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Thursday, May 27, 2010

Hello from sunny Minneapolis

In case you're wondering, all of us who contribute to the blog are doing just fine, despite the sparse posting the last month.  I have just moved to Minneapolis (more on that in a later post), have had spotty internet access, and have been devoting most of my free time to getting the family Up North sanely and safely. 

In my free time I've been perusing the archives of the New Yorker for interesting articles, and thought I'd mention one I really enjoyed:  it's from 2001 and discusses the history, science, ethics, and philosophical meaning of 'brain death' and organ donation.  It's thought provoking, and one of the better summaries of the issues I've seen outside of the medical literature.  And, like all good reporting, it discusses the issues through the lens of how it impacts real people/families.  Good stuff.

Thursday, May 27, 2010 by Drew Rosielle MD ·

Tuesday, May 11, 2010

A Randomized Controlled Trial of "Death Panels"

...or rather, a randomized controlled trial of an intervention very similar to Respecting Choices, which is the program developed by the Gundersen Lutheran Medical Foundation in Wisconsin. (See Christian's post here for more on relationship between the Gundersen Lutheran program and the death panel "controversies.")

Researchers in Melbourne, Australia conducted a single institution prospective randomized controlled trial to investigate the impact of this advance care planning (ACP) intervention, (Respecting Patient Choices) on end of life care in older patients. BMJ publishes the results.

The intervention was delivered in a hospital setting primarily by a nurse or allied health worker who conducted a conversation to evoke the patient's goals, values, and beliefs, and to discuss and document their future choices about health care. Family members, especially potential surrogates, were encouraged to participate. The creation of advance directive documents was encouraged. In this study, the discussions lasted a median of 60 minutes spanning 1-3 visits. The intervention appears similar to POLST programs in the United States.

The participants included 309 medical inpatients aged 80 or more who were followed for six months or until the time of death. Of the 871 patients screened, reasons for ineligibility included a lack of decision making capacity (n=368), expected death during the hospitalization, previous advance care planning, no relative, non-English speaking patients, and the six patients who refused to participate.

At the time of enrollment, intervention and control groups were similar with respect to age (median 84-85), reason for hospital admission, code status, presence of appointed surrogate, and overall preference for life prolonging treatment. There seemed to be a trend towards having more males in the intervention group (54% vs 41%), but p values aren't reported.

Of the 154 patients assigned to the intervention group, the ACP intervention was delivered to 125 (81%). Of those receiving the intervention, 70 completed a written document and 38 expressed wishes verbally (which were then recorded by the facilitator for chart documentation).

The primary outcome examined was the proportion of patients who died at six months and whose end of life wishes were known and respected by their doctors. Compliance was determined by review of patients' charts after death to identify any documentation of patients' wishes, what type of care patients received, and how the patient's wishes impacted medical decisions. It was determined that of 25/29 patients who died in the intervention group, wishes were documented and followed versus 8/27 in the control group (p<0.001).

Yes, six month mortality was...ahem... no different between the two groups.

Even with attempts at blinding to intervention, it was probably evident upon chart review which patients had received the intervention. Whether this is problematic becomes irrelevant in my mind after reviewing some of the secondary outcomes:

  • Reduced risk of PTSD in survivors as evidenced by a reduced Impact of Events Scale scores in intervention group family members (including 0% vs 15% who had scores >30, which places them at higher risk of developing post-traumatic stress disorder, p 0.03)
  • Reduced Hospital Anxiety and Depression Scale scores (including 0% in intervention group having a depression or anxiety score >8, which indicates clinically significant depression or anxiety, vs. 30% and 20%, respectively, in the control group).
  • No patients died in ICU in intervention group vs. four patients in control group. Otherwise, the intervention didn't significantly impact place of death (hospital vs. home vs. palliative care/hospice setting).
  • Family members reported greater satisfaction in a survey regarding the patient's "quality of death" (83% very satisfied in the intervention group vs. 48% in control group).

The secondary outcomes are quite reminiscent of the French ICU study on physician-family communication in the ICU that showed a reduction in risk of PTSD, anxiety, and depression in family members in the intervention group. (See Drew's commentary on that study here.) When combined with the many recent Coping with Cancer study results and the fact that results are now coming in from a variety of countries (US, France, now Australia), we should be confident in these secondary outcomes.

