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A blog about recent hospice and palliative medicine research, publications, and news, aimed at health care professionals.
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by Christian Sinclair, MD in Pallimed: a Hospice & Palliative Medicine Blog
This week the New York Times talks about the rising costs of providing hospice care in America with a particularly juicy hook about a nearly $25 million whistle-blower settlement against an Alabama hospice. From there it talks about the focus of some hospices to seek patients who are likely to have longer lengths of stay, like dementia and stroke. One research analyst even goes as far to say "It's a lucrative business, at least under the current reimbursement system." They also feature an inspector general report that documentation for hospice patients in nursing homes was lacking.
Not a good start from a newspaper that has actually been quite kind to hospice in the past. The rest of the article goes on to discuss the various fixes including every hospice medical director's new task: the face to face certification visit. (We have not yet dedicated a blog post to face-to-face home visits for certification, but one is in the works so we can has that out at a later date.)
But the article leaves out a lot and I feel it is pretty one-sided. Apparently Don Schumacher, head of the NHPCO, has found some flaws in the article too as he is communicating with the NYT editorial board. There is relatively little about potential changes to the payment structure to focus greater reimbursement during the first 7 and last 7 days of service when need is thought to be the greatest. The article does not talk about or reference the article by another NYT reporter from 2007 with the title "In Hospice Care, Longer Lives Mean Money Lost" about the aggregate cap. Nor did it quote the Duke Study that found hospice care saved Medicare an average of $2,300 per beneficiary (OPEN ACCESS PDF), calling hospice “a rare situation whereby something that improves quality of life also appears to reduce costs.” Yeah, they missed some stuff.
Which is not to say we need to look closely at fraud issues. Good oversight is important for a multi-billion part of the health care system, but we have to realize that every problem started out as the solution to another problem. The system is perfectly designed for the outcomes it gets. So let your legislators know about what hospice means to you. Talk to your organizations and actually answer the advocacy emails that moment instead of promising to get back to them later.
As the NYT usually does there is no ability to comment on the article but there is a linked blog post at "The New Old Age" which allows for comments. As of this writing there are 64 comments. Here are a few I thought stood out:
It is amusing and annoying to be complaining about the costs of hospice care, when in fact hospice patients are forgoing the ER visits, hospitalizations, specialists' visits, procedures, and many medications that Medicare would instead be covering if not for the patient making a decision to pursue comfort care only. So, what was the cost SAVINGS to Medicare by having these people on hospice, even though they stayed on longer than usual? Alot.- ras
I don't even believe desperate old people are gaming the system via hospice. But if they are, it's because this country has utterly failed them, taken payroll deductions for a lifetime in exchange for medical care in old age, and then only given the kind of medical care 70-year-olds need, not 90-year-olds. Shame on us. - jane gross
Hospice is a critical service that is offered to all. It is necessary, compassionate, and well run. So, if we discontinue it or cut services, we are a nation without merit and compassion. We will not only be third world, we should not be in this world. - Julie
The article disingenuously ignores this broader care issue while it exploits an example of an Alzheimer's patient. Please, NY Times, get perspective on the bigger picture. Help the US face its fear of dementia that keeps us in denial and prevents us from preparing to fight a huge healthcare tidal wave. Take more leadership and make a difference. - Suzanne
So it's too expensive to have an MD check on hospice patients once every six months? The health care industry has become even more shamelessly and barbaricly greedy than I thought. - Cowboy Marine
TAYLOR JR, D., OSTERMANN, J., VANHOUTVEN, C., TULSKY, J., & STEINHAUSER, K. (2007). What length of hospice use maximizes reduction in medical expenditures near death in the US Medicare program? Social Science and Medicine, 65 (7), 1466-1478 DOI: 10.1016/j.socscimed.2007.05.028
Photo credit: Flickr user: castle79
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TAYLORJR, D., OSTERMANN, J., VANHOUTVEN, C., TULSKY, J., & STEINHAUSER, K. (2007) What length of hospice use maximizes reduction in medical expenditures near death in the US Medicare program?. Social Science , 65(7), 1466-1478. DOI: 10.1016/j.socscimed.2007.05.028
by Brian McMichael, M.D. in Pallimed: a Hospice & Palliative Medicine Blog
In this month's issue of the Mayo Clinic Proceedings is the first article reporting on a case series with inclusion of palliative medicine (PM) consultations as a routine, integrated part of pre-op or early post-op care for patients receiving ventricular assist device (VAD) as destination therapy (DT). Both Drew and Holly have posted previously on Pallimed about VAD DT.
The Mayo Clinic is a nationally and internationally recognized tertiary and quaternary referral center. As such, beyond the ordinarily sick patients, the Mayo Clinic treats some extremely sick patients, patients who come to be cured, as well as patients who are a mixture of both. The Mayo Clinic recently performed its 100th heart translpant, and they having been implanting VADs as both bridge therapy and as DT. As such, they offer sub-sub-specialty training in Mechanical Circulatory Support and Cardiac Transplantation.
Problematic situations and ethical quandries arise in these environments, given the complexity of the patients, the psycho-social stresses on patients and family members, the array of complications as well the spectrum of outcomes, including "destination nowhere," – a functioning VAD in an otherwise moribund patient. In response, a process of interdisciplinary dialogue at the Mayo Clinic concluded that it would be beneficial to offer PM consultations as a part of standard multidiscipinary care of these patients.
In this consecutive case series, 19 VAD implantations were performed, over a 50-week period. 13 patients (68%) received PM consultations, consisting of an initial intervention of a psychosocial evaluation by a social worker as well as a review of goals of care and advance care plans with by PM clinicians, with post-op follow-up. Most PM consultations were proactive and pre-op. The advantage of proactive PM consultations in having already established familiarity and rapport among the patient, family and the PM team was highlighted.
The case series is summarized with patient characteristics, PM consultation status, survival and assessment of end-of-life trajectory. During this period, 5 of these patients died, of which 4 had had PM consultations, 3 had completed a pre-VAD advanced directive. 6 illustrative cases are discussed.
The writers do a nice job of describing their extensive advance care planning process unique to this patient population. They refer to this product as their "preparedness plan," which goes well above and beyond traditional advance directives. The preparedness plan assisted patients and families in thinking about goals and expectations, post-op rehabilitation, psychosocial, spiritual/religious and financial considerations, caregiving concerns, QOL determinants, complications specific to VAD and DT, perioperative morbidity and mortality and ethical issues that may affect clinical DT outcomes. When adverse events occurred, the PM team assisted with preparedness plan implementation, symptom management, and family- and patient-centered support.
Some Thoughts
I noticed that as the series progressed there appeared to be emerging trends of decreasing frequency of PM consultations, more post-op PM consultations, and decreasing frequency of pre-VAD advanced directives (presumably the patients lacking a PM consultation also lacked the more thorough and arguably more useful, personalized preparedness plan). The post-op mortality improved as the series progressed as well. Previous to this endeavor no patients DT patients at Mayo received proactive PM consultations, and only 14% received any PM consultation. This is a small sample and the signal-to-noise ratio is high. Nonetheless the pattern made me wonder if this represents post-conversion, systemic back-sliding, although this is expressly not reflected in the discussion.
Swetz KM, Freeman MR, Abouezzeddine OF, Carter KA, Boilson BA, Ottenberg AL, Park SJ, & Mueller PS (2011). Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy. Mayo Clinic proceedings. Mayo Clinic, 86 (6), 493-500 PMID: 21628614
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Swetz KM, Freeman MR, Abouezzeddine OF, Carter KA, Boilson BA, Ottenberg AL, Park SJ, & Mueller PS. (2011) Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy. Mayo Clinic proceedings. Mayo Clinic, 86(6), 493-500. PMID: 21628614
by Drew Rosielle MD in Pallimed: a Hospice & Palliative Medicine Blog
Journal of Supportive Oncology recently published the results of a pilot trial of an evidence-based decision aid for patients with metastatic cancer (free full-text available here, as always with JSO papers).
This was a small, single cancer center study of 27 patients with metastatic solid tumors (mean age 63 years, 56% African American, with a mixture of metastatic breast, colon, lung, and hormone refractory prostate cancers). All patients at the center (it's not clear how the patients were identified - if this was a consecutive vs a convenience sample, etc.) who were potentially eligible were referred to the study after approval of their oncologist. The primary oncologist or oncology nurse could decline allowing the patient being enrolled due to concerns the patient would have 'great emotional difficulty' if they received straight-forward prognostic information. While they note they didn't measure this, they estimated about 10% of eligible patients were not approached at the request of their oncologist.
Patients were introduced to the study, and given screening questions about whether they actually wanted to hear full prognostic information (1/27 declined full information - they note that patient started the aid then stopped it) and a 'pretest' to determine their current estimations of having a chance of cure and treatment outcomes specific to their type of cancer. They were then administered the decision aid and their knowledge about chances of cure and estimation of the effect of treatment was measured again. Hopefulness was measured before and afterwards on a hope scale. And yes, thankfully, this was IRB approved.
There is an example of the decision aid in the appendix available online. For instance, the 'Lung Cancer 2nd Line Chemotherapy' aid gives information along the lines of:
[2nd line chemotherapy] improves the chance of being alive at 1 year by 18 out of a 100 people. With chemotherapy, 37 of 100 people were alive at one year. Without chemotherapy, 11 of 100 were alive. ...In this setting, there is no chance of cure. It also gives information about side effects, effects on pain and quality of life, and suggestions patients should address advance directives, code status, values and care goals. The image above is an example from the lung cancer aid.
All patients said they wanted full information (as above, one stopped mid-intervention; they note that that patient's hopefulness did not change). Patients overwhelmingly overestimated the chances of cure of a patient with metastatic cancer (which, for the type of cancers discussed, which all the patients had, was zero): 52% (only 41% indicated accurately that their cancer was incurable). Patients grossly overestimated their chances of the cancer shrinking by half, as well as estimated survival (2/3 initially said over 3 years). The decision aid itself had some impact (the numbers here are too small to measure statistical significance): most strongly in patient's understanding that their cancer is not curable (it went down to 30% after the intervention). Generally, the group's time-based estimations became shorter (=more accurate) by a little. Other misconceptions (chance of the cancer shrinking by half with chemotherapy, chance of cancer symptoms being improved) didn't seem to change with the intervention: they remained over-optimistic.
