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by Michael Pottash (@mpottash)

Comfort Care, whatever does that mean? This is the important question asked by my colleagues Anne Kelemen and Hunter Groninger in the September 2018 issue of JAMA Internal Medicine. The term is ubiquitous and its interpretation influences how patients with end stage illness are cared for at the end of their lives. In their article they argue that the language of Comfort Care is confusing and easily misunderstood. They suggest improving the understanding around end of life care and moving to a less ambiguous term for care of the dying. I worry that any term to describe dying care will always be problematic.

So what is Comfort Care? One common definition comes from Blinderman and Billings, writing in the New England Journal of Medicine, defining it as “the most basic palliative care interventions that provide immediate relief of symptoms in a patient who is very close to death.” Another is from the National Institute on Aging, describing Comfort Care as “care that helps or soothes a person who is dying ... to prevent or relieve suffering as much as possible and to improve quality of life while respecting the dying person’s wishes.” Both definitions are simple enough, and yet lack any specifics or direction for clinicians. This leaves the practice of Comfort Care up for interpretation.

Kelemen points out the pitfalls in operationalizing this vague term. First, it promotes a dangerous misconception that clinical care is binary and that patients must choose between focusing on comfort or not. Second, Kelemen cites a study demonstrating that while the term is ubiquitous, clinicians don’t actually know what it means. This leads to ambiguity around what kinds of medical interventions constitute Comfort Care and to a wide disparity in which medical interventions clinicians apply under the circumstance. Worse, some seem to think that it means methodically titrating up an opioid infusion: “Nearly half [of surveyed physicians] expressed a belief that Comfort Measures Only care is itself an indication for more aggressive opioid administration than for other patients, regardless of clinical condition. This is of concern because it seems to obviate the critical need for nuanced assessment that drives symptom management.” Administration of inappropriately high dose opioids will hasten death; this is at best bad medicine and at worst euthanasia.

Blinderman agrees:

“However, the term is often used in a misleading or imprecise manner — for example, when such care is automatically considered equivalent to a do-not-resuscitate order and, perhaps even without discussion with the patient, is extrapolated to mean the exclusion of a full range of palliative measures appropriate for a dying patient. Rather than simply writing orders for “comfort care” (or “intensive comfort measures,” the term that we prefer), the medical team should review the entire plan of care and enter explicit orders to promote comfort and prevent unnecessary interventions.”

A Pallimed post by Drew Rosielle from 2016 made a similar protest:

“One, it amplifies the already irksome and unnecessary dichotomy we have set up in medicine between 'cure' and 'comfort’... What we are trying to do in palliative care is to reduce the gap between the two, to help our patients feel better as they live longer… Two, it's confusing for patients and should never be said in front of them. I've seen it lead to stupid miscommunication many times. Like someone asking a patient 'Do you want comfort care?' 'Do you want us to focus on keeping you comfortable?' and the patient saying 'Yes of course' not realizing that the clinician was actually saying 'Should we stop efforts to prolong your life and *only* provide ongoing interventions to alleviate symptoms/provide comfort?'”

To summarize: Comfort Care is confusing to patients and families, no one knows how to provide it, and it can be harmful.

Here is the kicker from Kelemen:

“End-of-life care plans must be specific to the patient and family, reflecting their values and goals for that critical event and universal experience. To highlight this, we coach colleagues and families to consider every therapeutic intervention—for example, each medication, laboratory test, imaging study—and evaluate whether that intervention promotes the goal of alleviating symptom burden during the dying process. If it does (eg, oxygen administration in hypoxia), we continue it; if not (eg, the ubiquitous statin therapy), then perhaps it could be discontinued after reassuring communication with patients and families.”

Let’s treat dying patients as we would treat any patients: as thinking clinicians. Continue treatments that meet the goals of the patient and family, and discontinue treatments that do not. If the goals of the patient and family are to prioritize symptom management over life prolongation then ask the question of every test, intervention, or medication: Does this promote quality of life? Some life-prolonging interventions can be continued without impacting quality, if the patient so chooses. This will all depend on the patient’s preferences and the clinical context. That is why it is impossible to create a Comfort Care algorithm, bundle, or pathway - clinical reasoning is still required.

While my colleagues believe that we should use clearer language or work towards a unified understanding of Comfort Care, I would argue that we should get rid of it altogether. Do we need a term for taking care of dying patients in the hospital? If it does not indicate a clinical pathway or answer an urgent clinical question, then what is its benefit? Rather, in my experience, I have only seen it cause confusion, miscommunication, and unethical medical practice. Kelemen has identified a crucial blind spot in our collective medical practice, one that I fear is a symptom of a general misunderstanding and discomfort with how to care for the dying. Let’s teach our trainees to continue reasoning through clinical decisions to the end of a patient’s life, and to provide good medical care even if all that entails is sitting at the bedside to hold their patient’s hand.

Disclosure: Anne Kelemen and Hunter Groninger are dear friends and colleagues.

Michael Pottash MD MPH is a Palliative Medicine Physician at MedStar Washington Hospital Center and Assistant Professor of Medicine at Georgetown University School of Medicine. He is currently very curious to know who will end up sitting on the Iron Throne.

