Thursday, March 26, 2015

Stopping statins in serious illness doesn't change survival...or does it? Sorting out the message



by: Alex Smith, @AlexSmithMD

We've talked previously on GeriPal about Dumb Medicine: continuing preventative treatments near the end of life.
  • In one study of patients diagnosed with advanced incurable cancer and an average life expectancy of less than 2 years, up to 15% were being screened for another cancer that had no chance of harming them in their lifetime.
  • In another study of women with dementia and an average life expectancy of less than 3 years, 18% were being screened with mammograms for a breast cancer that if detected, would not harm them in their lifetime.  
Key features of both of these studies:
  • Preventive treatments have a lag time to benefit.  Cancer screening is designed to detect slow growing cancers that will not cause symptoms or harms for about 10 years.
  • The harms of testing are real.  False positives are no joke.  Detecting a clinically insignificant cancer can lead to tests and treatments (think biopsy, surgery, chemotherapy, radiation) for a cancer that is unlikely to harm the patient in their lifetime.
  • The focus on prevention displaces time that could be spent on supportive and palliative interventions.
This week, we have a new study by the fabulous palliative care researcher Jean Kutner and colleagues to add to this list.  I think the new study pushes the envelope of Dumb Medicine.  It's self-evident that we should not continue cancer screening for patients with life expectancies of 2-3 years.  The new study examines statin use for patients with a life expectancy of less than a year.  

Now statins are a slightly different beast from cancer screening.  They are preventative, certainly.  They have a lag time to benefit on the order of years.  They have harms, ranging from pill burden to cost, and risks, ranging from myopathies to rhabdomyolosis.  

But in the back of our heads, maybe we're wondering, might this medication be preventing a heart attack, or a stroke?  Maybe it's not so dumb to continue it after all.

Now we have new evidence that demonstrates that stopping statins (probably) doesn't change survival and likely improves quality of life.

Some of the aspects of the study are really important, yet because they're buried or in "researchees, i.e. the language of researchers" they are inscrutable to the average reader.  
  • 381 subjects with a life expectancy between a month and a year, about 1/3 in hospice, were enrolled from 15 sites in the Palliative Care Research Co-operative (PCRC).  The PCRC alone is BIG news.  You know how cancer trials are conducted in these research networks?  Now we have one for palliative care research! (disclosure - I'm writing this on a plane to the PCRC meeting)
  • 22% were unwilling to participate.  That's not a sky high number for enrollment in a study near the end of life.  However, it does suggest that some patients may be unwilling to even consider stopping statins.
  • Participants were randomized to continue statins or not.
  • This was a pragmatic trial.   This means that instead of trying to figure out why exactly statins might or might not impact survival under optimal research conditions, the authors were interested in 
  • The study was not blinded.  People knew if they were still getting a statin or not. They didn't get sham pills that were possibly a statin or a placebo.  Their doctors knew they were either still getting a statin or not.  This is important, because it's possible that stopping the statin may have clued the doctor in to stop other medications. Indeed the group that stopped statins also stopped on average almost one additional medication.
  • Quality of life was modestly higher in the group that stopped statins over time.
  • Mean cost savings given the average online drug price were $716 per patient.
  • On the one hand, there was no difference in the primary endpoint of death at 60 days following randomization.  24% of those who stopped statins died within 60 days, and 20% of those who continued statins died within 60 days.  The p-value for this difference was 0.36, and did not reach the threshold our society accepts as reasonable for saying a difference exists, or 0.05.  Theoretically, if we repeated the study 100 times, 36 times we would find no difference between stopping and continuing, and 64 times we would find a difference.  If the p had been .04, we would have said 4 only times we would find no difference and 96 times we would find a difference.  
  • On the other hand, the study did not reach it's non-inferiority endpoint.  What does this double negative mean in plain english?  If we untwist the double negative, does it mean that stopping statins is superior?  Not really.  Not non-inferior doesn't mean superior.  Here's what it means.  It means that the range of possible outcomes given the sample size of the study included the possibility that stopping statins could result in as much as a 10% increase in mortality at 60 days compared to continuing.  At the other end of the range, stopping might decrease survival by 3%, but it's the possibility that stopping might increase mortality that is the focus of the "non inferiority" analysis.
What are we to make of these last two points?  Is this a "mixed message"?  Possibly.  The authors conclude that for those patients whose goals are quality of life, the physician could counsel the patient to stop statins.  For those patients focused on maximizing chance of survival, we can't really say there isn't a slim chance they might prolong life.  

So now I'm going to take a stand that is a more definitive stance than the authors could take in an academic journal:
Stop. The. Statins.
Continuing statins for patients with a life expectancy of less than 1 year is nonsense.  Just stop it.  It's dumb medicine.  Continuing has no demonstrable impact on survival, and stopping leads to a higher quality of life at a reduced cost to society. 

The biggest barrier to stopping isn't that niggling voice in the physician's head saying, "maybe there's a chance the statin is helping."  The biggest barrier is the lack of support, lack of training, and fear of talking with the patient about the reality of their limited prognosis, and the implications of that prognosis for treatment.




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Wednesday, March 25, 2015

BREAKING: cancer therapy prolongs survival 6 months, worth 2-3 billion/year


by: Alex Smith @AlexSmithMD

An article was published yesterday that provides supporting evidence that a treatment* for advanced cancer improves survival by up to 6 months (18 vs 12 months).  This study was conducted in a population of patients with advanced cancer who had a prognosis of less than 2 years.  The first, earlier study of this treatment* to examine survival demonstrated a survival benefit of about 3 months in advanced lung cancer.

