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Thursday, June 2, 2016

Thinking beyond hospice

I recently attended the death of a friend at his home. He had a disease that was terminal and untreatable and he and his wife had finally decided on no further medical treatments that would require hospitalization. He was not very old and had been cared for by his children and wife during the previous 4 months that he couldn't care for himself. Time had become short and valuable and he had become weak, so he didn't amend his POST (Physician's Order for Scope of Treatment) to indicate that he wanted no resuscitation, though his wife and family knew his preferences. He had not entered hospice because his needs were adequately fulfilled by his family, friends, his physicians and home health.

When his wife noticed his breathing had changed, she called me, a friend of the family. I had offered to be available to come over for any medical situation in which they might need a rapid house call. I arrived about 15 minutes later and he had just died. I confirmed the situation with my medical gadgets. We were all sad and tearful and we talked and hugged and talked some more. I called the police, reported the death and the fact that it was expected. A kind and respectful sheriff's deputy came out and took a picture and a couple of statements. I called the local funeral home and a couple of guys who were on call came over with their stretcher and bag and quilt to collect him. About 90 minutes after I got the first call, his body was on its way to the funeral home and thence the earth and eventually the far corners of the universe. We sat and talked as the sun went down.

It was a good death, as much as a death of a vital and gifted person with plans can be good. It was a hospice-free home death, surrounded by family and friends. Such a thing is becoming vanishingly rare, and it made me think. Maybe we could make this easier. Maybe our community could reclaim the wisdom that it takes to facilitate better deaths, with or without hospice, nuanced to our needs and resources.

Hospice care is intended to be a holistic approach to providing support to dying patients during their last 6 months of life. The concept of hospice dates back to medieval times. Wikipedia says that in 1090 there is evidence that places existed which were devoted to care of the incurably ill, staffed by crusaders. There have been institutions for treatment of people who are dying since then, likely because of the clear need for dedicated care for people who are vulnerable and in pain and unable to advocate for themselves. Hospice at home was encouraged by Elizabeth Kubler-Ross (author of the book On Death and Dying), arguing that we shouldn't institutionalize people who are going through a universal life process. Legislation to pay for hospice care passed in the early 1980's in America. Hospice care has increased in popularity, more than doubling the number of patients utilizing the service and the amount of money spent in the last 10 years. This year an industry report predicts that the US will spend over $25 billion on hospice care. (It will also save several times this amount of money by providing appropriate care for the dying rather than futile procedures in a hospital setting.)

Hospice is extremely valuable in our culture which has lost the habit and skills of taking care of the dying at home. They provide a consulting nurse who keeps in touch with both the patient and his or her doctor, providing adjustment of medication to ease suffering and equipment such as hospital beds or shower chairs that may become necessary. They provide 24 hour phone advice and expertise regarding the dying process. They organize volunteers who will spell a caregiver to go out for a walk or shopping and aides who can help with bathing. Besides being valuable, hospice is also extremely expensive (mostly paid for by insurance including Medicare) and often feels like a one-size-fits-all solution. Hospice is difficult for introverts and people who treasure their privacy. "Going on hospice" can be demoralizing. Hospice is mostly not available to people who are still undergoing life-prolonging treatments such as chemotherapy. The use of pain and anxiety medication often seems heavy handed. I have ranted about some of these issues in the past. All this aside, I am truly grateful for the existence of hospice services and devoted hospice workers who make dying at home and in peace easier.

But I think we can do more and maybe better. My friend who died, and his family, needed his wise friends and his multidisciplinary team organized by his specialist, his flexible and understanding primary care physician and, in the end, me to smooth the difficulties of his passing. It turned out that he needed a bare minimum of medication and remained intelligent and interactive up until nearly his final breath. He didn't need hospice, but he did need help. I think there is support that a community can provide that is beyond what a hospice organization does.

