Monday, September 23, 2013

Medical errors and deaths: Is the problem getting worse?

Medical errors are a real problem. I won't deny that.

It was bad enough when the often-quoted Institute of Medicine figure that 98,000 deaths per year in the US are caused by medical errors was in vogue, but now a paper in the Journal of Patient Safety states that adverse medical events result in 210,000 to 440,000 deaths per year and 10 to 20 times those numbers of serious harms.

Since the paper disparages the medical profession, it has received a lot of media attention.

Most articles about it simply regurgitate the dismal estimates without any real attempt to dig into the paper's methods.

Let's take a closer look.

As is true of many papers, the abstract is a bit sketchy when describing how the paper arrived at its conclusion.

The full text of the paper reveals the author found four studies that looked at what are described as preventable adverse events in US hospitals within the last seven years. All four used the Global Trigger Tool which involves the screening of records for adverse events by nurses or pharmacists and a secondary review by physicians.

Based on opinions by "experts," the author made a key, but erroneous, assumption that all adverse events are preventable.

The basis of that assumption was apparently this statement in the methods section of a 2011 paper in Health Affairs about the Global Trigger Tool.

"Because of prior work with Trigger Tools and the belief that ultimately all adverse events may be preventable, we did not attempt to evaluate the preventability or ameliorability (whether harm could have been reduced if a different approach had been taken) of these adverse events."

The "belief that ultimately all adverse events may be preventable" is not supported by any facts, which are not necessary I suppose if one simply has a "belief."

Personally, I do not share the belief that all adverse events are preventable. Let me give you a few examples of why.

Aspiration of gastric contents is considered a preventable adverse event, yet I can see no way to prevent every single occurrence of aspiration. If you can, please share it with the rest of us.

Leukopenia [a dangerously low white blood cell count], which often leads to sepsis, and is a common side-effect of cancer chemotherapy could be prevented by never using chemotherapy, but is that a realistic solution?

Repeated studies of deep venous thrombosis have found that no measure, be it drug or mechanical device, is 100% effective in preventing DVTs.

Several papers addressing the use of the Surgical Care Improvement Project guidelines for prevention of surgical site infections after colon surgery have found that even when guideline adherence is nearly perfect, at least 8-10% of patients develop SSIs.

Sometimes adverse events are due to patient-related factors. From an editorial in this month's JAMA Surgery commenting on a paper about SSIs:

"[W]e are left with the yet unanswered question about how to remediate the problem [SSI] beyond adherence to SCIP. Short of a large scale public health campaign to address smoking, obesity, and comorbid disease, the findings do not expose a practical way forward."

Pop quiz.

The Journal of Patient Safety paper estimating 210,000 to 440,000 deaths due to preventable adverse events was based on four papers with a total of how many deaths?

a. 38
b. 380
c. 3,800
d. 38,000
e. 380,000

If you said "c. 3,800," you would have only been wrong by a factor of 100. The correct answer is "a. 38."

Adverse events and deaths due to medical errors are serious issues that need to be addressed. But inflating the incidence of these problems does nothing but further erode the already shaky confidence of the public in the medical profession.

And creating the impression that such events are totally preventable leads to unrealistic expectations and unachievable goals.

Note: Upper range of supposed deaths from medical error corrected from 400,000 to 440,000 on 2/24/14.


Anonymous said...

SS, I feel certain that I could prevent all aspiration of gastric contents, by ligating the gastro-esophageal junction. And heparinization plus ambulating the hospitalized patient 20 times a day could prevent all DVT's! And why can't you rocket scientists administer wbc infusions? (Sorry, sarcasm + gallows humor.)

The collectivists are using the specter of medical errors merely to tear down the current medical system, so we can go to something worse: healthcare of, for, and by Uncle Sam. It is easier than pie, to drum up stories of wrong-site surgery, screaming/instrument throwing surgeons, ad nauseum.

You and I know, having worked in health care, that the best way to prevent medical errors is to have good people working in health care -- doctors and nurses who are well-educated, conscientious, and caring -- and who have enough time! (Unfortunately, people meeting this description seem to be in ever shorter supply.) Of course I agree with sensible checklists, with double checks, etc.