This is big news folks. 

A major question for our society - can we afford this treatment*? 

By way of comparison, Avastin (bevacizumab) increases survival by about 4 months, about the same as the average survival benefit of this treatment*. Avastin had sales of about $2-3 billion per year at the time it was released.  The average cost for Avastin per patient is between $40,000-100,000 per course of treatment.

How much as a society are we willing to invest in a treatment* that improves survival by 4 months in advanced cancer?

*Treatment is early outpatient palliative care.  Costs of outpatient palliative care are generally offset by cost savings from reduced resource use (hospitalizations, emergency department visits).  Costs are likely minimal to negative.  If this was a drug it would be worth billions, and the US would pay for it.
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Tuesday, March 17, 2015

The art of being a hospice genie: experience, presence, and caring

Photo by Joan Teno
Blog by: Amy Getter, a hospice nurse who blogs at hospicediary.com

I had been drained with frustration and immersed in the medical disaster we call home care this past week. Perhaps if I had never known the simplicity of visiting hospice nurses, before the medical giants of organizations and corporations had grabbed such a firm hold to significantly alter just a home visit by a nurse to a dying person, I would not have recognized what was startling.

Okay, I have agreed that it is imperative to standardize what we do, what we say, ensuring that our care is cloaked in the vestiges of the acceptable and researched and validated hospice and palliative care approach.

Last week we learned of a new shortage and increased cost of a medication (atropine) used for years for an end of life symptom: to reduce the gurgling sounds present at the last hours of many dying people, what hospice nurses term “respiratory congestion” and what the untrained average person still might call “the death rattle”. Very simply; it is no longer profitable to produce this very inexpensive medication. And some studies would report how ineffectual it is, though most of us who have initiated atropine drops early on, before respiratory congestion becomes something heard down the hall of the room where someone lies inert in their bed, breathing in gasping breaths- we would share with you in fact, it did help. It’s one of the latest terms I frequently read in research reports, with a sneering mention of the “anecdotal evidence” (just you uninformed hospice staff who work at the bedside and observe the results who might believe something)… not according to the lengthy research data gathered and scientifically reported that might question or even invalidate what you do.

This past week also brought a stunning fact to light; a medication that I used well over a decade ago as a daily injection to treat my patient’s bowel obstruction, (and long since beyond the trial period of patent and trademark regulations requiring exorbitant amounts of reimbursement to the pharmaceutical research and development team); that same medicine, for that same treatment, is suddenly difficult to obtain, but not the once-a-month-injection at the cost of nearly $4,000 dollars. (Yes, I am talking about Octreotide.) Research and Development, latest studies that defunct effective treatments, insurance reimbursement issues clog my hospice pores!

Enough ranting; back to my visit.

I called to say I was stopping by. The husband, a little harried sounding on the phone, said “That would be great”. As I entered, I could hear his dying wife mumbling in the bedroom, she had been incoherent and incontinent overnight, becoming increasingly restless and even a little belligerent, and he seemed at a loss how to begin to disturb her. I spoke quietly to her, explaining what we wanted to do in order to get her cleaned up; I could see just a flicker of understanding with a mumbled okay. We turned and washed the dying woman’s body, adjusting pillows and limbs and soothing her with quiet words, and just then her sister came back home. While I finished my careful check of signs that indicated she had only hours or perhaps a couple of days left in her struggle to leave this life, I heard her family in the hall whispering, “How did she know?” When I came out of the room, the sister said simply, “I have to hug you. You are like a genie, showing up just when we need you -Our own hospice genie- I believe it is the way things happen in life, and I’m just so thankful”.

The startling truth: I do this work to share these moments with family who are struggling to keep their loved one in their own home and provide a peaceful, loving environment. I did no great thing, I arrived and showed compassion, I knew the medicine that would alleviate some of her discomfort, I knew how to help turn someone in a bed when they cannot help themselves, I knew how to drizzle a little medicine into lips that could no longer purse together around a straw, I knew how to touch a hand and whisper comfort to a person who was not my loved one, but another struggling human being who, like us all, is having to come to terms with losing all her human abilities and becoming totally dependent on others at the end of her life.

Please, please, please… as we yearn to do more, and do better, for the suffering that we call dying…let us not lose the simple truth of caring for people as their life is ebbing. Buried beneath the latest research and experimental treatments lies a mere act of humanity: to be present and to care. As Mother Theresa said, “Not all of us can do great things, but we can do small things with great love”.
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Saturday, March 14, 2015

Ageism in Healthcare Hurts Our Patients


by: Stephanie E. Rogers, MD @SERogersMD

For the first time in human history, adults older than age 65 will outnumber children younger than age 5.(1) In medical school, we receive training in treating young patients during the pediatrics lecture series and later in an extended clinical rotation, yet the training we receive for treating geriatric patients is significantly lacking. It was not until I entered my fellowship in geriatrics - after completing four years of medical school and three years of internal medicine residency - that I received any formal training in the care for older adults.

Pediatric units are common at most hospitals, where multidisciplinary teams including nurses and pharmacists are specialized in treating children and most children have access to an outpatient pediatrician. In contrast, few health systems have adopted the specialized models that exist to provide cost-effective care for older adults in hospitals, clinics, and at home. Furthermore, plenty of research literature exists regarding the care and treatment of children, while it is commonplace to exclude older adults from clinical trials due to age or multiple comorbidities, despite the fact that they are likely to benefit from the study interventions.

