Monday, February 11, 2019

Goodbye to Compounded Analgesic Creams

by Drew Rosielle (@drosielle)

Annals of Internal Medicine has just published one of the better trials of compounded analgesic creams I've yet to see, and unfortunately it's pretty damning.

It's a randomized, double-blind, placebo-vehicle controlled, intention-to-treat, 3 parallel armed study of 3 different compounded creams for adult patients (median age ~50 years, ~50% women) with localized chronic pain (the 3 groups had neuropathic, nociceptive, or mixed pain syndromes). It took place at Walter Reed. Each arm had about 130 subjects (which, for this type of research, and compared to many other investigations of compounded creams, is quite a lot). Patients needed to have chronic pain (longer than 6 weeks), rated at least 4/10, and localized to a body area or two extremities. Broadly speaking about half the subjects' pain was incited by an injury or surgery. Pain was classified as nociceptive vs neuropathic vs mixed based on a pain physician's assessment, more or less. About 20% of patients were on systemic opioids.

Subjects were prescribed one of 3 compounded creams (or the placebo/vehicle cream which was PLO) and asked to apply it to their painful region three times a day:
  • Neuropathic: 10% ketamine, 6% gabapentin, 0.2% clonidine, and 2% lidocaine
  • Nociceptive: 10% ketoprofen, 2% baclofen, 2% cyclobenzaprine, and 2% lidocaine
  • Mixed: 10% ketamine, 6% gabapentin, 3% diclofenac, 2% baclofen, 2% cyclobenzaprine, 2% lidocaine

The primary outcome was average pain score after 1 month of treatment. They presented several prespecified secondary outcomes too. The study had 90% power to detect a pain reduction of 1.2 (out of 10) points with 60 patients per treatment arm, which they met.

Basically there weren't any statistically, let alone clinically, meaningful differences between the groups, regardless of pain type. For all groups, pain was reduced at a month by around 1-1.4/10 points on the 0-10 NRS, regardless of receiving active drug or placebo cream. Secondary outcomes including patient judgement of a positive outcome (ie, the percent of patients who reported they considered the cream a success) were the same between all the groups too (around 20%). Health related quality of life did not differ either between groups at a month.



This study is one of the largest and best-designed study I'm aware of of these creams, and the findings are pretty clear: such creams benefit patients via placebo mechanisms, aka they don't work.

Note that there is a separate body of research on some other topicals which should not be confused with this study. Eg, the 5% lidocaine patch for post-herpetic neuralgia, topical capsaicin for a variety of neuropathies, and at least some topical NSAIDs for osteoarthritis, and topical opioids. I'm not broadly endorsing those either - it's complicated - however they weren't tested here and the take home point is we should stop making our patients pay exorbitant out of pocket costs for these compounded analgesic placebos, not necessarily those others.

Particularly for painful axonal neuropathies, many of us struggle with how to control those adequately, especially chemotherapy induced ones which don't respond well to most systemic drugs, and I've ordered plenty of fancy creams in the past for my patients, most of whom paid out of pocket for them, and I think it's time to stop doing that.

For more Pallimed posts about journal reviews.
For more Pallimed posts by Drew click here.

Drew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle.

References

1 Brutcher RE, Kurihara C, Bicket MC, Moussavian-Yousefi P, Reece DE, Solomon LM, et al. "Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial." Ann Intern Med. [Epub ahead of print ] doi: 10.7326/M18-2736

Monday, February 11, 2019 by Drew Rosielle MD ·

Friday, January 11, 2019

A Randomized Controlled Trial for Fan Therapy in Dyspnea

by Bob Arnold (@rabob)

Winter suits me just fine since I do not like heat. I have a lot of sympathy for patients with chronic obstructive lung disease who do not have an air conditioner during the summer. I am told that there is nothing worse than sitting in hot, humid weather and not being able to breathe.

As a palliative care physician, I love fans. When my patients are short of breath and opiates do not work (1,2) I send their families down to the local ACE hardware store to buy a hand-held fan. Therefore, I was excited to see an article in the Journal of Pain and Symptom Management on fan therapy being effective in treating dyspnea in patients with terminal cancer. (3) The previous data for fans (4) has been meager so I have always been a bit hesitant to recommend fans in my academic hospital for fear that the other doctors would think I was goofier. I was hopeful that this article could make a difference in how they thought about me (a bar that might be too high for any single article).

Briefly, this was a randomized controlled trial of 40 palliative care unit patients with advanced cancer in Japan. The patients all had dyspnea at rest with a score of at least 3 points on a 0-10 numeric grading scale, oxygen saturations greater than 90%, and an ECOG Score of 3-4. The only patients who were excluded were those with a fever, anemia, or a disease or treatment affecting the trigeminal nerve (the purported mechanism for the action of fans). The intervention was a fan blowing across one side of the patient’s face for five minutes. The control group was not blinded but did have air flow directed onto the patient’s exposed legs for five minutes. The outcome measure was a change in the patient’s dyspnea score.

The two groups were similar in characteristics and causes of dyspnea. Importantly, there was no difference in the oral morphine equivalent doses at baseline (although the patients who got leg fans had slightly higher doses; the investigators tried to control for this by having a washout period before initiating therapy). The patient’s cause of dyspnea and their performance status also did not differ

What did differ were the results. People who had fans to the face had a greater change in their dyspnea score (-1.35; range of -1.86 to -.84 versus -0.1; range -0.53 to 0.33). More importantly, 80%of patients who had a 1 point reduction in their dyspnea rating and 35% had a reduction of two or more points versus 25% and 5% in the fan to the leg group.

Was the study valid?

They had to screen a lot of patients to enroll 40. This makes me worry whether this is a very select group of patients that may not be representative of the general patients I see. On the other hand, they were palliative care unit patients with advanced cancer who sound like my patients. The assignment of patients to the two groups was evenly randomized; all the patients were accounted for at the conclusion and there was complete follow-up. The study was not blinded, and I could not tell if the people who were collecting the data knew which groups the patients were in as that might be a problem if they assessed the symptom differently.