What we need is a network of people in our community who are good for different things, to share with each other and with people somewhere on the dying spectrum what they know. Emergency medical technicians know what needs to be done when somebody dies at home of a terminal disease and so do I, but families of dying people should know too. It would be reassuring. Lawyers know about what is needed to have a valid will. Priests, nuns and other clergy people are skilled in helping people find meaning in the process of dying. There are people in my community who always seem to be there when someone is very sick and they are comfortable with some of the worldly aspects of the end of life. There are people who have special relationships with animals who could give comfort by visiting with a cuddly creature. There are musicians of all description and artists who can brighten a dreary space. People who have recently gone through the death of a loved one might be glad to sit down for a cup of coffee or come along for a doctor's appointment to take notes or ask the right questions. They may know how to make the funeral process less expensive. There are social workers who would be founts of good advice. Some people know about helping write a life history. Some people can do guided imagery or hypnosis for symptoms control. There are needs and solutions I haven't thought of, and somebody in my community knows about them.

When I was pregnant with my second child, we hired a doula. She was a woman who had lots of experience with birth and who helped me with questions I didn't want to ask an obstetrician. She encouraged me, shared stories and sat with me the entire time I was in labor, which was a long time. Because of her confidence I didn't feel frightened and I didn't need labor anesthesia. There are also doulas for the end of life. There are none in my community, but I think there are people with the basic wisdom and experience to be a companion for a patient and family during the dying process. Death can be frightening but it doesn't need to be.

This network of people would not displace traditional hospice, at least not in most cases. It would be a volunteer organization and, with the possible exception of doulas, there would be no requirement to be "on-call." This would create new connections within our community. There would be unexpected and probably positive consequences. Each person who volunteered would know that, although they are giving now, they will be receiving at some point because death is going to happen to all of us.

The hospice movement that gained steam in the 1980's was very important. It helped move death out of the hospital and the intensive care unit and back home, where we can be surrounded familiar things that bring us comfort. I think we are ready to take the next step. We may be ready to use our collective wisdom to find the meaning in life's end, beyond the mistaken concept that death is a failure of medical technology. Life is valuable in part because we know we will die. Like birth, we only get to do it once. Maybe we can be intentional about it and help each other out by sharing what we do well.

Thursday, May 26, 2016

Is there a pill to make you live longer? The HOPE-3 trial and the hype that will surely follow ...


Today in the New England Journal of Medicine (NEJM) an article has appeared reporting the results of the Heart Outcomes Prevention Evaluation-3 (HOPE-3)trial. Exciting simplifications are sure to follow in the news. If you would like to stop reading now, the answer to the question posed in the title is probably no.

The question:

For many years researchers have discussed the possibility of a creating a pill that might contain several kinds of medication that would reduce people's risk of dying of cardiovascular disease. It is an attractive thought. Since cardiovascular disease is the major cause of death globally, reducing that risk has the potential to vastly reduce death and disability. Originally we thought that a suitable "polypill" might contain something to lower the blood pressure, something to lower cholesterol and something to reduce the risk of blood clots. Many studies have looked at the mortality benefits of various blood pressure pills, cholesterol lowering strategies and anti-clotting drugs and we have found that some of them help some people to some extent and some cause some people problems. Drat. So complex.

The history:

The original HOPE trial looked at a blood pressure pill (ramipril) which was added to whatever other medication a group of people at high risk of cardiovascular disease were taking. It lowered the risk of heart attack, stroke and death significantly enough that the study was stopped early and drugs in the ramipril class (Ace inhibitors) were aggressively prescribed, especially for patients with diabetes, probably to good effect.

The HOPE-2 trial looked at using vitamins to reduce homocysteine levels, which appeared to be a significant risk factor for heart attack and stroke. The studied doses of vitamin B6, B12 and folate did not reduce any of the outcomes they looked at. HOPE-2 was dashed.

