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What To Do About Dr. Johnny Zellmer

7/30/2015

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The details surrounding the botched, horrifying execution of Clayton Lockett in the state of Oklahoma can be read in full here (June Atlantic issue).  Clayton Lockett had confessed to the grisly murder of a 19 year old woman in 1999.  He spent 15 years on death row.  By the time all appeals had been exhausted and an execution date set, the process for how capital punishment is carried out in Oklahoma, and in many states where lethal injection is employed, had changed considerably.  

As the public appetite for electric chairs and hangings and the firing squad waned, lethal injection became the predominant killing method for states where the death penalty is still legal.  It was seen as clean, anti-septic, humane, clinical.  No more hooded figures thrashing about strapped down in a chair, rapidly cooking from the inside.  No more Wild West public hangings.  No more Gulag-style firing squads with criminals lined up against a graffiti-littered wall.  It was a neater, cleaner, more "civilized" way for the government to go about ending a human's life.  A clean quiet white room.  Medical personnel in white masks.  The beeping of a monitor indicating heart rate and oxygen levels.  An IV inserted adroitly in the forearm.  Then, a series of three drugs, infused in quick succession.  One to anesthetize, one to paralyze, and then the killer--- high dose potassium chloride to stop the heart.  Bing, bang, boom.  The convict lies sedately on a flat white bed.  His eyes close.  He seems to be sleeping.  And then the rhythm monitor goes flat.  He is pronounced dead.  The state has completed its act of retributive justice.  We can all go home feeling satisfied.   

But not all is always as it seems.  Sometimes things don't go as expected.  In the United States, it has become very difficult for states to acquire the preferred sedative, sodium thiopental, due to international pressures on pharmaceutical companies who produce it.  You see, the countries where capital punishment occurs with the highest frequency are: China, Iran, Iraq, Saudi Arabia, Somalia, and..... the United States.  This is not a collection of nations one would ordinarily like to find oneself grouped.  The United States, paragon of freedom and liberty and western civilization, executes more people than all but a few repressive, authoritarian regimes.  The drug giant Hospira, the only FDA approved distributor of sodium thiopental, no longer sells its products to states for use in executions.  The European Union outlawed export of drugs to be used in lethal injections in 2011, thereby forcing states to adopt more creative methods.  Our nation has staked out a position on an island, morally and ethically.  We kill our criminals.  The rest of the advanced world has deemed the practice barbaric and backward.  

My original intent was not to make this an anti-death penalty rant (although perhaps that is the way it is trending).  My intention is to focus on a specific aspect of how the death penalty is carried out in general, and the Clayton Lockett execution in particular.  To wit, what is the role of a physician in all this?  The American Medical Association (AMA) statement on capital punishment and the practicing physician is as follows:
An individual’s opinion on capital punishment is the personal moral decision of the individual. A physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution. Physician participation in execution is defined generally as actions which would fall into one or more of the following categories: (1) an action which would directly cause the death of the condemned; (2) an action which would assist, supervise, or contribute to the ability of another individual to directly cause the death of the condemned; (3) an action which could automatically cause an execution to be carried out on a condemned prisoner.
The AMA, of course, has no legal authority to punish or discipline any doctor who chooses to violate this dictum.  It cannot suspend medical privileges or revoke state licenses.  It is simply a clarification of expected physician conduct, an elucidation of a code of ethics to guide physician behavior.  Violations are violations of spirit, not of law.  The American Board of Anesthesiology, actually stepped up in 2014 and incorporated the AMA code of conduct into its own professional standing policy.  This actually has some teeth.  Anesthesiologists who actively participate in executions run the risk of having board certification status revoked.  Many hospital systems will only credential and issue privileges to board certified physicians.  No privileges = no income.  For all other specialties, however, the AMA directive on capital punishment is essentially an elective guideline.  State medical boards have historically not taken action against physicians who involve themselves in state executions.  No physician in America has ever had her state license suspended or revoked due to actions related to an execution.   

