Sunday, March 10, 2019
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.
Sunday, March 10, 2019 by Drew Rosielle MD ·
Monday, February 11, 2019
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
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 ·
Friday, November 2, 2018

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 24, 2018
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, September 28, 2018
October TW, Dizon ZB, Arnold RM, Rosenberg AR. Characteristics of Physician Empathetic Statements During Pediatric Intensive Care Conferences With Family Members: A Qualitative Study. JAMA Network Open. 2018;1(3):e180351. doi:10.1001/jamanetworkopen.2018.0351
Ask any patient what qualities they desire in a physician, and empathy will almost always make the list. A physician’s ability to demonstrate empathy has been shown to significantly impact patient outcomes1, increase patient satisfaction2, and raise physician “compassion satisfaction,” which may hinder burnout (3). Though much debate surrounds empathy’s teachability, learning how and when to make empathetic statements is a crucial aspect of physician training. Many of us struggle with finding the right thing to say, but a recent open access study published in JAMA Network Open shows there may be more power in pauses made after empathetic statements than in the words themselves.
The study recorded 68 pediatric intensive care unit conferences over four years. Transcripts of every meeting were made, and empathetic statements were noted using the infamous NURSE criteria (naming, understanding, respecting, supporting, exploring). “Missed opportunities” to express empathy were noted as well. Empathetic statements were placed into two categories, “buried” and “unburied.” A buried statement was one in which the physician expressed empathy, but did not allow time for the family to respond. This most commonly occurred with the physician immediately segueing into clinical jargon, but was also counted as buried if another member of the team interrupted, or if the physician finished the statement with a closed-ended question.
Transcript analysis showed that physicians are fairly good at identifying when to express empathy, taking advantage of 74% of the opportunities analyzers identified. However, almost 40% of these statements were buried, and “medical talk” accounted for the vast majority of buried statements (95%). Interestingly, non-physician team members (typically a social worker or nurse) spoke only 5% of the time, but when they offered empathy, they did so unburied 87% of the time, further demonstrating the importance of a multi-disciplinary team in fully supporting patients and their families.
Physicians have a wealth of medical knowledge to share, but timing is paramount, and tacking jargon onto the end of a well-intentioned empathetic statement may prevent patients and families from even recognizing the empathetic effort at all. In October’s study, when physicians made unburied empathetic statements, families were 18 times more likely to respond with additional information, to express their fears, and to discuss their goals. Clear communication is an obvious cornerstone of the physician-family relationship, and while buried empathetic statements may be better than no expressions of empathy at all, they may leave families with a feeling of being unheard and ignored.
Though a busy clinician may not feel they have the time to open the Pandora’s box of family concerns and fears, investing time in “a pause” may pay dividends for all parties involved. For physicians, better communication skills have been shown to decrease instances of burnout, lower rates malpractice suits, and raise patient satisfaction scores4. Meanwhile, the family leaves these conversations feeling heard and understood, and the patient receives care tailored to them, with every fear, concern, and hope kept in mind.
If, as cellist Yo-Yo Ma would assert, “music happens between the notes,” perhaps the heart of medicine lives in the pause.
More Pallimed posts from Kayla Sheehan can be found here. More journal article reviews can be found here. More posts on communication can be found here.
Kayla Sheehan is a third-year medical student at California Northstate University. She enjoys singing, sharp cheddar, and long walks with her Australian Shepherd, Posey.
References:
1) Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. PubMed PMID: 15312283.
