Exploring Lean in Tel Aviv
A colleague and I are in the midst of an introductory training session about the Lean process improvement philosophy at Sheba Medical Center on the outskirts of Tel Aviv, Israel. We were invited by Dr. Eyal Zimlichman, head of quality management for the hospital (seen here with Jessica Livneh, head nurse of the oncology outpatient unit.) As is often the case, we find highly committed, engaged staff and managers facing the usual assortment of hospital management problems. Their interest in the opportunities offered by Lean is palpable, but part of our job is to explain that adoption of this philosophy takes extensive time and effort. Our hope is that this session will give them a taste of the possibilities so they and their leaders can make a more informed decision about the path forward.
We were honored to be joined by Boaz Tamir, Israel's Lean guru. You see him here with (from right to left--appropriately!) Yoav Shalem (pharmacist); Dr. Einat Shacham Shmueli (head of the oncology GI unit); and Miriam Adam (director of pharmacy services).
We were honored to be joined by Boaz Tamir, Israel's Lean guru. You see him here with (from right to left--appropriately!) Yoav Shalem (pharmacist); Dr. Einat Shacham Shmueli (head of the oncology GI unit); and Miriam Adam (director of pharmacy services).
Competition matters on both sides of the Atlantic
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There is often a lot to learn by comparing the US and UK health care systems, but as often as not we revert to Shaw’s “two nations separated by a common language” when looking for lessons. Let me give one example.
Although the UK has had a single payer, nationalized system for over six decades, there also exits a small but vibrant private sector system. In this sector, private insurance companies—supported by premiums paid by individuals or corporations (on behalf of employees)—contract for services from private hospitals and consultants (i.e., doctors.) The system operates in a similar fashion to the US private care system. Insurance companies negotiate with the provider groups as to the rates that will be paid for the various clinical services.
As in the US, there are some private provider groups that have sought to obtain geographic dominance in certain markets. One purpose of that dominance is to have monopoly-like leverage over the insurance companies to obtain super-normal profits.
In the US, when this kind of dominance occurs, it is—for the most part—ignored by public policy makers and regulatory officials. Indeed, it is explained away by assertion that such ACOs (as we now call them) are better able to coordinate care for their patients and thereby achieve efficiencies that will lead to lower costs. As best I can tell, no one with training in economics believes that such an offset is likely to be the result.
Recent rulings by the Competition Commission in the UK have given the lie to those kinds of hopes. The CC found that dominant private health care networks, particularly by not exclusively those in major metropolitan areas, were able to extract monopoly rents from the insurance companies. The regulatory response: Requiring the divestiture of a sufficient number of hospitals to enable competition to emerge. The specifics remain to be decided, and portions of the ruling are likely to be contested or appealed, but the logic of the CC will remain intact: Too much market concentration is bad for consumers.
I am struck by how this differs from the situation in the US. Even Don Berwick, one of the most informed candidates for public office when it comes to health care, avoids the market power issue in his recent platform statement—notwithstanding how many times it has been documented that the dominance of one health care provider network in Massachusetts single-handedly accounts for a substantial portions of the state’s high health care costs.
The CC’s report should be required reading for US health care policy-makers. The UK has a lot to teach us if we can learn to understand our common language.
IWantGreatCare advances the Lean agenda
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I don't think Neil Bacon (of IWantGreatCare* fame) meant to reinforce one of the main tenets of Lean process improvement in a recent blog post, but he did do so. I also don't think Neil meant to enhance the Lean philosophy by adding a new key dimension, but he did that, too. Let's start with his story from University Hospitals Morecambe Bay Trust:
The senior nurse from the surgical unit recounted to her colleagues how last week an elderly patient had used his iPad, from his hospital bed, to provide feedback on his care, highlighting a problem and concern he had using the iWantGreatCare pages for the hospital.
The nurses on the wards are able to receive instant alerts if there are concerns that need addressing for their ward – and thus the nurses were instantly made aware of a problem. Interestingly, in his comment the patient said something along the lines of “this needs sorting at some point, but I don’t want to interrupt anyone now”. Whilst the comments on iWantGreatCare are anonymous there were not many elderly patients sitting in bed with iPads! Thus the nurse was able to go directly to the patient and say “Let’s solve that problem now”.
I am told that the patient (who is still in the hospital) was completely amazed, not really expecting anybody to do anything ever, let alone seconds after he had given his feedback – this was not what he had come to expect from the NHS! Not only was the problem fixed, but the patient has been telling all his visitors and family about the incredible hospital and how the staff really listen, really care and get things fixed. His confidence is high, as is the morale of the staff who see people talking about the great care they deliver.
Lean is about front-line driven process improvement. We encourage staff to call out problems they see in their work environment, and then managers "swarm" on those call-outs--in real time--and invent experiments that might improve the situation.
Here, though, we've gone a step further. Here, the patient has been added to the front-line team by being given a simple technological approach that permits him/her to be empowered to make the call-out.
Whether Neil knows it or not, he just advanced the science of process improvement in the health care environment by one great leap forward. Well done!
--
* Think TripAdvisor for health care to get the concept.
The senior nurse from the surgical unit recounted to her colleagues how last week an elderly patient had used his iPad, from his hospital bed, to provide feedback on his care, highlighting a problem and concern he had using the iWantGreatCare pages for the hospital.
The nurses on the wards are able to receive instant alerts if there are concerns that need addressing for their ward – and thus the nurses were instantly made aware of a problem. Interestingly, in his comment the patient said something along the lines of “this needs sorting at some point, but I don’t want to interrupt anyone now”. Whilst the comments on iWantGreatCare are anonymous there were not many elderly patients sitting in bed with iPads! Thus the nurse was able to go directly to the patient and say “Let’s solve that problem now”.
I am told that the patient (who is still in the hospital) was completely amazed, not really expecting anybody to do anything ever, let alone seconds after he had given his feedback – this was not what he had come to expect from the NHS! Not only was the problem fixed, but the patient has been telling all his visitors and family about the incredible hospital and how the staff really listen, really care and get things fixed. His confidence is high, as is the morale of the staff who see people talking about the great care they deliver.
Lean is about front-line driven process improvement. We encourage staff to call out problems they see in their work environment, and then managers "swarm" on those call-outs--in real time--and invent experiments that might improve the situation.
Here, though, we've gone a step further. Here, the patient has been added to the front-line team by being given a simple technological approach that permits him/her to be empowered to make the call-out.
Whether Neil knows it or not, he just advanced the science of process improvement in the health care environment by one great leap forward. Well done!
--
* Think TripAdvisor for health care to get the concept.
Terry Wise shares
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Terry Wise is an extraordinary person--wise, empathetic, warm, thoughtful, and vulnerable. She shares all these attributes with us in her book Waking Up, but she shares the benefit of her work with others through The Missing Peace Foundation:
The Foundation provides financial assistance, public speaking and other resources to entities that lack funding to advance their efforts to help those confronted with mental and physical health issues. Qualifying recipients include organizations, communities, schools, and other associations who aspire to raise awareness and educate others on topics related to long-term caregiving, grief, depression, mental health, suicide prevention, and the process of recovery.