Both objectively (by the hope index) and subjectively (by the researcher's anecdotal reports), patients were not distressed, upset, and did not 'lose hope' by being told accurate prognostic information. This is not to say that all patients were all smiles and peaches about the news. The paper gives sampling of patients comments about the intervention, which are illuminating. Many seemed grateful or neutral (already knew it). Many seemed to acknowledge they were told prognoses that were shorter than what they were anticipating but were perfectly happy to ignore that information, and assume it doesn't apply to them ("There were some things I didn't know - I didn't know about the 1-2 years - I'm not going to accept it though - I'm planning on more.") A few seemed upset ("...it's a bummer") - after all they were given upsetting news - but as before this did not translate into changes in the hope index, etc. And, of course, one expressed gratitude for gaining knowledge which will help them plan the timing of When To Party. 25 patients indicated afterwards they thought the information was helpful.
Reflections on this, ignoring for now discussions of the limitations of this small, uncontrolled pilot trial, etc:
This is further (Do we need more? Yes I think so!) data supporting the long-held wisdom that we (clinicians, docs) generally have little power to take away hope from our patients, at least via sharing knowledge, information with our patients about what we expect. It's really, really tough to do. Hope, like religious faith, doesn't spring from a sober assessment of one's material being and surroundings. These patients were given flat out frank information: 'no chance of cure' and 30% of them came out of there counting on one nonetheless. Anyway: let's beat the drum that routine, straight-forward prognostic disclosure should be the standard of care for all patients with advanced illness.
That point, plus, gee whiz, it's tough to get patients to understand what seems like very straight-forward information. Never, ever, underestimate one's ability to mystify and fail to communicate effectively with our patients. I've been a grown up palliative doc for 5 years now and still impress myself with my ability to mystify my patients. So much so that I've begun to stop considering that some sort of 'screw up' and instead just assume it's happening and endeavor to double, triple check things which I think are particularly important.
Part of this makes me wonder what really matters - what should our outcome be because accurate numeric understanding is probably unobtainable for a substantial minority of our patients - should we care about this? Ignoring patient characteristics (of which we have no control), what is it we say, do, share, disclose, don't disclose, etc with our patients which actually improves the quality of their care and the sanity of their medical decision making? Data, and patient knowledge are some part of this (and clearly there is a wide and measurable gap there), but of course so are other things - relationship/trust, clinician willingness to not recommend treatments unlikely to benefit a patient. Maybe it's patient belief about what will happen to them, and, like hope, we may have so little control over that. Maybe of course it's variable, individual, and fluctuates over time, and a young doc's desire to Understand These Things Systematically needs to yield to the wisdom of sitting at the bedside, and listening to an individual patient's story.
I meant that, but nonetheless I'll move on from my embarrassing attempts to sound wise and ask - does anyone know of another study which involves, as part of the intervention, effectively telling patients who think they can get cured that their cancer is incurable? I'm not concluding there haven't been other studies which do this, I just can't think of any. Is this a milestone or been done before? I know some of the authors of the study read the blog, so if you read this guys, let us know in the comments if this was at all challenging with the IRB or not. The Coping With Cancer Study very studiously did not disclose prognostic information to patients per their protocol (as best I understand it): patient's prognostic understanding was measured however. One of the important reasons to do this sort of pilot intervention as publishable research, not just a QI project, is to demonstrate in the pilot setting that this sort of intervention is safe. The safety data from this, and hopefully follow-up studies, plus the 'effectiveness data' from the CWCS (ie prognostic awareness** is associated with improved EOL & bereavement outcomes) could be used to argue for a larger trial of prognostic disclosure in cancer patients.
**That's an oversimplification of what the CWCS was measuring, but now is not the time to belabor that.
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Smith TJ, Dow LA, Virago EA, Khatcheressian J, Matsuyama R, & Lyckholm LJ. (2011) A pilot trial of decision aids to give truthful prognostic and treatment information to chemotherapy patients with advanced cancer. The Journal of Supportive Oncology, 9(2), 79-86. PMID: 21542415
by Suzana Makowski MD in Pallimed: a Hospice & Palliative Medicine Blog
Last year, about this time, the New England Journal of Medicine (NEJM) rocked the world of Oncologists and Palliative Care Specialists, publishing an article about how early palliative care interventions not only add to quality of life, but also length of life. This year, NEJM published an equally provocative piece, a "Sounding Board" article that addresses the need to curve the cost of cancer care. Get ready Palliative Care colleagues to respond once again.
The anticipated growth in cost of cancer care is hard to fathom: rising from $104 billion in 2006, to possibly $173 billion in 2020. That is more than many countries entire GDP - (Indonesia's GDP is $174 billion, Thailand's is $132 billion.) To prevent bankrupting the US healthcare system, Oncologists will face the challenge of how to curve this cost curve while still providing optimal care for their patients. Palliative Care is sure to play a major role in this shift.
Thomas Smith and Bruce Hillner propose some changes to the current model of care:
Changing the Behavior of Oncologists:
Shift surveillance testing from routine to evidence-driven (and symptom driven);
Limit second and third line chemotherapies for metastatic solid-tumor disease to sequential monotherapies;
Consider chemotherapy only for patients with high performance status (a-la-ECOG approach) - of course, with exceptions for patients with untreated, highly chemo-sensative disease, or with poor performance due to unrelated issues.
Decrease use of white-cell-stimulating factors, and instead lower dose of chemotherapy in metastatic solid tumor treatments;
When chemotherapy success is unlikely, symptom directed care (i.e. Palliative Care) should be provided. In other words, when cancer progresses despite three consecutive chemotherapy regimens, except for patients wishing to enroll in clinical trials, therapeutic intervention should shift to symptom-directed, non-chemotherapy care (aka Palliative Care Team).
Changing Attitudes and Practice:
Acknowledge that these practice changes are needed, that we may be at risk of having the cost may drive out the ability to care;
Have end-of-life discussions earlier - even though they are hard. Data now shows that while these discussions lead to a decrease the patients' severity of depression and anxiety, fewer ventilator-dependent deaths, and decreased aggressiveness of care, they also improves the health and well-being of surviving caregivers. Go figure, these conversations have a role in preventing illness and promoting health (in survivors). Despite this, in a recent study, few patients admitted to hospital with a cancer diagnosis had a discussion about advanced care planning or how they wished to be cared for at the end of life. Less than half of patients had discussed hospice with their physicians two months prior to their death.
Expectations of outcomes need to be more realistic for patient and physician alike. We have known the data of how physicians as a whole are overly optimistic when it comes to prognostication. Well, because information is obtained from their physicians, patients tend to be as well. This influences decision-making and has implications for the quality of informed consent. After all, if I were to believe that an intervention had a chance of curing me, when in fact it may simply add some weeks or perhaps months, would my decision to forgo time with family and friends for hospitalizations and the hope for a cure change? The article suggests that many oncologists lack the skills of assessing prognosis and negotiating transitions of care from curative chemotherapy to palliative non-chemotherapy. Palliative care clinicians may be taking an increased role in facilitating these conversations and training the next generation of oncologists in these conversations.
Compensation for cognitive services needs to be valued more, as compared with chemotherapy. Our current system now relies on over 50% of oncology compensation supported by chemotherapy sales. The current system does not adequately reimburse oncologists for some of their most important work: referrals to clinical trials, counseling about advanced-care-planning and code status, and other patient-centered and patient/family-valued work that is time-consuming. Innovations in healthcare delivery models to shift this paradigm may help sustain the workforce and improve patient care.
Earlier and more thorough integration of palliative care into the overall cancer care is needed. As the author's so aptly put it, "Improved coordination of care that lets patients choose their course while not requiring an artificial switch from usual care to hospice will be a triple win: better quality and quantity of life plus meaningful cost savings."
The need for cost-effectiveness studies as new drugs are rolled out.
So, how are we going to respond?
What practice changes are you implementing or planning to implement?
From my perspective, these suggestions may help define practice guidelines for when and how to integrate palliative care, perhaps with automated referrals or integration of assessment into multi-disciplinary clinics for patients with metastatic solid tumors. I agree with the authors' statement that more fluid and early integration with eliminate the either-or mentality, the fear of abandonment, and eliminate the notion of "death panels." Instead, the often tainted name of our specialty may take on a new meaning, one of coordinated, concomitant care, that assures shared decision-making and good symptom management.
I for one, hope that this important essay influences the role that palliative care should take in the future of quality care, ACOs, and the healthcare debate.
Smith TJ, & Hillner BE (2011). Bending the cost curve in cancer care. The New England Journal of Medicine, 364 (21), 2060-5 PMID: 21612477
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Smith TJ, & Hillner BE. (2011) Bending the cost curve in cancer care. The New England Journal of Medicine, 364(21), 2060-5. PMID: 21612477
by Drew Rosielle MD in Pallimed: a Hospice & Palliative Medicine Blog
A few recent studies about mitigating chemotherapy complications have caught my eye and bear mentioning.
The first couple are about neurotoxic complications of chemotherapy. I've been seeing a lot of patients who have had quite severe problems from (usually chronic) peripheral neuropathies related to their chemotherapy. At least occasionally these complications are devastating - leading to very difficult to manage, disabling pain. I haven't seen this confirmed in the literature, not that I've gone looking, but my sense is that these sorts of complications are becoming more and more common, perhaps in part to expanding use of taxane-based chemotherapy, and other newer neuropathic agents like bortezomib. Despite this, there are no proven (ie, in well designed, controlled trials) analgesic therapies for painful chemotherapy associated neuropathies, at least the last time I looked at the literature (when I was editing this Fast Fact) - I haven't seen anything major come out since, but please leave comments if you know of controlled studies I'm missing.
