scholarly journals 461 Assessing the content validity of the sf-36, the skindex-29+3 patient reported outcomes (pro) instruments, and pain, fatigue in patients with cutaneous lupus erythematosus (cle)

2017 ◽  
Author(s):  
M Vanya ◽  
M Cho ◽  
S Chen ◽  
A Kao ◽  
K Howard ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Content Validity ◽  
Patient Reported Outcomes ◽  
Cutaneous Lupus Erythematosus ◽  
Sf 36 ◽  
Patient Reported ◽  
Pro Instruments ◽  
Cutaneous Lupus

Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial

Lupus ◽  
2019 ◽  
Vol 28 (14) ◽  
pp. 1628-1639 ◽  
Author(s):  
M Jolly ◽  
N Annapureddy ◽  
L Arnaud ◽  
H Devilliers
Keyword(s):  
Disease Activity ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Patient Reported Outcome ◽  
Sf 36 ◽  
Patient Reported ◽  
Outcome Scores ◽  
Activity Measures ◽  
Flare Index ◽  
The Mean

Objectives To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). Methods Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. Results Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. Conclusions Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.

scholarly journals Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus

2018 ◽  
Vol 45 (3) ◽  
pp. 397-404 ◽  
Author(s):  
Shanthini Kasturi ◽  
Jackie Szymonifka ◽  
Jayme C. Burket ◽  
Jessica R. Berman ◽  
Kyriakos A. Kirou ◽  
...  
Keyword(s):  
Mental Health ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Measurement Information ◽  
Physical And Mental Health ◽  
Validity And Reliability ◽  
Sf 36 ◽  
Patient Reported ◽  
Health Domains

Objective.To assess the feasibility, validity, and reliability of the Patient Reported Outcomes Measurement Information System Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE).Methods.SLE outpatients completed PROMIS10, Medical Outcomes Study Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS computerized adaptive tests (CAT) at routine visits at an SLE Center of Excellence. Construct validity was evaluated by correlating PROMIS10 physical and mental health scores with PROMIS CAT, legacy instruments, and physician-derived measures of disease activity and damage. Test-retest reliability was determined among subjects reporting stable SLE activity at 2 assessments 1 week apart using intraclass correlation coefficients (ICC).Results.A diverse cohort of 204 out of 238 patients with SLE (86%) completed survey instruments. PROMIS10 physical health scores strongly correlated with physical function, pain, and social health domains in PROMIS CAT, SF-36, and LupusQoL, while mental health scores strongly correlated with PROMIS depression CAT, SF-36, and LupusQoL mental health domains (Spearman correlations ≥ 0.70). Active arthritis, comorbid fibromyalgia (FM), and anxiety were associated with worse PROMIS10 scores, but sociodemographic factors and physician-assessed flare status were not. Test-retest reliability for PROMIS10 physical and mental health scores was high (ICC ≥ 0.85). PROMIS10 required < 2 minutes to complete.Conclusion.PROMIS10 is valid and reliable, and can efficiently screen for impaired physical function, pain, and emotional distress in outpatients with SLE. With strong correlations to LupusQoL and SF-36 but significantly reduced responder burden, PROMIS10 is a promising tool for measuring patient-reported outcomes in routine SLE clinical care and value-based healthcare initiatives.

scholarly journals Performance of the PROMIS After Operative Interventions for Shoulder Instability

2019 ◽  
Vol 7 (5) ◽  
pp. 232596711984692 ◽  
Author(s):  
Christina J. Hajewski ◽  
Natalie A. Glass ◽  
Robert W. Westermann ◽  
Matthew Bollier ◽  
Brian R. Wolf ◽  
...  
Keyword(s):  
Physical Function ◽  
Effect Size ◽  
Shoulder Instability ◽  
Patient Reported Outcomes ◽  
Ceiling Effect ◽  
Excellent Correlation ◽  
Surgical Interventions ◽  
Sf 36 ◽  
Patient Reported ◽  
Pro Instruments

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to capture patient-reported outcomes (PROs) in an efficient manner. Few studies have assessed this instrument postoperatively. Purpose: To compare the PROMIS Physical Function computer adaptive test (PROMIS PF CAT) and Upper Extremity (PROMIS UE) item bank to other previously validated PRO instruments and to evaluate ceiling and floor effects and construct validity responsiveness in patients who underwent operative interventions for shoulder instability. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 72 patients who underwent operative interventions for shoulder instability completed the American Shoulder and Elbow Surgeons (ASES) assessment form, Marx shoulder activity scale (Marx), 36-Item Short Form Health Survey physical function (SF-36 PF) and general health (SF-36 GH), Western Ontario Shoulder Instability Index (WOSI), PROMIS PF CAT, and PROMIS UE before surgery and then at 6 weeks and 6 months postoperatively. Correlation coefficients were calculated among these tools. The effect size of change was also calculated for each tool at each time point. A total of 91 patients who had also undergone surgery for shoulder instability completed these PRO instruments 2 years postoperatively. The percentage of patients hitting the ceiling and floor effects of each of the PRO instruments was calculated at all time points. Results: The PROMIS PF CAT demonstrated excellent-good correlation with the SF-36 PF at all postoperative time points (0.61 at 6 weeks, 0.68 at 6 months, and 0.64 at 2 years; P < .01 for all). The PROMIS UE showed excellent correlation with the ASES at 6 weeks postoperatively (0.73, P < .01). Both the PROMIS PF CAT and PROMIS UE demonstrated the ability to detect change after surgical interventions with a medium to large effect size. The PROMIS UE demonstrated a ceiling effect at 6 months (68.1%) and 2 years (67.0%) postoperatively. The PROMIS PF CAT demonstrated no ceiling effect at any time point. Conclusion: The PROMIS PF CAT demonstrated good to excellent correlation with other previously validated PRO instruments that assess physical function in patients with shoulder instability postoperatively. The PROMIS UE demonstrated good correlation with other PRO tools but had a significant ceiling effect and is not recommended for this patient population. Both tools demonstrated an ability to detect change after surgical interventions with a good effect size.

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