Development and psychometric evaluation of a physician global assessment for type 2 systemic lupus erythematosus symptoms.

Manifestations of SLE can be categorised as type 1 (classic signs and symptoms of SLE) or type 2 (fatigue, widespread pain and brain fog with an unclear relationship to inflammation). While measures of type 1 SLE activity exist, most current physician-reported measures do not encompass type 2 SLE manifestations. To better evaluate type 2 SLE symptoms, we developed and psychometrically evaluated a physician-reported measure of type 2 symptoms, the Type 2 Physician Global Assessment ('Type 2 PGA'). The Type 2 PGA was developed and evaluated by six rheumatologists practising in the same academic lupus clinic. The study began with a roundtable discussion to establish consensus guidelines for scoring the Type 2 PGA. Following the roundtable, the Type 2 PGA was psychometrically evaluated using data prospectively collected from 263 patients with SLE enrolled in the Duke Lupus Registry. There was strong intra-rater and inter-rater reliability (intraclass correlation coefficient=0.83), indicating the Type 2 PGA scores were consistent within a rheumatologist and across rheumatologists. The Type 2 PGA was correlated with patient-reported symptoms of polysymptomatic distress (r=0.76), fatigue (r=0.68), cognitive dysfunction (r=0.63), waking unrefreshed (r=0.62) and forgetfulness (r=0.60), and weakly correlated with the Type 1 PGA and the Systemic Lupus Erythematosus Disease Activity Index. The Type 2 PGA performed well as a physician-reported measure of type 2 SLE symptoms. The incorporation of the Type 2 PGA into a routine rheumatology visit may improve patient care by bringing the provider's attention to certain symptoms not well represented in conventional measures of disease activity.

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© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.

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Competing interests: MEBC has received grant support from AstraZeneca, Pfizer, Exagen and Immunovant. JLR has received grant support from Pfizer, Exagen and Immunovant, and consulting fees from Aurinia, Immunovant, Janssen, Eli Lilly, Ampel Biosolutions, GlaxoSmithKline and Amgen. TC has received grant support from Merck and consulting fees from Regenxbio. DSP has received grant support from Immunovant and Exagen, consulting fees from Immunovant and GlaxoSmithKline, and served on a Data Safety Monitor Board for Bristol Myers Squibb. MM has received consulting fees from AstraZeneca. AME has received grant support from Pfizer, Exagen and Immunovant, and consulting fees from Amgen.