Annals of Oncology has the results of a randomized, double blinded study of venlafaxine for the prevention of oxaliplatin neurotoxicity. The patients (n=54, median age 67 years, most with metastatic colorectal cancer) all had experienced acute oxaliplatin neurotoxicity in the past. They were randomized to 50mg of venlafaxine 1 hour prior to oxaliplatin infusion, followed by 37.5mg of venlafaxine extended release bid on days 2-11 after chemotherapy (vs matching placebo). This same regimen was re-started for subsequent oxaliplatin cycles - they don't talk about how many cycles on average patients ended up receiving venlafaxine/placebo. Primary outcome was the fraction of patients who had complete prevention of acute neuropathy - they looked at several secondary outcomes including chronic neuropathy symptoms.
Venlafaxine came out looking very good. 31% of patients experienced no acute neuropathy on venlafaxine, vs 5% with placebo. For those who did have symptoms, a greater proportion on venlafaxine reported greated than 50% relief in their symptoms (69% vs 26%) compared to placebo. Notably, they asked patients 3 months after the cessation of oxalaplatin-based chemotherapy; fewer patients who had received venlafaxine reported serious persistent neuropathic symptoms (0% vs 33%). All these differences achieved statistical significance (ie P less than 0.05, using 2 sided tests). Venlafaxine had more immediate side effects (nausea, vomiting, asthenia) compared to placebo. They did not measure unblinding effects, although they did mention they had difficulty meeting accrual because very quickly clinicians began perceiving venlafaxine as effective and stopped being comfortable referring patients to the study. Drop outs were similar between groups.
To me this is convincing evidence that venlafaxine reduces the incidence and severity of oxalaplatin acute neuropathy, as well as prevents and attenuates its chronic neuropathy, at a modest price of its immediate side effects. This is a small study, but I've become, lately, more of a fan of well designed small symptom studies. You want symptom interventions to be immediately effective, have a wide therapeutic index, and have very low NNTs (less than 5 patients). If you need 200 patients to show a marginal benefit it's probably not a highly effective therapy (cf the vertebroplasty trials - there was a trend towards effectiveness in one of the trials which may be 'real' - however if you need even more people to demonstrate a marginal benefit I just can't see how this is a great thing at least in the population in which it was studied).
The caveats here are to remember this is only about the prevention of oxalaplatin neurotoxicity. The physiology of neurotoxicity from other agents probably is different, and one can't conclude that because agent X prevents neuropathy with chemo Y, that it is generally effective to treat/ameliorate the pain from an established neuropathy from chemo Z. Of course it might, maybe for some patients, we don't know, and I'll probably continue to cycle through my cadre of analgesics and adjuvants, systemic and topical, hoping that something works which, you know, sometimes it does. What are others doing? Any luck with topical agents?
Roxy Paine: 'Dendroid Drawings & Maquettes @ James Cohan
The other novel intervention, which has some promise as a non-specific palliative intervention for chemotherapy induced peripheral neuropathy, is a cutaneous electrostimulation device ('a scrambler' device - not TENS, but in that ballpark). This is the only (unblinded, uncontrolled, pilot) study of it I've seen, but the magnitude of the results are certainly compelling enough, and it seemed to be effective for multiple varieties of chemotherapy induced peripheral neuropathy, that one is looking forward to the controlled trials.
The other study I noted about acute chemo complications is this one from Journal of Clinical Oncology about the natural history of paclitaxel-associated acute pain syndrome. This was something I've seen clinically now and then, but appreciated a chance of reviewing it more in depth. About 3/5 of patients reported worsening pain with/after paclitaxel dosing, which peaked on day 4. Development of the acute pain syndrome , which includes diffuse body achiness/myalgias as well as sensory symptoms like tingling & numbness, seemed to predict developing a chronic peripheral neuropathy. The authors also conclude that the characteristics of the pain syndrome argue that it is a neuropathy (acute neurotoxic symptoms) despite its common manifestation of whole body myalgias which could also suggest a myopathy/myositis.
And finally, gabapentin was studied in a randomized, blinded, placebo controlled trial in the prevention of chemotherapy induced nausea and vomiting (added to ondansetron, dexamethasone, and ranitidine - this was a Brazilian-based trial group). Patients received gabapentin for 5 days before and 5 days after chemotherapy (or placebo). Patients receiving gabapentin had lower rates of both acute and delayed nausea & vomiting. I've never used gabapentin for nausea (either its prevention or treatment): anyone have any experience with this?
J. P. Durand, G. Deplanque, V. Montheil, J. M. Gornet, F. Scotte, O. Mir, A. Cessot, R. Coriat, E. Raymond, E. Mitry, P. Herait, Y. Yataghene, and F. Goldwasser (2011). Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity: results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial Journal of Clinical Oncology : 10.1093/annonc/mdr045
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J. P. Durand, G. Deplanque, V. Montheil, J. M. Gornet, F. Scotte, O. Mir, A. Cessot, R. Coriat, E. Raymond, E. Mitry, P. Herait, Y. Yataghene, and F. Goldwasser. (2011) Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity: results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial. Journal of Clinical Oncology. info:/10.1093/annonc/mdr045
Smith TJ, Coyne PJ, Parker GL, Dodson P, & Ramakrishnan V. (2010) Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy. Journal of pain and symptom management, 40(6), 883-91. PMID: 20813492
Loprinzi, C., Reeves, B., Dakhil, S., Sloan, J., Wolf, S., Burger, K., Kamal, A., Le-Lindqwister, N., Soori, G., Jaslowski, A.... (2011) Natural History of Paclitaxel-Associated Acute Pain Syndrome: Prospective Cohort Study NCCTG N08C1. Journal of Clinical Oncology, 29(11), 1472-1478. DOI: 10.1200/JCO.2010.33.0308
Cruz, F., Iracema Gomes Cubero, D., Taranto, P., Lerner, T., Lera, A., Costa Miranda, M., Cunha Vieira, M., Souza Fêde, �., Schindler, F., Carrasco, M.... (2011) Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study. Supportive Care in Cancer. DOI: 10.1007/s00520-011-1138-4
by Thomas Quinn, APRN, CHPN in Pallimed: a Hospice & Palliative Medicine Blog
An unusual and sobering study on the state of the “palliative oncology literature” has recently been published online. Searching 6 bibliographic databases, this group from M.D. Anderson undertook a massive review of the palliative oncology literature, comparing from 2004 and 2009 the number of articles, proportion of all oncology articles, topics, and study designs.
The paper begins by highlighting the familiar barriers to palliative care research: limited research funding, few personnel trained in palliative care research, difficulty in recruiting and retaining patients/subjects, methodologic issues. They also pointed out that there still isn’t a consensus taxonomy and classification system for palliative care literature (can you tell they had professional research librarians on the teams?). An issue in designing this study is the great complexity and diversity of the palliative care literature. Here’s a sentence I loved: “Unlike other disciplines, palliative care transects numerous domains.” Ever seen ‘transect’ in a palliative care paper? The number of clinical issues, populations (multiple subsets), disciplines involved, and something they didn’t mention, the diversity of publication titles, makes the task of reviewing the whole of the literature for a specific major disease class pretty overwhelming to contemplate. They admitted, in a bit of understatement, that it was a “labor intensive” project.
I’ll skip over the study methods and jump to the results. Combining the 2 periods,
Of over 6000 articles screened 1213 were reviewed. A significant proportion of studies were excluded from this review because they involved topics such as palliative chemotherapy with survival as the primary endpoint
70% of papers were original studies
42% of the studies were published in palliative care journals while 19% appeared in oncology journals
Over 400 journal titles had at least one palliative oncology paper.
“The palliative oncology literature is flooded with descriptive studies when we urgently need more practice-changing analytic studies.”
Physical symptoms, health services research and psychosocial issues were the most common topics. There were many “orphan” (under-studied) topics even under physical symptoms).
Pediatric palliative care was “largely unexplored.”
Providers and lay caregivers are under-studied
Over the 5-year study period:
The proportion of palliative care articles in the oncology literature remained below 1% and even decreased slightly, despite an increase in absolute numbers of papers.
There was a 47% increase in original studies.
The percent of randomized controlled trials decreased from 7% to 5%
Overall, the results show a disappointing lack of improvement in the overall quality and quantity of the palliative care articles focused on the oncology population. This is inherently limiting in addressing the total palliative care literature, but it would be time and cost prohibitive to do the same analysis over that larger universe. The barriers to doing palliative care research, especially improving the evidence base for treatments, haven’t changed and, despite increases in overall numbers of papers, methodology remains weak. Perhaps this paper will help to focus attention on improving the science of palliative care research.
By the way, articles in The Oncologist have recently been made freely available (again) with registration to individuals.