In 2007 HOPE-3 began, looking at a combination of blood pressure medication and cholesterol medication, specifically to reduce death from heart attack or stroke, new heart failure, cardiac arrest or non-fatal heart attack or angina. The study was performed in academic medical centers all over the world, including the US, Europe, China and India, South Africa and Southeast Asia. Over 14,000 patients were enrolled, limited to men 55 and over and women 65 and over with intermediate cardiovascular risk (calculated at about 1% per year). Women 60-65 years of age were eligible if they had one of several specific risk factors, including glucose intolerance, smoking and high waist to hip ratios. These were people who had never had heart problems or strokes.

Drug company involvement:

Astra Zeneca helped fund this study along with the Canadian Institutes of Health Research. The cholesterol and blood pressure medication used in the study was on patent and sold by Astra Zeneca. The cholesterol pill was rosuvastatin (Crestor) and the blood pressure medication was candesartan/hydrochlorothiazide (Atacand/HCT). There were many drugs to choose from in the categories of effective blood pressure reducers and statin cholesterol medication, some of which would have been cheap and generic. The drugs they did choose are now generic but not yet cheap. I suspect Astra Zeneca hoped the study would have ended in time for them to reap financial benefits as their particular drug proved miraculously effective, or that the combination of the drugs could be made into a new formulation that would extend their market share.

So what happened? Getting to the point.

First there was a run-in phase. The 14,000+ patients were given the study drugs and about 2000 of them dropped out because they didn't tolerate them or didn't want to participate anymore. 12,000 patients were left. Of these about 3000 took placebo pills, 3000 took the blood pressure pills only, 3000 took the cholesterol pill only and 3000 took both blood pressure and cholesterol medication. After about 5.5 years, the patients taking blood pressure medication did not have a significantly lower risk of death, heart attack or stroke or the other cardiovascular outcomes. The patients taking cholesterol medication did have a reduced risk of death and cardiovascular outcomes. Taking both blood pressure medication and cholesterol medication was no better than just taking the cholesterol medication.

How big was the effect and how much does this cost?

The article quotes a hazard ratio of 0.71 for patients taking the combination medication, meaning that the medicated patient has 7 tenths the risk of a bad outcome of the unmedicated patient. The raw numbers are way more interesting. After about five and a half years of taking the combination of drugs or placebo, 163 patients in the active drug group had died and 178 of the placebo group had died, a difference of 15. At the present cost of these drugs, about $280 per month, it would cost about $3.7 million per life saved, which is pretty steep. Just taking the cholesterol medication, which is really the only one that had a positive effect, would cost about $2.6 million per life saved. If there were drugs on a $4 a month plan that did the same thing  we might get down to a very reasonable cost of $53,000, assuming no other associated costs like doctor visits or lab testing (which is not a fair assumption.) Death is not the only thing we care about, of course, but other differences, such as numbers of hospitalizations, were not much more impressive when I reviewed the supplemental data.

How about side effects?

To begin with, 2,000 of 14,000 patients did not like or tolerate the study drugs, so some of them probably had intolerable side effects. During the study, however, there weren't many important side effects except a bit more dizziness in the patients on blood pressure medication, which apparently didn't do them much good anyway. There was some muscle pain, but patients on placebo also had that. The dose of the cholesterol pill was very low, which might have explained the pretty awesome side effect profile. Also the patients most bothered by side effects probably dropped out in the run-in period. By the end of the study only about 70% of patients were still taking the prescribed drugs, so there may have been intolerance that was not reported. There was no excess of development of diabetes, perhaps because of the very low statin dose. Good studies have shown more development of diabetes in statin users, but doses are often significantly higher.

Other interesting findings from the supplemental data:

I was very pleased that the NEJM published a well written summary of data that didn't get discussed in the article. There were some really weird things that showed up.

  1. South Asians and to some extent Chinese subjects did not have near as much benefit from the study drugs as did subjects of European descent. 
  2. Stroke risk was actually higher for patients with borderline high blood pressure when they were treated with the blood pressure lowering drugs, though reduced for patients with higher and lower blood pressures. 
  3. Patients with the highest cholesterol levels (LDL greater than 141, mean of 166) did not benefit from treatment with cholesterol lowering drugs. That's really strange and counterintuitive.