I doubt the sincerity of the current "medical error" hysteria.

artiger said...

Gun violence is completely preventable are we doing on that one?

I can't say it much better than Anon, only to add that such hysteria often has an ulterior motive. If we follow the trail of dollars, we often find out its creators.

Skeptical Scalpel said...

Thanks for the comments. I wrote this post because I feel that someone must say something to balance the argument.

Anonymous said...

Here's a couple of things:

Anon: "You and I know, having worked in health care, that the best way to prevent medical errors is to have good people working in health care -- doctors and nurses who are well-educated, conscientious, and caring -- and who have enough time! (Unfortunately, people meeting this description seem to be in ever shorter supply.) "

Frankly, it also takes people willing to admit they make mistakes and fix them. When I have docs who refuse to admit they're wrong on small things, don't document a problem in surgery, etc. things like that tear down the trust that is created and built. Until the medical community starts doing some serious work on fixing those types of things, rather than 'CYA comes before your health', I don't see it happening.

I've spent time working with a number of great people who made mistakes and we fixed them together. Didn't need a lawyer. Its called teamwork. Those that didn't do this, why did you get into medicine? It surely wasn't for the patient. When you're patient says work with me and lets fix things together, and that isn't the docs attitude, they shouldn't be practicing.

Get rid of blackballing, iatrogenic neglect. Face up to those things and work to get rid of it.

Next, figure out who among patients are truly interested in nothing but lawsuits, those I have no problem with missing out on some care. No offense, but whether its a doc or patient, whoever is just looking for the "legal way out", find something else to do and not make it things such a problem for others.

Next, "well educated" ... when I can easily figure out from medical, peer reviewed literature who is
1) "well educated"
2) who is keeping up with at least some of the current literature
3) who can't look at medical literature & figure out whether or not a condition exists
the list of docs who "can" gets smaller. Life is no longer cookie cut medicine and I see docs who only want the easy problems. Learning to think ... critical.

For starters ...

I think that the issue medicine needs to face is that they're going to see articles like this until there is a cleanup in medicine on the above issues. While I understand the point about wanting to get people into socialized medicine and who is doing it, it is the medical profession itself that is helping to create this atmosphere. Don't give them the ammo, ok?

Skeptical Scalpel said...

Anon, thanks for the comments. I agree that people have to be able to admit when they have made a mistake. Unfortunately, the culture of medicine has not reached a point where admitting a mistake is not punished. That inhibits people from being open about errors.

Learning to think is important, and it is not taught in most med schools.

BlueFoggyDay said...

First, maybe you have a different definition of "adverse event?" Here's a good one:

"An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study."

If someone uses a medical treatment, device or procedure, of COURSE it is preventable by not using it in the first place! You can prevent getting food poisoning by not eating. You can prevent being in an airplane crash by never flying. Are these things realistic? Probably not. But MANY medical situations are, which are what's talked about in the article.

In your examples, you could prevent aspiration by making sure a patient hasn't been given a sedative shortly before given food or beverage to eat/drink, like my disabled sister was which helped lead to her death. You can make sure that there is a nurse watching over the patient in high-aspiration-risk scenarios, instead of being totally absent as was the case with my sister. You can make sure the person isn't laying in such a position in bed so as to exacerbate the aspiration, as my sister was. Her record mentions many times "aspiration danger," but no one on the medical staff did anything to prevent the aspiration that led to her death.

I know nothing of leukopenia, but a quick google search of "prevent leukopenia" turned of several articles including:

As for preventing DVT, "adverse events" aren't about prevention of any condition, it's about preventing ones that are clearly preventable. Are you saying that an adverse event, like carelessness by a doctor, can cause DVT?

Surgical site infections of COURSE can't be 100% prevented. But even in the 100% safe case scenario, chance can always lead to an adverse event. Someone can still forget and leave an instrument inside a patient causing an infection. Someone could throw up on the patient during surgery.

Adverse events are not always purposeful.

And finally, the article ESTIMATED a number of deaths. Your pop quiz is asking about the true number of deaths in the study? How are the two numbers related?? If I do a study of how many people shop at my local Ralphs grocery store on a certain Monday, and the number is 4,000, I can estimate that 208,000 shop at Ralphs on Monday in a year. Is it a true number? NO. Is 4,000 the real number for any other Monday? No. But it doesn't change the point and accuracy of the estimate.

