Classification Criteria Study

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:

1. 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
2. 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.

1. Letter of Invitation for Participation -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/letter_of_invitation_to_IMCCP.pdf)   (74.5 KB) -- Letter of Invitation for Participation -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/letter_of_invitation_to_IMCCP.doc)   (38.5 KB)
2. 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)  
3. 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)  
4. Skin Rash Examples for the Data Collection Form
   The following files demonstrate examples and definitions of the skin rashes in the data collection forms.
   1. 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)
   2. Teaching Slide Collection of the Cutaneous Manifestations of the Myositis Disease Activity Assessment Tool (Flash presentation) (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/activity/mitax/07_MITAX_Cutaneous_Teaching_Slide_Set.swf)   (44.7 KB)
   3. 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 )
5. 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.
   
   
   1. 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)  
   2. 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)  
   3. IRB Protocol Summary -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Protsummary_to_IRB.pdf)   IRB Protocol Summary -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Protsummary_to_IRB.doc)  
   4. 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)  
   5. Sample Minor Assent Form -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Sample_Minor_Assent_Form.pdf)   Sample Minor Assent Form -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Sample_Minor_Assent_Form.doc)  
   6. HIPAA Authorization Form-- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/HIPAAauthorization.pdf)   HIPAA Authorization Form -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/HIPAAauthorization.doc)  
   7. HIPAA Authorization Waiver -- PDF format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Authorization_Waiver.pdf)   HIPAA Authorization Waiver -- Word format (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/Authorization_Waiver.doc)  
   8. IRB approval at coordinating center, Karolinska Institute
      • Image of document (with signature) (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_approval.pdf)   (192 KB)
      • Text of document in Swedish (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_approval_text.pdf)   (72.9 KB)
      • Text of document in English (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/IRB_approval_english.pdf)   (65.8 KB)

1. 2005 Working Committee Meeting Summary (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/summary2005.pdf)   (283 KB)
2. Agenda (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/agenda.pdf)   (12.8 KB)
3. Myositis Classification Criteria And Project Overview (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/criteria_and_project_overview.pdf)   (635 KB)
4. International Myositis Classification Criteria Project Workshop Presentation (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/criteria2005.pdf)   (45.2 KB)
5. Preliminary Variable List (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/form_and_variables.pdf)   (24.8 KB)
6. Participants (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/participants.pdf)   (16.3 KB)

1. 2004 Steering Committee Meeting Summary (http://www.niehs.nih.gov/research/resources/collab/imacs/docs/criteria/summary2004.pdf)   (52.5 KB)
2. Myositis Criteria Overview, Miller (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/01/01%20Miller%20IIM%20criteria%20overview.swf)   (44.7 KB)
3. Polymyositis and Dermatomyositis RCT Criteria, Hoogendijk (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/02/02%20Hoogendijk%20PM%20DM%20RCT%20criteria.swf)   (44.7 KB)
4. Polymyositis and Dermatomyositis Biopsy Research Criteria, Lundberg (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/03/03%20Lundberg%20PM%20DM%20Bx%20research%20criteria.swf)   (44.7 KB)
5. Myositis Criteria Review, Amato (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/04/04%20Amato%20IIM%20criteria%20review.swf)   (44.7 KB)
6. Juvenile Myositis Criteria Review, Rider (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/05/05%20Rider%20JIIM%20criteria%20review.swf)   (44.7 KB)
7. IMACS Approaches, Miller (http://www.niehs.nih.gov/research/resources/collab/imacs/restrict/bethesda2004/06/06%20Miller%20IMACS%20approaches.swf)   (44.7 KB)