GeriPal - Geriatrics and Palliative Care Blog

Point/Counterpoint: Using Deception, Study Finds Clinics Violate Disabilities Act; Should Clinics Be Protected?

2013-05-13T13:00:00.000-07:00

Point: Physicians do not deserve IRB protections like vulnerable patients

by: Sei Lee

The recent article by Lagu and colleagues entitled, “Access to Subspecialty Care for Patients with MobilityImpairment” in Annals of Internal Medicine found that when subspecialty practices in 4 US cities were contacted about a patient who was obese and hemiparetic, 22% stated they could not accommodate this disabled patient. As disturbing as this finding was, I was even more surprised to hear that the authors were required by their Institutional Review Board to shred identifying information as soon as research was completed. Thus, when they were contacted by the attorney general in one city and asked to identify which practices were discriminating against disabled patients, they informed the AG that at the instruction of the IRB, they had destroyed the information.

First, I am not an ethicist and therefore may be ignoring important considerations. However, it seems that research ethics appropriately centers on the vulnerable patient. Often, those who are sick and requiring medical attention may not feel that they can refuse an invitation to participate in research and are thus appropriately considered vulnerable. They need protections to ensure that powerful physicians and healthcare systems fully account for their interests when conducting research which may put them at additional risk.

In this case, it seems to me that the vulnerable population that we should be protecting are the disabled patients. Although physicians and subspecialty practices may be the research subjects here, they are not vulnerable and should not receive the same level of protections as vulnerable research subjects. Maybe the answer is not to call this research, but some other form of standardized inquiry. A colleague remarked that this seems more like investigative reporting than research, and that may be a more apt model. In this work as well as investigative reporting, the objects of inquiry are the powerful who have the resources to defend themselves if necessary. They do not need additional protections from the research protections infrastructure that has been built up to protect the vulnerable.

Counterpoint: Researchers Should Avoid Being an Arm of the Law

By: Anna Chodos, MD

The study mentioned by Dr. Lee above is unusual in two ways with regard to possible ethical violations. First, the practices that were called to request an appointment for a hypothetical patient did not go through an informed consent process because the investigators chose a “deceptive technique” to get at their research question. (In this way, as Dr. Lee points out, it seems like investigative journalism). The IRB required them to send a letter to the practices they included in their study to let them know that they had been included after the fact (and according to the lead author, Dr. Lagu, during an oral presentation of her paper, this resulted in some unfavorable responses from those practices). Second, they were required to destroy the data after the analysis to protect the subjects who subsequently could be linked to the violation of a federal law. The publication of the study led one city to call the investigators to ask for the practices’ identifying information so they could take legal action and then, when they discovered it did not exist, to consider conducting the same study themselves to get the information they wanted.

It strikes me as ethically sound that the IRB asked the investigators to destroy the information. The research question was to determine if these subspecialty practices were accessible to patients with disabilities; finding that they were not is effectively finding them in violation of the law. The main research question is equivalent to, “How often are subspecialty practices breaking the ADA and denying their services to patients with disabilities?”, and that could be seen as a legal question. These are medical researchers who are, presumably, interested foremost in the health implications of their question, though likely also interested in influencing the enforcement of this important law. But, they are neither enforcers nor defenders of the law in our society and it is not their role to aid such activity through their research in a specific way. By keeping the information with identifiers in a cabinet somewhere they would legally endanger the research subjects, ie. the subspecialty practices, beyond what these practices were already doing to endanger themselves. Again, I see it as far beyond the intention of research to directly aid enforcement of a law.

Fundamentally, I think health researchers must be careful not to consider themselves on the side of the law or not. Health researchers should be seeking to improve the health, not legal standing, of people and society. We hope laws related to public health will protect and promote health. But, as far as I can tell the law is not perfect, its enforcement is not perfect, and many laws are far from being in the right or wrong in any morally sound way. Were researchers to use their powerful tool of human observation and analysis—that has (mostly) gained the trust of people and society—with the aim of enforcing laws, they would have no credibility as objective scientists with loftier goals.

I think you can still be concerned about the ethics of this research on other counts, though. They truly may not have conducted their research at acceptable risk (to society or the subjects) for two reasons. First, the practices were not consented. The reason for this is clear because the information they would have obtained had they consented people would have been terribly inaccurate and practically useless. So the IRB evidently decided that a post-enrollment letter explaining the study was acceptable in order to answer this important question. Second, just by publishing their design, they gave anyone who wishes to enforce this law the roadmap to do it. Just have an intern with a spare half hour call all the OB/GYN practices in your city (of which they know a whopping 44% were inaccessible in this national sample). So did they effectively protect these subspecialties from being held accountable? Probably not. If these practices get fined huge amounts and close up shop, they may be able to serve no one at all. Is that fair? Frankly, it’s not my place to say.

Leadership IS a geriatrics competency

2013-05-11T15:58:00.000-07:00

by: Helen Chen, MD

Riding back to DFW on the airport shuttle after attending the Pioneer ACO presentations during the last session of the last day of #AGS13, I struck up a conversation with another attendee who is in private primary care practice. After learning that I am a PACE medical director, she responded, “What’s PACE?” I was surprised at the context, but not by the question. This is a conversation I have at least once a week in the community.

Invariably, after describing how the integrated, coordinated, PACE model of care serves frail , nursing home eligible, mostly dually eligible elders with the goal of helping them to remain in their communities as long as safely possible, most people I talk with want to know, “How can I get that for my mom, grandfather, (other older relative)?” Unfortunately, as many regular readers of GeriPal know, even though On-Lok began PACE in the early 70s, 40 years on, it is available in only 30 states, and serves a combined national panel size smaller than many FQHC systems in single states or regions. And, for elders with even modest resources, PACE is generally not obtainable because of financing or regulatory issues.

But the good news/bad news is that more recently, many health plans have taken notice. They are not waiting for the published results of various innovations or demonstration projects. Many large health systems are already looking to provide PACE-like “integrated and coordinated care” for their members, some of whom resemble the multimorbid, psychosocially complex elders cared for in PACE. Some ACOs are also beginning to bring some practical systems on line to address the needs of the complex elder. However, many of these decisions are being driven by economics: the financial incentives driving the management of adverse risk and reduction of hospitalizations and readmissions, among other outcomes.

The question is how many of us in the GeriPal world are in the boardrooms or the executive management meetings when these programs and systems are being created, or critical decisions are being made? We are a small tribe, but the very patients we care deeply about are going to have a lot of skin in this game. We need to effectively leverage our leadership abilities and skills. And, those of us who are directly involved in education need to prepare our fellows and other trainees to take on these leadership challenges which in the near term must include systems redesign and increased attention on “quality”. Otherwise, we will run the risk of continuing to be small islets of geriatrics excellence unable to influence much change in the choppy seas of “innovation” that may not adequately meet the needs of older adults, especially those who are the most complex.

by: Helen Chen, MD

When Staying Silent is No Longer Acceptable

2013-05-09T13:00:00.000-07:00

A Guantanamo detainee's feet are shackled to the floor, April 27, 2010. (AP Photo/Michelle Shephard, Pool) (Credit: Associated Press)

Recent issues in the news these past weeks have given me pause to reflect on my social responsibility as a physician in my global, national and local community. I do not think I was alone in being shocked and angered when I read Kellermann’s and Rivara’s perspectives piece in February’s JAMA highlighting the systematic and complete stifling of scientific inquiry into the impact or effects of gun related violence. Starting with cutting CDC funding by $2.6 million dollars-the exact amount budgeted for the Center for Injury Prevention. When this money was eventually restored it was earmarked for traumatic brain injury research. The final appropriation contained language that no funds for injury prevention or control could be used to promote or advocate gun control. This vague yet restrictive language effectively halted research into gun violence. This edict was later extended to all Health and Human services agencies including the National Institutes of Health. What continues to disturb me is the question-why was this tolerated for 17 years? Where were the public health advocates? Where was I? Why was any special interest or agenda allowed to suppress the intellectual freedom of scientific research?