Having said that, I just quickly perused the article by the Journal of Patient Safety and while only 38 people died (out of 4,252 records studied), 670 were considered "serious adverse events." That's about 16% of all the records studied. Of the second, third and fourth studies, 44%, 100% and 63% were found to be preventable, respectively. the major causes of "lethal events" were medication, sepsis, aspiration, procedure, pulmonary, HA1 virus (influenza), and renal.

I'm not sure what your point is for singling out only how many people died. Does that make the serious adverse events more acceptable?

Preventable adverse events, not ones that you choose to deflate the study, should lead to no serious conditions and no deaths. Again, we're not talking about situations that would and could happen anywhere, anytime in a different place and time, where the chances of it occurring are fairly high.

So I think you're just trying to stir the pot with these accusations and have totally missed the point of the study/article.

Skeptical Scalpel said...

Blue, your comments are noted.

The definition of an adverse event you cited in your 2nd paragraph is not the one the author of the paper used.

I focused on the deaths because that is what the media reports about the paper focused on.

The point of the pop quiz was that the extrapolation of 210,000 deaths in 34.4 million hospital discharges was based on 38 deaths in 4,252 records reviewed.

At the beginning and end of my post, I stated that medical errors are a big problem and I wasn't denying that they occurred.

I think you missed the point of my post which was that exaggerating the scope of the issue is not necessarily helpful.

Anne said...

"exaggerating the scope of the issue is not necessarily helpful"

This is exactly right! And I don't know why they do it, because laypeople have gotten so accustomed to discounting for the "turn it up to 11" factor embraced by so many activist-alarmists that they look askance at any figures now.

We have actual problems, and we need to work towards actual solutions, but having some proportion of the populace running around screaming that doctors are killing 400,000 Americans every year, and some other proportion of the populace shrugging, "Meh, it's just more hype and lies, you can't believe anything they tell you anymore", is not helpful.

Skeptical Scalpel said...

Anne, thanks for agreeing with me.

Jeremy, that is a very interesting link. That paper estimates the number of excess deaths in the US at 2500, just over 10% of Journal of Patient Safety estimate. Also, it claims the UK is doing so much better than we are. But what I've been reading is that the UK's NHS is in shambles, and many hospital trusts are performing poorly. How can these discrepancies be explained?

Anonymous said...

SS: "Anon, thanks for the comments. I agree that people have to be able to admit when they have made a mistake. Unfortunately, the culture of medicine has not reached a point where admitting a mistake is not punished. That inhibits people from being open about errors.

Learning to think is important, and it is not taught in most med schools. "

I agree with you there. I lost faith in the admin of a place because I asked that they *HELP* and I mean ASKED, please give an "excellent" doctor another pair or hands or two. What did they do? Take it out on me. From what I have heard of people who work for this place, I'm sure they probably took something out on the doc as well. If you kill someone (and I don't mean during a quad bypass operation) or leave a scapel inside them, that's one thing. What I complained about truly didn't require that. So how do we fix admin? Personally, I see risk managers and admin as about as big stumbling blocks as patients who are looking to sue "rich doctors and hospitals".

Second, I'm finding out you are completely correct. Ok ... I have more education and training than I tell docs, but ... if I can teach people how to read medical literature, maybe not MSTP type people stuff, but regular MD papers, and MD's can't figure it out (and all I know have passed their boards), well I know you are right. Sad and sorry to say.


Skeptical Scalpel said...

Anon, I appreciate the comments. Your frustration with the situation comes through loud and clear.

Anonymous said...

I have to agree with the comments on admitting medical mistakes. I tell my interns that the only thing worse than making a mistake is making it and not admitting it ... because then I have NO chance to fix it. I, personally, make a deal with them that if they tell me RIGHT AWAY I won't yell at them, which I know seems silly. But, since making this an open policy I personally get alerted to far more errors (usually medication type errors) and I honestly don't think that it's because people are more careless because they aren't afraid of being yelled at/berated.
It's a hard topic -- high stakes for mistakes, but at the end of the day, we ARE human. Our mistakes just tend to have far more serious consequences than the average job.