References

1 Kelemen AM, Groninger H. Ambiguity in End-of-Life Care Terminology - What Do We Mean by Comfort Care? JAMA Internal Medicine. 2018

2 Blinderman CD, Billings JA. Comfort Care for Patients Dying in the Hospital. New England Journal of Medicine. 2015.

3 National Institute on Aging. Providing Comfort at the End of Life. Accessed 2018. 4 Zanartu C, Matti-Orozco BM. Comfort Measures Only: Agreeing on a Common Definition Through a Survey. Am J Hospice and Palliative Care. 2013

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by Drew Rosielle (@drosielle)

Annals of Internal Medicine has published a fascinating trial of a web-based surrogate decision-making tool aimed at improving decisions for patients receiving prolonged mechanical ventilation in an ICU.

It's one of the most fascinating trials I've read in a long time, and also somewhat of a monster (in size/scope of data presented) - there are 4, lengthy online supplements attached to it (!), which is daunting, and so I'm mostly just going to write here about what I find most interesting about it.

Which is that I think this may be the trial which should convince us all that what's 'wrong' with ICU decision-making is not a lack of sharing good information -- what is wrong is our entire approach to surrogate decision making.

First the trial, briefly summarized. This was a randomized trial of a personalized, web-based decision aid for surrogate decision makers of patients with prolonged mechanical ventilation. It took place in several ( mostly academic medical center) ICUs in the US. The subjects were primary or secondary surrogates of actual ICU patients (~280 patients in total), all of whom had been mechanically ventilated for 10 days at least, and weren’t anticipated to be immediately extubatable.

The main intervention was that the surrogates received and were asked to interact with a personalized, web-based decision aid tool, which is a fascinating thing that I hope to be able to see in action one day (they have many screen shots in the supplement, but because the tool is connected to real patients there’s no way to access it publicly)

The tool involves giving the surrogates prognostic information about their loved one (based on a prognostic model) which gave an estimation of their loved one’s chance of 1 year survival; educational information about prolonged ventilation, the role of surrogates, and different care goals (eg life prolongation at any cost, maximizing comfort regardless of longevity, etc), and asked the surrogates questions about the patient’s values/preferences. Then the aid presented to the surrogate a ‘goals of care recommendation’, based on those reported values/preferences. The surrogates had an opportunity to disagree with what was presented, and indicate what they thought the actual care goals should be.

(If you’re curious, the prognostic model was probably pretty accurate. The model predicted 1 year survival for all subjects on average to be ~50%, and the actual 6 month mortality--that’s as far out as they have data--was 40%.)

The ‘output’ of the decision-aid was given to the treating clinicians, who were encouraged to incorporate it in the family meeting which was scheduled for day 2 after enrollment for all patients. Control patient surrogates received no decision aid or other information, and just received 'usual care', apart from that everyone was supposed to have a family conference on day 2 post enrollment (and nearly everyone did).

They measured many, many things here, but the major outcomes they were looking at were clinician-surrogate concordance about prognosis, surrogate understanding of prognosis, surrogate well-being both acute and long-term (anxiety, trauma symptoms, etc), patient outcomes like LOS, in-hospital and long-term mortality, etc.

The simple way to summarize their findings is that the intervention had nearly no measurable effect on anything: most importantly on what happened to the patients (eg, ICU and hospital LOS, ICU and hospital mortality, long-term mortality, % who received tracheostomies, % who had discontinuation of life-prolonging technologies, etc), as well as what happened to the surrogates (anxiety and trauma symptoms, satisfaction with care and communication, etc). One of the numerous pre-specified secondary outcomes (changes in a decisional-conflict scale), was slightly better in the intervention group - by 0.4 points on a 5 point scale. Note that the family meetings which were part of the protocol for everyone were recorded and similar content was discussed at these meetings, regardless of randomized group.

The very, very interesting findings were, at least to me, the ‘concordance’ and prognosis findings (if you want to look at this yourself, the best place to go is Online Supplement 3, by the way).

Concordance (meaning surrogate and clinician ‘agreement’ on prognosis which here was measured as chance of 1 year survival) was not improved by the intervention. Fundamentally, that seems to be because surrogate’s assessment of prognosis was essentially impervious to information about prognosis as either presented by the prognostic model in the decision aid or a clinician in the family meeting.

Notably, the physician’s prognostic estimations were quite accurate on average (I don’t know if they had access to the prognostic model prognosis or not). For the entire study the the physicians and model both predicted a ~50% 1 year survival for the patient group on average. The physicians also did a pretty good job of estimating what the surrogates thought the prognosis to be (which was around 70% 1 year survival on average). The surrogates who had the decision aid did a little better at articulating what they thought the physicians’ prognostic estimation was (they guessed around 58% 1 year survival, when it was actually around 49%). Control surrogates, who did not get the decision aid, did a worse job of articulating the physicians’ estimation (they guessed ~67%). However, regardless of what group they were in, the surrogates in both groups articulated a prognosis of around 70% 1 year survival. Ie, the intervention didn’t improve the surrogates’ own prognostic estimation, even though they knew it was significantly different than the physicians’ estimate of survival.



Along these lines, they were also able to show that even after answering questions about what the patient’s values would be, and then being told by the decision aid some sort of conclusion (eg your loved ones care goals fit best with eg, balancing longevity with quality), a large number of surrogates actively adjusted that conclusion (‘disagreed’ with that conclusion so to speak, although the surrogates themselves were the one who gave the answers to the questions about patient values), and almost all of them who did that adjusted the care goals towards being more aggressive (see the figure - this was about 40% of the group).



