April 23, 2018
11 EDT/10 CDT/9 MDT/8 PDT
Attending: Doris Auth, Robin Barrale, Colville Brown, Leslie Christy, Jennifer Dunleavy, Ilana Hardesty, Cynthia Kear, Linda Kitlinski, Joanna Krause, Tom McKeithen, Rahul Natarajan, Linda Noa, Kate Regnier, Sheila Robertson, Amy Smith, Valerie Smothers, Marsha Stanton, Amy Tan, John Teppen, Mark Tyrrell, Dimitra Travlos, Tina Latch, Avon, Tim Warneke, Andrew Yazwa, Yvonne?
1 Review minutes
The minutes were accepted as submitted.
2 Discuss any “pilot” of data the FDA has requested
Cynthia sent raw data from January to the RPC and Doris, and Sheila sent a prototype. Valerie was the only respondent. They will not pursue with Medscape until they have further feedback and direction. Ilana added Joanna sent Valerie a spreadsheet of what they are currently collecting on Friday April 13. Valerie forwarded to the full working group.
Joanna explained spreadsheet of what Boston collects including registrant and completer data set, years in practice, state of primary practice and specialty list. Doris will share with the FDA. Linda questioned completed evaluation column that indicates course complete. Joanna clarified anyone who has completed the evaluation and has gone through the entire program is considered complete. Valerie noted the data not collected to date is institutional verses individual registration. She asked if there are other ways this group can be helpful. Cole asked about the timeline for CE provides to collect new learner level data.
3 Discuss time needed to update systems
Kate commented this was a two-fold question: 1) how long would it take CE providers to change and update their systems and start collecting data 2) how long would it take accrediting bodies to update their system to gather the information collected.
Cynthia noted it would be difficult to go back and change existing activities but easier to implement the change as we launch the new version. She suggested building into the 2019 grant. Valerie added that new requirements are coming out with updated REMS; it makes sense to be a part of that. Mark requested clarification on specific demographics to be included. Doris emphasized learner level data will be the requirement. There will be some transition data. She was unsure about having reporting system for the old requirements.
Cynthia noted some activities might not be renewed. Kate questioned whether REMS activities conducted March 1 to February 28, 2019 continue gathering aggregate data until next reporting period. Doris will clarify with her group. Valerie asked if there was an interim approach to getting accrediting body report to the ACCME for 2019. Kate expressed concern about dealing with ongoing activities and changes that will need to be made to collect data to report to the ACCME and then to the FDA. How will the two types of activities, those that have aggregate data and those that have learner level co-exist in the system? Doris confirmed the need for an interim data approach. Valerie asked about reporting year for activities offered March 1, 2019 and collected February 2020. Doris’s concern is activities offered before February 2019.
Woman wondered whether Polaris should be involved in the decision-making since data is sent to them. Valerie noted that is an RPC decision. Cynthia agreed with Polaris being involved since they are going to be handling data. She suggested they be brought into the loop. Cole agreed and will discuss at the next RPC meeting. He inquired if it was feasible to collect both aggregate and learner level and then stop at a certain point. Marsha thought it depended on who is collecting data and if they are collecting in two processes. Dimitra suggested taking a step back to expand the health care team to include other health care professionals.
John noted that we need to understand the outcomes we want to get. What answers do we want to get from the education program? Valerie clarified this group focuses on the data side of things. Our charge is to provide data standards for compilation of data to fulfill FDA requirements.
Doris agreed on the difficulties evaluating change. There are studies planned with additional learner level data necessary to frame studies. Tom added they have been taking sampling of programs assessing level five changes to assess generalizability. Dimitra noted not everyone is on board next year to do it. Cynthia suggested implementing change while implementing associated changes because of new REMS approved and released blueprint.
4 Discuss proposed approach and specification
Valerie noted on the last call MedBiquitous has existing data standards for exchange of learner information. She met with the co-chairs of the various working groups, and drafted a proposal from the chair of the activity report-working group to use that standard. It is a standard for conveying digital CE certificate or MOC activities. It can be used to provide identified learner data for maintenance of certification or a list of de-identified participants and their demographics.