Were the results clinically important?

Well this is a bit of a problem. When you try to decide what counts as clinically significant on a dyspnea scale, there is a fair amount of variation depending on the scale. However, in my very quick search of the literature regarding visual analogue scales it seems like a clinically important change is between 10-20 on a 0-100 scale (this would translate to one or two points on the scale used in this study - more on Minimally Clinically Importnat Difference here). So, the difference in this study may be clinically important.



Might other factors have resulted in this difference?

I think the investigators did quite a good job in trying to control for other medications that the patients received that might have increased or decreased dyspnea. I was particularly impressed with how they handled and reported on opiates.

Does this change my practice?

This is a little bit like the aromatherapy article that I reviewed. There is almost no risk and my experience, like the study, is largely positive, so it did not really change my practice because I was doing it anyway. Though an article might help me to lead to a more educated and intellectual discussion with my residents and fellows – the answer to that is yes and that is always a good thing. (I am currently trying to figure out if folks think I am less goofy).

More Pallimed posts from Bob Arnold can be found here.
More Pallimed journal article reviews can be found here.
More Pallimed posts on dyspnea can be found here.


Robert Arnold MD is a palliative care doctor at the University of Pittsburgh and a co-founder of VitalTalk. He loves both high and low brow comedy (The Good Place and Nanette), pop culture (the National Enquirer and Pop Culture Happy hour) and music of all kinds (not opera tho!)

References

1 Clemens K E,, Quednau I, Klaschik E. Use of oxygen and opioids in the palliation of dyspnoea in hypoxic and non-hypoxic palliative care patients: a prospective study. Support Care Cancer 2009;17:367–77

2 Kamal AH, Maguire JM, Wheeler JL, et al. Dyspnea review for the palliative care professional: treatment goals and therapeutic options. J Palliat Med. 2012. 15, 106-14.

3 Kako J, Morita T, Yamaguchi T, et al. Fan Therapy Is Effective in Relieving Dyspnea in Patients With Terminally Ill Cancer: A Parallel-Arm, Randomized Controlled Trial. JPSM. 2018. Vol 56, 493-500.

4 Bausewein C, Booth S, Gysels M, et al. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010; 9: 22.

5 Riles AL. Minimally Clinically Important Difference for the UCSD Shortness of Breath Questionnaire, Borg Scale, and Visual Analog Scale." COPD. 2005. Vol 2, 105-110.

Fan Therapy Is Effective in Relieving Dyspnea in Patients With Terminally Ill Cancer: A Parallel-Arm, Randomized Controlled Trial.

Friday, January 11, 2019 by Pallimed Editor ·

Tuesday, January 8, 2019

Grieving with Mr. Pickles: Thoughts on Showtime’s ‘Kidding’

by Christine Bridges

“I don’t think I could stand to be around that much death. All that sadness!” When I announced my career change and plan for a Hospice and Palliative Medicine (HPM) fellowship the reaction of most, in healthcare or not, was concern for my emotional wellbeing. Internally my initial response was: 1. Why do people think that death is reserved for HPM alone? and 2. Death and grief are all around, they are a part of life.

Perhaps it is my current vocation, but it seems that modern media agrees. Death and grief are showing up in unexpected formats. Most recently the new ‘dramedy’ on Showtime, ‘Kidding,’ starring a shockingly sedate Jim Carrey. In the pilot episode, we see our central character Mr. Pickles, a pseudo- Mr. Rogers, waiting to be interviewed on Conan Obrien’s talk show. We learn quickly that this famous man recently lost his son. The episode draws us into his life and the way his son’s death has ricocheted through his family. We see him turn to his work to cope with his grief. Mr. Pickles is planning a show where he will openly address his son’s death. Quickly the old anthems come, “People don’t want to hear about death.”



I imagine myself and my HPM colleagues nearly jumping from our chairs, arms waving, “But people do want to talk about death, they do!” We have learned this the hard way, stepping into complex family meetings and hearing that no one has talked about death or the dying process. Now at the very last inescapable moment, there it is, death on the doorstep. 10 years ago Holly Prigerson's research group published a study showing that earlier discussions around end-of-life care lead to lower rates of caregiver depression. When patients and families are surveyed about preferences regarding the outcomes they are seeking for the end of life they list ‘knowing a doctor is comfortable talking about the end of life,’ and ‘clear decision making, preparation for death.’ A decade later the average length of stay in hospice remains a minuscule 2 weeks. Fourteen days is a tiny window to get to know a patient, their family, their goals, and manage their most difficult symptoms. With that small time to prepare, families are confronted with death more suddenly than they expect.

This was the most commonly repeated experience in a recent spousal-loss support group that I attended. So many of the remarkable people who filled that room echoed each other’s frustrations that the medical community had not told or prepared them for death. At the end of life their own doctor seemed to indicate this outcome had been inevitable. The doctor knew Ms. Jones or Mr. Smith was dying, but the patient and family did not. The spouses mentioned the legal and practical concerns of managing shared assets, but they also mentioned the missed chance for one last vacation, or one last day at home together. Doctors can talk about death, or we can avoid the topic Death comes anyway, and it leaves grief behind as its last gift.

I have a slightly unique perspective, losing my father unexpectedly when I was 20 years old. The other day in lecture the organ and tissue donation organization shared about their work in our community. They showed a picture of the medal they give donor families. That same medal sits next to our brown leather family Bible because my father was also a tissue donor. I felt lost, for just a few breaths and it becomes clear that my work of grief may never be done. Even though we are healers, we as medical providers have all experienced loss. How does our past loss affect our future work? How do we carry our personal and professional losses with us and allow them to be transformed into healing? The opportunity exists for us to help our patients and family begin their journey with grief together, to start that difficult journey through grief hand in hand.

