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Oct 28, 2015 · Articles on PFACs

Dear PFACs,
Have permission to share a recent webinar from AACH, “Partnering with Patients to CO-Design Healthcare: Developing Patient Preferred Practices”, you can watch this recording here: https://amrms.adobeconnect.com/p49jao9xxrb/?launcher=false&fcsContent=true&pbMode=normal

Slides are here: http://aachonline.org/dnn/Portals/36/Webinars/AACH%20-%20October%208%202015%20-%20Planetree%20Presentation%20Final.pdf

Fran

Sep 27, 2015 · Articles on PFACs

ACOs Facing Clinical Data Integration, Exchange Challenges
By Kyle Murphy, PhD on September 14, 2015

https://ehrintelligence.com/news/acos-facing-clinical-data-integration-exchange-challenges#.VfghpWJqsCA.linkedin

From this article, “That being said, a majority of ACOs are using consumer-facing tools to address patient engagement. The most common are post-discharge/care coaching (66%), patient portals (62%), and patient navigators (57%).

The main takeaway from the survey is the need among ACOs for solutions to clinical data integration and exchange to ensure that all members of a patient’s care team are on the same page.” Read more

Sep 27, 2015 · Articles on PFACs

FDA seeks patient advocates to review medical devices
By Steven Ross Johnson | September 21, 2015

http://www.modernhealthcare.com/article/20150921/NEWS/150929984

For the first time, a Food and Drug Administration advisory committee will focus on providing the perspective of patients in the review of medical devices.

The news comes as women who were adversely affected by a female sterilization device participate in an FDA hearing later this week.

The agency announced plans to create a Patient Engagement Advisory Committee in a blog post co-written by Dr. Robert Califf, FDA deputy commissioner for medical products and tobacco

Some of the topics under the panel’s purview include FDA guidance and policies, the design of clinical trials and patient preference studies, device labeling, unmet clinical needs, and determinations of benefits and risk of a medical device’s use.

However, Califf, who was recently named the White House’s pick to become the next FDA commissioner, warned about the extent of the committee’s influence.

“When assessing whether valid scientific evidence shows that a device’s probable benefit outweighs its likely risks, FDA may consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing,” the post read. “However, patient preference information will not be used to justify approval of unsafe or ineffective devices: If FDA determines the device would expose patients to an unreasonable or significant risk of illness or injury, or that the benefits do not outweigh the risks for a defined target population, FDA would not approve such a device.”

The FDA has been under fire for a device that was approved in 2002 but which thousands of women have said led to unintended pregnancies, organ perforation and pain.

Many of them are gathering this week in Washington, D.C., to review the safety and efficacy of Essure, a device that has generated more than 5,000 adverse-event reports.

Essure consists of a small flexible nickel coil that is inserted into each fallopian tube and causes tubal blockage. The implants are placed without a skin incision, through the vagina.

One major issue likely to be raised in the hearing is the sparse post-market studies evaluating the long-term and real-life experiences of patients and clinicians following FDA approval of products.

Those are the types of concerns likely to be addressed by the committee’s members.

Nine voting members will be chosen from the areas of clinical research and primary-care patient experience, as well as one nonvoting member who will serve on the panel as an industry representative.

Committee members will be asked to stay on the body for up to four years. The commissioner will select the members. The group would meet approximately twice a year and those meetings would be open to the public.

Those interested in being considered for inclusion on the committees should apply by Oct. 21.

Sep 27, 2015 · Articles on PFACs

I thought we might enjoy a place to post articles that we find, that PFACs members and leaders may be interested in reading! If you have an article you’d like to share, post it to the thread below!

Sep 23, 2015 · Dear PFAC members! We are currently looking for some PFAC members to [...]

Dear PFAC members!
We are currently looking for some PFAC members to participate in a workshop next week Tuesday morning. I realize this is short notice, but please let me know if you are able to participate by replying to this thread.

This opportunity is a “maker lab”, takign place during the Transform Symposium next week, Tuesday, September 29 from 7:00am to 11:00am in the Mayo Clinic Center for Innovation, on Gonda 16. They are currently seeking 5 patients to be part of this workshop that will include nurses and physical therapists.

Description is below:

Jose Gomez-Marquez and Anna Young from the MIT MakerNurse program will be speaking and hosting a pop-up maker lab at Transform 2015. They will also be facilitating a MakerNurse pop-up lab with the Department of Nursing on Tuesday, September 29 from 7:00am to 11:00am in CFI. We would like to invite up to 5 patients to participate with 20-30 nurses and physical therapists.

*** Here also is some information on the MIT “Maker Labs”… http://news.mit.edu/2014/mits-mobile-fab-lab-at-white-house-maker-faire-0620

The “maker movement” is one that is growing and is participatory, bringing people together to work on problems they are sharing, and “pop-up” simply is a catchy way of saying its “mobile”… and that is why it is coming to Transform AND why they want to make sure patients are involved!

It’s really a good thing!

Please let me know if you can be part of this on Tuesday, September 29 from 7:00am to 11:00am in CFI! Future communications will be coming!

Aug 10, 2015 · EXTENDING THE SURVEY'S UNTIL AUG. 31st! Please take the survey's to let us know your thoughts...

Visit the Resources tab, to take the surveys and watch videos if you missed them.

Jul 29, 2015 · Your link for the bedside handoff survey goes to the PFAC database [...]

YIPPIE! Thank you for sticking with me!

From: Mayo Clinic Connect [mailto:rgl-5412b17e-41-85784-5984@email.healthcareinnovators.com]
Sent: Wednesday, July 29, 2015 2:56 PM
To: Ripple, Francesca B., M.A.
Subject: cdr replied to discussion “Your link for the bedside handoff survey goes […]” [Mayo Clinic Connect]

Jul 29, 2015 · Your link for the bedside handoff survey goes to the PFAC database [...]

I think I found it! I just noticed the other smaller box what had the link, and I just updated that link too! Please check again and let me know all is good! (Or not, if it’s not) THANK YOU!