The fact that this is not a physician-led intervention should be highlighted. Physicians were drawn into the discussions to help clarify diagnosis, treatment options, and prognosis, but they were not central to the process. This is an important consideration as we confront workforce issues in palliative care and is an example of a "disruptive innovation" in medicine. By no means does this diminish physician involvement in expert palliative care teams nor does it relieve other physicians of their duty to be mindful of advance care planning.

Also notable is that this is not a primary care, office based intervention. It makes sense in some ways that the hospital would be the locus for this type of intervention rather than an office. Patients are captive in terms of having time to spend thinking about this and they are also more likely to see the importance of it (ie in an office, "why are you bothering me with this now? I'm just here for a cold.") Family members are more likely to be around in the hospital. Patients who are most likely to benefit from the intervention are "batched" in the hospital making it easier for those applying the intervention.

Only about 1/6 of patients had died by the six month mark. I'd be quite interested to know if the results hold as a greater proportion of patients die. If so, it only strengthens the above conclusions in my mind. If not, it would be interesting to know why (patient preferences changed? conversations need to be reiterated periodically?)

In the article's conclusion, the authors discuss the fact that advance directives were once much ballyhooed and more recently have been derided as ineffective at changing care at the end of life. They propose reasons why their intervention may be more effective than other previous attempts:
"We specifically focused on a model with five key elements identified by others as crucial to successful advance care planning: trained facilitators, patient centred discussions, involvement of family in discussions, correctly filed documentation, and systematic education of doctors.....Four of these five key elements were absent from the SUPPORT study, a project that relied on a research nurse to relay information verbally to the treating doctor about a patient’s preference for cardiopulmonary resuscitation, but which did not facilitate patient centred discussions, involve the patient’s surrogate, and ensure that the treating doctor was aware of the patient’s advance care plan when end of life decisions were made."
Should hospitals implement programs like this? If so, what role should palliative care teams play in developing and implementing such programs? The palliative care team is a natural home for the direction of interventions like this--these conversations are the bread and butter of our daily work, although the patient population we see is generally sicker than the population included in this study. An intervention like this may represent an opportunity for earlier formal palliative care involvement (through triggers) versus an opportunity to insert palliative principles into the patient's care through separate but related programs. Physician and non-physician leaders alike can play an integral role in the development of programs and the training of other health care professionals to conduct these conversations (without needing to insert ourselves into every advance care planning event, which is, of course, impossible). We'll still be needed for the more complex scenarios, no doubt.

A number of possibilities exist to incentivize hospitals/providers to institute interventions like this. For instance, I wonder if there's an opportunity to include this somehow in the "national pilot program on payment bundling" (included in the health care reform bill, PPACA, Sec. 3023). See Dr. Brad Stuart's recent commentary at Geripal on issues related to health care reform and palliative care.

Many locales throughout the United States that have implemented POLST interventions, and I don't practice in one of them. Feel free to leave any ideas you have below, especially if I'm missing some major demonstration or pilot project.

See also Alex Smith's thoughtful commentary on this and a related article at Geripal.

Tuesday, May 11, 2010 by Lyle Fettig ·

Friday, May 7, 2010

Overuse, underuse, misuse and the physicians' obligation to patients

During the 1998 Institute of Medicine (IOM) Roundtable on Quality, experts in the field categorized medical error into one or more of three areas: underuse, overuse, or misuse. Much discussion and research has focused on the topic of underuse (barriers to access of care, especially to preventive care), misuse (avoiding hospital-acquired infections, etc.) and others over the topic of overuse (provision of tests and interventions that have no clinical benefit and while still having associated risk).