2) Pollak KI, Alexander SC, Tulsky JA, Lyna P, Coffman CJ, Dolor RJ, Gulbrandsen P, Ostbye T. Physician empathy and listening: associations with patient satisfaction and autonomy. J Am Board Fam Med. 2011 Nov-Dec;24(6):665-72. doi:10.3122/jabfm.2011.06.110025. PubMed PMID: 22086809;
3) Gleichgerrcht E, Decety J (2013) Empathy in Clinical Practice: How Individual Dispositions, Gender, and Experience Moderate Empathic Concern, Burnout, and Emotional Distress in Physicians. PLoS ONE 8(4): e61526. https://doi.org/10.1371/journal.pone.0061526
4) Boissy, A., Windover, A.K., Bokar, D. et al. Communication Skills Training for Physicians Improves Patient Satisfaction. J Gen Intern Med (2016) 31: 755. https://doi.org/10.1007/s11606-016-3597-2
Altmetric for this study: October TW, Dizon ZB, Arnold RM, Rosenberg AR. Characteristics of Physician Empathetic Statements During Pediatric Intensive Care Conferences With Family Members: A Qualitative Study. JAMA Network Open. 2018;1(3):e180351. doi:10.1001/jamanetworkopen.2018.0351
Friday, September 28, 2018 by Pallimed Editor ·
Monday, September 24, 2018
For every rule, however, there is an exception. I am completely enthralled with aromatherapy and thus found an article in the Annals of Emergency Medicine by Beadle on isopropyl alcohol nasal inhalation for nausea in the emergency department. It was a randomized controlled trial which made it swoon-worthy. The only problem was it was a placebo trial and so my friend(s) pooh-poohed the article. I was thrilled to see the follow-up, double-blind RTC article by April: “Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial,” in February 2018, again in the Annals of Emergency Medicine. The fact that it was positive means that anyone who I talk to has to hear about it (as well as how they must watch Nanette and how excited I am about the new season of The Good Place).
The aim of the 2018 study was to compare nasally inhaled isopropyl alcohol versus oral ondansetron (aka Zofran) for the treatment of nausea among emergency medicine patients. They looked at 120 adult patients with nausea or vomiting who did not require an IV. The patients who were randomized into the three groups: (1) isopropyl alcohol plus 4 mg of oral ondansetron; (2) isopropyl alcohol plus oral placebo; (3) inhale saline plus 4 mg of ondansetron. (They did not do a double placebo because there is placebo-controlled data that both drugs work). The isopropyl alcohol was a commercially prepared, medical pad placed 1-2 cm from the patient’s nose and the patient was instructed to nasally breathe to inhale the isopropyl alcohol. Measurements were made at 10, 20, 30, and 60 minutes and then hourly until disposition using a 0-10 cm visual, analog scale.
Mean nausea scores decreased 30 mm in the alcohol and ondansetron group, 32 mg in the alcohol placebo group, and 9 mm in the saline ondansetron group (this was statistically different). Patients in the isopropyl alcohol groups also had better nausea control at the time of discharge and higher satisfaction with no adverse events.
On to the evaluation questions:
Was this study valid?
The assignment of patients to treatment was evenly randomized. All of the patients who entered the study were accounted for at the conclusion and there was complete follow-up. They asked the patients and clinicians if they could tell what group they were in (they could not). The patients seemed to be treated in an identical manner. Rescue antiemetics were less common in the groups who got the isopropyl alcohol versus the ondansetron alone.
Were the results clinically important?
The investigators used 20 mm as a clinically significant result, which seemed to be reasonable. They did not make any adjustment for compounding variables, but I really was not sure what the confounding variables should be; this seemed reasonable.
The problem with the study is the question whether the results will help me care for my patients. My patients are not young, relatively, healthy individuals with viral illnesses who do not need an IV. That is unclear and if I am being my normal, cynical self, I probably should just move on!
On the other hand, given that this trial has absolutely no side effects and I can carry alcohol swabs around in my coat, I stick with my love of this article. I mean seriously, why wouldn’t you try this in the hospital on patients with nausea and vomiting.
So, I am going to urge you to watch Nanette, the Good Place and carry around isopropyl alcohol swabs in your pocket on rounds. Tell me if you think I am wrong!
Robert Arnold, MD is a palliative care doctor at the University of Pittsburgh and a co-founder of VitalTalk (@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!) You can find him on Twitter at @rabob.
