Abstract
Objective: Lupus disease measures such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index are challenging to interpret. The Lupus Foundation of America–Rapid Evaluation of Activity in Lupus (LFA-REAL) is intended to provide an efficient application of anchored visual analog scores, each representing the individual severity of active symptoms, with the sum of individual scores deriving an overall disease activity assessment. Our objective was to compare the performance of LFA-REAL to systemic lupus erythematosus disease activity assessments and compare scores between trained lupus clinical investigators and clinicians. Methods: Investigators scored the SLEDAI, BILAG, physician's global assessment (PGA), and LFA-REAL, while the clinicians scored the LFA-REAL. The level of agreement between physicians and instruments was determined. Results: The study included 99 patients (93% women, 31% white, mean ± SD ages 43.4 ± 13.2 years). At the first visit, the mean ± SD SLEDAI score was 5.5 ± 4.5, BILAG score 6.7 ± 7.8, and PGA score 33.6 ± 24.5. The mean ± SD investigator LFA-REAL score was 46.2 ± 42.9, and clinician LFA-REAL score 56.1 ± 53.6. At the second visit, the mean ± SD investigator LFA-REAL score was 41.3 ± 36.7, and clinician LFA-REAL score 48.3 ± 42.6. Total LFA-REAL scores correlated positively with PGA, SLEDAI, and BILAG (ρ = 0.58–0.88, P < 0.001). LFA-REAL scores produced correlation coefficients of ρ > 0.7 for musculoskeletal, mucocutaneous, and renal BILAG domains. The intraclass correlation coefficient between the LFA-REAL scores of investigators and clinicians was 0.79 for visit 1 (P < 0.001) and 0.86 for visit 2 (P < 0.001). Conclusion: The LFA-REAL provides a reliable surrogate for more complicated disease activity measures when used by lupus clinical investigators or clinicians.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1058-1063 |
| Number of pages | 6 |
| Journal | Arthritis Care and Research |
| Volume | 70 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 2018 |
ASJC Scopus subject areas
- Rheumatology
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Comparison of the Lupus Foundation of America–Rapid Evaluation of Activity in Lupus to More Complex Disease Activity Instruments As Evaluated by Clinical Investigators or Real-World Clinicians. / Askanase, Anca D.; Nguyen, Samantha C.; Costenbader, Karen et al.
In: Arthritis Care and Research, Vol. 70, No. 7, 07.2018, p. 1058-1063.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Comparison of the Lupus Foundation of America–Rapid Evaluation of Activity in Lupus to More Complex Disease Activity Instruments As Evaluated by Clinical Investigators or Real-World Clinicians
AU - Askanase, Anca D.
AU - Nguyen, Samantha C.
AU - Costenbader, Karen
AU - Lim, S. Sam
AU - Kamen, Diane
AU - Aranow, Cynthia
AU - Grossman, Jennifer
AU - Kapoor, Teja M.
AU - Baker-Frost, De Anna
AU - Aberle, Teresa
AU - Thanou-Stavraki, Aikaterini
AU - Hanrahan, Leslie M.
AU - Kim, Mimi
AU - Merrill, Joan T.