Research by The RAND Corporation quantified some of the overuse: 20-40 percent of some surgical procedures are performed on patients who cannot, on scientific grounds, be expected to benefit from them (Leape et al. 1991). - From Don Berwick's Eisenberg lecture, April 2005

The national debates over healthcare reform have once again brought to the fore this 3rd cause for medical error - particularly due to its financial implications.
According to the American College of Physicians (ACP) 2009 policy paper, Controlling Health Care Costs While Promoting the Best Possible Health Outcomes, the Congressional Budget Office estimates that 5% of the American gross domestic product (roughly $700 billion per year) is spent on medical tests and proceduresthat do not improve health outcomes. (Introduction to interview with Steven Weinberger, MD, FACP - on Medscape)

Despite increased attention on the topic - it continues to be extremely heated, including now infamous phrases such as "Death Panels." Overuse at the end-of-life becomes a particularly contentious issue, partly because what one person calls overuse, another may consider appropriate. We know that practice standards regarding use of tests and interventions for the very same circumstance vary widely not only between countries, but also between and within states.

I for one, look forwards to seeing what ACP brings forward with regards to evidence-based recommendations to address this question. In my practice in palliative care, it has not been uncommon for me to be called to address questions of intensity of care - not only from the patient's perspective, but through conflicting points of view between the physicians caring for patients. One very personal story for me was when I was called to another state, to the bedside of a dear friend who had been in a horrific car-on-bicycle accident. He on his regular 50 mile Sunday bike ride when a car swerved ever-so-slightly and hit him head-on. He was rushed to hospital with massive head and chest injuries. He had bilateral brain contusions and bleeds. After a couple of weeks of giving it their all, there was clear conflict between clinicians information being shard with families:
  • One physician pointed to the small improvements each day: the wounds were healing, his face less swollen, cardiac function improving. His honest perspective was that he was getting better, and could continue to improve to leave the hospital. This physician treasured life over all else. In the words of Dr. Epstein's article referred to by Dr. Levy in his blog "Running a hospital:"
    "The Role of the Physician in the Preservation of Life." Q J Med 2007; 100:585–589.

    We physicians belong to an ancient profession, standing apart from all others in its primary concern and respect for human life and its enmity to death. And in the long run, that attitude of the profession may be as important to society as any miracle that modern technical medicine can perform.
    That, however, what he missed was meaning of the next part of Dr. Epstein's speech -
    The fact is that for all our talk and our science, we do only a little. Life cannot be prolonged indefinitely, and death comes at last. But the little we can do has an importance that transcends the patient, for it carries a message to all our patients and to the world: Human beings are important.
  • The other physician saw a very different picture: a young man, an athlete and artist who would never return to his previous vigorous self and should he survive this hospitalization (a big if) would likely remain on life-support for his remaining years would definitely always be completely dependent for all activities of daily living, unable to carry on a conversation. He saw the ongoing aggressive life-sustaining interventions as possible overuse, given the dismal outcome.

Harm from overuse is not merely harm to the patient and family (providing risky or painful procedures that have little to no benefit - principle of beneficence and non-maleficense) society (cost, burden - from the principle of justice), but also may harm staff: physicians, nurses, other caregivers. In some settings: test after test, procedure following procedure in a patient with progressive end-stage disease who remains minimally interactive but winces to the interventions. One physician ordering this, while others are the ones doing it, protesting as they do, questioning the rationale and the harm with perceived little-to-no benefit, as nurses pick up the pieces. Nurses, resident physicians, and attending physicians have spoken to me of their sense of struggle, their inclination to avoid patients to whom they are "forced" to provide care they see as not having benefit but instead harm. For the ordering physician, the drive may indeed be patient preference, or perhaps that personal and professional commitment to valuing life and fighting of its enemy - i.e. death.

In our field we weave through cultures of medicine and preferences of patients, families and even clinicians that represent a wide range of perspectives, even on the value of prognosticating stating that maybe this patient will be the one to beat the odds and question the role of epidemiology of prognostication or EBM in prognosis. (Thank you Drew for your review of the article on Prognosis in the Neuro ICU.)

One of our roles as the palliative care clinician or team-member, is to navigate in this world of uncertainty. To support families struggling as they see the patient slowly, ever-so-slowly die as more and more is done to prevent or slow down the death per their request, while supporting the healthcare team who struggles with the procedures that seem to have little to offer, while supporting and watching with the physician who is also doing all he or she can to keep this person, their patient alive - as he or she believes we can clinicians are called to do.