Hui, D., Parsons, H., Damani, S., Fulton, S., Liu, J., Evans, A., De La Cruz, M., & Bruera, E. (2011). Quantity, Design, and Scope of the Palliative Oncology Literature The Oncologist DOI: 10.1634/theoncologist.2010-0397
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Hui, D., Parsons, H., Damani, S., Fulton, S., Liu, J., Evans, A., De La Cruz, M., & Bruera, E. (2011) Quantity, Design, and Scope of the Palliative Oncology Literature. The Oncologist. DOI: 10.1634/theoncologist.2010-0397
by Brian McMichael, M.D. in Pallimed: a Hospice & Palliative Medicine Blog
The lead research article in the current issue of the American Journal of Physical Medicine and Rehabilitation is Inpatient Rehabilitation Improved Functional Status in Asthenic Patients with Solid and Hematologic Malignancies. It was written by a team from the Department of Palliative Care and Rehabilitation Medicine and the Department of Biostatistics at the University of Texas, MD Anderson Cancer Center. This study sought to compare functional outcomes in asthenic patients with hematologic malignancies with those of asthenic patients with solid tumors after inpatient rehabilitation.Their hypothesis was that asthenic patients with hematologic malignancies were less likely than patients with solid tumors to make functional improvement after rehabilitation. This was a retrospective chart review of 60 asthenic cancer patients (30 consecutive patients with solid tumors and 30 consecutive patients with hematologic malignancies) who completed inpatient rehabilitation at a comprehensive cancer center between October 2005 and October 2007. Patients in whom the admitting physiatrist determined asthenia to be the main cause for admission to the rehabilitation unit were included in this study. Patients who developed new focal functional deficits because of brain or spinal cord lesions (same hospital admission) and patients who were unexpectedly transferred back to acute service were excluded. All patients admitted to the inpatient rehabilitation unit received 3 hours or more of therapy per weekday.The main outcomes included total, motor, and cognitive Functional Independence Measure (FIM) scores (I'll offer some information on FIM scores below), hospital and rehabilitation length of stay (LOS), and FIM efficiency (calculated by dividing the total improvement in FIM score by the rehabilitation LOS).The solid tumor patients were significantly older than the hematologic malignancy patients (mean ± SD (range), 71 ± 11 (48-93) vs. 64 ± 12 (33-88); P = 0.02). Most patients had advanced disease. A significantly higher percentage of patients in the solid tumor group underwent recent surgery (70% vs. 17%; P = 0.0001), whereas a significantly higher percentage of patients in the hematologic malignancy group received recent chemotherapy (67% vs. 17%; P = 0.0001). Similarly, a significantly higher percentage of patients in the solid tumor group underwent previous surgery (43% vs. 17%; P = 0.02), whereas a significantly higher percentage of patients in the hematologic malignancy group received previous chemotherapy (70% vs. 30%; P = 0.001).FIM, SCHMIMThe FIM™ instrument is a validated, rehabilitation assessment tool in wide use at skilled nursing facilities, subacute facilities, long-term care hospitals, Veterans Administration programs, international rehabilitation hospitals, and other related venues of care. It was developed at SUNY-University at Buffalo (UB), and is administered within the FIM System® on a subscription-basis by the Uniform Data System for Medical Rehabilitation, a division of UB Foundation Activities, Inc. The FIM instrument enables clinicians and programs to document the severity of patient disability, the results of medical rehabilitation and establishes a common measure for the comparison of rehabilitation outcomes. It is widely recognized by, and familiar to, most rehabilitative staff across disciplines. It operates as the gold standard for measuring and documenting the functional status, from admission to rehabilitative care through discharge and follow-up. In short, the FIM instrument functions at the core of rehab IDT communication and decision-making.It is a 18-item instrument, which assesses the following areas:MOTOR Self Care (1. Eating, 2. Grooming, 3. Bathing, 4. Dressing - Upper Body, 5. Dressing - Lower Body, 6. Toileting)Sphincter Control (7. Bowel Management, 8. Bladder Management)Transfers (9. Bed/Chair/Wheelchair, 10. Toilet, 11. Tub/Shower)Locomotion (12. Walk/Wheelchair, 13. Stairs)COGNITIVE Communication (14. Comprehension [auditory/visual], 15. Expression [vocal /non-vocal])Social Cognition (16. Social Interaction, 17. Problem Solving, 18. Memory)These items are scored on a 7-point, natural-number scale, i.e., 7 through 1, assessing the level of functioning from complete independence to complete dependence, as follows:INDEPENDENT7. Complete Independence - All of the tasks described as making up the activity are typically performed safely without modification, assistive devices, or aids and within reasonable time.6. Modified Independence - Activity requires any one or more of the following: An assistive device, more than reasonable time, or there are safety (risk) considerations.DEPENDENT Modified Dependence 5. Supervision or Setup - Subject requires no more help than standby, cueing or coaxing, without physical contact. Or, helper sets up needed items or applies orthoses.4. Minimal Contact Assistance - With physical contact the subject requires no more help than touching, and subject expends 75% or more of the effort.3. Moderate Assistance - Subject requires more help than touching, or expends half (50%) or more (up to 75%) of the effort.Complete Dependence2. Maximal Assistance - Subject expends less than 50% of the effort, but at least 25%.1. Total Assistance - Subject expends less than 25% of the effort.If this sounds to you like performance status, then you'd be right. There are various performance scales that have arisen the oncology and palliative medicine communities for clinical decision-making and prognositcation, e.g., the ECOG Performance Scale, the [New] Edmonton Functional Assessment Tool (EFAT), the Katz Index of Independence of Activities of Daily Living, the Karnofsky Perfromance Status Scale, and the Palliative Performance Scale. Please see the Pallimed Prognosis Links for more information on these. Perhaps the most corresponding is the Palliative Performance Scale version 2 (PPSv2) developed at the Victoria Palliative Research Network. Average FIM scores can be calculated quickly by dividing the total FIM score by 18 yielding a global assessment of functional independence.We now return to our regularly scheduled programmingThe mean admission FIM score was 80 ± 14, the mean discharge FIM score was 96 ± 14, and the mean total increase in FIM score was 16 ± 10, and these did not differ significantly (P = 0.64, 0.21, and 0.25, respectively). The groups' mean rehabilitation LOS of 10 days, and hospital LOS were similar (P = 0.82, and 0.41, respectively). The mean FIM efficiency was 1.7, but the FIM efficiency was significantly higher in the patients with hematologic malignancies than in the patients with solid tumors (1.9 ± 0.9 vs. 1.4 ± 1.0; P = 0.049). Also, the congitive FIM at discharge compared with admission was significantly higher in patients with hematologic malignancies, but not in the patients with solid tumors (31.0 ± 3.7 at admission, 31.8 ± 3.7 at discharge; P = 0.004 vs. 31.5 ± 3.8 at admission, 31.5 ± 3.6 at discharge; P = 0.82). Some ThoughtsThis study adds information about functional gains from inpatient rehabilitation of advanced-cancer patients with asthenia. Most previous inpatient cancer rehabilitation studies looked at functional gains in patients with neoplastic brain injuries and spinal cord compressions, which were similar to those without cancer. Other previous studies looked at inpatient cancer rehabilitation for patients with a broad range of problems, where asthenia was only a small subset. I like this study for several reasons. First, the scientist in me likes this because this is the first time in a long time that I have seen a study in a peer-reviewed journal with a clearly stated alternative hypothesis, with the data supporting acceptance of the null hypothesis. So, props on the team, and ... Read more »
Guo, Y., Shin, K., Hainley, S., Bruera, E., & Palmer, J. (2011) Inpatient Rehabilitation Improved Functional Status in Asthenic Patients with Solid and Hematologic Malignancies. American Journal of Physical Medicine , 90(4), 265-271. DOI: 10.1097/PHM.0b013e3182063ba6
by Lyle Fettig, MD in Pallimed: a Hospice & Palliative Medicine Blog
Vancouver 2011
We don't usually comment on stuff from the main palliative care journals, but the Journal of Palliative Medicine published a study that supplements the NEJM trial on early palliative care in metastatic non-small lung cancer. (See our initial reactions to the NEJM study here, here, and here.) The present study examines the content and length of time spent during the initial outpatient consultation that took place during the trial.
In the study, palliative care notes from the EMR were reviewed to determine the amount of time spent (as estimated by the clinician who performed the consult) on each of the following tasks: management of symptoms, illness understanding, treatment decision-making, patient and family caregiver coping, and care planning and referrals. The median time spent during initial consultations was 55 minutes with a range of 20-120 minutes. When looking at the components of consultation, a median of 20 minutes was spent on symptom management, 15 minutes was spent on coping, and 10 minutes spent on illness understanding with no recorded time spent on decision-making or planning and referrals.
Somewhat in keeping with the above results, a retrospective chart review revealed that 50% of clinicians documented a discussion of spiritual or religious practices (related to coping) but only 20% documented a discussion about surrogate decision-makers or code status. Unless the clinician was merely noting what was already in the chart related to these topics, the latter result is inconsistent with the audit that suggested that no time was spent on decision-making or referrals. This perhaps highlights a minor weakness of the method used for tracking time spent on the components, but we get the gist anyway.
Regardless, in most patients, end of life decisions were not discussed at all during the initial consult. The authors cite the fact that patients with metastatic NSCLC have a high symptom burden at time of diagnosis, thus prompting the need for this to be the main focus at first. Furthermore, the intense focus on symptoms and coping engenders trust and helps build the rapport necessary to talk about end of life planning. Time spent discussing the patient's understanding of disease/trajectory lays the groundwork and also likely signals to the patient that further conversations about EOL decision-making may follow (and provides hints to the provider regarding goals of care).
As I reflect on my own practice, I think the same type of thing often happens in the inpatient arena: during the first visit, focusing on immediate needs (both symptom and psychosocial), disease understanding, as well as trying to really get a good picture of the patient's "organic" support all take precedence over code status discussions, etc, in most cases. (I often remind rotating learners of this: If we're consulted "to talk about code status", that doesn't mean that you delve right into talking about code status.) Perhaps the inpatient consultation differs in that the hospitalized patient is already likely at a moment of crisis which allows for concrete discussion about wishes and goals in the context of that crisis. In other words, discussion about the patient's understanding of their disease/acute illness (for instance, dealing with a malignant pleural effusion) seems like a more natural entree into goals exploration and preferences for life prolonging measures than a patient who is waiting around for their first cycle of carbo/taxol.
Another major difference is the timing between visits in the clinic vs. the hospital. In the hospital, you may not delve into details about the patient's goals or decision-making on the first day for various reasons (symptoms out of control, not the right setting, not enough trust established, etc, etc). You can risk-stratify how likely it will be that you will have the opportunity to return the next day to deepen the conversation. In the clinic, I have experienced a very minor sense of anxiety that I haven't "done my job" if I haven't talked about decision-making/end of life planning, etc during an initial visit because there may be weeks in between the visits. (And visions of the patient being admitted to the ICU pop into my head with the ICU doc saying to me, "Fettig, the family told us that the patient wouldn't have wanted all of this, and you saw this patient 3 weeks ago. What were you doing?") So I find this study reassuring.
More details are also provided about the structure of the randomized controlled trial intervention. The providers consisted of 6 palliative care physicians and one nurse practitioner, although the NP provided 45% of initial consultations. It's noted that visits were scheduled in conjunction with patients' oncology appointments when feasible. I still have further questions about logistics (partially based on my own experience providing consultation in a general oncology clinic over the last year):
How often was it not feasible to see the patient on the same day as the oncologist?
What logistical dilemmas arise from doubling/tripling the time patients spend in clinic and how are those dilemmas managed? (Clinic room/space limitations, patients not wanting to wait around due to symptoms/other factors or needing to proceed to infusion, etc.)
Was time patients spent in the infusion clinic used at all by PC clinicians?
If the patient has a primary care clinician, how involved was that clinician, and how was care coordinated with him/her?
