Monday, November 21, 2011
We Are Ruining Our Children’s Future Health
That is my interpretation of the report issued a few days ago by the Centers for Disease Control (CDC) on seven criteria known to the associate with ideal cardiovascular health as part of the National Health and Nutrition Examinination Survey. They are defined, briefly, as 1) a diet with 4 ½ servings of fruits and vegetables per day, 3 servings of whole grains per day, fish twice per week, no more than 1500 mg of sodium (salt) per day, and less than 36 oz of sweetened drinks per week. Also 2) a normal body mass index (BMI) which roughly means not being overweight, 3) not smoking, 4) having at least one hour of physical activity per day, 5) a normal level of cholesterol, 6) normal blood pressure and 7) normal blood glucose (blood sugar.)
Infants start out life with a normal risk for heart disease but risk increases rapidly from preteens and into adolescence. We have known for some time that kids are getting less and less exercise, even less as they progress into the teenage years.
But this new report is striking. Not one child out of 4157 aged 12 to 17 in the study group monitored between 2003 and 2008 was in the “ideal” category for diet. And only 16% of the boys and 11% of the girls were in the ideal range for all of the remaining six categories.
Looked at differently, 20% were obese (not just overweight); about 20% smoked; about 50% had too little physical activity; cholesterol was elevated in about 30%; and glucose was somewhat high in about 40%. One bright spot – blood pressure was elevated in less than 10%.
This report is important for at least two reasons. We know that atherosclerosis begins to build up in childhood and young adults even though angina and heart attacks are not common until a few decades later. It is essential to maintain a healthy lifestyle and this needs to begin in childhood. Second, we know that the 7 criteria are each associated with a lessening of heart disease risk when kept to the normal or ideal level (diet, weight, not smoking, etc) and that each, when not meeting the standards, add together to increase the risk of cardiovascular disease in later life.
These are not impossible standards to meet. Diet might be most difficult, especially for kids in urban or rural poor areas who have less access to fresh fruits and veggies but there is little excuse for over indulging in salt and sodas. One big problem is the ready availability of processed foods – foods high in salt, fat and sugars including high fructose corn syrup – along with ubiquitous sodas, often in very large containers.
Parents – they are your children. They need good food, they need lots of activity, and they need parental support to avoid tobacco and processed foods. They are your (and all of our) future.
Friday, November 18, 2011
Frailty – Common In Older Ages But Is It Preventable?
You know a person is frail when you see him or her – instinctively you will think a person is “frail” if they are “skinny,” weak, tired, inactive and slow. But frailty can actually be measured. Among the systems is one developed by the Cardiovascular Health Study, a longitudinal program that evaluated cardiovascular risk factors with annual examinations from 1989 to 1999 for individuals over age 65. This was followed through to the present with annual telephone follow-ups. Their “frailty indicator variables” include unintentional weight loss of more than ten pounds (as some measure of loss of muscle mass), grip strength,(as a measure of weakness) , fatigue score on a standardized test (as a measure of tired), physical activity (measure of inactivity), and walking speed (“slowness.”)
Using this approach, and if we define “frail” as having three or more of these five characteristics, about 7% of adults over age 65 living in the community will be regarded as frail. Importantly, frailty is not the result of co-morbidities but co-morbidity is a risk factor for frailty and disability is a frequent outcome of frailty.
With this definition of 3 or more characteristics, frail individuals will be found to have more falls, more hospitalizations, more fractures, increased sleep disordered breathing and more difficulty with the activities of daily living. They also, on average, demonstrate certain biological differences such as elevated C-reactive protein.
One person – otherwise healthy – might become frail in his 70’s whereas someone else might not until his 90’s or even after 100. That would suggest a possible genetic component and some preliminary studies as consistent with this theory.
We know that our bodies begin to “decline” with aging beginning in middle age. Bone mineral density for example declines about 1% per year. So too does cardiac function, muscle mass, lung capacity, etc. These processes are “normal” but can be slowed. Regular aerobic and weight bearing exercise will help maintain all of these functions. The decline will continue but at a slower rate.
