OP-ED

Could It Be That Patients Aren’t Any Safer?

On the occasion of last year’s tenth anniversary of the IOM Report on medical mistakes, I was asked one question far more than any other: after all this effort, are patients any safer today than they were a decade ago?

Basing my answer more on gestalt than hard data, I gave our patient safety efforts a grade of B-, up a smidge from C+ five years earlier. Some commentators found that far too generous, blasting the safety field for the absence of measurable progress, their arguments bolstered by “data” demonstrating static or even increasing numbers of adverse events. I largely swatted that one away, noting that metrics such as self-reported incidents or patient safety indicators drawn from billing data were deeply flawed. Just look at all the new safety-oriented activity in the average U.S. hospital, I asked. How could we not be making patients safer?

I may have been overly charitable. This week, in an echo of the Harvard Medical Practice Study (the source of the 44,000-98,000 deaths/year from medical mistakes estimate, which launched the safety movement), a different group of Harvard investigators, led by pediatric hospitalist and work-hours guru Chris Landrigan, published a depressing study in the New England Journal of Medicine. The study used the Institute for Healthcare Improvement’s Global Trigger Tool, which looks for signals that an error or adverse event may have occurred, such as the use of an antidote for an overdose of narcotics or blood thinners. Following each trigger, a detailed chart review is performed to confirm the presence of an error, and to assess the degree of patient harm and the level of preventability. While the tool isn’t perfect, prior studies (such as this and this) have shown that it is a reasonably accurate way to search for errors and harm – better than voluntary reports by providers, malpractice cases, or methods that rely on administrative data.

Using this method in a stratified random sample of ten North Carolina hospitals, the authors found no evidence of improved safety over a five-year period, from 2002-2007.

Before taking out the defibrillator paddles and placing them on our collective temples, it’s worth considering the possibility that the findings are wrong. We know that the Trigger Tool misses certain types of errors (such as diagnostic or handoff glitches; it’s worth looking at this recent paper by Kaveh Shojania, which emphasizes the importance of using multiple methods to get a complete picture of an organization’s safety), and perhaps the study overlooked major improvements in these blind spot areas. That said, the tool does capture a sizable swath of safety activities – and the lack of improvement in those areas is still disappointing.

I guess it’s also possible that these ten North Carolina hospitals are unrepresentative laggards. But North Carolina has been relatively proactive in the safety world, and these hospitals volunteered to participate in the study, an indication that they were proud of their safety efforts. While I would have liked a bit more information about the state of the safety enterprise at each hospital (did they have computerized order entry during the period in question, for example), I think the findings are generalizable.

Another slight caveat surrounds measurement and ascertainment bias. Because safety is far harder to measure than quality (the latter can be captured with measures like door-to-balloon time and aspirin administration after MI – and, as Joint Commision CEO Mark Chassin notes in Denise Grady’s article in today’s NY Times that reviewed the Landrigan piece, these types of publicly reported quality measures have been improving briskly), there is always the risk that things will look worse when people begin looking for harms more closely… which, of course, they must do to make progress. This is the fatal flaw when we think about using provider-supplied incident reports to measure safety. While the Trigger Tool is more resistant to this concern, it is not completely immune. For example, the hospital that is more attuned to preventing decubitus ulcers will undoubtedly examine patients more carefully during their hospitalization for signs of early bedsores. The Trigger Tool might mistakenly read these “extra cases” as evidence of declining safety. The same holds for falls: our new attention to fall prevention may cause us to chronicle patient falls more carefully in the chart. But such issues only raise concerns for the minority of the triggers; I can’t see how measuring administration of antidotes for oversedation and overanticoagulation, or 30-day readmission or return-to-OR rates, should be biased by a hospital’s greater focus on safety.

So, despite my best efforts at nitpicking, I’m left largely believing the results of the Landrigan study. Lots of good people and institutions have spent countless hours and dollars trying to improve safety. Why isn’t it working better?

I think the study tells us something we’ve already figured out: that improving safety is damn hard. Sure, we can ask patients their names before an invasive procedure, or require a time out before surgery. But we’re coming to understand that to make a real, enduring difference in safety, we have to transform the culture of our healthcare world – to get providers to develop new ways of talking to each other and new instincts when they spot errors and unsafe conditions. They, and healthcare leaders, need to instinctively think “system” when they see an adverse event, and embrace openness over secrecy, even when that’s hard to do. Organizations need to learn the right mix of sharing stories and sharing data. They need to embrace evidence-based improvement practices, while being skeptical of ones that seem like good ideas but haven’t been fully tested. And policymakers and payers need to create an environment that promotes all of this work – policies that don’t tolerate the status quo but steer clear of overly burdensome regulations that strangle innovation and enthusiasm.