Bottom line?

We have not discovered a pill yet that will make everyone live longer. Taking a statin drug which lowers cholesterol (who knows if that's the important effect) may lower your risk of cardiovascular disease or death, but you need to take it a long time to make a small difference and we aren't sure which one is most effective. Most people who take statin drugs (Lipitor, Crestor/rosuvastatin etc.) for primary prevention (meaning they haven't had heart attacks or strokes) will not benefit from them. Low doses of Crestor/rosuvastatin usually have a low risk of side effects. Treating normal or slightly high blood pressure with low dose candesartan/HCTZ doesn't reduce the risk of heart attacks, strokes or cardiovascular death. Navigating the pros and cons of all of these pills and potions is neither obvious nor simple and is best done with a doctor who you know and trust.


Thursday, May 12, 2016

Medical error--the third leading cause of death, or not nearly so simple?

Splashed over news feeds this last week is a reference to an article published last week in the BMJ (formerly known as the British Medical Journal) that states that "medical error [is] the third leading cause of death in the United States."

What is this article actually about?

The new article refers to research done over the last 2 decades, and most recently an article by NASA toxicologist and patient safety advocate John T. James PhD in the Journal of Patient Safety in 2013. Dr. James evaluated 4 previous studies and estimated that 400,000 people, approximately, die yearly in the US of conditions that were either caused by or, more often, made worse by medical error.

That article, too, was met by outrage and was widely quoted and misinterpreted. I think hardly anybody actually read the article. Headlines read "Deaths by Medical Mistakes Claim the Lives of 400,000 People Each Year."

No new data, but a new way to think about it:

As far as I can tell from reading this most recent article, in BMJ, there is no new data. There is just the realization that if this many people are dying of medical error, it should be showing up somehow as a major cause of death, just like heart disease or cancer. The reason that it is not is because the questions that are asked on death certificates do not include anything about whether medical error had occurred. The article, quite correctly, states that this should be documented. Documenting this is the first step toward making major changes that will keep patients safer.

So what did the original article actually say?

When Dr. James' article came out in 2013, I read it and wrote a blog commenting on the study, its methods and what medical error looks like from my experience. Dr. James kindly responded in a comment,
"Thank you for putting my JPS study in an appropriate perspective. Some folks like to sensationalize the results as if these patients die only because of a medical error, and that is not what I wrote or intended."
The blog from 2013 was actually pretty good and completely relevant to the recent news release. You may want to read it. It does put the data into perspective.

Patient safety--very very important!

I am glad that this recent article has grabbed international attention for patient safety. What we read in USA Today and the rest of the popular press is not an accurate depiction of the problem, but the problem remains very real. Medical error is contributing to the deaths of hundreds of thousands of patients yearly. We, as physicians and healthcare providers, are trusted with the lives of vulnerable people, and it is up to us to build processes that allow our good intentions to be translated into good care.


Sunday, May 1, 2016

Practical and commonsense research from Ontario's Physician's Services Incorporated Foundation: Let them drink apple juice!

Today in JAMA online (the Journal of the American Medical Association) a delightfully practical article was published regarding how to help little children recover from gastroenteritis (stomach flu.) The authors, Doctors Stephen Freedman, Andrew Willan, Kathy Boutis and Suzanne Schuh, compared the health of over 600 children aged 6 months to 5 years, when given a medical rehydration solution to drink versus diluted apple juice along with the fluids that the child preferred. These children were not chronically ill or severely dehydrated, but were sick enough to have been brought by their parents to the emergency department and were at risk for needing hospitalization or intravenous fluids.

