Monday, February 05, 2007

Evidence

Some of the comments in my previous post Implants brought up the issue of evidence based medicine in the NICU. Evidence based medicine means using medical therapies that have been tested in well done studies and found to be beneficial, as opposed to practicing medicine according to the "Hey, this sounds like a good idea, let's see if it works" method. I am all in favor of using evidence based medicine and think that generally I practice it, but I have to say it's easier said than done.

There are a couple of ways by which people may fail to practice evidence based medicine. Some neonatologists, and physicians in general, fail to practice it by using therapies that have not been adequately tested for safety and efficacy. An example of this might be the liberal, unchecked use of high amounts of oxygen in the early days of neonatology that resulted in an epidemic of retinopathy of prematurity. (I'll post about another example in the next week or so.) At other times physicians don't practice evidence based medicine because they don't know the latest evidence. Neonatologists who continued to use steroids for BPD, even after studies showing their detrimental effect on neurodevelopmental outcomes, fall into this category. I know a couple of them.

Sometimes, though, we would like to practice evidence medicine but cannot, simply because evidence does not exist or is not conclusive regarding a given situation. Absence of data doesn't mean you don't have to treat a problem. I wish I knew the best way to treat hypotension (low blood pressure) in tiny premies - for that matter, I wish I knew when to treat hypotension in them - but the data isn't clear. That doesn't mean I can ignore the problem. In another example, I still have to feed babies, even though it's not well resolved how fast to increase a baby's feedings each day.

Although there is more to do regarding evidence based medicine in neonatology, there has been tremendous progress in obtaining good evidence through well done studies in neonatology. A very partial list of examples includes artificial surfactant, the use of IVIG to prevent infections, the use of oscillators versus conventional ventilators, Vitamin A for prevention of BPD, and phenobarbital for prevention of intraventricular hemorrage. All have been studied well, (some worked and some did not) resulting in better care for neonates. The establishment of networks like those of the NICHD neonatal research network and the Vermont Oxford Network have furthered the cause of evidence based neonatal practice and will continue to do so, as will the Cochrane collaboration.

We should all realize, too, that it is very difficult to do good studies in humans. Earlier in my career I did a couple of randomized controlled therapeutic trials. They were nothing earth shaking and very safe for the participants, but they were still tremendously difficult to carry out, requiring (appropriately) approval from the human investigation committee, informed consent from the parents, diligent supervision of the NICU staff to make sure they followed the protocol, and, last but not least, money. This was all in addition to my regular job taking care of babies. To say the least, it was a real pain to do.

Speaking of money, we could use all the help we can get in obtaining money for research. The NIH's budget is getting lower, not higher. Are you writing your congressmen to protest this? Are you voting for people who want to put a reasonable portion of your tax dollar into research? We're not perfect in neonatology, but unless you're part of the solution, you might be part of the problem.

17 Comments:

Blogger Laura said...

i would agree, based on my own short 16 years in neonatal nursing that some of the evidence based results that have culminated over the years would be one of a number reasons why one 24 weeker i know, and love so much, has had a better outcome compared to peers than say 10 years ago, or even 30 years ago.

12:17 PM  
Blogger abby said...

I agree with Laura. This is why we didn't hesitate to enroll our daughter in the one study that we were asked to join while she was in the NICU. Whatever knowledge can be amassed by neonatologists today will help preemies in the future. And I know for a fact that Hallie's survival -- and hopefully her good outcome -- correlates to the experience amassed over the past 20 or 30 years.

12:35 PM  
Anonymous maribeth, cnm said...

My biggest frustration comes when practitioners CHOOSE not to practice evidence-based medicine, for nothing but convenience. It happens everyday. How many babies are resuscitated at the bedside, still connected to mom with supportive oxygenation through the cord pulse, rather than swooped to a warmer? Not a one, in hospital, that I have ever seen. NeoDoc, do you encourage birth attendants to use evidence-based practices regarding delayed cord clamping being on births you are present for? I'm still smarting from one of our back up Neo's insisting that preemies, most of all, must have immediate cord clamping.

12:38 PM  
Anonymous Helen Harrison said...

Neonatal Doc said:

"For those of you would sneer or make snide comments about the lack of evidence based therapy in neonatology, I would say, what have you done to help?"

I'm not sure who you are referring to when you talk about
"sneer[ing]" or "snide comments," but I will tell you what I have personally done to help.

I have spoken and written extensively in medical journals and parent publications, medical grand round and parent meetings, in the US and Canada, on the need for evidence-based medicine.

I try to convince parents that having a child in an RCT is a win-win situation for everyone involved.

I work with MDs to develop informed consent procedures for parents in tricky situations (for example, mothers who are about to deliver).

I have worked on RCTs myself, helping doctors frame the issues in a parent-friendly way, and helping to uncover issues and outcomes of interest to parents.

As someone who has received NIH funds for neonatal and outcomes research myself, you *bet* I vote for candidates who support this crucial institution. I give freely of my time and money in support of evidence-based medicine and the policy makers who favor it.