What can we each do now? After checking in with your health care provider, a reasonable regimen might include:
Daily aerobic exercise for about 30 minutes
Resistance exercises (weights, Nautilus, etc)
Balance training
A personal trainer or physical therapist might be useful to give guidance and check out if the exercises are being done correctly and with enough intensity.
Then it might be good to add in a
Nutrition consultation to be sure your diet is appropriate for your age and lifestyle. For example, do you get enough protein in your diet?
And you might want to include some mental exercises to complement your physical ones. Studying a foreign language, playing chess or bridge, or Sudoku challenges your brain – but not TV watching or mindless books (even if they are interesting.)
This approach will slow the normal aging process and it may even help prevent the onset of frailty and is sequela. And for certain you will feel better, have fewer falls and other problems common with older age.
Monday, November 7, 2011
Reasonable Goals for Health Insurance Coverage and Defining Medical Necessity
One of the major goals of the Affordable Care Act is to reduce the number of uninsured from the current about 50 million people (or 16+% of the US population) by both offering Medicaid to many more individuals and creating state-based insurance exchanges for individuals who cannot obtain insurance at their worksite. Medicaid will be available for those at <133% of the federal poverty rate (currently $22,050). The insurance exchanges will be available to everyone but those with income below 400% of the poverty level ($88,200 for a family of four) will be eligible for tax credits based on actual income. Unlike Medicaid which has essentially no cost sharing by the individual, insurance from the exchanges will be purchased at one of four levels – 60, 70, 80 or 90% of the approved covered expenses will be paid by the insurance; the remainder will be the individuals’ responsibility. Higher deductibles will likely correspond to lower premiums.
The Institute of Medicine (IOM), at the request of the Department of Health and Human Services, formed a committee to consider the process for defining “essential health benefits” which ultimately will translate into what is covered or not by the insurance from the exchanges. The IOM, wisely in my opinion, emphasized he need for affordability rather than just comprehensiveness. They argued that coverage should be “evidence-based, specific and value promoting over time.” They proposed that medical necessity should be based upon clinical appropriateness, best scientific evidence and a likelihood of providing an “increased health benefit…that justifies an added cost.” [For a fuller discussion of the IOM recommendations, see John Iglehart’s article in the New England Journal of Medicine, Oct 20, 2011]
These seem like wise and sensible proposals. Too often there has been a “push” to insist on very comprehensive coverage, little attention to evidence-based criteria and little or not cost sharing by the patient.
My own hope is to see insurance that carries high deductibles to encourage each of us to personally monitor our health expenditures. When we have our own money at stake, we are more likely to ask our physician if that MRI, procedure or specialist visit is really needed of if it is “just to be complete.” That high deductible may also encourage us to maintain a better life style and maintain our health. That is good for us and reduces the overall costs further.
My new book discusses these topics in detail – “The Future of Health Care Delivery, Why It Must Change and How It Will Affect You” will be published in Feb, 2012 by Potomac Books
Tuesday, November 1, 2011
Kudos for Electronic Medication Ordering But Problems with Electronic Physician Documentation
I then asked to see a physician using the electronic medical record to enter an order. The doctor showed me how it was done and how it helped her to avoid mistakes. Basically she was very complimentary of the new system.
So I then asked if she also found it effective for writing her medical documentation such as history and progress notes. Medical documentation is the essential communication tool providers use to collaborate on patient treatment. “No way,” was the immediate response. “It [Electronic Physician Documentation] is too cumbersome, takes much too much time, does not allow me to enter information in a logical manner – basically it wants me to use [the computer’s] logic, not mine. So I just hand-write my notes.” Not a good recommendation, so I asked a few more physicians at different locations and got the same response. I checked with the hospital CIO and learned that few physicians actually used the “physician documentation” part of the system although they gave high marks to the other elements such as ordering tests and reviewing results and images. Since then I have asked similar questions at multiple hospitals, using different major vendor systems, always with about the same response. Clearly, there is a problem here.