Mr. Pickles compares grief to losing an object that you can never find again. He sings about feelings, letting us know that there are no right or wrong emotions. He argues with producers who do not think children can handle talking about death as if children do not grieve. Perhaps parents, much like providers, can feel out of control, torn free of their moorings when the discussion turns to death. Just like a parent, we must help with the transition from death to grief. There are no shortcuts in grief. We are all grieving something, loss of freedom, or youth, or expectation, and often, missing the people we have lost. We in healthcare cannot use our work as a tool to avoid grief, but like Mr. Pickles, use our losses as a way to do better and give back to those around us. Spending a moment in the shoes of those actively grieving is humbling. It is in service to the goals of patients and their loved ones that we must talk about death.

As physicians, we fear causing harm by sharing ‘bad news.’ The idea that we could prevent grief, to keep it at bay by refusing to allow its presence in the same room as our precious patient, may be a dangerous one. If we listen to our patients, listen to the wisdom even in a TV show, we hear the truth: our patients want to know, and their families need to know that death is imminent. It is not always the patient’s death or family’s grief that we dread. We must recognize our own fear of grief, our sense of failure, our frustrations at being left with uncertainty. We as the medical community must conquer the fear of our perceived enemy: death. As my father often said, “We all leave this world sick enough to die.” It is a simple truth that we are all mortal. It is a complex challenge to acknowledge this in the practice of modern medicine.

I look forward to taking the journey with Mr. Pickles and his family. I will try to make death an old friend, and grief a teacher.

Christine Bridges, MD is a hospice and palliative medicine fellow at the University of Louisville Health Science Center. She enjoys baking and watching zombie movies with her husband.

Wright AA et al. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8; 300(14): 1665–1673.

Steinhauser KE, Christakis NA. Preparing for the End of Life: Preferences of Patients, Families, Physicians, and Other Care Providers. Journal of Pain and Symptom Management. Volume 22, Issue 3, September 2001, Pages 727-737.

Steinhauser KE, Clipp EC. In Search of a Good Death: Observations of Patients, Families, and Providers. Annals of Internal Medicine. 132(10):825-832

Tuesday, January 8, 2019 by Pallimed Editor ·

Tuesday, January 1, 2019

First Ever Medical Humanities Chat (#MedHumChat)



by Christian Sinclair (@ctsinclair)

What started off as a spontaneous tweet by resident Colleen Farrell, MD (@colleenmfarrell) generated a swell of interest from the health care Twitter community and now is being fully realized with the first Medical Humanities chat on Twitter (#MedHumChat) starting tonight January 2, 2019 at 9pm ET.

While not directly focused on our field, we know many hospice and palliative care clinicians have a deep appreciation and connection to the humanities and thought this chat would be of significant interest to the Pallimed online community. We know how hard it is to get Twitter chats started and sustained, and since this chat occupies the same time frame as the old weekly #hpm chats, many of you may be looking for something to fill that gap we left open back in 2017.

Dr. Farrell was kind enough to answer some questions about the chat below.

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CTS: What key reasons make the humanities are important in training of clinicians?

CMF: Oh so many reasons! My organic chemistry professor in college (David Richardson at Williams) urged me to take classes to “understand the human condition.” (I ended up no sticking with my chemistry major as planned and majored in women’s and gender studies with a minor in Spanish.) I think so much of what we do in medicine is trying to understand the human condition, but our ways of doing so in medicine are somewhat limited. For millennia, humans have been telling stories and creating art to make sense of human experience and the mysteries of life and death. We sometimes make the mistake of thinking we only need modern medicine to make sense of life and death but so much mystery remains. I find turning to stories and art helps me make sense of the vastness of what my patients are experiencing and my own experience as a doctor. I think art ultimately raises more questions than it answers, and when it comes to suffering and death, what we need, as doctors, is to recognize the unanswerability of these questions and at the same time the vital necessity of embracing them.

I wrote my senior thesis on the early years of the AIDS epidemic in the US, focusing on the experiences and responses of gay men in particular. (I worked with an incredible US historian Sara Dubow.) I read a lot of patient memoirs, studied the AIDS Quilt and its role in collective memory, and examined artistic representations of Kaposi’s sarcoma. My take away from the project was that illness isn’t fundamentally biomedical with social overlays, but rather a fundamentally social and biological phenomenon. The two simply can’t be separated.

CTS: What Twitter chats have you followed or participated in that might have inspired this?

CMF: I’ve been peripherally following the #womeninmedicine (Sundays 9pm ET) chat. That’s what introduced me to twitter chats. And though I’m not an active participant myself, I’ve seen the sense of community it’s created and how empowering it has been for so many women. The internet gets a bad reputation. A place where people go because they can’t face the real world. But the internet can be a force for good. It creates space to say honest, vulnerable things you maybe can’t share in your normal environment. And it allows connections between people who need each other but are often isolated from each other, whether it’s women in medicine or folks with disabilities.

CTS: What has surprised you most about the response to your initial tweets?

CMF: About the chat? I was so surprised people are so interested! I really just tweeted the initial idea as a whim. I really hadn’t thought it through. But then there was so much interest, I thought maybe I’d touched a nerve, identified some kind of gap in people’s experience with healthcare. Maybe. So I’m taking it on as an experiment. We’ll see how it goes!

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The two pieces of work that will be discussed at the first #MedHumChat will be “Practicing Medicine Can Be Grimm Work” by Valerie Gribben and “Intensive Care” by Jane O. Wayne.



I strongly encourage the online #hpm community to come out and support this first #MedHumChat January 2nd at 9pm ET. You can find out more by following @MedHumChat and @colleenmfarrell)

Christian Sinclair, MD, FAAHPM is the editor-in-chief of Pallimed, co-founder of #hpm chat, and palliative care physician at the University of Kansas Health System. When he isn't writing for Pallimed, you can probably find him updating one of several social media accounts to help advocate for hospice and palliative care.

Tuesday, January 1, 2019 by Pallimed Editor ·

Monday, December 31, 2018

Writing a Book

by Robert Macauley

I could write a book about that…


But do I really want to? That’s the question I asked myself a few years ago, when I was invited by Oxford University Press to submit a formal proposal for a comprehensive book on the ethics of palliative care. So I reached out to mentors for advice, and they all said the same thing: Enlist twenty of your friends to each write a chapter, and you can be the editor.

