Medical Evidence and Getting the Right Care

Choosing Medical Treatments Wisely

The spate of media articles on unnecessary procedures and treatments which do not improve health and can harm patients is a sentinel cry to the public. This article addresses the types of questions patients and their families need to ask when faced with health care decisions and where to get answers.

Understand the Disease Evidence

One of the statistical principles which patients should understand is that an increase in the incidence (precursor) of a disease does not mean an increase in the invasiveness or death from the disease. A good example of this is thyroid cancer, here-to-for a relatively obscure disease which has now hurtled into 9^th place in the cancer lexicon, as elucidated by Dr. R. Michael Tuttle in Medscape Oncology. [1] What this phenomena means to the general public as well as clinicians is the surveillance and testing for this condition has increased in specificity and volume. This does not in fact mean that there are more invasive thyroid cancers or that more people are dying from it, merely that smaller nodules are being found because of the improvement in imaging. The same can be said for the explosion in breast cancer in the U.S. where conditions which are pre-cancerous are lumped into the cancer milieu, causing an increase in prophylactic breast amputations.

 Before you consent to a medical procedure, whether it involves radiology (radiation transmitted into your body), treatment with drugs, or an invasive surgical procedure, there are questions you should ask.  I am citing Dr. Nortin Hadler’s prolific publishing and seminal work at the University of North Carolina, as the expert in debunking the medicalization mythology. Dr. Hadler states, “The best we can do today is to impose rationality on the current (healthcare) system- iron clad, science supported, and patient-driven rationality with the goal of assuring health and providing recourse when that assurance falls short.” [2]

Rational Questions for Patients and Families

Does the lab test contribute to an increased cancer risk?

What are the risks and side effects of the procedure or the prescription?

Are there other treatment options such as watchful-waiting?

Organizations Which Can Help Inform Your Medical Decisions

The ABIM Foundation, which is a physician driven nonprofit working to discern and promote methods to provide high value health care, has created the Choosing Wisely Campaign which aims to focus on reducing the overuse of tests and treatments.[3] The ABIM Foundation has come up with a list of 70 procedures that physicians and patients should question.[4] Here is my short list, but follow the link in the footnotes to find all 70: 

1. Colonoscopy is often done too frequently- Unless you have an irregular test (polyps or other cancer risk factors), this test need only be done every 5 or even 10 years. This is a baseline test folks, not part of your “annual physical” and it is a very expensive test, running over $2,000 (U.S.) and requiring the use of anesthesia, which has other risks.
2.   Screening tests regardless of health condition- These ubiquitous “fishing” tests are often promoted by “special clinics” or at “shopping malls” and offer full body scans, which are unnecessary and not shown to improve health or extend life. Again, it is best to avoid the extra doses of radiation when you can. Yes, a full body scan may find something wrong with you, but this information won’t necessarily impede your health or hasten your death.
3.    Prescribing Opioids for chronic pain-In laypersons terms these drugs are known as Vicodin, OxyContin, or Percocet which are designed to work in the short term (following surgery) and over time they become less effective for pain relief. Also, one fourth of all patients who use these medications become addicted and they can cause death. Other side effects include world class constipation, nausea, confusion, mental disturbance, and if that isn’t enough, liver damage if you take enough of the stuff.
4.   Medical tests administered at the end stages of life-For example after your cancer has spread to Stage V, it is wise to start asking quality of life questions, such as: Will the treatment help you live longer or What are the side Affects and Risks? Ask about palliative care, which does improve your life. These same questions can and should be asked by all octogenarians. In other words, how is the test or treatment going to improve your life? 
5.   Ubiquitous testing for urinary tract infections- This is a test frequently given when no symptoms exist and results in an over use of antibiotics. Taking antibiotics kills friendly bacteria which your body needs to fight infections and over use causes super bugs which are resistant to treatment. 

Initiatives to Help Patients Make Informed Decisions

Currently, there are a number of medical initiatives in the Unites States, which are researching how to create and test patient and doctor shared decision making tools.  The Centers for Medicare and Medicaid provided $9,332,545 to a Texas initiative called Med Expert International, which is testing a shared decision making process. This award is a collaborative effort with California, Idaho, Texas, and Washington State.[5]

Things you can Read to Improve Your Health Care IQ

Dr. Nortin Hadler has been a persistent voice for clarity in how we much waste we have in U.S. healthcare and his most recent book, The Citizen Patient, published by the University of North Carolina Press, in 2013, reveals critical information about hospitals, interpreting scientific findings, and health care procedures which are more about revenue than enhancing health. [6] Dr. Nortin Hadler has also written, “Aging: Growing Old and Living Well in an Over Treated Society”, University of North Carolina Press.[7]

Roberta Winter is the author or Unraveling U.S. Healthcare-A Personal Guide
http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972
 And this is the healthpolicymaven signing off encouraging you to share this article with anyone whom may benefit. "healthpolicymaven" is a trademark of Roberta E. Winter, a graduate of the University of Washington School of Public Health and Community Medicine and the Daniel Evans School of Public Affairs. This article in no way provides medical advice.