I think physicians fall in all areas of believe around these topics - influenced, of course, by personal values and education. I remember when I was a medical student meeting another med student at a wedding. On his way to the wedding he had seen a massive accident with multiple deaths. He told me that there he met our shared enemy - death. At that moment, I began to believe that there are two general places where people fall - on one end of the extreme: death the enemy, on the other, suffering the enemy. At risk of influencing this readership, I will share that in my mind, I believe that our call as physicians (and nurses, and all in healthcare field) is to prevent premature or preventable death, but the primary role - as Eric Cassell so eloquently wrote in numerous articles, is to alleviate suffering - in all its manifestations.

Particularly in our field of palliative medicine, we walk on this ledge of uncertainty, of differing opinion and values, lending strength and comfort to any who suffer due to the illness and complications of treatment. We are also called to lend our expertise in preventing medical error - whether overtreatment, undertreatment, or mistreatment - in the time of life when patients, their families, and their clinicians often most struggle with defining what this means. Even when we personally may disagree with the choices made, our role is to lend strength, to practice non-abandonement, and - as Dr. Epstein was known to do - to "fluff the pillows" for patients and even to colleagues whether .

Friday, May 7, 2010 by Unknown ·

Wednesday, May 5, 2010

Prognosis in Neuro ICU Patients

A couple articles about prognosis in seriously ill brain injuries in recent Neurology (see subsequent post for the second). 

First is a prospective study about the accuracy of neurointensivist's prediction of neurologic prognosis for critically ill patients in a neuro ICU. It is a single institution study (Standford), in which all neuro ICU patients (being cared for by one of 5 neurointensivists) who were mechanically ventilated for over 72 hours were eligible. The neurointensivists were asked to predict the patient's 6 month functional outcome (using a modified Rankin score: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out usual duties and activities; 2 = slight disability, unable to carry out all previous activities but able to look after own affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assist; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; 6 = death. Patients or surrogates received a 6 month follow-up phone interview. For this study the authors dichotomized predicted and actual outcomes into 'good' and 'poor.' 'Poor' was a Rankin of 4-6. A prediction was considered to be correct if the qualitative range (ie 'good' vs 'poor') was correct.

The neurointensivists were were relatively young (mean years in practice after fellowship 2 years), perhaps reflecting the relatively recent rise of their practice as a discreet discipline. 144 patients were enrolled: median length of stay in ICU 12 days; median time to prediction of prognosis was 4 days from ICU admission; 50% of patients had bleeds (intracranial or subarachnoid); 18% ischemic strokes; 12% status epilepticus.  50% of the patients died by 6 months - 71% of those after a decision to discontinue life prolonging treatments.  The median Rankin at 6 months (of the survivors) was 3, and 85% of survivors were available for follow-up.

Overall, the neurointensivists predicted a lower percentage of poor outcomes at 6 months than what actually occured: 54% vs 68% (with over half of those poor outcomes being death). However their predictions (good vs. poor) were accurate in 80% of cases, although more accurate when they predicted a poor outcome (94% of the cases in which they predicted poor outcomes were accurate vs 63% of the cases in which they predicted good outcomes). Excluding patients for whom life support was discontinued didn't change the accuracy of predictions by much (87% accurate for poor outcome predictions vs. 73% for good outcome predictions).

They did a few subanalyses. One of them looked at exact agreement in predicted and actual Rankin score - this exact agreement was only 43% with 74% of incorrect predictions being over-optimistic. This effect went away once patients who died were excluded. In addition to asking the docs to predict prognosis, they also asked them whether life-support should be discontinued assuming the patient's wishes were unknown. They don't disclose whether or not that was communicated to families (one assumes that within the study protocol it was not - this was just an assessment of the treating doc's opinion). They do note that 'withdrawal of care' was recommended in 27 patients and it was instituted in 23 of these - it's unclear from the paper but I think they mean that in these 27 patients the docs actually communicated a recommendation to withdraw life prolonging treatments in those 27 patients. 