The presence of ageism is a glaring deficiency in our current health care system. Ageism is the “systematic stereotyping of and discrimination against people because they are old, in the way that racism and sexism discriminate against skin color and gender.”(2)  In our study published online today in the Journal of General Internal Medicine,(3) we report that this systematic discrimination by doctors and hospitals leads to earlier functional decline in patients. Using the Health and Retirement Study, a nationally-represented sample of 6,017 adults older than age 50, we found that 1 in 5 older adults reported experiencing discrimination in the healthcare setting. Those who reported the most frequent discrimination were more likely to have developed new or worsened disability over the next 4 years. The most common reason reported for this discrimination was age.

Promoting health and well being for our diverse population cannot be achieved without paying attention to the precise needs of our aging nation. As a healthcare system, we have neglected our future selves long enough. Our older patients deserve our devotion, in particular because of their age. Their long life experience and contribution to society should allow them the same attention and quality of care we offer to our children.


References
  1. UN Department of Economic and Social Affairs Population Division: World Population Prospects, 2012 Revision http://esa.un.org.ucsf.idm.oclc.org/unpd/wpp/index.htm (accessed March 3, 2015). 
  2. Butler, RN. Why survive? Being old in America. Johns Hopkins University Press, Baltimore, MD; 1975. 
  3. Rogers, SE. et al. (2015). Discrimination in Healthcare Settings is Associated with Disability in Older Adults: Health and Retirement Study, 2008-2012, Journal of General Internal Medicine. DOI: 10.1007/s11606-015-3233-6.
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Friday, March 13, 2015

Searching for Successful Aging


by: Jeffrey M. Levine MD, AGSF (jlevinemd@shcny.com), www.jmlevinemd.com

Successful aging is hard to define. The concept took root in 1987 when Rowe and Kahn published an article distinguishing “successful aging” from “usual aging.” Since then, scholars have been grappling for a definition but with little consensus. As discussed in a recent special issue of The Gerontologist (V 55 #1, February 2015) there are numerous directions from which the successful aging concept can be approached (see also this previous GeriPal post).

As a geriatrician who spent much of my career in nursing homes with the sickest sick I grapple with the concept of successful aging. Early on I noticed that two persons of the same advanced age can have vastly different states of health, functional status, family structure, economic status, and social standing. Lifestyle, personal choices, attitude, and coping mechanisms often had an influence on how people lived in their advanced years.

The Gerontologist is the flagship journal of the Gerontological Society of America, and I have been exploring successful aging through visual expression on its covers. The first cover I published was in 1996, not long after completing my geriatric fellowship. It featured my teacher, Dr. Manuel Rodstein, who was well into his 80’s and Director of Research at the Jewish Home, affiliated with Mount Sinai Medical Center. A gentle scholar and towering intellect, he published hundreds of papers on geriatric cardiology and taught me Latin phrases that he learned in medical school.

Back then to do photography you needed heavy equipment and a darkroom full of chemicals – a far cry from the pocket devices that proliferate today. My first Manhattan apartment was a small brownstone walk-up that I converted into a studio and darkroom which had barely enough space to sleep. As photographic technology evolved and my career progressed I continued to explore successful aging on the cover of The Gerontologist and my images have appeared on over 50 covers. Each one has its own story.

When the editors of The Gerontologist asked me to provide a cover for their special issue on Successful Aging I knew who I would photograph. I contacted Tao Porchon-Lynch who, in her 90’s, is in the Guinness Book of World Records as the oldest living Yoga instructor. She is also a dancer, and I met her at the Fred Astaire dance studio in Westchester with her 26 year old dance partner, Vard Margaryan. I spent an hour photographing her as she glided across the floor, and her personality was as sparkling as her dress.

As a geriatrician I am constantly aware of the common human destiny of growing old and the need for a view of aging that inspires and teaches. I use my images to demonstrate how human beings can thrive as they journey into old age while probing their spirituality and showing diversity and strength. My goal is to open a door to the fullness of the life experience and come into closer creative contact with my own aging. Hopefully I too will be successful.

Note:
Watch a video that features Dr. Levine’s Gerontologist cover photos through 2011 (YouTube link here)

 

Dr. Levine’s photographic exhibit entitled An International Celebration of Aging will be on Exhibit at the University of Michigan as part of their Gifts of Art program from June 15th to August 23rd. Dr. Levine’s blog is at www.jmlevinemd.com. Follow Dr. Levine’s art on Instagram @jlevinemd.
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Wednesday, March 11, 2015

Does Octreotide Work for Malignant Bowel Obstruction?


by: Colin Scibetta, MD (@colinscibetta)

Malignant bowel obstructions are a known complication of advanced cancer, especially in ovarian and gastrointestinal, and a frequent reason for admission to the hospital. Somatostatin analogues (such as octreotide) reduce gastric secretions and intestinal activity and there is some evidence for their use in improving symptoms of malignant bowel obstructions.

A randomized control trial published last year out of Australia[1] sought to understand the benefit, if any, of adding IV octreotide to a standardized regimen of steroids and histamine blockers.

A little about the Study

This was a double blind, placebo controlled randomized trial of patients with nausea and vomiting from a confirmed malignant bowel obstruction. Patients were enrolled at multiple sites by providers from different specialties (ER, general medicine, oncology and palliative care) after the diagnosis was confirmed and assuming they did not meet criteria for immediate surgery or chemotherapy. Patients were randomized into Standard Therapy (placebo + IV dexamethasone, Ranitidine, IV hydration) or Octreotide groups (standard therapy + octreotide 600mcg infused over 24 hours). They included patients older than 18 years with advanced cancer, presenting with vomiting from malignant bowel obstruction between August 2008 and May 2012.