This past week’s story of hunger strikes at Guantanamo Bay hit even closer to home, at least in a philosophical metaphorical sense. Over a hundred prisoners have been on a hunger strike as conditions deteriorate at the prison with no resolution in site. Due to concerns of starvation and death, military officials at the prison have ordered the forced placement of an NG tube to deliver artificial nutrition to Guantanamo Bay prisoners against their consent. We, as palliative care providers, are the champions and guardians of autonomy. We work to ensure that patient preferences are respected and honored. Autonomy forms the cornerstone of Western bioethics. This means consent for medical interventions and the freedom to refuse these interventions. The autonomy of prisoners is afforded extra protection under the Belmont report -as vulnerable agents at risk of coercion, medical research must undergo additional scrutiny.

Undoubtedly, the situation at Guantanamo is complicated. Large-scale deaths of prisoners due to electively forgoing food and water for the purposes of political protest could lead to massive and even violent demonstrations throughout the Islamic world. This administration has faced many difficulties and challenges in its efforts to close this facility. However, when the twice daily forced placement of NG tubes for the purposes of delivering artificial nutrition came to light, Ronald Flanders, a spokesman for the U.S. Southern Command, stated that the technique is similar to that used for elderly and small children. The aspects that seem quite different to me, is that the prisoners are shackled at the wrists and ankles for this procedure and do not give consent or assent.

As a palliative care physician, whose passion is to protect autonomy and the right to refuse unwanted medical interventions, I would like to join my voice to that of Dr. Jeremy Lazarus, president of the American Medical Association, and state unequivocally, that forced feeding without consent represents assault of the prisoners and violates our core ethical principles. I do not want to sit silently at the sidelines. So I will be writing my Congressional representatives as a physician to implore them to stop this human rights violation and honor autonomy. And invite other readers, who may have also been experiencing a nagging sense of social responsibility to join me in letting your voice be heard.

~Stacy Fischer, MD

University of Colorado SOM

That Place Between Youth and Scattered Ashes

2013-05-08T15:20:00.000-07:00

Marching up 5th

Being a New Yorker, I am a bit obsessed with the windows of the dowager department stores that march down Fifth Avenue. When I first moved here, I most identified with the Lord & Taylor windows -- maybe because I grew up going to Lord & Taylor on those occasions when we needed to buy a special outfit. More recently, I've been entranced by the Bergdorf Goodman windows (#BGwindows) and have photographed and blogged frequently on same on my personal blog (#BGWindows Follies, Wow!, and Head Shots).

This month, Bergdorf's landlord (a descendant of one of the original founders) released a documentary – Scatter My Ashes at Bergdorf's. In the great tradition of most big-budget fantasy movies these days, the social media folks created a game to go along with the move release. It was highly addicting (four of my windows grace this post) while it was up and a great way for me to unwind as we prepped for #AGS13 and recovered from all the hustle and bustle of our time in Grapevine. Tellingly, my first effort (Marching up 5th) is just a pretty window while the window I designed on the plane home (Reimagining Oz) asks "What if Dorothy was framed"? The prize for the winner of this social media contest is a $1,000 gift certificate - just about enough to cover a stylish pair of sensible shoes!

Channeling Gatsby

By now, you are scratching your head and wondering why I'm posting this post to GeriPal rather than my own blog. What on earth does fashion have to do with us, you are asking. A lot.

May, as GeriPal readers will know, is older American's month and I've been thinking about how we need a month to celebrate older Americans yet our youth-obsessed culture celebrates young people every day. The #BGwindows are no different. They are populated by rail-thin mannequins that are purportedly ageless but the clothing choices are clearly those of young women. The subliminal messaging if one puts the windows and the movie together? We celebrate youth but the Bergdorf's shopper is so devoted to us that she wants her ashes scattered here. Prompting me to ask David Hoey (the mad genius behind the #BGwindows):

Out and About, NYC

Isn't there a way station in between youth and the ashes that come out of a crematory that we could be celebrating? Could you ever see yourself designing windows that celebrate older women?

I know that David has it in him. I know he could design some awesome windows that celebrate older women in the the way that Sacha Goldberger celebrates his Mamika (my little grandmother). Sacha's collaboration with his 93-year old grandmother showcases Mamika as a superhero. His work has been chronicled in the New Old Age blog at the NY Times, in the Huffington Post, and on Twisted Sifter. And, if Louis Vuitton can make a life-like replica of Yayoi Kusama surely Bergdorf's could do the same with Sacha's grandmother! Mamika clearly has the chops to carry ALL of the 5th avenue windows. 93-year old superhero meets fashion on 5th Avenue -- what could be better than that?

Perhaps David Hoey would want to look a little closer to home for a collaborator. For that he could turn to photographer Ari Seth Cohen and his blog Advanced Style. There is a certain fashion panache that comes with getting older. It's less about what is in fashion now and more about what a woman's style is and Ari captures that perfectly. For this collaboration, I could see David inviting some of Ari's subjects into Bergdorf's and working with them to put together the outfits that would grace the models in his windows. Of course, those models should come in all sizes and shapes. it would even be good if some of them were wearing -- gasp -- sensible shoes and using canes or walkers.

Game of Fashion in Five Parts

Tim Gunn recently said to the designers on Project Runway, "in the real world, good fashion is both timeless and ageless." It would be great if David Hoey could exemplify that in the #BGWindows that line 5th Avenue. Timing the display for May 2014 (and then annually thereafter) -- in celebration of Older Americans month would be even better.

We need to chip away at society's obsession with youth every time we get a chance. I always figure that it is better to ask for something and not get it than to wonder "what if". Case in point? Last year I challenged FIRST Robotics to tackle aging in their competitions (Pillbox Fill: An Idea for the First Robotics Competition) and this year they did (Make It So) -- proof positive that dreams do come true. Maybe this one will too!

by: Nancy Lundebjerg

Using YouTube Movie Clips to Teach Breaking Bad News

2013-05-07T13:00:00.000-07:00

Some of my favorite teaching incorporates video. Recently, I saw an End-of-Life Nursing Education Consortium (ELNEC) DVD with movie excerpts. A GIANT THANK YOU to whoever put the ELNEC DVD together! It's a fantastic teaching tool!!!

I can't reproduce the DVD, but I thought it would be fun to try and find some of these and other movie excerpts on YouTube and create a teaching guide.

I have tried pieces of what I'm publishing below, but never all of it together. Please let us know in the comments if you try it, what works or doesn't work, or if you have other suggestions for online movie experts.

Time 30 min -1 hr, depending on how many excerpts you show, and how long you let discussion after each clip continue. Excerpt times are included at the start of each video.

Format: Show video clip, then discuss. Questions for discussion are included after each clip - feel free to come up with your own. Some of these are in-your-face, and some more nuanced.

Target Audience: Health Professionals or trainees - medical students, nurses, residents, fellows, social workers, doctors, physician's assistants, nurse practicionners - any health professional really.

Intro: All of you will have to break bad news multiple times in your professional careers. Today we're going to view movie clips that can help us become better at breaking bad news. After each video we will have a discussion.

Some of these excerpts are short, some of them long. Some of them are with physicians or nurses, some of them are not with health professionals at all. But all have some lessons for us about how to talk in a humanistic way about a potentially terrifying subject.

Legal: Using these video clips for teaching purposes is legal - see this link.

Materials: Eric tried this with our Geriatrics fellows, and recommends brining tissues - the last clip from WIT is a doozy.

1. 3:30 CLIP The first video is from the movie WIT, starring Emma Thompson, based on the play by the same name. (play this link from 30 sec to 4:05. It has Spanish subtitles, I couldn't find an excerpt without them. In this excerpt an oncologist tells a patient she has advanced cancer and leaps into discussing treatment.)

What went well about this breaking bad news discussion (this will be a challenge for the trainees, who may audibly groan at all the poor communication skills displayed. Some things did go well - checking in with the patient, making eye contact, trying to relate to her as a professor).