Sage advice, which I didn’t take. Partly because I like challenges. Partly because I don’t really like the unevenness of multi-author texts. And partly because I drastically underestimated how much time and energy it would take to write such a book single-handedly.

Rita Mae Brown once said that “good judgment comes from experience, and experience comes from bad judgment.” I’m not sure if my decision constitutes bad judgment, but it gave me a lot of experience that might be helpful to others who are thinking about writing a book.

Can you really write a book about that?


In formulating my outline, I divided the content into thirds:
   - One-third I could write without much preparation (for the pediatrics section, it helped to be a pediatrician)
   - One-third I knew a bit about and needed to deepen my knowledge (like palliative sedation)
   - One-third I needed to start from the ground up (for the dementia section, it didn’t help to be a pediatrician)

In the process of writing, I realized that I had a long way to go in areas where I’d thought I was savvy, while knowing more about other stuff than I’d given myself credit for. So it’s important to determine where you’re starting from and how far away is the finish line.

Also figure out how much “credit” you’ll get for writing a book, such as by inquiring of your dean/chair/promotion and tenure committee. Each chapter was expected to be the quality of a publishable journal article, but most institutions give you more credit for twenty peer-reviewed publications than one book.

Even if you can write a book, do you want to?


The British comedian Peter Cook once said:
I met a man at a party and he said, “I’m writing a novel.”
I said, “Really? Neither am I.”
The idea of writing a book is romantic, but actually writing one is a slog. It involves setting (and missing) lots of deadlines, declining cool opportunities that could distract from the “big project,” and encountering annoying headlines about how textbooks are dead.

Does the world need the book you want to write?


There are a lot of books out there. Some address really narrow topics that appeal to only a few people, while others try to take a unique spin on a topic that others have already covered. In rare cases, there may be a need for something that hasn’t been written.

In researching my book proposal, I was ready to find a comprehensive book on palliative care ethics that was clinically relevant, historically informed, and philosophically rigorous. If someone else had already written it, I was ready to walk away. But no one had, so I gave it a shot.

Be strategic


   - Before starting, read the contract carefully. My attorney (a.k.a. my sister) reviewed mine, and this time I (thankfully) took the advice. Evidently, even boilerplate language can be changed if you stand your ground.
   - Block time on your calendar, rather than relying on the crumbs left over from a busy clinical day. (A sabbatical is a great idea if you can pull it off.)
   - Be willing to cut into personal time (like evenings and weekends) to find bigger chunks.
   - Be strategic with teaching topics: when I was asked to give a talk, I would choose a subject covered in the book so all that lecture prep fit seamlessly into the manuscript.
   - Dare to satisfice, which is a combination of “satisfy” and “sacrifice.” In other words, if you demand that every word be perfect, every reference be the most relevant and up-to-date, etc., you’ll never make it to page 200 (let alone, in my case, to page 570).

Gather a team of rivals


I did call those twenty knowledgeable people but instead of asking each of them to write a chapter (as my mentors had suggested), I asked them to offer feedback on one. Taking a lesson from Abraham Lincoln, who famously compiled his executive cabinet from old rivals, I made a point of not choosing “yes-people.” No former students or colleagues who seem really smart because they tend to agree with me.

If I asked friends to review a chapter, they had to be good enough friends that they felt comfortable using strong words, like weak and sucks. If I asked for help from folks I didn’t know as well, they had to be an expert in that field, ideally, someone whose viewpoint differed from my own. If there were holes in my arguments, I wanted reviewers to find them. And I was struck, time and again, by the generosity of people who made time to review a chapter and the candor of those who couldn’t.

There’s a thin line between love and hate


I loved the idea of writing a book. I was thrilled when the proposal was accepted. I felt fortunate to have a reason to dive deeper into the field I love.

Over time those emotions shifted. I resented lost opportunities. I became demoralized when the finish line stayed perpetually out of sight. I hated—there, I said it—reading a section over for what I thought was the final time, only to discover weak arguments and outdated citations.

What kept me going? The point of no return. By the time I fell out of love with the idea of writing a book, I’d invested too much time and heart to turn back. So I named the emotions I was feeling–I am a palliative care doc, after all—and kept on writing, being strategic, satisficing, etc.

The end


I never really believed it would get done. When my editor called to say that the books had been printed and were being shipped to by sea, I thought for sure the freighter would sink, the Russians would hack my computer and erase all the electronic copies, and I would be left with piles of highlighted articles that I barely remember reading.

But a week later a box of books arrived at my door, complete with heart-warming “blurbs” from some of my palliative care heroes. My kids saw Dad’s name on the cover, and the dedication to them on the first page. The omnipresent guilt of the last five years—when no matter what I was doing, I was perpetually aware that I could have been working on the book instead—dissolved into thin air.
And in that moment, it was all worth it.

Robert Macauley, MD, FAAHPM, is Cambia Health Foundation Endowed Chair in Pediatric Palliative Care at Oregon Health and Science University. His textbook Ethics in Palliative Care: A Complete Guide—which Ira Byock has called “a new classic” and Diane Meier describes as “a brilliant distillation of history, culture, and clinical practice”—was published by Oxford University Press.

Monday, December 31, 2018 by Pallimed Editor ·

Monday, November 26, 2018

National Academies Webinar on Opioids in Serious Illness This Thursday

by Christian Sinclair (@ctsinclair)

Many of us who work in palliative care and hospice have seen a major shift in how patients and families respond to opioid prescribing for pain in serious illness. Because of the significant impact of opioid abuse on communities across the country, many new policies and rules are being put in place to reduce the prescriptions of opioids. Of course, this also places a burden on prescribers and patients seeking to utilize opioids judiciously for pain from advanced disease.

For the past few years, I have represented the AAHPM at the Roundtable on Quality Care for People with Serious Illness hosted by the National Academies of Sciences, Engineering and Medicine (NASEM) (formerly known as the Institute of Medicine IOM). This Thursday, November 29, 2018, NASEM is streaming a free, live conference on "Pain and Symptom Management for People with Serious Illness in the Context of the Opioid Epidemic."