The case of Johnny Zellmer, MD bears scrutiny.  Dr Zellmer is listed as a family practice physician in Oklahoma City, Oklahoma.  He has been in practice 15 years and the Lockett fiasco was the second execution where he had been present.  In general a physician is retained on the day of an execution in order to legally pronounce death.  As per AMA guidelines, physicians are not expected to participate in the actual killing mechanism.  But that's not the role Dr Zellmer chose to fill that day.  After numerous failed attempts to gain IV access, the paramedic in the death chamber called for assistance.  Inexplicably, Dr. Zellmer responded to her call.  He tried to get an IV in Lockett's jugular vein.  He tried several times to get a triple lumen catheter in his subclavian vein.  He asked for the availability of an intraosseus needle.  Then he moved to the groin.  They had been trying to get an IV into Lockett for an hour.  For some reason he used a standard short length (1.5 inch) angiocatheter to obtain access to Lockett's femoral vein (generally we like to insert 5-8 inches of catheter length into the access site) .  Lockett was covered in drapes and the execution commenced.  Unsurprisingly, the catheter retracted out of the vein and most of the infused drugs went into Lockett's subcutaneous fatty tissue instead of his vascular system.  No one noticed this right away.  After infusion of the death cocktail, Lockett was still able to speak and move.  Dr. Zellmer then entered the chamber, pulled back the drapes and noticed a giant swelling in the groin where the IV had been placed; unmistakable evidence of subcutaneous infusion.  So Zellmer then decided to place another line in the opposite groin.  He hit the artery instead of the vein and called for more drugs to be administered.  The paramedic demurred, insisting that he must access a vein.  He pulled  the catheter from the artery.  He held pressure.  Blood was all over the drapes.  Chaos reigned.  No one knew what to do.  Zellmer and the paramedic briefly considered the idea of resuscitating the still alive Clayton Lockett with CPR.  An emergency phone call was placed to the governor's office.  Permission was granted to halt the execution.  But by that time, enough of the lethal cocktail had been absorbed through his subcutaneous tissues that his breathing and heart rates slowed and eventually stopped.  He was declared dead an hour and a half after the initial attempt to gain IV access.  It was a long, slow, agonizing death.  

Dr Johnny Zellmer participated in the execution of an inmate last year in Oklahoma.  This is undeniable.  Without Zellmer's intervention, no matter how incompetent or maladroit it may have been, Clayton Lockett would not have died that day.  The estate of Clayton Lockett has filed a lawsuit naming Dr Zellmer as defendant for 8th amendment violations.  It is highly unlikely that this will amount to much.  But I think this is a case where our profession needs to keep its own house in order.  We need to make sure an episode like this never happens again.  I think the AMA ought to publicly censure Dr Zellmer by name.  Area hospitals where Zellmer may practice ought to consider this event when evaluating him during the credentialing process.  The state medical board of Oklahoma has the authority to determine his eligibility for license renewal.  At minimum, a suspension of his license seems appropriate.  From my perspective, Johnny Zellmer, due to his actions on April 29 of last year, has forfeited his privilege to call himself "doctor" for the rest of his days.  


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Surgeon Scorecard 2.0

7/28/2015

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Now that a lot of the hullabaloo surrounding ProPublica's release of their "Surgeon Scorecard" last week has died down I thought it would be a good time to take a step back and assess things pragmatically.  ProPublica did a disservice both to American patients in need of guidance, and to practicing surgeons.  That much is undeniable.  The "best" defenses I have heard for the scorecard is that it was "a good start" or a "first step forward on the road to transparency" or"Bob Wachter thought it was just great!" or the remarkably inane, "it's better than nothing!"  

In a previous post I outlined the flaws and derivative inconsistencies in the methodology used to compile the Scorecard.  And I am not alone in my lack of enthusiasm; the overwhelming consensus opinion from surgeons and physicians across America has been strongly negative.  Even the American College of Surgeons has weighed in, submitting the following op-ed to the Washington Post (unpublished as of today):
Surgeon ratings need to be a shared responsibility

The American College of Surgeons strongly believes that patients and their families deserve to have meaningful information available to assist them in selecting the right surgeon. This week, two public interest groups launched websites promising to assist with surgeon evaluation. Unfortunately, the usefulness of the information they shared is questionable for a number of reasons.

The two groups used differing methodologies, including how many years of Medicare data they reviewed, procedures studied, and rating scales used. A patient who visited both websites could potentially find the same surgeon rated very differently or only find a surgeon on one of the two websites.

Use of clinically validated data would have more fully taken into account the severity of the patient’s condition when assessing surgeon performance. For example, an 80-year-old diabetic patient with heart disease undergoing a gall bladder removal faces many more challenges than a healthy 40-year-old undergoing the same operation. Without factoring in surgeons’ success rate with the more challenging patients, the potential for wrongly directing patients away from these surgeons certainly increases. And as troubling, some insurers might restrict access to these surgeons in the future.

The importance of relying on clinical data to accurately measure surgeon performance is well documented in scientific literature, and clinical registries are considered the standard for collecting this information. As recently as this year, this point was underscored in a peer-reviewed article by Lawson et al in the Annals of Surgery.

Collection and dissemination of accurate clinical data, however, is a shared responsibility because it is a labor- and cost-intensive process. Private payors, government, professional societies, and public interest groups—all of whom are invested in transparency—must share this responsibility.

Two other issues bear consideration. First, surgery is a team experience. The surgeon works closely with the anesthesiologist and surgical nurses during an operation. While using clinical data can get us closer to measuring surgical performance, the reality is that in the operating room, many factors and many individuals contribute to the surgical outcome. Rating a surgeon’s skill in performing a particular operation, without factoring in these other considerations, leads to an incomplete analysis.