Unknown said...

To Skeptical Scalpel (from the study author):

I did not make an erroneous assumption that all adverse events are preventable. I gleaned from the Classen study that the 10 authors of that report asserted that all adverse events may be preventable. It was their opinion, not mine. I should point out that all decisions of preventability are subjective opinions. Theirs was more “global” than other studies where the reviewers attempted to make that subjective judgment on individual records. In fact I assumed that 69% of adverse events are preventable based on the opinions of the authors of the three major studies, including a 100% belief from the Classen authors.

How much difference did the 100% belief make? Let’s suppose I had used only 80%. Then the average to which it contributes drops to 63%, which is precisely the estimate from Landrigan’s study. This change drops the total estimate to (34,400,000 x 0.0089 x 0.63 x 2) + 20,000 = 406,000. Should we argue about the difference between my estimate of 440,000 and 406,000?

I want to point out that I did not attempt to exaggerate the count. One choice I had to make was whether to use a simple average of the incidences of lethal adverse events or use a weighted average. I knew the estimate based on weighted averages would be lower, and I used it (0.0089). I could just as easily have taken the simple average (1.1 + 1.4 + 1.1 + 0.6)/4 = 1.05%. How much difference would this have made? Substituting in the above equation and going back to a 69% preventability of adverse events gives (34,400,000 x 0.0105 x 0.69 x 2) + 20,000 = 518,000, well above 440,000.

As far as his “pop quiz” goes, he surely knows that incidences in a large population can be estimated by appropriate statistical sampling of that population. Election predictions are done like this all the time. The fact that the incidences in the 4 studies did not vary too much (0.60 to 1.4%) is reassuring, especially since I gave the reasons to expect the 0.60% to be below the national average and the 1.4% to be above the average.

I think the public has reason to have their “shaky confidence” in the medical profession eroded. But first I should point out that medical errors are made by many other care givers besides physicians, so no one is pointing a finger at that profession alone. Given what I know about grandfathering of board-certified specialists, a continuing education system that cannot keep up with new clinical knowledge, an ineffective peer-review system in many hospitals, impotent medical boards, off-label prescribing of drugs, reductions in nurse-to-patient ratios, financial interests of hospital administrators, and the tradition of keeping mistakes a secret, I regret to say that I am personally afraid of going into a hospital. I am not alone.

BlueFoggyDay said...

Funny how the victim of medical negligence doesn't see any exaggeration but the medical community does. Funny how victims see the need to reform tort reform, but the medical community doesn't.

You just want to magnify the parts of the article that make a point you want to make. Most lay readers wouldn't take the article that way and can discern the true meaning without the need for dramatic interpretation.

On Twitter you also accused me of not reading the article and the article of having a "debatable" definition of "preventable," even though the article clearly says,

""investigators must be aware of what they can and cannot find. AEs that cannot be traced to commission of error should not be called AE."

Skeptical Scalpel said...

Anon, I agree with your policy of wanting to be told promptly about errors, and in a non-punitive setting. I did this myself. I always told the residents that I didn't want to hear about errors from risk management first.

John, I really appreciate your detailed comment. And I am sincerely sorry for your loss. I do not dispute in any way that the system is a mess and needs radical changes.

As luck would have it, I just got home from having rotator cuff surgery an hour ago. I am in no condition to deal with your explanation of the intricacies of your study tonight. I might not be able to even if I was clear-headed. I had a positive experience in an excellent hospital. I know, it was an n of 1.

Blue, again I appreciate the comment and your passionate opinions on the subject.

Anonymous said...

I hope the author should check the sobering statistics here

Honest Doc

Skeptical Scalpel said...

Good link. Everyone should read it. Thanks.

Anonymous said...