The long standing written methodology for physician documentation works sort of like this: the doctor writes an “Admission Note” which includes the patient’s history of the present illness, social and medical history, examination findings, diagnostic test findings, a presumed diagnosis, further testing to be done and a treatment plan. Concurrently, the doctor writes “Orders” such as bed rest, frequency of vital signs to be collected, type of diet and drug orders. Thereafter, the doctor enters “Progress Notes” on a daily or greater basis that summarizes the patient’s status since the last physician visit, new information, supplemental orders for additional testing and new treatment approaches. With an electronic medical record many commercial systems try to adjust this process to use “Check offs” and to eliminate or markedly reduce typing which cannot be readily manipulated for later analysis. Some details are readily done by “check offs” such as age, race, gender and even much of the examination. But the “history,” especially that of a person with one or more chronic illnesses, is by nature a narrative not readily amenable to check offs. A second issue is that the physician deals with the patient and therefore with the chart in a discontinuous manner. For example, he or she might visit each patient early in the morning, then go to radiology to review the films with the radiologist, then to pathology to look at slides with the pathologist, etc. Meanwhile the nurse calls with a problem to be resolved with a verbal order or an electronic order urgently. Each of these encounters may need an update to the medical record and so it needs to be adaptable to that requirement. In teaching hospitals, the intern and residents need a simple manner to sign out to each other with a list of problems for each patient – absent that it means taking notes at a sign out conference. Each of these are issues that most of the current commercial vendors have not resolved which is why the doctor I queried responded “No way.” This problem needs to be resolved promptly if electronic medical records are to gain their full potential.
There is hope, however, with innovative niche companies and new technologies to solve these problems where the vendor market has traditionally been unable to do so. Companies such as Salar, Inc., which have carefully observed how physicians work, have found ways to extend hospital EMR’s to deliver a more flexible templating solution. [Disclosure: I was a Salar board member for five years.] Furthermore, advances in voice recognition and natural language processing give promise of allowing physicians to continue to document in their own methods (allowing for narrative and flexible workflow) while coding the information and delivering the information to the EMR.
I believe that once good systems are in place for physician documentation, the electronic medical record will be rapidly adapted with the attendant advantages for patient, doctor, hospital and insurer. This will be especially important as we increasingly need to care for patients with multiple chronic illnesses with the multi-disciplinary team-based approach. The question at hand is why have the major vendors not corrected/improved their systems to make physician documentation easy and thorough for the doc? I suspect that it is because they have large bureaucracies with software written by those who have not actually observed how physicians work. Hopefully this will change.
My new book “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published Feb 28, 2012 by Potomac Books
Thursday, October 20, 2011
Targeted Therapies Lead To Exciting Improvements in the Treatment of Melanoma Patients
Melanoma, as with all cancers, has its own genotype variations. There are at least five melanoma genotypes which can be detected with molecular profiling (for more information look at Vanderbilt’s “My cancer genome”). Each type has its own different mutations.
Just fewer than 50% of melanomas have a mutation in BRAF, a cell signaling pathway. Approximately 90% of the BRAF mutations produce a substitution of glutamic acid for valine at codon 600 in the gene product. This is apparently a critical factor in the development and aggressiveness of melanoma cells. About 20% of melanomas have an NRAS mutation, 1% have both BRAF and NRAS and 30% have neither mutation. Interestingly, among patients 20-30 years old, 86% will have the BRAF mutation but only 22% of those over 70 years have it. As a result, the new drugs that target the BRAF mutation gene product will be of relatively more utility in younger than in older individuals.
One of the new targeted drugs is an inhibitor of the BRAF mutated gene product called Vemurafenib – the name based on “V600E mutated BRAF inhibitor.” Vemurafenib (Zelboraf) decreased the relative risk of death by 63% and the risk of tumor progression by 74% when combined with dacarbazine (an alkylating agent also known as DTIC or imidazole carboxamide which has been the long time standard of care for metastatic melanoma) compared to dacarbazine alone in a large cohort of patients with the BRAF V600E mutation in their melanoma. The FDA approved this drug for treating melanoma in August, 2011 for BRAF mutation positive patients as determined with a companion diagnostic device called the BRAF V600 Mutation Test.
