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The March 8^th New York Times publishes a remarkably insightful opinion piece by Atul Gawande.  Gawande reminds us of a lesson learned long ago in a completely different professional context.

In 1935 the U.S. Army Air Corps held a flight competition for airplane manufacturers competing for the privilege of building the next generation long-range bomber.  Boeing seemed, to those in the know, to be the obvious winner.  It could carry five times as many bombs as the army had requested, it was fast and could travel almost twice as far as the existing equipment.

The competition was a disaster for Boeing.  Moments after takeoff the plane crashed killing the pilot and two of the five crew members.  After investigation it was clear that pilot error was the cause of the incident.  The pilot was required to attend to four engines, retractable landing gear, wing flaps, trim tabs and propellers for each engine whose pitch had to be regulated with hydraulic controls.  The pilot attending to all of these matters at the same time omitted to release a locking mechanism on the elevator and rudder controls.  The contract went to Douglas Aircraft and Boeing faced financial ruin.

Fortunately, the army purchased a few of the Boeing aircraft as test planes.  A group of test pilots came up with a brilliant and elegantly simple solution.  They created a checklist which if followed would assure that each matter that needed to be attended would be attended to at the time and in the order necessary to assure that the pilot would not be confronted with having to recall all of the various interactions since the simplest omission could be fatal.  These same pilots flew Boeing’s entry nearly 2,000,000 miles without a single accident.   The army ordered 13,000 of the aircraft which became known as the B-17.  This famous aircraft contributed to our victory in World War II.

The same lesson learned by the pilots who helped make the B-17 a safe aircraft have been resurrected sixty years later in an attempt to address preventable medical errors.  Just as the original pilot who crashed the then experimental B-17 was overwhelmed by the many routine but essential things that needed to be done and done in a particular order, similarly physicians today face the same problem.  Physicians are virtually assaulted by such a mass of information and important facts must not be overlooked, especially when to overlook a matter would be ruinous to a patient’s life.

Peter Pronovost, a critical care physician at John’s Hopkins Hospital was among the first, if not the first to give it a try.  In 2001 he created a checklist designed to tackle just one recurring problem in medicine: line infections.  He plotted the course one should take in order to avoid infections when putting in a venous or arterial line.  1.  Wash hands with soap.  2.  Clean patient’s skin with appropriate antiseptic.  3.  Put sterile drapes over the entire patient.  4.  Wear a sterile mask, cap, gown and gloves.  5.  Put a sterile dressing over the catheter site once the line is in.

Note that these steps had nothing to do with attempting to articulate the surgical skills needed to safely place the line.  Indeed, these steps have been known and taught for years.  However, Pronovost had nurses in his ICU observe doctors for one month putting lines into the patients.  In more than one-third of the patients the nurses observed that physicians omitted at least one step.

Pronovost was able in one year to reduce the ten-day line infection rate from 11% to 0.

What Pronovost observed is certainly a reality that we all confront.  Mundane matters are easily overlooked especially in the middle of a medical emergency.  Since Pronovost’s original work, other institutions have attempted similar undertakings.

Forward thinkers like Pronovost and others who followed, unfortunately are whispering in the midst of a storm.  Gawande called Pronovost recently and reports a certain pessimism.  According to Gawande, Pronovost told him, “At the current rate, it will never happen.  The fundamental problem with the quality of American medicine is we fail to view the delivery of healthcare as a science.  Once we acquire an understanding of the disease and find effective therapies for that disease, there seems little attention to assuring that the therapies are effectively delivered.”

We must not allow “The Art of Medicine” to be used as an excuse for individuality which is not a matter of informed choice but instead forgetful omission.

See related article concerning the Surgical check list

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Online Journal watch is a publication which surveys medical newly published medical literature and comments on various relevant medical issues. One of the January’s postings reported upon a study of patients being evaluated by  cardiac CT scan.  The study addressed, among other things, the value of utilizing information made available by reason of the study having been performed, though such information was not the reason for the scan being done.

The editors of Journal Watch published my remarks under the title captioning this post.  For my remarks see Journal Watch .

