That misleading study rears its head again...

NightHawkeye wrote: So, RG . . ., how does this sort of blatant error get corrected? Do you know? I realize this may sound like a rhetorical question, but I mean it in all seriousness. In my line of work, many avenues exist to address such discrepancies, but I haven't a clue how one would even begin to address this within the medical community.

I'm not sure there is any "blatant error". I don't have access to the full text of the article but at least in the Abstract there's nothing I would call an error. Read the comments by sleepydave in the other forum thread that RestedGal linked to. The study was not designed to evaluate the effectiveness of CPAP or compliance with therapy. It was designed to quantify the rate at which OSA causes strokes and death in the real world today (where many people are not compliant with therapy).

Brent Hutto wrote:From the perspective of an epidemiologist, if the "treatment" for a certain condition involves receiving a prescription and a CPAP machine, then everyone who has received a prescription and a CPAP machine has been "treated". So it's perfectly valid to look at a population of people and point out that some subset of them have received the usual standard of care for that condition.

Take a simpler example where compliance isn't the issue. Let's say you give a few hundred people the best available, maybe the only available chemotherapy for a certain cancer. Let's say that chemotherapy only works half the time. It's a true statement to conclude that "Half the people who get that cancer die from it even when everyone receives treatment". If you want to know whether people die even when the drug works that's one question. If you want to know if prescribing the drug works, that's a whole different question.

Lack of compliance is no different than lack of efficacy of a drug. If you want to know whether prescribing CPAP and giving them a machine works, that's the first question. If you want to know whether being fully compliant with CPAP treatment works, that's another. From a public health perspective the first question that matters is whether OSA is killing people. The second question that matter is whether the usual treatment reduces the number of people killed by OSA. How to get people to be compliant is purely a clinical matter and unfortunately it's a problem with no really effective answer.

Brent, you are the medical professional, but I don't agree that lack of compliance is the same as lack of efficacy. To me, the equivalent would be prescribing medication to be taken daily, and the patient takes the medication every two days, or three days, or worse randomly. Would you still call this "treated"? Maybe you would, but I think it's different nonetheless.

Regarding a prescription. Would a physician write a prescription for a patient and then consider them "treated" without asking whether they actually took the medication? Again, maybe that's how things work, but it seems inadequate, and impossible to ascertain the efficacy of the medication.

In the chemotherapy examle, if the patients are coming to the hospital to get treatment, then at least you "know" that they are all receiving treatment. That's far different then giving them the medication which they don't bother to take. How do you determine efficacy in that case? If you are given medication which you take according to your prescription, that is equivalent to being given a cpap machine and being 100% compliant. I don't see any other way to determine efficacy.

Cheers,
BP

BP,

Hold up a moment and let me clarify. I am far, far from being a medical professional. I've never even played one on TV. My training is in biostatistics which is the quantitative discipline in public health. Never taken a biology course in my life.

I agree that completely understanding the efficacy of CPAP treatment means taking into account compliance. If you want to know whether the treatment works, you need to know how efficacious it is at various levels of compliance and also what the distribution of compliance is in the target population. The combination of those effects will give you the effectiveness in that population of prescribing the treatment. The efficacy as prescribed is only a small part of the story.

That said, the problem I have with the alarms being raised over the study in question is that it isn't a treatment efficacy study at all. As far as I can tell, its purpose is to describe the effect of OSA on stroke and mortality and the fact that treatment was prescribed to the subjects who were diagnosed with OSA is just a complicating factor to be mentioned in interpreting the results of the real study question.

Brent Hutto wrote:I'm not sure there is any "blatant error".

I plead guilty to blatant hyperbole, Brent. I don't have access to NEJM either, so can't speak directly to the original study. I'll simply restate what RG posted:

Rested Gal wrote:Sleep Apnea and Death Association Point to Need to Examine Treatments

By: Mayo Clinic on Mar 08 2006

The troubling part of this study is that most people in it were already receiving treatment for obstructive sleep apnea, Dr. Somers [Virend Somers, M.D., Ph.D., a Mayo Clinic cardiologist] says. "So is the stroke risk even higher for people not being treated, and how much do patients benefit from treatment?" he asks.

I guess this just falls into the category of esteemed medical practitioner at prestigious medical facility simply misunderstanding and/or mis-stating results from esteemed medical study.

Apparently, the concerns raised on this forum months ago about the conclusions expressed in this study being very misleading, and the concern that these conclusions would propagate further through the medical community are beginning to come to fruition.

So, I'm left to conclude, sadly, that there is no real feedback mechanism available for correcting these sort of [pick one: errors, omissions, mis-statements]. That's kind of how I thought things were when I posted earlier today, but was really hoping to hear otherwise.