In previous studies oral rehydration with electrolyte solutions such as Pedialyte, which contain over twice as much sodium and 6 times as much potassium as sports drinks, along with much less sugar, had performed well in preventing hospitalization or return to the emergency department. Theoretically, children would need electrolytes to replace the ones lost in diarrhea or from vomiting, and extra sugar would just draw more fluid into the intestines, worsening the diarrhea. In the children studied in this recent research, however, giving a teaspoon of dilute apple juice every 2-5 minutes and treating vomiting with a very effective anti-nausea medication, ondansetron, by mouth, worked at least as well, actually significantly better than the same routine using bottled electrolyte solutions. This was particularly true in the children who were over 2 years old and so had definite taste preferences. Children given dilute apple juice and then liquids that they preferred were less likely to be admitted to the hospital or need intravenous hydration than children who were provided oral electrolyte solutions.

There has been a magic associated with giving children Pedialyte or similar solutions for their mild intestinal ills, despite the fact that it is more expensive (1 liter costs about $9, though may be as cheap as $5 when bought in bulk) and doesn't taste very good. Children mostly don't mind it, but some really do, which can be a big factor when they are feeling queasy. This study presents evidence to allow parents to give their children pretty much any liquid that sounds good, making an extra trip to the pharmacy with a sick child unnecessary.

Now oral electrolyte solutions and apple juice have both been available from many manufacturers for many years. What drug company, then, would be interested in funding this lovely research? None, of course. Could it have been funded by a governmental agency? Yes, I guess so, though much of that grant money is very hard to get. This study, though, was funded by a private foundation with a very interesting story.

In 1947 physicians in Ontario, Canada, joined together to create a pre-paid health plan. The physicians pro-rated their fees to stay within budget, and eventually 8000 doctors participated. In 1969, the Physician's Services Incorporated health plan ceased to exist and was replaced by a state run entity, now the Ontario Health Insurance Plan. There was still money in their account when they stopped providing services (they must have been doing something right) and the physicians decided to use it to create a foundation to improve the health of the citizens of Ontario. The original investment of those physicians was $16.7 million, and in the years since inception over $167 million has been paid out in grants. They now have around $90 million from which they fund over $3 million in grants yearly.

If you are interested, read the 2015 annual report for the foundation. The projects they fund are wonderful. There are little grants, one for $5500 to a physician who wanted to study lower doses of a testosterone product for female to male transsexuals. There are larger grants as well. There is a project to grow mats of human cartilage from small numbers of cells to heal the damage of osteoarthritis, reducing the need for joint replacements. There is a fellowship for a researcher who will take scientific research and bring it to the bedside, this year a nutritional expert who works on creating healthy diets. The money granted to this person is to free them up to do work that will not provide them any likely financial benefit. There is a study to look at the side effects and impacts of those side effects on patients who take the (often not very effective) drugs for Alzheimer's disease. There is a study looking at whether giving children who receive antibiotics in the hospital a probiotic milk product (kefir, I'm thinking) reduces their risk of getting antibiotic associated diarrhea. The studies are all like that: practical, meaningful, unlikely to increase healthcare costs and likely to improve health. They are studies that are not often done in the US, where drug companies are our major funding source, expecting to make more money selling drugs than they spend on research.

The PHI foundation is much smaller than the Rockefeller, Howard Hughes or Bill and Melinda Gates foundations which privately fund research in the US. Even so, they helped Dr. Freedman et al publish a paper that will allow the next generation of babies and toddlers to drink dilute apple juice rather than electrolyte solutions and be more likely to stay out of hospitals as they recover from their tummy troubles. Their other grants are just as good. They are a model of medical research funding I have not seen before. They are private individuals, doctors even, who have worked together to do something great. They are not super rich philanthropists, drug companies or federal government agencies.  This organization is making a powerful and positive impact by funding and encouraging researchers who are wise and curious.

Friday, April 22, 2016

How bedside ultrasound was awesome last week

I sometimes do locum tenens assignments as a hospitalist in rural hospitals. It is a good way to find out how other systems work, or don't work, and meet new people and interact with new communities. It's great to be home and also good to go away and come back later.  Besides the usual trappings of doctoring, including stethoscope, otoscope and white coat, I wouldn't be caught dead without my pocket ultrasound.