Please check out the website to see if the foundation might be able to help your organization, or whether you might feel moved to contribute money to help the work of the foundation.
The Foundation provides financial assistance, public speaking and other resources to entities that lack funding to advance their efforts to help those confronted with mental and physical health issues. Qualifying recipients include organizations, communities, schools, and other associations who aspire to raise awareness and educate others on topics related to long-term caregiving, grief, depression, mental health, suicide prevention, and the process of recovery.
Please check out the website to see if the foundation might be able to help your organization, or whether you might feel moved to contribute money to help the work of the foundation.
"Wounded" comes to America
Emily Mayhew's book Wounded, about which I wrote in early October, is now available in the United States through Amazon. This is simply the best book I have read about World War I, the 100th anniversary of which occurs this coming year. It tells the intimate stories of doctors, nurses, and other medical personnel assigned to the front during this terrible war.
Transplantation of HIV+ organs: from ban to HOPE
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Organ donation from HIV positive patients has been prohibited in the USA since 1988. Pre-transplant screening for HIV is mandatory using nuclear amplification test (NAT), though false negative results during “window period” are a potential concern in donor selection.
Elmi Muller spoke at our Transplant Grand Rounds yesterday and told us about the challenge she faces in South Africa, where HIV infection affects more than 15% of the population, HIV patients frequently develop HIV-associated nephropathy (HIVAN) and progress to ESRD. Moreover, the availability of renal replacement therapy (hemodialysis) is limited.
In the early 90's, there were a number of uncertainties related to transplanting HIV positive patients including the worrisome concern about introducing a donor-derived virus that could lead to out of control HIV infection (resistant strain?); the effect on the immune system of HIV infection in combination with immunosuppression (worse immunodeficiency?); and the financial burden of expanding the services of transplantation to HIV+ patients in a country with limited health budget.
Against all the odds, Elmi performed four cases of HIV positive kidney donors to HIV positive recipients in South Africa in 2008. No IRB approval... Elmi reported having some intuition that it would work and she was in touch with other physicians around the world who shared her view. In her side, HIV resistance rate is very low in South Africa.
After performing those transplant, her colleagues and the hospital prosecuted her and banned her from performing surgery for more than 1 year. This past week, the HIV Organ Policy Equity (HOPE) Act was approved by the US Congress, permitting donation from HIV-positive organs to HIV-positive recipients. It took time but she is now recognized as a pioneer in the field and her courage to perform those surgeries were remarkable. The law that passed will help expand the availability of organ donors to HIV positive patients and will help with organ shortage.
Some challenges though still remain. HIV resistance is much higher in the States (~19%) and HIV+ transplant recipients experience a higher rate of rejection and significant difficulties with drug-drug interactions (P450 inhibitors). Details about a recent trial can be reviewed on this prior blog. In contrary to the idea of over-immunosuppression, recent paper suggests that ATG may be a better induction therapy choice for these patients. Closely monitoring of these patients will be essential as we learn more about HIV and transplantation. By bending rules, Elmi changed a transplant policy and made history.
Naoka Murakami
Leo Riella
Elmi Muller spoke at our Transplant Grand Rounds yesterday and told us about the challenge she faces in South Africa, where HIV infection affects more than 15% of the population, HIV patients frequently develop HIV-associated nephropathy (HIVAN) and progress to ESRD. Moreover, the availability of renal replacement therapy (hemodialysis) is limited.
In the early 90's, there were a number of uncertainties related to transplanting HIV positive patients including the worrisome concern about introducing a donor-derived virus that could lead to out of control HIV infection (resistant strain?); the effect on the immune system of HIV infection in combination with immunosuppression (worse immunodeficiency?); and the financial burden of expanding the services of transplantation to HIV+ patients in a country with limited health budget.
Against all the odds, Elmi performed four cases of HIV positive kidney donors to HIV positive recipients in South Africa in 2008. No IRB approval... Elmi reported having some intuition that it would work and she was in touch with other physicians around the world who shared her view. In her side, HIV resistance rate is very low in South Africa.
After performing those transplant, her colleagues and the hospital prosecuted her and banned her from performing surgery for more than 1 year. This past week, the HIV Organ Policy Equity (HOPE) Act was approved by the US Congress, permitting donation from HIV-positive organs to HIV-positive recipients. It took time but she is now recognized as a pioneer in the field and her courage to perform those surgeries were remarkable. The law that passed will help expand the availability of organ donors to HIV positive patients and will help with organ shortage.
Some challenges though still remain. HIV resistance is much higher in the States (~19%) and HIV+ transplant recipients experience a higher rate of rejection and significant difficulties with drug-drug interactions (P450 inhibitors). Details about a recent trial can be reviewed on this prior blog. In contrary to the idea of over-immunosuppression, recent paper suggests that ATG may be a better induction therapy choice for these patients. Closely monitoring of these patients will be essential as we learn more about HIV and transplantation. By bending rules, Elmi changed a transplant policy and made history.
Naoka Murakami
Leo Riella
Leadership Skills on WIHI
Madge Kaplan writes:
The next WIHI broadcast — New Leadership Skills for Better Health and Health Care — will take place on Thursday, November 21, from 2 to 3 PM ET, and I hope you'll tune in.
Our guests will include:
- Gary R. Yates, MD, President, Sentara Quality Care Network; former Senior Vice President and Chief Medical Officer, Sentara Healthcare
- Lee Sacks, MD, Executive Vice President & Chief Medical Officer, Advocate Health Care; Chief Executive Officer, Advocate Physician Partners
- Derek Feeley, Executive Vice President, Institute for Healthcare Improvement
- Andrea Kabcenell, RN, MPH, Vice President, Institute for Healthcare Improvement
IHI has been doing a lot of thinking of late about leaders and leadership… in particular the skills, behaviors, and outlook necessary to steer today's health care organizations toward a very different future. A new IHI white paper (working title: High-Impact Leadership) will be out before the end of the year that captures this complex transition. Among other things, it offers a new framework for leaders who are not just responsible for making change manageable, but enthusiastically supported by all staff. You can get an early look at the new leadership framework on the Nov. 21 WIHI: New Leadership Skills for Better Health and Health Care. One of the goals of this WIHI is to describe the interdependence between the growing focus on population health, the shift from volume to value, and the corresponding leadership skills required to address these challenges.
At Advocate Health Care, Dr. Lee Sacks has been hard at work learning by doing, with the help of other physician leaders. He’ll explain in concrete terms what his team’s leadership practices look like day to day, including those needed to lead an Accountable Care Organization (ACO). Sentara’s Dr. Gary Yates will spend his time on WIHI outlining key leadership behaviors that signal to staff how change is going to come about and what’s expected of everyone. If leaders want to alter the perception that they alone have all the answers, hashed out in some corner office, they must become a regular, approachable, and authentic presence throughout the organization. Discussions in the hallways talking with staff, and learning from patients and patient stories, need to become the norm.