Regards,
Bill

Bill,

I'm sorry but I still don't think the Mayo Clinic guy is in error. It sounds like semantics but "receiving treatment" in this context refers to people who have been to a doctor of some sort, been diagnosed and have received whatever it is that doctor offers for their condition. If you looked at all the people that have OSA, you might group them like this:

1) Undiagnosed
2) Diagnosed but untreated
3) Treated

You'd prefer he have more categories like:

3a) Prescribed but not compliant
3b) Compliant

but that's not the way he thinks about it.

It's hard for us to reconcile ourselves to but an awful lot of people get their diagnosis, get their prescription, take home a CPAP machine, try it briefly and then put it in the closet and that's it. That's the only "treatment" they ever get. Not surprisingly, it doesn't do squat for their OSA. But they are never going to progress to the next step "Actually use the CPAP machine every day and stay compliant the rest of their life".

A treatment that someone doesn't use is not effective. These two scenarios have the exact same end result:

A) Mr. John Doe is given a CPAP machine, puts it in the closet, he dies of a heart attack five years later.

B) Mr. John Doe is given a CPAP machine, uses it every night, it does not cure his sleep apnea, he dies of a heart attack five years later.

Either way, he's going to show up in a population study was someone who 1) has OSA, 2) got a machine, 3) died of a heart attack. If you're looking for ways to improve the effectiveness of CPAP therapy, then in Scenario A you would start figuring out ways to get him to keep it out of the closet and use it. In Scenario B you'd look at something beside compliance. But the point I've been making is this: The study being discussed in this thread was not looking for ways to make CPAP therapy more effective.

In fact, the Mayo Clinic guy rightly suggests that someone needs to be looking at that very question since what we're doing now isn't working. Note that he didn't say the machines don't open up people's airways or that we need to use a different kind of machine. He just said that prescribing CPAP and sending a machine home with people doesn't seem to keep them from dying more often than non-OSA sufferers. I think we can all agree with that conclusion.

P.S. And by the way, in a perfect world I would very much like to see the quotation from the Mayo Clinic guy say "We're pretty sure the problem isn't the treatment itself but the fact that many people refuse to use it." but for whatever reason that didn't make it into that particular quote.

Brent Hutto wrote:I'm sorry but I still don't think the Mayo Clinic guy is in error.

I think that's a generous interpretation of his statement, Brent, but I do understand where you're coming and I also agree with the semantic nuances you're stating. Accurate for legal purposes, but misleading, nonetheless. Another case of the devil being in the details.

Brent Hutto wrote:It's hard for us to reconcile ourselves to but an awful lot of people get their diagnosis, get their prescription, take home a CPAP machine, try it briefly and then put it in the closet and that's it.

That's not hard for many of us here to reconcile at all, Brent. I'm just a new guy here, but that's what this forum is all about - minimizing that very problem. My observation, based on how I've seen things work is that this forum, like many support organizations, is very effective at helping folks with their therapy.

What illustrates this effectiveness to me is the large number of folks who come here regularly out of desperation. They come here ready to give up on CPAP, yet somehow get enough help/support/encouragement to hang on until things get better. I assume this biases things significantly, so that the folks who wander in here are, in large measure, the very ones who might have given up otherwise. Of course, I have no way to prove that, but that is my gut feeling.

Brent Hutto wrote:The study being discussed in this thread was not looking for ways to make CPAP therapy more effective.

In fact, the Mayo Clinic guy rightly suggests that someone needs to be looking at that very question since what we're doing now isn't working.

Yes, indeed . . ., I know a number of folks here who can point him in the right direction, if that is truly the desired result.

Regards,
Bill

Brent Hutto wrote:A) Mr. John Doe is given a CPAP machine, puts it in the closet, he dies of a heart attack five years later.

Yet, he's still counted in the "received treatment" category in the study.

Brent, I agree with so much of what you have been pointing out. A lot of the conclusions people draw (correctly or erroneously) from that study depend on definitions of terms and semantics.

It bothers me a lot that a medical professional speaks of people in that study as having "received treatment" when a goodly portion of the subjects may very well have received a machine but received no treatment at all.

Brent Hutto wrote:P.S. And by the way, in a perfect world I would very much like to see the quotation from the Mayo Clinic guy say "We're pretty sure the problem isn't the treatment itself but the fact that many people refuse to use it." but for whatever reason that didn't make it into that particular quote.

LOL!! There ya go! I'd never have started this topic if he had just made that clear.

NightHawkeye wrote:That's not hard for many of us here to reconcile at all, Brent. I'm just a new guy here, but that's what this forum is all about - minimizing that very problem. My observation, based on how I've seen things work is that this forum, like many support organizations, is very effective at helping folks with their therapy.

Well, this works for some people. Keep in mind that for everyone who gets the help they need by participating (if only for a little while) in a forum like this there are many others for whom saying "you could get a lot of help from cpaptalk.com" is about like saying "you'd be better off if you could sprout wings and fly". I can think of dozens of people I know personally for whom interacting on-line to help themselves deal with a medical condition is totally beyond consideration.