They excluded patients who had immediate indication for surgery or cancer directed therapy after consultation with the patient’s oncologist. Additional exclusion criteria included severe renal impairment, cirrhosis, existing venting G or J tube, a previous adverse reaction to any of the study drugs, and an Australian-modified Karnofsky performance score of less than 30.

The authors looked at a lot of different outcomes. The primary outcome was the number of days free of vomiting as reported by patients at 72 hours. They also looked at a host of secondary outcomes, including a patient-rated Global Impression of Change (GIC) scale, number of patient-reported episodes of vomiting per day, survival, nausea, brief pain inventory, functional status, PRN medication use (as dictated by the study protocol), and treatment failure. Treatment failure was defined as persistent vomiting, insertion of NG or venting G tube, or surgery.

The PRN medication protocol included hyoscine butylbromide (an anti-spasmodic medication) for colicky pain, opioids for non-colicky pain, and haloperidol or metoclopramide for nausea and vomiting.

Did Octreotide work for malignant bowel obstruction, as measured by the primary outcome?

No. There was no difference in mean number of days free of vomiting between the octreotide (1.87 days) and Standard Therapy group (1.69), with p-value of 0.47. In fact, patients in both groups demonstrated a significant drop in number of episodes of vomiting between day 0 and day 1.

There were also no differences detected in patients reported Global Impression of Change scores, presence or intensity of nausea, pain scores, or survival. Patients in the octreotide group were more likely to be administered hyoscine butylbromide for colicky abdominal pain (p=0.004). The study was not powered to detect differences in secondary outcomes.

Of note, the authors comment in the results section of the paper that after an adjusted multivariable regression analysis of secondary outcomes, they found a statistically significant reduction in the number of episodes of vomiting in patients treated with octreotide (RR=0.40, p=0.019). Interestingly, this was not mentioned in the discussion section and did not appear to influence the authors conclusions.

Key things to consider when interpreting this study

It is worth mentioning that the dose of octreotide used in this study was higher than that in previous studies (600 mcg/24 hours), and the authors do not address this. In addition, the standard regimen of IV ranitidine and dexamethasone used in both the control and treatment arms of the study is far from universal, and in fact varies widely across clinical practices. Importantly, patients in both arms of this trial reported marked improvements in symptoms and overall GIC score over the course of 3 days -- in particular between days 0 and 1. This change was statistically significant, and highlights that patients in both arms tended to improve, regardless of whether they received octreotide. Whether this reflects the natural history of malignant bowel obstructions in this population or the efficacy of the "standardized" medical therapies given to both groups is not clear.

Additionally, this study does not tell us about the potential benefit of octreotide therapy beyond a 72 hour window. Questions about the benefit of longer term dosing of octreotide in patients with recurrent or non-resolving malignant bowel obstructions are not addressed by this study.

What’s the take home point?

Ultimately, the results of this well designed and rigorously implemented randomized control trial do NOT support the use of IV octreotide in the acute management of malignant bowel obstruction. Not only did octreotide fail to demonstrate a reduction in vomiting over a 72 hour period (primary outcome), there was no meaningful difference in any of the secondary outcomes – such as pain, episodes of vomiting, or nausea.

The lack of demonstrated benefit is important because octreotide is a costly medication that requires either continuous, frequent subcutaneous or IV dosing, or long-acting depot formulations that may take several weeks to reach therapeutic levels. Furthermore, the observed increased use of anti-spasmodics in the treatment group raises the possibility that octreotide may even contribute to abdominal discomfort in these patients.

References
[1] Currow DC, Quinn S, Agar M, et al. Double-blind, placebo-controlled, randomized trial of octreotide in malignant bowel obstruction. Journal of Pain and Symptom Management. 2014.09.013. [Epub ahead of print]
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Wednesday, March 4, 2015

How to Succeed at the #ThickenedLiquidChallenge

by: Kelley Babcock, MS, CCC-SLP, BCS-S, @kelleybabcock

The #thickenedliquidchallenge has certainly raised awareness of how difficult it can be for patients to enjoy honey-thickened liquids. Many physicians and speech pathologists have never tried the liquids they so frequently prescribe to patients, so this increased awareness may help initiate important conversations with patients, clinicians and family members about quality of life and patientʼs rights to decline recommended interventions.

Unfortunately, this challenge has been named the “thickened liquid challenge,” which could be confusing for patients who find these videos on YouTube. A more accurate name would be the “honey-thick liquid challenge.” While I almost never recommend honey-thickened liquids (see my blog here for rationale), I do recommend nectar-thickened liquids with appropriate patients. I do this judiciously and using the following decision-making process:
  1. Does the patient show consistent aspiration on an instrumental evaluation of swallowing?
  2. Is there a significant reduction in aspiration with trials of thickened liquids during the instrumental evaluation?
  3. Is the patient at increased risk of pulmonary infection? (see blog post here on factors other than aspiration that place patient at risk for pneumonia) 
  4. Have I attempted compensatory modifications that have been unsuccessful in eliminating aspiration (e.g.: postural techniques, improving sensory awareness, and modifying the volume & speed of food presentation)?
From this algorithm, I can present the patient with an objective diet recommendation as well as the rationale behind the recommendation. The patient then has the opportunity to ask questions and communicate their wishes regarding the diet, and finally a diet is ordered based on this shared decision-making interaction.

