Taking It to Heart: What Every Woman Needs to Know in February

February is National Heart Month and the Go Red for Women campaign reminds us to bring awareness to cardiovascular disease in women all month long.  Today in the US nearly 44 million women are living with heart disease.  Even though heart disease is quite prevalent in women, only 1 in 5 women are aware that they are at risk for developing a cardiovascular problem in their lifetime.

Cardiovascular disease is the #1 Killer of American women. More women than men die of heart disease every single year—in fact, one woman dies from heart disease every 80 seconds. Most women believe that their greatest health risk comes from breast cancer. However, one in eight women will develop breast cancer in their lifetime and one in THREE women will develop cardiovascular disease. Nearly 90% of all women have at least ONE risk factor for heart disease.

Heart disease affects men and women differently.   Biologic and hormonal differences in men and women contribute to the ways in which heart disease develops and progresses.   Studies have shown that after menopause, women have an even higher risk for heart disease—Estrogens seem to promote better cholesterol profiles as well as have other cardio-protective metabolic effects.

Women tend to present to a healthcare provider far later in the course of the disease process and have more diffuse and widespread cardiovascular disease as compared to men. While we are making progress in reducing deaths from heart disease in the US, rates continue to be disproportionately high in women.   In fact, women who suffer from a heart attack have a much higher mortality in the first year following the event. In the first six years following a first heart attack, women have a much higher rate of a second heart attack as compared to men.

So, What Can Every Woman Do to Prevent Heart Disease?

As we recognize February and the American Heart Association’s Go Red for Women campaign, here are Four Questions for Every Woman Must Consider:

  1. How big a problem is cardiovascular disease in women?

Women are under-treated and underserved when it comes to heart disease. Heart disease has long been associated with men—truth is, it affects both sexes equally. However, men tend to be treated more aggressively and earlier in their disease. Women present later and often have more extensive disease. MORE WOMEN THAN MEN DIE FROM HEART DISEASE IN THE US TODAY.

  1. What are the symptoms of heart attacks in women? Are they different from men?

In women, heart disease symptoms can be quite vague and nonspecific. Traditional symptoms are chest pain or pressure, sweating, nausea and pain in the arm or neck. Shortness of breath may also occur. Women may experience these traditional symptoms BUT sometimes they do not.

In women, symptoms are more difficult to tease out. Sometimes they may have a feeling of dread, flu like symptoms, fatigue, anxiety or pain in the back.   . The key to preventing unnecessary cardiac deaths in women is for both patient and doctor to KNOW their risks and interpret symptoms within the context of the risk.

  1. Are women and men with cardiovascular disease treated the same? 

There is a larger gender disparity in the way in which men and women are treated. Men are more likely to receive more timely and more aggressive therapies. Much of this disparity may be due to the fact that women are not diagnosed as quickly, may not recognize their own symptoms and may be billed as anxious or depressed when presenting with a heart attack—because they may have atypical symptoms. While there are lots of advanced treatments available for heart disease, men tend to be treated more quickly are more likely to receive advanced therapies—women do tend to have higher complication rates with cardiac catheterizations and bypass surgery and this increased risk may also explain some disparities in care.   Unfortunately, women who suffer a heart attack are less likely to be prescribed well-studied medications–such as ACE inhibitors, Aspirin, Statins and Beta Blockers–that have been proven to reduce mortality in patients with documented coronary artery disease. In addition, female patients are less likely to be referred to cardiac rehabilitation following a cardiac event even though studies show that women reap a bigger benefit than men from these activities.

  1. What can every woman do to reduce her risk for heart disease?

The most important thing all women can do is to recognize their risk for heart disease and engage with a healthcare provider. By understanding risk factors women are able to work to modify their risk through diet, exercise and, if necessary, treatment of other conditions such as hypertension, diabetes and hyperlipidemia. Women must work to take control of their own cardiac health—every woman must take stock in her own heart health—understand her risk and work with her healthcare provider to modify those risk factors

While we have made great strides in reducing cardiovascular death rates in women over the last 20 years, we still must continue to educate and advocate for women of all ages—this advocacy begins with dispelling the common myths surrounding heart disease in general. It is my hope that through efforts such as the Go Red campaign every February, we can promote better heart health for millions of American women. Ultimately, we must engage women and their families in order to most effectively eliminate needless cardiac related deaths in the next decade. Women MUST understand their individual risk and actively work to take control of their own heart health.  Physicians MUST engage with their female patients and advocate for them in order to ensure that all women get the very best cardiovascular care.