More Pallimed posts from Bob Arnold can be found here. More journal article reviews can be found here. More posts on nausea can be found here.
References
Beadle KL, Helbling AR, Love SL, April MD, Hunger CJ. Isopropyl Alcohol Nasal Inhalation for Nausea in the Emergency Department: A Randomized Controlled Trial. Ann of Emergency Med. 206: 68 (1):1-10
Hines S, Steels E, Chang A, et al. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012;(4):CD007598.
April MD, Oliver JJ, Davis WT, Ong D, Simon EM, Ng PC, Hunter CJ. Aromatherapy Versus Oral Ondansetron for Antiemetic Therapy Among Adult Emergency Department Patients: A Randomized Controlled Trial. Ann of Emergency Med. https://doi.org/10.1016/j.annemergmed.2018.01.016
Monday, September 24, 2018 by Pallimed Editor ·
Monday, September 17, 2018

The aim of the article was to assess outcomes for nursing home residents with advanced dementia who did and did not undergo surgical repair of a broken hip. Advanced dementia was defined as a Cognitive Performance Scale (CPS) of 5 or 6 and diagnosis of “dementia” or “Alzheimer disease.” By outcomes they meant survival (the primary outcome), pain, anti-psychotic use, physical restraints, pressure ulcers, and ambulatory status. The authors used the MDS (Minimum Data Set) assessment and linked this to Medicare claims to conduct a cohort study of 3,083 long-staying nursing home residents with advanced dementia and hip fracture.
They found, as have other studies of nursing home residents with hip fractures, that patients who underwent surgery had lower mortality rates (the literature stressed the importance of surgery within the first 24 hours). While 35% died within 6 months, and 61% within two years, the mortality was significantly greater in patients who did not have surgery. These results were greatest in the first 30 days; 11% mortality with surgery, 30% without surgery, and resulted in a median survival of 1.4 years with surgery versus 0.4 years if the patient did not undergo surgery. Adjustment attenuated the findings, but they remained significant.

Residents who underwent surgical repair also had less pain, less anti-psychotic drug use, physical restraint use and pressure ulcers; although once these results were adjusted for differences between the two groups there were no differences according to surgical repair. Interestingly the inverse probability of treatment waiting models, which adjusted for differences in characteristics before the hip fractures, suggested that there was less pain and fewer pressure ulcers among patients managed with surgery. (I need someone who knows more about statistics than me to explain why two different ways of statistical correction resulted in different secondary outcomes).
So, the question is how I should use these results in my patient:
1. Are the patients in this population relevant to the ones I care for? Well, as a hospital-based palliative care doctor these are exactly the kinds of patients for which I am consulted.
2. Are the outcomes that the authors measured the correct ones? Well, it seems to me that pain, survival, and restraints are all things that my patients’ families want to know about. Sadly, for these secondary outcomes they could only look at one point in time. Also, to have data on the secondary outcomes, the patient had to live at least six months (it has to do with when MDS data is collected). Thus, for a lot of the patients we do not have these secondary outcomes.
3. Were the two groups similar in characteristics prior to the operation? Sadly, the answer is no. Residents treated non-operatively were much more impaired at baseline. For example, 26% of the non-operative residents were completely dependent in activities of daily living as opposed to only 5% of the surgical residents. Moreover, despite the large number of variables in the MDS, it is likely there were differences between the two groups that were unmeasured that led the surgeons to choose not to do surgery. In addition, it is unclear whether the decision to do surgery was based on patient/family preferences. Thus, one does not know if the reason for the difference in outcomes was based on surgery or whether other variables led both to the decision to have surgery and the outcomes. This is a limitation of not doing a RCT. Finally, the outcomes could be due to a self-fulfilling hypothesis. Given the non-surgical patients’ greater illness/morbidity, there may have been a decision only to focus on comfort. Given this, the treatment these patients received was less focused on prolonging life and thus they died sooner. (This would have nothing to do with the impact of surgery on survival or clinical outcomes).