To summarize: surrogates substantially overestimated patient’s survival, even when presented with the decision aid, and even when they understood that the physician thought otherwise. Many surrogates also disagreed with the goals of care as summarized by their own statements of their understanding of patients’ own values, and wiped that all away to state that the plan of care should be aggressively prolonging life.

There is this idea that what we need to do is somehow say the right words to these terrified, grieving, desperate families, and once we figure out the right words, spoken by the right person/presented in the right way (like a decision aid which focuses on clearly stating prognosis and prompting surrogates to reflect on the patient's values/preferences) that will lead the surrogate/s to make the 'right' decision. 'Right' decision meaning, I guess, the one purportedly the patient would have made ('substituted judgment'), acknowledging that that is typically unknowable. The problem with this model of surrogate decision making is that it does not at all seem to be what surrogates actually do, and data from this study basically show even when surrogates know things about a patient's values and preferences, many of them are unwilling to 'enact' those. Indeed, a substantial number of the surrogates in this study seem impervious to 1) objective data-based prognostic information, 2) accurate prognostic information shared by the patient's treating physician, and 3) acknowledgement of the patient's own values and preferences when they make decisions. And, in fact, it appears that a substantial number of surrogates don't really make any decision at all, and you wonder if they even perceive there to be any decision to be made, because the only 'decision' they are going to endorse is 'do everything.’ I’m really grateful for this study for really showing us that this approach may not be helpful.

And my question to us, collectively, as a medical community, is: so what? Do we think this is a problem? And if so, why? Why is anyone surprised or perturbed that fearful grieving families don't make the same decision that an ethical robot would? The only reason we think it's a problem is because there's been this collective decision the last several decades that, in fact, the right people to be making decisions about what technologies to be applying to a dying body are not the highly trained health care professionals, most of whom went to school/trained for over a decade (and sometimes much longer) just so they can know their way around an ICU, but the shocked, grieving, fearful families, who hear us demand from them, again and again, and in ways that make them feel that they have their loved one’s life in their hands, What do you want us to do? I ask this because if you listen closely to your colleagues, and even palliative people sometimes, you get a sense from some of them is that they believe the problem here is the grieving families, who are ‘in denial’, or ‘unrealistic’, or ‘just don’t trust us’. And, fundamentally, I think that’s the wrong take here.

We’re the problem, not the families.

It also bears noting that in the entire history of our species up until the mid 20th Century, virtually no one had to make end of life decisions for their loved ones, because there wasn't anything that could even be done. Now, it's not at all uncommon for us to have conversations with people about highly technical decisions about where tubes go (or don't go) into their dying relatives' bodies. No one should be surprised it often doesn't go well, and that it's a 'problem' that can't be fixed with communicating data more artfully.

I get it; this is complicated.

There are, for instance, a certain number of patient/families for whom this very nice idea I described above, the happy version of how surrogate decision making is supposed to work, does seem to ‘work.’ Honestly, I’m not too worried about those families - we just need to get them good, realistic information, and they’ll make patient-centered decisions. I also get how unrealistic (and unwise) it is to think we are going to go back to the authoritarian-paternalism days, where an individual physician's personal judgment, subject to all its biases and blind spots, is the unassailable measure of a good decision.

The only way out of this is forward, although I don't myself here have any specific 'policy' proposal to fix this, and I worry all the focus on patient choice (which originally was meant to be a way to empower patients in saying "No" to things, not a way of us in medicine of giving up our role in decision making) just makes things worse, by amplifying this idea that families get to choose medical treatments off a menu at the end-of-life, when there is nowhere else in medicine where we really do that. All the things we are taught to do in palliative care - focus the conversation on the patient, emphasize long-term health and functional outcomes and discuss care goals in that context as opposed to focusing on technical questions, careful, interprofessional attention to the grief and loss the family are experiencing, and actively making recommendations about what we think the best plan is (based on what we know of the patient) - help, undoubtedly, to an extent. But it’s not enough.

For more Pallimed posts about journal article 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 Cox CE, White DB, Hough CL et al. "Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial" Ann Int Med. 2019. Vol 170, 285-297.

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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

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by Kristina Newport (@kbnewport)

In 2016, the palliative care community lost a dedicated advocate and compassionate caregiver when Eloise “Ellie” Coyne died. She was well-known to the Virginia Commonwealth University (VCU) Community where she held the position of Volunteer Coordinator but her colleagues knew the all different roles she played for patients and staff on the 11 bed unit: mother, advocate, healer, listener, comforter and mother. Of all the many things Ellie provided to her patients and colleagues, perhaps the most important was here complete acceptance of all people, with an uncanny ability to meet people exactly where they were and see value in each person.

Ellie regularly provided opportunities to create legacy through story telling, artwork, photos and mementos. It was rare for a patient to leave the Thomas Palliative Care unit without a pillow case of signatures or a plaster caste with a handprint. One of the legacy projects that now lives on in her absence has been lovingly named “Ellie’s Box”.

While Ellie was still living, she worked with Palliative Care RN Dawn Quinn to create small glass stones backed by pictures or words that are meaningful to patients and their family members. On the back of the pictures, families could have the fingerprint of their loved one done in archival ink. It was just another one of the ways this caring team helped families and loved ones to make a meaningful connect in they could carry with them. “This is so much about the importance of connection,” states Quinn. “When I see someone find the "perfect stone", I feel touched with privilege to help create a new way for them to remain connected to their loved one.”

