scholarly journals Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): data from the Peruvian Almenara Lupus Cohort

2020 ◽  
Vol 7 (1) ◽  
pp. e000419
Author(s):  
Manuel Francisco Ugarte-Gil ◽  
Rocio Violeta Gamboa-Cardenas ◽  
Cristina Reátegui-Sokolova ◽  
Victor Román Pimentel-Quiroz ◽  
Paola Zeña-Huancas ◽  
...  

ObjectiveThe Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (ClinRO) and the LFA-REAL patient-reported outcome (PRO) were developed in order to capture manifestations of SLE from the perspective of both the clinician and the patient. The aim of this study is to compare the LFA-REAL ClinRO and PRO with other lupus disease activity measures.MethodsA cross-sectional analysis of patients from a single-centre cohort was performed using Spearman’s correlation. Disease activity measures included were LFA-REAL ClinRO (range 0–1400), LFA-REAL PRO (range 0–1200), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), clinical SLEDAI-2K and Physician Global Assessment (PGA, range 0–100).ResultsTwo hundred and twenty-seven patients with SLE were studied. The mean age was 46.3 (SD: 13.8); 212 (93.4%) were female. The mean (SD) LFA-REAL ClinRO was 25.4 (34.7), LFA-REAL PRO was 241.1 (187.6), PGA was 11.9 (15.4), SLEDAI-2K was 2.3 (3.3) and clinical SLEDAI-2K was 1.6 (2.9). The LFA-REAL ClinRO correlated with PGA (r=0.758, p<0.001), SLEDAI-2K (r=0.608, p<0.001) and clinical SLEDAI-2K (r=0.697, p<0.001); the LFA-REAL PRO correlated modestly with PGA (r=0.160, p=0.016), SLEDAI-2K (r=0.121, p=0.069), clinical SLEDAI-2K (r=0.143, p=0.031) and LFA-REAL ClinRO (r=0.161, p=0.015).ConclusionsThe LFA-REAL ClinRO and the LFA-REAL PRO had good and weak correlations, respectively, with several physician-based disease activity measures in a cross-sectional study, suggesting their potential usefulness in establishing disease severity. Longitudinal studies will be required to determine their value in monitoring patients with SLE.

Lupus ◽  
2019 ◽  
Vol 28 (14) ◽  
pp. 1628-1639 ◽  
Author(s):  
M Jolly ◽  
N Annapureddy ◽  
L Arnaud ◽  
H Devilliers

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.


RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000754 ◽  
Author(s):  
Karen Holten ◽  
Joseph Sexton ◽  
Tore K Kvien ◽  
Anna-Birgitte Aga ◽  
Espen A Haavardsholm

ObjectiveTo evaluate the responsiveness of the Rheumatoid Arthritis Impact of Disease (RAID) score compared with other patient-reported outcome measures (PROMs), inflammatory markers and clinical disease activity measures in patients with early rheumatoid arthritis (RA).MethodsDisease-modifying antirheumatic drug–naïve patients with RA with short disease duration were included in the treat-to-target ARCTIC trial and followed for 24 months. The responsiveness of the RAID score was evaluated using standardised response mean (SRM) and relative efficiency (RE) with respect to tender joints by Ritchie Articular Index (RAI). SRMs and REs were also calculated for other PROMs, inflammatory markers and clinical outcome measures. An SRM with value above 0.80 was considered high.Results230 patients with RA were included. The mean±SD symptom duration was 7.1±5.4 months and the baseline mean±SD  RAID score was 4.49±2.14. At 3 months of follow-up, the mean±SD change score for RAID was −2.25±1.98  and the SRM (95%  CI) −1.13 (−1.33 to −0.96). The RAID score showed high responsiveness both at 3 and 6 months (SRM≥0.80) and was more sensitive in detecting change than the reference, tender joints assessed by RAI.ConclusionsThe RAID score proved to be highly responsive to change in patients with RA with short disease duration who followed a treat-to-target strategy. The RAID score was more efficient in detecting change than the reference (RAI) as well as most other PROMs.