Second, we must ask ourselves how much data is helpful to a patient’s decision. The American College of Surgeons fully supports sharing the right data with the right person at the right time. We are open to collaborating with other stakeholders, including those in the public and private sector to identify the data that will serve the public interest.

At its core, the American College of Surgeons is committed to improving the care of the surgical patient and believes that sharing meaningful data is key to that endeavor. Let’s do it right and together. 

The most influential physician in modern times on data analysis, physician transparency, patient safety and quality control---Peter Pronovost MD, PhD, director of the Armstrong Institute of Patient Safety and Quality at Johns Hopkins--- has this to say about it:
The ProPublica measure is not valid. Though the methodology does account for some of the potential biases that might unjustly influence findings, it fails to account for another significant bias. For the ProPublica method to be a valid measure of surgical quality, all patients facing a potential readmission should have the same probability of being readmitted. Only then could readmission rates serve as a surrogate for complication rates and thus surgeon quality.

But patient factors such as their social support system, physician factors such as willingness to accept risk, and factors effecting access to care such as the presence of observation units or care in the emergency department, all impact whether a patient will be readmitted. Indeed, CMS has stopped reimbursing hospitals for admissions lasting less than two days because they recognize that the decision to admit a patient is arbitrary and that many of the same patients could be managed under observation.

The Methodology Needs Improvement: Even with these adjustments to the model, like any new quality measure, this would need to be tested and validated before it should be presented as a valid tool intended to assist consumers in their medical decision-making. In summary: the model uses an indirect measure of complications that fails to properly account for the variation in the reasons for a readmission.

The Scorecard was a disaster, in terms of validity, usefulness, and presentation.  That we can all agree.  But the core nugget of truth that led to its creation-- that patients ought to be able to have relevant and reliable data metrics at their fingertips when going about the process of choosing a surgeon--- remains unsolved.  I believe we can create a Scorecard.  Scorecard 2.0 if you will.  Now I don't know enough about hip or knee replacements or prostatectomies to comment on how go about assessing quality for those procedures but I do know a thing or two about gallbladder surgery, laparoscopic cholecystectomy.  

Here's what I would do:

  • Mandatory reporting for all cholecystectomies performed in the United States.  Then divide into elective vs emergent procedures
  • Data on common bile duct injuries, unexpected bile leaks, and intra-operative deaths compiled for every surgeon and made available publicly.  Those surgeons who exceed expected complication rates would be red flagged.  
  • Higher than expected rates of conversion to open cholecystectomy, although not  considered a "complication" by surgeons, would be published as an indirect  indicator of surgeon skill
  • 30 day readmissions could be included as part of it, but only if the data is analyzed by practicing surgeons in order to exclude those admissions occurring due to unrelated medical issues.
  • Surgical site infections (SSI's), although not as useful in the realm of minimally invasive procedures, is always a reasonable, objective metric to include
  • Surgeons who perform a higher percentage of emergent or urgent laparoscopic cholecystectomies could be highlighted as potentially more technically adept, assuming complication rates are equivalent to those surgeons who tend to perform more elective procedures.  


Not only should the data be compiled and published, but there ought to be internal review process (perhaps run in concert by the American College of Surgeons and the American Board of Surgery) wherein those surgeons who exceed expected complication rates would be required to undergo remedial training or have their next 20 cases proctored via video analysis.  Failure to comply would potentially result in revocation of "board certified" status.  

These are just random ideas from a nobody general surgeon in Cleveland.  I am sure colleagues at the higher levels of my profession would have plenty of useful insight as well.  We all have emails and published office numbers.  The next time Marshall Allen et al. want to put together another physician evaluation tool, they can always reach out, drop us a line.  We'd be happy to assist.  
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The Surgeon Scorecard: Much Ado About Literally Nothing

7/19/2015

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With much hype and fanfare, the independent investigative journalism outfit, ProPublica this week released their so-called "Surgeon Scorecard", assessing individual specialist surgeons who perform elective knee and hip replacements, spinal surgery, prostate surgery, and gallbladder removal surgery.   I had blogged about the impending release last week.  My trepidation about the idea of a non-medical, non-scientific organization analyzing complex surgical data concerned issues such as patient accrual, exclusion/inclusion criteria, definition of terms, and the method of analysis that would be utilized.  Alas, none of these questions were satisfactorily answered.  Nothing about the scorecard really works very well.  It distorts reality, clouds data, confuses patients, and proffers no insight in how a surgeon might improve his/her results.  It essentially presents meaningless, poorly powered raw numbers in the form of fancy statistics and charts (to be elucidated shortly).  The collective response from the community of practicing surgeons has been "what the hell is this?".  Even some members of the journalism guild have questioned the validity of the findings--- one going so far as to assert that ProPublica committed "journalistic malpractice" and should retract the piece.  That's not for me to say.  But let's break a few things down.  