Quinn recalls a time when a family was struggling with the timing of removing their loved on from life-prolonging artificial support. After they had the opportunity to choose stones that reflected their loved one and had her finger prints placed on them, it was as if the memento they received had ensured their connection would not be lost. The family held tightly to the stones in their hands and allowed extubation and a peaceful death to proceed.

At VCU, the stones are kept in boxes that families can look through and choose from, on the palliative care unit. The idea has spread, however, throughout the hospital, to the point that the palliative team tubes the stones throughout the hospital to other units where patients are in their last hours or days.

So now, families leave VCU with a memento and memory of their loved one, due in part to Ellie’s work and influence on the providers in that system. If it had been up to Ellie, all suffering patients and families would have a hand to hold, a comforting blanket and a memento to take home with them that can continue on. It is only fitting that Ellie’s Boxes be made and offered to people in other health systems as well. It is just the way Ellie would have wanted.

Kristina Newport, MD, FAAHPM, is a palliative medicine physician in Central pennsylvania who will soon join the Palliative Care team at Penn State Health as Section Chief and Assistant Professor in the College of Medicine. You can find her on Twitter at @kbnewport. You can read her other Pallimed posts here.

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by Rick Strang (@rickstrang)

Bed pressures in busy hospitals often means that less acute patients are moved to different wards in order to make space for patients admitted from the emergency department. We are often faced with some difficult decisions in our current NHS. End of Life (EoL) patients seem particularly at risk of being moved, which can be very distressing for families, friends, the patient and the care teams. It is also quite common for these moves to occur into the night or at weekends. These periods are covered by site managers, bed managers, and on-call clinicians rather than the usual ward teams and therefore their knowledge of the patients can be very limited. Indeed, they will often require sitting down and reading through the notes before making decisions. This is where we thought we may be able to have an impact by flagging clearly those patients whom we should not move. The Blue Ribbon Patient sticker idea came out of that.

The scheme is not exclusive to EoL patients, although it predominantly affects them and was started particularly for them. For example, we had an elderly man who had been profoundly deaf since childhood with several other very complex needs on one of the wards. As he became better he was likely to get moved. However, some of the staff had learned to sign and he had built up an important trusting relationship. Moving him and starting again wasn’t going to be helpful so he was made a Blue Ribbon patient.

It is vitally important that “Blue Ribbon” doesn’t become a label for “going to die”. It just means, for a whole host of reasons, that this patient should not be moved. It’s also very important not to overuse the scheme. Patients must be carefully considered and nominated by a senior nurse or nurse specialist.

6 wks ago we noted EoL patients had multiple bed moves to make beds for new patients. We acted immediately and within 24 hrs had implentmented our “Blue Ribbon” scheme. Blue Ribbon patients must NOT be moved. Since then not a single EoL patient has had a non-clinical bed move. pic.twitter.com/lHBXRL6uRp

— Rick Strang (@rickstrang) December 15, 2017

Blue Ribbon patients are notified to the Site Manager who keeps a “Blue Ribbon List” with her notes.

Blue Ribbon patients are noted and discussed at Bed Meetings, reminding folks that they are not to be moved.

A key element of the scheme is to ensure that there is VERY senior input into a decision to move the patient. This makes sure we really, really are in last resort territory before a move is made. If there is a requirement to move a Blue Ribbon patient for a non-clinical reason this must be agreed by the Head of Nursing or by the on-call Director if it is out of hours. Either the Head of Nursing or the on-call Director must then contact the family to explain the reasons for the move and apologise. We’ve deliberately made it a very senior responsibility as we view moving these patients as a very important decision if it has to happen.

All Blue Ribbon patients have the requisite sticker placed on the front of their notes and any care planning documentation. In this way, even clinicians unfamiliar with the patient are reminded that there are extenuating circumstances around this person that means that moving them to another ward is unlikely to be in their best interests.

The Blue Ribbon Patient scheme is integral to our Transfer of the Dying Patient policy.

Prompted by two quite difficult episodes involving the movement of dying patients we implemented this scheme rapidly; a two-hour discussion with key teams and stickers back from the printers within 24 hours. That was six weeks ago. Since then not a single EoL patient has been moved despite ongoing bed pressures. We have stopped all non-clinical transfers for dying patients thanks to this scheme. It’s been quite a revelation and folks have really taken to it. It’s not complex or expensive to implement. It seems that sometimes simple just works!

Rick Strang RN is Emergency Care Improvement Lead at Isle of Wight NHS Trust in England. When not involved in all types of emergency care Rick is usually finding innovative ways to avoid household chores.

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by Jenni Linebarger

What is a “lethal condition” really? How does the definition change as medical advances are made? Several times a year, I meet parents who’ve had providers tell them that their baby has a “lethal diagnosis” (or worse, that the diagnosis is “incompatible with life”) when testing detects trisomy 13 or trisomy 18. Such dire prognostication sets the stage for all future interactions with the health care community. For some, it becomes a rallying cry to prove providers wrong, for others it becomes a sealed fate. For all, it declares a level of certainty that we just do not have.

This summer, a paper published in JAMA by Katherine E. Nelson and colleagues sought to provide “more data about survival in general and after interventions” for families who have children diagnosed with trisomy 13 or trisomy 18. They conducted a retrospective, population-based cohort used linked health administrative databases for all children born in Ontario between 1 April 1991 and 31 March 2012 with a diagnostic code for trisomy 13 or trisomy 18. The data from this cohort confirms that survival is not as uncommon as once thought.