There are some people who can go to the doctor, get a CPAP machine and then use it and do well on their own.

There are others who don't even need the doctor, give 'em an APAP and they end up doing fine.

Still others can get through it with a little help from online forums.

And still others for whom A.W.A.K.E. or similar meetings make the difference.

The problem is, add all these up (and taking into account overlaps) and you've only covered maybe two out of three people who have been diagnosed with OSA or similar SDB conditions. The tough part is how to help those. I'd bet you tomorrow's lunch money that the Mayo Clinic guy has no better idea than I do how to get that missing 1/3 (or 1/4 or whatever it is) sleeping better and getting healthier.

The fact is, there are issues inherent to CPAP that irreducably limit its tolerability. If you can't find a way to deal with the mask and the pressure then it doesn't work. For someone in that boat, whatever CPAP treatment coulda, woulda, shoulda accomplish if only they could tolerate it is a very theoretical thing.

Brent Hutto wrote:I'd bet you tomorrow's lunch money that the Mayo Clinic guy has no better idea than I do how to get that missing 1/3 (or 1/4 or whatever it is) sleeping better and getting healthier.

LOL. I'm pulling my hair out here, Brent! OK, not really, but . . .,

I can't bet ya, cuz I agree with ya!

I'll be especially interested in your opinion in a few months after you've had an opportunity to adjust to xPAP therapy, Brent. I'd be surprised if you don't find that the tips and techniques described on this forum are generally applicable to the entire population of xPAP users. This isn't exactly rocket science here, ya know.

Regards,
Bill

NightHawkeye wrote:...I'd be surprised if you don't find that the tips and techniques described on this forum are generally applicable to the entire population of xPAP users. This isn't exactly rocket science here, ya know.

I didn't mean the advice wouldn't work. Just that they wouldn't find the advice in the first place and/or wouldn't pay attention to it if it were placed before them.

For some people that I know, "The doctor [or nurse, or therapist] told me..." is as good as gospel and "My friend [or someone at church] told me..." is maybe worth believing but "I read it on the Internet..." is like saying "I read it in the National Enquirer".

It might seem strange to us, but it's true. I know that for some of my older relatives, whatever the doctor tells them or gives them either works right away like magic or else it's no good and they drop it and don't even consider figuring out what might have gone wrong. You'd be totally wasting their time and yours to give them a CPAP and expect them to use it.

Brent Hutto wrote: For some people that I know, "The doctor [or nurse, or therapist] told me..." is as good as gospel and "My friend [or someone at church] told me..." is maybe worth believing but "I read it on the Internet..." is like saying "I read it in the National Enquirer".

lol Brent, you're a trip!!


I might add that everyone staring at this screen right now not only has access to a computer and internet but also knows a little something about them. We're fortunate. But then there's my brother, a baby boomer, who views computers as necessary evils good only for email, and he quit his cpap early on because of not being able or willing to tolerate it. It wasn't until I told him about this and that I'd learned from people on these forums did he consider giving it another try (and no, it wasn't my influence, he seldom listens to me). Never underestimate the power of pestering family members.

.... Hmmm. Let's plant a story in the National Inquirer, "CPAPs Make You Rich and Famous!"

L.

I'm not about to jump into this "discussion" with an opinion, but I decided to do a little searching on the Internet on "the Mayo Clinic guy". Found a lot of stuff. Here are some of the links to info on him and "papers" that he's written:

http://www.mayoclinic.org/nephrology-rst/13434012.html

http://mayoresearch.mayo.edu/mayo/resea ... mers_v.cfm

http://mayoresearch.mayo.edu/mayo/resea ... d=13434012

Maybe someone should contact him and express the questions raised in these threads about the validity of what the researchers considered "treatment" or "being treated". THAT might be interesting.

By the way, the thread from this forum from last November (when the article first hit the various publications) showed up in that search.

FWIW

Den

Here's a study that says the opposite.

14.8% to 1.9%. in our favor.

abstract
...Obstructive sleep apnea syndrome (OSAS) has been associated with increased morbidity and mortality, principally from cardiovascular disease, but the impact of nasal continuous positive airway pressure (CPAP) therapy is unclear. METHODS: We performed a long-term follow-up study of 168 patients with OSAS who had begun receiving CPAP therapy at least 5 years previously, most of whom had been prospectively followed up, having been the subject of an earlier report on cardiovascular risk factors in OSAS patients. The average follow-up period was 7.5 years. We compared the cardiovascular outcomes of those patients who were intolerant of CPAP (untreated group, 61 patients) with those continuing CPAP therapy (107 patients). Deaths from cardiovascular disease were more common in the untreated group than in the CPAP-treated group during follow-up (14.8% vs 1.9%, respectively; p = 0.009 [log rank test])...