I just got back from a week of 12 hour shifts in a 48 bed hospital and once again was very happy to have the ultrasound. They do have ultrasonography in the radiology department at this hospital, but echocardiography (ultrasound of the heart) is only available on weekdays from about 8 to 5, and it needs to be scheduled in advance. Also the ultrasonographers don't necessarily look at the things I find interesting, and can't combine imaging with physical exam findings and what the patient tells me in real time. Patients also really enjoy seeing what's going on inside when we both look at the pictures together. Ultrasound has been part of my usual practice for 4 years now, and you might think it would get old or boring, but it hasn't.

These are a few of the cases in which it made a huge difference to a patient that I had access to ultrasound at the bedside as part of the physical exam:

1. A man came in with a history of heart valve surgery and swelling of the legs. It was not clear how well he took his medication at home, but he was known to have congestive heart failure. He had had a large pericardial effusion with tamponade (fluid surrounding the heart causing it to fail) a few months before I saw him. The bedside ultrasound ruled out tamponade and showed that his heart failure was in pretty good control. He improved impressively with just staying on his regular medication and keeping his feet up. Without the reassurance of the ultrasound I might have given him extra diuretic medication and perhaps caused kidney failure. I also might have had to send him to another hospital for a full scale echocardiogram to rule out tamponade, which would have required an emergency intervention.

2. A person with a long history of alcohol abuse came in feeling generally terrible. After treatment for alcohol withdrawal, he developed very low blood pressure and high heart rate with a low grade fever. Ultrasound of the left lung showed a definite pneumonia, though the chest x-ray visualized that area poorly, missing the pneumonia completely. Having this diagnosis helped considerably in diagnosing sepsis and choosing the right antibiotic as well as ruling out a heart problem as the cause of the vital sign abnormalities.

3. A very old man came in from home with a recent history of bleeding from his urinary catheter due to pulling on it. The family was worried about blood clots obstructing the catheter. A very quick ultrasound reassured them that all was working as it should have been. The patient was saved having the catheter unnecessarily removed and replaced.

4. After a motorcycle wreck which caused rib fractures and a pneumothorax (popped lung) a patient had persistently low blood oxygen levels. She was also a smoker so the differential diagnosis included worsening pneumothorax or simply not breathing deeply due to pain. The little ultrasound detected no pneumothorax so treatment was aimed at improving breathing rather than considering placement of a chest tube. There are many other imaging procedures that could have made this determination, but none of them were instantly at hand when I needed the answer.

Bedside ultrasound is gaining popularity as a tool for internal medicine physicians and hospitalists, but is nowhere near being universally or even commonly a part of our practice. It does take training, practice and the little machine in the pocket or easily available on a cart in the clinic or hospital floor. Truly, these are obstacles, but totally worth tackling.

Sunday, March 27, 2016

What's up with people who are in the hospital a very long time?

I just finished reading a very delightful "A Piece of My Mind" essay in JAMA (The Journal of the American Medical Association.) The JAMA is primarily a research journal, filled with new scientific or semi-scientific studies and comments on those, plus reviews of the literature and editorials on science or politics. There are also letters and announcements and educational sections for doctors or patients, even poems, but the part I like to read all the way through is called "A Piece of My Mind." These essays are almost always stories about something that has made a profound impression on the writer. The most recent title was "A Place to Stay," written by Benjamin Clark, an internist at the Yale New Haven Medical Center. He describes a patient who is stuck in the hospital probably for the rest of his life due to a medical condition whose treatment requires management that can't be done anywhere else. It's lovely, and true (even if the details are not, and I'm guessing they aren't) and I won't describe it more fully because it is available in full at the link.

It made me think about the vast diversity of patients I've known who have stayed in the hospital for way too long.

The “Piece of My Mind” story was about a well-educated and deeply lovable person with a bad disease that was in no way his fault. Most of the patients we end up taking care of for very long stretches are not this way. This sometimes makes them less appealing. Still, all of them are people with whom we become intimately familiar, knowing their families and their prospects as well as their everyday quirks, preferences and routines. We fuss and connive about how we might move them out of our hospitals and eventually, for most of them, this happens. They don’t usually die with us. 