Rheumatology ◽  
2020 ◽  
Author(s):  
Sizheng Steven Zhao ◽  
Gareth T Jones ◽  
Gary J Macfarlane ◽  
David M Hughes ◽  
Robert J Moots ◽  
...  

Abstract Objective Whether comorbidities influence disease activity assessment in axial SpA (axSpA) is unclear. Comorbidities inflate DAS28 in rheumatoid arthritis through the patient global score. We examined whether axSpA disease activity measures are differentially affected, and whether comorbidities inflate the AS disease activity score (ASDAS) through the patient global component. Methods We used baseline data from the British Society for Rheumatology Biologics Register for AS, including 14 physician diagnosed comorbidities. Linear models were used to compare disease activity (BASDAI, spinal pain, ASDAS) and ESR/CRP according to comorbidity count, adjusted for age, gender, BMI, smoking, socioeconomic status, and education. The same models were used to examine whether the patient global score was associated with comorbidities, additionally adjusting for other ASDAS components. Results The number of participants eligible for analysis was 2043 (67% male, mean age 49 years); 44% had at least one comorbidity. Each additional comorbidity was associated with higher BASDAI by 0.40 units (95% CI: 0.27, 0.52) and spinal pain by 0.53 (95% CI: 0.37, 0.68). Effect size for ASDAS (0.09 units; 95% CI: 0.03, 0.15) was not clinically significant. ESR and CRP were not associated with comorbidity count. Depression, heart failure and peptic ulcer were consistently associated with higher disease activity measures, but not CRP/ESR. Patient global was associated with comorbidity count, but not independently of other ASDAS components (P = 0.75). Conclusion Comorbidities were associated with higher patient reported disease activity in axSpA. Clinicians should be mindful of the potential impact of comorbidities on patient reported outcome measures and consider additionally collecting ASDAS when comorbidities are present.


2020 ◽  
Vol 4 (s1) ◽  
pp. 128-128
Author(s):  
Bryan Garcia ◽  
Abigail Grady ◽  
Lilian Christon ◽  
Patrick Flume ◽  
Susan Dorman

OBJECTIVES/GOALS: Non-tuberculous mycobacteria (NTM) is an emerging infection in the United States. Therapeutic development is impaired in NTM due to lack of biomarkers associated with disease activity and treatment response. To address this, we established a cross-sectional patient registry and biorepository from NTM patients. METHODS/STUDY POPULATION: Beginning August 2019 patients were recruited in a cross-sectional format from the bronchiectasis and NTM clinics at our institution. All patients provided at least one sputum sample in the six months prior to inclusion. Clinical and epidemiologically relevant data was obtained, patient reported outcome measures including the SGRQ were provided, and blood specimens were processed and preserved. Patients were grouped based on clinical phenotype and descriptive statistics were reported as means and standard deviations. Serum inflammatory profiles will be analyzed using standard Luminex assays. RESULTS/ANTICIPATED RESULTS: 72 patients with prior NTM isolation from sputum have been recruited including 28 patients that do not meet ATS guidelines for NTM treatment (colonized), 29 patients are currently receiving treatment, and 15 patients that have a history of completing therapy. Among all NTM patients, the mean age was 59.5 ±17.6 years and 80.8% were female. The mean FEV1 percent predicted among these patients was 68.0 ±21.5% and mean BMI was 22.35 ±4.1. The most common mycobacterial species isolated was Mycobacterium Avium Complex (47%). The mean SGRQ total score was 40.2 ±20.3 among all NTM patients. We plan to perform standard Luminex assays to identify inflammatory profiles associated with disease phenotype. DISCUSSION/SIGNIFICANCE OF IMPACT: We developed a cross sectional cohort of NTM patients including a registry of clinically relevant data for phenotyping and an accompanying biospecimen repository. Our long-term goal is to identify biomarkers indicative of disease activity and treatment response using these components.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 617.1-617
Author(s):  
H. Wohland ◽  
N. Leuchten ◽  
M. Aringer