Fresh from his leadership perch at NHS Scotland, IHI’s Derek Feeley has been thinking hard about what’s applicable and relevant to the US context and in many other countries seeking better health and health care for their citizens. He, along with Andrea Kabcenell, will discuss how leaders can better manage and prioritize all the tasks necessary to succeed. WIHI host Madge Kaplan invites you to put on your leadership cap wherever you reside in your organization, and take part in this next discussion on Nov 21. Tell us what you’re doing to lead differently, with a different future in mind, and what impact this is already having.
I hope you'll join us! You can enroll for the broadcast here.Fresh from his leadership perch at NHS Scotland, IHI’s Derek Feeley has been thinking hard about what’s applicable and relevant to the US context and in many other countries seeking better health and health care for their citizens. He, along with Andrea Kabcenell, will discuss how leaders can better manage and prioritize all the tasks necessary to succeed. WIHI host Madge Kaplan invites you to put on your leadership cap wherever you reside in your organization, and take part in this next discussion on Nov 21. Tell us what you’re doing to lead differently, with a different future in mind, and what impact this is already having.
Aristolochic Acid Nephropathy
Aristolochic acids (AA) are found in products derived from the aristolochia genus of plants which are used extensively in herbal medicines, particularly in Asia. Nephrotoxicity resulting from AA exposure was originally described in a case series of women taking diet supplements in Belgium but has subsequently been identified in the US, Europe and Asia. Consumption of products containing AA remains endemic in some areas with an estimated exposure in up to 40% of the Taiwanese population. The disease known as Balkan endemic nephropathy – described the population living around tributaries of the Danube river- is now thought to result from contamination of wheat flour with seeds of plants containing AA.
Patients with AA nephropathy typically present with renal insufficiency and anemia. Urinalysis reveals a few red cells and mild proteinuria. The rate of decline of renal function varies but may depend on the cumulative dose of AA. Renal histology is characterized by extensive interstitial fibrosis with tubular atrophy and low numbers of inflammatory cells. There is a very high incidence of urothelial atypia and carcinoma. Exposure to AA can be confirmed by the presence of AA-DNA in biopsy tissue.
Therapy consists of routine management of CKD alongside regular screening for urothelial malignancy. A trial of steroids can be considered in selected patients. The risk of urothelial malignancy is so high that some consider patients for bilateral nephrouretecomy once RRT as been established.
Despite being banned in many countries, products containing AA remain available. The true incidence of CKD and urothelial malignancy resulting from AA exposure remains unknown. It is possible that a lack of awareness means that a significant proportion of AA resulted morbidity remains undiagnosed. For a comprehensive review of the subject see here.
Image from Wikipedia.
Posted by Jonathan Dick
I have no way of knowing whom I may have hurt
A colleague writes with a thought-provoking story:
As is often the case, learning the meaning of something can happen well after the actual events that precipitate our own maturation. So it was for me when my mother developed a growth on her esophagus just before her stomach, in the fall of 2009.
As is often the case, learning the meaning of something can happen well after the actual events that precipitate our own maturation. So it was for me when my mother developed a growth on her esophagus just before her stomach, in the fall of 2009.
My mother was scared and my father was trying not to appear scared. Together, they were preparing themselves to be lead by the healthcare system in the discovery of exactly what my mother was afflicted with and how it would be treated. Having started my life in healthcare 29 years ago, working then as an X-ray Technologist, it took no time for me to launch into an effort to assist my mother and father in navigating through this event. The reflexive urge I felt to help is well known by all those who work in healthcare. As healthcare professionals of all disciplines, we know, that despite the best intentions and the best training in the world, there is no predicting how a health episode will go. Nor is there an outcome that can be reliably delivered.
After some phone calls by me, my mother was seen, biopsied and got her results well ahead of the typical time frame for these millstones of care. She also had the benign growth removed well ahead of what would have been normally scheduled.
When I recount my efforts to help my family, with my friends and acquaintances, who also work in healthcare, every person affirms they would do the same for their spouse, children, family members and friends. Normally, this affirmation is heartily expressed like those who are part of an exclusive club. It was not until earlier this year that I was struck with a profound sense of guilt as I reflected on my actions. I most certainly delayed the care that would have otherwise been given to someone with a malignant growth. Someone who my mother and father, knowing her growth was benign, would have gladly had go ahead of them. I have no way of knowing whom I may have hurt or if my actions had no consequence at all.
Aim for muscle fitness
My friend, colleague, and neurologist Seward Rutkove has invented several new fascinating medical devices. One of these--Aim--is designed for the general marketplace (as opposed to medical clinics.) He and his partner have started an Indiegogo campaign through which you can support the introduction of this device, plus get one for yourself. What does it do?
Press Aim against any major muscle to measure the fat percentage and muscle quality (MQ) for that muscle.
Press Aim against any major muscle to measure the fat percentage and muscle quality (MQ) for that muscle.
- Each measurement takes less than a second and results are immediately displayed
- By measuring four muscles (biceps, triceps, abs, and thigh), you get an accurate estimate of your total body fat percentage and MQ
- Aim sends your results to an online dashboard via Low Energy Bluetooth
- You can review your results on the online dashboard to track progress and get tailored fitness advice
Expanding our horizons as teachers
Bradley Flansbaum tells an amusing story about an international medical graduate he was mentoring and then concludes:
Watching an international graduate take his first step assimilating into a new professional role, American style, opened my eyes once again to the valuable guidance we provide as teachers. I consider moments with them as prized as the interactions with my patients. What is the difference really? In both instances, you provide the knowledge and comfort the other side lacks.
The learning is a two way street however, and I get as much as I receive. Over the years, I have absorbed distant perspectives on religion, the roles of gender and family in the home, and viewpoints on sickness and death. As a result, I believe my connection with trainees from other countries has made me a better person.
A lovely, concise, and perceptive observation.
Watching an international graduate take his first step assimilating into a new professional role, American style, opened my eyes once again to the valuable guidance we provide as teachers. I consider moments with them as prized as the interactions with my patients. What is the difference really? In both instances, you provide the knowledge and comfort the other side lacks.
The learning is a two way street however, and I get as much as I receive. Over the years, I have absorbed distant perspectives on religion, the roles of gender and family in the home, and viewpoints on sickness and death. As a result, I believe my connection with trainees from other countries has made me a better person.
A lovely, concise, and perceptive observation.
Coaching as a leadership theme
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Dr. Brian Wong has written a book called Heroes Need Not Apply. A number of friends have recommended it to me. I've not read it yet, but I did watch Dr. Wong's video in which he answers the question: "In your book, why does coaching become such an important leadership theme?" I found his answers thoughtful and compelling and recommend the short video to you. I'll look forward to reading the book some day.