In other words, the fact that we haven’t sorted all this out only seven years after the launch of the Good Ship Safety shouldn’t be too surprising. And my sense – although I can’t prove it – is that things are starting to improve more rapidly. Remember that the observation period in the North Carolina study ended in 2007. The first several years of the safety field involved skill building and paradigm changing. Some of the big advances in safety – the embrace of checklists, more widespread implementation of less clunky IT systems, mandatory reporting of certain errors to states, widespread use of root cause analysis to investigate errors – all began in the 2005-2008 period (and some, like IT, are really only cresting now). It will be crucial to follow up this study over time to see if there are signs of progress. I suspect the results will be more heartening.

What now? As I’ve noted many times before, I worry that a harmful orthodoxy has crept into the safety field. We need to figure out ways to ensure that we do the things that we know work, like checklists to prevent central line infections and surgical errors, fall reduction programs, and teamwork training. We need to develop new models for those areas that haven’t worked as well as we’d hoped, like widespread incident reporting and CPOE. We must do the courageous and nuanced work of blending our “no blame” model with accountability when caregivers don’t clean their hands or perform a pre-op time out. And we must allocate the resources, at the institutional and federal level, to do these things and study them to be sure they’re working.

The study by Landrigan and colleagues is a wake-up call. Let’s figure out what’s working, and do more of it. Let’s figure out what’s not working, and do something different. And let’s not stop until we can prove that we have made our patients safer.

Happy Thanksgiving to you and yours.

Robert Wachter, MD, is widely regarded as a leading figure in the modern patient safety movement. Together with Dr. Lee Goldman, he coined the term “hospitalist” in an influential 1996 essay in The New England Journal of Medicine. His most recent book, Understanding Patient Safety, (McGraw-Hill, 2008) examines the factors that have contributed to what is often described as “an epidemic” facing American hospitals. His posts appear semi-regularly on THCB and on his own blog, Wachter’s World.

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DavidAlisonKerry OConnellMD as HELLmaggiemahar Recent comment authors
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David
Guest

Even i did go through the IOM Report and that was a set back for me as well. Everything has become a source of malpractice and hospitals are not far away.
i would like to suggest to every reader regarding the website Findrxonlin, a sheer assistance for every patient as it has been for me.
Regards,
David.

Alison
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Alison

So where do we go for an objective view of all this?

MD as HELL
Guest
MD as HELL

You can’t sell “reform” until you bash the system you which to “reform”. It has to be a very bad system. It has to need to be reformed and people have to be clamoring for any reform that promises to deliver. Never mind that the system really is not that broken and the promises made are pie in the sky. You can sell anything. Look at pet rocks, mood rings and bottled water. Don’t for get the Ford Pinto and the Chevy Vega and the Chevette. Why not EHR and why not the notion that we are not broke and… Read more »

Kerry OConnell
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Kerry OConnell

Hello Bob It sounds like you have changed your outlook a bit since we spoke in Keystone. The dearth of studies this year showing no safety improvement is certainly not a surprise to patients who have been harmed, nor do I believe it is a revelation to our physician community who witness the harm every day. A better question might be why we would expect patients to be any safer when physicians and nurses still work utterly insane hours. After 10 years we still cannot agree on the really simple things like the color and type of connectors IV tubes… Read more »

Gary Lampman
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Gary Lampman

Good points by both of you. Lets find out what is being implemented and find out what works or what doesn’t. This is where transparency can deliver the best results. The JCAHO or The Joint Commission is a tremendous waste of manpower if it draws precious resources from Patient Safety. AS a outsider,I find them as part of the problem and a joke to deal with on most platforms. I do understand that these institutions are not only state wide but in many cases own Hospitals in several States. Which means that it would not be difficult to kill a… Read more »

Margalit Gur-Arie
Guest

Maggie,
I understand all that, but don’t you think it would be helpful and instructive to know what safety measures those hospitals had implemented over the years, so we can assess their effectiveness or lack thereof?
Somehow just reporting that the level of errors has not decreased without reporting on what changed, if anything, seems ambiguous.
Should one conclude that hospitals are not implementing safety measures? Or should one conclude that (some) safety measures are ineffective?
An evaluation of the studied hospitals safety procedures and protocols could add a lot of value to the results here.

