The PROCESS Trial: End of the Line for Central Lines?

A lot of things change for doctors once we’re done with training. Most of us leave behind the ivory tower that is the academic medical center to plow the common fields of private practice. We no longer have the weekly journal clubs, the Grand Rounds, the CME lectures. But what we gain is practical hands-on experience with what works, and what doesn’t. A nuanced knowledge of what’s accepted vs. what’s acceptable.

One such area has been the approach to sepsis. Manny Rivers et al published  their game changing study on early goal directed therapy (EGDT) in the treatment of septic shock in 2001, and the result became scripture in the field of Critical Care Medicine. The knowledge that tying sepsis resuscitation to the measurement of central venous oxygen saturation (ScvO2) and central venous pressure (CVP) using a central venous catheter, lead to a surge of recommendations.

The brain trust spewed forth these recommendations in various forms;  Surviving Sepsis Campaign, Sepsis guidelines, Sepsis bundles, Sepsis video games and Sepsis action figures. Somewhere in that sentence I may have transitioned to hyperbole.

Those of us in clinical practice didn’t always follow the drumbeat. Many of our patients with sepsis it seemed, did just fine without a routine central line or blood transfusions, or dobutamine drips. Why use invasive measures when we don’t really need them, and we’re not really sure that they’re helping? Still, when I talked to my ivory tower friends, the response was same, “We always use central lines and follow the EGDT”, they would say.

In case you’re thinking that I’m a maverick, well, it wasn’t just me. Surveys/studies that have looked at compliance with EGDT show compliance anywhere from as low as 0.1% to just above 50%. Clearly people were pushing back against the guidelines, and many began to publicly question whether results of EGDT could be generalized to the general population with sepsis.

Numerous studies showed that the overall mortality from sepsis appeared to be much lower than that in the original EGDT article. It began to become apparent that the patients in the original EGDT study were much sicker with higher lactic acid levels, lower ScvO2 levels, and higher mortality than in other studies. Possible explanations included selection bias, earlier presentation, or that they simply were sicker. Any of those explanations  however harmed  the external validity of the study.

The ProCESS trial aimed to answer the questions raised regarding EGDT. It randomized 1,351 patients at multiple sites to three different arms. One was EGDT which included placement of a central line to measure ScvO2, and CVP, as well treatment with dobutamine and blood transfusion if indicated by the protocol.

The second arm was protocolized therapy but without the EGDT protocol interventions. Patients had 2 large bore peripheral intravenous cathethers placed, and would receive a central venous catheter only if the former failed. Patients would then receive IV fluid boluses and pressors if required (this group most closely mirrors my own clinical practice as well as many other critical care physician colleagues in private practice) The third group was “usual care”, wherein critical care providers could treat as they would normally, without any recommendations from the study monitors.

The results of the study were quite illuminating. Overall mortality for the 3 groups was about 20%, in line with more recent studies on sepsis. More importantly, there was no significant difference in survival among the three groups. (Oddly, the “usual care” had the lowest incidence of renal replacement therapy (2.8%) vs. 6 % in the protocolized therapy arm, which was statistically significant). There were no significant differences among the three groups in survival,  length of stay in the hospital, or in the ICU.

And finally, to my point, among the patients in the protocolized therapy arm, only 56% of patients required a central line. Let me you remind you that the study was conducted only at academic centers which routinely adhere to the Surviving Sepsis Campaign Guidelines.

It was both intesting and telling that treatment in the “usual care” arm, in which the physicians were left to their own devices,  more closely mirrored the interventions in the protocolized arm than the care in the EGDT arm. Again, this at academic centers that adhere to the Surviving Sepsis Campaign recommendations.

So what can we take away from this? Was Early Goal Directly Therapy wrong? Was it simply an unneeded detour in the science of managing sepsis?

No, it was timely. There was a time when we needed a simple instruction manual, a “how-to” guide in resuscitating patients from septic shock. EGDT gave us that guide during a time when those of us in the medical community were still naive about the diagnosis and treatment of sepsis. But thanks to the study by Dr. Rivers and the efforts of our leadership, we’ve gotten better at finding and treating sepsis. We now have a better idea of what works, and what doesn’t. So now it’s time to remove the training wheels and discard the notion that we need to have static goals in the treatment of sepsis.

What else can we take away from this? That 20% of patient still die from sepsis, and that’s 20% too many. So for the time being I’ll keep working the fields of clinical practice, and continue to look to my ivory tower colleagues for the next innovation that will help my patients survive sepsis.

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How to Fix Healthcare, From a Doctor on the Frontlines: Part 3.

This is the last of a 3 part series by Dr. Moeller, the infamous Doctor on the Frontlines. In this series he explores ways in which our healthcare system is failing, and how it can be improved from the perspective of those who live and breathe healthcare every day. . . doctors.