First, there are loads of problems with the methodology.  The entire data base is composed of Medicare billing records for in-patient only hospital stays from the years 2009-2013.   This is a red flag from the start for two reasons.  One, it excludes outpatient Medicare cases.  It excludes Medicare patients admitted through the ER.  It excludes the vast numbers of patients with private health insurance.  Two, and most glaringly concerning, the entire analysis of "surgeon quality" was based entirely on billing records.  There was no case-specific analysis.  No chart review.  This may not have been possible given HIPAA and availability of data to journalists but it is a critical weakness.  Conclusions were based solely on ICD and DRG codes, context-free.  This is like determining the best baseball player in America by evaluating batting average alone, independent of any and all context, and finding out that the award has to be given, not to Mike Trout, but to an 11 year old boy in Huntsville, Alabama who bats cleanup and plays shortstop for his summer travel team because he finished the season hitting at a .744 clip, with 14 homers to boot.    

I can't reiterate enough the paucity of data that is analyzed.  Laparoscopic cholecystectomy (LC) is generally either an outpatient procedure performed on a patient between the ages of 20-60 or it is done semi-urgently on a patient admitted through the ER with acute cholecystitis.  Both of these scenarios would be excluded from the analysis pool.  What's left is a tiny proportional sliver of the total actual LC's performed in this country as the basis upon which to judge and assess quality.   It's just silly.  I'm a practicing general surgeon in Cleveland, Ohio so of course I spent some time reviewing the data on LC in my area.  What I found was both ridiculous and inexplicable.  If you try to find the LC complication rates of surgeons who operate at the main campus of the Cleveland Clinic you will only find one surgeon listed who qualifies for analysis (a minimum of 20 procedures performed over the 5 year time period).  At University Hospitals main campus, there are zero surgeons who made the cut for analysis.  So, at the mother ship hospitals for the two massive health care providers of Northeast Ohio, there is apparently only one surgeon who did enough LC's to qualify for the "Surgeon Scorecard".  I mean, didn't an editor at ProPublica find this odd, that the Cleveland Clinic allegedly doesn't do enough LC's to qualify for the scorecard?  I use to operate a good bit at the east side community hospital Hillcrest.  The two busiest general surgeons there from 2009-2013 also don't qualify.  None of it makes any sense.  

We also have to talk about boring statistical terms like "confidence intervals".  ProPublica uses a 95% confidence interval when presenting their data.  Given the relatively low number of procedures performed, the results of many surgeon's ratings often straddle two, and sometimes three, categories (low, medium, high) of complication rates.  As ProPublica itself admits:
 There is a possibility that a surgeon whose adjusted complication rate is “high” might be equivalent to a doctor listed in the “medium” category. The further apart the doctors’ rates stand, the less probability there is of an overlap.
When I reviewed my data, I found that my "risk adjusted complication rate" was 4.2%. (For what it's worth, my complication rate was "better" than all but one surgeon in the Cleveland area-- hooray, I guess) I don't really know what to make of that 4.2 as a raw number but when you account for the 95% confidence interval, it is just as likely, based on the shaded areas of the CI that I could be either a low, medium, or high complication surgeon.  So...... I could be good or bad.  I could be medium.  In fact, all surgeons in the Cleveland area who perform LC's and qualify for assessment fall within a rather narrow complication rate band of 4.1-5.5%.  But then the confidence intervals scatter the results of Cleveland surgeons all over the board of low, medium, high.  What is a patient to do with such unreliable, discordant information?  How does this help an anxious patient make an informed decision?  Nothing is gained.  Nothing is learned.  It's like you're 19 again and some girl broke your heart; all is meaningless, full of sound and fury, signifying nothing. 

Another troubling aspect to the scorecard is the rather arbitrary way the term "complication rate" is defined.  Per ProPublica, a surgeon gets dinged if one of two things occur: the patient dies during the same admission when the surgery was performed or if the patient is readmitted within 30 days of surgery and a panel of doctors determines that the readmission was "related to the surgery".  This is terrible on multiple levels.  The 30 day readmit criteria is not clarified.  We don't know what factors were considered.  We are simply told that "a panel of physicians" determined whether a readmission was "related" to the recent surgery.  The word "related" is doing a lot work in that sentence.  So the 84 year old patient 3 weeks out from hip replacement who is admitted through the ER with "increasing confusion" due to insomnia and overuse of narcotic pain meds is a red mark against the orthopedic surgeon.  Urinary tract infection 2 weeks after spinal surgery in a patient with known BPH.  The anxious 27 year old lady readmitted at midnight 2 days after a LC because of refractory nausea.  The 49 year old male who develops chest pains 10 days after lumbar fusion surgery.  All these are reportable offenses that don't necessarily have anything to do with the quality of said procedure performed. 

