SLE disease activity measure | Psychometric properties | Administrative burden | Responsiveness to patient care |
---|---|---|---|
BILAG and BILAG-2004 | Reliable, valid, and sensitive to small change over time | A computer is needed. | Responsive |
Laboratory studies are required. | Fibromyalgia syndrome may complicate the assessment of lupus disease activity. | ||
Strength: Disease activity and severity are incorporated. | Time: 50Â minutes | Â | |
Training is required. | |||
Cost: $$$ | |||
Weakness: Formal training is essential for optimal performance. | commercial/academic | ||
SLAM and SLAM-R | Reliable, valid, sensitive, and responsive to change over time | A physician is to complete history and physical. | Highly responsive |
Strength: includes both disease activity and severity | Laboratory studies are needed. | ||
Time: 15Â minutes | |||
Weakness: subjective scoring by patients | Training is required. | ||
Cost: $ | |||
commercial/academic | |||
SLEDAI, SELENA-SLEDAI | Reliable, valid, sensitive, and responsive to change over time | A physician is to complete history and physical. | Responsive |
SLEDAI-2Â K | |||
Strength: practical, most commonly used for clinical and research purposes | Laboratory studies are needed. (There are no immunologic tests for the Mexican version.) | ||
Weakness: The SLEDAI versions do not capture improving or worsening and do not include severity within an organ system. | Time: 10Â minutes | ||
Training is required. | |||
Cost: $ | |||
commercial/academic | |||
SLE Responder Index (SRI) | Reliable and valid | A physician is to complete history and physical. | Modest responsiveness |
Strength: SRI-50 is superior to the SLEDAI-2Â K in identifying patients with 50 % or greater improvement. | |||
SRI-50 | Laboratory studies are needed. | ||
Time: 15Â minutes | |||
Training is required. | |||
Weakness: The SRI may miss the signal toward improvement. | Cost: $$ | ||
commercial/academic | |||
Organ-specific outcome measure | Reliable and valid | A physician is to complete history and physical. | Responsive |
Strength: focused response criteria | |||
Lupus nephritis outcome measure | Weakness: Defining the optimal endpoint of organ-specific response criteria is needed. | Laboratory studies are needed. | |
Time: 30Â minutes | |||
CLASI | Long-term outcome studies are essential. | Training is required. | |
Cost: $$ | |||
commercial/academic | |||
The BILAG-Based Composite Lupus Assessment (BICLA) | Reliable and valid | A physician is to complete history and physical. | Responsive |
Strength: BICLA criteria require a stringent response in all body systems that are involved at baseline and require that there be no new flares in the remaining body system. | |||
Laboratory studies are needed. | |||
Time: 50Â minutes | |||
Training is required. | |||
Cost: $$$ | |||
commercial/academic | |||
Weakness: Formal training is essential for optimal performance. | |||
SELENA-SLEDAI Flare Index (SFI) | Reliable and valid | A physician is to complete history and physical. | Responsive |
Strength: The revised SFI suggests specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe on the basis of the treatment decision. | |||
Laboratory studies are needed. | |||
Time: 20Â minutes | |||
Training is required. | |||
Cost: $$ | |||
commercial/academic | |||
Weakness: Training is essential for optimal performance. | |||
BILAG-2004 flare index | Reliable and valid | A physician is to complete history and physical. | Moderate responsiveness |
Strength: A strict criterion is needed to define flare. | |||
Laboratory studies are needed. | |||
Weakness: Scoring of worsening in the renal and hematologic domains is not yet available. | Time: 50Â minutes | ||
Training is required. | |||
Cost: $$$ | |||
commercial/academic | |||
Lupus Foundation flare | Strength: The flare must be considered clinically significant by the assessor. | A physician is to complete history and physical. | Responsive |
Weakness: The emphasis is on clinical judgment in determining flare significance. | Laboratory studies are needed. | ||
Time: 15Â minutes | |||
Training is required. | |||
Cost: $ | |||
A strict intention to treat is required. | commercial/academic |