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Natasha Singer, in her  recent New York’s Times opinion piece suggests that saying you’re sorry is difficult in the health care industry. Indeed, her article addresses the pharmaceutical industry as well.  It is interesting that this issue requires any discussion. We all learned as children the importance of apology in making right a harm resulting from our wrongful conduct. Moreover, that there might be adverse consequences associated with admitting wrongdoing was to be expected and was not ever deemed a justification for remaining silent.

It is remarkable that silence as a substitute for apology has become a standard of conduct for healthcare providers. They argue that if they apply to this that someone might try to hold them accountable for their conduct. In other words unlike what their parents  told them as children, healthcare providers, who once knew that apology was the ethical and proper thing to do have come to believe that silence and obfuscation represent the ethical thing to do.

Remarkably, as pointed out by Singer, those medical centers such as the University of Michigan health Center have discovered honest apology makes they are victims feel good and reduces malpractice claims. The Michigan experience has been duplicated elsewhere. Honesty is not only the right thing to do but also represents a sound business practice.

One has to look elsewhere for the origin of the “conspiracy of silence” than fear of consequence.  Arrogance is a better explanation.

What do you think?

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January 1, 2010 Journal Watch summarizes a remarkable article entitled “Investigation of incidental findings on cardiac CT.”  The article was based on a study conducted at a Canadian institution where the investigators evaluated the incidence, clinical importance, and costs of these incidental findings.

It’s first important to note that these researchers used the word incidental as  equivalent to the word, occult.  In medical imaging, an occult finding is an unexpected finding that has clinical consequence.  Such findings are made with great frequency and have dramatically improved the lives of many.  For example, a chest x-ray searching for a rib fracture reveals a lung cancer mass which was otherwise completely unexpected.  A CT scan of the abdomen performed because of a complaint abdominal pain reveals a dissection of the thoracic aorta.

The Canadian researchers are strangely troubled by the discovery of   unexpected conditions.  The test they are evaluating is cardiac CT.  Imaging data obtained during a cardiac CT includes imaging information of structures or tissues outside the heart.  in an examination of 966 consecutive patients who underwent cardiac CT during 12 months at a single Canadian institution, incidental findings were noted in 401 patients.  12 of the patients were found to have clinically significant conditions, many of them, life-threatening without treatment.

Even if one accepts the very conservative assessment that only 12 of the patients were found to have clinically significant conditions,  that means that 3% of everyone who had a cardiac CT performed had a condition that might have seriously harmed or killed them if it had not been accidentally seen in this study.

The researchers do not see the benefit derived by the 3% as a bonus.  They don’t question that all the patients benefited from having a cardiac CT.  In fact, no one questions that this method of scanning provides an important and noninvasive method of evaluating patients suffering coronary calcification and arterial disease.  However, 68 patients exhibited incidental findings such as nodules or cysts in the lungs or liver.  There’s the rub.

Confronted with 68 patients of the 401 who had abnormalities deemed to be indeterminate (undetermined significance)  researchers worry that the abnormalities found might lead some to conduct further testing or evaluation.  The solution, as they see it, is to not format the data concerning non-cardiac tissue and structures.  They want to ask patients to consent to keeping the non-cardiac information invisible.  If they see no “evil”, they need speak no “evil.”

I think this is insanity. What do you think?

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For a comprehensive review of literature dispelling the myth that there is a big difference between high risk and low risk patients and screening for cervical cancer please read NUNS, VIRGINS, AND SPINSTERS’. RIGONI-STERN AND CERVICAL CANCER REVISITED, MALCOLM GRIFFITHS.

Put simply,  over a long period of time a concept often explained and often repeated, acquires an authoritative stature it may not deserve .  The concept’s very foundation may be faulty but the “test of time”  is no test  if, in all the retellings, the foundation is never reexamined.

In his article, Griffiths examines the much quoted proposition that low risk women do not require rigorous screening for cervical cancer.   Who is at lower risk than a nun?  It turns out this is a trick question because the risk of developing cervical cancer is about the same for a nun as an unmarried women and about half that of married women.

In the debate surrounding screening for cancer advocates of opposing positions tend to pick and believe evidence which agrres with therir respective positions.  This is a debate in which women cannot afford to be driven by bias.  They deserve the truth, their lives depend upon it.