Sweet to be mentioned. Thanks!
How lovely to have this blog listed as one of the "100 Important Sites for Healthcare Leaders and Executives" on the MHAPrograms.org website. They note: "Blogs, news sites and magazines in the healthcare industry often dedicate articles to covering the latest news on health leadership, promoting upcoming leadership conferences, and sharing advice that administrators can use to improve the efficacy of their organization."
Indeed, one of my hoped-for audiences is current and future health care administrators, and I am honored to be included.
Indeed, one of my hoped-for audiences is current and future health care administrators, and I am honored to be included.
Patty Skolnik adds "author" to her credentials
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Congratulations to patient advocate Patty Skolnik in her new role as co-author in an international journal, Teaching and Learning in Medicine. The title of the article is "Patient Safety Education: What Was, What Is, and What Will Be?" You can find it here.
The abstract:
Patient safety is an important topic that has been receiving more attention in the current health care climate. Patient safety as a curriculum topic in medical schools has only become apparent in the late 1990s, and much more needs to be done. This article summarizes patient safety curricular content as it occurred (or did not occur) in medical education circles in the past (pre-1990s), and present. It also makes some recommendations for the future of medical education curricula in the area of patient safety, using a framework for the development of expertise using the Dreyfus educational model.
The abstract:
Patient safety is an important topic that has been receiving more attention in the current health care climate. Patient safety as a curriculum topic in medical schools has only become apparent in the late 1990s, and much more needs to be done. This article summarizes patient safety curricular content as it occurred (or did not occur) in medical education circles in the past (pre-1990s), and present. It also makes some recommendations for the future of medical education curricula in the area of patient safety, using a framework for the development of expertise using the Dreyfus educational model.
Schwartz Center brings all together again
Petra Langer reminds us of an event that has become a mainstay of the New England healthcare community. This may be one of the few places where the intensely competitive actors in the region join forces in total unanimity!
More than 150 doctors, nurses and other hospital staff who treated those injured in the Boston Marathon bombings will be honored at the 18th annual Kenneth B. Schwartz Compassionate Healthcare Dinner on Thursday, November 21, at the Boston Convention Center. Adrianne Haslet-Davis, a professional dance instructor who lost her lower leg in the bombings, will speak at the event beginning at 7pm. More than 2,000 people are expected to attend.
“The Marathon bombings seven months ago cast a bright spotlight not only on the courageous first responders and volunteers at the scene, but also on the extraordinary people who work in healthcare in the Boston area,” said Julie Rosen, executive director of the Schwartz Center for Compassionate Healthcare, a Boston-based nonprofit that works to strengthen the relationship between patients andtheir healthcare providers. “We’re thrilled to honor them. Their professionalism and compassion have been critical to the collective healing of our community.”
The Schwartz Center will also celebrate the 15th anniversary of its prestigious Schwartz Center Compassionate Caregiver Award®. The award was established in 1999 to honor healthcare providers who display extraordinary compassion in caring for patients and families. Past recipients will be in attendance, and this year’s recipient will be announced at the dinner.
More than 150 doctors, nurses and other hospital staff who treated those injured in the Boston Marathon bombings will be honored at the 18th annual Kenneth B. Schwartz Compassionate Healthcare Dinner on Thursday, November 21, at the Boston Convention Center. Adrianne Haslet-Davis, a professional dance instructor who lost her lower leg in the bombings, will speak at the event beginning at 7pm. More than 2,000 people are expected to attend.
“The Marathon bombings seven months ago cast a bright spotlight not only on the courageous first responders and volunteers at the scene, but also on the extraordinary people who work in healthcare in the Boston area,” said Julie Rosen, executive director of the Schwartz Center for Compassionate Healthcare, a Boston-based nonprofit that works to strengthen the relationship between patients andtheir healthcare providers. “We’re thrilled to honor them. Their professionalism and compassion have been critical to the collective healing of our community.”
The Schwartz Center will also celebrate the 15th anniversary of its prestigious Schwartz Center Compassionate Caregiver Award®. The award was established in 1999 to honor healthcare providers who display extraordinary compassion in caring for patients and families. Past recipients will be in attendance, and this year’s recipient will be announced at the dinner.
Abatacept for Glomerular Diseases: A New Era of Intelligent immunosuppression?
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At ASN Kidney Week there was some interest in abatacept as a targeted therapy for glomerular diseases. T-cell activation requires 2 signals; (i) binding of the T-cell receptor to the antigen-MHC complex on the antigen-presenting cell and (ii) a co-stimulatory signal involving CTLA-4 on the T-cell and B7-1 on the antigen presenting cell. Abatacept is a fusion protein composed of the Fc region of IgG1 fused to the extracellular domain of CTLA-4 which inhibits the T-cell co-stimulatory pathway via B7-1 binding.
FSGS
The headlines must go to the small case series of abatacept in FSGS published in NEJM. The rationale for its use was the observation that B7-1 expression is not apparent in normal human podocytes but is found in certain diseased podocytes including a subset of FSGS patients. The series included 4 patients with recurrent FSGS post-transplantation (rituximab-resistant) and one with glucocorticoid-resistant primary FSGS. All patients achieved either partial or complete remission.
In vitro studies demonstrated that α3-Integrin knockout mice constitutively expressed B7-1 in podocytes and abatacept blocked B7-1 mediated podocyte migration in these cells. The molecular mechanism of B7-1-induced podocyte dysfunction was shown to be disruption of activation of the glomerular protein β1-integrin. The authors conclude that B7-1 immunostaining of biopsies may identify a subgroup of patients who would benefit from treatment with abatacept.
2 Lupus Nephritis
The late-breaking session included a randomized controlled trial of Euro-lupus regime cyclophosphamide (i.e. low dose IV) with or without abatacept for proliferative lupus nephritis [Access Trial]. Azathioprine was introduced at 3 months and stopped at 6 months in the abatacept group if they had achieved a remission. Overall, there was no difference in remission rate between the groups. Despite the neutral outcome, 2 points should be taken from the study: (i) The Euro-lupus regime appeared to work in a US cohort of patients where almost 80% were either Hispanic or African American. (ii) Abatacept patients who achieved remission maintained this at 1 year despite coming off immunosuppression at 6 months. However, with the growing confidence in Mycophenolate-based therapy for lupus nephritis and the lack of improved remission with Abatacept in this study, its place in the treatment of proliferative lupus nephritis remains uncertain.
3 Diabetic Nephropathy
An oral presentation on abatacept in Diabetic Nephropathy [FR-OR010] reported increased B7-1 expression in both murine podocytes cultured in high-glucose and on human glomerular podocytes from biopsy specimens. The use of Abatacept in diabetic mice prevented an increase in albuminuria.