Most appallingly, these minor events are categorized in the same vein as a freaking peri-op death when assessing individual surgeon quality.  So a surgeon who has a tendency to operate on older patients and subsequently sees a higher percentage of his patients readmitted with tangentially related minor medical issues could conceivably have a higher "adjusted complication rate" than a true hack surgeon who kills a few otherwise healthy patients every year.  Furthermore,  why does ProPublica exclude all complications that occur during the surgical admission except death?  Why is "return to OR" not there?  What about post operative hemorrhage and need for transfusion?  What about a surgeon who all too regularly whacks a common bile duct and transfers the patient immediately to a tertiary care center where it is promptly repaired and the patient never gets readmitted?  What about an orthopod who is careless about post op DVT prophylaxis and sees an unacceptable level of blood clots and pulmonary embolisms on his patients?  What about surgical site infections?   Why is death the only metric deemed appropriate for inpatient quality assessment?  It's really an embarrassing lapse in judgment and methodology.   

You see, surgeons across America are not afraid of transparency.  Cardiac surgeons have had to publicly report their CABG results for years.  The American College of Surgeons has made transparency and quality improvement a focus of inquiry.  Justin Dimick MD at Michigan and Karl Bilimoria MD at Northwestern and Conor Delaney MD at UH Case Medical Center are doing yeoman's work getting some of this complicated data into peer reviewed journals.   Through initiatives such NSQIP and PQRS reporting, the College has begun the long, arduous process of quality-assessment to ensure that patients and payors are presented with data that are accurate, comprehensive, and fair to surgeons.  ProPublica calls out a urologist at Johns Hopkins, one of our elite tertiary care centers, for having a higher complication rate than some of his colleagues, without accounting for any mitigating factors.  What's his patient population?  Does he tend to operate on sicker patients?  How many did he do?  What exactly were his so-called "complications"?  Did he perform a lot of "re-do" or revisional surgery?  None of these critical, enlightening factors are considered by Marshall Allen et al.  They wanted to get their story up on line ASAP.  They wanted to be first, which is a fundamental principle that drives a lot of modern journalism, but isn't so useful when it comes to presenting highly complex, scientific data to the general public.  You can't just vomit up a thin sliver of data based on a select cohort of patients and arrogantly title your findings "Surgeon Scorecard" as some sort of definitive, go-to patient resource.  And by releasing an article on Dr Constantine Toumbis, a spinal surgeon in Florida who apparently has a higher than normal complication rate and was recently discovered to be an ex-felon dating back to a stabbing incident 20 years ago while a medical student,  as a companion piece to the "Surgeon Scorecard", ProPublica veers precipitously close to the yellow journalism of Horace Greeley and Gawker and the New York Post.  It's a low moment for an otherwise esteemed investigative operation that has been deservedly recognized for its work in exposing corruption, deceit, and greed across a wide range of subject matter.  But this project is no good.  We all know that the worst surgeons are either too tentatively slow or way too reckless and fast.  ProPublica rushed this study to print without doing the due diligence of vetting it with actual surgeons who are actively attempting to perform the exact  same task of assessing and improving surgical outcomes.  There are no short cuts to this.  It will take some time.  It's complex.  It will take some twisting of arms within the surgical community.  But it's coming.  No longer will we as surgeons be able to hide behind our surgical masks or the "MD" certificate  hanging on our office walls.  We will have to demonstrate proficiency and excellence.  I am confident that most board certified surgeons in this country are unafraid of such a proposition.  As long as it's done the right way......   
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Libby Zion Redeemed?

7/14/2015

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Bilimoria, et al have an interesting paper up on JACS (on line only for now) that attempts to quantify the effects of surgical resident work hour reform on patient morbidity and mortality.  
Study Design:  Patients from 5 surgical specialties (neurosurgery, obstetrics/gynecology, orthopaedic surgery, urology, and vascular surgery) were identified from the American College of Surgeons NSQIP. Data from one year prior and two years after the reform was implemented were obtained for teaching and non-teaching hospitals. Hospital teaching status was defined based on the percentage of operations with a resident present intraoperatively. Difference-in-differences models were developed separately for each specialty and adjusted for patient demographics, comorbidities, procedural case mix, and time trends. The association between duty hour reform and a composite measure of death or serious morbidity within 30-days of surgery was estimated for each specialty.