4. Were the circumstances and methods for detecting the outcome similar? The answer here is yes. The MDS is a very complete way of detecting the outcomes of interest. Although pain was evaluated by the health care provider rather than the patients, there is no reason to think that there would be differences based on which group they were in.
5. Was follow-up sufficiently complete? Again, the answer seems to be yes, although as previously noted, for patients who did not live six months we do not have any of the secondary outcomes.
6. Are the differences big enough that I should care? Again, the answer is at least with the primary outcome the difference did seem quite large as noted before, the secondary outcomes, differences, particularly after adjustment, are much smaller.
So, what does this mean? In the end, as Johnston et al. summarized, the decision to have surgery depends a great deal on the surrogate decision-maker’s view about the patient’s quality of life preoperatively and what is most important postoperatively. I have to say that this article would, for many of my patients, lead me to do surgery and continue aggressive palliative care (the increased rate of ambulation postoperatively -10.7% in the patients with surgery versus 4.8% in those without surgery - would be a big factor for many families). While a randomized controlled file would be better, it is unlikely that one will ever be conducted. (I am given pause by the mostly negative data presented by Johnston on hip fracture repair. She points out, for example, there is the Cochran review of five randomized controlled trials that shows no difference in medical complications, mortality or long-term pain in conservative care versus surgery. While this is not a study of demented patients, it made me realize the data is controversial).
A coda: What I and the editorial found distressing were the high rates of pain and the low rates of hospice in severely demented patients even after they have hip fractures (particularly in the non-operative patients). It also was quite curious that the median time to utilize hospice was 56 days. Given this article, I wonder whether hospice should be discussed and/or recommended for all patients who have severe dementia and a hip fracture. This article should lead you to talk to your trauma surgeons and/or orthopedists to develop a routine palliative care or hospice consultation for these patients.
Robert Arnold, MD is a palliative care doctor at the University of Pittsburgh and a co-founder of VitalTalk (@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!) You can find him on Twitter at @rabob.
More Pallimed posts from Bob Arnold can be found here. More journal article reviews can be found here.
References
1. Berry SD, Rothbaum RR, Kiel DP, Lee Y, Mitchell SL. Association of clinical outcomes with surgical repair of hip fracture vs nonsurgical management in nursing home residents with advanced dementia [published online May 7, 2018]. JAMA Intern Med. doi:10.1001/jamainternmed.2018.0743
2. Mehr DR, Tatum PE, Crist BD. Hip Fractures in Patients With Advanced Dementia What Treatment Provides the Best Palliation? JAMA Intern Med. 2018;178(6):780–781. doi:10.1001/jamainternmed.2018.0822
3. Johnston CB, Holleran A, Ong T, McVeigh U, Ames E. Hip Fracture in the Setting of Limited Life Expectancy: The Importance of Considering Goals of Care and Prognosis. Journal of Palliative Medicine 2018 21:8, 1069-1073
4. Morrison RS, Siu AL. Survival in end-stage dementia following acute illness. JAMA. 2000;284(1):47-52
Monday, September 17, 2018 by Pallimed Editor ·
Wednesday, September 5, 2018
by Ben Skoch (@skochb)
Review of Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients with Cancer. A Randomized Clinical Trial. Patel MI, Sundaram V, Desai M, et al. JAMA Oncology July 2018. doi:10.1001/jamaoncol.2018.2446
I’m sure many, if not most health professionals who have spent time around an oncology unit have encountered patients receiving care in the late stages of their disease and had the thought, “Is this really helping?” Or possibly, “Has anyone asked this patient how they feel about this treatment?” As a palliative medicine physician, it feels like having these conversations have become a cornerstone to the type of care I provide. Knowing palliative care is a relatively young field, the number of cancer patients is increasing, and that those patients on the whole are living longer with their diseases, it becomes clear palliative care clinicians will need help in having these conversations. Furthermore, a dedicated effort to document these conversations will be imperative to communicate those wishes to all of the patient’s healthcare providers.