This topic is of utmost importance for any palliative care clinician and with the high caliber of speakers and curated information I strongly encourage someone from your organization or team to make room on Thursday to participate in the stream. There will be the ability to ask questions via Twitter at the end of sessions, so you have a chance to get the information you need.

I have been lucky enough to attend all of the public workshops for the Roundtable and I can say that the speakers are first-rate and the information is key to managing care for the seriously ill. They are one of the best free online learning experiences in the realm of palliative care in the last few years. So sit down and carve out sometime on Thursday. And if you cannot make this one, NASEM is great at posting videos online afterward.

Register today!

You can also follow on Twitter at #SeriousIllnessCareNASEM.

Christian Sinclair (@ctsinclair) is a palliative care physician at the University of Kansas Health System and is editor-in-chief of Pallimed. When not traveling to Washington DC for the Roundtable, he can be found surfing online for other palliative care learning experiences.

Monday, November 26, 2018 by Christian Sinclair ·

Friday, November 2, 2018

Nope. We STILL Shouldn't Claim Prolonged Survival in Hospice and Palliative Care

by Drew Rosielle (@drosielle)

A group of investigators from Tulane recently published a meta-analysis in Annals of Behavioral Medicine indicating that outpatient palliative care improves survival and quality of life in advanced cancer patients (free full-text available here, although I'm not sure if that's permanent).

Perhaps you'll remember in June of this year when I pleaded with our community to stop claiming that palliative care prolongs survival (my little Twitter rant about this starts here).

My basic plea was this:
Hospice and palliative care community, I'm calling for a moratorium on all blanket, unqualified claims that hospice and palliative care improve survival.
I still, 100%, stand-by that plea as stated.

However, this meta-analysis does, I think, show the way forward for future investigators to continue to pool survival data across trials, as some of the trials show trends toward a survival benefit which aren't statistically significant and pooling data in a meta-analysis is reasonable. I just don't think this one really adds much to the discussion, unfortunately.

We've been able to for a while now, and still should, I think, continue to be able to make basically unqualified claims that hospice and palliative care programs improve the quality of life for patients living with serious illness, because the preponderance of the evidence continues to show that, and this meta-analysis also looked QOL outcomes too and showed, not surprisingly, broad and consistent improvements in QOL (I won't really talk about this in this post because, while awesome, it's also not really news).

So - great news! However we'll look through the metaanalysis and I hope you'll conclude with me that it's hardly the final story on this.

Nor does it change the concern that I have that our (over-) exuberant trumpeting of such outcomes as a community may not be in our best interest long-term. At the very least, I think we should continually be on the forefront of articulating the idea in any and all venues available to us, the desperately necessary moral position, that longevity alone is not the fundamental goal of medicine.

Living longer is great, as long as it's living well (whatever that may mean to someone), and we have to be one of the key groups of professionals clearly, proudly articulating the idea that living well is as important as living longer. We all know too well the physical and emotional/existential devastation that longevity-obsessed, technology & organ-focused medical 'care' brings to too many of our dying patients and their families. Helping those patients receive medical care which actually helps them is our gig, and the longevity bonus we may bring sometimes is of course totally swell, especially as it lowers barriers to us being able to see the patients we can actually help.

On to the meta-analysis. Basically the analysis confines itself to high-quality, randomized (either by patient or cluster-randomization) trials of specialist, outpatient palliative care services for patients with advanced solid tumors. There's a lot they looked at, but it basically is a meta-analysis of the 2 big Temel studies (NEJM 2010, JCO 2017), 2 of the Bakitas ENABLE studies (JAMA 2009 and JCO 2015) and Carla Zimmerman's 2014 Lancet study. (They sort of partially included 3 more preliminary and lower quality studies, but most of the headline findings here are restricted to the 5 larger, higher quality studies listed above.)

The Temel studies were basically looking at early (near the time of diagnosis), automatic, ambulatory palliative care for patients with metastatic lung (2010), or lung and GI cancers (2017) vs usual care. Both studies showed some QOL improvements, the 2010 study famously showed a survival benefit, the 2017 one did not. Both studies took place at Massachusetts General Hospital.

The Bakitas studies are a little complicated, but look at a package of interventions which include a visit with a specialist clinician (an APRN in 2009, unclear who they were in the 2015 study) and then regular phone calls for support and coaching around a variety of important concerns - life review, coping, end-of-life planning, etc. The 2009 study showed improvements in QOL and a non-statistically significant trend towards improvement in survival. The 2015 study showed improvements in longevity but not QOL. Perplexing, right?

The Zimmerman study is a Toronto cluster randomized (by different cancer clinics all within the same organization) trial of automatic clinic-based palliative care for advanced cancer patients which basically showed improvements in QOL (but not longevity that I know of).

So, to be clear, the meta-analysis involves 3 studies involving palliative care clinics within 2 organizations, and the 2 ENABLE studies involve a sort of intervention which, while scalable and probably beneficial to patients, is sort of its own thing, and not something most people would recognize as typical ambulatory palliative care services.

But, as it turns out the meta-analysis doesn't even really include all these studies in the actual primary analysis (they are included in the qol analysis and secondary analyses), because they chose survival at 1 year their primary outcome, and only the Bakitas studies and Temel 2010 have 1 year survival data available. I.e., Temel 2017 and Zimmerman 2014, neither of which showed a survival benefit, were even included in the analysis (and they also happened to be the largest of the 5 studies).

I.e., this is a meta-analysis of the famous Temel 2010 study, and the 2 Bakitas studies, one of which bizarrely showed a survival benefit and no QOL benefit (which, again, is interesting, and I honestly don't know what to make of it, but it's not the sort of trial I am going to make broad generalizations about, especially given that it doesn't involve a clinical model that is routinely used in ambulatory palliative care.) If you're interested, the pool survival benefit was 14.1% at 1 year (56.2% surviving vs 42.1% with usual care) in the Bakitas and Temel 2010 studies.