What did not go well? (long list, includes leaping from diagnosis to treatment without pausing, most patients don't remember anything said after the diagnosis -- use the first 2:30 sec of this how-to-break-bad-news documentary to make this point, no attention to the emotional reaction of the patient, lack of empathetic body language, use of medical terminology rather than lay language, no space for questions, no discussion of benefits and risks of chemo and impact on prognosis, or any discussion of prognosis, etc, etc)

2. 30 SEC CLIP. The second video is from the movie the Shootist, staring John Wayne as an aging sharpshooter cowboy receiving a diagnosis of advanced cancer from a doctor, played by James Stewart. (play the first 28 seconds of this link).

What went well about this discussion? (fires a warning shot, acknowledges how hard the discussion is, and when asked to give the news "flat out" he does, in no uncertain terms. He almost challenges the cowboy in an aggressive way, in a somewhat shocking manner, but this confrontational style seems suited to a sharpshooter cowboy. Difficult to see a hug working in this situation. Underlying message is you need to tailor your conversation to the patient, rather than taking a cookbook or one-size-fits-all approach)

What could have gone better? (Hard to say)

3. TWO 60 SEC CLIPS. In this clip from the movie 50:50, the Joseph Gordon Levitt character tells his friend that he has cancer. His friend, played by Seth Rogan, hears the bad news and feels sick. (play this whole clip, there is an add at the beginning, but you can skip it after 10 seconds; for a slightly funnier version with profane language, click here).

In this 60 second clip from Dumb and Dumber, staring Jim Carrey, he asks a woman he likes to estimates his chances with her. (play this whole excerpt).

Why did we play these clips? What do some patients hear or caregivers hear when we tell them a horrific prognosis? What does this say about needing to ascertain a patient's core values? (a prognosis of 50% or .1% will be terrible to some - Joseph Gordon Leveitt's character or the woman from Dumb and Dumber - and terrific to others - the Seth Rogan character and the Jim Carey character. Some are willing to go through enormous pain and suffering for a remote chance of success. Others would rather focus on quality of life rather than take such risks).

4. 2:20 CLIP. This clip from Little Miss Sunshine portrays the reaction of a teenager to the bad news that he is color blind and will be unable to become a fighter pilot. The teenager had previously taken a vow of silence, and had not uttered a word up until this point in the movie. (play this whole clip).

What does this clip say about our patients reactions to bad news? (This teenager has a visceral reaction to the news in a family setting. In a physician's office, patients may try to hold it together for social reasons, but they may be screaming inside. Contrast his reaction with the Emma Thompson character's reaction in the first clip, for example.)

5. 3:30 - 6:30 CLIP. This excerpt is from WIT again, this time with a nurse breaking the news to a hospitalized patient that the cancer is not responding to chemotherapy. (Play this link from the beginning to 3:25, or if you want to include a DNR discussion that follows the breaking bad news discussion, to 6:30.)

What went well about this discussion? (Very strong on empathy, comfortable environment, begins with shared experience of popsicles, if you go to the DNR discussions - describes concerns and outcomes of CPR).

What didn't go well? (This video was controversial when I showed it to a graduate-level nursing class - some felt the nurse overstepped her "role" and undermined the authority of the physicians, particularly by engaging in the DNR discussion; on the other hand, others noted that she said about the physicians was true, and someone needed to break the news and have a frank conversation about code status. The DNR conversation was about the procedure itself and did not start with her goals and values - this could have been better).

by: Alex Smith @AlexSmithMD

Honoring Nurses

2013-05-05T20:24:00.002-07:00

National Nurses week begins on May 6, the birthday of Florence Nightingale, the “founder of modern nursing”, and continues through May 12. The American Nursing Association can give you more information on the history of Nurses Week. And here’s a fact sheet on stats of licensed nurses in the United States and one on nurseaides/orderlies/attendants (in my opinion the unsung heroes of nursing).

Here’s the real message for the week:

No one, yup, no one in the US has not been impacted by the work of a nurse.

Our job is to protect, promote, and optimize health, prevent illness and injury, alleviate suffering, care for the sick, disabled and dying. We are bedside nurses, researchers, primary and specialty care providers, educators, clinic workers, care coordinators, discharge planners, managers, administrators, anesthetists, midwives, and more. We make sure you have the right medicines, keep you clean and safe, change your diapers, dress your wounds, clean up your vomit, put in IV lines, nasal, gastric, urinary, and rectal tubes. We work with high tech equipment and perform life saving measures on a daily basis. We hold your hand when you need comfort, sit with you in the night when you are scared, speak up for you when you cannot. Your lives and the quality of your lives are in our hands.

We work in clinics, hospitals, urgent care, emergency departments, long-term care and assisted living facilities, private homes, urban and rural communities, schools, psychiatric facilities, camps, military facilities, and industries. We are legal and insurance consultants. We help bring babies into the world; we make sure you die well. We are the frontline. We are behind the scenes.

This week I am reminded of the awe and pride I feel to be a part of this dedicated group of people called nurses.

by: Patrice Villars

Are Older Persons Being Over Treated for Nonmelanoma Skin Cancer?

2013-05-02T06:00:00.000-07:00

One could argue that nonmelanoma skin cancer should not even be called Cancer. While under the microscope it looks like cancer, it doesn't really act like what most people think of when they hear the word, "Cancer." Unlike the much less common melanoma or cancers of other organs, plain old run of the mill skin "cancer" almost never metastasizes (ie, spread to different organs). It usually grow very slowly, and is almost never fatal. Often it is asymptomatic and has no impact on quality of life. This condition just does not deserve the dread and fear associated with word, "Cancer."

Since nonmelanoma skin "cancer" usually poses no threat at all to survival, the reason to treat the "cancer" is to improve well being. We can enhance well being by treating a "cancer" that is currently bothersome to the patient, or will become bothersome if it grows and expands. But this is where it gets interesting. Since many of these "cancers" grow very slowly, some will never become problematic in the patient's lifetime. This is a very important consideration as skin "cancer" is predominantly a disease of older people. Many persons with skin "cancer" are very old or very frail. Patients with limited life expectancies may do fine with either minimal treatment, or perpaps even no treatment at all. This suggests that the best treatment for a particular "cancer" needs to consider the age and health status of the patient.

But, in actual practice, when a patientt has skin "cancer", does the treating provider consider the individual characteristics of the patient in front of them, or do they use a one size fits all approach, focusing on the "cancer", but not the person?

A fascinating study in JAMA Internal Medicine suggests we are overtreating skin "cancer" in patients who are very old or very frail because of a one size fits all approach to treatment. The study was led by Dr. Eleni Linos, with senior author Dr. Mary-Margaret Chren, both Dermatologists at UCSF. They examined treatment of patients with nonmelanoma skin "cancer" at UCSF and the San Francisco VA. They did a very interesting comparison of how skin "cancer" treatment varied in patients with long vs limited life expectancies. The limited life expectancy group included persons over the age of 85, or with many medical conditions.

They found:

Patients are almost always treated. The no treatment option was chosen for only 3% of skin "cancers". Of note, 60% of "cancers" were not on the face, and in only 22% of cases were patients significantly bothered by their "cancer", suggesting that very conservative management of deferred treatment should have been reasonable in at least some patients.

Patient characteristics are not considered in the treatment decision. There are a number of treatment options for patients ranging from very simple and less invasive options like destruction (i.e., freezing) to surgical options. The most invasive option, Moh's surgery was used in 34% of patients. Moh's surgery takes on average 3 hours and is also the most expensive option. Patients with long life expectancies and short life expectancies were equally likely to get Moh's surgery. Thus very advanced age or severe co-existing disease seemed to make not one iota of difference in treatment.

This study suggests we need to revisit how we treat skin cancer, especially in the very old. Perhaps we should at least inform patients that deferring treatment may be a viable option. When treatment is deferred, patients have the option of getting treated later if they change their mind, or the skin cancer seems to be growing. When the skin cancer is treated, patients need to have more of a say in their treatment options, and given the choice of less invasive and bothersome treatments with less risk of complications.

by: Ken Covinsky (@geri_doc)

#AGS13: Views of Geriatrics and Palliative Care from Four Continents

2013-04-30T07:12:00.000-07:00

This years' American Geriatrics Society (AGS) meeting in Grapevine, Texas, is fast approaching. The schedule is jam packed with great talks to attend. I'd like to mention one special event not listed on the final program.