Diet modification should be the last compensatory strategy utilized in management of dysphagia (Logemann, 1998), but it is a reasonable and appropriate recommendation for many patient populations. The participants in the #thickenedliquidchallenge make the recommendation of a thickened liquid diet look impossible to complete, but as I watched the videos, I kept thinking to myself, “they are doing this all wrong!” I completed a 12 hour challenge and drank over 80 ounces of fluid without getting sick, overly thirsty, overly full or feeling dry. I also didnʼt drink anything that could be called “gross,” “goopy,” or “sludge.” Below are a few recommendations for SLPs, physicians and patients on how to succeed on a thickened liquid diet.

1. Change your thickener. The most common thickener I saw used in the #thickenedliquidchallenge was the super cheap cornstarch-based thickener that is found at the local pharmacy. Though this thickener will certainly do the job, it can also turn your beverage into sludge. Because cornstarch continues to thicken over time, what was initially created to be a nectar-thickened liquid may become pudding-thick after sitting around for a while. Cornstarch-based thickeners are also more difficult to use with carbonated beverages and can thicken way too much with hot liquids.

Xanthum gum-based thickeners are a newer breed of thickener which maintain a more consistent viscosity (thickness) across time, temperature and base fluid (Mills, 2008). They have been found to have a more “slick” feeling in the mouth which is reportedly more pleasant for consumption. Unfortunately xanthum gum-based thickeners are more expensive and many facilities refuse to transition to them.

Many of my patients prefer pre-mixed thickened fluids. They maintain their viscosity over time and are a consistent, convenient option.

Below are two 4 ounce glasses of nectar-thickened liquid after sitting for 45 minutes. The image on the left is the xanthum gum-based thickened liquid while the goop on the right is the cornstarch-based thickener.



2. Prepare thick liquids correctly. This may seem silly, but make sure that the amount of thickener and liquid is correctly measured when mixing up thickened liquids. Most thickeners come with measuring spoons right inside or are in individual packages for single use. If your thickener does not have a measuring spoon, grab one out of the kitchen drawer & leave it in the container for easy measuring. I recommend patients use shaker bottles that have ounces printed on the side so they can quickly identify the correct amount of liquid to prepare. These bottles are sold in grocery stores, and if the patient wants to be really fancy, they can pick up a bottle designed for protein shakes - these are quite large & have a mixer component within so consistent mixing is easy. If the liquid does not look to be the correct thickness, check the directions to ensure you have allowed the thickener enough time to work - donʼt just keep adding thickener.

3. Go naturally thick. Many liquids are naturally nectar-thick. Nectar-thick liquids should have a viscosity, or thickness level, of 51-350cP (centipoise). I recommend fruit  nectars (peach, apricot), Kefir, Kroger brand yogurt smoothies, thick tomato juice & soup and buttermilk. Many of the oral nutritional supplements found in hospitals are also nectar-thick. Resource Health Shake (150cP), Resource 2.0 (70cP), MightyShake Regular No Sugar Added (51-350cP), ProMod Liquid Protein (51-350cP), Carnation Instant Breakfast Lactose-Free Very High Calorie (95cP) are all nectar-thick without adding any thickener (Olsen & Kavlich, 2011).

4. Tips for improving mouth moisture. One of the major complaints from the #thickenedliquidchallenge participants was that their mouths felt very dry. I recommend ice chips and small spoonfuls of water after good oral care for patients who are on thickened liquid diets. Our lungs can tolerate small amounts of aspiration of water (Coyle, 2011). What they do not tolerate well are large amounts of aspiration of soda, coffee and juice. There are a few lines of oral moisture products - mouth sprays, mouthwash, gum, toothpastes - that can help the mouth feel less dry. Good oral care also helps keep the mouth feeling moist and helps protect against pneumonia.

Thickened liquids themselves have not been found to “dehydrate” patients on their own. In 2007, Sharpe and colleagues found that both cornstarch- & gum-based thickeners released 95+% of their fluid content in both rat and human trials. What the #thickenedliquidchallenge sought to highlight was reduced oral intake of fluids when patients did not prefer the liquids they were prescribed. While this certainly can occur, we as clinicians must ensure that patients understand the risk they are taking when refusing a prescribed diet. The patient in the image below did not believe that he had any difficulty swallowing. He had been hospitalized three times in one year for pneumonia - once with sepsis, but never coughed or had any overt signs of aspiration during mealtime. On modified barium swallow study, he was found to have profound dysphagia with thin liquids, but was able to significantly reduce the quantity of aspiration when his liquids were thickened to nectar-thick. He did great with a nectar-thickened liquid diet and has not had pneumonia since. 

Remember that even though thicker liquids may seem to be less pleasant to you, aspirating and coughing throughout a meal is also not pleasant. Each patient deserves our thoughtful consideration of their present situation, prognosis, and wishes when determining their personal diet recommendations. Just as no clinician would recommend that every patient with dysphagia be placed on a thickened liquid diet, no clinician should say that patients should never be placed on one. Many more studies of the long-term outcomes of the use and non-use of thickened liquids in dysphagia are needed, and I invite the geriatric community to join us in the speech pathology world to engage in these investigations. We speech-language pathologists need to engage with patients, families, and other team members to implement evidence-based practice, support ethical decision-making, and provide good guidance in the implementation of thickened liquids so that any negative impact on quality of life can be minimized or avoided and any expected benefits fully realized (Balandin, Hemsley, Hanley, & Sheppard, 2009).