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[1]Overdiagnosis in Thyroid Cancer: The Case for Observation, Medscape Multispecialty, Gabriel Miller, August 25, 2015

 http://www.medscape.com/viewarticle/849893

[2] Nortin M. Hadler, M.D. The Citizen Patient-Reforming Health Care for the Sake of the Patient, Not the System, University of North Carolina Press, 2013, p. 182

 http://www.amazon.com/The-Citizen-Patient-Reforming-Lillian/dp/1469607042

[3] http://www.choosingwisely.org/new-grantees-will-focus-on-reducing-overuse/

[4] http://www.choosingwisely.org/patient-resources/

[5] http://innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/California.html

[6] http://www.amazon.com/The-Citizen-Patient-Reforming-Lillian/dp/1469607042

[7] http://www.amazon.com/Rethinking-Aging-Growing-Overtreated-Society/dp/0807835064

Cancer Drugs-Cost Versus Benefit the New Paradigm

Recently, both the New York Times and the Los Angeles Times have published articles about oncologists' new consumer tool to gauge the effectiveness of cancer drugs. This effort was spurred after harsh rebukes of the pharmaceutical industry from clinicians at the Mayo Clinic and Harvard Medical School.  Both of the "Times" articles cite information from the Journal of the American Medical Association (JAMA) article, which ranked cancer fighting drugs from 2009 through 2013 for effectiveness and cost. (1) Oncologists have embraced this new consumer decision aide as it provides health care purchasers and their families with another basis for decision making. And, as it often turns out, the most expensive medication is not necessarily the most effective. Using a scale of 0 to 130 rating system, the cancer drug treatments are ranked for efficacy. Here are the most expensive oncology medications, based on the analysis of experts at JAMA in this study, costs are expressed annually and their effectiveness ranking is listed below:
       RX Ranking by cost-

1. Omacetaxine for chronic myeloid lukemia-$168,366
2. Ibrutinib for mantle cell lymphoma-$157,440
3. Crizotinib for non-small cell lung cancer-$156,544
4. Pomalydomide for multiple myeloma-$150,408
5. Sorafenib for papillary thyroid cancer-$141,984
6. Regorafenib for colorectal cancer-$141,372
7. Ponatinib for chronic myeloid lukemia-$137,592
8. Trametinib for malignant melanoma-$125,280
9. Lenalidomide for mantle cell lymphoma-$124,870
10. Cabozantinib for medulliary thyroid cancer-$118,800

      Same RX showing effectiveness and extended life expectancy due to drug observed response
     Note that some of the drugs lack a proportional effectiveness ranking, this is not an omission.
     Observed effects are quoted from the JAMA article findings.

1. Omacetaxine for chronic myeloid lukemia-14.3% effectiveness, 12.5 months median observed effect
2. Ibrutinib for mantle cell lymphoma-66% effectiveness, 17.5 months median observed effect
3. Crizotinib for non-small cell lung cancer-7.7 months median observed effect versus 3 months on other treatment
4. Pomalydomide for multiple myeloma-29% effectiveness,7.4 months median observed drug effect
5. Sorafenib for papillary thyroid cancer-10.8 months median observed effect versus 5.8
6. Regorafenib for colorectal cancer-2 months median observed drug effect versus 1.7 for other
7. Ponatinib for chronic myeloid lukemia-54% effectiveness, 3.2 to 9.5 months median observed drug effect
8. Trametinib for malignant melanoma-4.8 months versus 1.5 median observed effect
9. Lenalidomide for mantle cell lymphoma-26% effectiveness, median observed effect 16.6 months
10. Cabozantinib for medulliary thyroid cancer-11.2 months median observed effect versus 4 months

As you can see, a high price tag does not assure a fantastic response rate, especially when compared to plain old chemotherapy. Or for example, the non-small cell lung cancer drug, Erlotinib (Tarceva) scored a 44% effectiveness rate and costs $4,600 per month versus the outrageously priced Crizotinib at more than twice that price. Also in comparison, the widely marketed Avastin drug for lung cancers scored only a 16% effectiveness ranking, and it costs $12,000 a month. (2)

Oncologists have banded together to create a Value Framework (3) from which patients and their families can assess the total efficacy of a cancer drug, including cost, response to drug, and a comparison to other treatments. This welcome tool is called a decision aide and it is the latest trend in getting health care quality and purchasing information to the individual patients.