The Palliative Care Special Interest Group (SIG) is schedule for Saturday, May 04, 2013 from 7:00 pm - 8:30 pm. To spice things up this year we have decided to go a little off the general SIG format. What we have in mind is combining the Palliative Care SIG with the International SIG for the first hour (7-8pm) in order to fit in the following presentation:

Difficult Conversations at End of Life (EOL): Opportunities & Techniques to Avoid Cross-cultural Landmines: Views from Four Continents

This special SIG session will be led by Maura Brennan and will feature:

Maria del Carmen Castillo Gallego, MD
Reham Shaaban DO
Ariba Khan, MBBS MPH
Michael Lerch, MD. MBA
Shobhana Chaudhari MD

Each of the speakers will will discuss Geriatrics and Palliative Care issues from the viewpoint of the 5 different countries (Spain, Germany, Pakistan, India and Egypt). It will also feature a panel discussion facilitated by Sandra Liliana Oakes MD .

After this we will split back up into our respective SIGs (or you can just enjoy what looks like will be a beautiful evening in Texas)

I hope you can attend, and don't forget to start tweeting with #AGS13

by: Eric Widera (@ewidera)

Surrogate End Points in Drug Trials: Caveat Emptor

2013-04-29T06:00:00.000-07:00

It seems like such a good idea. Before a patient takes a new drug, they would like to know that it is going to improve a health outcome they really care about. Will it make me live longer? Will it lower my risk of becoming disabled?

But the problem is that it often takes a long time for a study of a new drug to show that it has meaningful impacts on patient outcomes. Enter the brilliant idea of surrogate outcomes. A surrogate outcome is an outcome that is associated with the health outcome a patient may really care about. For example, a patient may want to take a drug to reduce their risk of getting dementia or Alzheimer's Disease. They may care so much about preventing dementia that they will even take a drug that gives them side effects. But, it may take a pharmaceutical company years to conduct a trial to determine if a drug prevents dementia.

Surrogate endpoints seem like a brilliant solution to this problem. We know that biomarkers such as amyloid, that is found on a brain scan, or tau protein, that is found in the spinal fluid, are associated with dementia. A patient may not care about reducing their level of amyloid or tau protein in and of itself. But, the theory is that a drug that reduces amyloid or tau should also reduce the risk of dementia. It will take a lot less time to prove that a drug has an effect on biomarkers than to prove it has an effect on dementia. Testing a drug and treating a patient on the basis of these surrogate markers makes it possible to bring a drug to market much more quickly.

Doesn't that sound great? Well, as eloquently described by Svensson and colleagues in JAMA Internal Medicine, it may not be so great after all. While surrogate endpoints sound good in principle, in practice they often do not work. Not only do they not work, but there are numerous examples where reliance on surrogate end points had disastrous consequences and harmed patients. Svensson notes several notorious examples in the e-table of the article. For example :

Clofibrate reduced cholesterol in persons at risk for heart disease. Lower cholesterol is associated with a lower risk for heart disease. Unfortunately, patients who took clofibrate were more likely to die.
Encainide reduces the number premature heart beats (PVCs) is persons who have had heart attacks. PVCs are strongly associated with a higher risk of death after a heart attack. Unfortunately, patients who took encainide after heart attacks were much more likely to die. It is estimated that encainide caused thousands of excess deaths.
Rosiglatazone lowers the glycohemoglobin level in persons with diabetes. Diabetes is a risk factor for heart disease and lower glycohemoglobin levels indicate better diabetes control. Unfortunately, patients who took rosiglitazone had more heart attacks.

It is curious why there is so much enthusiasm for the use of surrogate end points in dementia drug trials when there are so many examples of how the use of surrogate endpoints in other diseases led to such awful public health outcomes. Hopefully, history will not repeat itself.

by: Ken Covinsky (@geri_doc)

Do patients need to know they are terminally ill?

2013-04-26T13:05:00.001-07:00

The British Medical Journal (BMJ) has published a couple of interesting pieces this week that might interest you (controversy alert ahead at the end!). Get a copy of this weeks version and read it! (subscription may be needed for links)

First, there is a wonderful piece about an outstanding example of hospital care for patients with dementia by Kate Sartain - a celebration of good care delivery!

Next up, there is a Pair of articles discussing Prognosis Research: A framework for researching clinical outcomes and Stratified medicine research . (I wonder if Eric or Alex know any good bloggers about prognosis who could comment?)

For education of the "competent novice" there is an article on Caring for the dying patient in the hospital that is going into my teaching file (Do people still have those?) along with a thoughtful editorial by Fiona Godlee, the editor of BMJ entitled Helping patients to die well

Do Patients Need to Know They Are Terminally Ill?

Finally, there is a fascinating debate that I am really interested in seeing GeriPal readers participate in on the BMJ site. In the head to head section, two authors face off over the question of do patients need to know they are terminally ill:

Collis and Sleeman argue Yes.
Leslie Blackhall tackles some interesting issues in the NO argument. Read it. In short, the argument is that we don't know what terminal means, and the discussion can set up false choices and the real focus should be on best care. (for example, don't offer feeding tubes in advanced dementia)

I thought what was missing in the discussion was the question of suffering that comes from not knowing what to expect. I think the fundamentally important question is "What do YOU WANT to know?"

I figured my friend David Oliver, cancer patient, gerontologist and blogger ( and STAR of AAHPM 2013) would have a thought or two. He asked me to share it. Here's the whole response:

"I can hardly believe that Blackwell would propose that not revealing a prognosis to a terminal patient can be a good thing, and even beneficial. I suppose it may be beneficial and make life easier for the doctor, but certainly not for the patient. As one with Stage IV terminal cancer I can tell you right now that not knowing what is coming, and potentially when, cause far more suffering. I will use chemotherapy as an illustration. In my case, neither the oncologists or the nurse oncologist, in fact, no one told me what to expect in terms of the side effects (only that I might have a bit of nausea), or when to expect them to rear their ugly heads. I was able, after one treatment, to predict not only what was coming, but on what day (there were 21-days between my treatments). If I can do this with almost 100% accuracy for all subsequent days between five more treatments, surely someone on the oncology clinical team (fragmented as it is) can predict as well. I still have major resentments toward not being told what to expect, and in the case of chemotherapy, what to do when the side effects surfaced. Blackwell is simply misinformed and has learned little from patients; having little understanding of what patients need and want -- probably because the time is never taken to talk to them about such matters.

I have an equally sore spot for the oncologist not making an immediate consult with a palliative care physician or team at time of the diagnosis. These two specialties should be on the same team; there should be one plan of care developed in consultation between the oncologists and the palliative care providers. Had this happened during the course of my chemotherapy treatments I may not have suffered so much when the side effects appeared. My patient education was reactive, not proactive. Perhaps someday we will figure out how to fuse oncologists, palliative care providers, patients, and patient educators…….not to mention social workers, pharmacists, and other important members who should be on the same team.

Finally, the patient and whomever is identified as the #1 caregiver should be an integral part of the team as well. They experience the full continuum of cancer care, and they are the only ones, if indeed no team discussions occur about the course of ongoing care, then no process improvements in the delivery of care will ever be made. And, most importantly, the patient preference(s) for what kind of care is preferred is an absolute necessity yet is often never asked. Once all the options are explored, it should ultimately be the patient who directs the care. If the Blackwell approach is adopted we will be further away from what needs to happen than we are now."

by: Paul Tatum with David Oliver

Google and Why Modern Medicine is in a Rut

2013-04-25T15:12:00.002-07:00

I'm at the annual SGIM meeting and the following topics came up in conversations w/various folks, so I thought I should write about it.

First, I was struck by a recent news article about Google and how the expectation is that each one of their new products should be 10 times better than the competition. In an interview, Larry Page talked about how setting the bar that high forces everyone to think "outside the box" and come up with new, transformational ideas, rather than tinkering around the edges to make something marginally better.