They found:

• Median survival of 12.5 days for children with trisomy 13 , and 9 days for children with trisomy 18
• The rate of deaths slowed around 3 months of age in children with trisomy 13, and 6 months of age in children with trisomy 18
• 1-year survival was 19.8 percent for children with trisomy 13, and 12.6 percent for children with trisomy 18
• 10-year survival was 12.9 percent for children with trisomy 13, and 9.8 percent for children with trisomy 18
• ~50% of all the children had an organ system with a congenital anomaly (most often cardiac)

The researchers also looked at the surgical interventions patients with trisomy 13 or trisomy 18 underwent during their lives. ENT procedures were most common in children with trisomy 13 and procedures to implant medical devices were the most frequent for those with trisomy 18. Median survival after the first surgery was greater than 1 year for all except the children with trisomy 13 who had ophthalmic surgery and children with trisomy 18 who had cardiac surgery. The authors suggest such high survival following surgery “reflects both careful patient selection and procedural benefit.”

While the researchers hope that the survival data presented can help “guide decision making” there are many factors that influence decision making that this study was not designed to delve into. First, the data did not include all prenatal diagnosis, only those surviving to birth. Second, as the authors point out, survival and quality of life are not one in the same. (Although commentator Dr. John Lantos noted, “The concept of quality of life is too vague and subjective to be helpful as a criterion for deciding about the appropriateness of treatment.”) Additionally, the data does not touch upon the decision-making itself – for instance, they did not report the percentage of deaths following decisions to withhold or withdrawal life-sustaining treatments.

So what do I take away from this study on the survival of children with either trisomy 13 or trisomy 18?

1. It is time to change the language around the diagnosis of trisomy 13 and trisomy 18. These diagnoses are not universally “lethal” (since greater than 10% survive greater than 10 years) and all surgical interventions are not futile.
2. Discussing prognosis and survival is still tough and filled with uncertainty. Which babies with trisomy 13 or trisomy 18 will die after a few days and which will live a decade? We still lack useful predictors of long-term survival when facing an individual family in a prenatal meeting.

I also reached out to lead author, and colleague, Dr. Kate Nelson. She agreed with the core take home message, and stated “While the majority of children die within the first few weeks of life, the children who survive can live a decade or more. Since there are few markers associated with long-term survival besides mosaicism, prognostication is difficult. Therefore, care must be individualized, balancing the risks and benefits based on specific clinical situations and families' goals and preferences.” She also noted that readers may link surgical intervention to longer survival, and shared the following: “Children who received surgeries had to live long enough and be healthy enough to undergo procedures, so patient selection likely played a major role in the high post-operative survival rate. More work is needed to understand how surgeries impact survival among children with trisomy 13 and 18.” You can link to the press release from her institution here.

References:
Nelson KE, Rosella, LC, Mahant S, Guttmann A. Survival and Surgical Interventions for Children with Trisomy 13 and 18. JAMA 2016; 316(4):420-429.

Jenni Linebarger, MD, MPH, FAAP is a pediatric palliative care physician at Children's Mercy Hospital in Kansas City, MO.

Photo Credit: Trisomy 13 via Wikimedia Commons

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One of the most refreshing things about hospice and palliative care (HPC) is the person-centered focus of care. Many clinicians who discover palliative care are really drawn to this, because it gets back to the roots of caring for another human being. Add in a healthy dose of communication training and HPC clinicians are ready to jump into a patient/family meeting wherever they are needed. But what about the simple stuff?

Dr. Kate Granger is a physician in her last year of training in the UK ( in Elderly Medicine with a Palliative Medicine sub-specialty), who realized as a patient herself, the simple act of a kind and earnest introduction could make a great impact. She was diagnosed with a terminal cancer during her medical training in 2012. During a re-hospitalization with sepsis in August 2013, she made a acute observation that anyone who has ever been a patient will likely recognize: not every person caring for her bothered to introduce who they were. Even more important, she also recognized the following:

“But when somebody did introduce themselves, it made such a difference to how I was feeling about myself. It made me feel more human again.”

Yet Kate did not yield to the frustration of her initial observation as many of us might. She did not field an anonymous complaint to the suggestion box. She sought to change the behavior of health care professionals, (really all people) who may interact with a patient, be they doctor, nurse, therapist, intake person, volunteer, trainee. And what she did was extraordinarily brilliant yet simple and effective, she reflected on her own actions as a physician, wrote about her experience, and asked other health care professionals to join her in making a simple introduction the beginning of every patient interaction. “Hello, my name is…”
Now this started in the UK back in September 2013, and in 2014 the momentum has grown in the UK, and spread worldwide most notably in Canada, and Australia, but from my social media research it surprisingly has not been a big deal here in the United States*. But all of us...we can change that.


If your organization gets on board, please make sure to share it with @GrangerKate on Twitter or on her blog. If you let us know too, we will make sure to highlight some of the early adopters here in the United States. (If I missed that your organization in the US, did this a long time ago, let me know, I’ll re-edit the post!). If you are a health care social media influencer I challenge you to write about this and help make a difference in your own digital and IRL communities.


Additional Links:
Make the pledge on Twitter: Tweet #HelloMyNameIs
Follow @grangerkate
Change your avatar on social media to "Hello, my name is..."
Hello My Name Is...Website
Download Templates and Logos  
Kate and Chris' story on YouTube
Updates and Archives from Dr. Kate Granger on her website: http://drkategranger.wordpress.com/
Donate to Yorkshire Cancer Centre (Kate's chosen charity) via JustGiving
Download her books (Pallimed Amazon Affiliate Links)



*I did find a well written post by Dr. Peter Pronovost at Johns Hopkins, but despite the post it doesn't appear from other searches Johns Hopkins took him up on the great shared idea.

