Responsiveness of the 36-item Short Form Health Survey and the Lupus Quality of Life questionnaire in SLE

ObjectiveAs a health‐related quality of life (HRQOL) measure, the LupusQoL is a reliable and valid measure for adults with systemic lupus erythematosus (SLE). This study evaluates the responsiveness and minimal important differences (MIDs) for the 8 LupusQoL domains.MethodsPatients experiencing a flare were recruited from 9 UK centers. At each of the 10 monthly visits, HRQOL (LupusQoL, Short Form 36 health survey [SF‐36]), global rating of change (GRC), and disease activity using the British Isles Lupus Assessment Group 2004 index were assessed. The responsiveness of the LupusQoL and the SF‐36 was evaluated primarily when patients reported an improvement or deterioration on the GRC scale and additionally with changes in physician‐reported disease activity. MIDs were estimated as mean changes when minimal change was reported on the GRC scale.ResultsA total of 101 patients were recruited. For all LupusQoL domains, mean HRQOL worsened when patients reported deterioration and improved when patients reported an improvement in GRC; SF‐36 domains showed comparable responsiveness. Improvement in some domains of the LupusQoL/SF‐36 was observed with a decrease in disease activity, but when disease activity worsened, there was no significant change. LupusQoL MID estimates for deterioration ranged from −2.4 to −8.7, and for improvement from 3.5 to 7.3; for the SF‐36, the same MID estimates were −2.0 to −11.1 and 2.8 to 10.9, respectively.ConclusionAll LupusQoL domains are sensitive to change with patient‐reported deterioration or improvement in health status. For disease activity, some LupusQoL domains showed responsiveness when there was improvement but none for deterioration. LupusQoL items were derived from SLE patients and provide the advantage of disease‐specific domains, important to the patients, not captured by the SF‐36.

Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

Sensitivity to Change and Minimal Important Differences of the LupusQoL in Patients With Systemic Lupus Erythematosus

McElhone

Abbott

Sutton

et al. 2016

“…The LupusQoL and SF-36 have been found to be sensitive to change over time in patients with low and active disease (9,10). Devilliers et al reported that both the SF-36 and LupusQoL were responsive over a 3-month interval (11). The minimum clinically important differences (MCIDs) for SF-36 and LupusQoL have been established in longitudinal observational studies and in 1 RCT (10,12).…”

Section: Introductionmentioning

confidence: 99%

“…To the best of our knowledge, there is yet to be a study comparing the performance of differently defined MCIDs for the SF-36 with the LupusQoL in a cohort of patients with active SLE. The objectives of this study were, first, to determine the hypothesis-testing construct validity of the SF-36 and LupusQoL against disease activity in SLE patients with active disease and, second, to compare the sensitivity to change by the SF-36 and LupusQoL according to differently defined MCIDs, based on improvement and worsening (10)(11)(12) in the current cohort.…”

Section: Introductionmentioning

confidence: 99%

“…SF-36 MCID cutoffs, set by Strand and Crawford, were defined as follows: ≥+2.5 = improved, À0.8 to +2.5 = unchanged, and ≤ À0.8 = worse for summary scores (i.e., SF-36 PCS and MCS scores), and ≥+5.0 = improved, À2.5 to +5.0 = unchanged, and ≤À2.5 = worse for domain scores (12). Devilliers et al and McElhone et al have specified MCID cutoffs for each domain score (10,11).…”

mentioning

confidence: 99%

See 1 more Smart Citation

Comparison of the Sensitivity to Change of the 36‐Item Short Form Health Survey and the Lupus Quality of Life Measure Using Various Definitions of Minimum Clinically Important Differences in Patients With Active Systemic Lupus Erythematosus

Nantes

Strand

et al. 2017

Objective. The Medical Outcomes Study Short Form 36 (SF-36) and Lupus Quality of Life (LupusQoL) are healthrelated quality of life questionnaires used in systemic lupus erythematosus (SLE). We first determined the hypothesistesting construct validity of the SF-36 and LupusQoL against disease activity in patients with active SLE and then compared the sensitivity to change of SF-36 and LupusQoL domains according to different definitions of minimum clinically important differences (MCIDs) for improvement and worsening in the current cohort. Methods. Seventy-eight clinically active SLE patients concurrently completed both questionnaires at their baseline and followup visits. Questionnaire domain scores were correlated with the SLE Disease Activity Index 2000 (SLEDAI-2K) and evaluated for floor/ceiling effects. The sensitivity to change of domains in each questionnaire was analyzed first, according to the various MCID definitions and, second, by clinically meaningful changes in disease activity. The magnitudes of change in each domain score between the baseline and followup visit were evaluated using standardized response means. Results. In the 78 patients, the mean AE SD SLEDAI-2K scores were 9.7 AE 4.8 at baseline and 8.8 AE 5.1 at followup. SF-36/LupusQoL domain scores did not correlate with disease activity. The SF-36 showed floor effects, and ceiling effects were evident in both questionnaires. All domains of both questionnaires showed sensitivity to change over time. Specific domains that reflected worsening or improvement differed according to differing MCID definitions. Conclusion. In SLE patients with active disease, both the SF-36 and LupusQoL are sensitive to change, reflecting both improvement and worsening. More importantly, the LupusQoL SLE-specific domains (planning, burden to others, body image, and intimate relationships) were largely responsive to change.

Responsiveness of the Patient‐Reported Outcomes Measurement Information System Global Health Short Form in Outpatients With Systemic Lupus Erythematosus

Kasturi

Szymonifka

Berman

et al. 2020

Objective To evaluate the longitudinal responsiveness (sensitivity to change) of the Patient‐Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE). Methods Outpatients with SLE who were receiving care at an academic medical center completed the PROMIS10 at 2 visits that were a minimum of 1 month apart. Responsiveness of the PROMIS10 global physical and mental health domains to Patient‐Reported improvement or deterioration of health status was evaluated, as measured by standard validated instruments. Effect sizes of changes in PROMIS10 scores between visits were evaluated using Kruskal‐Wallis testing. Results A total of 223 SLE patients enrolled and completed baseline surveys, with 186 (83.4%) completing a second set of questionnaires. The PROMIS10 demonstrated mild‐to‐moderate responsiveness to Patient‐Reported improvement (effect size 0.29) and worsening (effect sizes –0.27 and –0.54) of health status for both global physical health and global mental health. Changes in the PROMIS10 correlated poorly with changes in physician‐reported measures of disease activity. Conclusion The PROMIS10 showed responsiveness over time to Patient‐Reported changes in SLE health status, but not physician‐assessed changes. These data suggest that the PROMIS10 can be used to efficiently measure and monitor important aspects of the SLE patient experience that are not captured by standard physician‐derived metrics. Further studies are needed to evaluate the role of the PROMIS10 in optimizing longitudinal disease management in SLE and to determine its responsiveness in other chronic health conditions.