Second, I was struck by a recent scholarly article by Mittra entitled, "Why Modern Medicine is in a rut" (PMID 19855121) (Props to Dave Aron who suggested the article to me). In it Mittra argues that the first 30 years after WW2 was characterized by transformational change: Dialysis, Ventilators, CABG, etc. However, the last 30 years have been characterized by incremental change despite a huge increase in research funding. He cites 2 reasons: overdependence on high tech research (i.e. Human Genome project) and overdependence on big RCTs (if you need 5000 pts per arm, by definition the effect is modest--truly transformational requires only small studies because the effects are so profound.)

I'd argue that we need more Google-like thinking in research. We shouldn't be investing $200million on a single study to figure out whether triple anti-platelet blockade is better than double blockade. Rather, we should be spending that money to 200 $1M grants to think about revolutionary approaches to atherosclerosis. I don't know what those revolutionary approaches would be, but I am fairly certain that few funded grants are proposing interventions that are 10 times better than current standard of care.

Finally, I was talking to Seth Landefeld, a mentor and disruptive thinker, who talked about how the projects he's most proud of are the ones that were not grant funded. I think this points to the fact that most researchers are drawn to transformative, high-risk projects. The problem is that the vast majority of what is funded is incremental research. So, the safe path is often to do that study on triple blockade rather than transformative research.

Luckily, most of us find some time to do both incremental and (hopefully) transformative research. But if we were able to align funding to reward potentially transformative research, I think we'd get more innovative research, and we'd be able to get Modern Medicine out of Its Rut.

by: Sei

$10,000 Design Challenge to Improve the Communication of End-of-life Preferences

2013-04-22T21:31:00.001-07:00

Do you have any good ideas on how to get more people to complete advance directives early, re-visit them periodically, and for people with serious illness document their end-of-life wishes via forms like POLST? Well, it’s time to turn those ideas into something more.

The California HealthCare Foundation (CHCF) Design Challenge is now in full swing. The goal of the challenge is to "raise awareness of end-of-life care issues and to generate a variety of ideas for compelling experiences that could lead to greater activation and conversation about end-of-life preferences". Anyone in the US is welcome to enter this design challenge, which will award $10,000 in prizes for inspirational solutions.

You can submit pretty much anything you think will get people talking about end-of-life preferences. Your proposed solutions can be something on a website or mobile app, it can be some type of product or object, it can be a marketing campaign, or even an art installation.

It also won’t take a lot to enter. You just need to:

Create a design brief of 500 words or less summarizing your proposed solution
Create a PowerPoint or video (max. 15 min) that visually communicates the proposed solution

Just keep in mind these three main guidelines:

Your submission should promote awareness and create a compelling experience that leads to greater activation and more people communicating their preferences by having a conversation, and completing an advance directive or POLST form.
Your submission should target non-activated people, and help take a person from pre-contemplation to contemplation, or contemplation to action.
Your submissions should not create additional advance care planning documents; existing forms and documents can be used.

Other than that, the challenge is pretty open ended. So get your creative juices flowing and submit something!

For more details, see http://healthcareexperiencedesign.com/eolc/

by: Eric Widera (@ewidera)

5 Misconceptions About Palliative Care

2013-04-22T09:44:00.001-07:00

Richard Besdine, MD medical officer for the American Federation for Aging Research, has a terrific piece in the Huffington Post about palliative care and misconceptions about the field. This is GeriPal to the core. Please follow this link to read the full version.

As a tantalizing preview, here are the 5 misconceptions in brief:

If you accept palliative care, you must stop treatment.
Palliative care is the same as hospice.
Electing palliative care means you are giving up.
Palliative care shortens life expectancy.
There isn't need for palliative care because my doctor will address pain anyway.

Sound familiar?

by: Alex Smith @alexsmithMD

Dr. Lee's Miracle Dementia Regimen

2013-04-17T16:00:00.000-07:00

Evidence is mounting that regular exercise may prevent dementia and reduce the decline in physical function associated with dementia. Dr. Covinsky recently decried the lack of a market for exercise interventions to prevent physical decline for patients with dementia, saying there are no "special interests with the resources needed to fight for their availability."

Our answer is home grown! During a recent Geriatrics Journal Club about the NEJM study on costs of dementia, Dr. Sei Lee realized that what is one man's trash is another man's treasure.

Presenting Dr. Lee's Miracle Dementia Regimen!

The first component is regular exercise, at least 3 times a week. Included in Dr. Lee's regimen are several outstanding DVDs. Here is a free preview:

The second really important part of the program is a miracle tonic (see photo). This tonic should only be taken after regular exercise. The tonic is called obecalp (caution, do not read backwards).

This program will not only be good for you, it is good for society. Reducing the burden of Alzheimer's will save our society billions of dollars.

Act now! Contact Dr. Lee for your special set of DVDs and first shipment of tonic.

by: Alex Smith

Should Failure to Follow Preferences be a Medical Error? #NHDD Question

2013-04-16T10:27:00.000-07:00

Today is National Healthcare Decisions Day. The day was created as “an initiative to encourage patients to express their wishes regarding healthcare and for providers and facilities to respect those wishes, whatever they may be.” Much of what will be going on today at various outreach programs will be focused on the first part of this initiative: educating the public on the importance of advance care planning. I'd like to take a second though and pose the following question to our audience:

Should the failure to follow end-of-life preferences be considered a medical error?

This question is derived from a recent JAMA Internal Medicine editorial by GeriPal contributors Theresa Allison and Rebecca Sudore. In it they make a persuasive argument that the disregard of patients' preferences is indeed a medical error. Here is an excerpt:

"Discussions about goals of care and code status constitute a medical procedure every bit as important to patient safety as a central line placement or a surgical procedure. Much as we have developed systems to improve patient safety in surgical procedures, we need to develop systematic approaches to discussing patient values and goals of care."

The Importance of this Question on National Healthcare Decisions Day

To understand the importance of this question, one needs to only turn to the study that accompanies the editorial by Allison and Sudore. The study, conducted by Heyland and colleagues, involving 278 patients and 255 family members in 12 Canadian hospitals. To be included, patients needed to be age 80 years or older and have either advanced pulmonary, cardiac, or liver disease, or metastatic cancer, or be to be someone whose death within the next 6 months would not be a surprise to any member of his or her care team.

Of these elderly patients who were at high risk of dying in the next 6 months, 76% reported that they thought about what kind of life-sustaining treatments they would or wouldn't want prior to hospitalization. And what did they want?

Few (12%) wanted aggressive use of heroic measures and artificial life-sustaining treatments, including CPR with a goal of life prolongation
A little more (18%) wanted “Full medical care” but no CPR in the event their heart or breathing stopped
Most (31%) would want their care either focused on 1) comfort if their health deteriorated including avoiding CPR and other life-sustaining technologies, 2) trying to fix problems but if not getting better, switch to focusing comfort even if it hastens death

The good news is that most individuals discussed their preferences with someone (88%). The bad news is that most patients just talked to their family members about these wishes. Only 30% had talked to their family physician, and only about half (55%) had talked to any member of their health care team.

The other good news is that nearly half of patients (48%) reported having completed a written advance care plan, and 73.3% had documented who they would like to be their surrogate decision maker. The other bad news though is that only one in four (25%) of these patients were asked about these prior discussions or written documents on admission to the hospital.

The most unfortunate finding of this study was that more than two-thirds of patients’ preferences were either not documented at all or documented incorrectly in the medical record. When the authors of the study looked at the 199 patients who expressed a preference for care and for whom a written goals-of-care order was present in the patient’s records, they found:

only a 30% agreement between patients’ expressed preferences and the documented goals-of-care order in the medical record
28.1% of patients (56 of 199) preferred comfort measures only, but this preference was documented in only 4.5% (9 of 199) of stated goals (Figure 2A).

