PhenX - systemic lupus erythematosus protocol 171001

Lupus SLE proto

Definition

The System Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ARC) Damage Index for Systemic Lupus Erythematosus is a method that physician investigators use to determine the extent of permanent damage to various body organs or organ systems due to lupus or to the treatment thereof. This method is widely used and allows the physician to determine if a person has had any nonreversible changes (i.e., damage) to organ systems. These changes have occurred since a person is being diagnosed with lupus, are not related to active inflammation, and are ascertained via a clinical assessment. Also, unless stated otherwise, these changes must be present for at least six months prior to the assessment. The SLICC /ARC Damage Index is a cumulative index that records damage that occurs in individuals with lupus, regardless of whether the damage can be definitively attributed to lupus or is due to another cause, such as a comorbid condition. Prior to completing this protocol, the PhenX Skin, Bone, Muscle and Joint Working Group (WG) notes that investigators must first confirm the presence of lupus in respondents. This can be done via the PhenX measure Autoimmune Diseases Related to Type 1 Diabetes. This measure uses one question to determine the presence of various autoimmune diseases (including lupus) in respondents or their children.