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Legal Report: Benefits and Risks of Using Guidelines


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Legal Report: Benefits and Risks of Using Guidelines

By Tom A. Augello, CRICO

Related to: Clinical Guidelines, Diagnosis, Primary Care, Obstetrics, Other Specialties

One physician expert argues that wider use of clinical guidelines will improve patient safety, while a seasoned defense attorney offers some cautions.

Guest Commentators

  • Mark Graber, MD, FACP; VA Medical Center; Northport, NY
  • Ellen Epstein Cohen, Esq.; Adler, Cohen, Harvey, Wakeman & Guekguezian; Boston, MA


 At the patient safety conference in the Harvard system in June 2009, the audience of clinicians and other patient safety leaders saw something very unusual. They got to see a health care expert present an argument for a patient safety intervention—and then they got to see a top Boston malpractice defense attorney pick it apart. They saw the benefits, and then they heard the risks…in real time…from people with specialized knowledge about benefits and risks. In the end, the attorney did not say ‘don't do it.' Just be aware of the liability pitfalls—and prepare for them.

Dr. Mark Graber is an Internist and Nephrologist and chief of the Medical Service at the VA Medical Center in Northport, NY. Dr. Graber has a national profile in patient safety, and a focus of his research is understanding and reducing diagnostic errors in medicine. He argued that the literature is rife with experiments showing variability among clinicians diagnosing the exact same clinical scenarios, such as radiologists interpreting films or physicians interpreting symptoms that could be two different diseases.

"This variability in clinical performance is really a critical factor that detracts from quality and safety, and the question is is there anything we can do about this? So I think there is, and I would like to tell you about it and it's pretty simple."

His solution? Wider and more consistent use of clinical guidelines and algorithms. Dr. Graber maintained that many clinical studies have shown that rules based on actuarial judgment usually work better than individual clinical judgment.

"It's something that's based on rules. You can mathematically come up with these things, and they have enormous potential to improve quality, and the central paradigm in this field is that the model of the judge outperforms the judge himself, predictably so, and that that's what we should do if we want to have the best possible outcomes. Actuarial judgment is really the norm throughout industry. That's how people decide whether we should get our health insurance policy, what we should pay for it, whether we should get a loan, whether somebody should be paroled. It's been applied to that kind of thing. Who's the best teacher? Who should we admit to graduate school? It's really achieved unanimous acceptance mostly outside of medicine, I'm sad to say…

So, why don't we use these more? Are there any in medicine? Well, there certainly are. There's the Goldman chest pain rule derived right here in Boston. And Goldman was troubled by the question of people coming to the emergency room with chest pain. Should you go to the ICU or can you go home? How do you know the best thing to do? Should we rely on the clinician's judgment. And Goldman studied 10,000 cases in his validation, his derivation set, and he looked to see who had complications in the next day or two. And based on all the data and there were 40-50 different parameters that they examined, he came up with a rule with only four that predicted with substantial accuracy how well somebody was going to do. The four things were on your EKG, are you having an MI or are there signs of ischemia? Is your blood pressure less than 110? Do you have rales in your lung? Do you have a past history of MI? That's it, four parameters, and on the basis of those, he could divide people very effectively. People in the lowest risk group had complications 0.2% of the time in the next couple of days as opposed to people in the highest quartile who had problems 25% of the time.

And this was just not a theoretical study. It was tested very effectively at Cook County, but the people at Cook County looked at case scenarios to see how well the Goldman rule would do and they also looked at real patients. So they actually did a pre and post type of study looking at this and the rule worked extremely well. The rate of missing somebody who had a complicated MI dropped from 11% to 6%, big, big drop. And the number of people who were inappropriately admitted to an ICU who really didn't have to be at that level of care was reduced from 38 to 27%.

So these rules work. They work outside of medicine. They work inside of medicine. They work in theory and they work in practice. And I'd like to propose that if we could only use these rules, we'd have more quality and more safety in medicine today."