I have had the privilege of working with major proponents of evidence-based medicine including Iain Chalmers, William Silverman, Nigel Paneth, Jon Tyson and many, many others.

And I am involved in ongoing research.

Finally, I carry a card in my wallet (inspired by Iain Chalmers) reading "In the event I suffer a serious injury or illness, randomize me in a controlled trial."

I'm with you all the way on this one, neo doc!

1:12 PM  
Blogger NeoNurseChic said...

Hi ND - I really hope that nothing I said in my comments on the previous post were offensive or made you feel like I was being critical of you or anything. Because that wasn't my intention!! I agree with everything you've written in this current post - just wanted to make it known that I'm sorry if anything in my other comments made you upset!

And I appreciate what you wrote in the response to the comments about people like me who need to try things based on anecdote from time to time. I find that the headache center where I am treated is constantly making huge pushes to get as many trials done and drugs approved as possible. I think they were largely part of the reason for why topiramate became an approved preventive for migraine and also are working very hard to get botox approved for migraines, too. So even though a lot of things aren't FDA approved - there is a lot of research out there that shows evidence - so it is still evidenced-based. I guess I didn't really think about that distinction when writing my other comments, either. There may be only a handful of preventives that are FDA approved to prevent migraine and other headache types, but there are hundreds of studies looking at the efficacy of the drugs that they use to treat these conditions. I stand by my original comment though, that a lot of these things were first looked at because somebody had an anecdote of a patient being treated for temporal lobe epilepsy with topamax, for example - had relief of her migraines while on the drug. So that anecdote was expanded and tested...and now we have the evidence. I guess what I'm saying is that anecdotes sometimes lead to investigations and evidence in the long run. When I went on the methotrexate for RA, my neuro told me that it may help the clusters, and I asked why. He said that at a conference he'd been to, there was a case report or poster presentation or something about at least one cluster patient being treated for guillian barre (sp?) or other autoimmune diseases that respond well to plasmaphoresis also had relief of their clusters from the plasmaphoresis, so this made him wonder if even possibly something like methotrexate or other drugs being used for the AI disorders might also have an effect on CH. Who knows? I was thinking that it would have more of an effect on my constant migraine than the CH - but I am just watching very carefully to see what happens!!

And as for my pic - I actually changed it quite awhile ago! :) My grandfather had taken that pic of me playing the piano on the 4th of July, and I liked it because I felt like even though it's not showing my hands at the piano, my face is very telling of what I'm feeling while playing a certain piece. Most people probably wouldn't see it that way or even be able to tell what it was I was feeling just by looking at my face. But I know myself, so I can! lol I just liked that pic. :)

Gotta get ready to go to work myself!

Take care,
Carrie :)

1:22 PM  
Anonymous Anonymous said...

I didn't comment on the other post, but your comment that judges are "supposedly" educated rankled a little bit. How about I call you only "supposedly" educated because you've not read the hornbooks and recent law review articles on health law? How about I call you "supposedly" educated because you don't understand the complex issue of whether YOU or a PARENT should have the choice of whether to take a neonate off of a ventilator -- a topic you've discussed before.

Make snide comments about "supposed" education all you like, but in the end, if the lawyers for the pharma companies failed to properly educate the judges and juries through the use of those studies, then they have no one to blame but themselves.

As for settlements that occur before trial, they occur approximately 90% of the time.

I do understand what you were trying to say about silicon breast implants and, as a lawyer, I am often embarrassed by unmeritorious cases that make the news and make all lawyers sound like we're out to make a cheap buck. Nothing could be further from the truth. I work a part-time job for $16k/year in an area of health law devoted to people who are often mistreated by society. I just don't get the contempt I hear from doctors about lawyers... we can be your friends, too.

1:59 PM  
Blogger The Preemie Experiment said...

Neonatal Doc wrote: "We're not perfect in neonatology, but unless you're part of the solution, you're part of the problem."

AMEN!! This is exactly why I started "the preemie experiment". Over the years, I have said (to other parents who do nothing but complain), "speak out!" How do we expect docs to know that something is causing common issues in older preemies. Even though it will not benefit my daugther, we have to be there for the future preemies. It's imperative!

ND... any suggestions... what can we do?? I am all ears!!

2:04 PM  
Anonymous Chris and Vic said...

Neonatal Doc, thank you for the suggestions about what we can do to help. Wouldn't it be awesome if there was a poster in yours and my NICU offering your suggestions and asking for help. We would feel as if we are all in this together--a team approach for a cause we all believe in.

To address some of your examples, I would make it clear to parents in the consents for treatment that they sign, that some of the treatments are unproven (and give examples, as you did in your post, of things that have research behind them vs. things that don't). This kind of consent acknowledges that even when there isn't solid research, you must still treat. As it stands now, our consent reads (rough paraphrase): the practice of medicine is an art and no guarantees can be made. That does not convey as clear a message as what you have stated.

Last, I think that you should be ready to take some heat about this. I think that there are legitimate criticisms that have been posted about the practice of neonatology on your blog. I understand that this may make you feel unappreciated. I sense that you are dedicated and believe strongly in doing no harm. But you are in a "messy" specialty. And the criticisms have been constructive, as I see it. The dialog that has resulted has been fruitful in opening up all our minds, or at least I hope that is so.