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Dr Kevin Campbell is the author of “Women and Cardiovascular Disease: Addressing Disparities in Care”

Mr Obama Went to Washington—And Placed Doctors In the Middle of a Gun Control Debate

 

First of all, let me make it clear—This blog is NOT about the issue of Gun Control. While the gun control debate is a very controversial issue and I certainly have an opinion regarding the protection of our Second Amendment rights, this particular blog is focused on the fallout that Presidential politics may have on our ability to care for our patients.

Obama’s executive action on gun control this week may have a significant and potentially long lasting impact on the doctor-patient relationship.   Doctors have always been held to a very high standard of conduct when it comes to protecting privileged patient information. When a patient steps into the exam room or establishes a doctor-patient relationship, a physician CANNOT discuss anything that the patient discusses (even with other physicians) WITHOUT the patient’s permission. Records cannot be released without a patient signature and, unless the patient makes statements that suggest that he or she is a danger to himself or others (or communicates threats), the physician cannot report any illegal activity to the authorities. This “zone of confidentiality” is in place in order to encourage patients to interact with physicians with HONESTY and develop TRUST with healthcare providers. This protected relationship is important as it provides doctors with accurate data when considering a diagnosis and treatment plan for a patient. More importantly, it protects patients from any repercussions from employers, family, government or others as a result of any information that they may voluntarily provide.

During his press conference, Mr. Obama outlined the specifics of his Executive Action (without Congressional approval) regarding changes to gun control laws in the United States. While the specifics of the new law are a bit difficult to understand it is clear that physicians are part of his plan for limiting access to guns. As part of the action, physicians apparently are no longer held to the high standards of the Health Care Portability and Privacy (HIPPA) act when it comes to patients with mental illness. The action relieves physicians of the duty to maintain complete patient confidentiality when an individual provider notes that a patient may be mentally ill—in fact physicians are encouraged to contact the National Instant Criminal Background Check System (NICS) and report the name of the patient. The NICS is a government organization that maintains a database that is used for determining if prospective firearms buyers are eligible to make a gun purchase. It was mandated by the Brady Handgun Violence Prevention Act (Brady Law) of 1993 and launched by the Federal Bureau of Investigation (FBI) in 1998. As part of the reporting process to NICS under the new executive action, no actual diagnosis or other privileged medical information can be revealed—only a physician’s hunch that a patient may suffer mental illness is necessary for disarming any patient. No guidelines as to what type of mental illness should be reported–so I guess anything is fair game from depression to social anxiety and beyond.  Any physician report, even without due process or investigation, will preclude a patient from purchasing a gun. More disturbing is the fact that ANY physician—even a cardiologist like myself who is definitely NOT trained in the diagnosis and treatment of mental disorders—MAY prevent a patient from purchasing a gun by filing such a report.

Don’t get me wrong—gun violence in the US is horrific. Mental illness is widespread and many patients go unnoticed, undiagnosed and untreated. No one with mental illness should be allowed to own or possess a firearm. We must make changes to prevent senseless killing. However, asking physicians to screen potential gun owners is NOT the answer. Our President should have thought more about the implications and fallout of using a “phone and a pen.” He may have forever changed the way doctors and patients interact and his executive action may serve to erode the purity of the confidential nature of the doctor patient relationship. His new “law” is also in direct conflict with a Supreme Court ruling from July 2015 when the Court upheld a Florida law that prohibits doctors from asking patients and families about gun use or possession.

As physicians our job is to use our training and our understanding of medical science to provide our patients with the best possible care in order to produce the best possible outcomes. We should NOT be put in the middle of a political debate regarding guns and mental illness.   We should not be put in a position to make a legal determination that may forever limit the rights of our patients. The Affordable Care Act and Electronic Medical Record mandates have already overburdened busy medical professionals in every specialty. Primary care doctors certainly screen for mental illness as part of their routine wellness visits (and are trained to do so) but surgeons and other specialists have little or no experience with the diagnosis of mental illness and quite honestly rarely consider these issues during a patient interaction. Psychiatrists and other mental health professionals are well equipped to make such determinations, but are often in short supply and unable to perform “emergency” consults outside of calls for commitments, etc from Emergency Department staff.