During their stays we feel frustration and experience dread as we repeatedly fail to do our job as hospitalists which is to get them better and get them out. As the days pass we adjust medication and perform diagnostic tests, consider and try new approaches and eventually manage expectations.

We feel that these cases are failures because we can’t get the patient well as fast as we think we should. This is partly because of the ways hospitals are paid to take care of people. For decades we have been urged to reduce the number of days patients stay in the hospital. This started decades ago when healthcare costs were first starting to be alarming to payers, especially Medicare. Patients who remained in the hospital for many days often were getting complications, pneumonia, other hospital acquired infections, confusion, and these extra days were costing insurance companies and the government lots of money. Payment models were changed and we were paid flat amounts for a given diagnosis. Because of this, our hospital made more money if a patient was cured more quickly than expected. This can be good all around. Patients don’t usually want to be in hospitals and often get sicker if they stay, and hospitals don’t want to foot bills that are made larger by more days and more tests and treatments. This method of payment gave us financial incentives to cure patients rapidly. They also left us no room in our hearts or minds for the outliers who take a long time to be ready to leave.

Beside the patient in the “A Piece of My Mind” story, who are these patients?

We just discharged a patient who had been in our hospital for over a month. She had been heavy all of her life, but after having children her situation became dire. She had a gastric bypass and lost 100 pounds, which brought her down to a manageable 300 pounds. Job changes resulted in gaining most of that weight back, and then a divorce made her even less active as she turned to alcohol for comfort. She finally sought help when she was 600 pounds, couldn’t get out of bed and was so swollen that half of her skin was oozing, some of it covered with infected wounds. When she got to our emergency department it was difficult to maintain her oxygen level. She could barely breathe and was so heavy and weak that she could only just move her arms. Her chronically low oxygen levels had led to severe pulmonary hypertension and so much of her weight was retained fluid. We began the process of giving her diuretics to remove extra fluid, cleaning and dressing her wounds, using mechanical lifts to be able to lift the skirt of fat and fluid to care for the skin underneath. She was horribly malnourished, since her diet was terrible and her gastric bypass made her unable to absorb nutrients well. She was depressed with horrible self esteem, and was surprised to learn that we thought this was a problem. Over the course of 5 weeks she was able to lose nearly 200 pounds of primarily water weight, with daily attention to replacement of rapidly depleted electrolytes. Physical therapy worked with her daily and by the time of discharge she could climb stairs and walk the halls alone. She will get further rehabilitation which should allow her to cook and bathe and even drive independently. During the 5 weeks we all got to know her well and discussing her success became a high point of all of our day. There was no point during those 5 weeks that she could have successfully left the hospital.

Another patient arrived with high fevers and back pain. He had been in recovery from heroin abuse but had relapsed. He had Staph aureus growing on one of his heart valves and had been throwing little infected blobs to his spine, his spleen and his kidneys. He was treated with the proper antibiotics, but ended up with abscesses in his brain, which made him confused and difficult to handle. He had a long term central intravenous catheter (PICC line) that we placed in hopes that he might be able to get antibiotics as an outpatient, but his parade of misfortunes made it impossible for him to survive outside of an actual hospital and the temptation to inject heroin into his pristine PICC if he were on the outside made it unwise once he stabilized. Nursing homes do not like young drug addicts because they assume that they won’t play well with their primarily ancient clientele. He needed at least 6 weeks of intravenous antibiotics. He was ours. No other options. After he stopped being a complete pain in the rear he was like a family member.

Who pays for all of these hospital days? It varies. In actual fact, we all do. Hospitals eat some of the costs and pass them on to other payers if they are to remain solvent. All of us who work, pay taxes, buy insurance or use medical services pay in some way.

