Estimates of Responsiveness, Minimally Important Differences, and Patient Acceptable Symptom State in Five Patient‐Reported Outcomes Measurement Information System Short Forms in Systemic Lupus Erythematosus

Abstract

Objective. Examinations of Patient-Reported Outcomes Measurement Information System (PROMIS) measures in adult systemic lupus erythematosus (SLE) have provided support for their cross-sectional validity in SLE. We estimated responsiveness to change, meaningful changes (minimally important differences [MIDs]), and the patient acceptable symptom state (PASS) for five PROMIS short forms to facilitate longitudinal use and interpretation of PROMIS scales in SLE.Methods. Data from five administrations of PROMIS short forms in the FORWARD SLE cohorts were used. Pearson correlation coefficients were used to assess associations between changes in PROMIS measures and changes in anchor measures for responsiveness analyses. Worse, same, or better groups were defined for each anchor. Differences in PROMIS scores were calculated for each consecutive PROMIS administration; mean changes in PROMIS scores of individuals in the worse, same, and better groups were calculated. Both anchor-based and distribution-based methods were used to estimate MIDs. PASS was defined as the 75th-percentile positive score among those who considered their health to be acceptable or who were somewhat or very satisfied with their health.Results. All PROMIS short forms showed adequate responsiveness to changes in related patient-reported outcomes. However, only the fatigue and pain interference scales were responsive to self-reported SLE activity. Taking into account all methods, we estimated MIDs for each scale to be approximately two points. All PASS values were better than the population mean T-score of 50.Conclusion. These results support use and further study of PROMIS short forms in SLE and should facilitate interpretation of PROMIS scores and changes.Funded by Bristol-Myers Squibb.

Measures of Anxiety in Rheumatic Diseases

“…In a study comparing different anxiety self‐report tools in RA, the PROMIS Anxiety demonstrated the highest internal consistency of 0.93 and a high test‐retest reliability of 0.82 (47). Similar studies have been performed in SLE (111–117).…”

“…In this study, they compared the differences in change between different measures and found mental health domains, such as mental global health and anxiety, had smaller changes when compared with those in the physical health domains, which is consistent with results from studies of legacy instruments assessing those same domains (102). The responsiveness of the PROMIS Anxiety was also demonstrated in studies of SLE (112,131) and osteoarthritis (132). Studies have also shown that the PROMIS can discriminate between clinical groups, suggesting its suitability for use in clinical trials and comparative effectiveness studies (118,128–130,133–135).…”

“…Further research is needed to determine the MID in PROMIS in patients with RA and other rheumatologic conditions. The MID and PASS was recently determined in patients with SLE in five four‐item PROMIS short forms (physical function, fatigue, pain interference, sleep disturbance, and participation in social roles and activities), but the PROMIS Anxiety was not included (112).…”

Measures of Sleep in Rheumatologic Diseases: Sleep Quality Patient‐Reported Outcomes in Rheumatologic Diseases

“…In an SLE cross‐sectional study, a distribution‐based estimate of the MID was approximately 4 points, and anchor‐based estimates of the MID were 2 points for worsening and 1 to 2 points for improvement (119). Other PROMIS measures not measuring sleep had MIDs that varied from 2 to 3 points (120–122).…”

“…Psychometric properties of PROMIS sleep measures have been assessed in RA (115,118), SLE (116,119), scleroderma (112), cancer (124,125), and elderly populations (123). Additionally, PROMIS sleep measures have been used in multiple sclerosis (126), inflammatory bowel disease (127), and hospitalized patients (128) to study the prevalence of sleep problems.…”