Besides the obvious major limitations with the paper (single institution, only 5 docs), I have a few thoughts about this.  In reading the discussion at the end you get the sense that the authors aren't really sure whether to conclude that these docs were doing a good job of prognostication or not.  I myself think this is basically excellent.  For these patients, especially those with poor prognoses, these docs were quite accurate.  ~90% is very good for any sort of 6 months prediction, and I can't think of a prognostic index for a similar patient population which is that good (but please comment if you do).  At least when it comes to critically ill patients there has been some talk recently that docs tend to over-estimate how poorly patients will do (e.g. COPD patients being admitted to an ICU) and at least this study/in this population this does not seem to be the case.  

One can't of course argue from this 'trust your intensivist' given the limited scope of this study; it is a reminder however of how clinicians' global assessment remains one of the best prognostic 'tools' out there (which is as much a reflection of how weak our tools are as it is how 'good' clinicians are; plus the eternal folly of thinking that it's even possible to predict the future with anymore accuracy than what they were measuring in this study). 

There has also been an ongoing discussion in the neurologic literature about prognostication, and the concern that 'treatment-limiting' decisions are skewing the data.  That is -  in some of these studies the actual outcomes are so bad not because a certain number of the patients wouldn't have recovered but because families made decisions to limit life-prolonging treatments due to their expectation of an unacceptable outcome.  These authors tried to probe that question by looking only at patients for whom no decision to withdraw life-support was made, and the accuracy of the docs' predictions remained excellent (for predictions of poor outcomes at least).  That said, some of the lack of this effect is due to the dichotomous outcomes:  neurointensivist predicted Rankin 4, family decide to discontinue life-prolonging treatments, patient died.  For this analysis, the Rankin 4 and death are treated as the same outcome, even though the neurointensivist didn't think the patient would die from their injury....

Stepping back from those issues, one of the aspects of this sort of literature which troubles me is the clumping of a relatively heterogeneous group of patients together (into the 'poor outcome' group).  This is not to argue that ending up with a Rankin score of 4 or 5 is a 'good' outcome, but that that clumping may not have the discrimination our families need in order to make decisions about what to do.  There's no mention of communication ability, and in fact either Rankin 4 or 5 could describe a completely cognitively intact quadriplegic who needs however 24/7 care.  Ask your local quadriplegic: many of them are perfectly fine with their 'limitations.'  Given the sort of injuries described in these patients it's unlikely that really anyone ended up quadriplegic, but it's the lack of measurement of cognitive and communication ability that gives me pause about these sorts of scales.  Presumably most, if not the vast majority, of patients in this study who ended up at Rankin 4, 5 had cognitive impairments, but it's just not measured or described here.  While I do meet families all the time for whom physical disabilities are sufficient ('Dad said 'never let me end up in a nursing home - no matter what.'' 'If he couldn't get himself to the bathroom, he wouldn't want to go through any of this.'), just as often families 'criteria' center around cognition, and communication - the ability to recognize and interact with family, etc.  And understandably so.  The reverse of this of course are there are patients for whom a Rankin 3 would be unacceptable, even though it's measured here as a 'good outcome.'  (In fact in one of the secondary measures of this study they asked the survivors who could communicate how they'd rate their quality of life and 38% of those with Rankin 0-3 rated it as 'fair or poor.'  That's a different measure of course than whether they think it was a good thing that they lived!)

Finally, what I really wanted to know half-way through reading this, is what these docs actually said to their patients' families.  Undoubtedly it was not that the patient would end up with disabilities placing them as a Rankin 5.  The prognosis we formulate to ourselves may not be the one we disclose, and I've seen docs who tell me 'this patient is never going to get any better' tell families 'it's impossible to know.'  I've also seen the opposite - patients who (at least in my opinion) had very indeterminate prognoses - probably bad, but I also wouldn't have been surprised if they did ok - in which language loaded with words like 'never' were used to describe their future (never walk again, never be able to feed herself). 

Image from Wikipedia.
ResearchBlogging.orgFinley Caulfield A, Gabler L, Lansberg MG, Eyngorn I, Mlynash M, Buckwalter MS, Venkatasubramanian C, & Wijman CA (2010). Outcome prediction in mechanically ventilated neurologic patients by junior neurointensivists. Neurology, 74 (14), 1096-101 PMID: 20368630

Wednesday, May 5, 2010 by Drew Rosielle MD ·

Hypothermia, SSEPs, and Prognosis

As a follow up for today's top-post, some more floundering about prognosis in brain injuries, and yes this one is for the progno-wonks out there. 

