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Jerome Groopman’s article in Wall Street Journal: “Why ‘Quality’ Care is Dangerous”. Is he right – or wrong? Or both?

2009-04-09 14:41:51
By: Dr. Richard Hellman

On April 8^th, the Wall Street Journal published an op-ed article by Jerome Groopman and Pamela Hartzband. The article was sharply critical of a reported effort of Medicare to tie pay-for-performance incentives to quality metrics that they have designed. He points out that the state of Massachusetts is also using “quality metrics” and has developed an elaborate and punitive system to force doctors and hospitals to conform to their standards.

In the article he gives several examples where recent published data are providing evidence that the metrics used by Massachusetts may be wrong. Two of the examples he uses are the NICE-SUGAR trial, reported this March in the NEJM, and the ACCORD trial, published in the NEJM in June 2008.

While Groopman and Hartzband are right regarding the ill-conceived plan of both Medicare and Massachusetts to institute pay-for-performance initiatives that in both cases run beyond the clinical evidence, they are wrong in their interpretation of the two trials they used as evidence for their position. In both of the trials, the poorer than expected outcomes may have been due to factors not anticipated by the study investigators, unmeasured events that altered clinical outcomes. In the case of the ACCORD trial, a trial that ran counter to the results of both the ADVANCE trial and the VADT trial, there is evidence that undiagnosed hypoglycemia may have been more frequent than they had observed. There is also suspicion, based on the comments of the investigators, that the complexity and rigidity of the protocol may have been very difficult for many of their patients and may have resulted in patient errors and deviation from their plan.

In the case of the NICE-SUGAR trial, the deviations from the protocol were significant, as we have previously reviewed, and the lack of data regarding post-randomization events makes the final results less likely to be widely applicable.

While Groopman is right that it is unreasonable to do “corrective” counseling for a doctor whose patient has glucose levels that are higher than the original targets suggested by Van Den Berghe in the Surgical ICU study in 2001, he is wrong that the two studies discredit the notion that intensive control of glycemia does not have merit. It does, in an appropriate setting, with appropriate systemic support, and as long as control of glycemia is not resulting in unacceptable levels of hypoglycemia.

However, I think Groopman and Hartzband are more right than wrong, for the great danger of the quality movement in medicine is that the process is at risk of being politicized, and politics is running ahead of the evidence, focusing on what we would like to accomplish, instead of what we can do that is scientifically grounded. His discussion of the current misapplication of quality metrics in the state of Massachusetts is probably one of the best examples of politicians run amok – choosing to punish or reward doctors based on flimsy scientific basis.

On the one hand, the work of Carolyn Clancy, the administrator of the Agency for Health Care Research and Quality (AHRQ), is a model of how the scientific method can be applied to quality improvement in a positive way. The AHRQ website has evidence of comparative effectiveness research that is backed by evidence. For example, the current data showing the pluses and minuses of various fixed combination insulin preparations are presented together with the appropriate supporting citations. In an editorial that she wrote for the public, she stated, “In health care, one size does not fit all, and treatments that are good for one patient aren’t necessarily good, or even safe, for you”. Her comments are a far cry from others’ attempts to use claims-based data, without any risk stratification adjustment, to make judgments on the quality of care.

Mark Chassin, the President of the Joint Commission, in a recent statement and pod-cast which can be found on the AHRQ M&M website, made the point that claims data-bases do not produce as highly valid quality measures as most of the clinically based core measures. He also does not believe that information technology is the solution to all our quality and safety issues. He stated, “Computers do not make us less stupid, they make us stupid faster”. His point is that a poorly designed IT solution, for example a Computer Physician Order Entry system, can do a great deal of harm. I think he is keenly aware of the dangers of assuming that technology alone can improve the processes of care that are so broken in many of our health centers.

I think there is more than enough data to tell us that quality of health care and patient safety issues are a world-wide problem in both inpatient and outpatient settings. The settings are different, the focus and resources may be very different, but we see commonality wherever health care is being provided.