Results:  The unadjusted rate of death or serious morbidity decreased during the study period in both teaching and non-teaching hospitals for all surgical specialties. In multivariable analyses, there were no significant associations between duty hour reform and the composite outcome of death or serious morbidity in the two years post-reform for any surgical specialty evaluated (neurosurgery: OR 0.90, 95% CI 0.75-1.08, P=0.26; obstetrics/gynecology: OR 0.96, 95% CI 0.71-1.30, P=0.80; orthopedic surgery: OR 0.95, 95% CI 0.74-1.22, P=0.70; urology: OR 1.16, 95% CI 0.89-1.51, P=0.26; vascular surgery: OR 1.07, 95% CI 0.93-1.22, P=0.35).

In 1984, an 18  year old college student named Libby Zion died less than 24 hours after being admitted to New York Hospital.  Her father was a prominent NYC attorney and her mother a former publishing executive.  An investigation revealed that Ms Zion died as a result of a deadly medication interaction.  She had presented to the hospital ER with several days of flu-like symptoms, including fevers and a tremor.  Her medical history included depression, anxiety and substance abuse (toxicology screen was positive for cocaine metabolites).  Her  psychiatrist had prescribed the anti-depressant Nardil (phenelzine).  Her initial ER records indicated a temperature of 103.5, an elevated WBC, and "hysterical symptoms".  She was then admitted to the floor at 2AM and evaluated by an intern and a 2nd year medical resident.  The working diagnosis was "viral syndrome".  For increased agitation and shivering, she received an intra-muscular injection of demerol.  Her mental status deteriorated even more; increased confusion and thrashing about in her bed.  Soft restraints were ordered and she received a dose of the anti-psychotic Haldol.  By 6am her temperature had spiked to 107.  Shortly thereafter she went into cardiac arrest and was unable to be revived.  

It was revealed that the resident and intern on call that night were finishing out a 36 hour in house shift.  An autopsy confirmed that Ms Zion had died from serotonin syndrome, arising from the lethal combination of phenelzine, demerol, and the cocaine abuse.  Mr Zion launched an offensive against the hospital, the residents involved in the case, and the entire medical resident training paradigm.  He was convinced that the long, unregulated work hours of the residents directly contributed to his daughter's death.  Criminal proceedings were considered but ultimately a grand jury declined to indict for murder.  At civil trial, a jury found for the Zion estate that the physicians involved in the case were negligent and a $375,000 settlement was ordered to be paid to the Zion family for "pain and suffering."

Afterwards the New York State Health Commissioner established an ad hoc advisory committee, led by Bertrand Bell MD,  tasked with evaluating the training and supervision of residents in the state of New York.  This "Bell Commission" then formalized a set of guidelines that was implemented by residency training programs in the state of New York in 1989.  Specifically, it was mandated that residents could not work more than 80 hours in a week.  Over the course of the next 15 years, the idea of work hour reform seeped into the national consciousness and, in 2003, the ACGME enforced the 80 hour work week nationwide, with residents being limited to no more than 30 consecutive hours of continuous duty.  By the 2011, the reforms were further revised.  Interns are now not allowed to work more than 16 hours continuously and there is some nonsense in there about senior residents being forced to take naps if on call for a 24 hour period.

The impact of work hour reform has been hard to quantify.  Theoretically it would see to make sense--- less tired residents would be more attuned to detail, less likely to make errors.  Further, putting more onus of responsibility on the shoulders of senior residents and Attending physicians would presumably lead to fewer errors, better patient outcomes.  The data from numerous studies, however, has been less than compelling.  This, this, this, this, this, and this all magnify the conclusions drawn from the above referenced Bilimoria paper----work hour reform has had no appreciable impact on patient outcomes.  Keeping trainees out of the OR, sending them home, forcing them to take naps----none of it has improved patient morbidity or mortality.  Not to mention the unforeseen consequences of resident hand-off errors and the still yet to be quantified impact on the quality of medical and surgical training.  

But we really ought not to be too surprised.  Libby Zion died tragically at the too young age of 18.  She died in a hospital, under the watchful eye of two inexperienced, overworked residents.  But her death may have been unavoidable.  Serotonin syndrome was a poorly understood mechanism back in 1984 and the interaction between phenelzine, demerol, and cocaine was even less well recognized.  After the Grand Jury indicted the resident and intern for "gross negligence" the Hearing Committee of the State Board for Professional Misconduct investigated the charges over the course of 30 hearings.  Several of the witnesses were Chairmen of Internal Medicine Departments at prominent medical schools who, under oath, testified that they had never heard of the interaction between demerol and phenelzine prior to the Zion case.  The initial autopsy, for gods's sake, listed cause of death as "bronchopneumonia".  The cause of death was a true medical zebra.  Most of the best medical minds of the time would have missed it, well rested or otherwise.  