This quality improvement study indicates help might not be as far away as it might seem. What the study calls a “lay health worker” (LHW) was one individual with a BA degree currently doing a part time health education program. That person received additional training in the form of online training modules, as well as shadowing the institution’s palliative care team. Once trained, the LHW performed five tasks under the supervision of a registered nurse. The LHW provided the intervention group of patients with education on goals-of-care principles, establishing care preferences, identifying a surrogate decision maker, filing an advance directive, and encouraging patients to discuss care preferences with providers.
A part-time, blinded study was conducted at a single center, a VA medical system in California. Patients had either newly diagnosed stage III or IV solid tumors, or recurrent disease. The two groups were divided into an intervention arm (where they worked with their oncology team in addition to the LHW) and a usual care arm (oncology team alone), with over 100 patients in each arm. It is important to note 99% of the patients in this study were men, 77% of whom were Caucasian.
The primary objective was simply to see if the system could increase documentation of patient wishes and goals of care in late stage cancer. The usual care group had 17.6% and 24.1% goals of care documentation at 6 and 15 months post-randomization, while the intervention group had 92.4% and 93.3% at the same checkpoints. An advance directive was documented 25.9% and 33.3% of the time for usual care, and 67.6% and 74.3% in the intervention group. Secondary outcomes showed higher patient satisfaction, low emergency department utilization within 30 days of death, lower hospitalization rates within 30 days of death, higher hospice utilizations within 30 days of death, and decreased overall healthcare costs within 30 days of death in the intervention arm. And all of them were statistically significant. The authors point out cost savings did not translate to the groups when examined at 15 months post-randomization.
Interestingly, mortality rates among the two groups were nearly identical (57.1% for intervention and 55.5% for control). Some might expect the control group who utilized hospice at a higher rate within the last thirty days of life would have a significantly higher mortality rate, but this was not the case.
The knee-jerk reaction to this study is, “Let’s get a lay health worker trained!” It’s especially appealing when it was described that implementation costs (about $20,000) paled in comparison to rough estimates of net savings for the health care system (about $3 MILLION). It seems to me that this would be a legitimate feeling, especially considering that palliative care usage did not differ among the two groups. In other words, this LHW was able to locate people who did not need specialized palliative care to have these conversations, they simply needed someone to have them with. So often it is cited clinicians don’t have enough time during a regular patient visit, or think they have more time in the future to address these issues. That is, until often it becomes too late for a person to make their wishes known. Maybe this intervention really could be a game changer moving into the future of health care.
But before you go singing this from the mountain tops, I’d caution you to practice a healthy sense of skepticism. As was stated, the study population was fairly uniform (mostly white men in the VA system in California). A repeat of this study across hospital systems in other geographic locations would be extremely helpful to see if the results are reproducible and generalizable. But at the very least, I hope this helps spread the message that people might be more ready than physicians think to have goals of care and advance care planning conversations. Perhaps we just need to ask more.
Ben Skoch, DO, MBA, a Hospice and Palliative Medicine physician at the University of Kansas Medical Center. Outside of Family Medicine and Palliative Medicine, he enjoys most sports, black coffee, and most especially spending time with his wife and two adorable children.
More posts from Ben Skoch here. More Pallimed posts about advance care planning can be found here.
Wednesday, September 5, 2018 by Pallimed Editor ·
Monday, August 27, 2018
by Christian Sinclair (@ctsinclair)
We are prognosticating beings. It is how we survive. Many everyday decisions begin with an estimation of likely future outcomes. If my first clinic appointment is at 9:15am, and my drive from the hospital to the clinic usually takes 25 minutes, then I need to leave by 8:50am at the latest to give myself time to spare for bad traffic light timing, lack of a good parking spot or some other problem that may delay my arrival. I make my estimates, and go with the safest choice. I could go with my gut and my experience or I could use Waze, an app where I can select where I am leaving from, where I am going and what time I want to arrive by and it will tell me the best time to go based on a much bigger data set from drivers on the roads at that moment. Not only that, I could also use Waze to send an updated map to the clinic team to let them know when I will be there, so they can plan ahead as well.