References
  • Balandin, S., Hemsley, B., Hanley, L., Sheppard, J.J. (2009, September). Understanding mealtime changes for adults with cerebral palsy and the implications for support services. J Intellect Dev Disabil. 34(3):197-206. 
  • Coyle, J. (2011, December). Water, Water Everywhere, But Why? Argument Against Free Water Protocols. SIG 13 Perspectives on Swallowing and Swallowing Disorders (Dysphagia). Vol. 20, 109-115. 
  • Logemann, J. A. (1998). Evaluation and Treatment of Swallowing Disorders, (2nd Ed.), Austin, TX: Pro-ed Publishers. 
  • Macqueen, C. E., Taubert, S., Cotter, D., Stevens, S., & Frost, G. S. (2003). Which commercial thickening agent do patients prefer? Dysphagia, 18, 46–52. 
  • Mills, R. H. (2008, October 14). Dysphagia Management: Using Thickened Liquids. The ASHA Leader. 
  • Olson, E & Kavlich, S. (2011, November). Viscosity Levels for Oral & Enteral Feedings. Retrieved from http://www.nutrition411.com/content/viscosity-levels-oral-and-enteral- feedings 
  • Pelletier, C. A. (1997). A comparison of consistency and taste of five commercial thickeners. Dysphagia, 12, 74–78. 
  • Sharpe, K., Ward, L. Cichero, J., Sopade, P., & Halley, P. (2007). Thickened fluids and water absorption in rats and humans. Dysphagia, 22, 193-203.
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Wednesday, February 25, 2015

Using video to jumpstart The Conversation: a book review


Reviewed: The Conversation, by Angelo Volandes

Reviewed by: Alex Smith

Using video to help patients with serious illness make decisions about future care seems like a “no brainer.” Think back to your early training. Remember being at the code for that patient with advanced cancer, wondering why he wasn’t DNR? If he could only have “seen” what it was like to be coded, to be in the ICU, to live on machines. The allure of video is obvious. But as with any thing that seems too good to be true, the reality of using videos to jumpstart goals of care conversations is more laden with potential pitfalls than is apparent on the surface.

Thankfully, we have Angelo Volandes. In his book The Conversation, Angelo uses stories of patients he has cared for to build the case for video. He does this slowly, deliberately. He exposes the limitations of language through his own stories of caring for patients, where he wishes the conversation had gone differently. He does this with humility. He exposes his own mistakes with a touch of self-deprecation, as in this conversation with Helen, a Harvard poetry professor hospitalized with an invariably fatal form of brain cancer, who asks Angelo:
“What happens at the end?”

“In the end the intracranial pressure becomes untenable, causing the blood pressure to elevate drastically, the lungs to stop breathing, and the heart to slow until it stops. It’s called Cushing’s Triad.”

A bead of sweat ran down my forehead. Had I really just said “Cushing’s triad?” I was hiding behind medical jargon. What I really needed to say to Helen was that no matter what anyone might do, she would die very soon.
Angelo later takes Helen on a tour of the ICU. In the midst of the tour Angelo is called into a code blue for an ICU patient. The code is witnessed by Helen and her husband.  Disturbed by what she sees, Helen decide to shift to focus on comfort care. Helen is discharged with hospice and dies at home, surrounded by family and her students.

This is the ah-ha moment. To reach more patients, Angelo unites his passion for improving goals of care conversations with his boyhood dream of becoming a film-maker. He starts to use video in the care of patients with serious illness to dramatic effect.  He creates video examples of what it would be like to chose life prolonging care, limited medical care, or comfort care.  Angelo starts to study the use of video.  After viewing the video, patients are more informed, would recommend use of the video to others, and are more likely to chose a comfort oriented approach when compared to a scripted conversation.

Now, I happen to know Angelo well. We were in fellowship at the same time - he in bioethics, me in palliative care – and we did our research training together. I know that the story is more complicated and the journey toward video rockier than depicted in the book.

I remember a research class where Angelo showed a video of a woman with Advanced Dementia. In the video she is lovingly cared for by her family. The voice-over describes the clinical course of advanced dementia. Our course instructor for this session, a Geriatrician, asked the class, “did anyone notice anything unusual about the woman in the video?” We didn’t. “Her mouth was open and her tongue was hanging out of her mouth. Many people with advanced dementia don’t have that appearance. Might the image of the tongue lolling out of the open mouth sway the viewing audience toward a decision that living in such a state is undignified?” We acknowledged that it might.

Angelo has put a tremendous amount of thought and work into addressing concerns such as these. The primary concern with the use of video is that it the video will be biased biased toward a comfort-oriented approach.  In response to these concerns, Angelo has removed testimonials from his videos, and decided to depict CPR on a dummy rather than on a live (or dying) person.

We need this sort of hard work and attention, because Angelo is right: video is a remarkably powerful tool. As one of his patients says, “if a picture is worth a thousand words, a video is worth hundreds of thousands.” Angelo likens his videos to the Kahn academy’s inversion of the schoolroom – empowering students with knowledge and leaving class time for discussions with teachers. And similarly, patients can be “activated” by videos to engage their physicians in thoughtful conversations about goals of care. He is careful to note that videos should supplement, not replace, conversations with healthcare providers.