To improve the quality of care beyond where we are at present, we need to be both more humble and more scientifically grounded. We may want to improve one hundred different clinical processes of care, but if we have data to clearly indicate the best approach in only ten processes, then we should focus on the ten processes we know have the evidence to support what we intend to do.

We cannot sacrifice scientific rigor because the public demands we do something, even if it is wrong. If we know that co-morbid or demographic factors play a significant role in a measurable outcome, then when we measure the outcome, we need to use the co-morbid or demographic data so we can fairly assign responsibility to those who are involved in the care. To reward or punish health care providers for things for which they cannot control will only cause cynicism and resistance, and, ultimately, a public outcry and failure of the effort to improve quality.

The middle ground is probably to encourage ongoing scrutiny of important clinical data for quality improvement, and to link reporting of clinical data to quality improvement efforts. If we just focus on reporting, we are missing the whole point of what we are trying to do, to improve quality of care and safety as measured by clinically important outcomes. It is not easy to change processes of care, to create systems that capture errors before they injure patients. It is even harder to develop the discipline to check your own work, to admit that you may be at times prone to diagnostic errors, and to work with systems that will make the possibility of patient injury remote.

The clinical community needs to embrace quality improvement, not just by words, but by deeds. But it is much harder to force change by using a carrot and stick approach, and the pay-for-performance efforts at present, are, for the most part, not scientifically sound. We need to redouble our efforts to be sure that the health policy community and those in Washington understand why we need to make scientific validity a central part of our efforts to improve safety and quality of care.

Leave a Comment

There are 7 comments

Prasanna Rao-Balakrishna – UK

July 14, 2009 - 17:23

Subject: Preventing Hypoglycaemia is as important as the tight glycaemic control

Preventing hypoglycaemia is as important as the tight glycaemic control. It is important to note that glycaemic control depends on the insulin regimen, patient's own counter regulatory hormone response & insulin resistance status, the calorie intake, frequency of testing for blood glucose, interpretation and acting on the results. During acute illness it is not possible to control the counter-regulatory hormone response and the insulin resistance status, but with adequate training, frequent testing and appropriate structured response should be possible, thereby preventing a hypoglycaemia. A trial which focuses as much on hypoglycaemia avoidance as well as tight glycaemic control is needed.

Reply to Prasanna Rao-Balakrishna

Richard Hellman MD

July 16, 2009 - 11:25

Subject: RE: Preventing Hypoglycaemia is as important as the tight glycaemic control

Dr Rao-Balakrishna makes a very interesting suggestion, that preventing hypoglycemia is as important as the tight glycemic control, and suggests a trial that focuses on two end-points, the avoidance of hypoglycemia as a co-equal goal in importance to tight glycemic control.

In fact, there is a great deal we do not know about hypoglycemia in critically ill states, and it is far from clear what the short and long term consequences are of mild, moderate, or even brief periods of severe ypoglycemia for critically ill patients. We do know that severe hypoglycemia can be a marker for increased mortality, as it was clearly shown in the VADT trial, but interestingly, those deaths did not usually occur during the hypoglycemic episodes, and the relationship between severe hypoglycemia and subsequent mortality was strongest in the conventional therapy group, suggesting that the hypoglycemic events may have been a consequence of an underlying vulnerability rather than the cause of mortality.

One of the limitations of an approach focused just on the outcomes of glycemia is that from the patients' standpoint, the most important issues are their clinical outcomes: mortality, morbidity, and disability. In contrast, those outcomes may not match the relative frequency of hypoglycemia at all. For example, there is a disconnect between the very high frequency of hypoglycemia in the Van Den Berghe RCT's in critical care published in 2001, 2006, and 2009. Both the surgical ICU study of 2001 and the 2009 pediatric studies showed very excellent outcomes with respect to mortaliy and morbidity in the presence of relatively frequent hypoglycemia.