With so many palliative care providers involved, were there any issues with continuity of care between visits?
Question for Pallimed readers: It's been a full seven months since this important trial was released. What impact have you seen and how have you used it to advance your services?
Jacobsen, J., Jackson, V., Dahlin, C., Greer, J., Perez-Cruz, P., Billings, J., Pirl, W., & Temel, J. (2011). Components of Early Outpatient Palliative Care Consultation in Patients with Metastatic Nonsmall Cell Lung Cancer Journal of Palliative Medicine DOI: 10.1089/jpm.2010.0382
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Jacobsen, J., Jackson, V., Dahlin, C., Greer, J., Perez-Cruz, P., Billings, J., Pirl, W., & Temel, J. (2011) Components of Early Outpatient Palliative Care Consultation in Patients with Metastatic Nonsmall Cell Lung Cancer. Journal of Palliative Medicine, 2147483647. DOI: 10.1089/jpm.2010.0382
by Lyle Fettig, MD in Pallimed: a Hospice & Palliative Medicine Blog
A reporter for the New York Times recently made this statement (see video below):
"I think the Japanese tend to try to maintain a veneer of calm and not breech topics that might be alarming or insulting (emphasis added). For example, until recently, it was the norm for families not to tell a family member who had cancer (about the cancer) just to save suffering on the part of the family member and we see some of that mentality at play in some of the communications we have seen from Japanese officials who have refused to confirm what turns out now to be a very serious situation at the Fukushima Daiichi plant. They were very slow in acknowledging some of the dangers."
The earthquake, tsunami, and nuclear plant crisis in Japan have inflicted unspeakable loss and suffering onto the Japanese people. It goes without saying that there are differences between a government communicating risk of nuclear disaster and a physician or family communicating cancer diagnosis/prognosis with a patient. The comparison is interesting though, as commonalities exist including asymmetric information, fear, uncertainty, and the specter of unpredictable complications.
This comparison started me thinking about cultural differences in communication regarding prognosis and prompted a brief search for research regarding preferences for disclosure of diagnosis and prognosis in a Japanese population. In reviewing palliative medicine journals regularly, there is a significant amount of HPM research from Japan, so it was no surprise that I found some work on this question.
For example, a survey published (Open Access PDF) in the Journal of Medical Ethics in 2005 asked members of the general population in Tokyo about their preference for information about diagnosis and prognosis in the event of a cancer diagnosis. Almost all respondents wished for partial or full disclosure of both diagnosis and prognosis. With respect to prognosis, about a third wished for full, immediate disclosure regarding the prospect for complete recovery and expected length of survival. Most of the remainder of respondents wished for either gradual, full disclosure or partial disclosure. The authors note that the results are similar to findings in American and British studies.
One's preference for disclosure is not the only factor that goes into determining if the information is actually disclosed. In my practice, I will sometimes encounter a family member who requests that prognostic information be withheld from the patient. While it is paramount to identify and address the concerns which underlie this request, Americans generally understand the elevated and protected status of the principle of autonomy in our society. Most people seem to understand the physician's desire to assess the patient's information needs in this context. How does this work in a society where autonomy isn't quite as prominent?
This question is addressed in a separate paper from the same Japanese study in Tokyo. (Open Access PDF) The methodology could have been a little cleaner (and described more clearly). It appears that subjects who wished for full, immediate disclosure would be less likely to allow their physicians or family to go against that wish (i.e. withhold information about dx/px) than those who wanted less than full disclosure or no disclosure. However, a significant minority of subjects who wished for disclosure thought it was appropriate for either family or the physician to be given authority to withhold diagnosis or prognosis.
So there is heterogeneity in terms of disclosure preferences as well as the desired role that family and physicians play in the decision to disclose. Cultural differences aside, I think we see significant heterogeneity in the U.S., too- e.g. patients who want us to tell them their prognosis privately vs. those who tell us to talk down the hall with their loved ones because they don't want to hear it, etc. I would be curious how many autonomy-obsessed people in the U.S. who want full disclosure immediately would give their loved ones and/or physicians discretion in disclosure. (Not aware of any research looking at this.)
This brings us to the main barriers to disclosure in any setting: fear of harming the patient and avoidance of difficult communication tasks. Does greater emphasis on the collective in Japan make it easier for physicians and families to ignore the results of the above studies, citing the harm, indeed insult that may come through disclosure? Recent American research (e.g. Coping with Cancer) suggests that end of life discussions may even be salutary for dying patients and their families from a psychological standpoint. How might this apply in Japan or other cultures? At least one study seems to suggest that psychological morbidity appeared slightly lower in patients with malignant head and neck cancer who were "informed about their condition" vs. those that were not informed (unclear what exactly "being informed" entailed).
In the discussion section of this study, they mention that it is the norm for physicians to ask the patient's family about disclosure of cancer, even if the patient has early stage cancer. This study was published in 1999, and it sounds like things might have changed some in the last decade based on the articles above as well as what the NYT reporter says.
Bottom line: The key in any setting is undertaking a skilled process of determining how the information is to be handled, accounting for individual preferences as well as family processes which are both influenced by culture. For American providers caring for native Japanese patients, one might anticipate that a family would expect you to talk to them about how to handle information and may request that disclosure to the patient be withheld. If approached by a family with this request, I think it's important once again to make sure you fully understand their concerns and explain that you will respect the family's wish if the patient tells you they want to defer to family.
As far as a nuclear disaster goes, if I'm ever in one (let's hope not) give me information that either calms my fears or information that is actionable. (ABC World News did a great job of sending mixed messages on Friday, verbally telling the U.S. audience....appropriately.... that "we're ok" but displaying an ominous red background throughout the show as well as a map that showed a plume of minuscule but detectable radiation that had traversed the Pacific.)
All pictures from Boston.com The Big Picture (see link for photo credits)
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Miyata H, Takahashi M, Saito T, Tachimori H, & Kai I. (2005) Disclosure preferences regarding cancer diagnosis and prognosis: to tell or not to tell?. Journal of Medical Ethics, 31(8), 447-51. PMID: 16076967
Miyata, H., Tachimori, H., Takahashi, M., Saito, T., & Kai, I. (2004) Disclosure of cancer diagnosis and prognosis: a survey of the general public's attitudes toward doctors and family holding discretionary powers. BMC Medical Ethics, 5(1), 7. DOI: 10.1186/1472-6939-5-7
Hosaka, T. (1999) Disclosure of true diagnosis in Japanese cancer patients. General Hospital Psychiatry, 21(3), 209-213. DOI: 10.1016/S0163-8343(98)00075-9
by Christian Sinclair, MD in Pallimed: a Hospice & Palliative Medicine Blog
(Disclaimer: I currently work for a non-profit hospice agency and have not worked for a for-profit agency)
This has been a question that many in the hospice community have asked but the research on the subject has been pretty minimal and most strongly influenced by strong anecdotal experiences from people who have worked on either side of the for-profit (FP) and non-profit (NP) divide. JAMA’s lead article this week ("Association of Hospice Agency Profit Status With Patient Diagnosis, Location of Care, and Length of Stay") is a retrospective study on the demographics of 4705 patients who discharged from hospice (16% discharged alive). (Available free online)
First let’s look at the stats before we get to what I might consider the ‘spin’ placed on this article. The authors looked at a few key variables and found FP hospices had more patients with dementia (OR 2.32) and more patients in nursing homes (OR 1.32). What understandably follows is that FP had longer Length of Stay (LOS) (Median FP – 20 vs NP – 16), not very surprising. Of note they found no difference in number of nursing visits, and more visits for social workers in NP, and more visits for home health aides in FP.
From this data the authors conclude:
Compared with nonprofit hospice agencies, for-profit hospice agencies had a higher percentage of patients with diagnoses associated with lower-skilled needs and longer lengths of stay.And from that the media concludes:
I think most of us in the field have seen some of the findings this article confirms. FP hospices do a good job of developing relationships with nursing homes and with more dementia patients there and the increase in efficiency from visiting multiple people in one location you could probably do better on margins. Makes good business sense to me. So with FP hospice agencies can have margins of 12-16% compared to losses of 2.9-4.4% at NP agencies. along with the growth in FP hospices has Medicare looking into the reimbursement structure. (See chapter 8)
But I think we have to ask ourselves as a field, is this study trying to be more ambitious in its conclusions? And has the media amplified that?
We have to be very careful to examine the assumptions of this article. Nothing in this article tells us why any of the results are true. Maybe it is good to have a different mix of disciplines for patient in nursing homes or with different diagnoses? What is really the best combination for high quality hospice service to be delivered? Ask yourself what the conclusions would have been if there were a lot more SW or nurse visits for patients in a nursing home or with dementia. Would we then clamor and say ‘that is too many visits compared to a patient at home or with cancer!’
The authors note in the comments the many limitations for this study and most importantly I will highlight this paragraph since the majority of the world will stop at the summary and never even read the article:
Finally, and perhaps most importantly, we are unable to assess the relationship between profit status and quality of care. While our study improves on previous research by assessing the number of visits per day by various hospice personnel, we lacked important information on the length of each visit and care provided. For example, we could not distinguish between a home health aide visit that consisted of a 5-minute “check-in” and a half-day visit providing assistance with activities of daily living. We are also unable to determine whether higher rates of home health aide visits in for-profit hospices reflect additional care or substitution of other types of unmeasured (and potentially more expensive) clinical services. We also could not distinguish between visits delivered by registered nurses and licensed vocational nurses; past research suggests that registered nurses, who are more skilled and more expensive, deliver a lower proportion of nursing visits in for-profit hospices vs nonprofit hospices.Now I may be wrong but I imagine there are a lot of NP hospice agencies that may use this article as evidence they will do a better job. But I am not sure this article really supports those conclusions. Maybe I am being cynical and no one in the US hospice world would ever draw those conclusions from this article but if the LA Times is hyping it that way, I can't be too far off. If you are looking for more detailed info I think the MedPAC report (Chapter 8) has a lot more to say about the differences between NP and FP.
I am not someone who will come out to defend profit making and accountability to investors as a good practice model for health services, but I also don’t want to see our field tearing itself apart over these philosophical differences because we did not read the whole article and just depended on the summary.