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Third Party Transparency for Surgeons

7/11/2015

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The non-profit independent investigative journalism organization ProPublica has announced plans to release a "Surgeon Scorecard" next week.  From the statement:
Millions of patients a year undergo common elective operations – things like knee and hip replacements or gall bladder removals. But there’s almost no information available about the quality of surgeons who do them. ProPublica analyzed 2.3 million Medicare operations and identified 67,000 patients who suffered serious complications as a result: infections, uncontrollable bleeding, even death. Next week, we report the complication rates of 17,000 surgeons – so patients can make an informed choice.
This will be interesting to see.  Many questions immediately spring to mind, however. 
  •  Will this just be a massive data dump without any attempt at analysis by knowledgeable medical practitioners?
  •  Will there be an attempt to correct for patient factors like age, pre-existing medical conditions, degree of overall health at the time of surgery?
  • Will the data break down the cases into elective vs emergency operations?  
  • Will they account for surgeons who provide a majority of care to lower income and Medicare/Medicaid patient populations vs those who only rarely operate on patients with subsidized healthcare?  
  • How will they define terms like "post operative sepsis" and "complication rate"?  Who decides on whether or not to categorize an outcome as "good" or "bad".


I remain wary of the coming publication, of course.  I'm willing to suspend judgement until I get a chance to review it but I think all surgeons are a little anxious about having a third party, non-medical organization present some sort of definitive, simplified "Surgeon Scorecard"  (with A's and B's and F's???) to describe a complex data set for the general public.

I think we as surgeons dropped the ball on this by not being more pro-active in responding to public demands for greater transparency in all professional fields.  We could have gotten involved early, to ensure that what is presented to the public as an evaluation tool is accurate, fair to surgeons, and reliably instructive in guiding patient decision making.  With ProPublica going solo on this, we have lost the ability to mold the narrative.

We shall see how this plays out next week..... 
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Who Admits a Bowel Obstruction?  Does it Matter?

7/8/2015

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The Journal of the American College of Surgeons (JACS) has an article this month that I missed last fall, originally presented at the Western Surgical Association meeting in California, that explored differences in outcomes of patients with a bowel obstruction who were admitted to either a medical or surgical service. 

 This takes me back to my Chicago residency days and fond memories of arguing with ER Attendings at 3 AM regarding whether or not the next name on my endless deluge of consults ought to be admitted to surgery or medicine.  It got so bad, administration from both the medical and surgical departments had to articulate actual policies on who would admit certain diagnoses.  All bowel obstructions went to surgery.  Cellulitis to medicine.  Cholecystitis to surgery.  Cholangitis to medicine with immediate surgery/GI consults.  Pancreatitis could go either way.  Mild alcohol pancreatitis went to medicine but severe gallstone pancreatitis with a lot of Ranson criteria had to go to surgery.  This eliminated a lot of the unhealthy inter-departmental bickering and resentment.  But that was a large academic teaching hospital.  You could set policies and make residents do what you want.  In the world of private practice and community hospitals it's different.  I found that many of the cases I had been forced to take on my service as a resident were now being admitted to medicine with surgery consults.  I'd get phone calls at 3 AM from laid back, bro-talking ER docs telling me about so and so with a "hot gallbladder" who was being admitted to Dr Johnson and he was hoping I would consult first thing in the morning.  Hell yeah, I said.  I'm all for that.  The reason for the shift soon became clear.  Old school medical doctors who take a lot of ER call actually like having a lot of patients on their primary service.   Because they have mortgages and car leases and private school tuition to pay.  Plus many of them were actually awesome doctors who saw their patients no matter where they needed care and demanded that, if one of their patients was admitted to the hospital, they were notified and had the patient admitted to their own damn service.  I liked those guys. 


The article cited above retrospectively compared outcomes  of 555 patients admitted between 2008 and 2012 with a primary diagnosis of adhesive-related bowel obstruction.  Results and conclusions in block quote verbatim form:
 
Results:  Median LOS among patients whose ASBO resolved nonoperatively was similar for those on SS and MHS (2.85 days vs 2.98 days; p = 0.49). In patients without nonoperative resolution of ASBO, those admitted to MHS had longer median LOS when compared with those admitted to SS (9.57 days vs 6.99 days; p = 0.002) and higher median charges ($38,800 vs $30,100; p = 0.025). Patients admitted to MHS who had an operation, had a greater median TTO than operative patients on SS (51.72 hours vs 8.4 hours; p < 0.001). Multivariate analysis did not identify factors independently predictive of increased LOS, TTO, or charges.

Conclusions:   Adhesive small bowel obstruction patients are treated in a heterogeneous fashion in our hospital, causing disparate outcomes depending on admitting service when patients undergo operation. Admitting all suspected ASBO patients to SS has the potential to dramatically decrease LOS and reduce waste in those requiring operation, thereby reducing health care expenditures.

NB: MHS = medical hospitalist service, SS = surgery service

The claim is that patients with a primary diagnosis of a small bowel obstruction who end up requiring operative intervention spend more time in the hospital and accrue higher overall hospital costs.  Ergo, in order to save costs and get patients home faster, all bowel obstruction cases ought to be admitted to a surgical service.  

