The International Myositis Classification Criteria Project
A number of differing classification criteria for myositis threaten to divide the community of myositis researchers and make comparisons of research studies in this area difficult.
There is also a lack of reliable information on the sensitivity and specificity of each of the current classification criteria for myositis and the availability of new technologies and approaches that offer new opportunities to revise definitions of myositis.
For these reasons, IMACS members and other collaborating groups have initiated an international multi-disciplinary project to develop classification criteria for adult and juvenile myositis.
The two primary goals for this project are:
To develop classification criteria for use by basic and clinical researchers that distinguish the idiopathic inflammatory myopathies (IIM) from other major mimicking conditions with high sensitivity and specificity; and
To develop classification criteria for use by basic and clinical researchers that separate the major subgroups of the IIM from each other with high sensitivity and specificity.
This project is international in scope, addresses both adult and juvenile disease, and includes specialists in all fields that deal with myositis patients.
It is hoped that support for and eventual acceptance of the new criteria by professional societies in many specialties around the world will allow for a standardized approach to classifying myositis and its subgroups.
So far we have received support from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
Details of the project meetings, plans, and evaluation forms are listed below.
Study Proposal -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Proposal_myositis_crtieria.pdf) --
Study Proposal -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Proposal_myositis_crtieria.doc)
Data Collection Form -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IMCCP_final_data_collection_form_rev_20081111_wo_changes.pdf) --
Data Collection Form -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IMCCP_final_data_collection_form_rev_20081111_wo_changes.doc)
Skin Rash Examples for the Data Collection Form
The following files demonstrate examples and definitions of the skin rashes in the data collection forms.
Skin Slides for the IMCCP project (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IMACS_skin_slides_for_IMCCP.pdf) (531 KB)
MDI Cutaneous Teaching Slide Set (http://www.niehs.nih.gov/research/resources/collab/imacs/http://www.niehs.nih.gov/research/resources/collab/imacs/docs/damage/mdi/09_mdi_cutaneous_teaching_slide_set.swf) (44.7 KB )
Sample Institutional Review Board Documents
The following documents are a sample IRB proposal and consent forms that investigators may use to submit the study proposal to their institutional review board/ethics board.
Upon receipt of IRB approval, investigators should contact Dr. Ingrid Lundberg, the project coordinator, at Ingrid.Lundberg@medks.ki.se and provide a copy of their IRB approval. Upon receiving a copy of their IRB approval, Dr. Lundberg, will provide a password to the online data entry system and study identification numbers to that investigator for patients being enrolled in the study.
IRB Cover Letter -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_Cover_Letter.pdf)IRB Cover Letter -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_Cover_Letter.doc)
IRB Face Sheet -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_facesheet.pdf)IRB Face Sheet -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_facesheet.doc)
Consent Template -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/ConsentTemplate.pdf)Consent Template -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/ConsentTemplate.doc)
Contact information of Lead Investigator:
Ingrid Lundberg, MD, PhD
Rheumatology Unit,
Department of Medicine,
Karolinska University Hospital,
SE- 171 76 Stockholm, Sweden
Email: Ingrid.Lundberg@ki.se
Phone: +46- 8 -5177 6087
Fax : +46- 8- 5177 3080