Neurology also has an article looking at the prognostic importance of bilateral absence of the N20 response of median nerve somatosensory evoked potentials for patients with hypoxic-ischemic encephalopathy (anoxic brain injury) who have undergone therapeutic hypothermia. 

Some background (although this NEJM review is the best place to go for a quick summary) on why I'm even mentioning this.  Absence of the N20 response of median nerve SSEPs more than 24 hours after a cardiac arrest has been reported in multiple studies to indicate a uniformly poor neurologic prognosis (comatose patients after cardiac arrest who have these SSEP findings have uniformly poor outcomes), and it's become a well-established marker (among several) to identify patients with essentially no chance of a good neurologic recovery (see today's other post for more about 'good neurologic recovery'). 

In the last several years therapeutic hypothermia has been widely adopted for patients who survive initial resuscitative efforts after an arrest (essentially patients are cooled to ~32 deg. C for 24 hours - this is thought to attenuate some of the brain damage that occurs during/after an arrest and has been shown to improve neurologic recovery).  Most of the research on prognosis for comatose patients after cardiac arrest was done before hypothermia was adopted, so there's some concern that previously established prognostic criteria are no longer valid (or at least not as powerfully predictive).   See for instance this study, which attempts to investigate whether absent SSEPs still invariably predicts a poor outcome for patients who undergo hypothermia (it indicates they do).

The current article, which is a retrospective case series from a single German ICU in which they looked at all patients who underwent hypothermia and had SSEP measurement performed, presents data about two patients who suggest this isn't necessarily the case.  Of 36 patients with bilateral absent N20 responses, a 43 year old (who had absent N20 responses at day 3 after his arrest) went on to have a normal cognitive recovery (so much so that apparently he went on to resume drinking and they were able to measure SSEPs 18 months later when he was hospitalized and in alcohol withdrawal - a very sad detail they shared - he had recovered N20 responses at that measurement).  (They also report on a patient who had abnormal/barely detectable N20 responses who went on to have a normal cognitive recovery).

35 out of 36 patients with absent N20s did not recover, despite hypothermia.  (While that makes 97%, one should be cautious; this is a retrospective case series and it's inappropriate to establish event rates from this study design.)  One did.

My suspicion is that we will be seeing similar findings for other established 'uniformly bad' prognostic indicators in anoxic injuries.  It always seemed, in a perverse way, too good to be true - that there were not just one but several findings which implied, based on all the available research, that if a patient had one or more of them they have essentially no chance of recovery.  It will not be that these markers are worthless - they still will be (and this series supports it) - evidence of devastating injury with slim chance of recovery, but not some sort of 100%/clean cut/no questions asked evidence.  The world's too messy for that, especially when it comes to brain injuries.

I'm curious as to whether anyone is seeing this used in clinical practice, and having conversations with colleagues about the effect of  hypothermia protocols on how and when to examine patients and perform tests (for prognostic purposes), and how and when to talk with families about what we are concluding?

ResearchBlogging.orgLeithner C, Ploner CJ, Hasper D, & Storm C (2010). Does hypothermia influence the predictive value of bilateral absent N20 after cardiac arrest? Neurology, 74 (12), 965-9 PMID: 20308680

by Drew Rosielle MD ·

Palliative Care Grand Rounds May 2010: Medical Futility

Palliative Care Grand Rounds is up at the greatest blog written by a law professor about medical ethics and decision making with life threatening illness, "Medical Futility" by Thaddeus Pope, J.D., Ph.D.  He cranks out a ton of great information on his blog featuring very interesting court cases.  His grand rounds post is a classic covering many great hospice and palliative care blogs.

Go comment over at Medical Futility and seek out the other blog posts featured in Grand Rounds.  Share it with your friends on Facebook, Twitter and your IDT.

As for Thaddeus' blog, if you EVER give a talk on Medical Futility or Ethics and DON'T reference/highlight his blog, I won't consider you to be an expert who knows what they are talking about.  (Redundant last point, but worth it.)

by Christian Sinclair ·

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