In their secondary analysis, which included survival at 3 months (and thus data from all 5 high quality trials), there was no survival benefit. There was a tiny benefit at 6 months (using data from all the trial except Zimmerman which, by the way, was the largest of the trials), and they looked at 9, 15, and 18 month survival but these basically were the same trials as the primary outcome trials.

So, to try to summarize all this, the actual headline finding here is that when you combine data of 2 of the studies to actually show a survival benefit with one which showed a non-statistically significant trend in survival benefit, you end up with a result which shows a statistically significant survival benefit.

This is why I don't think this paper should change how we talk about survival benefits from palliative care. It's still unclear, a lot of studies have shown no benefit, a few have, maybe we do some times, in narrow circumstances, but that's still not clearly been shown in any generalizable way, and that's about all yo
u can say about it. We can continue to say that we don't worsen survival, because only one study I know of has shown that, and we should continue to shout from the fucking mountaintops that we improve the quality of life of our very sick, very much suffering, seriously ill patient population. And I'm damn proud of that.

I do look forward to more meta-analyses in the future, and think it's a good approach to pool data from heterogenous trials to try to get some clarity on the possibility that there's a sort of 'generalized' survival benefit to palliative specialist services or not, and I'm glad these authors tried this approach, although I don't think it ends up adding much to the survival debate. So, onwards we go....

Drew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle. For more Pallimed posts by Drew click here.

Friday, November 2, 2018 by Drew Rosielle MD ·

Wednesday, October 31, 2018

NEW Clinical Practice Guidelines for Quality Palliative Care Released!!

by Christian Sinclair (@ctsinclair)

Happy Halloween!

Today is the beginning of a new era in palliative care as the 4th edition of the Clinical Practice Guidelines for Quality Palliative Care (aka NCP Guidelines) are being released into the wild to begin changing practices all over!

Well, that is the plan and the hope, of course. With any sort of guidelines or statement document, the real work comes AFTER they are published.


To be effective, policymakers, front-line clinicians, and healthcare leaders need to make time in their hectic schedules to review these new guidelines, compare what they are doing to what the standards are, and devise a plan to close those gaps. Over the next month in celebration of National Hospice and Palliative Care Month and the release of these guidelines, you will see posts on Pallimed and our social media accounts highlighting different aspects of the guidelines with straightforward action steps that you can implement.

You may be thinking, "4th edition? I never even heard of a third edition. What are these guidelines and who is telling me how to do my job?" If so, you should know that these guidelines date back to 2002 when The National Consensus Project began. That was a time when palliative care was beginning a rapid period of acceleration but still not widely available nor part of the mainstream of healthcare. The NCP released previous editions in 2004, 2009 and 2013. There is a good chance that some of the things you take for granted today in palliative care indirectly result from the standards set out in these previous editions. From my point of view, the NCP guidelines are designed to stretch us and enable our programs to become more efficient, effective and equitable.

The guidelines are structured to cover eight domains and my quick way of remembering what they are:
  • Structure and Processes of Care - who is on the team and what do they need to know
  • Physical Aspects of Care - how to assess and treat symptoms
  • Psychological and Psychiatric Aspects - how to assess and treat psych-related issues
  • Social Aspects of Care - how to assess and address social support
  • Spiritual, Religious, and Existential Aspects of Care - how to screen and support spiritual issues
  • Cultural Aspects of Care - how culture impacts care delivery
  • Care of the Patient Nearing the End of Life - how to excel in the special time of final days and weeks
  • Ethical and Legal Aspects of Care - regulatory, ACP, and ethics
Some big changes in this edition include a bigger emphasis on the caregiver as a locus of care, the burden of transitions, culture and diversity, and lifting up the science of communication. There is also more content that demonstrates the importance and growth of community-based palliative care and a more extensive reference section to ease access to the primary literature supporting the guidelines. I think many will appreciate the inclusion of examples which will enable teams and organizations to see themselves narratively and not get stuck on using imagination to make potentially dry guidelines come to life.

If you like what you see in these guidelines, please give a big thanks to the team behind it, co-chairs Betty Ferrell and Martha Twaddle, writer and editor Kathy Brandt, the National Coalition for Hospice and Palliative Care led by Amy Melnick and the NCP team of Gwynn Sullivan, Cozzie King, and Vivian Miller.


Lastly, to help all of us be more accountable, I want to encourage you to leave a comment telling the world what you plan to do with these guidelines. It could even be as simple as reading this post or sharing it with key people in your organization.

I'll tell you what I already did this morning, I went to my division chief, Karin Porter-Williamson and volunteered to be part of a small workgroup which will compare our current inpatient and outpatient programs at the University of Kansas Health System with the NCP Guidelines. To my delight, she said, 'Guess what just showed up in my email this morning? The new NCP Guidelines!"

So tell the world, what will you do with these blueprints?

Christian Sinclair, MD, FAAHPM, is the Editor-in-Chief of Pallimed and member of the palliative care dork club. When not reading guidelines over chai tea, he can be found reading rules to boardgames. See more posts from Christian Sinclair here. You can also find him on Twitter at @ctsinclair.

Wednesday, October 31, 2018 by Christian Sinclair ·

Wednesday, October 24, 2018

Antipsychotics Don't Help ICU delirium

by Drew Rosielle (@drosielle)

It just gets worse and worse for the idea that antipsychotics have efficacy for delirium.

Last year I posted about the RCT of haloperidol, risperidone, or placebo for delirium symptoms in 'palliative' patients. I'm pretty sure I called for more controlled, 'high quality,' trials, and we are lucky enough to have another.

This one is a randomized, double-blinded, registered, controlled trial of haloperidol, ziprasidone, or placebo for ICU delirium, just published in NEJM.

The trial took place in a geographically diverse group of US-based intensive care units. They enrolled adult patients in medical or surgical ICUs, who had delirium detected by the CAM-ICU (a well-validated tool: lots of info on it here if you want to read more). They did something interesting - they consented patients for the study (some of them at least) before the onset of delirium.  They also did prospective, broad case-finding, using research personnel to evaluate patients twice daily to see if delirium was present or not. They did not rely on clinical personnel in the ICU to identify delirium but instead proactively found them, which is a nice touch given how under-recognized delirium can be. My sense is that they consented patients rapidly upon admission to the ICU (or their surrogate), then followed them closely to rapidly identify those who developed delirium.