(UPDATE 11:35PM Here is the response from the NHPCO. Which includes this great quote: "The study authors seem to conclude that such patients are 'lower skill' – the implication being that their care needs are minimal. This reflects a fundamental misunderstanding of the important unmet needs for persons dying from dementia. A person dying from dementia may still experience pain," remarked noted researcher Joan Teno, MD, MS, of Brown University and a member of the NHPCO board.")
(By the way, I will leave a lot of leeway for comments on this article, but I ask that you be civil and support your points well.)
Wachterman, M., Marcantonio, E., Davis, R., & McCarthy, E. (2011). Association of Hospice Agency Profit Status With Patient Diagnosis, Location of Care, and Length of Stay JAMA: The Journal of the American Medical Association, 305 (5), 472-479 DOI: 10.1001/jama.2011.70
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Wachterman, M., Marcantonio, E., Davis, R., & McCarthy, E. (2011) Association of Hospice Agency Profit Status With Patient Diagnosis, Location of Care, and Length of Stay. JAMA: The Journal of the American Medical Association, 305(5), 472-479. DOI: 10.1001/jama.2011.70
by Christian Sinclair, MD in Pallimed: a Hospice & Palliative Medicine Blog
The physical exam is an important skill for the practitioner of palliative medical arts because we may be working with patients in their home where technical diagnostic options are limited or in a treatment mode that has been defined by avoiding further diagnostic tests. So I am particularly interested by any article that discusses clinical examination skills relevant to palliative medicine. Of course the title did not hurt in causing me to pause. "Gurgling Breath Sounds May Predict Hospital Acquired Pneumonia" by Dr. Rodrigo Vasquez et al. published in Chest (article behind paywall) is one of only 6 articles in all of PubMed that have 'gurgling' in the title.
The research team from Bridgeport Hospital in Conencticut, examined patients in the 24 hours near admission by auscultating over the throat (glottis) during quiet breathing and speech. Interestingly they mention examination near admission but they also include this caveat: 'or at any time during admission.' How often people were diagnosed on admission versus during the admission is not presented which may affect some of the results. For example is gurgling a cause or an effect of hospital acquired pneumonia? And if you are studying gurgling being a risk factor for the acquisition of hospital acquired pneumonia I think it would be important to just evaluate on admission. Moving on....
They compared demopgraphics, residence co-morbidities, treatments, and outcomes to see what was asosicatied with gurgle on admission (or at any time during admission). They enrolled 80 patients (20 with gurgle and 60 matched cohorts) on the same day of admission. Those who were found to have a gurgle had higher incidence of hospital acquired pneumonia (55% v 1.7%), intubation, transfer to ICU and were associated with a increased age (78.5 v 65.2), nursing home residence, treatment with opioids or antipsychotics.
In Table 2 I do have some concerns about their conclusions since they leave out some key details, in particular the timing of events.
The authors write:
"In multivariate analysis, dementia (OR = 23.4; 95% CI, 4.2-131.9) and recent (within 24 h) treatment with opiates (OR = 14.7; 95% CI, 2.2-97.5) emerged as the only statistically significant independent predictors of gurgle (Table 2)."But could a reasonable conclusion also be that patients with dementia, of an advanced age, who acquire a pneumonia in the hospital and stay in the ICU and hospital an average of 14 days, may at some point receive opioids as the goals change away from a fading chance at recovery and more towards comfort measures only?
The main finding was that gurgling was far and away the biggest predictor (or associated symptom) of hospital-acquired pneumonia.
So what can we take away form this? Well if we hear gurgling in a patient it is important to document it, and to add in your notes this may be a risk factor for hospital acquired pneumonia and counsel the patient and family appropriately. I am not sure we need to auscultate over the larynx. Thoughts?
Another thing we can do is take this study, improve upon it and try and complete it from a hospice setting, or maybe in your own hospital. I think the fundamentals are good, but some of the conclusions may be a bit premature. Hopefully this also proves an important point of not relying on the summary from the authors and reading the article fully if you are going to change your practice. Heck don't even trust me, go read it for yourself. Apparently the writers of The Hospitalist didn't. I originally saw this article highlighted in a clinical summary there. They also agreed with the conclusion that opioid were also a predictor of gurgles, which I do not agree with.
I do have to compliment the authors on bringing up this important topic and for the following paragraph on the history of 'gurgling' in medical literature (emphasis mine).
Although the exact origins of the term “death rattle” are not clear, in 1853, Barclay attributed it to Laennec, who also described “gargouillement” (gurgling). Laennec initially used the term “rale” (French for rattle) in his writings but recognized it might frighten patients familiar with the term “death rattle.” In 1859, Thomas Inman indicated that “…an abundant perspiration, and the ‘death rattle’ in the throat, have long been recognized in many diseases as immediate harbingers of death.” Although many have studied or discussed the acoustics and pathogenesis of adventitious sounds, gurgling does not fit authoritative descriptions of rales, wheezes, or ronchi. So, although gurgling has been appreciated by clinicians for centuries, its technical features and pathophysiology have not been well studied. Ours is the first study, to our knowledge, to suggest that not all seriously ill patients who gurgle die and that this examination finding is associated with HAP.It seems they tried hard to avoid the term 'death rattle' as the mere use of the term presupposes the outcome, much like terminal delirium. Both of these I feel should be used more in a retrospective manner when discussing about a particular patient or in a tone that discusses them as a possibility not a certainty. I am curious why they didn't go for my term of choice and the much more clinical/academic sounding 'oropharyngeal secretions?'
Vazquez, R., Gheorghe, C., Ramos, F., Dadu, R., Amoateng-Adjepong, Y., & Manthous, C. (2010). Gurgling Breath Sounds May Predict Hospital-Acquired Pneumonia Chest, 138 (2), 284-288 DOI: 10.1378/chest.09-2713
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Vazquez, R., Gheorghe, C., Ramos, F., Dadu, R., Amoateng-Adjepong, Y., & Manthous, C. (2010) Gurgling Breath Sounds May Predict Hospital-Acquired Pneumonia. Chest, 138(2), 284-288. DOI: 10.1378/chest.09-2713
by Brian McMichael, M.D. in Pallimed: a Hospice & Palliative Medicine Blog
In the current issue of Archives of Internal Medicine, under the category, "Health Care Reform" is a Research Letter entitled, Hospital-Based Palliative Medicine Consultation: A Randomized Controlled Trial. It is brought to you by the good folks at UCSF. It was a 2-year, randomized, prospective, clinical trial of patients 65 years or older with heart failure, cancer, chronic obstructive pulmonary disease, or cirrhosis, who were able to give informed consent, and who spoke English.Patients were randomly assigned to the intervention or usual care group. The intervention group received a physician-based palliative medicine consultation (PMC) on enrollment and was followed up every weekday during hospitalization. The patients were routinely assessed for symptoms as well as psychosocial and spiritual needs. The PMC physician discussed treatment preferences, and consulted a pharmacist and chaplain as needed. The PMC physician communicated with the patient's team via a medical chart note and by telephone. The usual care group received a brief visit from the PMC physician who gave them a packet of information on diet and exercise. Patients were rated as dependent or independent for Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales, and were rated on the 15-item Geriatric Depression Scale (GDS-15) for depression. Pain, dyspnea, and anxiety were assessed daily by a research assistant who was blinded to group assignment. All patients completed a telephone survey 2 weeks after discharge to reassess symptoms, rate physician and nursing care, and recall discussions of preferences. Medical records were reviewed to determine patients' primary diagnosis on admission.107 patients were enrolled; 81 patients completed follow-up surveys. Most patients were male (62%) and white (71%) and had some college education (56%). The mean (SD) age was 76 (7.5) years, and 45% were married or partnered. The primary diagnoses were heart failure (51%); cancer (22%); chronic obstructive pulmonary disease (20%); and cirrhosis (6%). The mean (SD) hospital length of stay was 5.5 (5.8) days. Most participants were dependant in 1 or more ADL (71%), and 21% had a GDS-IS score of 6 or higher. The groups differed in mean age (77 and 74 years in the intervention and usual care groups, respectively; P = .007) but not in other characteristics.Symptom scores for all subjects improved from baseline to follow-up for pain (4.2 vs 2.3; P <.001), dyspnea (3.8 vs 2.0; P <.001), and anxiety (4.8 vs 2.4; P <.001). There was no additional improvement in pain (P = .30), dyspnea (P = .50), or anxiety (P = .08) for patients assigned to the intervention at any assessment period. At follow-up, most patients believed that the staff understood what they were going through and that physicians and nurses listened to their hopes, fears, and beliefs. However, a minority of patients reported that the physician discussed their preferences for care (43%), their chance of surviving hospitalization (42%), or their religious beliefs (31%). There were no differences between groups for any of these items. The writers point out that the subjects, of this single-institution study, were not those that would otherwise be referred for PMCs and thus may have lacked issues that a PMC would affect. They wondered whether palliative care may have an impact on different outcomes or require ongoing engagement. Also, the intervention was not by interdisciplinary team. Some thoughts:I agree that the physician-based intervention made over a short-course with patients who were not necessarily into end-stage disease was not likely to make significant effect over usual care. Right patient, right treatment, right dose, right time, etc. What we seem to have here is equivalence or a failure to show inferiority for inclusion of PMCs, at least with respect to the trial design and tested parameters. But they present and discuss pooled data for symptom-levels and then note that there is no significant additional improvement for PMC, rather than testing the difference between group means.Now, in the category of retrospective data-mining:According to the Figure there were no significant intergroup differences (with respect to 95% CIs) between usual care and PMC for interval-matched measurements of pain, dyspnea and anxiety. However, I did note that for the usual-care group, between baseline to follow-up, there was no significant difference (with respect to 95% CIs) in the levels of pain [3.5 (2.4 - 4.8) vs. 2.1 (1.1 - 3.1)], dyspnea [3.0 (1.8 - 4.2) vs. 1.6 (0.6 - 2.5)] and anxiety [3.8 (2.7 - 5.0) vs. 2.5 (1.3 - 3.6)]. One could suggest that for these patients their usual-care admissions had no effect on these symptoms.Alternatively, for the PMC group, between baseline to follow-up, there was significant difference in the levels of pain [4.9 (3.8 - 6.0) vs. 2.4 (1.4 - 3.4)], dyspnea showed equivalence at the lower and upper values of the 95% CI [4.4 (3.3 - 5.5) vs. 2.4 (1.5 - 3.3)], and again there was significant difference for anxiety [5.5 (4.2 - 5.5) vs. 2.5 (1.5 - 3.6)].I think there is food for thought here in terms of future trial design. Is this difference real? For these chronically ill patients, from admission to follow-up, do hospitalizations with PMCs show significant decreases in symptoms compared to no significant difference in symptoms with usual-care admissions? Do admissions with PMCs using interdisciplinary-team interventions show significant differences over usual-care admissions?Pantilat, S., O'Riordan, D., Dibble, S., & Landefeld, C. (2010). Hospital-Based Palliative Medicine Consultation: A Randomized Controlled Trial Archives of Internal Medicine, 170 (22), 2038-2040 DOI: 10.1001/archinternmed.2010.460
... Read more »
Pantilat, S., O'Riordan, D., Dibble, S., & Landefeld, C. (2010) Hospital-Based Palliative Medicine Consultation: A Randomized Controlled Trial. Archives of Internal Medicine, 170(22), 2038-2040. DOI: 10.1001/archinternmed.2010.460
by Christian Sinclair, MD in Pallimed: a Hospice & Palliative Medicine Blog
I know many palliative care practitioners were cheering the news that the world's least effective opioid propoxyphene (Darvocet (w/ APAP) /Darvon) (similar efficacy to acetaminophen) is being pulled off the market by the FDA. Along with meperdine (Demerol) I am not sure if a medicine exists that produces as much disdain as propoxyphene amongst palliative care clinicians.