Concern for the efficacy of health care treatments is being expressed by governments as well, with multiple states passing laws requiring drug companies to share their development cost data and not just the drug price. California, Massachusetts, North Carolina, Oregon, and Pennsylvania all have bills pending for pharmaceutical transparency and disclosure. (4) This is all part of the increased effort for greater transparency in health care, driven to the consumer, who actually has to pay for the insurance, the treatments, or the taxes for all of the above.  Although the pharmaceutical pricing model is price-to-whatever-the-U.S.-market-will-bear, this is increasingly becoming a free fall for the consumer who can't afford the treatment and for publicly funded health care programs which are balking at the price gouging.

In 2013, in my book, http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972 I wrote about discerning quality in health care services and this is one more step in empowering patients and their families to make better decisions for their health treatments. To increase your health purchasing IQ continue to read what the healthpolicymaven has to say.  Other articles which may be of interest include:
http://healthpolicymaven.blogspot.com/search/label/cost%20of%20health%20care
http://healthpolicymaven.blogspot.com/2010/11/state-by-state-analysis-of-patient.html

And this is the healthpolicymaven signing off. This article does not offer medical advice and may be shared virally, with appropriate attribution to the writer of course. The healthpolicymaven is a graduate of the University of Washington School of Public Health and Community Medicine and the Daniel Evans School of Public Affairs.

(1) Sham Mailankody, MB BS¹; Vinay Prasad, MD, MPH,  Five Years of Cancer Drug Approvals, Innovation, Efficiency, and Costs, JAMA, July 2015, Volume 1 No. 4
http://oncology.jamanetwork.com/article.aspx?articleid=2212206&utm_source=google_plus_page&utm_medium=sohttp://oncology.jamanetwork.com/article.aspx?articleid=2212206&utm_source=google_plus_page&utm_medium=so

(2) Melissa Healy, Cancer Drugs get a new consumer's guide, Science Now, The Los Angeles Times, June 22, 2015
http://www.latimes.com/science/sciencenow/la-sci-sn-cancer-drugs-consumers-guide-20150622-story.html#page=1

(3)   Lowell E. Schnipper, Nancy E. Davidson, Dana S. Wollins, et, al. American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options,
American Society of Clinical Oncology, August 2015
http://jco.ascopubs.org/content/early/2015/07/08/JCO.2015.61.6706http://jco.ascopubs.org/content/early/2015/07/08/JCO.2015.61.6706

 (4) Andrew Pollack, Drug Prices Soar, Prompting Calls for Justification, The New York Times, July 23, 2015
http://www.nytimes.com/2015/07/23/business/drug-companies-pushed-from-far-and-wide-to-explain-high-prices.html?_r=0

Hospital Safety In Light of Ebola Scare

Hospital Safety In Light of the Ebola Scare

Due to public hysteria and resulting quarantine for Ebola patients, family members, and anyone who may have come in contact with any of these unfortunate individuals, this is a good time for consumers to re-acquaint themselves with patient safety standards through publicly available sources. First a primer on the main causes of adverse patient safety events in hospitals in the United States. In patient safety lexicon when something goes wrong in health care treatment while in a hospital setting, this is referred to as an adverse event. There are a number of health care organizations within the nation that track patient safety information including: the Centers for Disease Control, Joint Commission for Hospital Accreditation, the National Quality Forum and several nonprofit entities. Of the nonprofit leaders, The Leapfrog Group® is known for its annual hospital quality and patient safety survey, of which over 5,000 hospitals participate. In addition to this, the Commonwealth Fund[1] has also published patient safety and health care outcome information, including the average number of safety events by category and by county.

A detailed analysis of patient safety tracking entities is provided in Unraveling U.S. Healthcare-A Personal Guide[2] and no less than three chapters detail hospital quality and patient safety, by facility and by state. However, since this is a monthly health care column and not a book, I am using Hospital Safety ScoreSM, The Leapfrog Group® annual hospital quality survey to highlight how hospitals rank which are handling Ebola patients[3]. This is meant to provide consumer information on basic patient safety rankings, so that the informed patient will use sound information and not hysteria when making health care decisions. To that end, here are the rankings, starting with Dallas Presbyterian Hospital:

Dallas Presbyterian Hospital Survey Results as of August 2013[4]

Infection rates observed in patients versus the expected rate are listed below for two common metrics

Central Line Infection Rate is .56, which nearly matches the national average of .55, which is a solid performance.

