and associated flights. It'll darn sure be more perilous (statistically speaking) than a trip throught the CT scanner.

Also, why angst over your vacation versus beginning treatment? You've likely had apnea it for some time. Possibly years. A few days delay to start treatment is nothing. Enjoy your vacation then start your (properly supervised) CPAP treatment when you get home.

Brad

[griz]

My guess is that they use CT instead of MRI is because it is cheaper and faster.

[Waitone]

Maybe it is because CT's and MRI's don't exactly see the same things.

[Scout26]

As other's have posted, you get more radiation on one airline flight then you do in an X-ray or CAT scan.   You might even get paid for it.  I know they advertise on the radio here all the time for various studies going on at Northwestern, University of Chicago, and Loyola hospitals.  It generally includes all doctor visits, procedures/study meds, and some $$ for travel, meals and being a study participant. 

Three CAT scans beats having to take some unknown med (or a placebo) for weeks or months at a time.


Do the study. 

[MechAg94]

Either way, I hope the breathing machine helps you.  I have had mine about 6 months now and I definitely sleep better.  I never was one to spring out of bed in the morning, but I don't have trouble with drowsiness during the day.  Sugar highs/lows had been hitting me harder before also and that went away almost immediately.   

I also notice that I haven't had issues with getting my breathing stuffed up overnight and waking up with nose stuffed up and a dry throat.  The pressurized breathing tends to force the passages open.  I had a brief sinus cold last month.  In the past, that would always translate to a chest cold as I would end up with a stuffy nose and hacking and coughing.  It didn't happen.  I never got stuffed up and it passed. 

[roo_ster]

Given your circumstances, I would not do it.

1. CPAP is a game-changer...if you start & stick with it.  Give yourself the best possible chances of success with it.
2. Never know when you might need beau coup x-rays or CAT scans or where.

I have had both CT scan "slices" of my skull as well as a full-up 3-D CT imaging deal.  I am at my limit for such radiation to my noggin.  Had I previous x-rays to my melon, my exposure level would move from "Meh" to "Hmmm."

If they really want the data, let them use MRI. 

[Doggy Daddy]

Either way, I hope the breathing machine helps you.  I have had mine about 6 months now and I definitely sleep better.  I never was one to spring out of bed in the morning, but I don't have trouble with drowsiness during the day.  Sugar highs/lows had been hitting me harder before also and that went away almost immediately.   

I also notice that I haven't had issues with getting my breathing stuffed up overnight and waking up with nose stuffed up and a dry throat.  The pressurized breathing tends to force the passages open.  I had a brief sinus cold last month.  In the past, that would always translate to a chest cold as I would end up with a stuffy nose and hacking and coughing.  It didn't happen.  I never got stuffed up and it passed. 

ALL of this!  ^^^^^

Especially re the stuffiness part.  And the drowsiness part.  Before I got the CPAP, there was a student that the other instructors ragged on for being so dull that I fell asleep while the student asked me a question.   

Also, after all these years my body "knows" that once the mask goes on it's sleep time.  Seldom do I take more than 3 to 5 minutes to doze off once the mask is in place.  Two minutes would probably be the norm.

[Scout26]

^^^^ Well, now we know how to put DD to sleep without even using Chloroform !!!!

[Doggy Daddy]

^^^^ Well, now we know how to put DD to sleep without even using Chloroform !!!!

The fact that you would want to put me to sleep concerns me.  (discreetly putting a coaster over my drink)

[Scout26]

http://www.youtube.com/watch?v=iLGsyhu5mPY&feature=youtube_gdata_player

http://www.youtube.com/watch?v=n_iZM-Mz8BA&feature=youtube_gdata_player


I'll see if he can come visit you since he's right there in Vegas.


 

[roo_ster]

Either way, I hope the breathing machine helps you.  I have had mine about 6 months now and I definitely sleep better.  I never was one to spring out of bed in the morning, but I don't have trouble with drowsiness during the day.  Sugar highs/lows had been hitting me harder before also and that went away almost immediately.  

I also notice that I haven't had issues with getting my breathing stuffed up overnight and waking up with nose stuffed up and a dry throat.  The pressurized breathing tends to force the passages open.  I had a brief sinus cold last month.  In the past, that would always translate to a chest cold as I would end up with a stuffy nose and hacking and coughing.  It didn't happen.  I never got stuffed up and it passed. 

All of this including a sinus infection that cleared up without antibiotics because the cpap kept thing open at night.