Bottom Line: The FSGS case series beautifully illustrates how targeted therapies may be applied to immune-mediated renal diseases. While this case series is very small, it demonstrates the potential for reclassifying disease based on pathogenesis (i.e. B7-1-mediated) rather than crude pathological patterns (focal segmental sclerosis). This is similar to the recent re-classification of MPGN into complement or immune complex-mediated forms. With new targeted therapies like abatacept (and eculizumab for complement mediated glomerulopathies), we may be entering an era of intelligent immunosuppression based on molecular pathogenic signals rather than crude histological patterns.
A modest proposal
I’m going to offer an idea that is so outrageous it might actually have merit. This concerns the Boston area health care market, but my readers from other regions might also find it of interest.
There are two health care entities in Massachusetts that face uncertain futures. One is Tufts Medical Center, a relatively small but highly respected academic medical center with a notable history, going all the way back to its antecedent’s founding by Paul Revere and other patriots. The other is Steward Health Care, a chain of hospitals purchased from the Boston Archdiocese several years ago by a private equity company, which converted it into a for-profit organization.
Not withstanding superb executive and board leadership over the past dozen years and a dedicated medical staff, Tufts remains trapped by the lack of an extensive referral network of doctors and community hospitals. It suffers, too, from some bad luck going back to leadership decisions made several decades ago. For example, although located in Boston’s Chinatown neighborhood, the community health center serving that densely populated neighborhood decided to affiliate itself with another academic medical center several miles away. When people in Boston say, as they sometimes do, that there are too many academic medical centers in town, Tufts is the one that is most often suggested for elimination. Such facile comments are, of course, unfair, in that the quality of clinical care, teaching, and research at Tufts is excellent: Were this institution to close, the community and the world would suffer a true loss.
Nonetheless, in the changing world of healthcare, a lonely academic medical center surrounded by other such centers with large (and growing networks) is at a disadvantage. Tuft’s inability to keep and create significant strategic alliances with physician groups and community hospitals is a major vulnerability going forward.
Steward Health Care presents a totally different performance problem. Owned by a private equity firm, the hospital system’s leadership has done what private equity managers do. Assets have been stripped away to create cash flow for the owner. Actions have been taken to increase the top line performance of the company: Acquire, at high price, physician practices to increase referrals; sign front-ended loaded global payment contracts with the largest insurance company; sell (and lease back) real estate; sell clinical laboratories (and enter into a long-term vendor relationship with the purchasing firm); and minimize capital investment in the system, to produce earnings before depreciation that look robust.
But even those steps cannot hide the fact that actually running a hospital system in the Massachusetts market is not a highly profitable enterprise. Payment increases from private insurers, Medicare, and Medicaid seldom rise at rates greater than overall inflation. Meanwhile, service worker unions expect wage and salary increases to exceed that rate of inflation. Renewal and replacement of capital facilities and medical equipment by far exceeds the original cost of such investments. A for-profit firm faces the additional challenges of relying on taxable debt rather than tax-exempt debt; having to pay sales tax, local property taxes, and the like; and being unlikely to attract philanthropy to support its programs.
The private equity business model calls for a sale (or flip) of purchased companies within a short time frame. Indeed, the investors in private equity funds are promised such terms. In general, two types of sales are envisioned: An initial public offering, in which the company’s shares are offered to the general marketplace; or a secondary sale to another firm in the private equity market. In either event, the selling entity needs to create a colorable story that the enterprise has a high chance of financial success, meeting the hurdle rate of the new investors.
From reports I see in the media, it is unclear to me that Steward has much to offer to new investors. As mentioned, its financial strategy seems to have been tied to stripping cash out, leaving questionable value for the next investor. Profitability seems difficult to achieve. Indeed, we can imagine the current firm seeking concessions from its labor unions and perhaps even asking for property tax relief from municipalities if its earnings deteriorate significantly. Such actions would be a precursor to a loss of political support.
There is talk of selling Steward to one of the large American private hospital companies. But what can Steward’s owners truly expect such a company to offer in the way of a purchase price, when the likelihood of the system meeting a private market’s hurdle rate is so small? If I were the current owner, I would be searching for a way to get out—to take solace in the cash I have been able to extract, and to avoid the possible future costs of running the system. Indeed, I might even be willing to give away the investment to cut future losses and report a reasonably successful investment result to my private equity fund participants.
It is that thought that swiftly leads me to today’s modest proposal. I suggest that Tufts and Steward would both be better off if they reach an agreement under which Steward sells itself to Tufts for $1and in which the hospitals in the Steward network are re-established as non-profit institutions within a greatly expanded Tufts network of physician groups and community hospitals. Overnight, Tufts would become the second or third largest health care network in the state, with outposts throughout the Boston metropolitan area. It would thereby enhance its ability to negotiate with the private insurance companies. Steward’s tertiary referrals, which today go to the high-priced Partners Healthcare System, would instead be treated at Tufts’ main campus in Boston, offering lower priced care of equal quality. As non-profits, the community hospitals could again return to their tax-exempt status, saving millions in costs over the coming years and benefitting from the generosity of local donors. And, by the way, the two hospital systems are already part of the Tufts Medical School training program, so there are benefits of better coordination for graduate and undergraduate medical education.
How crazy is this? If you think through the alternatives for the two parties, the approach I outline doesn’t look so bad—and could look quite good. The public policy ramifications are also positive: Beyond solving the sentimental problem of keeping Paul Revere’s legacy alive, the proposal offers the potential for the entry of a third vibrant competitor in a health care marketplace that is looking more and more like a duopoly. Contestability in this sector requires at least three competitors. This proposal could help make that scenario more likely.
Ultrasound and Nephrologists
Registration has opened for the Spring session of the Ultrasound course for Nephrologists at Emory University. It will be held on Feb 1-2 2014, in Atlanta.
The brochure for the upcoming course is available here.
The brochure for the upcoming course is available here.
A normal day at the NHS
Those of us in the US who have been overwhelmed lately by overly excited health care stories in the media look fondly across the Pond. We are confident that we can find a much calmer discourse about these issues in the UK. After all, a single payer system, well established, and held in fond regard by the populace can’t be very controversial. Well maybe.
Here’s a synopsis of one day’s news coverage about the NHS from The Times and The Daily Telegraph. Make sure you read all the way to the last one. My head is spinning.
•A hospital trust whose staff were allegedly forced to alter waiting times of cancer patients has been put in “special measures” by Monitor, the health regulator. An “improvement director” will be appointed by Monitor to ensure the [Colchester Hospital University NHS Foundation Trust] turns itself around. “The leadership of the trust will be reviewed as part of our scrutiny of the trust’s governance arrangements and, if necessary, further regulatory action will be taken.”
•Hundreds of teenage girls have had genital cosmetic surgery on the NHS, prompting doctors to call for an end to state-funded “designer vaginas.” Internet pornography has driven a five-fold increase in female genital surgery in the past decade and more than 2,000 women a year now have the procedure on the NHS. Ruptures are reported in up to a third of cases and NHS surgeons report seeing women with complications caused by surgery in the private sector. There is no evidence that the surgery improves women’s lives.
