September 23rd, 2010
As of today, GSK will cease promoting Avandia (rosiglitazone) following rulings in Europe that removed the drug from the market and from the FDA that severely restricted its use. At the time of these actions, Avandia was used by a small percentage yet sizable number of patients with diabetes. In the United States, the FDA ruling indicates these patients may be able to continue to use Avandia and new patients may consider using Avandia. The FDA ruling requires that these patients be told about all the available options and about the risk associated with using this medicine (best available evidence suggest an increased risk of myocardial infarction with this drug of OR 1.4). The FDA states:
The FDA is restricting access to rosiglitazone by requiring the drug sponsor to submit a Risk Evaluation and Mitigation Strategy, or REMS. Under the Food and Drug Administration Amendments Act of 2007, the FDA can require a drug sponsor to issue a REMS to impose certain restrictions so that the benefits of a drug continue to outweigh its risks. When the REMS for rosiglitazone is implemented, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take pioglitazone for medical reasons. Current users of rosiglitazone will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns. The agency anticipates that the REMS will limit use of rosiglitazone significantly.
We cannot imagine who would be interested in this medicine (we did not prescribe it before the 2007 black boxed warning, and continued to not prescribe it after), but certainly complying with the FDA ruling will be difficult without a tool that would help communicate the risk increase associated with rosiglitazone.
To communicate the available options, you can use our diabetes cards (you can see them here). We are evaluating an updated version (DA- Diabetes Choice Pamphlet) that includes gliptins as an option, and a cost card.
To estimate the 10-year coronary risk for patients with type 2 diabetes, you can use the UKPDS risk calculator. Here is a version that requires no math! (Paper-basedestimatorCVriskinType2Diabetes)
Let us know if you find these tools helpful, although we are not sure if there will or should be many actual users for these.
It is very important to note that all these tools were designed for and should be used DURING a consultation with a clinician.
September 17th, 2010
The Knowledge and Encounter Research (KER) Unit at Mayo Clinic has developed diabetes medication decision aid tools based on the Agency for Healthcare Research and Quality (AHRQ) comparative effectiveness review. Nilay Shah, Ph.D. and his research team were recently highlighted in AHRQ comparative effectiveness case studies, which also discusses attributes of a diabetes treatment for making a decision. Read more here.
August 21st, 2010
Mayo Clinic patients have access to a broad array of healthcare education and counseling services through the Barbara Woodward Lips Patient Education Center, which enables them to be partners in their health care. The Center makes efforts to reach diverse audiences, as seen in its new design for teen patient education material.
In this video, patients and staff discuss the Barbara Woodward Lips Patient Education Center:
August 21st, 2010
Mayo Clinic's Center for Innovation (CFI) is a multidisciplinary team that imagines healthcare and redesigns it to meet the needs of patients of today and tomorrow. CFI's 2009 Annual Report can be read here.
View the day two opening video of the Transform 2009 Symposium:
August 20th, 2010
Shared decision making tools for use at the point of care can enable patients to contribute to their medication decisions. These tools are developed, evaluated, and implemented through the Wiser Choices Program at Mayo Clinic. The program's director, Dr. Victor Montori recognizes the value of patient-doctor conversations.
In this video, Dr. Montori and Rebecca Mullan, M.S. discuss their publication: "The Diabetes Mellitus Medication Choice Decision Aid: A Randomized Trial."
August 20th, 2010
One Voice empowers patients and their families to have a say about processes and outcomes in the Division of Cardiovascular Diseases at Mayo Clinic. Bob Dimler, a Mayo Clinic patient and participant in the One Voice program shares his story, "You have been given a life sentence!" Here is an excert:
I was introduced to One Voice through my participation at Gonda 4 and have found it to be a growth experience beyond belief. The opportunity to meet and learn from other patients and family members who have had similar experiences, to be involved in the Caring Hearts Visitor program, to meet and interact with professional staff members, to observe their knowledge, caring and passion, to attend seminars and symposiums regarding cutting edge concepts in medical care and to be in the same room with all of these people and have your input listened to and valued. I am AMAZED!!
In this video, members describe their experiences with One Voice:
August 9th, 2010
by Victor Montori, MD (Wiser Choices Program)
As we reflect on the present and future of healthcare, it is key to consider the value of an unhurried conversation.
At the Mayo Center for Innovation 2009 Symposium, Maggie Breslin made a compelling case to focus on conversations as a key strategy to improve healthcare. Watch her inspiring and inspired proposition here.
Becca Camp, a visiting student at our KER UNIT, recently wrote a blog post of an experience at Mayo Clinic she was privileged to witness. In it she noted the relationship between an unhurried conversation and the opportunity to contextualize care to a patient’s specific situation, a requirement of both evidence-based practice and patient-centered care. A recent rigorous and careful study documented how failure to pay attention to context can lead to poor quality care.
Don Berwick in his address to the Yale Medical School 2010 Graduating Address, he noted the critical importance of patient-centered care and the role that clinicians can play in treating patients with respect and humanity, urging them to
...recover, embrace, and treasure the memory of your shared, frail humanity – of the dignity in each and every soul.
Meantime, we seek to measure value in healthcare and we find it difficult to articulate how to capture the value of the unhurried conversation. How do we know that our systems promote these conversations? Should we protect these, and if so how, when economic considerations (payment, demand, access) threaten them?
The unhurried conversation, a key component of the Mayo Model of Care, should be the focus of intense investigation. How much time is necessary to achieve this experience? How should care professionals be trained to participate? How do new requirements for healthcare provision affect these?
I believe it will be up to patients -- thru a strong patient movement -- to make sure the unhurried conversation remains a possibility as healthcare changes. And it will be up to us to provide the resources and knowhow to realize that possibility.