Background/Purpose: Accurate measurement of patient reported
outcomes (PROs) is particularly important in SLE, a heterogeneous disease in
which similar symptoms can have disparate impact across patients. PROMIS offers dynamic computer adaptive
tests (CATs) to precisely and efficiently measure PROs in a variety of relevant
domains. The aims of this study were to: 1) assess the feasibility of
administering PROMIS CATS serially to SLE outpatients; 2) correlate PROMIS CATs
with legacy PRO measures, SLE disease activity and organ damage; 3) assess
retest reliability of PROMIS CATs.

Methods: Adults meeting ACR SLE classification criteria were
recruited from a SLE Center of Excellence. Subjects completed the Short Form-36
(SF-36), LupusQoL-US, and selected PROMIS CATs. SLE disease activity, flare,
and damage were evaluated with the SELENA-SLEDAI and SLICC-ACR damage index.
PROMIS domains were compared with disease activity, damage, and similar domains
in legacy instruments using Spearman correlations. Retest reliability was
evaluated among subjects reporting stable SLE activity at two assessments a
week apart using intraclass correlation coefficients (ICC).

Results: Of 114 patients approached, 101 (89%) completed at
least one assessment (Table 1), 81 (80%) completing it remotely. 91 (90%)
completed a retest. Most PROMIS domains showed moderate to strong correlations
with similar domains in both legacy instruments, although social function and
fatigue CATs showed poor, non-significant correlations with similar SF-36
domains (Table 2). On average, flaring subjects scored a clinically meaningful
half standard deviation worse on PROMIS pain and social function CATs (p
<0.05). However, correlations between PROMIS and SLEDAI were overall weak
(mean r = 0.24, p <0.05). SLICC scores did not consistently correlate with
PROMIS. PROMIS retest ICCs were 0.78 to 0.89.

Conclusion: To our
knowledge, this is the first study to assess the feasibility and validity of
administering PROMIS CATs to adult SLE outpatients. These data show that PROMIS
CATs can be successfully administered to diverse SLE patients at the point of
care or remotely, and are valid, reliable and responsive for many SLE relevant
domains. The weak correlations of social function and fatigue CATs with
corresponding SF-36 domains point to a knowledge gap and the need for further
study. Importantly, PROMIS scores did not correlate well with the
SLEDAI. This
disconnect between objective signs and symptoms and the subjective patient
disease experience underscores the crucial need to integrate PROs into clinical
care to ensure optimal disease management.