•Nine of the world’s biggest pharmaceutical companies have warned that innovative new medicines are being blocked from use in the NHS and are calling for an overhaul of the commissioning process. They said that, since 2005, the National Institute for Health and Clinical Excellence (NICE), the body that selects drugs for use in the NHS, has approved “fewer than one-in-three medicines” and needs to be given a new mandate to make the UK a world leader in innovation. In a statement, NICE said the companies had “wildly underestimated” the proportion of drugs approved and it “supports more than 80pc of the drugs appraised. The NHS needs to be confident that the treatments it buys with its increasingly stretched resources are both clinically and cost effective.”
•Wider use of statins will have minimal benefit and could needlessly expose thousands to severe side-effects, a leading doctor has claimed following a change in US prescription guidelines. Dr. Aseem Malhotra, a cardiology specialist registrar at Croyden University Hospital, south London, said he would be “disturbed” if Britain followed America in changing prescription guidelines to widen use of statins. Side-effects experienced by up to one in five patients include severe muscle aches, memory disturbances, sexual dysfunction, cataracts and diabetes.
•And here are two presentations of the same story:
The Daily Telegraphstory, headlined, “Return of ‘proper family doctors:’”
A new contract for GPS will see the return of “proper family doctors” responsible for out-of-hours care for the elderly, Jeremy Hunt, the Health Secretary, announced today. The deal agreed with the British Medical Association reverses changes introduced by Labour that allowed family doctors to abandon responsibility for care outside office hours. Mr. Hunt says that the changes are crucial because the failure to care for older patients is behind a crisis in NHS emergency care, with millions of patients admitted to hospital because they cannot get help in time from their GPs.
The Times headline was, “GPs told to reveal their pay:”
Family doctors will have to reveal their salaries from next year, under changes to be outlined today by the Health Secretary. Jeremy Hunt said that he had secured the agreement of the British Medical Association to publish the pay of GPs, in return for waiving a series of targets and handing nearly £300 million of performance-related pay directly to doctors.
[Hunt said,] “Transparency is always uncomfortable. People will get used to it, but it needs to be linked to outstanding performance.”
Both stories talk about the elimination of 40 percent of GP performance targets. Here’s the Telegraph quote:
Under the targets framework, doctors have been paid for improving their handwriting, or ensuring staff undergo training, or for asking their patients how often they take part in activities such as DIY, cooking or gardening.
And the Times quotes Dr. Chaand Nagpaul, chairman of the BMA’s GP committee, applauding the change as:
Freeing up resources for GPs to use their clinical judgment—not a checklist—when treating their patients.
And finally:
•GPs are seeing up to ten patients a day who are lonely rather than ill, according to research. Three quarters of GPs questioned said it was usual to see between one and five patients a day in their surgeries primarily because they were desperate for human contact. However, some doctors had even higher rates of patients suffering loneliness with one in ten saying that they saw up to ten patients a day who came in for the company. Half said they were not confident about whether they could help their lonely patients.
What's your QI IQ?
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Here's an excellent program for residents and attending physicians in the New York City area who are interested in enhancing their quality improvement skills. It is offered jointly by CIR/SEIU Healthcare.
A summary:
This is a great educational opportunity for residents and attendings who are interested in taking their QI project to the next level and plan for publishing their work. Publication of a manuscript is a process that starts when you think of a QI topic, and requires thoughtful planning and execution. You will learn from leaders and national experts in the field of QI how to plan, execute and publish. Interactive and hands-on activities comprise a large part of this conference.
What: What's Your QI IQ? How to be Scholarly in Quality Improvement
When: Saturday, November 23rd, 2013 from 9:00am - 3:30pm
Where: New York Academy of Medicine
1216 5th Ave, New York, NY 10029
Who: Housestaff, Faculty, Administration
Cost: Complimentary
Register here: bit.ly/QIIQNov23
A summary:
This is a great educational opportunity for residents and attendings who are interested in taking their QI project to the next level and plan for publishing their work. Publication of a manuscript is a process that starts when you think of a QI topic, and requires thoughtful planning and execution. You will learn from leaders and national experts in the field of QI how to plan, execute and publish. Interactive and hands-on activities comprise a large part of this conference.
What: What's Your QI IQ? How to be Scholarly in Quality Improvement
When: Saturday, November 23rd, 2013 from 9:00am - 3:30pm
Where: New York Academy of Medicine
1216 5th Ave, New York, NY 10029
Who: Housestaff, Faculty, Administration
Cost: Complimentary
Register here: bit.ly/QIIQNov23
Sportsmanship supreme
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You don't have to be a soccer fan to enjoy this video clip. Summary:
Al Nahdha's goalkeeper Taisir Al Antaif was about to make a clearance early in the second half with the score still at 2-2 but noticed that his shoelace had come undone, and was clearly nervous about his boot coming off as he kicked.
The opposing striker bearing down on him, a Brazilian by the name of Jobson, noticed what was going on - but instead of trying to take advantage, he ran up to his opponent and did his shoelace for him.
Al Antaif slapped his new friend on the back as thanks, and gave him a high five afterwards before getting on with the game.
But, here's where it turned sour, with the referee penalising the keeper for taking too long with his clearance.
He awarded an indirect free kick inside the area, and the home side lined up, clearly fearing the worst as Al Ittihad's strike force discussed their attacking options.
But in one of the most subtle and greatest insults given to a match official, Al Ittihad did the decent thing and merely passed the ball safely off the pitch. Even the supporters cheered at the gesture.
In a single stroke, the players managed to endorse a magnificent moment of sportsmanship between two opponents, while highlighting what an idiot the referee had made of himself.
Al Nahdha's goalkeeper Taisir Al Antaif was about to make a clearance early in the second half with the score still at 2-2 but noticed that his shoelace had come undone, and was clearly nervous about his boot coming off as he kicked.
The opposing striker bearing down on him, a Brazilian by the name of Jobson, noticed what was going on - but instead of trying to take advantage, he ran up to his opponent and did his shoelace for him.
Al Antaif slapped his new friend on the back as thanks, and gave him a high five afterwards before getting on with the game.
But, here's where it turned sour, with the referee penalising the keeper for taking too long with his clearance.
He awarded an indirect free kick inside the area, and the home side lined up, clearly fearing the worst as Al Ittihad's strike force discussed their attacking options.
But in one of the most subtle and greatest insults given to a match official, Al Ittihad did the decent thing and merely passed the ball safely off the pitch. Even the supporters cheered at the gesture.
In a single stroke, the players managed to endorse a magnificent moment of sportsmanship between two opponents, while highlighting what an idiot the referee had made of himself.
Different priorities
A thought for the day from the world of coaching girls soccer, with thanks to a colleague at Northwestern Medicine in Chicago.
After a soccer game between two teams of seven-year-old girls:
Frustrated coach: Your heads were just not in the game! Where were they?