For further information on cervical cancer and the importance of proper cancer screening see Meyersmedmal.com

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According to the American Cancer Society’s most recent estimate for 2009, 11,270 new cases of invasive cervical cancer will be diagnosed and 4,070 women will die from the disease.

Prior to 1955 cervical cancer was one of the most common causes of cancer death for American women. As a result of the development of the Pap smear screening test between 1955 and 1992, the cervical cancer death rate declined by 74%.

Since half of the cervical cancer cases arise in patients who have never had a Pap smear or whose last Pap smear preceded diagnosis of invasive cancer by more than five years, the problem is not that too many Pap smears are being done but that not enough Pap smears are being done.

Nevertheless, the guidelines for screening of Pap smears have resulted in fewer Pap smears being done. For a test that is misinterpreted when it shows abnormalities between 20 and 40% of the time, frequent repetition of the test is needed to assure one appropriate interpretation. Even when an appropriate interpretation of Pap smears is made and abnormalities are found which require treatment, the appropriate treatment is not given 10% of the time.

For a test associated with little cost, and which is essentially risk free, the pressure to limit the performance of even this test is clearly present.

Matthew Mintz, M.D. writes at KevinMD.com medical web blog on November 17, 2009, “Why Doctors are Doing So Many Unnecessary Pap Smears.” In his opinion piece, Dr. Mintz asserts that the Pap smear is a symbol of our healthcare system’s problems, yet the only evidence he quotes in support of this proposition is a study from the Annuals of Internal Medicine which demonstrates doctors are doing more frequent Pap smears on women than some guidelines recommend.

The fact that more Pap smears are being done does not mean that they are needless and they certainly are not harmful.

When even well-informed physicians can reach such wrong-headed conclusions it is not surprising that it is so difficult to fix the healthcare system.

Where is the alarm about the high rate at which Pap smears are wrongly interpreted as negative when in fact they show ominous changes?

Not all screening tests have been as successful as the Pap smear. The fact that we could have for example better screening tests for breast cancer than a mammogram does not negate the importance of women having an option to have a mammogram. We should be searching for better screening tests improving the performance of existing texts and not failing to screen with the tests available simply because the tests are imperfect.

With such controversy swirling about healthcare reform it is difficult to hear the truth in the midst of all the noise that is being made. Staying well informed and being skeptical is the safest approach to receiving appropriate medical care.

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November 16, 2009 the Washington Post reports new screening guideline issued by the U.S. Preventative Services Task Force now recommending against women receiving routine screening with mammograms for breast cancer prior to age 50.

Petitti, Chairman of the Task Force, asserts that the new recommendation will result in “just” 0.7 deaths for every thousand women who now will not be screened. His justification for this remarkable statement is that allowing these 0.7 women per thousand to die will prevent many from suffering the anxiety of a false-positive result. He goes on to say that 33 more women per thousand would be spared unnecessary biopsies. I wonder how many women would be willing to take a 3.5% risk of an unnecessary biopsy to avoid a .7 in 1000 chance of dying.

It is incredible that this Task Force apparently values a women’s life so cheaply.

I guess 0.7 deaths are hard to give a name. Perhaps they should have put it differently. For every 1,429 women who now will probably not be screened, one woman will die.

What do you think?

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Gardasil is a HPV vaccine produced by Merck.  HPV, Human Papilloma Virus, has clearly been demonstrated to increase the risk of a woman developing cervical cancer so it would seem to be a good idea to provide young woman, even as teenagers, with a vaccine that would guard against the virus and prevent the development of  invasive cervical cancers which would otherwise be produced by the virus.

In 2006 Merck Pharmaceuticals received the go ahead.  The FDA approved the distribution of Gardasil, a Human Papilloma Virus vaccine manufactured by Merck Pharmaceuticals and Merck promptly began the distribution of the vaccine.

Later in the same month the distribution began, the advisory committee on immunization practices recommended routine vaccination of girls 11 to 12 years old.  Remarkably, these recommendations were issued before completion of the so-called phase III trials demonstrating whether advanced pre-cancerous lesions of the cervix are prevented by the use of the vaccine.

In fact, only two of the fifteen types of HPV known to have a cancer-producing potential have been shown to be affected by the vaccine.