The unilateral actions of our President are likely to have far reaching (and likely unintended) impacts on healthcare. It is essential that there is a bond of trust between doctor and patient and this relationship must remain sacred. Patients should feel free to discuss anything with their physician without fear of legal repercussion or fear of imposed limits to their constitutional rights after a visit with their healthcare provider. I fear that patients may not be as forthcoming with their physicians during regular visits due to a perceived lack of confidentiality—how can they know that they will not be reported as mentally ill to the FBI?  This new law influences what doctors and patients may say to one another during the most critical part of the doctor-patient relationship, when the patient is most vulnerable—the private medical exam. Most importantly, patients may not follow up regularly with their physician due to a fear of being reported to government agencies and losing their right to bear arms. The exam room is designed to be a safe place—a place where patients can share intimate details of their lives and health history and develop a bond with their healthcare provider. I fear that this legislation will only serve to erode the sanctity of this very unique relationship and ultimately impact health outcomes in a negative way.

While in my state physicians do have an obligation to report any patient who communicates threats to harm themselves or others, this new “law” calls on physicians to do something quite different—report any patient whom you suspect MAY have any type of mental illness—irrespective of any stated threat or danger. Doctors need to care for patients. Doctors must respect patient privacy. Doctors should not be FBI informants. Politics has no place in the exam room and government should not be in the business of dictating the way highly trained medical professionals practice Medicine. As Doctors, we must stand up for our patients’ rights. We must protect our privileged relationships and we must leave gun control debates to the politicians and lawmakers. Gun violence prevention efforts should be focused on the communities in which they occur and target the criminals who commit the heinous acts—these laws should NEVER come between doctor and patient. So Mr. Obama, I implore you, let doctors do what they do best—Heal.

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On the Defense and Driving Up Costs: Doctors’ Diagnostic Choices Dictated by Fear Not Fact

For decades, many physicians have been pushing for comprehensive tort reform on the national level. Malpractice claims in the US are twice those of other developed countries such as England, Canada and Germany. Payouts in a US claim can easily reach 3 million dollars or more, in Germany most claims are around 30K dollars or less. A survey conducted by RAND in 2011 estimates that 99% of American physicians in high-risk specialties such as neurosurgery will face a lawsuit at least once in their career—In Europe, that number is only 20%. All the while, the costs of healthcare in the US are skyrocketing and the Affordable Care Act has been ineffective in reducing costs. While there are many causes of the inflated costs of care in the US, the ACA only addresses a few and leaves others unchecked.

Recently, an observational study of the relationship between physician spending and risk for malpractice claims was conducted in the US and the results were published in the British Medical Journal in October 2015. In the study, hospital data for more than 24K physicians were sampled and the investigators found that the higher the resource use, the lower the risk for malpractice claims—in a nutshell, doctors who ordered more tests were significantly less likely to be sued for malpractice. This finding was consistent across 6 of 7 different specialties evaluated and was particularly pronounced in Obstetrics. Defensive medicine, defined as medical decision-making and care provided solely for the purpose of avoiding malpractice litigation, accounts for a significant proportion of healthcare costs in the US today. Physicians, while striving to provide excellent care for their patients are faced with the harsh realities of our litigenous society—many are always looking over their shoulders for the next “ambulance chaser” to appear. In medical school, physicians are taught to think like Sherlock Holmes. When a patient presents with a set of symptoms and physical findings, we develop a differential diagnosis (a list of possible etiologies) and then we work to eliminate the possibilities through logic and objective data. The role of diagnostic testing is to help eliminate or confirm a particular diagnosis and allows physicians to zero in on a particular cause so that therapy may be initiated quickly. In many cases, a diagnosis can be confirmed simply by talking to and examining the patient—the Medical History and Physical Exam—which is becoming a lost art.

When defensive medicine is practiced, the entire system is perturbed. Why would we order a test when it is unlikely to substantially change what we do—Think “fork in the road”. If a test is ordered, the result should point us one direction or the other.

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So, just how can we expect to lower healthcare costs if we are playing defense in the clinics and emergency rooms of America? How does defensive medicine impact patients?

