Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research

Mikdashi, Jamal; Nived, Ola

doi:10.1186/s13075-015-0702-6

Table 1 Systemic lupus erythematosus disease activity measurements and their psychometric properties, administrative burden, and responsiveness to patient concerns

From: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research

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

BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; SELENA-SLEDAI, Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index; SLAM, Systemic Lupus Activity Measure; SLAM-R, Systemic Lupus Activity Measure-Revised; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SLEDAI-2 K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI-50, SLEDAI-2000 Responder Index 50.

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ISSN: 1478-6362

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