Background:Fatigue is among the top complaints of patients with systemic lupus erythematosus (SLE), but only in part associated with SLE disease activity. Physical activity can help to reduce fatigue and should therefore be recommended to SLE patients. Vice versa, fatigue may arguably lead to reduced physical activity.Objectives:To investigate the extent of physical activity and the perception of fatigue and sleep quality in patients with SLE.Methods:Starting in February 2019, SLE patients were invited to participate in a cross-sectional survey study of fatigue and physical exercise during their routine outpatient clinic visits. Participants filled out a ten-page paper questionnaire focused on physical activity. To evaluate fatigue, we primarily used a 10 cm visual analogue scale (0-100 mm, with 100 meaning most fatigued), but also the FACIT fatigue score (range 0-52). Sleep quality was estimated using grades from 1 (excellent) to 6 (extremely poor).Results:93 SLE patients took part in the study. All patients fulfilled the European League Against Rheumatism/ American College of Rheumatology (EULAR/ACR) 2019 classification criteria for SLE. 91% of the patients were female. Their mean (SD) age was 45.5 (14.3) years and their mean disease duration 12.1 (9.4) years. The mean BMI was 25.2 (5.6). Of all patients, 7.5% had a diagnosis of (secondary) fibromyalgia. The mean fatigue VAS was 32 (27) mm and the mean FACIT fatigue score 35.7 (10.3). As expected, fatigue by VAS and FACIT was correlated (Spearman r=-0.61, p<0.0001). The mean SLEDAI was 1 (1) with a range of 0 to 6. Median glucocorticoid doses were 2 mg prednisolone equivalent, with a range from 0 to 10 mg.Out of 66 patients in payed jobs, 64 (97%) reported details on their working space. One person (2%) worked in a predominanty standing position, 37 (58%) worked in essentially sedentary jobs and 26 (40%) were in positions where they were mildly physically active in part. The mean fatigue VAS was 31 (24) mm for patients with partly active jobs and 27 (30) mm for those in sedentary jobs. Sleep was graded 2.9 (0.9) by those with active and 3.1 (1.3) by those with sedentary jobs.Half of the patients (51%) reported more than one physical recreational activity. 44 (47%) were walking and for five persons (5%) this was the only form of activity. Cycling was reported by 19 patients (20%), 18 of whom also practiced other activities. For transport, 52 (56%) in part chose active modes, such as walking and cycling. Patients who reported any of the above activities showed a mean fatigue VAS of 28 (25) mm, compared to 36 (28) mm in the patient group without a reported activity. Sleep quality was very similar: 3.1 (1.2) and 3.2 (1.1) for more active and more passive patients, respectively.65 (70%) patients regularly practiced sports. Of these, 39 (60%) practiced one kind of sport, 15 (23%) two, 7 (11%) three, and 2 (3%) each four and five kinds of sports. Fatigue VAS of patients practicing sports was 27 (25) mm versus 43 (28) in those who did not (p=0.0075). Sleep quality was 2.9 (1.1) in the sports cohort and 3.5 (1.1) in the no-sports cohort (p=0.0244).Conclusion:A majority of SLE patients in remission or low to moderate disease activity regularly practiced sports, and those doing so reported lesser fatigue and better sleep quality. The absolute values on the fatigue VAS were in a moderate range that made fatigue as the main cause of not performing sports rather unlikely for most patients.Disclosure of Interests:Helena Wohland: None declared, Nicolai Leuchten Speakers bureau: AbbVie, Janssen, Novartis, Roche, UCB, Consultant of: AbbVie, Janssen, Novartis, Roche, Martin Aringer Speakers bureau: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, Chugai, Gilead, GSK, HEXAL, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Astra Zeneca, BMS, Boehringer Ingelheim, GSK, Lilly, MSD, Roche, Sanofi, UCB