I want every person in America to have access to quality health care all at a reasonable price because our citizens deserve this. Unfortunately, universal access to care at a reasonable price cannot materialize unless lawmakers look to doctors on the front lines of care for specific input.  We as doctors know in many ways why costs are high and why the public is unfortunately misinformed about how it all works.  But we need a representative sample of practicing doctors in Congress discussing these issues so that these “insider” insights can be applied to our current laws. In post, I look at the last of three central  ideas that would lead to better and more affordable care.

3. Health Savings Accounts.

The third solution highlights increasing patients’ roles in their own health, which would lead to more patient satisfaction, and actually lower costs.  This could be accomplished with health savings accounts.  These accounts would be funded by patients with pre-tax dollars and contributions made by employers and/or government subsidy stratified based on the individual’s income and job status.   With actual money in these accounts, patients would be able to discern costs better and use this money as if they were consuming any other good or service, such as handyman services.   This money could grow each year like an investment account and even be passed on to heirs at the time of death, keeping that sense of ownership with loved ones. Continue reading

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How a Journal Club and a Blog Challenged the Mighty NEJM

Could this be end of the Tonka-Scope?

Much has been written about how Web 2.0 tools can change the healthcare landscape.  It would appear a recent set of circumstances has upped the ante.

This story begins with a recent study that attempted to tackle the problem of ICU infections. ICU infections are a challenging problem, patients who are admitted to the ICU are at risk of worsening illness and death from infections such as MRSA which can be acquired while in the ICU setting. To counteract this risk, current practice is the performance of surveillance cultures on people who are admitted to intensive care. If the person tests positive for certain infections they are placed in isolation (and health care providers are asked to wear silly gowns and share a useless stethoscope).

The success of this strategy is dubious, ranging from successful in some studies to nearly useless in others. Based upon my personal observations of my own hospital’s isolation practices, my only conclusion has been that yellow is not a good look for me.

But I digress. In this study, patients underwent “universal decontamination” with chlorhexidine, a commonly used antiseptic. The study found a dramatic drop in the numbers of MRSA infections and bloodstream infections. The study was peer reviewed and published in the flagship of medical publishing, the New England Journal of Medicine (sorry JAMA). Continue reading

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A Dream About U.S. EMR’s; A Reality in th U.K.

I’m back at it again, talking about my continued love/hate relationship with EMR’s. From my conversations with doctors at different hospitals in our region, it seems that most docs appear to be falling into the “hate” column. Meanwhile, I’m still chugging along with the Allscripts Professional EHR that’s been installed in my office. And while it works just fine for the needs of a 3 physician single-specialty outpatient practice, it’s hardly the type of technology that, by itself, can change medical care for the better for a large number of people.

A recent study challenges that notion. In a study published in Chest, researchers in England sought to determine if inhaled steroids are a risk factor for pneumonia among asthmatics. It has already been shown inhaled corticosteroids are associated with an increased risk of pneumonia among patients with COPD. To determine this they looked at a database of medical information known as The Health Information Network (THIN).

In the UK, EMR’s have been in use for years, and general practitioners are encouraged (but not required) to participate in THIN. When a general practice elects to participate in THIN, software is installed in their EMR which runs in the background. The program collects data, while de-identifying it. The anonymized data is then uploaded to THIN, where approved researchers may have access to it.  There is no cost to the practices for participating, and in return for their participation practices not only receive in depth practice metrics, they also receive a percentage of any research revenue generated from the use of the THIN data. At the time that the study was conducted, the database contained data from 9.1 million patients.

But back to the question at hand. From a cohort of 359,172 people with asthma the researchers were able to identify 6857 people with pneumonia, along with 36,312 control subjects.  They were thus able to find a positive correlation between inhaled steroids and pneumonia. (for more on these findings, see my previous post: ) Continue reading

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How to Fix Healthcare, From a Doctor on the Frontlines: Part 2.

This is the second of a 3 part series by Dr. Moeller, the infamous Doctor on the Frontlines. In this series he explores ways in which our healthcare system is failing, and how it can be improved from the perspective of those who live and breathe healthcare every day. . . doctors.

I want every person in America to have access to quality health care all at a reasonable price because our citizens deserve this. Unfortunately, universal access to care at a reasonable price cannot materialize unless lawmakers look to doctors on the front lines of care for specific input.  We as doctors know in many ways why costs are high and why the public is unfortunately misinformed about how it all works.  But we need a representative sample of practicing doctors in Congress discussing these issues so that these “insider” insights can be applied to our current laws. In this post, I look at the second of three central  ideas that would lead to better and more affordable care.