In this phase 3 trial of 675 patients, there as 48% response rate and a 5.3 month median progression free survival with Vemurafenib compared with dacarbazine with its 5% response rate and 1.6 month progression free survival median. Exciting as this sounds, it is no panacea and certainly not a cure although some patients had both excellent tumor shrinkage and long survivals, both rarely seen with dacarbazine. Side effects were acceptable but squamous cell skin cancers developed in some and activity declined over time. To deal with the latter, new trials are evaluating combined targeted therapy by adding a MEK gene product inhibitor. In early results, there was increased activity and fewer skin tumors developing.
The cost, according to the manufacturer, Genentech, will be about $60,000 for a course of therapy over about six months. Vemurafenib tends to have rapid responses and so might be especially important for patients with extensive disease or severe symptoms. Despite the enthusiasm for a drug that actually has real benefit, it is not curative therapy nor does it produce truly long lasting responses. Still it is a major improvement and offers real benefits and hope to patients, a testament to the concept of targeted therapy based on genomic information.
Another drug, ipilimumab (Yervoy) also has shown substantial activity against metastatic melanoma. Ipilimumab is a monoclonal antibody that binds to the cytotoxic T-lymphocyte antigen 4 (CTLA 4) and acts to enhance T-cell activation. In other words, it activates the immune system. It was approved by the FDA in March, 2011. The basic clinical trial that led to approval had 502 poor prognosis patients yet with good performance status. Patients randomized to ipilimumab plus dacarbazine had a longer time of progression free survival and the responses that developed persisted longer (19.3 vs. 8.1 months) than those who received dacarbazine alone. Overall survival was 11.2 months compared to 9.1 months but there were about 25% alive at four years which is quite noteworthy. Unfortunately, it can cause or exacerbate autoimmune disease because it allows T-cells to stay activated. The manufacturer, Bristol Meyers Squibb, at the request of the FDA, has sent a booklet to all medical oncologists to guide attention to these potentially serious side effects. It costs about $120,000 for a course of treatment.
So these are encouraging improvements for a tumor that has been exceptionally resistant to new approaches to treatment over the years. The key has been to understand the genetic mutations in the tumor, then to analyze the gene product and finally to create a drug that inhibits the gene product’s activity – genomic targeted therapy. Going forward, treatment will probably be a combination of compounds that interact with various mutations’ effects, hopefully augmenting the activity shown by these two drugs to date.
Thursday, October 13, 2011
Primary Care Physicians Can Greatly Reduce The Costs Of Care, Especially For Chronic Diseases
Ellen is an elderly lady who had been going to the same primary care physician (PCP) for over twenty years. On nearly every visit she said that she felt “tired.” Repeated history and exam revealed no cause nor did logical tests such as those for anemia or hypothyroidism. She then developed syncopal episodes – times she would black out and fall to the floor, once bruising her head when she fell against the stove, and then waking up in a few minutes. Evaluation showed that she had intermittent episodes of bradycardia, or very slow heart rate, resulting in the drop attacks. In consultation with a cardiologist, it was decided to insert a single lead pacemaker. The pacemaker senses the electrical action in the heart and when the rate drops below a set level, it immediately begins to send out an electrical stimulus – on demand - to the heart muscle so that it will contract at a normal rate. The pacemaker is expensive and the procedure to place it is expensive as well. But it worked perfectly and she no longer had the attacks that were not only scary and medically dangerous but seriously impacting her quality of life. A good return on investment.
A few months later during a visit to her daughter, she went to that daughter’s internist for an unrelated reason; he urged her to see a cardiologist colleague. Both the internist and the new cardiologist heard the usual complaint of “being tired” and assumed it related to her cardiac status. This cardiologist in turn recommended that she needed a “dual lead” pacemaker instead of the single lead one she had. [It has been found that having more than one lead can sometimes improve the heart’s output for very carefully selected patients with heart failure.] When the PCP much later received the cardiologist’s mailed consult report, he disagreed, noting she did not have heart failure, just syncopal attacks – an electrical not a mechanical problem in her heart. Further, the current pacemaker was only needed about 10% of the time meaning that her heart beat at a normal rate at least 90% time, so the pacemaker was not even active most of the day. This lady did not need the proposed new, even more highly expensive pacemaker. No pacemaker, no procedure, no risk of insertion, no risk of post operative infection or bleeding. A lot of money could be saved and the patient could be spared a straight forward yet somewhat risky procedure – which she did not need. The fundamental problem was the lack of care coordination. One would like to believe that had her medical record been easily available digitally, the newly involved internist would have never even suggested the need for a cardiologist opinion and even if sent on, the cardiologist would have rapidly recognized the lack of need for the new device.