I again would like to thank Dr Rao-Blakrishna for pointing us again to this very unsettled issue of the importance of hypoglycemia prevention, for the debate as to what we can and should do rages on. There are many creative ideas that have been proposed, but we need more data to guide us as to how to obtain the best clinical outcomes with the tools we have without either unacceptably high levels of hypoglycemia or hyperglycemia.

Richard Hellman MD
Editor-In-Chief
Patient Safety Exchange Website

MRR – Texas

March 31, 2009 - 16:29

Subject: NICE_SUGAR

Several interesting points came to mind when I reviewed the NICE-SUGAR study; the degree of severe hypoglycemia, the degree of cardiovascular mortality, the conventional group’s blood glucose levels are significantly lower than the vast majority of other outcome studies, and the number of severe septic patients in the intensive control branch of the study. According to the 2008 sepsis guidelines, the glycemic control target level for the septic patient is already in question and perhaps sepsis should be an exclusion criteria?

I was tasked with the development and oversight of a Tight Glycemic Control Program pilot study from May 2006 through April 2008 for a South Texas community hospital/level 2 trauma center. This included a 14 bed CCU, 12 bed M/S ICU and 12 bed trauma ICU as well as 4 M/S wards. Clinical inertia was our most difficult element to overcome and for the most part this was never accomplished. Clinical inertia was not only evident on physician's part, but also administration, nursing, nutritional services, pharmacy, and the patients themselves. Accountability to noncompliance to protocols was lacking as well. The philosophy that inpatient glycemic control was not necessarily treating diabetes, yet acute hyperglycemia was never fully accepted. When results like ACCORD, ADVANCE, and VADT were released, I would usually take the phone off the hook and leave the hospital because those wbeepdo not support inpatient glycemic control would come out en mass wishing to compare apples to oranges. That is not necessarily the case with NICE-SUGAR. In our Trauma ICU, where support was highest, for the entire year of 2007, we had only 7% BG > 200mg/dL, less than 2% hypoglycemia under 50 mg/dL, and nearly 75% BG between 80 - 150 mg/dL.

Overall, I applaud the NICE-SUGAR research team for a job very well done and thank them for their contribution to this ongoing discussion. I do support further research to differentiate specific glycemic control target ranges for specific diagnosis, but I too fear this could cause a pendulum swing in the opposite direction resulting in less facilities participating in inpatient glycemic control resulting in less data for differentiation.

NISSIM GABAY – VENEZUELA

March 26, 2009 - 15:25

Subject: NICE -SUGAR

I think that the central goal of the ADA/AACE impatient glucose targets is safe with the protocols .
Hospitals should have protocols in place for using insulin to treat and prevent hyperglycemia.
Subcutaneous insulin may be used for both purposes in most noncritically ill patients, whereas intravenous infusion of
insulin is preferred in critically ill patients.
Be careful with this trial [NICE -SUGAR] to overcome clinical inertia.

Dr. Orlin Sergev – Charleston, SC

March 16, 2009 - 16:28

Subject:

Dear Dr Hellman:
I enjoyed all the editorials on patients' safety that you have recently published. I think that they raise questions which we as physicians are not always open about. Safety itself is frequently a topic that we love to discuss but it's never our fault. In this connection, the article about overconfidence and medical errors is timely - especially, at this time of expected health care changes. Briefly, I do not think we as physicians are different from any other specialists in different areas. Lack of adequate knowledge in a special area is always a good reason to be noisy and seemingly overconfident. Most of us agree that the more you know the more you realize how much more you do not know. Overconfident behavior in front of outsiders seem to be the cover of ignorance. I think we have to improve medical education in order to make medical decisions safer. Just remember the pilot of the plane that landed in Hudson river - quiet professional on top of his performance. We in medical profession must lead in patients' safety. In order to do that we have to lead the health care reform. We have to regain our authority, responsibility and accountability. (accountability without authority and responsibility is meaningless - see Dr Hellman's article on Medicare). We have to lead the health education of the society - most of the tragic mistakes in life happen from ignorance. First and foremost, of course, we have to maintain the superiority in medical knowledge. We must improve the quality of medical education. Instead of multiple choice questions we have to put back in place the stern professor wbeepmade clinical judgements based on knowledge, experience, and gut feeling and set up a good personal example for the next generation of physicians. Pilot "Sully" did not read the manual and the guidelines how to handle the critical situation - all his life before, however, prepared him for the right on the spot decision. Decisions based on profound knowledge and experience are the safest! Let's start the health care reform with ourselves.
Do not stop learning and teaching your team about sound and safe medical practices. When we have achieved that, we can confidently go out and regain our authority over various bureaucracies (government agencies-Medicare, insurances, medical malpractice law, etc).