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You will often hear the lament from people within and outside of the hospice and palliative care fields, that doctors are pretty bad at making effective prognostication. Patients and families frequently search for a predictable road map to understand the course they are likely on, and even when they cede the understandable uncertainty to the physician, the doctors will often reply with an unhelpful retorts like, “I don’t know what may happen. There is only one person who does.”

I doubt all of those physicians are referring to Dr. Mark Cowen, but they may want to take notice of what he and his colleagues at St. Joseph Mercy Hospital in Ann Arbor, Michigan have been doing for the past couple of years. Having already developed and validated a 30-day mortality prediction rule (MPR) (published in 2013), the team now advanced the idea to a prospective, real-time mortality prediction rule study. Published online in the Journal of Hospital Medicine this month, “Implementation of a Mortality Prediction Rule for Real-Time Decision making: Feasibility and Validity” may help clinicians move from pre-contemplation to contemplation when it comes to applicable prognostication.

The MPR in this study was completed on almost 10,000 patients admitted to the hospital (78%) and an outpatient surgery center (22%) at a tertiary community teaching hospital over the Fall 2012 to Winter 2013 (yup, flu season!). Some high mortality risk (dialysis units, transfers from outside hospitals) and low mortality risk admissions (child birth/OB) were not included, most likely because the ability to implement the rule before having a bed assigned was more challenging to accomplish. Since this is not only a validity study, but also a feasibility study, they nicely discuss the diplomacy, champion-finding, and need for paid support staff for this project to work. Interestingly, the authors note the ED staff were open to this prediction rule only if they could accomplish the task “within the time a physician could hold his/her breath.” Be careful what you say in a research administrative meeting, you may see those words published in a journal article some day!

The rule was Web-based and pre-populated data from the EMR without any manual effort. Updates were done to the Web-based rule as often as every minute! Then ED doctors or surgery center nurses reviewed the pre-populated information and made overrides if necessary. Samples of the questions asked include:

History or presence on admission of:

• Atrial fibrillation
• Solid-tumor cancer
• Metastatic cancer
• Cognitive deficit
• Leukolymphoma
• Other neuro deficit

Patient’s current condition/treatments:

• Respiratory failure
• Heart failure Injury
• Sepsis
• Abnormal vital signs

At first the clinicians did not have access to the score but that changed over the course of the study, which to me is one of the weaker parts of the study. It treats this whole group as one, but really this is equivalent to having a study where you have blinded the clinicians and the patient, and then midway through you started to un-blind some of them as to the treatment/test/intervention. The authors talk about two care processes put in place as these scores became available which may impact the true validity of this MPR de novo. Wouldn't it make more sense to test this MPR without changing any behavior (via knowing the score), and then test how it could impact clinical delivery and patient outcomes? The impact of this MPR was a slight bit muddled because of that contamination of the study population.

They split the population into 5 risk categories by quintiles, with the highest risk population having an approximate 7-35% chance of 30d mortality.

But let’s get to the real meat of what Pallimed readers care about, did this study group look at palliative care consults, or hospice utilization? Sorta, kinda. We're going to need to do a little hypothesizing and I will expand on that in an upcoming post. We will talk about what an accurate MPR could do for palliative care and hospice utilization.

Of note, nurses worked with this tool, so if anyone says that prognostication is not the role of a nurse, you can point them to this article.  Nurses should not be excluded from prognostication based on credentials. I appreciate when nurses give me an honest assessment of prognosis, and I hope other doctors out there do as well.

Some other information that would be really helpful is understanding the outliers in the high risk strata.  Who were the people who lived but were high risk? And for how long? Do they have any significant quality of life issues post-hospitalization?

Other info that would be great to see is how much overlap there was in the different groups. For example, if you had palliative care while in the hospital, what was your likelihood of a 30d readmission.

So overall, this is a really good study, and is very accessible in the way it is written. Since it is published in a non-core HPM journal it should be quite easy to approach your hospitalists and ED colleagues to talk about possibly doing a validation study in your local hospitals.

Credits: Future Road Sign - iStockPhotos; Quote - Illustration by Pallimed; Chart - From article under Fair Use guidelines for for nonprofit educational purposes. Full copyright of that figure is retained by the journal.

Cowen, M., Czerwinski, J., Posa, P., Van Hoek, E., Mattimore, J., Halasyamani, L., & Strawderman, R. (2014). Implementation of a mortality prediction rule for real-time decision making: Feasibility and validity Journal of Hospital Medicine, Early Publication DOI: 10.1002/jhm.2250

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Ms BB is a 57 year old woman with fallopian tube cancer with multiple mesenteric and peritoneal metastases and a history of large and small bowel obstructions. She presented with nausea, vomiting, and abdominal distention. She was found to have another bowel obstruction and had an NG tube placed with improvement in her symptoms. She then went to the OR for an exploratory laparotomy. She was found to have massive carcinomatosis and ascites and it was felt that a debulking was not possible so a venting gastrostomy tube (g-tube) was placed and the operation was aborted.