But let's look a little closer as to why this happened. The FDA cites the increasing cardiotoxicity and risk of heart arrythmias in a post-market study conducted by Xanodyne. It is a little difficult to find out more exact information since the study is not published but lets do a little Scooby Doo-like sleuthing.
Propoxyphene is a synthetic derivative of methadone.
Methadone causes QT prolongation of questionable clinical significance in palliative care patients.
QT prolongation is a risk factor for ventricular arrhythmias.
Searching beyond just the press releases and news articles I found this FDA memo from Dr. Sharon Hertz *(Deputy Division Director Division of Anesthesia and Analgesia Products) noting that Xanodyne was asked to do a Thorough QT study. Never heard of that before? Well all new drugs since 2005 have had to pass through one before being approved. Given this increased risk of QT prolongation and the fear of resulting ventricular arrhythmias, the risk of the drug started to overwhelm the very minimal benefit it offered.
Interestingly the FDA has no evidence of QT Prolongation Adverse Event related deaths with Propoxyphene. Here is a quote from the memo: (emphasis mine)
At the 2009 advisory committee meeting, FDA staff shared postmarket data that have been suggestive, but inconclusive, about the risk for propoxyphene-related cardiac toxicity when used at therapeutic doses. No cases of torsades de pointes (TdP) causally associated with propoxyphene have been reported despite extensive use for many years. In an analysis of serious adverse events reported to the Adverse Event Reporting System (AERS) covering the period from marketing to February 2, 2005 (approximately 33 years), there were 91 U.S. deaths associated with Darvocet, the most commonly dispensed formulation of propoxyphene. Most of the reports identified opioid drug overdoses in individuals with profiles of drug dependency, in which there was coingestion of multiple medications, or in those attempting suicide.What is really interesting about this memo is section 1.2.1.1 on page 20, where they discuss QT studies of other opiate agonists. 6 lines of the report are redacted and in the whole 20 pages there is not one mention of methadone despite nearly all other opioids being mentioned. Redaction? Should we call Wikileaks founder Julian Assange?
So in the end I am not sure if propoxyphene being removed is really about cardiotoxicity and QT, minimal effectiveness, abuse and overdose potential or a combination of all of the above.
Well all this may be a whole lot of nothing but my real concern is that methadone may be a drug in the crosshairs of the FDA soon. It already has four strikes against it:
1) documented QT prolongation
2) stigma of heroin treatment programs
3) accelerating percent of all deaths related to opioids
4) methadone could be considered an orphan drug
And evidence of methadone being a very useful medication is possibly not strong enough to overcome these issues. So while we can cheer propoxyphene disappearing we should also be cautious and gather better evidence for the medications we wish to keep in our arsenal to ensure good pain control for years to come.
Beaver, W. (1984). Analgesic Efficacy of Dextropropoxyphene and Dextropropoxyphene-containing Combinations: a Review Human and Experimental Toxicology, 3 (1 suppl), 191-220 DOI: 10.1177/096032718400300118
Collins, S., Edwards, J., Moore, R., McQuay, H. (1998). Single-dose dextropropoxyphene in post-operative pain: a quantitative systematic review European Journal of Clinical Pharmacology, 54 (2), 107-112 DOI: 10.1007/s002280050430
Ripamonti, C., Bianchi, M., Brue... Read more »
Beaver, W. (1984) Analgesic Efficacy of Dextropropoxyphene and Dextropropoxyphene-containing Combinations: a Review. Human , 3(1 suppl), 191-220. DOI: 10.1177/096032718400300118
Collins, S., Edwards, J., Moore, R., & McQuay, H. (1998) Single-dose dextropropoxyphene in post-operative pain: a quantitative systematic review. European Journal of Clinical Pharmacology, 54(2), 107-112. DOI: 10.1007/s002280050430
Ripamonti, C., Bianchi, M., & Bruera, E. (2004) Methadone: An Orphan Drug?. Journal of Palliative Medicine, 7(1), 73-74. DOI: 10.1089/109662104322737278
by Brian McMichael, M.D. in Pallimed: a Hospice & Palliative Medicine Blog
In the December 1st issue of Pediatric Blood and Cancer is an article that presents the validation of a prognostic tool in pediatric hospice care. The study was produced by a team from the Hospital A.C. Camargo, a large cancer center in São Paulo, Brazil. Their overall survival rate in the treatment of pediatric cancers is just over 75%, roughly on par with those in the United States at approximately 80%. At this institution, a nurse-led, multidisciplinary palliative care team was developed in 1999. Patients are referred to it when 3 pediatric oncologists reach a consensus that a particular patient has no chance for a cure. In 2005, the same group had developed the prognostic tool to predict 60-day survival of pediatric oncology patients. Factors associated with length of survival were identified through Kaplan–Meier and Cox analysis. Variables with the highest predictive values were identified and relatively scored. The salient variables were: Diagnosis, CNS/Solid Tumors being the reference scored as 0, and Leukemias/Lymphomas scored as 1Hemoglobin Level, greater than 8.0 g/dl being the reference scored as 0, and less than 8.0 g/dL scored as 1Home Care Giver, Mother being the reference scored as 0, and Other scored as 1Performance Scale scored by the Home Care Giver (Lansky Play Perfomance Scale for patients aged 0-16 years, Karnofsky Performance Scale for patients older than 16), 100 - 80 being the reference scored as 0, 70 - 20 scored as 1, and 10 - 0 scored as 2.5.These variables were re-tested in this study, and the variable “number of symptoms” was added for testing, which was found not to change the predictive value. Total scores ranged from 0 – 6.5. The patients were divided into three terciles (2005-study probabilities in parentheses): A, scores 0, 60-day survival probability 80% (84.4%) B, scores 1.0 – 1.5, 60-day survival probability 38% (57.8%) C, scores 2.0 – 6.5, 60-day survival probability 28.5% (15.4%).Some thoughts: To think the unthinkable is what we do. Being involved in the care of families with children with terminal cancer is difficult. Having validated notions of where things stand is helpful in gauging the type, timing and frequency of team interventions is grounding. Plus, they provide a focus for communication with these families. I didn’t find much out there lately on prognostic tools for pediatric patients with non-acute, life-threatening/life-limiting diagnoses; there's a fair amount on acute-illness, ICU survival. Semantically, the authors/editors use the term palliative care when it more precise to use the term hospice, which I used in this post for framing. The logician in me didn't like the presentation of data/criteria that used greater-than and less-than, but did not account for values of equal-to. So, I think that there are some theoretical and systematic issues for full generalizability to practice in the Developed World, and to individual national health systems. However, these parameters are easily accessible and make clinical sense. We would do well to replicate and validate such prognostic tools for this population across systems. Kurashima, A., Latorre, M., & Camargo, B. (2010). A palliative prognostic score for terminally ill children and adolescents with cancer Pediatric Blood & Cancer, 55 (6), 1167-1171 DOI: 10.1002/pbc.22644... Read more »
Kurashima, A., Latorre, M., & Camargo, B. (2010) A palliative prognostic score for terminally ill children and adolescents with cancer. Pediatric Blood , 55(6), 1167-1171. DOI: 10.1002/pbc.22644
by Brian McMichael, MD in Pallimed: a Hospice & Palliative Medicine Blog
An article in the December 1st issue of Pediatric Blood and Cancer presents the validation of a prognostic tool in pediatric hospice care. The study was produced by a team from the Hospital A.C. Camargo, a large cancer center in São Paulo, Brazil, which developed the prognostic tool to predict 60-day survival of pediatric end-stage oncology patients.... Read more »
Kurashima, A., Latorre, M., & Camargo, B. (2010) A palliative prognostic score for terminally ill children and adolescents with cancer. Pediatric Blood , 55(6), 1167-1171. DOI: 10.1002/pbc.22644
by Brian McMichael, MD in Pallimed: a Hospice & Palliative Medicine Blog
On a new paper in the Annals of Internal Medicine by Alex Smith & Eric Widera of GeriPal.... Read more »
Smith AK, Cenzer IS, Knight SJ, Puntillo KA, Widera E, Williams BA, Boscardin WJ, & Covinsky KE. (2010) The epidemiology of pain during the last 2 years of life. Annals of internal medicine, 153(9), 563-9. PMID: 21041575
by Brian McMichael, M.D. in Pallimed: a Hospice & Palliative Medicine Blog
I thought I would post on what I hope will turn out to be an occasional series on sexuality here on Pallimed. We've covered sexuality some before. A post that leaps to mind is one by Christian in 2007 about the controversy that arose over a case where the staff at the world's first hospice designed specifically for young adults openly deliberated and decided to facilitate a 22-year-old patient's request to have sex before he died.