N1 - Funding Information: A total of 99 SLE patients participated in the study, of whom 70 returned for a followup visit. Table summarizes the demographic characteristics and background medications of this population, who, with expected rates of 93% female and mean age of 43.4 years, were only 31% white, providing a broad spectrum of typical lupus clinic populations. Mean disease activity scores for the total LFA-REAL (sum of each visual analog scale) from investigator and clinician, and SLEDAI, BILAG, and PGA scores at visits 1 and 2 for each of the 4 participating sites are shown in Table. Values are the percentage unless indicated otherwise. Medication use at first visit. Disease Activity Scores are the total global scores for each instrument. V1 = visit 1, baseline; V2 = visit 2, followup; LFA-REAL = Lupus Foundation of America?Rapid Evaluation of Activity in Lupus; SLEDAI = Systemic Lupus Erythematosus Disease Activity Index; BILAG = British Isles Lupus Assessment Group; PGA = physician's global assessment. The investigator LFA-REAL correlated well with the SLEDAI, BILAG, and PGA scores. Spearman's rank correlation coefficient values were 0.63?0.72 for the SLEDAI, 0.61?0.86 for the BILAG, and 0.79?0.81 for the PGA (P < 0.001 for all analyses) (Table). The LFA-REAL was the most highly correlated with the BILAG at both visits. The correlation was lower with the change of the BILAG from visit 1 to visit 2, possibly due to the BILAG's limited responsiveness to change. While the correlations between the clinician LFA-REAL and disease activity measures were lower, all the correlations were still in the moderate-to-high range (0.42?0.81). The degree of agreement in LFA-REAL scores between the investigator and clinician was also high, with the ICC ranging from 0.68?0.86 (P < 0.001 for all ICCs). Spearman's rank correlation coefficients. P < 0.001 for all correlations. LFA-REAL = Lupus Foundation of America?Rapid Evaluation of Activity in Lupus; SLEDAI = Systemic Lupus Erythematosus Disease Activity Index; BILAG = British Isles Lupus Assessment Group; PGA = physician's global assessment; ICC = intraclass correlation coefficient. Investigator vs. clinician LFA-REAL scoring. Additionally, individual LFA-REAL scores for the most commonly involved organs (musculoskeletal, mucocutaneous, and renal) correlated well with the corresponding BILAG domain scores (Table). The correlations for the cardiovascular, neuropsychiatric, and hematologic domains were less interpretable because of the small number of patients with activity in these organs/systems. At both visits, fewer than 7 patients experienced cardiovascular and neuropsychiatric activity with BILAG scores of C or more in that organ. Twenty patients had hematologic activity at visit 1, and 16 at visit 2. The organ-specific ICCs of LFA-REAL between investigators and clinicians ranged from 0.48 for neuropsychiatric to 0.87 for renal (P < 0.001 for all organ-specific ICCs). LFA-REAL = Lupus Foundation of America?Rapid Evaluation of Activity in Lupus; BILAG = British Isles Lupus Assessment Group. P = 0.05; P values for all other correlations < 0.001. Systemic lupus erythematosus (SLE) is a chronic, disabling, and potentially life-threatening autoimmune disease characterized by heterogeneity and unpredictability. The formidable challenges for disease management include years of exposure to toxic yet ineffective medications and progressive damage to vital organs, quality of life, families, and careers. Optimal management of lupus depends on accurate assessment of disease activity, organ damage, and well-being. The ability to distinguish clearly between these factors is critical to the selection of effective treatments. Although efforts have been made to improve standards of clinical practice, therapeutic trials have been difficult to evaluate, in part due to the complicated outcome measures. The clinician's toolkit for assessing patient progress lacks a simple, scalable index to accurately measure improvement or worsening on either an organ-specific or global level.Significance & Innovations This is a novel, simple, and efficient lupus disease activity measure. This study evaluates the interrater reliability of the instrument between trained lupus clinical investigators and clinicians. The Lupus Foundation of America?Rapid Evaluation of Activity in Lupus correlates with other lupus disease activity measures (i.e., Systemic Lupus Erythematosus Disease Activity Index, British Isles Lupus Assessment Group, and physician's global assessment) with a correlation coefficient of 0.58?0.88. The correlation between investigator and clinician was >0.79. This is a novel, simple, and efficient lupus disease