The lesson is one doctor needs to be the orchestrator of all of the patient’s care. A good PCP, like this one, coordinates the care of his or her patients with chronic illnesses and in so doing avoids excess referrals, tests, procedures and hospitalizations along with unneeded drugs or devices – all the elements that drive up the total cost of care – and in the process assures quality care, safer care and a close doctor-patient relationship. But sometimes a patient is elsewhere, sees a new physician and the medical history is not readily available. All too often as in this case, the patient ends up getting tests, images or procedures that he or she just does not need.
One of the most effective ways to reduce medical care costs is with good coordination of the care of individuals with chronic illnesses. As the story of Ellen above and of Henry from the earlier post exemplify, there is a strong tendency today for patients with chronic illnesses to either be referred to various specialists or else to go on their own. When this occurs without coordination, the visits add up, the number of tests and images ordered go up, the number of drugs prescribed rises rapidly and the number of procedures and even hospitalizations climb. Unfortunately, many of these are simply not needed – excessive and wasteful, not the best quality and obviously very costly. The value of a good digital medical record in both of these patients is obvious because communication among providers is critical to optimal care.
The primary care physician is in the best position to coordinate care. He or she knows the patient, the patient’s family and socio-economic situation and of course the patient’s various illnesses. Ellen did not need to see a second cardiologist and did not need the dual lead pacemaker. The PCP knew that “tired” was just her normal statement at every visit; not a reason to do more tests, add a drug or do a new procedure. It was unfortunate, indefensible but not at all uncommon that the new cardiologist did not make the effort to call the long time PCP. It would have been quickly determined that Ellen did not need a very expensive new pacemaker.
Henry suffered because he did not have a PCP. Instead he had four doctors, each one dealing with all of his problems and none communicating with the others. Once he had a single PCP, his prescriptions plummeted from 23 to seven, he felt better, had fewer drug-induced side effects and both he and his insurers were saving a lot of money.
Care coordination is critical; it improves the quality of care; it reduces risk; it reduces the costs of care; and it ultimately improves patient satisfaction. A good PCP (or occasionally a specialist) is needed to the orchestrator of that coordination. The electronic medical record has an integral part to play in robust care coordination.
Why, with all of these attendant advantages, do not all PCPs engage in excellent care coordination? I believe it is twofold – dollars and lack of training.
My new book, “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published in February, 2012 by Potomac Books
Monday, October 10, 2011
Care Coordination Is Critical For Those With Chronic Conditions Like Diabetes or Osteoarthritis
So as time goes on, more and more of these disease-based programs will emerge for the care of complex, chronic diseases. To some degree this may seem to threaten the primary care physician in the community. But it is really a benefit and an adjunct to both the physician and the patient. The primary care physician still sees the patient for the bulk of their individual care but knows that he or she and the patient have an expert team available to help either occasionally or more often as necessary.
Here is an example of team based care in orthopedics. Marshall Steele, III, MD is an orthopedic surgeon in Annapolis, Maryland who did a lot of knee and hip replacements. He was frustrated that the system just was not efficient nor was it patient or provider friendly or convenient. So he and some collaborators worked with their hospital, Anne Arundel Medical Center, leadership to devise a totally new approach to total joint replacement. Briefly, it works like this. A unit of the hospital was set aside solely for total joint replacement patients with its own dedicated staff. A single leader who had full responsibility but also the needed authority was placed in charge, eliminating the traditional silos that exist in most hospital management systems. Instead of being focused entirely on the inputs which dominates organizations structured in departments, this new model focuses first on the outputs (outcomes) of their work from the perspective of all stakeholders. All patients for the week are brought in the week before to meet each other, meet the staff, tour the facility and attend a class taught by a nurse navigator or coordinator of what will transpire during their stay. They are then all brought to the hospital for surgery the same day, necessitating that extra ORs be available for the orthopedists. After surgery the patients are put into a wellness environment outside of their hospital room. There they are brought together for some meals each day and for beginning physical therapy. They even return as outpatients for physical therapy together.