So, my foray is on an article that came out in the July-September 2010 issue of Sexologies. This English-French bilingual publication is, and I quote, "the official organ of expression of the European Federation of Sexology (EFS), published with the scientific cooperation of the Inter University Hospital Association of Sexology (AIHUS), which has gathered French academic teachings of Sexology since 1983." So, it's scientific, it's academic and it's French. Need I say more?
It turns out, that this article actually was available online this past April, but there's no time like the present. Titled, "Sexuality of individuals in the end-of-life stage," it was authored on this, our very own continent by M.-I. Rothenberg, PhD, a psychotherapist and clinical sexologist in private practice in Orlando, FL and A. Dupras, PhD, a professor in the Department of Sexology, Université du Québec, Montréal, QC.
The article is a theoretical and often psycho-dynamic discussion with case studies, which uses the Kübler-Ross "Five Stages of Death" model as a framework. I particularly appreciated the part in the introduction that highlighted the common experience of reticence and hesitancy on the part of professionals to address sexuality in palliative care, and that if we do address it, we tend to medicalize it, rather than offer information and support that is responsive, reflective and anticipatory. I also found that the narratives from the case studies were interesting, illuminating, some even compelling.
After our humanity, sexuality is our next great category of being, ranging from gender through sex roles, attachment and reproduction. It is at once social and deeply personal. The physiology of aging, life-limiting-disease pathology, pharmacology, surgery, radiation therapy, pain, family dynamics and existential suffering can all have bearing upon one's sexuality. Our reluctance to address these issues, to contextualize and normalize them, particularly our diffidence to even bring it up, creates a sound of silence that can be deafening.
The Kübler-Ross model has been criticized as non-scientific, i.e., that it did not arise as a predictive model accounting for validated, objective data of a phenomenon, but rather from reflection on global interviews of dying people. A lot of criticism also centers on attributions of progression and linearity. However, Kübler-Ross herself wrote that not everyone goes through every stage, that their order and direction is often fluid, alternating and circuitous, and above all individual. I think the main boon of the Kübler-Ross model, as a starting point, and this application of it with regard to sexuality is they lead us to give some thought and allow some room. They poise us to better grasp, accommodate and support the complex, individualized and sometimes confounding needs and behaviors that come up in taking care of patients and family members living with death and dying.
Rothenberg, M., & Dupras, A. (2010). Sexuality of individuals in the end-of-life stage☆ Sexologies, 19 (3), 147-152 DOI: 10.1016/j.sexol.2010.03.006
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Rothenberg, M., & Dupras, A. (2010) Sexuality of individuals in the end-of-life stage☆. Sexologies, 19(3), 147-152. DOI: 10.1016/j.sexol.2010.03.006
by Lyle Fettig, MD in Pallimed: a Hospice & Palliative Medicine Blog
Drawing of a nasal cannula from Wikimedia Commons
It's a common assumption amongst both the general population as well as medical professionals that breathlessness equals some problem with oxygen delivery, and therefore, every patient with dyspnea should have at least a little bit of oxygen delivered through a nasal cannula regardless of their oxygen saturation (sometimes endlessly). Because of the ubiquitous nature of oxygen therapy, why not? It helps many patients, and it makes sense that the higher concentration of O2 molecules represents the critical component of the therapy. It's been shown to palliate dyspnea, improve functional status, and prolong life in patients with COPD with hypoxemia.
Hypoxia isn't always the cause of dyspnea, however, and Abernethy et al. set out to test the hypothesis that room air delivered by a concentrator at 2 liters per minute might rival the efficacy of oxygen delivered at the same rate for patients with advanced disease, refractory dyspnea, and normal blood oxygen concentrations (Pa02 >55 mmHg). The results of the double-blind, randomized control trial were published in Lancet recently.
The trial population included patients with a variety of primary diagnoses with COPD (60-63%) the most common, lung cancer (13-15%) second most common, and several others. The average age was 73-74. At baseline, patients were also similar with respect to dyspnea measurements, QOL, and partial pressure of arterial oxygen and carbon dioxide. The majority of patients had an ECOG performance status between 1 and 3.
Of 567 patients referred, 239 were eventually randomized with the most common exclusion criteria including the presence of a recent prescription for O2, acute cardiopulmonary event recently, hypercapnea, hypoxemia, anemia, or delirium.
Patients received seven days of either oxygen or room air delivered by a concentrator. Why seven days? Because in a pre-trial survey, it was determined that palliative care practitioners might be influenced by a trial that lasted for at least seven days! (Great planning.) The primary outcome measured was the patient's rating of restlessness on a numerical scale (0-10) in the morning after waking up and before going to bed for each of the days. A clinically significant response was defined as a reduction in breathlessness rating of >1 on the numerical scale, and measurements for the two groups were compared on all days of the study (as well as a few days before). There were several secondary outcomes.
The primary outcomes:
Breathlessness measurements were similar throughout the seven days of the trial when the two groups were compared.
Morning dyspnea: 58 (52%) of 112 patients assigned to oxygen and 40 (40%) of 101 patients assigned to room air responded to the interventions (statistically significant difference).
Evening dyspnea: response rates were 42% for both interventions
(oxygen, n=47; room air, n=42).
Over intervention period, breathlessness scores of both groups improved significantly.
Secondary outcomes such as other measurements of dyspnea and quality of life did not differ between the groups. The proportion of patients reporting severe dyspnea or dyspnea that disturbed sleep decrerased in both groups similarly.
Severity of baseline dyspnea did predict response to therapy in both groups for both morning and evening measurements (the patients with worse dyspnea were less likely to respond to either therapy). Use of oxygen did predict morning response but not evening response.
Breathlessness was not measured with activity, but subjects desire for Oxygen therapy was measured at the end of the trial. Interestingly, distributions of preferences were similar between groups:
18% of all participants didn't want oxygen therapy afterwards.
26% said they derived no benefit
48% requested oxygen
The population studied was heterogeneous. The authors draw no conclusions regarding differences based on disease state. I look forward to the authors' further analysis to help determine whether diagnosis matters.
This study got me thinking a little more about some questions:
When is room air really room air?
Medical air may have the same concentration of oxygen in it as room air, but the effect of flow/ turbulence produced by the nasal cannula may have a salutary effect on dyspnea regardless of the concentration of oxygen. In addition to a placebo effect occuring in both groups, there is likely therapeutic benefit of forced air (the authors reference studies indicating the benefit of a simple, hand-held fan, for instance).
Should we provide air via concentrator rather than concentrated O2 in some cases?
No. Maybe if oxygen therapy weren't so ubiquitous and medical air were the standard of care already, maybe you could make that case. Although I don't know for sure, I'm going to guess that a room air concentrator is similar in cost to an oxygen concentrator, so I'm unsure of any cost implications. Even though the the null hypothesis has been confirmed, the authors suggest that oxygen therapy should still be tried briefly and then "less burdensome" strategies should be considered depending on the effect in the individual patient.
Is that conclusion strong enough?
I'd go a mini-step further. For hospice patients where I practice (and I'm assuming with most American hospices), even a hint of dyspnea often equals automatic ordering of oxygen therapy. The symbolism of oxygen arriving at a person's home is rich. Hospices are rightfully out to win the trust of patients and families, and the efficient delivery of DME (especially something that patients are only accustomed to seeing in ambulances, emergency departments, and hospitals) sends a signal that the hospice means business! This study doesn't influence any of that symbolism.
Perhaps if a patient with mild to moderate dyspnea does not have oxygen in the home (and especially for those who may have a recent documented normal oxygen saturation), this study helps us put a mental brake on ordering oxygen momentarily. This study may corroborate that there are a number of patients who have experienced nasal cannulas, hate them, don't want them, but many will silently submit to our desire to help by throwing one on them. For these patients, turn up the fans and give them a little morphine (if they so desire). This study doesn't prove the efficacy of a nice fan vs. oxygen, but it's probably as close as we'll get, and the results show that O2 isn't the be-all, end-all. So we shouldn't feel compelled to say "you have to wear it or else."
Other patients may be ambivalent. Concerns should be explored and perhaps a trial of other therapies offered. Many patients will still ask for oxygen therapy, and this study wouldn't change our response to that request but informs how we teach patients about their symptom regardless.
What about the hospitalized setting and sicker patients?
Indeed, the authors point out that this was a population that still had a fair performance status and little dyspnea at rest. This was entirely an outpatient population. The former point is especially important to keep in mind- the results may not apply to a sicker crowd with more severe symptoms.
What do you think? Does this study influence your practice or intrinsically change how you view dyspnea? This is a great one for journal clubs.
Abernethy, A., McDonald, C., Frith, P., Clark, K., Herndon II, J., Marcello, J., Young, I., Bull, J., Wilcock, A., & Booth, S. (2010). Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial ... Read more »
Abernethy, A., McDonald, C., Frith, P., Clark, K., Herndon II, J., Marcello, J., Young, I., Bull, J., Wilcock, A., & Booth, S. (2010) Effect of palliative oxygen versus room air in relief of breathlessness in patients with refractory dyspnoea: a double-blind, randomised controlled trial. The Lancet, 376(9743), 784-793. DOI: 10.1016/S0140-6736(10)61115-4
by Brian McMichael, MD in Pallimed: a Hospice & Palliative Medicine Blog
focused on an ethical dilemma at end-of-life. It got coverage in the mainstream media as well, about a women who collapsed on an airplane with a pulmonary embolism, had severe anoxic brain injury, and the family requested her oocytes be harvested.... Read more »
Greer DM, Styer AK, Toth TL, Kindregan CP, & Romero JM. (2010) Case records of the Massachusetts General Hospital. Case 21-2010. A request for retrieval of oocytes from a 36-year-old woman with anoxic brain injury. The New England journal of medicine, 363(3), 276-83. PMID: 20647203
by Drew Rosielle MD in Pallimed: a Hospice & Palliative Medicine Blog
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?
Leithner 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
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Leithner 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
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