This is a very important book.  It presents a remarkably compelling case for the use of video in advance care planning.  To be sure, the book is not without flaws. At times Angelo seems to want to teach a lay audience the intricacies of medicine, when a simpler explanation will do. The citations,  including journal names within the text, will likely be distracting for a lay audience. These are the challenges of someone who is used to writing meticulously cited journal articles learning to write a book for public consumption.

Overall however, we should be grateful for Angelo’s hard work in this area. Video, used correctly, does have the power to “revolutionize” end-of-life care, as the subtitle of the book suggests. It needs to be done thoughtfully, and with great care, an appropriately high bar for someone crafting a goals of care video for thousands, perhaps tens of thousands, perhaps millions of people.

Angelo Volandes

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Tuesday, February 24, 2015

#Thickenedliquidchallenge from a patient's point of view: provocative comments and a poll


http://youtu.be/GhnYXHupMYE?list=UUSYPBA9b_-26RCVY0Ps3Vog

by: Stan Terman

Michael Ellenbogen has dementia.  He took the #thickenedliquidchallenge.  He never wants to have thickenedliquids again, even if his life depends on it.  Is this ethical?

Click this link if the video doesn't appear below.



Michael Ellenbogen's video addresses the #Thickenedliquidchallenge from a patient’s point of view. 

Mr. Ellenbogen tries orange soda, one of his favorite drinks, with thickener.  He reports, "The taste was terrible.  The drink lost all of it's flavor, all of the enjoyment of my favorite drink was gone."  He goes on to say, "Many people do not understand that there's a lot more to eating than just getting the nutrition into our bodies.  The texture contributes a lot to how much you enjoy it." 

Mr. Ellenbogen states that if he had advanced dementia he would never want to be fed thickened liquids, "even if my physicians thinks that my life my continued living depends on it."

More generally, his experience and request bring up the issue on what people can or cannot request in Living Wills, and whether health care providers will honor their wishes. Patients who reach the stage of advanced dementia may have few choices other than to forgo food and fluid because they may have "No Plug To Pull"; that is, they may not depend on any high-tech, life-sustaining treatment.

In a recent blog, Tia Powell, M.D., asked this question: "Can advance care directives ethically specify that oral feeding be withheld?" (Her essay’s lead title is: "Bioethics is not about technology" and can be found at this link, along with some discussion.

Dr. Powell stated, "A patient cannot decline a basic healthcare measure that is not a medical treatment. People cannot request that they not be bathed, or kept warm, or covered... Oral food and drink belong in this same category of basic human care, rather than in the category of medical intervention. An advance directive cannot appropriately ask that basic nourishment be withheld from a person in end-stage dementia..." Powell then asks: "Can an Advance Directive Be Cruel?" Her answer (in part) is: "An advance directive can clarify values and preferences for future treatments, but cannot ask a person, an actual person, to do something he or she should not be asked to do."

Michael Ellenbogen and I disagree. Michael is living with dementia. I helped him complete his Advance Care Planning (including his Natural Dying—Living Will) in 2012. Michael passionately hopes health care providers will honor his wishes to implement Natural Dying if someday he reaches the stage of Advanced Dementia and no longer can feed himself.

Now Michael also wants to move up the time when "Natural Dying" may be implemented by also refusing thickened food and liquids--if his risk of aspiration pneumonia is high. Definition: "Natural Dying" withdraws the act of assistance by another person, hand-feeding/drinking, but Natural Dying never withholds food and fluid from the patient since food and fluid are always placed in front of the patient, within reach. (Note that Dr. Powell used the word, "withheld" in the title and text of her essay.)

Please take the following poll.  Feel free to elaborate on your answers in the comments.











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Another Pneumonia Vaccine for Seniors: What's the evidence on Prevnar13?

In September 2014, the Centers for Disease Control and Prevention (CDC) issued a new guideline1 recommending the administration of Prevnar13, a type of pneumonia vaccines, to adults 65 years and older.  This is to be given in addition to Pneumovax23, the pneumonia vaccine that adults 65 years and older already receive based on prior guidelines.

Mr. R, my 67-year-old patient who already received Pneumovax23, was not enthusiastic about the idea. “But I already got one! Why do I need another? What is the difference from the one I already got?”

All good questions. Let’s look closely at the guidelines to see if we can answer these questions.

What is the difference between Pneumovax23 and Prevnar13?
Pneumovax23 stands for pneumococcal polysaccharide vaccine (23-valent). First used in 1945, it was an important landmark in medical history. Pneumovax23 was the first pneumonia vaccine, and the first to be made from capsular polysaccharide, which can help induce immunity in host body.  It is called 23-valent because it aims to protect against 23 types of pneumococcal capsules, which translates to 50-80% efficacy2.

Prevnar13 stands for pneumococcal conjugate vaccine (13-valent). It is made from bacterial cell membrane sugars conjugated with a diphtheria toxin protein called CRM197 to induce a stronger immune response. It is traditionally given to children and adults over 19 years old with certain medical conditions (lack of spleen, compromised immune system, etc.)  It is called 13-valent because it aims to protect against 13 types of pneumococcal capsules, 12 of which were exactly the same as the ones covered by Pneumovax23. The only serotype covered by Prevnar13, but not by Pneumovax23, is serotype 6A.