Player: I was thinking about princesses and puppies.
After a soccer game between two teams of seven-year-old girls:
Frustrated coach: Your heads were just not in the game! Where were they?
Player: I was thinking about princesses and puppies.
Northwestern Medicine learns from patients and families
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I had the pleasure of making a presentation at a leadership meeting at Northwestern Medicine today. Afterwards, while sitting through some other business sessions of the team, I saw this simple graphic representation. It is emblematic of the types of changes that can occur when patients and families help set a health system's priorities. Northwestern has convened a patient-family advisory council and was discussing with them the various metrics the hospital uses to portray progress on several clinical fronts. The PFAC members made a persuasive case that the evaluative framework employed by the health system, and the corresponding set of metrics to measure progress along that framework, had a number of gaps. What evolved was the new framework shown above. Over the next couple of years, NW will design and add metrics to their corporate scoreboard to fill in the gaps noted by the PFAC.
This is a fine example of the kind of partnership that can develop between a health care system and the people it serves.
Chutzpah
The classic definition of chutzpah is provided by the man who kills his parents and then pleads for mercy from the sentencing judge on the grounds of being an orphan.
Now, we have a story by Julie Donnelly in the Boston Business Journal about the CEO of a hospital system who bemoans the fact that "any savings from layoffs in the health care industry are constrained by labor agreements that often force hospitals to lay off the youngest, cheapest workers."
Let's recall that it was this CEO who aceded to a neutrality agreement to facilitate the ability of the SEIU to organize his hospital system back in 2009 and who then was responsible for negotiating and approving the collective bargaining agreement with that union. Such an agreement contains the seniority rules that govern the order in which layoffs occur. At the time, some of us thought of these as steps along the way to ensure that union's support in front of state officials when the non-profit system's acquisition by a for-profit entity required state approval.
But now, the gentleman pleads for mercy.
Now, we have a story by Julie Donnelly in the Boston Business Journal about the CEO of a hospital system who bemoans the fact that "any savings from layoffs in the health care industry are constrained by labor agreements that often force hospitals to lay off the youngest, cheapest workers."
Let's recall that it was this CEO who aceded to a neutrality agreement to facilitate the ability of the SEIU to organize his hospital system back in 2009 and who then was responsible for negotiating and approving the collective bargaining agreement with that union. Such an agreement contains the seniority rules that govern the order in which layoffs occur. At the time, some of us thought of these as steps along the way to ensure that union's support in front of state officials when the non-profit system's acquisition by a for-profit entity required state approval.
But now, the gentleman pleads for mercy.
The word from Mt. Sinai
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There’s some good stuff happening at Mt. Sinai Hospital in downtown Toronto, and I thought I’d take a moment to share examples with you. I was there because the folks at the hospital had invited me to give grand rounds and also to participate in some sessions with senior leadership and with their quality improvement champions. As is often the case, I learned more than I imparted, and I walked away impressed with the organization’s commitment to quality and safety improvement, transparency, and staff engagement.
Here’s one example. While I had heard about the concept of a patient navigator before today, including at my own former hospital, the navigator service was usually designed to help people of different cultural backgrounds maneuver through the complicated labyrinth of the tertiary care system. At Mt. Sinai, they have taken the concept to its logical conclusion, providing patient navigators for all general internal medicine, surgical oncology, and inflammatory bowel disease patients.
Here, for example, is Heather Siekierko, a navigator assigned to the “D” group of doctors and nurses serving patients in the general internal medicine area. When a patient arrives on the floor from the emergency department, Heather is already on the case, handling a multitude of tasks that previously would have taken time away from nurses or other clinical staff. Heather’s academic training? Fine arts!
With one navigator assigned to each of the four clinical teams, there used to be some confusion as to which person was assigned to which team. A doctor might spend time asking, “Are you in our group?” The problem was solved when a doctor suggested creating simple badges indicating each navigator’s group affiliation.
This program is supported by philanthropy, as the payment regime from the province of Ontario does not include funding for this kind of service. It is so effective, though, in terms of patient satisfaction and clinical improvement, that the hospital is working on a way to provide sustainable funding.
Here’s a second example, implementation of the Releasing Time to Care™ approach developed by the UK’s National Health Service. The focus is on team huddles, design of work flows, and attention to key clinical indicators--most importantly characterized by empowering front line staff to identify concerns and drive improvements themselves. As folks at Mt. Sinai have noted:
RTC is about changing the way we manage and do our work--it is not an "add-on" improvement initiative but rather a fundamental strategy that is embedded in the core works of our units and our team.
The program is supported and enhanced by a remarkable degree of transparency. Take a look at these charts—presented for all to see—on the walls of the clinical care floors. There’s no holding back when things do not go according to plan. Everyone is aware.
As you can see from these two falls-related pictures from two different floors, these presentations are not necessarily high-tech computer-generated graphs working off sophisticated databases: They are filled out by hand or constructed by the staff on the floor. People’s participation in creating the visible displays of key metrics is part of the process. They own the numbers, and when the numbers indicate problems, the team swarms on the issues and creates experiments of possible solutions. The feedback on the effectiveness of those experiments is quickly and clearly displayed to all in real time.
So that’s it for now. Two examples of thoughtful attention to the issues facing many hospitals. To the Mt. Sinai folks, this is a good start, but they are modest in their assessment of what has been accomplished. From my vantage point, this is truly front-line driven process improvement, enhanced by support from the senior leadership and from members of the Toronto community. The momentum has been building, and I, for one, expect to see great things in the future.
Here’s one example. While I had heard about the concept of a patient navigator before today, including at my own former hospital, the navigator service was usually designed to help people of different cultural backgrounds maneuver through the complicated labyrinth of the tertiary care system. At Mt. Sinai, they have taken the concept to its logical conclusion, providing patient navigators for all general internal medicine, surgical oncology, and inflammatory bowel disease patients.
Here, for example, is Heather Siekierko, a navigator assigned to the “D” group of doctors and nurses serving patients in the general internal medicine area. When a patient arrives on the floor from the emergency department, Heather is already on the case, handling a multitude of tasks that previously would have taken time away from nurses or other clinical staff. Heather’s academic training? Fine arts!
With one navigator assigned to each of the four clinical teams, there used to be some confusion as to which person was assigned to which team. A doctor might spend time asking, “Are you in our group?” The problem was solved when a doctor suggested creating simple badges indicating each navigator’s group affiliation.
This program is supported by philanthropy, as the payment regime from the province of Ontario does not include funding for this kind of service. It is so effective, though, in terms of patient satisfaction and clinical improvement, that the hospital is working on a way to provide sustainable funding.
Here’s a second example, implementation of the Releasing Time to Care™ approach developed by the UK’s National Health Service. The focus is on team huddles, design of work flows, and attention to key clinical indicators--most importantly characterized by empowering front line staff to identify concerns and drive improvements themselves. As folks at Mt. Sinai have noted:
RTC is about changing the way we manage and do our work--it is not an "add-on" improvement initiative but rather a fundamental strategy that is embedded in the core works of our units and our team.