Once delirium was identified, patients were randomized to 2.5mg of haloperidol or 5mg of ziprasidone (or matching placebo) IV, then q12h. (Older patients received lower starting doses.) The dose of the study drug/placebo was doubled with each subsequent dose if the patient did not improve up to a maximum of 20 mg a day of haloperidol or 40 mg a day of ziprasidone. They halved the dose of the drug if a patient later had no delirium per the CAM-ICU, or stopped it if a patient was on the lowest dose already, or if the patient had 4 consecutive assessments indicating no delirium. Regardless, the trial drug/placebo was stopped at 14 days or ICU discharge if the patient made it that far and was still delirious.

The primary endpoint was days alive without delirium (per the CAM-ICU) or coma.

566 patients underwent randomization, 89% of those had hypoactive delirium. Median age was around 60 years old, 43% female, ~83% were white.

The median duration of exposure to a trial drug/placebo was 4 days, with the mean daily doses of 11 mg of haloperidol and 20 mg of ziprasidone.

Active treatment did not seem to do anything. The median number of days alive without delirium or coma was the same in both groups (8.5 vs 8.7). Secondary outcomes were similar between 'active' and placebo groups too - 30 and 90-day survival, time to discontinuation of ventilation, time to ICU discharge, ICU readmission, time to hospital discharge -- all the same.

Safety endpoints were the same across groups too with the exception that QT prolongation was more common in the ziprasidone group (it's not clear to me if this was statistically significant or not). Other side effects, including excessive sedation, were no different between placebo and the study interventions.



What does all this mean?
At the end of the day, I think it underlines the idea that antipsychotics have no routine role in the management of delirium.

It took me a while to accept this, but at this point I'm looking for any compelling data to suggest otherwise. We just don't have it, and I've mostly stopped prescribing antipsychotics for delirium. While any study like this has elements you can pick apart (e.g., I wouldn't exactly dose haloperidol like they did), at the end of the day they used reasonable doses, doses that I have commonly used, and they allowed relatively high doses to be used (this was not a study of super careful, wee doses). They identified the patients prospectively and rigorously - I don't think it likely that we're going to see a substantially better-designed study in the near future than this.

Notably, most of these patients had hypoactive delirium, and they did not break down their findings by patients who were hyperactive vs hypoactive. I imagine some people are going to argue that they should have done that but overall I'm glad they didn't. It was only 10% of their subjects, and it's better they didn't data-mine their findings that way. It could have been a prespecified analysis, which as far as I can tell it was not, and the study wasn't powered to detect differences between so few subjects, and so I'm glad they left it be.

I think it would be reasonable to argue that we still really need a similarly well-done, large, study only for hyperactive ICU delirium - I think we do - but I also don't see any reason any of us should advocate for the idea that antipsychotics are effective for hyperactive delirium in the meantime. They might be, but I don't think that's very likely personally. If someone does it, I really hope they include quetiapine as one of the arms, as it's used a lot around many institutions, and I suspect for the worse (although I truly don't know), and would welcome any good data on it.

At this point, I think a lot of the perceived benefits people have of antipsychotics is that they sometimes sedate people, even if only mildly at times, and so patients 'look better,' but we've actually done nothing to modify the course of their delirium or improve their cognition.

Sedating someone can sometimes be a perfectly reasonable/helpful/legitimate therapeutic outcome: for very agitated patients who may pose a risk to themselves, or for patients very near the end of life for whom our care goals are really centered on preventing and actively minimizing any sources of suffering.

But it's not a great outcome for most of our other patients, and like a lot of things we deal with (eg, cancer-associated appetite disturbances and muscle loss) delirium is a complex phenomenon and needs complex interventions to prevent/mitigate, and perhaps the entire idea that there is a 'right drug' (or drug class) to help it was wrong all along.

For more articles by Drew Rosielle, click here. For more articles about delirium, click here. For more articles about the ICU, click here.

Drew Rosielle, MD is a palliative care physician at the University of Minnesota Health in Minnesota. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle

Reference
1. Girard TD et al. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Oct 22. doi: 10.1056/NEJMoa1808217.

Wednesday, October 24, 2018 by Drew Rosielle MD ·

Friday, October 5, 2018

On Football, Palliative Care, and Quality Measurement

by Arif Kamal (@arifkamalmd)

Transition into the Fall months means one thing for a boy like me from the Midwest – it’s football season. Snare drum cadences, referee whistles, and the crunch of linemen helmets were the soundtrack to many memorable evenings growing up. In football, winning requires strategy and execution, while embracing the humility that even the most exquisite gameplan, well steeped in planning and expertise, can fall flat. Though the two worlds seem unrelated, I often think of football analogies when approaching palliative care quality improvement.

Football offenses across college and professional leagues are increasingly calling the Run-Pass-Option (or RPO for short). In the RPO, a quarterback has three choices after the snap – hand the ball off to a running back, pass the ball to a wide receiver, or start running the ball himself. The overall goal is to keep defenses guessing, while matriculating the ball down the field efficiently. Based on the situation, the quarterback chooses where the ball will go. For example, if time is short and there are no timeouts, the quarterback may choose to throw a long pass to a wide receiver streaking down the sideline to both gain yards and stop the clock. If the defense is playing back, then the quarterback may run the ball himself for a big gain. Notice that all three options (throw, running back run, quarterback run) are always available, can meet the goal of moving the ball down the field, but are decided upon based on the needs of the team and the alignment of the defense.