So, the question I have for you on this National Healthcare Decisions Day is whether you agree with Drs Allison and Sudore that this failure to document end-of-life preferences should be considered a medical error?

by: Eric Widera (@ewidera)

The Benefit of Exercise in Alzheimer’s Disease and Dementia: The Finalex Trial

2013-04-15T21:37:00.000-07:00

Alzheimer’s Disease and other dementias have impacts far beyond cognitive function. Alzheimer’s patients also experience steady declines in physical function. Over time, these patients lose the ability to do basic activities of daily living such as getting dressed or bathing, becoming dependent on family caregivers. Walking ability also steadily declines. For this reason, patients with Alzheimer’s disease fall frequently.

A landmark study published today in JAMA Internal Medicine demonstrates that a patient-centered exercise intervention administered by trained physical therapists can slow the physical deterioration of Alzheimer’s Disease.

The investigators randomized 210 patients (average age= 78) with moderate to severe Alzheimer’s Disease to either usual care or one of two exercise intervention groups as follows:

Home Exercise: A physical therapist visited the patient’s home for one hour twice a week for one year. The treatments were goal oriented and tailored to the patients problems in physical functioning and mobility
Group Exercise: Patients attended a day health center for 4 hours twice a week for one year. Exercise sessions, which lasted for about 1 hour, were administered by two physical therapists to groups of 10 patients. Exercise focused on endurance, balance, strength training, as well as cognitive exercises

It is important to note that this type of exercise program is far different from what a patient in the United States would receive with a physical therapy referral. The intensity and duration far exceeds what is generally available under the Medicare benefit. In addition, the Finalex study used therapists with particular expertise in dementia.

Was this intensive exercise intervention worthwhile? The answer is a resounding yes! The key results are as follows:

The exercise program slowed declines in physical function. Patients getting usual care declined an average of 14 points over 1 year on the functional independence measure. Patients getting home exercise declined 7 points and patients in the group exercise declined 10 points. (The difference between both exercise groups and usual care was statistically significant. The difference between the exercise groups was not significant)
The exercise groups had far fewer falls. The group exercise subjects had 40% fewer falls, and the home exercise subjects fall rate was more than cut in half. This impact makes this study one of the most effective fall intervention programs ever devised
Even when accounting for the cost of the intervention, the health costs in the exercise groups were not more expensive than the costs of usual care. The cost of this intensive intervention was compensated by lower rates of health service use in the exercise groups. This goes to show that the best things in life sometimes really are free.

Based on this study, it would be reasonable to offer a similar exercise intervention to most patients with moderate to severe Alzheimer’s disease. Since the group and home exercise interventions both worked, the choice between the two approaches can be guided by the needs of individual patients.

Unfortunately, it will be nearly impossible to make these types of intervention available to patients with dementia in the United States. Structurally, our health system seems incapable of providing such intensive patient-centered services on a long-term basis. Also, the intensity of physical therapy considerably exceeds that which is typically approved by Medicare.

Its not that the US health system does not spend a lot of money on Alzheimer’s Disease. We pretty much can get as many MRIs as we want. We can also spend as much as we wish on the repeated hospitalizations that are often related to the physical deterioration that exercise interventions may prevent. It is the nature of the US health system that we are often able to spend vast sums of money on stuff that does little to help our patients, but are unable to spend much less on the stuff our patients really need.

If these exercise interventions were drugs, they would be on the fast track to approval. But they are not drugs and there will be no special interests with the resources needed to fight for their availability.

Can you imagine the uproar that would occur if CMS announced that it would it no longer pay for dementia drugs such as donepezil (Aricept) because their marginal benefits do not justify their costs? Surely, there would be screams of rationing. But the inability to provide patients these types of exercise interventions, as well as other multidisciplinary caregiver focused interventions that have been proven to improve outcomes in Alzheimer’s disease, is rationing just the same. Why is there no uproar?

by: Ken Covinsky

Aging with HIV

2013-04-04T13:01:00.001-07:00

From the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

It has been over three decades since the first cases of AIDS were observed in the United States, and in one month we will be marking the 30th anniversary of dual publications in Science attributing a novel retrovirus as the potential cause of AIDS.

Since this time, and in large part due to the development of antiretroviral therapy, mortality due to HIV & AIDS has significantly decreased, so much so that it is now considered a chronic rather than an acutely fatal disease. With these changes, HIV is also now becoming a disease of the elderly. By 2015, half of HIV positive individuals will be older than 50 years of age.

This is the background to what I consider one of the most important review articles in JAMA this year. Starting off with a case of a 74 year old who was diagnosed with HIV in 1984 (when AIDS was almost a uniformly fatal disease) the authors, Meredith Greene, Amy Justice, Harry W. Lampiris, and Victor Valcour, walk us through the prevention and management of HIV in Advanced Age.

Here are a couple issues presented in the article that should make this a must read for any provider caring for older adults (you can read the entire manuscript here):

Under-diagnosis: There is a delay in the diagnosis of HIV due in part to common misconceptions that HIV is a disease of the young and that older adults aren’t at risk because they don’t have sex (or at least we dont ask about it.)

Screening: Age as a cut off for screening is changing. Because of shifting demographics seen in HIV infections, routine opt-out screening is now recommended regardless of age.

Antiretroviral Treatment: CD4 counts should not change the decision of when to initiate antiretroviral therapy. In the US, antiretroviral therapy should be started in all older patients regardless of CD4 counts.

Psychosocial Care Matters: Older HIV-positive adults are at risk for social isolation, which has been shown to negatively impact health outcomes (see here)

Prognostication: Patients overall goals and life expectancy should play a role in decisions around health care maintenance and prevention in this population (and they included a link to ePrognosis!)

Advance Care Planning & Palliative Care: Discussions and documentation of end-of-life preferences need to occur more frequently and Palliative Care can play an "emerging role in improving quality of life" in these patients

The review also does a beautiful job in helping clinicians understand how specific antiretrovirals are chosen in older HIV positive adults and common drug interactions between antiretrovirals and other medications.

To wrap things up, I'll end with a quote from the article on where we need to be going as a field:

Optimal models of care must be identified—with HIV specialists, primary care clinicians, and geriatricians working together to make successful aging for this population achievable.

Well said!

by: Eric Widera (@ewidera)

Three Things to Put Your Name Behind in Geriatrics and Palliative Care

2013-03-25T06:30:00.000-07:00

Dr. Tatum with Sen. Blunt

1. The Palliative Care and Hospice Education and Training Act (PCHETA)

We have written about PCHETA before and we will continue to advocate for it. You can read more about it in one of our earlier GeriPal posts (here), but in brief PCHETA will greatly expand opportunities for interdisciplinary education and training in palliative care. We need you to act now to move this bill forward on Capital Hill. Please take 5 minutes to go to the AAHPM Legislative Action Center where you can quickly learn how to ask your representative to sign on as supporters of the bill.

2. Amy Abernethy as one of the "100 Most Influential People in Healthcare"

Let's get our social media machine working to get AAHPM President Amy Abernethy listed as one of 2013’s "100 Most Influential People in Healthcare." If picked she will be featured among other leaders in health care in Modern Healthcare's August 2013 edition. Nominate her here.

Nominate AAHPM Pres Amy Abernethy as one of 2013 "100 Most Influential People in Healthcare" modernhealthcare.com/section/100-Mo… #hpm #aahpm #asco #hpna
— ssmithaahpm (@ssmithaahpm) March 24, 2013

3. A National Caregiver Corps

This idea is very much in it’s infancy, but the basic idea is to create a program similar to the Peace Corps that would rely on volunteers, young and old, to support community-based programs serving older adults and caregivers. Janice Lynch Schuster both dreamt up the idea and created a petition on the White House website. Let's get her to 100,000 signatures to see how the administration responds!

by: Eric Widera (@ewidera)

Special Mentoring Opportunity at AGS!

2013-03-23T11:05:00.000-07:00

“A Longitudinal Senior Faculty and Peer Mentoring Program for Junior Investigators and Educators”

Who: Junior faculty (Assistant Professor/Instructor or equivalent)

What: Symposium to describe practical ways to get the most out of mentoring relationships as an investigator or educator, establish a longitudinal peer mentorship group under the guidance of a senior leader in the field, and develop individual career goals for follow up during conference calls in the year following the symposium.