activity measure. This study evaluates the interrater reliability of the instrument between trained lupus clinical investigators and clinicians. The Lupus Foundation of America?Rapid Evaluation of Activity in Lupus correlates with other lupus disease activity measures (i.e., Systemic Lupus Erythematosus Disease Activity Index, British Isles Lupus Assessment Group, and physician's global assessment) with a correlation coefficient of 0.58?0.88. The correlation between investigator and clinician was >0.79. A number of instruments have been developed to measure disease activity, but they require specialized training and are usually considered too complex and time consuming to be useful in the standard clinical setting. Three of these indices, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) index, and the physician's global assessment (PGA), are widely used in clinical trials. However, it has been challenging to ensure the quality of data using these instruments in pivotal, international lupus trials, much of which is known to be related to errors in scoring and fundamental problems in the interpretation of glossary-based outcome thresholds. Issues with these instruments include either no attempt to distinguish different levels of symptom severity (SLEDAI), or restricted threshold levels separating mild, moderate, and severe manifestations, not all of which may be optimal for rating individual patients (BILAG). The BILAG also combines several features into each organ score that it provides, and thus would assign the same score to a patient with mild rash and another patient with moderate rash, cutaneous vasculitis, oral ulcerations, and severe alopecia. The PGA solves many of these problems by providing a linear, continuous scale, but the compression of mild, moderate, and severe manifestations (and often multiple manifestations) into a 100-mm scale is problematic. There is no way, in a single overall score, to distinguish a patient with mild arthritis and severe rash from one with mild rash and severe arthritis. The Lupus Foundation of America (LFA) supported the development of a simplified SLE disease activity index, the Rapid Evaluation of Activity in Lupus (LFA-REAL). This instrument was designed to eliminate the esoteric glossaries and scoring rules of SLEDAI and BILAG, while expanding the information obtainable (and scoring versatility) using the PGA. It provides a series of anchored visual analog scores, each constructed in a manner similar to the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLEDAI PGA but each only representing the individual severity of 1 currently active symptom, with the sum of individually weighted scores deriving an overall disease activity assessment. The data can be evaluated on the basis of individual features, organ-based scoring, or overall disease activity, and it is easy to distinguish between different combinations of mild, moderate, or severe manifestations, allowing each to contribute appropriately to an overall score without confusing the rater. There are no glossary-defined artificial thresholds for the LFA-REAL. Thus, a mild rash might be rated in the mild range, while moderate oral ulcers can be rated in the moderate range, unlike SLEDAI, which gives 2 points for each, regardless of severity, and unlike BILAG, which ranks all nonsevere rashes as moderate B scores (unless improving) and all nonsevere oral ulcers as ?mild.? Since the rater needs only to score the symptoms that are active in a given patient on a given day (usually not more than 2?4 total scales to score), the LFA-REAL can be completed in less than a minute for most patients but remains suitable to accurately track the course of disease over time, in response to therapy, in both trials and in general clinical practice. Because of its construction, the LFA-REAL can be scaled to model current trial end points, or to improve on them based on evidence-based definitions of clinically significant change. Since all past instruments have been devised or refined by groups of experts prior to testing and validation, the LFA-REAL represents the first instrument that can be scaled by real-world grounding. The LFA-REAL includes both a patient-reported outcome component and a clinician-reported outcome component. The current study was initiated to test the validity and interrater reliability of only the clinician-reported outcome component in a prospective clinical assessment of SLE patients at 4 clinics, evaluating results scored by lupus clinical investigators trained in scoring the SLEDAI, BILAG, and PGA, compared to clinicians trained in the management of clinical SLE but without SLE disease activity instrument training. Lupus disease measures such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index are challenging to interpret. The Lupus Foundation of America?Rapid Evaluation of Activity in Lupus (LFA-REAL) is intended to provide an efficient application of anchored visual analog scores, each representing the individual severity of active symptoms, with the sum of individual scores deriving an overall disease activity assessment. Our objective was to compare the performance of LFA-REAL to systemic lupus erythematosus disease activity assessments and compare scores between trained lupus clinical investigators and clinicians. Publisher Copyright: © 2017, American College of Rheumatology