My husband entered the Emory ER in Atlanta last year. He was admitted to the hospital because his white blood cell count was 800 (down from 8,500 24 hours prior to that when his blood was drawn on an outpatient basis). In addition to this dramatic drop in his white cell count in one day, e met all of the signs of severe sepsis, but first the ER nurse and then the ER doctor didn't use Emory's Sepsis Screening Tool. He more than met the criteria for being in severe sepsis and should have had blood cultures drawn and antibiotics administered within the hour. He lapsed into a non responsive state. He was admitted and no antibiotics were given for 10 hours even as I asked all medical personnel that came into his hospital room when he would receive antibiotics. It was only when I went to the nurses station to complain early in the morning that he needed treatment that they gave him antibiotics. It turns out that the hospital doctor ordered antibiotics in the middle of the night, but the night nurse just didn't read the orders. Only after I complained did they notice the orders were STAT administration of antibiotics. As one of the Emory administrators apologized to me, he said they "missed three opportunities to recognize he had sepsis and treat him with antibiotics.' Of course, the delay was too long and the problem couldn't be corrected. He went into septic shock and died late that night. If I hadn't launched a medicare complaint, they wouldn't even have investigated. It took months of my digging and asking questions to understand what happened. How many people are not as persistent as me? I would say there are many more medical errors than the estimate you cite because most are not investigated or even recognized by the physicians or other medical personnel as mistakes. They go on and off their shifts, so tired they just don't pay attention (like the ER doctor and nurse) and inept (like the night nurse - he deflected my plea for antibiotics with an untruth just to brush me aside). My husband had many medical errors made during the last 18 years of his life that I could write a book about them. Several almost cost him his life, and his poor health was due to the first really big medical error. So medical errors that beget poor health often lead to more hospitalizations which lead to more errors (that was our experience). That's why I was so hyper vigilant that night, but I couldn't make Emory treat him. Now they say they are very sorry and things will change, but of course they won't. The fundamental systemic changes won't be made. Medical errors result in injury and death to patients, but the ripple effect they have is so devastating to their loved ones. My life is destroyed. He was everything to me. Picture yourself losing a loved one because of a medical error, especially when you have begged for treatment. It is something I will never get over. I am so hoping one day I will get through it.

Skeptical Scalpel said...

What a tragic and terrible story. I am so sorry that this happened to your husband and you. Words cannot express my sympathy.

I appreciate your sharing this story. If you would like to flesh out the story by telling me what the original medical error was and any other details that would enhance a reader's understanding, I would consider using your account as a separate blog post so that more people could read about it.

Please email me at

Thank you.

Anonymous said...

So I have a question: What is a physician forces me to do an abdominal laparoscopy to remove a mass from the uterus and an adverse event had occurred during that surgery .... but another physician could have done the surgery using minimally invasive techniques but I had no idea that it could have been done minimally invasive bc the original physician didn't tell me that (i know this now in hindsight) ..... is the original physician "in error" simply bc she refused to refer me to reproductive endo who could have performed a "less risk" or less invasive surgery?

Anonymous said...

Sister anonymous: You have highlighted the issues. My uncle who had hypertension but otherwise healthy is admitted for a stroke and D/C to extended care facility but subsequently dies of a Catheter associated UTI. Surviving a stroke but dying of a UTI? What an insult to injury. I wish I had the opportunity to review the case at that time - bc I would have been interested in seeing what i could find in this medical chart. The focus shouldn't be on possible hyperinflation of numbers, but focusing on the cases that are the real issues and preventing the things that should be preventable. Once that's done, if there is a case to be made for anything else due to hypothesized hyperinflation of numbers, let the case be made at that time. But right now, people NEED to stop dying from things that are preventable.

Anonymous said...

I once worked in an ER that had a 10% recognition rate for sepsis..... only 10% of the pts admitted upstairs and were found to be septic had the diagnosis in the ER.
I'm not sure that's an acceptable number. There are tons of hospitals in America who are like this .... I'm sure you guys were in great ERs and hospitals who have tons of resources, but the fact of the matter is there are a lot of disadvantaged hospitals in America who do not have the appropriate resources :/

Skeptical Scalpel said...

Anon comment at 2:05, Laparoscopic surgery is considered minimally invasive. I am not sure what technique your reproductive endocrinologist would have used that is less invasive unless it was just a needle. Needle biopsies are often not as accurate as biopsies in which the entire lesion is removed.

Anyway, if what you said is true, your surgeon should have mentioned all the alternatives and their risks and benefits to you.

Anonymous said...

Thanks for posting this wonderful article.

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