Palliative care was consulted to assist with postoperative nausea and vomiting. Despite placement of the venting gtube, the patient had persistent nausea and held a basin next to her during the interview to catch her frequent episodes of emesis. She was despondent because the surgeons had told her that the g-tube was working well and draining large amounts of fluid but that it was unable to keep up. Antiemetics were not helpful. The patient thought that there was nothing left to do and that she would have to live the rest of her life with this level of discomfort. A trial of octreotide 0.1mg subcutaneously three times daily was initiated in addition to continued drainage by her venting gtube. She was also given around-the-clock intravenous haloperidol and PRN intravenous ondansetron. By the next day, her g-tube output had decreased and her nausea and vomiting had resolved. Her pain was controlled with a hydromorphone PCA. She was eventually able to be discharged home with plans to follow up with her outpatient oncologist to consider next steps. With her symptoms controlled, she was able to move past her initial distress and talk openly about her hopes for the future and how she wanted to spend the time she had left.



Discussion:

Malignant bowel obstruction can occur with any cancer but is most commonly associated with advanced ovarian cancer, where it occurs in up to 50% of patients. It generally indicates a poor prognosis and carries a heavy symptom burden predominated by nausea, vomiting and abdominal pain. Patients with carcinomatosis, like Ms BB, are generally not candidates for surgical correction of the obstruction or endoscopic stenting. Fortunately, medical management can be very effective. Abdominal pain is treated with opioids and nausea is treated with metoclopramide in partial obstructions and haloperidol in complete obstructions. Corticosteroids are also often used for help in symptom control and because there is some indication that they may promote resolution of the obstruction presumably by decreasing inflammation and promoting salt and water absorption. Gastrointestinal secretions can be controlled with anticholinergics (such as scopolamine) and/or somatostatin analogues (such as octreotide).

Two prospective, randomized controlled trials suggest octreotide is superior to scopolamine. Octreotide works by inhibiting the release of several gastrointestinal hormones thereby reducing secretions, slowing motility, increasing water and electrolyte absorption, and reducing bile and splanchnic blood flow. It is generally dosed 0.1-0.3mg subcutaneously TID. Some palliative care units will use continuous infusions at higher doses with anecdotal success.

Current guidelines suggest placing a venting g-tube if medical management is unsuccessful. A venting g-tube is similar to a traditional g-tube but is used solely for drainage of the gastrointestinal secretions and the liquids taken by mouth that are unable to bypass the obstruction. This drainage prevents the backup of these fluids that would normally stretch the viscus and stimulate vomiting. As experience with this intervention increases, many clinicians advocate g-tube placement early in the treatment algorithm because it can provide more complete relief of vomiting and allow more extensive pleasure feeding. Venting g-tubes can, however, place the patient at greater risk for electrolyte imbalances.

Most guidelines and many clinicians consider venting g-tube placement and medical management with octreotide/ anticholinergics as two separate treatment pathways. This case highlights the fact that, occasionally, both may be needed simultaneously. Although Ms BB’s venting g-tube was draining effectively, she still experienced severe nausea and vomiting, and it was not until octreotide was added to the regimen that her symptoms became controlled. This scenario is borne out in some of the data regarding venting g-tubes.

In one series of patients with gynecological malignancy and upper intestinal obstruction, 4 in 31 had incomplete resolution of their symptoms with placement of a venting g-tube alone. All 4 had complete symptom relief when octreotide was added to the regimen. Clinicians need to be aware that venting gastrostomy tubes and medical management with octreotide/anticholinergics are not mutually exclusive treatment algorithms and a small percentage of patients will require both for adequate symptom control. Fortunately, as was the case with Ms BB, this approach can allow almost all patients with malignant bowel obstruction to regain some measure of comfort.

References:

1. Ripamonti CI, Easson AM, Gerdes H. Management of malignant bowel obstruction. Eur J Cancer (2008). doi:10.1016/j.ejca.2008.02.028

2. Campagnutta E et al. Palliative treatment of upper intestinal obstruction by gynecological malignancy: the usefulness of percutaneous endoscopic gastrostomy. Gynecologic Oncology. 1996;62:103-105. doi:10.1006/gyno.1996.0197

3. Ripamonti CI et al. Clinical-practice recommendations for the management of bowel obstruction in patients with endstage cancer. Support Care Cancer. 2001; 9:223-233. doi:10.1007/s005200000198



Pallimed Case Conference Disclaimer: This post is not intended to substitute good individualized clinical judgement or replace a physician-patient relationship. It is published as a means to illustrate important teaching points in health care.

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(Ed. - Please welcome Jennifer Linebarger, MD, MPH, FAAP to Pallimed.  Jennifer joins us and will be helping beef up our pediatrics focus here at Pallimed. We are thrilled to have her! - Sinclair)

I had just begun reading Dr. Danielle Ofri's latest book, "What Doctors Feel: How Emotions Affect the Practice of Medicine", when I opened The New England Journal of Medicine to find David Korones' essay "What would you do if it were your kid?" As he points out, nearly all of us have been asked, have heard this "plea to share with them, as a partner, the heavy burden of decision making." And nearly all of us have squirmed in our seats a little each time.

I still remember the child in the ICU, sedated and on a ventilator as her parents waited for the fungus in her lungs to clear. The note on her door said, “Docs, if ‘Plan A’ didn’t work, the alphabet has 25 more letters! So stay cool.” Yet, the infection was persistent, and her parents were asked to decide – continue as is, perform surgery to remove the fungal ball, or to withdraw the ventilator support and keep her comfortable as she died. The whole team gathered with the parents – the ICU doc, the BMT primary, the infectious disease specialist, the cardiothoracic surgeon, and me, the palliative care doc. The options were presented. The table fell silent as the parents processed the decision before them. Then the father asked, “What would you do?” And after a few furtive glances, one-by-one every provider around that table shared their opinion.