Catheter Infection Rate is .19, which is far better than the average rating of .71 for the survey respondents.

Patient Safety Processes

Computerized Order Entry-100 (out of 100)

Physician Staffing in Intensive Care Unit-100 is a perfect score

Identification and Mitigation of Risks-120 (out of a possible 120)

Hand Hygiene-30 (out of a possible 30)

Nursing Workforce-100 (out of 100)

By all measures Dallas Presbyterian Hospital is a top-notch facility in terms of patient safety, but the Ebola patient who died was treated too late, and time-to-treatment is a key statistic for improving patient survival in many clinical interventions. Additionally, the man was autoimmune suppressed and taking medication for HIV. The laboratory delay was not the fault of the hospital, which used normal protocol, but reflected the dearth of resourcing from a disease prevention level at the Centers for Disease Control and Prevention.

Only the best hospitals are now accepting Ebola patients, those trained for the most acute care, including the venerable Bellevue Hospital in New York City, Harborview Medical Center in Seattle and Emory Health Care in Atlanta. Focusing on the patient safety processes of the Leapfrog survey, here are the scores for these facilities as well:

Note: The [Leapfrog] Hospital Safety Score grades hospitals on data related to how safe they are for patients. For more information, visit www.hospitalsafetyscore.org.”

Leapfrog Group Criteria for Emory Health Care-Atlanta[5]

Central Line Infection Rate-.522 (better than average)

Catheter Infection Rate-1.60 (much worse than the average reported of .71)

Computerized Order Entry-65 out of 100

Physician Staffing in ICU-65 out of 100

Identification and Mitigation of Risks-Did not report

Hand Hygiene-Did not report

Nursing Work force-Did not report

Leapfrog Group Criteria for Bellevue Hospital-New York City[6]

Central Line Infection Rate-.645 (worse than average)

Catheter Infection Rate-.682 (better than average)

Computerized Order Entry-65 out of 100

Physician Staffing in ICU-Categorized a 5 or the lowest score in this criteria, the average facility had a score of 31 and the top hospitals scored 100.

Identification and Mitigation of Risks-Did not report

Hand Hygiene-Did not report

Nursing Work force-Did not report

Leapfrog Group Criteria for Harborview Medical Center-Seattle[7]

Central Line Infection Rate-.46 (better than average)

Catheter Infection Rate-.71 (average)

Computerized Order Entry-50 out of 100

Physician Staffing in ICU-100 out of 100

Identification and Mitigation of Risks-120 out of 120

Hand Hygiene-30 out of 30

Nursing Work force-100 out of 100

Now that the CDC has stepped up its monitoring and support for Ebola, with airport screenings (not sure how effective this will be) and rapid lab responses for blood screenings, it is a good time to review how we resource disease surveillance in the nation. In the case of hospitals, with the exception of the Veteran’s Administration and university hospitals, most are private facilities. This means Texas Health Presbyterian Hospital in Dallas had to shell out the money for extra hazard gear, extra cleaning costs, and extra staffing for Ebola. If we are going to expect a private facility to provide this type of intensive support for prevention of highly contagious and highly fatal diseases, we need to look at how we fund these services. Certainly syphoning new Ebola patients to trauma centers is wise, but that in and of itself is not a cure, more like a Band-Aid.
Regarding the other facilities targeted for Ebola triage, of concern is the poor intensive care staffing score for Bellevue Hospital in New York City, sounds like this place could use an infusion of capital from the big apple. And it should be unacceptable for any publicly funded facility to refuse to provide patient safety reporting information on basic stuff like hand washing, identification and mitigation of safety risks, and their nursing staff standards & staffing (Bellevue and Emory). Finally, thank you to Texas Health Dallas Presbyterian for going first in this fiasco because the nation learned a lot at your expense. Clearly you run a first rate facility, based on your reported patient safety data, so maybe you can petition our federal government’s Health and Human Services for some disaster relief money.

And this is the healthpolicymaven signing off encouraging all readers to share this article virally, but with appropriate attribution for  the author of course. For more information on patient safety, read http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972#.

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[1] http://www.whynotthebest.org/reports/view/null/9142

[2] http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972#

[3] http://www.leapfroggroup.org/cp

[4] http://www.hospitalsafetyscore.org/hospital/texas-health-presbyterian-hospital-dallas

[5] http://www.hospitalsafetyscore.org/hospital/emory-university-hospital

[6] http://www.hospitalsafetyscore.org/hospital/bellevue-hospital-center

[7] http://www.hospitalsafetyscore.org/hospital/harborview-medical-center