2. Tort reform.

We as doctors have a calling to help patients.  But, as we all are human, mistakes can happen. It is very important that patients who are injured by mistakes be compensated in a way that the law is supposed to provide.  However, the point of law is to provide reliable decision-making that can sort good health care from bad health care.  Instead, currently, it is run ad hoc jury by jury with no set standards. The system currently favors a doctor if in fact something was done wrongly or it may favor a patient even if no mistake was made.  This unreliability leads to defensive medicine, ordering tests and procedures just to prove that you did something, or excessively documenting trivial facts to prove you looked at everything.  The estimates for defensive medicine has been estimated up to $200 billion per year.  The current laws neglect both the patient and the doctor and drives up costs with administrative and attorney fees.

Here is an example of the evolution of defensive medicine. If a family physician determines a patient’s headache is likely due to tension and there are no warning signs for something serious, the doctor may choose not to order a CT scan and have the patient follow up if symptoms do not improve. Rarely, a tumor or bleeding in the brain could present in such a way despite a normal clinical evaluation by the doctor.  If that patient ends up having a tumor or bleeding, they can sue the doctor for not ordering the CT scan earlier.  In turn, that doctor doesn’t want that to ever happen again, even though he did everything right by using his clinical knowledge to determine nothing serious was likely going on. Continue reading

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A Comedian Learns That He Has Sleep Apnea (Video)

Sleep Apnea is a serious condition that afflicts millions of people. The condition leads to reduced breathing during sleep which causes reduced oxygen to be delivered to the heart and brain. The condition may increase the risk of developing diabetes, hypertension, stroke, and depression. The reduced sleep quality can also lead to daytime sleepiness which can cause traffic and workplace accidents. In the video above comedian Jo Koy relates how he learned about the diagnosis of sleep apnea (he later got treated). Learn more about the disease and how you can get tested at SleepEducation.com.

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Controversies Surrounding Brain Death

by Chris Carroll, MD, MS.

The death of any person can be tragic, even more so when that person is a child.  Recently, there has been significant media coverage of the case of Jahi McMath, a 13-year old girl who according to news reports, underwent medical procedures to try to improve her obstructive sleep apnea and arrested following surgery. She was resuscitated and placed on a ventilator, but was pronounced brain dead on December 12th.  Our thoughts and prayers go out to the family during this difficult time and to the medical staff caring for Jahi and her family through this challenging and emotional situation.

 Although this case presents an opportunity to provide education about the determination of death, there has been little reasoned discussion.  Emotional discussions are understandable in situations like this one.  But for situations with as serious consequences as this, thoughtful discussions need to occur as well.

 The facts of this case are clear.  Although I am not involved in the care of this patient, from reading the outside neurologist’s report, her condition is not in doubt.  Legally and medically, she is dead.

 Brain death has been formally defined in the US since the 1980’s.  In a Presidential Commission that consisted of doctors, lawyers and bioethicists, brain death was defined as “the irreversible cessation of all functions of the entire brain, including the brain stem” and established detailed clinical steps needed to make that determination.

 So why do we have so much trouble with brain death? Continue reading

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How to Fix Healthcare, From a Doctor on the Frontlines: Part 1.

This is the first of a 3 part series by Dr. Moeller, the infamous Doctor on the Frontlines. In this series he explores ways in which our healthcare system is failing, and how it can be improved from the perspective of those who live and breathe healthcare every day. . . doctors.

I want every person in America to have access to quality health care all at a reasonable price because our citizens deserve this. Unfortunately, universal access to care at a reasonable price cannot materialize unless lawmakers look to doctors on the front lines of care for specific input.  We as doctors know in many ways why costs are high and why the public is unfortunately misinformed about how it all works.  But we need a representative sample of practicing doctors in Congress discussing these issues so that these “insider” insights can be applied to our current laws.

In this series of  posts I will outline 3 central  ideas that would lead to better and more affordable care.

1. Costs Need to Be Simple and Transparent.

The first idea involves making costs and reimbursement more simplified and transparent.  These changes would help clarify misconceptions about doctor’s pay.  Leaders need to stop attacking doctors for how much they earn because they do not really know how it works.  In all other professions, one gets paid what the bill says.  If a handyman comes in to fix your sink and charges $80, you pay him $80.  If you seek a lawyer, and he says he charges $250/hour and he works 4 hours for you, you owe him $1000.

Unfortunately, the medical billing is unique, confusing, and wrong.  The charges (bills) that patients see in the mail are not what doctors get paid.  These are inflated numbers derived from contracts between hospitals or groups and insurance companies.  A recent New York Times article headlines read “As Hospital Prices Soar, a Stitch Costs $500.”  Sadly, these inflated numbers have nothing to do with what the doctor gets paid. In fact, those bills do not go to the doctor at all, but rather to the hospital.