Data such as those recently provided by the BMJ suggests that the practice of defensive medicine is on the rise. It is also very clear that the over utilization of testing is a major contributor to the high costs of healthcare in the US. As physicians we are taught that the best time to order a test is when we have an intermediate index of suspicion or pre test probability of the presence of a particular disease state or finding—employing Bayesian statistics. If our pre test possibility is high then no testing is necessary—simply proceed with a therapeutic intervention. Conversely, if our pre test probability is determined to be quite low then no testing should be performed—simply move on to another diagnosis.

Defensive medicine and over testing effectively negates our statistical advantage when making a diagnosis. Multiple unneeded tests are ordered and sometimes these tests have false positive findings that may result in further testing and even unnecessary procedures. These procedures often are associated with complications—all of which could be avoided by more responsible and judicious use of diagnostic tests. Moreover, patients must deal with the psychological impacts that having a false positive test result often produces.

We must all work to continue to push for tort reform. Only by removing the motivation for frivolous medical lawsuits will we be able to better contain costs and limit testing to those tests that are clinically indicated. While physicians must be held accountable for their decisions and their actions (as well as their clinical judgment and thought processes), we must insist that there are more reasonable caps placed on damages. Those attorneys who repeatedly introduce ridiculous and frivolous complaints must be held accountable for the costs and waste that they place on the system. Until then, we will not be successful in curtailing costs and good physicians will continue to feel compelled to play defense in the clinic.

 

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Saving The World Through Better Coding! ICD-10 is HERE!

Thank goodness we made it to October 1st!  Finally ICD-10 codes have arrived in your doctor’s office and local hospitals!

Luckily we now all have a new medical coding system in place for our patients and their medical problems. Just by the fact that I now have the ability to code for an orca bite or (God forbid) an accident due to water skis on fire, I know that I will be able to provide better care for my patients.

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(Photo courtesy of PBS)

The use of ICD 10 is now mandated by the Federal government for hospitals and healthcare providers all across the US. Originally designed by the WHO as a way to track worldwide disease and collect health and wellness statistics, the ICD coding system was intended to be a way to identify and target certain diseases and injuries. The hope was that by tracking disease, specific interventions could be made in order to improve outcomes in areas where a particular health risk was present.

Since its inception, the US has adopted the coding system as a way to capture billing information for the purposes of reimbursing physicians and hospitals for the work that they perform. In the previous iteration, ICD-9, there were nearly 55K diagnosis and procedure codes. Under the new system there are almost 155K. Over the last year, doctors and hospital personnel have been required to undertake hours of “ICD-10” training in order to ensure competence with the new coding system by October 1st. The new system expands the types of diagnoses, and is intended to be much more specific—requiring that statements of laterality and the chronicity of a particular ailment or injury be included in the diagnostic code. For physicians, this means—you guessed it—tons of additional electronic paperwork. With EMR already in place (and barely functional in some instances) physicians are already overwhelmed with data entry and screen time. Now, in order to complete an office visit in the EMR, physicians must navigate a new, and even more cumbersome, coding system.   We have codes for injuries that occur while falling from a spacecraft, injuries sustained in a Macaw attack as well as a thermal injury that occurs while skiing on water skis that are, in fact, on fire.

Do any of these help us better care for our patients with diabetes, heart disease or hypertension? Do my patients benefit because I am able to carefully code in the EMR the fact that there chest pain is due to “native coronary artery disease with angina”? Wouldn’t the result be the same if I simply wrote in my office note that the patient has prior coronary artery disease and is having typical angina and likely needs an evaluation with a particular test?

In many cases, I expect that the codes that are recorded in the middle of a very busy office day will be no more accurate than the previous system—many providers will simply click a diagnosis that is “related” to the patient’s problem in order to move the electronic paperwork along. (Instead of searching an endless list of codes for the exact letter and number combination that is required).

When exactly did anyone prove—in a randomized controlled clinical trial—that more specific coding of diagnoses by physicians improved patient care and impacted outcomes?