2010 ◽  
Vol 38 (1) ◽  
pp. 60-63 ◽  
Author(s):  
DOMINIQUE IBAÑEZ ◽  
DAFNA D. GLADMAN ◽  
ZAHI TOUMA ◽  
MANDANA NIKPOUR ◽  
MURRAY B. UROWITZ

Objective.Adjusted mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; AMS) measures lupus disease activity over time. Our aim was to determine optimal visit frequency for calculating AMS.Methods.Patients followed monthly for 12 consecutive visits were included. AMS was calculated using all of the SLEDAI 2000 (AMSGOLD using all 12 visits), only quarterly visits (AMS3, using visits 3 months apart), semiannual visits (AMS6, using first, middle, and last visits only), and annual visits (AMS12, using only the first and last visits). Comparisons of AMS3, AMS6, and AMS12 with AMSGOLD are made using descriptive statistics.Results.Seventy-eight patients were included (92% women, mean age at SLE diagnosis 30.1 yrs and at study start 46.2 yrs). The mean (SD) AMSGOLD for the entire year was 2.05 (1.66), for AMS3 1.99 (1.65), for AMS6 2.12 (1.87), and for AMS12 2.08 (1.83). Mean (SD) of the absolute differences with AMSGOLD: for AMS3 0.29 (0.33), for AMS6 0.45 (0.59), and for AMS12 0.61 (0.58). Differences that were < 0.5 were considered minimal while those ≥ 1 were deemed important. Comparing AMSGOLD to AMS3, 82% of the differences were minimal and 3% were important. When comparing to AMS6, 68% were minimal and 10% were important, while comparing to AMS12, 50% were minimal and 21% were important.Conclusion.Usual clinic visits occurring quarterly offer a good estimation of disease activity over a 1-year period and are preferred over semiannual and annual visits.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1176.2-1176
Author(s):  
E. Eraslan ◽  
R. Bilici Salman ◽  
H. Satiş ◽  
A. Avanoglu Guler ◽  
H. Karadeniz ◽  
...  

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology that can affect any organ of the body. SLE is associated with adverse effects on both health and non-health-related quality of life (HRQOL and non-HRQOL). Lupus PRO is a patient reported outcome measure that has been validated in many languages. It has 44 items that cover both HRQOL and non-HRQOL (1). Health literacy is defined as the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions. Multiple studies indicate that people with limited health literacy have worse health status and higher rates of hospitalization (2).Objectives:We aimed to evaluate the relationship between the LLDAS (Lupus Low Disease Activity State) criteria and the Lupus PRO test, as well as the health literacy status of lupus patients.Methods:83 SLE patients (94% women) were included in the study. We performed Lupus PRO and the European Health Literacy Survey tests during the routine follow-up visits of lupus patients to our rheumatology outpatient clinic and admissions to rheumatology inpatient clinic. Available clinical data on medical records were obtained, physician global assessments (PGA) were recorded by the attending physician.Results:LLDAS criteria strongly and inversely correlated with the total score, as well as the mood subunit of the Lupus PRO. Similarly, it also significantly inversely correlated with the body appearence and goals subunits. Health literacy status of the patients did not correlate with their LLDAS scores, ie their disease activities.Conclusion:Our results suggest that lupus disease activity, assessed by LLDAS criteria, significantly correlates with measures of quality of life, spesicifically Lupus PRO test, but not with health literacy status. Further studies are needed to evaluate if health literacy is related with damage, hospitalization or mortality associated with lupus.References:[1]Jolly M, Pickard AS, Block JA, Kumar RB, Mikolaitis RA, Wilke CT, et al., editors. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Seminars in arthritis and rheumatism; 2012: Elsevier.[2]Paasche-Orlow MK, Parker RM, Gazmararian JA, Nielsen-Bohlman LT, Rudd RR. The prevalence of limited health literacy. Journal of general internal medicine. 2005;20(2):175-84.Disclosure of Interests:None declared


2010 ◽  
Vol 37 (11) ◽  
pp. 2299-2306 ◽  
Author(s):  
JENNIFER G. WALKER ◽  
RUSSELL J. STEELE ◽  
MIREILLE SCHNITZER ◽  
SUZANNE TAILLEFER ◽  
MURRAY BARON ◽  
...  