The program is supported and enhanced by a remarkable degree of transparency. Take a look at these charts—presented for all to see—on the walls of the clinical care floors. There’s no holding back when things do not go according to plan. Everyone is aware.
As you can see from these two falls-related pictures from two different floors, these presentations are not necessarily high-tech computer-generated graphs working off sophisticated databases: They are filled out by hand or constructed by the staff on the floor. People’s participation in creating the visible displays of key metrics is part of the process. They own the numbers, and when the numbers indicate problems, the team swarms on the issues and creates experiments of possible solutions. The feedback on the effectiveness of those experiments is quickly and clearly displayed to all in real time.
So that’s it for now. Two examples of thoughtful attention to the issues facing many hospitals. To the Mt. Sinai folks, this is a good start, but they are modest in their assessment of what has been accomplished. From my vantage point, this is truly front-line driven process improvement, enhanced by support from the senior leadership and from members of the Toronto community. The momentum has been building, and I, for one, expect to see great things in the future.
Southlake offers positive change
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I shared a delightful day with people from Southlake Regional Health Centre, in Newmarket, Ontario. I found a (large) community hospital that has dramatically updated its service lines over the past few years and has also made real efforts to improve quality and safety. You could see signs of staff engagement throughout the hospital, including this visual reminder regarding daily safety huddles.
I include, for lighter review, a video with a key aspect of the automated wayfinding system the hospital has installed, clearly delineating the path to the Tim Hortons coffee shop! (It also leads people to the various clinical departments and physicians.)
Extreme unusualness
I'm in Toronto to meet with the staff about quality and safety progress at Southlake Regional Health Centre and Mt. Sinai Hospital and am very much looking forward to that. Meanwhile, I get to read the Toronto Star, which has a story about the return to work of Mayor Rob Ford, "who ignited a firestorm last week when he admitted to smoking crack cocaine" and "will try to go back to business-as-usual."
Here's the quote of the day, the best I have seen about a leader in a long time:
"There's no 'business as usual' with Rob Ford. In a way there hasn't been for awhile, but now it's at the point of extreme unusualness," said Nelson Wiseman, a University of Toronto politics professor.
Here's the quote of the day, the best I have seen about a leader in a long time:
"There's no 'business as usual' with Rob Ford. In a way there hasn't been for awhile, but now it's at the point of extreme unusualness," said Nelson Wiseman, a University of Toronto politics professor.
Management of CMV after transplantation
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Pre-transplant:
All the donors and recipients of kidney transplants (both living and deceased) should be tested for status of CMV by CMV IgG in the blood. If there is history of recent transfusion, pre-transfusion status should be regarded as the true status of CMV. The status of both donor and recipient for a given pair. should be documented in the record post-transplant
Post-transplant:
Prophylaxis:
- CMV related illness is common in the KTRs and the risk is highest in D+/R- group and the least in D-/R-.
- We do prophylaxis KTRs with Valganciclovir (Valcyte) 900 mg daily (adjusted for renal function) for 6 months in D+/R- group, and 450 mg daily for 3 months for R+ group regardless of the donor status. No CMV prophylaxis is required for the D-/R- group (this group receives acyclovir for prophylaxis of other opportunistic viruses like HSV and HZV).
- Leukopenia is a side effect of Valcyte and the anti-metabolites. If leukopenia is encountered, valcyte dose or dose of the anti-metabolite (eg MPA derivative, azathioprine, or TOR inhibitor) or both be adjusted based on the physician’s discretion (consider checking for CMV pcr). Consider use of G-CSF if the absolute neutrophil count is less than 500. If Valcyte dose must reduced or discontinued for more than one week, weekly monitoring of CMV Quantitative (blood PCR) could be considered for a total of 3-4 months from the time of transplant.
- Routine CMV PCR testing is NOT recommended in patients receiving full doses of prophylactic therapy unless there is some other clinical suspicion for breakthrough CMV infection.
1. CMV infection:
Active viral replication (based on blood PCR) without any symptoms attributable to CMV. It is recommended to start treatment even at a low level of viral load. It should be noted that a change of viral load less than or greater than three times the previous value (0.5 times log 10) does not mean a true change in the viral load.
Valcyte at treatment dose (900 mg BID), adjusted for renal function) is recommended for treatment. Weekly Quantitative PCR in plasma is recommended while on treatment and duration of treatment to continue at least for two consecutive negative Quantitative PCRs, and not less than a total of 2 weeks. Secondary prophylaxis at the end of treatment (at prophylaxis dose of Valcyte) for a month or two after finishing treatment can be considered if suspicion for relapse is high.
2. CMV disease:
Active viral replication plus symptoms: Either 1) a flu-like illness with fever and general malaise, often associated with leukopenia or 2) tissue invasive disease (commonly GI but also including hepatitis, pulmonary and rarely uveitis and encephalitis).
Treatment either with Valcyte at treatment dose or IV Ganciclovir at treatment dose (for life threatening illness and GI disease). IV Ganciclovir can be switched to corresponding dose of Valcyte at any time during the therapy if considered appropriate. Monitoring for response and duration of treatment are similar to CMV infection treatment. Please note that tissue invasive disease can rarely occur with negative quantitative PCR in blood (especially when disease is limited to the GI tract). In that situation, duration of therapy should consist of at least two weeks of the antiviral or longer as guided by clinical response. Secondary prophylaxis at the end of treatment with Valcyte for a month or two (at prophylaxis dose of valcyte) can be considered if suspicion for relapse is high.
Lowering of immunosuppression should be considered starting with the anti-metabolite (definitely for life threatening illness) at the discretion of physician. If leukopenia is encountered, it is recommended to lower anti-metabolite rather than lowering valcyte dose to avoid failure of therapy and resistance of CMV to valcyte.
CMV resistance, although rare, should be suspected if no response to therapy even after a total duration of 5 weeks with Valcyte. If CMV resistance is confirmed, consider foscarnet for treatment, the dose of which should be also adjusted based on renal function
CrCl (ml/min) | Maintenance/Prophylaxis | Treatment |
Valcyte | | |
>60 | 900 mg q day | 900 mg bid |
40-59 | 450 mg q day | 450 mg bid |
25-39 | 450 mg q 2 days | 450 mg q day |
10-24 | 450 mg twice weekly | 450 mg q 2 days |
<10 | 100 mg 3 times a week, after HD | 200 mg 3 times a week, after HD |
| | |
IV Ganciclovir | | |
>70 | | 5 mg/kg q 12 hr |
50-69 | | 2.5 mg/kg q 12 hr |
25-49 | | 2.5 mg/kg q 24 hr |
10-24 | | 1.25 mg/kg q 24 hr |
<10 | | 1.25 mg/kg 3 times a week after HD |
Posted by Raj Sabaru
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