I would argue that is simply the result of the combination of continued government ignorance (and arrogance) when it comes to dabbling (or meddling) in healthcare. Bureaucrats love to create paperwork, committees, meetings and agendas. They often pontificate on the benefits of a particular plan or algorithm even when they have no data to support their position. Doctors care for patients—our government should let us all do what we do best—Spend time with our patients, connect with them and work to improve their health. For now, however, we must continue to look for the right code–especially when we encounter a person who has been injured by a jet engine. Better learn that one—its an everyday thing around the primary care office. Ahh, here it is…. V97.33XD: Sucked into jet engine, subsequent encounter

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The Cost of a Cure: What’s the Right Price?

Recently, two significant pharmaceutical breakthroughs have resulted in a renewed debate about the costs of drug therapy. In the last year, a new drug class for the treatment of Hepatitis C has been released by two different manufacturers and has been found to cure a once incurable chronic liver disease for nearly 90% of patients who are treated with a full course of therapy. The drug appears to be safe and highly effective—however, the cost of a curative course of therapy is nearly 80K dollars. As you might imaging, there are already barriers to access for many patients including those treated in the Veterans’ Affairs (VA) system as well as those on government based insurance programs such as Medicaid.

In the last several months, another remarkable, potentially “game changing” drug has been approved and released into the market. These drugs, made by Regeneron and Sanofi, are intended for patients who do not achieve adequate cholesterol reduction with standard statin therapy (the current standard of care).   According to some analyses, these drugs, when used in the appropriate patient population, may result in the prevention of thousands of cardiovascular related deaths. However, just as seen with the new hepatitis C drugs, the price tag for therapy is exorbitant—nearly 15K dollars annually. With the Hepatitis C drug, therapy is only required for approximately 12 weeks and then is no longer needed—with the cholesterol drug, the therapy will most likely be lifelong.

This month a study examining the cost effectiveness of these new cholesterol drug has been published and concluded that the drugs are far over-priced (nearly 3 fold) for the benefit that they produce. Based on a pure economic analysis, researchers concluded that the drugs should actually cost between 3K and 4K dollars annually rather than the current 15K price tag.

Did Healthcare Reform Forget Big Pharma?

The purpose of the Affordable Care Act (ACA) (as touted by supporting politicians and its authors) is to make health care accessible and affordable to all Americans. Certainly this is a noble goal and one that we should continue to strive to achieve. However, the legislation has failed to meet this mark. While addressing physician reimbursement and clinical behaviors (and limiting choice and physician autonomy), the ACA has done nothing to regulate the high price of pharmaceuticals. Big pharma is allowed to charge exorbitant prices (whatever the market will bear) without regulation. It is clear that pharmaceuticals must reclaim their research and development investments and make a profit—however, many of these drugs are far overpriced and pricetags are simply designed to exploit the system and maximize corporate (and CEO profits). IN addition, many of the most expensive drugs in the US are sold overseas and in Canada at a fraction of the cost. This seems to me to be clear evidence of the pharmaceutical industry taking full advantage of the inherent wealth in the US today.

However, Would it not follow that if we placed limits on the prices of new drugs and paid “fair and equitable” charges, that healthcare costs would significantly decline?

It seems our politicians have sought to attack the problem from a few angles and have failed to address other significant sources of excessive healthcare spending. While reimbursement for physicians and physician groups are set clearly in the crosshairs of the ACA, it appears industry and litigators are not even on the radar. There is hope—legislation is being introduced that will allow legal purchase of drugs from Canada for Americans. In addition, pharmaceutical companies would be required to disclose what they charge for the same drugs in other countries. I believe this is a step in the right direction. Lets continue to innovate and provide new therapies for ALL Americans. But lets do it in a way that is cost effective. The latest studies make it clear that these drugs are overpriced. We must find a way to negotiate a fair and reasonable price that promotes and rewards innovation BUT also provides access to the newest and most effective therapies for all who need it.

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Social Media and Pharma: How the FDA is “Keeping Up with the Kardashians”

This week, the Washington Post reports that the FDA has issued a warning letter to a pharmaceutical company concerning statements about a new prescription drug that were made by Kim Kardashian on her recent posts on social media. In her posts on Instagram and twitter, Kardashian touts the effectiveness of a prescription drug called Diclegis for pregnancy associated morning sickness. Ms Kardashian has a substantial following on social media—including nearly 35 million on Twitter and nearly 45 million on Instagram. Of note, Kardashian is a paid spokesperson for the drug maker Duchesnay USA.