But when it comes to medicine, we often deal with prognosis of many different outcomes, but we rarely use data and technology (evidence) and we rarely share this information clearly with others (documentation.) I recently finished the chapter on Prognostication for the new edition of the Oxford Textbook of Palliative Medicine, so prognosis has been on my mind a lot. One key article stuck with me and made me reflect on my practice of documenting evidence-based prognosis. Andrew Bruggeman and his colleagues at UC San Diego reviewed 412 inpatient palliative care notes for oncology patients and only 5 contained documentation of evidence-based prognostication. The validated tools used included the MELD score, the Walter Index, and the Lee Index. They looked for the Palliative Prognostic Score and the Palliative Prognostic Index as well but never found either of those documented.
First of all, I want to say kudos for publishing this research that basically says at their own institution a potentially critical part of a good palliative care note is missing. They are in good company thought because from my discussions with colleagues around the country I have not heard anyone else doing this on a consistent basis. At the organizations where I have and currently work, we do document prognosis but the note template and the EMR are not designed to easily include any particular evidence-based tool. This is consistent with other research of palliative care notes which showed 72% of notes contain survival estimates.
Secondly, we are entering a new age where machine learning and big data are crunching numbers and relationships with more power and speed then our simplistic point-based prognostic tools are capable of. But the output of these tools has not been widely tested, and how they construct their findings can be pretty enigmatic and not inherently logical to clinicians. These new black box prognostic machines may help us identify patients who may benefit most from palliative care, but I think we have not quite dealt with the ethical ramifications of what improved prognostic accuracy means for our clinical work and how it is delivered at scale.
We are barely starting to make evidence-based prognostication part of our clinical work and there are strong forces already at play using potentially more accurate tools that we don’t comprehend. This will be an important part of not only palliative care and hospice delivery, but health care delivery, health care reform, and even the overall insurance-based payment structure. We need clinician eyes, ears, and voices involved with the advances in prognostic science, and it begins with all of us being willing to use the tools we currently have and include them in our daily work.
If you are interested in this topic, I will be hosting a conversation about prognostication at the #hpm chat on Twitter Wednesday, August 29nd, 2018 at 9pET / 6p PT.
Christian Sinclair is the co-founder of #hpm chat and Editor-In-Chief of Pallimed. He leads the outpatient palliative care oncology clinics at the University of Kansas Health System. When he is not thinking about predicting the future, he can be found watching the Back to the Future trilogy looking for plot inconsistencies. You can find him on Twitter at @ctsinclair.
References
1: Bruggeman AR, Heavey SF, Ma JD, Revta C, Roeland EJ. Lack of documentation of evidence-based prognostication in cancer patients by inpatient palliative care consultants. J Palliat Med. 2015 Apr;18(4):382-5. doi: 10.1089/jpm.2014.0331. Epub 2015 Jan 21. PubMed PMID: 25608220.
2: Zibelman M, Xiang Q, Muchka S, Nickoloff S, Marks S. Assessing prognostic documentation and accuracy among palliative care clinicians. J Palliat Med. 2014 May;17(5):521-6. doi: 10.1089/jpm.2013.0454. Epub 2014 Apr 10. PubMed PMID:24720384.
Monday, August 27, 2018 by Christian Sinclair ·
Friday, August 24, 2018
by Ben Skoch (@skochb)
Opioid Problem. Opioid Epidemic. Opioid Crisis.
Call it what you will (as long as you don’t use the word narcotic, but that’s another article), but the United States has a real issue with opioids right now. It has been much talked about, publicized, criticized, politicized, has left some people ostracized, to a point where the concern has become supersized. Six years ago, a report stated enough opioid prescriptions were written for every adult in the US to have a bottle of pills, about 259 million. Couple that with the report from the CDC that over 42,000 people died from opioid (illicit and prescribed) overdoses in 2016, more than any year on record, and it’s easy to see why the topic has reached a fever pitch in our country.