Merck has seen to it that the public has been provided with a favorable view of the vaccine.  In a report by Rothman and Rothman published in the Journal of the American Medical Association this year, Marketing HPV vaccine: implications for adolescent health and medical professionalism, JAMA 2009 Aug 19; 302(7):781-786  the author shows how Merck employed the assistance of various important medical associations by providing the associations with ready-made presentation slide sets, emails and letters to promote the product.  All this publicity in favor of the use of the vaccine began before important trials had even been concluded.

Now, in the same issue of the Journal of the American Medical Association in which the report of Rothman and Rothman appears, there is an article from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration reporting adverse events occurring in the two and a half years following administration of Gardasil, Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine,  Slade, B.A., Leidel, L.,Vellozzi, C.; et al. JAMA 2009 Aug 19; 302(7): 750-757.    There were 752 adverse reports.  6.2% of the adverse reports involved serious adverse effects, including 32 reports of death but the system of depending on voluntary reports of adverse events risks underreporting and there is no real evidence that the adverse events reported resulted from the vaccine.  Such adverse events reports are based solely on an event occurring after the administration of the vaccine and not because of any other evidence proving the vaccine caused the event.

So, we don’t really know the extent of any benefit a young woman will receive as a consequence of being vaccinated and we also don’t know the risk.

What a nightmare for a parent with a decision to make about a teenager receiving Gardasil.  Cervical cancer continues to kill thousands of women every year. If the leading cause of the cancer is a virus that can be prevented by vaccination, how does one decide to not offer the vaccination?  If, as some have suggested, the chances are less than six adverse events per thousand doses distributed and only 6.2% of those represent serious adverse effects, that means that one serious adverse event would be associated with every three thousand doses distributed.  But even with a risk this small, has there been a sufficient benefit demonstrated to justify that risk?

In a completely different context, many years ago Jonas Salk pointed out to me the importance of focusing on the numerator.  If the chance is 1 in 10,000,000 and you are the one, it is little comfort that 9,999,999 other doses were administered safely.

Perhaps it was easier long ago when we knew little and simply did what we were told.  If not better, perhaps it was just a lot simpler.  What do you think?

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In 1998 the United States Advisory Commission on Consumer Protection and Quality in the healthcare industry adopted a Patient Bill of Rights. The same year Pennsylvania enacted a Patient Bill of Rights allegedly for the purpose of providing quality healthcare accountability and protection under Act 68 of 1998.

It is interesting that the legislature of Pennsylvania elected to call the Act a Patient Bill of Rights. It in fact bears no similarity to what the founding fathers of this country called a Bill of Rights. First, it doesn’t apply to healthcare directly but rather regulates how managed care organizations such as HMOs interact with their insureds. Since the relationship between an insurance company and its insured is defined by contract, the few items regulated by the so-called Patient Bill of Rights in Pennsylvania and in other states where similar bills have been enacted do little to enhance patient safety. Indeed, one does not have a right if one lacks the power to secure enforcement of that right. Enforcements provisions under the typical “Patient Bill of Rights” is, for example, limited in the case of a patient being denied access to a particular procedure being paid that sum which the insurance company had refused to pay. There are no other penalties and no provision for a patient to be represented by anyone in the appeals process.

Patients who cannot seek enforcement of rights have no right and the rights I have discussed thus far are trivial compared to those rights which most would consider fundamental with respect to the provision of healthcare.

A patient certainly should have a right to receive medical care at a level consistent with the principals of practice accepted by accredited institutions of learning and certifying boards of medicine. Everyone feels more comfortable if they are being treated by a physician who has received appropriate training and especially if a physician has been certified by a specialty board of medicine. Physicians are certified only after having been examined usually both in writing and orally. During the course of these examinations, everyone accepts that there are answers which are right and answers which are wrong as in any test.

A patient might therefore assume that the care provided them by a board certified physician would be consistent with those principles of practice which are taught in medical schools and residency training programs and which are the subject of certifying exams. Regrettably, this is often not the case.

Any medical resident who performed an initial assessment of a patient at the beginning of a hospitalization without taking a comprehensive history from that patient would be reprimanded by their supervisor in training. Such a reprimand would depend upon the supervisor becoming aware that such an error was made.

Improper histories and inadequate physical examinations and, most importantly, failed diagnostic process occur with frequency in every healthcare setting and when such errors are made often patients suffer harm. Diagnoses are incorrectly made or made too late for effective treatment to be given.