Why would we want to add Prevnar13 to Pneumovax23, which adults 65 and older were already getting?
It turns out that a percentage of severe illness in older adults is caused by the types of pneumococcal bacteria that Prevnar13 can protect against. For example, 20-25% of a disease entity called invasive pneumococcal disease (such as meningitis, bacteremia) is caused by bacterial serotypes that Prevnar13 covers1. It should be noted that even though Pneumovax23 covers these similar serotypes, it is stipulated that Prevnar13 will be more effective, because its conjugated protein should induce a stronger immune response than Pneumovax23.

Since many adults 65 years and older may have already received Pneumovax23 based on prior guidelines, it cannot be undone or replaced by Prevnar13. The only policy option for these adults would be to add Prevnar13 to the pre-existing vaccine schedule. And we might as well – Prevnar13 should be compared to the status quo, a kind of non-inferiority trial. If it is not better than what we were doing, then why do it?

What kind of evidence was used to back up the new guidelines?
The guidelines stemmed mostly from a large trial conducted by Pfizer, the manufacturer of Prevnar 13. Called the CAPiTA trial3, this study was the first to measure important patient-centered outcomes related to pneumonia vaccines, such as the incidence of pneumonia or invasive pneumococcal diseases among older adults. All prior studies only measured titers, the amount of immune response generated by vaccines, but it is unclear what measured titers mean in real life, how it translates to the number of pneumonia cases prevented, the number of pneumonia-related deaths averted, etc.

The CAPiTA trial looked at 84,496 adults 65 and older who had not received any pneumonia vaccines of any kind (neither Pneumovax23 or Prevnar13). It then randomized these patients to either getting Prevnar13 or placebo. The study reported the overall efficacy of Prevnar13 against the bacterial serotypes it was designed to cover (if patients were infected with bacterial serotypes not covered by Prevnar13, these cases of failure were not counted towards the efficacy calculation). According to the CAPiTA trial, the overall efficacy of Prevnar13 was 45.6% against overall pneumonia, 45.0% against non-bacteremic pneumonia and 75.0% against invasive pneumococcal disease.

On the surface, these results appear significant. But, comparing Prevnar13 against getting no vaccine is not a fair fight. A better comparison would evaluate 2 groups of patients: those who only received Pneumovax23 (status quo) vs those who received both Pneumovax23 and Prevnar13. The CDC included a cost-effectiveness analysis4 of adding Prevnar13 compared to status quo, but no actual research study was conducted to see how the analysis holds up in the real world. In addition, the results of the CAPiTA trial were only reported as part of a research abstract – these results have not been published in any peer-review medical journals, and the validity of the trial cannot be evaluated.

Illustration showing sequential administration and recommended intervals for pneumonia vaccines in adults aged 65 and older (Source: CDC)
What is the best sequence of administration of the two vaccines?
Another study included in the guideline attempted to determine the sequence of pneumonia vaccine administration: should we give Prevnar13 or Pneumovax23 first? The study5 randomized 720 adults between the age of 60 to 64 years old (excluding the population for which the recommendations are made) into 2 groups: the group receiving Prevnar13 followed by Pneumovax23 vs the group receiving Pneumovax23 followed by Prevnar13 (the reverse). The study found that giving Prevnar13 first followed by Pneumovax23 is the best way to go – it produces a higher titer than the other way around. However, the study found that adding Prevnar13 after Pneumovax23 produced lower titers than giving Pneumovax23 alone (status quo). The mechanism is unclear, but it seems that giving Pneumovax23 followed by Prevnar13 resulted in a dampened immune response. Based on this finding, it is unclear why the CDC would recommend adding Prevnar13 in adults 65 and older who have already received Pneumovax23 based on prior guidelines, which is likely the majority of adults 65 and older currently living in the US.

What is the punch line?
At a closer look, the guidelines appear to be based on a trial of Prevnar13 conducted by its manufacturer with possible conflict of interest, based on unpublished data, studies measuring immune titers with unclear benefits to patients, a mathematical calculation that was not tested in the real world, a study to determine vaccine sequence that excluded the target population (adults 65 years and older), and the possibility that giving Prevnar13 to patients who already received Pneumovax23 might actually be worse than not giving it. Given the lack of clear evidence, physicians should evaluate the new CDC guidelines with caution.

Back to Mr. R: I couldn’t give him a good reason why he should get Prevnar13, so I let him be. So far, no pneumonia yet.

By Dr. June Howell, a geriatric fellow at Icahn School of Medicine at Mount Sinai who blogs at Medium and tweets @junehowellmd.

This post is part of the #GeriCases series, in which we discuss a clinical case in geriatrics and palliative medicine and the attempt to provide patient-centered care with the use of best available evidence. 
Ravishankar Ramaswamy, MD
@RavRamaswamy
Section Editor, #GeriCases

References: 
1. CDC. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2014; 63(37);822-825.
2. Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34):1102-1106.
3. Bonten M, Bolkenbaas M, Huijts S, et al. Community Acquired Pneumonia Immunization Trial in Adults (CAPiTA). Abstract no. 0541. Pneumonia 2014;3:95. Available at https://pneumonia.org.au/public/journals/22/PublicFolder/ABSTRACTBOOKMASTERforwebupdated20-3-14.pdf.
4. Stoecker C. Incremental cost-effectiveness of modifying PPSV and PCV recommendations for adults age 50 and over. Presented at the Advisory Committee on Immunization Practices June 25, 2014 meeting, Atlanta, GA; 2014. Available at http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-06/pcv13-02-stoecker.pdf. 
5. Greenberg RN, Gurtman A, Frenck RW, et al. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine–naïve adults 60–64 years of age. Vaccine 2014;32:2364–74.
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