Several issues here.  First, there was no difference in hospital length of stay in patients who resolved their bowel obstructions with conservative management.  Which is good, right?  But they found that in those patients who required surgical intervention for refractory obstruction, the patients initially admitted to a surgeon's service had an operation quicker and therefore were discharged from the hospital sooner.  But are they neglecting selection biases here?  In my experience, the patient with a bowel obstruction admitted to a medical service is more likely to be elderly and have multiple co-morbidities (CHF, CAD, DM, COPD, anti-coagulation medicines etc etc).  So the ER calls the surgeon at 4 am.  Surgeon tells the ER to place NG, start some fluids, and admit to medicine for optimization of medical issues.  Surgeon sees patient first thing in the morning and every day thereafter.  This is exactly what he would do whether he was the admitting doctor or a consultant.  Furthermore, most surgeons are going to treat a more frail/elderly/unhealthy patient a hell of a lot more conservatively before they decide to recommend surgery (assuming the absence of peritonitis/acute abdomen, of course).  An 84 year old patient with severe CAD is probably going to get an extra day or two of NG decompression before you whisk her off to the OR.  That isn't delayed intervention due to primary service mis-assignment.  It's smart clinical judgment.  Conversely, the 46 year old lady with no medical problems gets admitted to surgery no questions asked.  And if her films are crap in the morning there's a damn good chance she gets added on to OR that afternoon.  

Overall, there was no difference in mortality or major morbidity in the two groups.  Readmission rates were the same.  The paper simply affirms something all us in clinical practice already know.  It really doesn't matter whether the patient gets admitted to Dr. Medicine or Dr. Surgery.  As long as the surgeon is notified from ground zero and allowed to follow/manage the patient from the very beginning of admission-- either as admitting physician or consultant---then outcomes will be optimized.  It's almost unheard of for a patient to be admitted to medicine without a concomitant surgical consult.  The paper tries to imply that the patients admitted to the medical service had a delay of surgical intervention because the surgeon was not consulted for an opinion until too much time had elapsed.  But they don't document this.  It's a major weakness in the paper. 

As far as I'm concerned, as long as you let me know a bowel obstruction is in the ER, you can admit him to the psychiatry service for all I care.  I'll manage the patient the same way as always.   
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Richard Dawkins Doesn't Understand Diabetes

7/8/2015

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The renowned atheist/evolutionary biologist Richard Dawkins tweeted the following  June 21: 

Diabetic Muslim lost toe after defying doctors' orders and insisting on Ramadan fast. Isn't faith wonderful. http://t.co/xovOIH36ae

— Richard Dawkins (@RichardDawkins) June 21, 2015
This is a silly, uninformed tweet, desperately grasping on to a sliver of fact and distorting the complex reality.  Oh so ironic for such a self-declared champion of science and empiricism as Mr Dawkins.  He links to an article on the Huffington Post that misleadingly equates the Ramadan fast with a diabetic Muslim man who ended up losing his toe.  Lifelong diabetics, especially those who do not control their blood sugars well, are at risk for peripheral neuropathies and vascular insufficiencies, especially of the smaller vessels supplying the feet and toes.  This can result in gangrene of the toes and festering, non healing ulcers of the feet.  It is an accumulatory, life long complication of decades of sustained, uncorrected hyperglycemia.  Of course, Dawkins grabs this rope of opportunity and rides it all the way to Islamophobia-ville.   His conclusion is based on a fundamental misunderstanding of how diabetes affects human physiology.  

The patient in question did not lose his toe because he had fasted during Ramadan.  There is a danger in fasting for diabetics.  But it has nothing to do with gangrenous feet and the lopping off of toes.  If you fast, have diabetes, and you are taking either insulin or oral hypoglycemics you run the risk of hypoglycemia, or low blood sugars.  Profound hypoglycemia can lead to a comatose state, even death if left untreated.  The neuropathic and vasculopathic complications of diabetes are the accumulative result of years and years of hyperglycemia.  In the context of Mr Dawkins' tweet, this is an important distinction.  During Ramadan, a devout diabetic who fasts increases his risk of hypoglycemic coma, seizures, sudden death.  What demonstrably won't happen is that his toes will suddenly become necrotic and require an emergency amputation.  

This is pure dissembling exploitation.  This is  donning the false mantle of Scientist Sage strictly for the purpose of scoring points in an ideological crusade.  He is not looking to illuminate or unveil hidden knowledge.   It is choosing ideology over empiricism.  Dawkins has fallen prey to the very logical fallacy that he accuses his theistic foes of committing everyday.  He would rather bend reality or willfully misunderstand facts if  the empirical results do not support a pre-determined conclusion.  




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    Jeffrey C. Parks MD, FACS

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