Why: Mentoring is critical to professional success! Mentors and mentees have a two-way relationship based on feedback, commitment, engagement, balance, self-awareness, and advocacy (Gillespie, 2012). We need many mentors both senior and peer for various aspects of our professional development.

When: Saturday, May 4th 12:30-2pm

Where: American Geriatric Society Annual Meeting in Grapevine, Texas

Speakers include: Louise C. Walter, MD, Sharon Levine, MD, Mary K. Goldstein, MD and Annette Medina-Walpole, MD

Brief Description:
In this session, successful senior faculty members in research and education will share their perspectives and advice regarding mentorship. Participants will then break into groups based on their career focus (investigator or educator) for a discussion with peers and a senior faculty mentor to share career challenges, receive advice and guidance, and develop best practice tips for success. Participants will be required to bring questions for the discussion portion and will be expected to participate in at least two follow-up phone calls with their senior faculty mentor and small group in the year following the symposium. Space is limited and participants will be selected on a first-come, first-serve basis.

***SPACE IS LIMITED - sign up HERE***

Looking forward to seeing you all at AGS!

Best,
Amy M. Corcoran, MD
Amy S. Kelley, MD, MSHS

Literature Potpourri

2013-03-21T13:00:00.000-07:00

Here are a smattering of interesting articles on my desk I've wanted to blog about, but haven't had time to work into full posts. Writing about them here briefly doesn't preclude anyone (you?) from posting about these stories in greater detail later!

The February issue of the Journal of General Internal Medicine, or JGIM, should be subtitled "The GeriPal Issue." Lots of great articles on social media, geriatrics, and palliative care topics, including:

An article by Matthew DeCamp on social media and conflicts of interest. Did you know that 65% of patients trust information about cancer obtained from the internet? (for comparison, 93% trusted information from a physician). Lot's of nefarious potential here for big pharma and docs in their pay to steer patients to their products without adequate disclosure.
This study by Amy Kelley on of out-of-pocket costs during the last five years of life. Amy is on a roll, see this post about her recent Health Affairs article. Did you know that one quarter of older adults spend down their assets to nothing in the last five years of life? In the accompanying editorial, Michael McWilliams asks, how much should society protect people against going broke before they die?
Elizabeth Eckstrom wrote a terrific thought piece about challenges in cancer screening in older adults. She laments that, "There is little research to guide busy primary care providers and practices in effectively performing cancer screening." Amen to that. I like the way she asks the tough questions, like, "Can older adults understand screening complexities in the context of multi-morbid illness?"
Deb Barnes presents a prognostic index for recovery of function, persistent dependence, or death following a hospital acquired disability. Older adults don't just care about whether they will live or not, they also care about what state they will be living in. Functional ability, or the ability to provide basic daily care for oneself is a part of that. The article features cool multicolored triangles that visualize this three part outcome.

A paper by Yoko Tarumi in the Journal of Pain and Symptom Management adds to the weight of evidence that docusate adds nothing to senna based laxatives for opioid related constipation.
AAHPM decided to keep the "H" (for hospice), as reported by Tim Quill in the fall AAHPM quarterly (online for members only). See this previous post introducing the controversy. The process of deciding about the "H" was thoughtfully done, including focus groups and a member survey. Only 11% of members responded (guilty as charged) but 87% of those who responded felt the current name describes "who we are and what we do."

by: Alex Smith

Why Choosing Wisely Will Have Limited Success

2013-03-20T10:12:00.001-07:00

Foreword: The views expressed in this essay are my own and do not reflect the opinions of the GeriPal Blog editors and other GeriPal contributors participating in Choosing Wisely. I support the ultimate goal of Choosing Wisely and have the highest respect for those working on this important endeavor.

Choosing Wisely is a campaign led by the American Board of Internal Medicine (ABIM) Foundation with strong collaboration from specialty societies representing nearly all medical disciplines and support from various health and health care organizations. Choosing Wisely seeks to reduce wasteful and unnecessary health care services. The underlying premise is that health care is too expensive due largely to waste and unnecessary utilization. Berwick and Hackbarth (JAMA 2012) demonstrated that 20% to 50% of expenditures are wasteful. Choosing Wisely seeks to address several categories of waste that are particularly expensive for Medicare and the broader health care system (e.g., overtreatment) and those categories of waste that physicians can be strong advocates for improvement (e.g., failures in care coordination and in execution of care processes). Targeting physicians makes sense because their decisions ultimately account for over 80% of all health care expenditures. Choosing Wisely appeals to an individual doctor’s sense of medical professionalism and belief in evidence based medicine.

The design of the Choosing Wisely campaign is elegant (each medical society identifies five specific decisions that lead to waste or harm as defined by best clinical evidence) and action-oriented (each is specifically described and stated in the language of professional directives). The Choosing Wisely campaign has been very careful to avoid any notion of cost control, government or insurance-based rationing, or weighting of group over individual good. Their focus group data, in addition to a recent study in Health Affairs (February 2013), suggests that doctors and patients will react instinctively and negatively to any campaign grounded in claims for societal good or distributive justice. To remove any doubt that Choosing Wisely is based on professionalism rather than rationing, Jon Tilburt and Christine Cassel recently published a Viewpoint in JAMA (February 2012) titled, “Why the Ethics of Parsimonious Medicine is Not the Ethics of Rationing.” They make the narrow claim that rationing is about limiting potentially beneficial resources ‘due to resource scarcity’ for societal good while parsimonious medicine is about ‘delivering appropriate health care that fits the needs and circumstances of patients’ and that ‘avoids wasteful care when that care does not benefit patients’. At its simplest level the difference between parsimonious care and rationing is a focus on individual needs versus societal good. The politics of the Choosing Wisely campaign is quite intelligent. Most Americans frown on central planning (whether by governments or monopolistic capitalism), believe that medical decision making should occur primarily at doctor-patient encounter, and have a romantic obsession with the early 20^th century ideal of medical professionalism. Choosing Wisely is on the right side of each of these normative beliefs about medicine and health care.

Despite all these strengths, I believe the Choosing Wisely campaign will ultimately only be a minor success. Despite remaining a darling of public opinion, it fails to address the primary drivers of waste, especially drivers of overtreatment by physicians. My judgment is based on the emphasis Choosing Wisely has placed on medical professionalism and its exclusive focus on physicians’ “good, sound judgment.” One might ask, how is parsimonious medicine any different from how doctors are supposed to act now? How effective has professionalism been over the past half century in reducing costs and waste? For example, most physicians understand that common back pain (without alarm signs or symptoms) does not warrant extensive imaging (e.g., MRI) unless it persists for many weeks. The doctor can talk about evidence suggesting very low risk of something serious occurring balanced against the potential harms of a diagnostic test, and some personalized discussion of costs (e.g., copays). However, when the patient states that he’s in severe pain and his wife told him to demand an MRI, relates a story about his uncle whose doctor misdiagnosed his metastatic prostate cancer, and that his copay is only $50; the distinction between rationing and parsimoniousness becomes quite blurred for the treating physician. This patient isn’t rare. He is your typical medical consumer (despite his romantic notions about professionalism)--who is neither quality nor cost conscious. Quite frankly the financial incentives for both doctors and patients are weighted towards overtreatment and against shared and informed decisions, and Choosing Wisely does little to shift these incentives. Furthermore, Choosing Wisely has ignored the elephant-in-the-room which is the perception among many doctors that defensive medicine drives overtreatment decisions. The perception of defensive medicine is critical (not the actual prevalence of malpractice-aversion) and this perception should be a central theme of the professionalism push by Choosing Wisely.