The FDA issued a letter to Duchesnay USA “The Office of Prescription Drug Promotion … has reviewed the Kim Kardashian Social Media Post,” the letter states “The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information.” In the letter the FDA points out that the social media posts fail to report information on potential risks and side effects. In addition, the FDA expressed concern over the fact that the social media posts do not mention that the drug has not been studied for women with certain pregnancy complications and that the drug is not suitable for women who are sensitive to several other types of medications.

Social media, when used properly, can be a powerful tool for patient engagement and patient education. It can also be a very effective marketing tool and can be utilized in the recruitment of patients for clinical trials. While the use of social media in medicine becomes more popular and more widespread, the FDA has been very slow to respond with a position statement. In 2012 a survey of social media use amongst biotech, pharmaceutical and device companies found that there were more than 211 industry related twitter feeds, over 115 Facebook pages and numerous YouTube channels actively communicating with doctors and patients. In fact, one company had nearly 115K tweets in one year. While the FDA vigorously regulates medical traditional communications regarding medical treatments, there has been a significant lack of regulatory guidance for the internet and social media use. In July 2014, the FDA attempted to produce a webinar to discuss the use of social media by industry and physicians—however, technical difficulties precluded access for many potential attendees. Ultimately, the FDA did issue a draft document to industry providing guidance for marketing on Twitter and other social media outlets.

What Did the FDA Draft Document Advise?

For the most part the draft document outlined requirements for a marketing based social media post.

  1. Each post must discuss both the benefits and risks of the drug or device—the information must be balanced. The benefit information must be accurate and not misleading in any way.
  2. Ideally, a hyperlink should be included in any twitter or social media post. This hyperlink should provide detailed information on risk and adverse effects of the marketed product.
  3. Both the chemical and brand names should be utilized in any social media post
  4. The Risk information must be just as prominent as the Benefit information contained within the post

What Exactly is the FDA doing in Social Media/Cyberspace regulation?

(Data obtained from White Paper “Eye on the FDA” by Mark S Senak, JD)

During the time period from 2008-2012, data from the Office of Drug Promotion reflects the fact that the FDA issued more violations for traditional media than those issued for media in the digital space. In fact, official warning letters were three times more likely to be issued to traditional media violations as compared to digital media postings. However, now it appears that with the Kardashian warning letter that the FDA is now poised to more closely scrutinize social media marketing efforts.

Advertising and marketing in the social media space is not the only new area of FDA regulatory interest in cyberspace. Now, the FDA is vigorously evaluating medically related applications for mobile devices. Regulated applications—those that the FDA considers to transform a mobile device into a medical device—are any applications that utilize sensors or attachments or any devices that provide patient specific analysis.

What About Clinical Trials?

Recently, social media has emerged as a very effective tool for the recruitment of patients for clinical trials. In most studies, the biggest barrier to a successful project is the effective recruitment of appropriate patients. In fact, patient recruitment typically accounts for nearly 30% of the time spent on a particular trial by research staff. The FDA now requires that social media ads, tweets, blogs and other forms of digital communication be reviewed in the same way that traditional recruitment materials are reviewed.

For Now, the FDA will  continue to “Keep up with the Kardashians”

This week’s action by the FDA makes it clear that more regulation of medical related activity in cyberspace is on the horizon. As consumers we must be careful of what we read and see on social media and must always consider the source—just as we often view traditional print and television media with a hint of skepticism.

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(photo courtesy of E!)

Pro Publica and Rating Surgeons: Garbage IN equals Garbage OUT.

Recently, the independent investigative journalism research group known as Pro Publica has received a great deal of attention for a newly published project for rating surgeons. This particular project has been met with a great deal of scrutiny by the medical community and has stirred significant debate since it was released in early July 2015. While providing patients with an objective metric by which they can evaluate physicians before deciding where and when to receive care is a lofty goal, Pro Publica’s attempt has fallen significantly short—and if anything—has created more confusion and frustration among both doctors and patients.  Several of my colleagues have written blogs and commented publicly about this rating system–Here is my take.