So what do we do about patients like this, ones who can’t go home? We struggle. We stew. We blame ourselves and them. Discharge planners shake their heads and make more telephone calls. We dread our daily visits in which there is nothing much to say that we haven’t all said before. At our best we finally come to peace with the fact that these patients and their epic hospitalizations are part of what is real about our job and not just inconvenient outliers.


Sunday, March 20, 2016

Why most published research findings are false, and why you usually can't read them anyway--the pioneering work of Dr. John Ioannidis

In 2005 Dr. John Ioannidis, a Greek researcher and professor of health policy at Stanford University, best known for his critiques of the science of medicine, published a paper entitled "Why Most Published Research Findings are False." This was not from the point of view of a science denier--actually closer to the opposite. Ioannidis loves good science, but points out that the vast majority of scientific studies today are biased, often asking the wrong questions and making the wrong inferences. In the case of medicine, this often means that claims of the effectiveness of a treatment or diagnostic test are exaggerated and often just plain wrong. This stems partly from the fact that positive and exciting results lead to further funding for the researcher involved and that the sources of this funding are often entities such as drug companies that stand to benefit from a certain outcome.

Recently Dr. Ioannidis published a new article, much more accessible than the first, entitled "Evidence Based Medicine Has Been Hijacked: A Letter to Dr. David Sackett." The first was very much based on math and statistics. He observed that most studies, when repeated, came up with different results. This was particularly true of studies with smaller numbers of subjects and ones where the effect sizes were small. Such studies were more likely to come out of fields in which there was money to be made out of a positive result and ones in which the field of study was particularly hot and there fore several groups were competing to get results.

The second and most recent article is a conversation with one of Ioannidis' most important mentors, a man named David Sackett who was possibly the first person to introduce the concept of evidence-based medicine. By this he meant combining understanding of science and research with clinical judgment and experience. This idea was inspiring to John Ioannidis and his relationship with David Sackett (physician and founder of the Center for Evidence-Based medicine at Oxford University) was profoundly influential in his career. David Sackett died in May of 2015. He was apparently not only a wonderful clinical teacher but a great and appreciative listener. Dr. Ioannidis has been explaining his hopes and frustrations to the David Sackett who remains very much alive in his mind, and in this article Dr. Ioannidis shares with his internal Dr. Sackett his frustration with what has become of evidence based medicine. It is a delightful article and well worth a read. In it he laments the growing body of crappy and biased research upon which much of our advice to patients is now built.

This article is important for all practicing physicians to read and yet, when I tried to find it, the journal in which it was published asked that I part with around $32 to see it. This felt a bit ironic. The article by the man who champions truth and transparency was guarded by trolls who wanted $32 a pop. But then, when I checked it a few days later, it became free, and if you click on the link above, you will be able to read it. I'm not sure there is a moral to this part of the story, but I'm guessing that the irony was noted by Dr. Ioannidis who told the journal editors that they could do whatever they wanted with the rest of the content of their issues, but they could jolly well make his article available for free. Still, in addition to the bias present in medical studies, lack of free access to the original articles further dilutes any truth to be found in them. Any scientific study that is likely to be "click bait"--that is to say interesting enough to readers that they will click on a link to read more about it--is described in the secondary literature by a journalist who strips it of any actual detail and spins it in any way that will engender further clicking behaviors. I venture to say that the vast majority of learning about clinical research by practicing physicians is through articles written about articles. These are produced by companies such as Medpage Today whose entire mission is to make money through advertising based on the number of times we click on their headline news. Their articles on articles appear to us to be a vital service, though, because most research articles are not free to us in their entirety and keeping up on the breadth of medical knowledge by subscribing to a vast number of journals is neither efficient nor affordable.

These are fascinating things to think about. My present distilled words of wisdom are:
1. Read Ioannidis' article while it's still free, before the journal changes its mind.
2. Don't take what passes for science too terribly seriously, especially if the effect is small or it goes against common sense and what you know about human physiology.
3. Really don't base your practice off of news releases about articles you haven't read or thought about.
4. Agitate for free and open access to important scientific research so you can read it critically for yourself.