June 10, 2011
10 AM CDT/11 AM EDT
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Attending: Francis Kwakwa and Sean Hayes, co-chairs; Jack Kues, Andy Rabin, Valerie Smothers
The minutes were approved.
2 Update on discussion with Paul Weber re: technology survey
Sean reached out to the Alliance to see what activities they have coming up and see if there is an opportunity for MedBiquitous to piggy back on a planned activity. He also wanted to see where they are in terms of their understanding of MEMS. Paul Weber is executive director of ACME. He would be open to a joint assessment process of their membership. He felt it might be useful for the alliance to better understand their membership. He asked us to put together a paragraph on what we want to collect. He brought up the institute for Outcomes Evaluation. The Alliance is putting forth a proposal for funding, what should the outcomes be, what do we need to do to prove the value of CME. They have some specific initiatives proposed. He felt MEMS could be a valuable approach to support that kind of cross program analysis, position the institute as an example of best practice. He will take the paragraph to the board.
Francis asked what timeframe the letter was needed.
Sean replied that Paul needs something within the next 3 – 4 to describe the data collection and how we could support the institute. Sean let him know that Jack had been a part of discussions. Jann Ballmer, Moss Blackmon, and Jack are key people on the institute. There will be a series of pilot initiatives.
Andy commented that he attended a recent meeting regarding the institute. They want to minimize the burden on providers to contribute, so they plan to leverage the PARS format. This group is also interested in individual question level responses. That will be a bigger hurdle. Andy questioned whether the institute would take the approach of using mems and their own wrapper. That could be a question for the Technical Steering Committee. IHE – integrating the healthcare enterprise, develops protocols for passing data back and forth.
Valerie questioned whether further development of the standard was necessary to capture each individual’s responses to specific questions. Andy agreed that was a great logical next step.
Sean commented that many of providers struggle with how to ask questions of attendees. There is a need for a pool of validated items.
Jack commented shared a recent conversation with Walt Fox, Linda Kelinski, and Dave Haddox. Walt pulled the group together to look at opportunities for broad outcomes study around FDA’s upcoming requirement for REMS related to opiod prescriptions. The FDA was not cognizant of how ACCME worked with certified CME providers and put the responsibility on pharma to educate physicians. Murray got involved. The FDA, ACCME, and institute are getting together to develop a mechanism to consistently gather outcome data around rems education for opiod use. He mentioned MedBiquitous as a group that needs to be at the table. There need to be some standards related to how data are gathered and analyzed.
Sean commented that they need comprehensive evidence across programs, and MEMS would be useful.
Jack added that this would be a first: an enterprise-wide attempt to gather data in a central repository that can address the impact of CME. No one has done that. In terms of engaging providers, unless we embark on this enterprise, we won’t get the average provider to pay attention to standards of any kind.
Sean agreed we need standardized data collection approach and standards for data exchange.
Francis questioned what the next steps would be.
Jack commented that the other people at the table that can help are CECity. They can talk about existing resources, talents available. The FDA has a deadline in august to have a plan in place to move forward. This won’t languish in committee. They need something up and running in short time. How does this look when pushed out to individual providers? Most CME providers will not have interest to get into rems market. The bigger providers more savvy, and the lowest common denominator will be high. That could set us up for success. Then we can look at next tier of providers.
Valerie questioned whether we need a new version of the standard that would support the work of the institute.
Jack replied that as a researcher, more detailed data is better than aggregate. He added that there is the tactical question of what are we most likely to implement. Aggregate data is easier to report.
Andy commented that a phased approach was likely. Initially the easiest approach would be to leverage the pars report.
Valerie commented that the pars report contains no outcomes data.
Jack explained that FDA rules want an indication that physicians have completed the education. They have not asked for anything about the quality or impact. Walt Fox’s ideas would be a value added for the rems project.
Francis questioned how much of what pars is collecting will be applicable for rems?
Jack explained that pars does not collect individual attendee data. FDA requires a way to verify that individual physicians completed the required rems training. They need to identify the individual physicians who attended.
Valerie commented that the Activity Report would be the appropriate standard for that use.
Jack went on to say that would be the minimum required by the FDA. The next step, to meet pharma needs, would be to collect data on the impact of the education, that it is doing what FDA intended it to do. This is a giant step beyond a registry of physicians completing training. The breakthrough seems to be having ACCME and FDA and the Alliance and others all sitting down saying this is a great opportunity to do something on a national level that gathers data on educational activities. And that opens a tremendous opportunity to take standards, develop tools and processes to collect more info in this area and similar info in broader areas.
Valerie asked what the next steps would be for this group.
Jack commented that there will be some more phone calls and then some proposal needs to be written before August.
Sean recommended that we show how we can be of value to support those efforts.
Andy added that we should address not just what the standard is now, but potentially extending it. We can offer ourselves as a venue for standards development.
Jack replied that is where we can be of most value. Someone needs to define what data needs to be collected. Then we can show what we have and see how well it fits, and make adjustments as needed. That would be well received.
Francis asked what we should include in our letter to Paul?
Jack replied we should convey our history and expertise in creating standards for educational outcomes evaluation and indicate we are happy to share and work with the Alliance on those standards. In areas where standards don’t exist we can lend process to helping develop them.
Sean added that our abstract had been accepted for the Alliance January meeting.
Jack commented Walt Fox is leading the initiative. He has better sense of what steps need to take place. Has been working with the FDA. Jack can provide feedback to make sure they recognize this group is out there and is a tremendous resource to move forward. Excited about possibility for huge visible laboratory.
Sean questioned whether the letter to Brian was still necessary given the discussion regarding a letter to Paul Weber.
Jack commented that it is no problem communicating with Brian. Brian chairs a new committee. They could do a wide range of things. They are the right committee to be talking to. Having this in front of them is a good idea. The Alliance provides access to potential users. That is a large, impactful communication channel. Brian and the committee have been working hard to get technology on the front burner. Jack recommended inviting Brian to a future call to discuss what is floating around in his head.
Sean agreed that was a good idea. He offered to review the letter and make sure it’s transparent about communications with Paul.
4 Open discussion
Andy asked if it made sense to start thinking about the individual response use case. He recoomended making that a topic on the next call.
Sean recapped that the letter to Paul should indicate why we think a survey of membership is needed, how we can position that with the other initiatives we’ve discussed. We would make sure that would have value to all stakeholders.
Valerie will draft a letter to Paul Weber for the group to review.