MD as HELL
Guest
MD as HELL

The patient is not safe because the nurse has been neutralized by policy and by the computer she massages. Bedside care is in the hands of non-nurses. These people are not the keenly observant trained patient care specialists that nurses used to be. Unfortunately neither are new nurses the highly trained care givers that old nurses are (were).
Nurses now bring policy to the bedside and leave the expertise in the past, since they are no longer allowed to use it.
The sooner the JCAHO is scrapped the sooner will patients be safer.

Gary Lampman
Guest
Gary Lampman

Almost everyone agrees that Medical Errors and Hospital Acquired infections are debilitating and Deadly for the Patient. Most Health Professionals agree that it is Bad for their Reputation and the Public’s perception as well. Lending to lies and cover ups that are supported by Medical Boards and State Investigators. Can we agree that something has to actively change to put a end to errors and infections? So how can we stop the eroding trust that Americans have in Medical Professionals and Hospitals? Public Transparency of infectious Rates and Medical errors would go a long way toward comparing Hospitals. The public… Read more »

Gary Lampman
Guest
Gary Lampman

Almost everyone agrees that Medical Errors and Hospital Acquired infections are debilitating and Deadly for the Patient. Most Health Professionals agree that it is Bad for their Reputation and the Public’s perception as well. Lending to lies and cover ups that are supported by Medical Boards and State Investigators. Can we agree that something has to actively change to put a end to errors and infections? So how can we stop the eroding trust that Americans have in Medical Professionals and Hospitals? Public Transparency of infectious Rates and Medical errors would go a long way toward comparing Hospitals. The public… Read more »

maggiemahar
Guest

Margalit– Checklists and hand-washing are not enough to ensure patient safety. A surgeon should not be serving as the patient’s translator during surgery–he/she has other things to focus on. Someone who is not part of the surgical team should serve in that role. (And it should not be hard to provide a Spanish-speaking translator). The hospital should have a rule that the surgeon always must mark the site himself. (If a nurse or someone else is asked to do this, they should be told to speak up: “I’m sorry, but the surgeon is supposed to do this–it’s part of the… Read more »

Tina Harris, MD
Guest
Tina Harris, MD

“Let’s figure out what’s not working, and do something different. And let’s not stop until we can prove that we have made our patients safer.” Let us be clear. CPOE and EMRs have NOT been working to improve safety. The report authors failed miserably by not reporting the penetrance of EMR and CPOE in their “White Paper”, and you Bob, ignore that matter. Prove what works has never been applied to CPOE and EMRs, albeit the latter is less malignant than the former. The safety breaches and adverse events occurring when care is directed by CPOE and EMR must be… Read more »

Margalit Gur-Arie
Guest

I didn’t see any information about the hospitals participating in the study. I think it would be interesting to know what safety measures, if any, they are already implementing. If they all use checklists and wash their hands religiously and have 100% CPOE adoption, where exactly do we go from here?

Vikram
Guest
Vikram

There are countries that don’t have proper legal structure to protect patients. Patients in those countries assume that doctors are prone to make mistake and have greed factor. So they go for second doctor opinion and educate themselves. There is no greater cause for corruption or lackadaisical attitude than a lack of review. Action Items: 1. Doctors to tell patients that they are mortals 2. Payors to promote and pay for second opinion. Until a viable alternative is determined for patient safety maybe malpractice laws should remain. When providers/boards start voluntarily de-licensing doctors for malpractice, then we would know time… Read more »

Gary Lampman
Guest
Gary Lampman

I have experienced some of these issues first hand and althought Law Suites are the only avenue for Legal remedies. The percentages of Court Cases are very small incomparison to those who would sue for Medical Errors and Death. Furthermore ,a person would have collected very daming evidence before it would have a chance for trial.The facts are; not all patients have attempted to sue for medical error or Hospital Acquired Infections. Although, they have experienced a life altering event. Which Fiancially burdens the patient for something that is no Fault of their own! Let me remind you that Doctors… Read more »

DeterminedMD
Guest
DeterminedMD

How about a rating of “D”, as in Dumb or Delinquent? Below is a link to a Washington Post article from Friday 11/26 re Medicare payment issues leading to less care for the elderly. http://www.washingtonpost.com/wp-dyn/content/article/2010/11/25/AR2010112503638_pf.html I’m sure the usual suspects will find interesting deflections to blame physicians for this situation, after all, we took a vow of poverty per these spokespersons, right? Think about this, although said before, we turn to politicians to right a system that is supposed to be primarily based on compassion and empathy, yet, this is a group that does not understand, much less practice these… Read more »