Many efforts to curb potential causes have been suggested, including a list of “promising state strategies” set forth by the CDC. It is worrisome given the rising number of opioid-related deaths, along with nature of the problem including abuse of both prescribed and illicit opioids, that the current interventions have yet to tame this complex issue.
A recent study published in Science examined a novel approach to influence prescribing patterns of healthcare professionals (including MDs, DOs, NPs, PAs, and DDSs/DNDs) in San Diego County. Over the period of one year (June 2016 to July 2017), the researchers worked with the medical examiner to investigate deaths that were directly related to schedule II, III, or IV drugs. Utilizing CURES database (California's Prescription Drug Monitoring Program (PDMP)), the identified 220 people who died by overdose, with 170 of the 220 having filled at least one opioid prescription in the last calendar year before their untimely deaths. They could also identify each prescriber who wrote prescriptions to each decedent, and on average there were 5.5 prescribers per decedent.
The authors clarify they are not addressing, “appropriate or inappropriate prescribing at the patient level.” The intervention included sending a letter to each prescriber, who wrote an opioid prescription to a decedent in the months leading up to that person’s death, could influence their prescribing patterns. They note the letters were “supportive in tone,” and also identified by name the patient that had died, discussed the value of the state prescription drug monitoring program, and reviewed the CDC’s recommendations for safe prescribing strategies. They examined prescribing patterns three months before, and one to four months after each letter was written. There were 82 decedents (representing 388 prescribers) in the intervention group, and 85 decedents (representing 438 prescribers) in the control group.
What they found, as the authors describe, is that receiving such a letter mentioned above resulted in fewer subsequent opioids dispensed. There was no change in the control group over the observation period (71.6 milligram morphine equivalents (MME) to 71.7 MME), while the intervention arm decreased their prescriptions by almost 10%, from 72.5 MME to 65.7 MME per prescriber per day. In other words, prescribers who got the letter were writing one and a half tabs of 5/325 Norco fewer, or one 5 mg Oxycodone tablet fewer, per day after reading the letter. Among other reasons they propose for why the intervention showed a statistically significant reduction is that, “Clinicians may prescribe with greater care when they perceive that they are being watched, particularly by figures of authority,” citing a 2003 paper out of Current Directions in Psychological Science.
While I believe that the authors of this paper have the right intentions in wanting to help cure our national opioid sickness, I am worried this approach will have significant and long-lasting unintended negative consequences. Yes, I worry that on some level this will make it increasingly difficult for patients who genuinely need these medications to obtain them. Additionally, I wonder if guilting physicians into practice changes is the best way to pursue systemic changes, particularly in a system where physicians are already suffering increasing levels of burnout. Guilt has been well described as a symptom of burnout , so it’s no big leap to think that scaling this intervention to a national level as the authors suggest could severely complicate this issue.
The conclusion of this article correctly highlights several pieces of this picture, each important in viewing and solving the bigger puzzle. I am hopeful that PDMPs at the state level will be functional, easily accessible, and above all helpful to clinicians who are tasked with treating those with legitimate pain sources. I am encouraged by efforts being made to identify instances where we are likely overprescribing and the guidelines being put into place because of those studies. I am hopeful we can find a solution to this growing problem without adding unneeded suffering to both patients and prescribers. I have my doubts, however, that the letters mentioned in the above article are the best way to get there.
Ben Skoch, DO, MBA, a Hospice and Palliative Medicine physician at the University of Kansas Medical Center. Outside of Family Medicine and Palliative Medicine, he enjoys most sports, black coffee, and most especially spending time with his wife and two adorable children.
More posts from Ben Skoch here. More Pallimed posts about opioids and pain control can be found here.
Doctor et al., “Opioid prescribing decreases after learning of a patient’s fatal overdose.” Science 2018:361, 588-590.
Friday, August 24, 2018 by Pallimed Editor ·