AANEM Connect

Home / Membership / Benefits of Membership / AANEM Connect

AANEM-Connect-Final

Join this vibrant community of professionals eager to exchange ideas, share resources, and engage in meaningful discussions. Use this platform as a sounding board to seek advice for navigating challenging cases or career decisions, and receive expert guidance from generous peers who want to help you succeed.

AANEM Connect

INVITATION FOR PUBLIC COMMENTARY ANNOUNCEMENT

Jeffrey Guptill5/31/22 2:21 PM (CDT)
The NIH-supported Rare Disease Clinical Research Consortium (RDCRC) for myasthenia gravis (MGNet), which is part of the Rare Diseases Clinical Research Network (RDCRN), views standardization of MG outcome measures as a critical need for clinical trials. To address this issue, MGNet convened an outcome measure symposium and a working group charged with refining specific MG outcome measures and their instructions for administration, based on consensus opinion. The goal was to improve the clarity of instructions and scoring and reduce outcome measure variability. The outcome measures included in this effort were the Quantitative Myasthenia Gravis Score (QMG), MG Activity of Daily Living Scale (MG-ADL), MG Quality of Life-15 (MG-QOL15 and MGQOL15 revised), MG Foundation of America Post Intervention Status (MGFA-PIS), MG Composite, and the MG Impairment Index (MGII). Ultimately, implementing these recommendations is expected to lead to less data variability, greater efficiency, and fewer errors at clinical sites.

As the next step in the process, we are holding a public commentary period to help ensure that the views of all stakeholders are heard. We would value your input on the proposed revisions. The revised instruments and a link to a survey where you can provide feedback for each outcome measure are located on the MGNet website at:
https://www.rarediseasesnetwork.org/mgnet/outcomes
 
The public commentary period was opened on May 9, 2022 and will end on June 24, 2022.

Following the public commentary period and final revisions, MGNet intends to develop a comprehensive set of training materials and case report forms for each outcome measure that reflect the recommended changes. MGNet anticipates holding training sessions for study teams at future meetings and offering initial and renewal certification processes for clinical trial raters.

Thank you for your input on this important effort to improve clinical trial conduct in MG.

Sincerely,
On behalf of the MGNet Clinical Trial Outcome Measure Working Group
 
There are 0 responses to this thread.

In order to comment on posts and view posts in their entirety, please login with your AANEM member account information.

AANEM Connect Terms of Use

I enjoy participating in the AANEM Connect Forum for a number of reasons. There are very fundamental questions posed on a frequent basis that cause me to pause and ask myself, ‘Why didn’t I think of that?’ Also, I continue to learn new things when others contribute their thoughts and experiences. Connect is an excellent opportunity for members to interact and to address any topic, including those that may not be discussed at an annual meeting or journal article.

Daniel Dumitru, MD, PhD