When a hospital or doctor submits a charge (bill), the insurance companies or Medicare/Medicaid, depending on the patient’s insurance, utilize a fee schedule.  This schedule consists of thousands of codes that give dollar amounts for individual procedures or clinic visits.  Each code has a dollar figure to determine how much to reimburse that doctor.  This is called a “Medicare fee schedule” and insurance companies will pay a certain percentage of the fee based on Medicare.  This can range from 80% to 180% of Medicare depending on the insurance carrier. Continue reading

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Dear Physicians: You Are Far More Wealthy Than You Know.

-By A. Joseph Layon, MD, FACP.

This article was written in response to Doctor Moeller’s Post: An Open Letter to Washington, D.C. From a Physician on the Front Lines

With interest, I read and re-read Matthew Moeller’s Open Letter.  My son, a first year medical student at Drexel University in Philadelphia, commented that this missive was being discussed by his colleagues in a tone of moral righteousness.  Interesting.

I know, I remember, what it was like to realize that the way to live an authentic life was to engage in providing health care for our people.  I remember debt, struggle, and 120 work-weeks. All of this, I remember.

And I remember being a third year medical student at The University of California, Davis – Sacramento Medical Center.  My professors, between patients on rounds, arguing how disastrous the health care system was becoming, how it was better in the “old days”, how they / we were suffering, how no one really understood what we had to go through.  Well, you get the idea.

While I understand, empathize and remember much of what Doctor Moeller says in his piece, and while he is – in my view on the mark in much of what he writes – I think he misses several points that are worth comment:

1. Medical School Debt: As a member of the Faculty Senate at the University of Florida I once got into a running argument related to the lack of breadth our undergraduates exhibited prior to their entry into professional school; lack of knowledge of history, language, and cultures other than their own.  Medical training is expensive.  In the not so distant past, a huge portion of this expense – certainly in the State of California where I was both an undergraduate and graduate student – was funded through tax revenue.  This was done not to be nice to our medical students, but because education was considered a social investment.  Proportionally, the monies in education have decreased (see Christopher Newfield, Unmaking the Public University – The Forty-Year Assault on the Middle Class, 2008, Harvard University Press), resulting in a grand portion of the debt saddling Doctor Moeller.  Nowhere in Doctor Moeller’s missive do I find any comment upon this.  The very policies that many in our profession cling to – physicians being, oddly to my mind given our work, frequently conservative and in the Republican or Libertarian camps – i.e., anti-taxation policies, put our medical students – and undergraduates, and graduates – at risk.  These policies put our future at risk.  Doctor Moeller rightly notes his difficulties; but Matt, what about the broader picture ?  This isn’t just a medical student issue. Continue reading

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Remember When We Used to Prescribe Inhaled Steroids for Asthma and COPD?

Press Release: Annual Conference of the Universal College of Chest Physicians October 2085; New Chicago, Mars.

The annual conference enjoyed another record attendance today as attendees flocked to Dr. Ramachandran III’rds keynote address reviewing exploits of physicians in the early part of the century. Dr. Ramachandran highlighted some key decisions and their consequences, such as the ACGME’s decree in 2032 that all residents should be swaddled before their scheduled hourly nap times. This of course led to the now infamous Great Hospital Apocalypses of 2033, 2034, and 2035.

Perhaps nearly as intriguing was the plight of inhaled corticosteroids for the treatment of respiratory diseases like asthma and COPD in the beginning of the 21st century. The period began with greater awareness and concern regarding the use of long acting beta agonist (LABA) bronchodilators such salmeterol. That risk was highlighted by findings published in the SMART trial (access through Chest archives here). There was increased concern regarding the potential harm caused by LABA which culminated in the placement of warnings on medications which contained LABA bronchodilators. These medications, experts said, were to be prescribed with extreme caution because of the possible increase in harm, particularly among children.

Scholars of the early 21st century thus highly recommended that asthmatics, especially children, be started on steroid inhalers before having to resort to using inhaled LABAs. Many also theorized that inhaled steroids had a protective effect when combined with LABA’s, possibly ameliorating their potential danger. Thus many at the time recommended a strategy of not using LABA inhalers at all, unless also simultaneously prescribing an inhaled steroid.

However, problems with this approach started to appear late in the first decade of the century. The TORCH study, a trial using combined inhaled LABA/inhaled steroids in adults with COPD suggested that there was an increased incidence of pneumonia among those treated with inhaled steroids. Early in the second decade a pivotal study then demonstrated that asthmatic children treated with inhaled steroids ended up being about half an inch shorter than they might have otherwise been (interestingly, a later study in 2035  correlated the reduced height with a statistically significant decrease in NBA dunking). Continue reading

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