There was not a unanimous response from the providers at the table. But everyone sat with the parents as they faced a heart-wrenching decision. Two years after her death, her parents sat before a group of second year residents and reflected on that family meeting, and on the empathy they felt. It buoys them on their waves of grief to this day.

While the word "empathy" does not appear in Korones’ essay, I think it is at the heart of everything he says. Perhaps it is because I was reading Ofri’s book, and on page 48 she explains,

“Empathy is a cognition, a thought process that allows you to understand the patient’s feelings while not necessarily feeling them yourself… and the empathic doctor needs to be able to clearly communicate that understanding” (p48).

When a patient or a family member asks, “What would you do?”, they are inviting empathy.

1. Korones DN (2013). What would you do if it were your kid? The New England Journal of Medicine, 369 (14), 1291-3 PMID: 24088090

2. Meyer EC, Lamiani G, Foer MR, Truog RD (2012). "What would you do if this were your child?": practitioners' responses during enacted conversations in the United States. Pediatric Critical Care Medicine 13 (6) PMID: 23034458

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JAMA Internal Medicine (JIM, you'll always be Archives of Internal Medicine to me) has published a study of an outcome prediction tool for in-hospital cardiac arrest. Specifically, a tool to predict the rates of neurologically intact survival after an in-hospital arrest. The developers of the tool call it GO-FAR (Good Outcome Following Attempted Resuscitation).

One could imagine ways of re-titling it FORe-GO, if one chose to spend one's time imagine such things.

This is the best tool of its kind that I've seen, although one needs to be very clear about what it's actually predicting.

The paper mostly describes, in detail, the derivation and validation of the tool. I won't belabor this - they did a good job of it, used a large dataset, created a model, tested and validated it to get the best receiver operator curve, etc. The data come from the massive, US-based, 'Get With the Guidelines Registry' (which used to be called the National Registry of Cardiopulmonary Resuscitation). The GWGR collects standardized data on in-hospital cardiac arrests from 366 hospitals in the US (all types and regions of hospitals) (the national rate of CPR survival to discharge of 18% which most of us are aware of comes from the GWGR). The GO-FAR data come from arrests between 2007-2009 (51,000 patients).

Worth belaboring, because this is critically important in understanding if one chooses to use this as a tool to help patients understand CPR outcomes, is how they defined a good outcome: a Cerebral Performance Category (CPC) of 1. CPC of 1 means:

"The patient is conscious, alert, and able to work but might have mild neurologic or psychological deficits (such as mild dysphagia or minor cranial nerve abnormalities). Patients with a CPC score of 2 have moderate cerebral disability and are able to live independently and work in a sheltered environment. Disabilities may include hemiplegia, seizures, ataxia, dysphagia, or permanent memory or mental changes. Patients with CPC scores of 3 through 5 progress through severe cerebral disability, coma or vegetative state, and finally brain death." 

This is important because while I'll venture to claim that nearly everyone would agree CPC scores of 3-5 are dismal outcomes, I think there could be a substantial number of people for whom a CPC of 2 would be acceptable. Not welcomed, not a 'good outcome' (which is, granted, what the researchers here are trying to predict), but better than death for some. So to be clear, the GO-FAR tool predicts rates of survival to hospital discharge with a CPC of 1, every other outcome from a CPC of 2 to death are lumped together as bad outcomes.

GO-FAR is being explicitly developed to help inform discussions at the time of hospital admission, so they deliberately excluded patient/CPR characteristics which predict outcomes but wouldn't be available necessarily to the admitting clinician (such as initial rhythm after arrest, site of arrest as someone may be admitted to the floor then transferred to the ICU prior to arresting). The characteristics which survived their analysis and were included in the final index are below. They very nicely also mentioned what the overall survival to discharge with good outcome was in all of these categories (remember, this is not overall survival, this is survival with a CPC of 1). The overall survival with good outcome rate for the entire dataset (all-comers) is 10%. 

• Neurologically intact/minimal deficits at time of admission - CPC of 1 (this predicted a better outcome; everything else here predicted worse outcome) (18%)
• Major trauma (reason for admission) (6%)
• Acute stroke (reason for admission) (3.7%)
• Metastatic solid tumor or any hematologic malignancy (5.2%)
• Septicemia (basically they mean active bacteremia here; not the sepsis syndrome) (3.6%)
• Medical non-cardiac diagnosis (reason for admission; ie, patients admitted with cardiac conditions did better) (5.6%)
• Hepatic insufficiency (bilirubin greater than 2mg/dl or AST more than 2 times the upper limit of normal) (4.4%)
• Admitted from a skilled nursing facility (3.2%)
• Hypotension or hypoperfusion (5.9%)
• Renal insufficiency (creatinine over 2mg/dl) or dialysis (6.4%)
• Pneumonia (5.2%)
• Age over 70; the older the worse the outcome (10.2% 70-74 down to 4.5% for over 85 years).

Ebell MH, Jang W, Shen Y, and Geocadin RG (2013). Development and Validation of the Good Outcome Following Attempted Resuscitation (GO-FAR) Score to Predict Neurologically Intact Survival After In-Hospital Cardiopulmonary Resuscitation. JAMA Internal Medicine PMID: 24018585