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Performance and psychometric properties of lupus impact tracker in assessing patient-reported outcomes in pediatric
Suhas K Ganguli1, Joyce S Hui-Yuen2,3, Meenakshi Jolly4
1Department of Pediatric Rheumatology, Marshfield Clinic, Marshfield, WI, USA.
Insights
The Lupus Impact Tracker (LIT) reliably measures patient-reported outcomes in pediatric systemic lupus erythematosus (pSLE), showing good validity against clinical measures. Further validation in a larger cohort is recommended.
Area of Science:
- Rheumatology
- Pediatric Medicine
- Clinical Outcomes Research
Background:
- Pediatric systemic lupus erythematosus (pSLE) significantly impacts patients' quality of life.
- Accurate assessment of patient-reported outcomes (PROs) is crucial for managing pSLE.
- Existing PRO tools may require further evaluation for reliability and validity in this population.
Purpose of the Study:
- To assess the reliability, validity, feasibility, and psychometric performance of the Lupus Impact Tracker (LIT) as a PRO tool in pSLE.
- To establish the LIT's utility in capturing the patient experience of pSLE.
Main Methods:
- A prospective, observational pilot study enrolled patients aged 12-25 years meeting ACR criteria for SLE.
- Patients completed the LIT, PROMIS-SFs, and CHAQ at three visits; rheumatologists used SLEDAI-2K and SLICC-ACR.
- Demographic, clinical, and laboratory data were collected for comprehensive analysis.
Main Results:
- 31 of 46 enrolled patients completed all three visits.
- The LIT demonstrated good reliability (ICC=0.70) and internal consistency (Cronbach's alpha=0.91).
- The LIT showed positive correlations with CHAQ-Disability Index and PROMIS-SFs, and construct validity against SLEDAI-2K.
Conclusions:
- Preliminary findings suggest the LIT is a reliable and valid instrument for assessing PROs in pSLE.
- The LIT shows promise for routine clinical use in monitoring pSLE.
- Further validation in a larger, multicenter cohort is warranted to confirm these findings.
Objective:
To evaluate the reliability, validity, feasibility and psychometric performance of the Lupus Impact Tracker (LIT) as a patient reported outcome (PRO) measure tool in pediatric systemic lupus erythematosus (pSLE).
Methods:
This is a prospective, observational, pilot study where patients aged between 12 and 25 years, fulfilling the 1997 ACR classification criteria for SLE, were enrolled. Over 3 consecutive, routine, clinical visits, the patients completed the LIT alongside the Patient-Reported Outcomes Measurement Information System-Short Forms (PROMIS-SFs), Childhood Health Assessment Questionnaire (CHAQ). Rheumatologists completed the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC-ACR) Damage Index. Demographic, clinical and laboratory data were also collected.
Results:
Of 46 patients enrolled, 38 patients completed 2 visits and 31 completed all 3 visits. Seventy-eight percent were female, 33% African American, 28% Asian, 15% Caucasian and 17% Hispanic. The mean (SD) age was 17.2 (2.7) years, with a mean (SD) disease duration of 4.6 (3.1) years. The mean (SD) SLEDAI-2K at enrollment was 3.54 (2.96). In the 38 patients who completed two or more visits, intra-class correlation coefficient and Cronbach alpha were calculated to be 0.70 and 0.91 respectively, signifying good reliability of LIT. The LIT showed positive correlation with CHAQ-Disability Index and majority of the PROMIS-SFs parameters. Construct validity was established against clinical disease activity (SLEDAI-2K).
Conclusion:
The preliminary results indicate that the LIT is a reliable and valid instrument to capture PRO in p-SLE. Prospective validation with a larger, multicenter cohort is the next step.
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