But Dr. Graber was followed by Boston malpractice defense attorney Ellen Epstein Cohen, of Adler, Cohen, Harvey, Wakeman & Guekguezian. Attorney Cohen has successfully defended numerous malpractice cases on behalf of the top physicians and hospitals in Boston. She was invited to offer a counter argument to the wider use of evidence-based rules in clinical medicine. But Cohen was clear that she supports the appropriate use of clinical guidelines and algorithms if properly implemented.

"I've been asked to give you the counterpoints, so please don't think that by doing that that I don't support the proposition of doing it. I just want to give you the flip side to think about. So I started out by going to the CRICO RMF website and looking up the guidelines and algorithms section, which I highly recommend to all of you if you're not familiar with it. There are, I believe, seven truly excellent pieces of a lot of hard work that culminates in these guidelines and algorithms.

But I'm the lawyer and I'm looking at it to try and figure out not best practice. That's what these are geared towards, helping you achieve best practice in a most consistent actuarial way. So I looked at it and this is what it says on the website, ‘We encourage physicians and nurses to use these as critical checks and rechecks to provide the safest, most effective patient care possible. As with all clinical decisions, documentation of adherence to a specific guideline or the rationale for alternate course of action is crucial for ongoing care and for the defense of any subsequent challenge of a patient's diagnosis or treatment.' Let me translate, challenge equals plaintiffs' lawyer, okay?

Then it says this, which is very important, ‘CRICO RMF is frequently asked if a guideline algorithm or similar decision support tool can be cited in a medical malpractice lawsuit as the standard of care. The answer is no. The standard of care is determined in a court. It is the consensus among experts of the typical practice of an average clinician in the local setting. These guidelines and algorithms are not mandatory but rather advisory.'

I agree with all that. That is a true and accurate legal statement. If I were on the other side of the fence, however, if I were the plaintiff's lawyer, I would argue about a doctor who says, ‘Well I was following the algorithm. It's a database, scientifically proven, you know, way to approach this problem. It just didn't work with this patient, but I was following the algorithm.' What you have to remember is that in any lawsuit, the standard of care is the burden of the plaintiff's lawyer, and by that I mean the patient suing some doctor or health care provider. It's their burden to prove to you what's the standard of care, to prove to the jury, and then to prove that this physician under these circumstances didn't meet that standard of care.

And what following a guideline can do from a legal perspective if you want the counterpoint is it can effectively shift that burden of proof. What I mean by that is it can make the defendant, the health care provider, the person who has to actually argue the rationale and reasonable of those actions, why this either was the standard of care and it was proper to follow even though the outcome may not have been ideal, or why in this patient in these circumstances the algorithm or guideline did not apply.

So number one, I would say if you're going to follow an algorithm or a guideline in providing care for a common patient presentation situation, make sure you understand it, you review it carefully, and you document why you did or didn't follow a certain protocol.

Then we heard about actuarial judgment, and that's what an algorithm basically does. It says we know that this is scientifically proven to give a better statistical result, and what I can tell you from the counterpoint is that when we take a case to trial, 100% of the people on the jury who are the ones evaluating the quality of the medical care are all patients. Every single one of them. And their mothers, fathers, husbands and wives and children and brothers and sisters are all patients. None of them are doctors. Most of the ones who come from a family of doctors and nurses and health care providers get kicked off the jury. So you are being evaluated by a jury of patients, and when we talk about actuarial judgment, most patients are not willing to accept the argument that ‘Well, it was 90%, you know, that's really high, I mean that's a really good reason that I as the doctor, you know, followed this particular approach to this problem.' They don't want to accept that they are in that 10% or even in that 2%. So while actuarial judgment or using the statistical evidence-based medicine that you use is a really good and important reason for following a certain course of workup and treatment, it's not necessarily a good way for us to approach juries.

So what I would say is from a best practices standpoint, I stand fully and completely behind algorithms, guidelines and following that methodology. So as long as it is accurate and as long as it's consistently followed, it can be a tremendous tool."

January 1, 2009
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