These steps plus many others have markedly improved physician, nurse and physical therapist coordination and satisfaction while working as a multi-disciplinary team, each with their own expertise unleashed for the care of these patients. The patients are much more satisfied and work together as a support group. At a formal luncheon one month later, patient and family input is sought and programs changed to respond to their needs and those of their families. Length of stay is down and complications have been reduced. Important hospital reported metrics are collected and shared with the team on easy to understand electronic dashboards. Patient reported metrics are collected on how effective the procedure was in reducing pain and return to desired activities. As word got around, more and more patients, many from great distances, sought out the team. Hospital revenues rose and the orthopedists became very busy. Other hospitals have tried to emulate this approach. But many fail. Why? Because, as Dr Steele points out, what is needed is a transformational change but most physicians, hospital staff and hospital managements are only able to muster incremental change. Incrementalism where transformation is needed just doesn’t work.
As medicine becomes more and more disease/patient-oriented, the traditional departments of medicine and surgery within a hospital will tend to be de-emphasized and in their place will come centers for cardiac care, cancer care, diabetes care, stroke care, joint replacement and the like. A multidisciplinary team approach to care will become much more common. Just as with the primary care physician, this shift will appear to many practicing specialists to be a “threat” to their autonomy and certainly to their long-held practice patterns. To be effective they must have an effective electronic medical record system. Moreover, insurers do not like to pay for a team to see a patient. Their approach is to pay one physician for one consult or one patient visit. To pay for three doctors to see one breast cancer patient all at once is anathema, and, in general, they may refuse payment. Hospital managers, like physicians, are “conservative” and traditional, with functions organized in a format that was effective many years ago but which is no longer. But change is difficult and as pointed out in the story above on joint replacement, the change needed is transformational, not incremental. The electronic medical record, critical to success of these arrangements, must be part of the transformational change. Change will not come easily; but it must occur and so it will, but not quickly. But the hospitals who figure this out first will have a competitive advantage.
These stories raise the question as to why it is so difficult for physicians and hospitals to change their ways when the new approach can be shown to be so much more effective in delivering improved quality of care at a reduced cost?
My new book, “The Future of Health-Care Delivery: Why It Must Change and How It Will Affect You,” from which this post is adapted, will be published February 28, 2012 by Potomac Books. You can find it now at Amazon at http://tinyurl.com/
Praise for Dr Schimpff
The craft of science writing requires skills that are arguably the most underestimated and misunderstood in the media world. Dumbing down all too often gets mistaken for clarity. Showmanship frequently masks a poor presentation of scientific issues. Factoids are paraded in lieu of ideas. Answers are marketed at the expense of searching questions. By contrast, Steve Schimpff provides a fine combination of enlightenment and reading satisfaction. As a medical scientist he brings his readers encyclopedic knowledge of his subject. As a teacher and as a medical ambassador to other disciplines he's learned how to explain medical breakthroughs without unnecessary jargon. As an advisor to policymakers he's acquired the knack of cutting directly to the practical effects, showing how advances in medical science affect the big lifestyle and economic questions that concern us all. But Schimpff's greatest strength as a writer is that he's a physician through and through, caring above all for the person. His engaging conversational style, insights and fascinating treasury of cutting-edge information leave both lay readers and medical professionals turning his pages. In his hands the impact of new medical technologies and discoveries becomes an engrossing story about what lies ahead for us in the 21st century: as healthy people, as patients of all ages, as children, as parents, as taxpayers, as both consumers and providers of health services. There can be few greater stories than the adventure of what awaits our minds, bodies, budgets, lifespans and societies as new technologies change our world. Schimpff tells it with passion, vision, sweep, intelligence and an urgency that none of us can ignore.
-- N.J. Slabbert, science writer, co-author of Innovation, The Key to Prosperity: Technology & America's Role in the 21st Century Global Economy (with Aris Melissaratos, director of technology enterprise at the John Hopkins University).