Helping the public make informed decisions about healthcare is an essential part of the process of improving the quality of care throughout the US—However, any information provided to the public must be easily digestible, RELIABLE and ACCURATE and supported by solid, well-conducted research. The methodology by which any data is assembled and any particular meaningful conclusions are reached is critical in determining whether or not the conclusions are of ANY use to the intended audience.

What Exactly is Pro Publica?

According to their website, Pro Publica is an “an independent, non-profit newsroom that produces investigative journalism in the public interest”. It is labeled as a non-profit organization and is funded by philanthropic donations as well as advertising dollars. The organization is staffed by nearly 45 investigative journalists and is located in Manhattan. Their mission statement is published as follows:

“To expose abuses of power and betrayals of the public trust by government, business, and other institutions, using the moral force of investigative journalism to spur reform through the sustained spotlighting of wrongdoing.”

What exactly was the Surgeon Rating project?

In the surgeon rating project, Pro Publica sought to produce a mechanism by which healthcare consumers could examine outcomes data prior to choosing a medical professional. In the project, journalists collected data from Medicare billing databases—these data were limited to a few selected low risk procedures and only included patients admitted to hospitals for these procedures. The analysis did not consider outpatient surgical center locations, nor did it evaluate data from patients admitted from the Emergency Department.   Doctors in particular specialties such as orthopedics, neurosurgery, general surgery and urology from all over the US were rated based on two outcomes—death and readmission—and all data was mined from a Medicare billing database. The journalists clearly state their methodology on their website. They examined records from in patient hospital stays from 2009-13 and looked at complications from what they defined as low risk surgeries. While Pro Publica does insist that they consulted with “experts” in each area evaluated, they do not mention if they had any guidance from statisticians, and other experts in the design of medical research investigations.

In their project, Pro Publica journalists collected information from nearly 3600 hospitals involving almost 17,000 surgeons. The outcomes of almost 64,000 Medicare patients were evaluated. A searchable “surgeon scorecard” was created online and has been available to the public since early July.

What DOES make a good surgeon?

The most important quality of a successful surgeon is judgement. Ironically, many outcomes are determined by the surgeon before operating—choosing an appropriate surgical candidate is often the most difficult decision a surgeon will make. This database does not take any of the pre surgery decision making into consideration. A good surgeon certainly has inherent physical talent and dexterity—most great surgeons have exceptional skill with a scalpel. In addition, patient volume is a huge determinant in surgical outcome. A surgeon with a large volume practice is much more adept at performing a routine procedure and is also much more skilled at handling intra operative surprises. Moreover, surgeons who have been well trained and well educated at academic institutions during their residencies and fellowships are more likely to practice evidence-based medicine and adhere to “best practices” and clinical guidelines.

Why is the Pro Publica project fundamentally flawed?

The project, while well intended, is of no practical use. The methodology is flawed at the beginning. Mining Medicare databases assumes that the data entered is in fact accurate. There are coding errors and data entry errors that occur every single day in hospitals and at CMS. The project does not take into consideration surgeons who accept patients that others would turn away—due to high risk, etc. In addition, the data analysis only takes into consideration inpatient procedures. Many of these low risk procedures are also performed in outpatient surgical centers—including these numbers would certainly bolster a surgeon’s “scorecard”. The research presented by Pro Publica was NOT peer reviewed. Any reputable medical journal requires that all investigations are reviewed by a minimum of two or three independent and anonymous EXPERTS in the discipline of interest. These experts are charged with evaluating not only the quality of the research and its findings but also the methods that were utilized in the study. Other than mentioning a group of physician experts that were consulted to identify complications, there is no mention of a peer review process and no mention of a methodology review.

Epilogue: Pending Impact of the Pro Publica Surgeon rating project?

 Ultimately time will tell. This database unfairly evaluates surgeons. While not all physicians are created equal, the methodology involved in arriving at the Pro Publica ratings has produced unreliable and inaccurate data. I fear that rating projects of this sort—that are not based on good, sound science—will result in many physicians refusing to treat sicker, higher risk patients. Ironically, it is the BEST surgeons that must take on the toughest cases. I, along with many of my colleagues, applaud any effort that can potentially empower patients to make informed decisions about their healthcare. However, I cannot endorse faulty science. If you put garbage data into a statistical program, you simply get well analyzed garbage out. As British economist Ronald Coase once said….”If you torture the data long enough, it will confess to anything…”

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