Objective.The absence of a standardized disease activity index has been an important barrier in systemic sclerosis (SSc) research. We applied the newly derived Valentini Scleroderma Disease Activity Index (SDAI) among our cohort of patients with SSc to document changes in disease activity over time and to assess possible differences in activity between limited and diffuse disease.Methods.Cross-sectional study of a national cohort of patients enrolled in the Canadian Scleroderma Research Group Registry. Disease activity was measured using the SDAI. Depression scores were measured using the Centre for Epidemiologic Studies Depression Scale (CES-D).Results.A total of 326 out of 639 patients had complete datasets at the time of this analysis; 87% were female, of mean age 55.6 years, with mean disease duration 14.1 years. SDAI declined steeply in the first 5 years after disease onset and patients with diffuse disease had 42% higher SDAI scores than patients with limited disease with the same disease duration and depression scores (standardized relative risk 1.42, 95% CI 1.21, 1.65). Patients with higher CES-D scores had higher SDAI scores relative to patients with the same disease duration and disease subset (standardized RR 1.22, 95% CI 1.14, 1.31). Among the 10 components that make up the SDAI, only skin score (standardized OR 0.59, 95% CI 0.43, 0.82) and patient-reported change in skin (standardized OR 0.64, 95% CI 0.45, 0.92) decreased with increasing disease duration. High skin scores (standardized OR 32.2, 95% CI 15.8, 72.0) were more likely and scleredema (standardized OR 0.58, 95% CI 0.37, 0.92) was less likely to be present in patients with diffuse disease. High depression scores were associated with positive responses for patient-reported changes in skin and cardiopulmonary function.Conclusion.Disease activity declined with time and patients with diffuse disease had consistently higher SDAI scores. Depression was found to be associated with higher patient activity scores and strongly associated with patient self-response questions. The role of depression should be carefully considered in future applications of the SDAI, particularly as several components of the score rely upon patient recall.


F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 126 ◽  
Author(s):  
Abidullah Khan ◽  
Iqbal Haider ◽  
Maimoona Ayub ◽  
Salman Khan

Background: Amongst the different clinical and laboratory parameters used to monitor disease activity in systemic lupus erythematosus (SLE), mean platelet volume (MPV) is a novel biomarker. Although MPV has been studied in other rheumatological conditions like rheumatoid arthritis, its role in adult SLE needs to be defined, especially in Pakistan. Methods: The aim of this study was to evaluate the role of MPV as a biomarker of disease activity in SLE. Fifty patients were recruited through a consecutive non-probability sampling technique for this cross-sectional study.  On the basis of their SLE disease activity index (SLEDAI) score of greater or lesser than 5, these 50 participants were divided into two equal groups respectively;25 patients with active SLE, and another 25 participants with stable, inactive lupus. MPV was measured in each group and compared using SPSS version 16. MPV was also correlated with SLEDAI and erythrocyte sedimentation rate (ESR). Independent sample t-test and Spearman’s rho and Pearson’s correlation tests were applied. Sensitivity and specificity of MPV were checked through ROC analysis.    Results: The MPV of patients with active SLE (n=25, mean [M]=7.12, SD=1.01) was numerically lower than those in the inactive-SLE group (n=25, M= 10.12, SD=0.97), and this was statistically significant ( P<0.001). MPV had an inverse relationship with both ESR (r=-0.93, P<0.001) and SLEDAI (rs= -0.89, P<0.001). However, there was a strong positive correlation between ESR and SLEDAI (rs=0.90, P<0.001). For MPV, a cutoff value of less than 8.5fl had a sensitivity of 92% and a specificity of 100% ( P< 0.001).  Conclusions: Higher disease activity in SLE is associated with a correspondingly low MPV.


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