No matter how much the Choosing Wisely campaign wants to avoid arguments about resource scarcity—this is simply why the campaign began in the first place. Our health care system (government, insurers, providers, and patients) is spending too much for the quality of care that is received. While I agree that government based rationing is un-American and unlikely to take root; I simply don’t believe in the quaint and romantic notion of parsimonious medicine changing health decisions. The Choosing Wisely campaign should be set within the context of a high cost, high waste, and comparatively lower quality health care system. The target should be quality-consciousness at the patient level and focused equally on patient and physician drivers of over-utilization--beyond patient education. We should be clear that rationing is the issue, but rationing at the individual doctor-patient encounter not the societal level. A patient who doesn’t benefit from an MRI for his uncomplicated back pain (based on the evidence) but still demands one—should be charged a significantly higher copayment for choosing a low quality (but anxiety averting) option. Doctors that act transparently within an evidence-based pathway should be shielded from not only frivolous lawsuits but also the rare cancer case that presents as uncomplicated low back pain. Diagnostic or treatment decisions based on quality-conscious, patient-centered communication do not occur frequently within American health care, however such decision making represent the most ‘American’ form of medical rationing. One might even call it the beginnings of an actual, functioning health care marketplace.

by: Aanand D. Naik @empoweringpts

#hpmparty New Orleans Thursday 9pm

2013-03-08T14:55:00.000-08:00

Trombone Shorty

If you're going to New Orleans for HIPNA/AAHPM I hope you will join for the annual Pallimed/Geripal social media get together.

We won't say right now where the party will start. This year we will harness the power of social media to make the night even better. Please tweet suggestions for where to go with the hashtag #hpmparty. We will tweet the starting location of the party with #hpmparty on Wednesday or Thursday at the latest. As the evening progresses, we may move locations, so be sure to follow the hashtag if you're joining us after 9pm.

This year is the focus is on music. My favorite music to come out of New Orleans recently is Trombone Shorty. I got to see him at Hardly Strictly Bluegrass a couple of years ago with my kids, and we had his album playing daily for weeks after. Here's a link to a documentary about him on youtube.

And here's one of his newer videos:

Trombone shorty won't be performing in New Orleans when we visit. Lets hope for some equally good music.

Looking forward to seeing everyone!

by: Alex Smith

The Shortsighted Argument in Limiting Hospice Access

2013-03-05T10:30:00.000-08:00

It feels like every passing day brings with it more news of an aggressive campaign to reign in the cost of Medicare hospice spending. For instance, federal government investigations of hospices that enroll patients who live longer than 6 months have resulted in the death of one of the most important organizations in our field, San Diego Hospice (as covered by Pallimed here). There have also been threats from those like the governor of Louisiana, Bobby Jindal, who attempted to make a case that eliminating Medicaid hospice care would save the state over a million dollars.

Hospice is associated with a host of benefits including reduced symptom distress, improved outcomes for caregivers, and high patient and family satisfaction. The underlying question though with Gov. Jindal’s argument is whether hospice programs cost more than they save for states like Louisiana or the federal government? According to the Louisiana Department of Health and Hospitals the answer to this question is clear (the following is a excerpt from their FAQ):

How much money does the State save by eliminating hospice?
The elimination of hospice will be a $3,295,729 savings in total dollars (SGF portion $1,101,433) for SFY 13, and an $8,342,802 savings in total dollars (SGF portion $3,090,174) anticipated for SFY14.

Without hospice, won’t a lot of these patients just go into hospitals for more expensive care?
Going forward, people who would have sought hospice care, either in a nursing home or community setting, will still be able to access most of the same services they receive today. For recipients in nursing homes, these facilities provide around-the-clock care to residents to help them stay comfortable, and many of these homes have established relationship with clergy members or nonprofit organizations who can provide emotional and spiritual support to residents. For those outside of nursing homes, they can still access services such as prescription drugs, home health and long term care personal care services for comfort and palliative care. The emotional support services previously offered through hospice can be accessed through community nonprofit and faith-based organizations.

However, according to a paper published in Health Affairs by Amy Kelley and colleagues on the costs of hospice care, the Jindal administration and the Department of Health and Hospitals is 1) shockingly shortsighted, and 2) blatantly wrong in regards to the second bolded point.

Dr. Kelley used data from the Health and Retirement Study and individual Medicare claims to compare costs for propensity score matched patients receiving hospice care to those of patients not receiving hospice care across four different periods of hospice enrollment: 1–7 days, 8–14 days, and 15–30 days, and 53-105 days before death.

After adjustment for other factors that may influence cost, the authors found that enrollment in hospice resulted in net savings to Medicare across all enrollment periods. The adjusted savings in total Medicare spending were

$2,561 for those enrolled 53–105 days prior to death
$6,430 for those enrolled 15–30 days prior to death
$5,040 for those enrolled 8-14 days prior to death
$2,651 for those enrolled 1-7 days prior to death

Dr. Kelley also found that hospice enrollees had reductions in hospital and intensive care unit admissions, hospital days, and rates of thirty-day hospital readmission and in-hospital death. Furthermore, a greater impact was seen in the reducing hospital and ICU stays if individuals were enrolled earlier in hospice. The adjusted decrease in total hospice and ICU days were:

9.0 hospital days and 4.9 ICU days for those enrolled 53–105 days prior to death
0.9 hospital days and 0.5 ICU days for those enrolled 1–7 days prior to death

Ultimately, Governor Jindal’s argument failed thanks to the effort from a lot of people, including members of AAHPM. The Medicaid hospice program now has a temporary reprieve, although Louisiana must cobble together some alternative before the same budget cut is scheduled to take effect in 5 months.

The good news is that this time around we have an even a stronger argument to make that 1) eliminating hospice will cost more money than it will save, and 2) that a lot of "these patients" will just just go into hospitals for more expensive care. The bad news is that shortsighted policymakers have a tendency to keep their glasses off when thinking about health care.

by: Eric Widera (@ewidera)

Is it better to look good or feel good?

2013-03-04T20:13:00.000-08:00

Shoes modeled by famous palliative care researcher KS

I'm reviewing grants for the National Palliative Care Research Center in New York, and always on the lookout for blog material. I can't discuss any of the grants themselves, of course, but some interesting items came up at dinner tonight.

Now I love California, but New Yorkers do have a few things on the rest of the country - they walk everywhere, have great fashion sense, and are first to try the latest cool gadgets.

And perhaps there's a lesson here somewhere here about mobility and older adults.

Take shoes.

Most of the shoes I've seen for older adults are utilitarian and plain. What if shoes for older adults were really fashionable - like those modeled by famous palliative care researcher K.S. in the photograph above? Ooh la la! Would older adults feel better about walking?

Fuel watch from RK's son Tønne

And in this picture we have a cool watch gadget that tracks daily "fuel" expenditure toward a set goal. (This watch belongs to the son of RK from ACS). Would older adults feel better about themselves if they had a cool watch giving them feedback?

by: Alex Smith

Terminal Delirium: Fatalism and Intellectual Laziness?

2013-03-02T12:31:00.000-08:00

(Picture from Wikimedia Commons)

In 1996, Catherine Sarkisian described the common geriatric diagnosis "failure to thrive" as the result of fatalism and intellectual laziness. Fatalism, in the sense that there doesn't seem to be anything to be done about the condition (ie throw up your hands). Intellectual laziness, because in fact with some thoughtful clinical sleuthing, the cause of failure to thrive can often be traced to five potentially treatable conditions: impaired functioning, malnutrition, depression, and cognitive impairment.

So is terminal delirium the failure to thrive of palliative care?

Delirium can often be traced to a cause or constellation of causes, such as medication side effects, dehydration, unfamiliar environments, or lack of sleep. Many of these conditions are treatable, for example by stopping the offending medications, encouraging fluid intake, encouraging family to stay, or improved sleep hygiene.

In palliative care do we too often jump to the diagnosis of terminal delirium? Really, as Eric Widera pointed out the other day, a diagnosis of terminal delirium should only be made in retrospect, after a patient has died. You don't know if it's terminal until it's terminal.

The risk of missing treatable causes of delirium is that the patient will lose the chance to spend their last moments of life conscious. It may mean an earlier, preventable death, given deliriums strong association with dying. For family members delirium feels like they've already lost their loved one, because the person they knew no longer seems present.

Fatalism and intellectual laziness indeed.

by: Alex Smith