It is widely acknowledged that this is so. In fact in November of 1999 the report of the Institute of Medicine entitled, “To Err is Human: Building A Safer Health System,” reported as many as 98,000 people die in hospitals each year as a result of medical errors.

Part of the current healthcare reform debate concerns now 10 years after the IOM report a continued search for how to make patients safer, no one currently believing that fewer people are dying today than were dying in 1999 as a result of medical errors.

It is therefore, I think, ironic that we hear news commentators talking about limiting patient’s rights to have legal advocates as a means of somehow making patients safer.

It defies common sense that drivers would operate vehicles more carefully if they were immunized in whole or in part from being held accountable for their carelessness. Patients who suffer severe and unexpected adverse consequences of a healthcare experience in the hospital or elsewhere cannot depend on their doctors, nurses or other healthcare providers to inform them honestly and openly of the causes of the unexpected consequences. It just doesn’t happen. A patient or a patient’s family must be free to consult with lawyers experienced in the management of medical malpractice claims. Such lawyers know how to readily and, usually at their own expense, obtain such information by family interviews or by examination of records as permit the lawyers to honestly advise a patient or their family of whether a bad outcome of medical care was preventable or should have been prevented. Lawyers through their research have access to the principles about which physicians are tested for certification and are taught in schools and through their residency training. Patients in fact have no other satisfactory means of obtaining such information.

In most hospitals, at the time of a patient’s admission, they will be informed of the existence of a bill of rights. They may even be given a paper enumerating these rights. Most hospitals now also have persons who they refer to as patient advocates. The hospital employee who is given the title “patient advocate” is truly powerless to obtain the information a patient requires to learn whether an unexpected injury or outcome was preventable or should have been prevented or not and if the advocate by chance believed the patient was mistreated and harmed as a result of carelessness, such a patient advocate wouldn’t have the power to do anything about it.

The function of a hospital employed patient advocate is to make patients feel better about the care they have received whether that care has harmed the patient or not. Independent patient advocates who have the power to conduct an investigation into the circumstances of a patient’s care and secure for the patient compensation for harms needlessly suffered do not exist outside of our legal system. Only lawyers have the power to be true patient advocates.

It is unfortunate that in so many states in our country rather than increasing patient rights and safety, there has been a relentless effort largely endorsed by medical societies and insurance companies to limit a patient’s access to legal representation or to limit the rights of a patient to be compensated when they have suffered needless harms. The imposition of such limitations is done under the title, “Tort Reform”.

Tort Reform advocates cause patients to believe that Tort Reform and patient safety are somehow related. Tort reformers have many justifications that they give for why reform is needed. They will talk about frivolous lawsuits but they don’t talk about the fact that most tort reform measures limit patients who have been seriously injured by clear carelessness from being compensated for their injuries. Patients will never be made safer by tying the hands of the only true advocates they have.

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Kevin Pho, M.D in his medical blog, Kevinmd.com, invites a discussion concerning whether elderly patients should choose premature death at home rather than being subjected to the complications that are associated with geriatric admissions.  He concludes that elderly patients admitted to emergency departments should be given the opportunity to choose going home rather than being admitted to a hospital.

An elderly patient should not be forced to forgo necessary treatment for a readily treatable condition and thereby face certain death in order to avoid death by “complications” faced by elderly patients who are admitted. This is certainly a choice between a rock and a hard place.

It is a mistake to assume an elderly patient cannot safely be cared for in a hospital setting. The morbidity our elders face is to a great extent avoidable by assuring that they are kept clean, hydrated fed and as active as their condition permits. Adverse changes in their condition should be promptly recognized and properly and timely treated. This is the level of care all patients deserve.

Because elders are more fragile they require more attention but tend to get less. Elders suffer more complications and more serious consequences not simply because they are fragile but more importantly because they to not receive the surveillance and attention they require.

The costs imposed on medicare are magnified because of inadequate treatment which results in needlessly prolonged geriatric admissions and readmissions and prolonged and useless rehabilitation admissions.

When these patients fail to thrive they are simply fullfilling expections. This is a self-fullfilling prophecy. The expectations need to be changed.

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