PY - 2018/7
Y1 - 2018/7
N2 - Objective: Lupus disease measures such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index are challenging to interpret. The Lupus Foundation of America–Rapid Evaluation of Activity in Lupus (LFA-REAL) is intended to provide an efficient application of anchored visual analog scores, each representing the individual severity of active symptoms, with the sum of individual scores deriving an overall disease activity assessment. Our objective was to compare the performance of LFA-REAL to systemic lupus erythematosus disease activity assessments and compare scores between trained lupus clinical investigators and clinicians. Methods: Investigators scored the SLEDAI, BILAG, physician's global assessment (PGA), and LFA-REAL, while the clinicians scored the LFA-REAL. The level of agreement between physicians and instruments was determined. Results: The study included 99 patients (93% women, 31% white, mean ± SD ages 43.4 ± 13.2 years). At the first visit, the mean ± SD SLEDAI score was 5.5 ± 4.5, BILAG score 6.7 ± 7.8, and PGA score 33.6 ± 24.5. The mean ± SD investigator LFA-REAL score was 46.2 ± 42.9, and clinician LFA-REAL score 56.1 ± 53.6. At the second visit, the mean ± SD investigator LFA-REAL score was 41.3 ± 36.7, and clinician LFA-REAL score 48.3 ± 42.6. Total LFA-REAL scores correlated positively with PGA, SLEDAI, and BILAG (ρ = 0.58–0.88, P < 0.001). LFA-REAL scores produced correlation coefficients of ρ > 0.7 for musculoskeletal, mucocutaneous, and renal BILAG domains. The intraclass correlation coefficient between the LFA-REAL scores of investigators and clinicians was 0.79 for visit 1 (P < 0.001) and 0.86 for visit 2 (P < 0.001). Conclusion: The LFA-REAL provides a reliable surrogate for more complicated disease activity measures when used by lupus clinical investigators or clinicians.
AB - Objective: Lupus disease measures such as the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index are challenging to interpret. The Lupus Foundation of America–Rapid Evaluation of Activity in Lupus (LFA-REAL) is intended to provide an efficient application of anchored visual analog scores, each representing the individual severity of active symptoms, with the sum of individual scores deriving an overall disease activity assessment. Our objective was to compare the performance of LFA-REAL to systemic lupus erythematosus disease activity assessments and compare scores between trained lupus clinical investigators and clinicians. Methods: Investigators scored the SLEDAI, BILAG, physician's global assessment (PGA), and LFA-REAL, while the clinicians scored the LFA-REAL. The level of agreement between physicians and instruments was determined. Results: The study included 99 patients (93% women, 31% white, mean ± SD ages 43.4 ± 13.2 years). At the first visit, the mean ± SD SLEDAI score was 5.5 ± 4.5, BILAG score 6.7 ± 7.8, and PGA score 33.6 ± 24.5. The mean ± SD investigator LFA-REAL score was 46.2 ± 42.9, and clinician LFA-REAL score 56.1 ± 53.6. At the second visit, the mean ± SD investigator LFA-REAL score was 41.3 ± 36.7, and clinician LFA-REAL score 48.3 ± 42.6. Total LFA-REAL scores correlated positively with PGA, SLEDAI, and BILAG (ρ = 0.58–0.88, P < 0.001). LFA-REAL scores produced correlation coefficients of ρ > 0.7 for musculoskeletal, mucocutaneous, and renal BILAG domains. The intraclass correlation coefficient between the LFA-REAL scores of investigators and clinicians was 0.79 for visit 1 (P < 0.001) and 0.86 for visit 2 (P < 0.001). Conclusion: The LFA-REAL provides a reliable surrogate for more complicated disease activity measures when used by lupus clinical investigators or clinicians.
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UR - http://www.scopus.com/inward/citedby.url?scp=85047553275&partnerID=8YFLogxK
U2 - 10.1002/acr.23445
DO - 10.1002/acr.23445
M3 - Article
C2 - 28992399
AN - SCOPUS:85047553275
SN - 2151-464X
VL - 70
SP - 1058
EP - 1063
JO - Arthritis Care and Research
JF - Arthritis Care and Research
IS - 7
ER -