If mine is one of the posts that you regard as "snide," I am sorry.
I don't perceive myself that way, but I will accept criticism, just as I hope you will. If it makes any difference, I am involved in research in my NICU . . . and I feel the frustration. I volunteer my time, which is part of the frustration.
Chris and Vic (CAK)

3:15 PM  
Blogger neonataldoc said...

Hi all: I decided I must have been pretty crabby when I originally wrote this post, so I modified it now to sound less strident. Thanks for the support.

ND

3:57 PM  
Anonymous Zelda said...

ND - can I come work for you please? I'm a epidemiologist with a chronic intrest in ethics... I'll provide stimulating discussion, interesting pov and generally be useful! (I run a mean journal search as well!).
I guess this is me say I really love what you are writing at the moment, and its really making me think, so Thank you.

8:49 AM  
Blogger The Preemie Experiment said...

Dear ND,

This is a little OT...

There is a group on line (over 4,000 members) of preemie parents of children that are mostly younger than school age. I would encourage all who work in the NICU to join...

http://groups.yahoo.com/group/preemie-list/

I have already cleared this with the list owner.

There are many parents on the list that are at different places of their journey. Some have kids still in the NICU, some have just brought their little ones home and others, who have older preemies, stay on the list for support.

I'm not posting this to benefit my "cause". Most likely it will do the opposite (only becuase the children on the list are so young-most of us don't experience the full effect of prematurity until school age), but I think it would be helpful to all.

9:30 AM  
Blogger Ex Utero said...

Totally agree about the voting thing. We have a right to life president who won't put his money where his mouth is. If we're going to save them, we've got to pay for them and for the research to make things better.

5:18 PM  
Anonymous Malaika said...

Hey,
I am a secret reader of your blog, and I always enjoy your insight. If ever you have time, I would love to hear your thoughts on the Canadian sextuplets.

It's like my interview question to get into med school, but six times more so - and I'd love to hear a real neonatal doc's opinion on the situation :)

But as always, your posts are fascinating (and inspiring to a wannabe neonatal doc like me)! Please keep it up!

2:14 PM  
Blogger neonataldoc said...

Thanks for the comments.

Anonymous 1:59 p.m., I actually don't think that all lawyers are bad. I suspect a group of lawyers is like a group of doctors; there are good ones and bad ones. I think we should work together on common concerns. But I still think that a lot of judges dropped the ball on the implant issue.

Malaika, thanks for the compliment. Someday I probably will post on the sextuplets.

Zelda, you're welcome to come work for me - as long as you don't mind working for free!

7:35 PM  
Anonymous Anonymous said...

Unfortunately the war costs money and it has to come from somewhere...

9:04 PM  
Anonymous J.net said...

ND, you asked what we are doing to be part of the solution rather than the problem.
Well, some of us are posting blogs trying to get the word out.
Some of us have taken armloads of studies to special education departments in our school systems in an attempt to prove that many premature children do have LDs and they don't necessarily catch up before school age.
Some write letters to local newspapers explaining the realities of raising children with disabilities. Some of us do write our congressmen and legislators.
Some of us get up on trembling legs and give speeches to groups who make the rules and deliver the funds. I gave such a speech to a state organization when my twins were in early intervention. Certain therapies had just been temporarily discontinued, because the program was in proration.
Some of us, myself included, allowed a reporter to interview us and take photos -- for a newspaper article that described the challenges of raising preemies with disabilities. It isn't easy to place your family in newsprint.

As for outcome studies, our twins went to follow-up clinic once - at 6 months and were never invited back. At the time, neither was diagnosed with cerebral palsy, but one had what they called hypertonia in all four limbs, and the other had hypertonia in one leg, and they couldn't tell us if either would walk or not. One did. One didn't.

I have just researched the Baby Doe law, and that has given me at least an understanding of why the medical staff seemed so callous. I still cannot understand, though, why it is illegal to allow a very early preemie who is born in very bad shape (in our case, no respiration, no heartbeat) to die naturally instead of forcing aggressive and lengthy resuscitation. Yet, it is legal to kill a baby the same gestational age just prior to birth through partial-birth abortion.
In my view, neither scenario is ethical.
There should be more flexibility in the "Baby Doe" law. When my full-term brother was born with a significant disability way back before Baby Doe, my parents opted against what was termed life-saving surgery based on the quality-of-life issue. They discussed the surgery with his doctors and prayed for God's guidance. They further consulted a minister and eventually decided against the surgery. Doctors predicted he would not live a year without it. But with it, he had a great chance of severe neurological impairment.
Guess what? He lived 40 years, and while he could not live independently, his worst neurological problem was LDs, and he attended regular school through ninth grade. Until his mid-20s, he lived a generally happy, healthy life.
Yet I shudder to think that today, my parents would not have had the option to seek guidance from above and participate in medical decisions regarding his treatment.
With the surgery, his life likely would have been miserable and knowing what we know now about that kind of surgery, much shorter.

5:06 PM  
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1:45 AM  

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