Which bring us to healthcare quality improvement and measurement. There have been increasing discussions in all of healthcare, including within palliative care, about the spirit of quality measurement. A recent Health Affairs article highlighted the burden of quality measurement at the organization level, concluding that clinicians and staff spend 15 hours per week addressing requirements for external quality reporting. Further, the study estimated $15.4 billion spent annually by four specialties (general internists, family medicine, cardiology, orthopedics) on such activities. The authors concluded that quality measurement activities should be prioritized, so that increasing demands are not just piled on to the plates of clinicians without a strong rationale. This spirit of reducing complexity also runs in the ethos of palliative medicine, as we frequently help patients and families avoid polypharmacy complications while simplifying medication lists. But we have found complexities in quality measurement in specialty palliative care, with lists of quality measures applicable to our field numbering over 300. There’s a sense that change is needed.

Oftentimes, critiques are made about the types of quality measures that exist. In healthcare quality measurement, there are three widely-accepted categories for quality measures. This three-part framework was introduced and proliferated by Avedis Donabedian, oft-considered the father of the modern healthcare quality improvement movement. Dr. Donabedian proposed that quality measures would either evaluate structure, process, or outcomes of care (to contrast from Run-Pass-Option – RPO – I will call this SPO for short). In SPO, quality measures are categorized by their intent. For example, if a measure aims to evaluate the infrastructure, resources, or policies in place, then it is a Structural measure. If a measure aims to assess whether something was done, then it is a Process measure. Health outcome measures are the third category, and most typically thought of as “a change in a patient’s health state.” Related to health outcome measures are those thought of as outcomes, but not affecting a patient’s health. The Donabedian SPO framework does not specifically account for these, but I often think of them as “system outcomes.” Examples are patient experience or satisfaction, costs and financial toxicity, and access.

To make this clear, let’s take the example of advance care planning, the primary “procedure” of palliative care professionals. A Structural measure related to advance care planning may involve personnel (“All members of the palliative care team receive annual CE in local and state laws, legal precedence, and policies regarding advance directives, physician orders for scope of treatment, and surrogate decision-making”). This measure is Structural because it evaluates a characteristic inherent to the team or the service. A Process measure may look like, “75% of patients seen by the palliative care team have a documented advance directive by the third visit.” Such a measure looks at whether something was done. A true Outcome measure would look like, “Percent of patients with moderate to severe pain with reductions in pain scores by at least 50% within 24 hours of the first consult.” This is measuring the change in a patient’s health state.

A brief word on patient-reported outcomes (PRO). Patient-reported outcomes are “report of the statue of a patient’s health condition that comes directly from the patient.” Readers may wonder where PROs fit in the measurement framework. Importantly, PROs themselves are quite simply the method to collect data, but are not quality measures themselves. Just like electronic health record data can inform a Process measures, data from the patients’ own voice can inform any of the SPO measures. Oftentimes, when people say “PRO” what they are really referring to is “PRO-PM” (patient reported outcome performance measure). A PRO-PM is performance measure that is based on patient-reported outcome data aggregated for measurement purposes (e.g., percentage of patients receiving specialty palliative care whose depression score, as self-reported by the PHQ-9, is improved within the first eight weeks).

So let’s bring football and quality measurement back together. When a best practice is defined and supported by the evidence, the natural progression to ensure the best practice is followed is to develop a quality measure. In football, a quarterback in an RPO has three options. Similarly, to ensure a best practice is followed with quality measurement, we can develop a Structure, Process, or Outcome measure. And choosing the type of measure to develop and use requires understanding whether you want others to “have something” (Structure), “do something” (Process), or “change something” (Outcome). It’s tempting to think that all quality measures should be Outcome measures, since improving patient outcomes is what we all ultimately set out to do. But there are two reasons to should proceed with caution.

First, Outcome measures require a clear sense of how differences in outcomes (between two organizations, or between “ideal” and “actual”) will be treated. For example, if a small, rural, safety net hospital with one part-time palliative care clinicians who makes rounds every third day cannot improve the proposed measure “Percent of patients with moderate to severe pain with reductions in pain scores by at least 50% within 24 hours of the first consult,” how do we reconcile the “actual” versus an “ideal”? Such a measure – exactly applied - would doom this program for failure. So how does one “adjust” for the limitations of access to the team (every third day versus daily)? Or what if there were patient or disease factors that made meeting this measure more difficult? The concept of acknowledging that not all things are equal is called “risk adjustment.” What we want to know is if a difference between actual and ideal is expected, due to factors beyond the team’s control, how is that difference handled?

The second complicating factor with Outcome measures is accountability. If I said that the palliative care consult team’s reimbursement would be cut by 10% if a patient’s post-hospitalization satisfaction score was below the 50th percentile, what would be the reaction? Many in palliative care would argue that a patient satisfaction score is reflective of an accumulation of experiences and interactions throughout the hospitalization, of which the palliative care team was part of only a minority. So how do we attribute good or bad outcomes to individual clinicians or individual teams, when we work in complicated networks of providers, clinicians, health staff, environmental staff, and administrative professionals?

Both risk adjustment and accountability challenges should give pause in rushing towards Outcome measures. But it does not mean the challenges cannot be overcome, nor that Outcome measures are not needed in palliative care. Certainly, to remain in-step with the rest of healthcare, we will need to think about the definitions and measurement methodologies for our own Outcome measures. But we should not in that process ignore important gaps in Structure and Process measures that should also be addressed. So, to come back to my football analogy, sometimes as an offense you “take what the defense gives you,” which means to move the ball down the field balancing the chances of meeting your goal (scoring points) with the challenges ahead (putting the ball where the defense is not).

We will be discussing this and more topics related to quality in palliative care at the 4th Annual Quality Matters in Palliative Care Conference streaming online on October 11th. This conference is co-sponsored by the American Academy of Hospice and Palliative Medicine (AAHPM), Center to Advance Palliative Care (CAPC), Palliative Care Quality Network (PCQN), and Global Palliative Care Quality Alliance (GPCQA). Registration and CE are complimentary and registration is encouraged for those who can’t attend that afternoon but want to watch the recording later. For more information and to register, visit http://www.gpcqa.org/qmc

I hope to see you there!

Arif Kamal MD, MBA, MHS (@arifkamalmd) is a youth soccer coach for his six-year old and professional beach bum. In his spare time he studies quality and workforce issues in palliative care.

Friday, October 5, 2018 by Pallimed Editor ·

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