james t poulos – west lafayette in

March 03, 2009 - 15:09

Subject: NICE-SUGAR

There was an article in acta scandinavia in january that showed very little hypoglycemia when intensive therapy is done right! I came across the article on medlinx in mid January, but it was actually published in October 2008. authors: Kaukonen KM et al in acta anaethesiol scandinavia and titled severe hypoglycemia in intensive insulin therapy.

Reply to james t poulos

Dr Hellman

March 04, 2009 - 16:12

Subject: Further thoughts related to the NICE-SUGAR study

Dear Dr. Poulos,

Thank you for calling attention to the study by Kaukonen KM et al. Your excellent point adds to the discussion generated by the NICE-SUGAR study. Their preliminary data analysis showed that error by provider was the most common cause of hypoglycemia. Their data implied, as I stated in my recent editorial, that improving the training and performance of those managing the insulin infusions greatly decreases the threat of hypoglycemia.

In this study by Kaukonen, done at the Helsinki University Central Hospital in Helsinki, Finland, the authors evaluated the incidence of hypoglycemia in all patients treated in two intensive care units between February 2005 and June 2006. They showed that severe hypoglycemia during intensive insulin therapy was rare in clinical practice. Analyzing data for 1124 patients and 61,203 glucose measurements, they found 36 measurements of severe (≤ 2.2mmol/L) hypoglycemia in 25 patients, with an incidence of 0.06% of severe hypoglycemia.

They commented that the frequency of blood glucose monitoring correlated inversely with the frequency and magnitude of severe hypoglycemia. In surgical patients, it is of note that five of the six instances of hypoglycemia occurred when a nurse failed to comply with the protocol.

The Helsinki group’s observations are entirely in keeping with the preliminary data from the NICE-SUGAR study and make a good deal of common sense. When the rate of decrease of glucose is rapid, for example greater than 1mg/dl/minute, simple arithmetic can tell us when the next glucose determination needs to occur to be able to safely avoid severe hypoglycemia. But if the frequency of checking of glycemic levels is arbitrary, and set too low, then hypoglycemia is to be expected much more often. The Kaukonen group avoided this by making sure the blood glucose sampling was relatively frequent.

In our clinical practice setting as well, the principles of safe handling of insulin infusions have been:

1.frequent monitoring, always at least hourly in ICU settings, more often when dealing with lower glycemic levels;
2.intensive training of nurses to make them expert in understanding how best to use algorithms;
3.specific points at which prolonged hyperglycemia or hypoglycemia necessitates immediate consultation with the responsible physician;
4.review of data to indicate variations in performance and appropriate correction and retraining when appropriate.

We too have extensive experience over many years with the safe use of insulin infusions in inpatient settings with relatively rare severe hypoglycemic episodes and little morbidity.

The NICE-SUGAR study should provide important information. We should not get too far ahead of their forthcoming data, but there is already abundant data, such as the important study from Helsinki, which show us that with a safer system of care, more ambitious glycemic control is both achievable and safe.

Kaukonen KM et al. Severe hypoglycemia during intensive insulin therapy, Acta Anaesthesiol Scand. 2009 Jan;53(1):61-65. Epub 2008 Oct 20.