Validation of an algorithm to identify incident interstitial lung disease in patients with rheumatoid arthritis.

BACKGROUND/PURPOSE: Interstitial lung disease (ILD) is an important problem for patients with rheumatoid arthritis (RA). However, current approaches to ILD case finding in real-world data have been evaluated only in limited settings and identify only prevalent ILD and not new-onset disease. Our objective was to develop, refine, and validate a claims-based algorithm to identify both prevalent and incident ILD in RA patients compared to the gold standard of medical record review. METHODS: We used administrative claims data 2006-2015 from Medicare to derive a cohort of RA patients. We then identified suspected ILD using variations of ILD algorithms to classify both prevalent and incident ILD based on features of the data that included hospitalization vs. outpatient setting, physician specialty, pulmonary-related diagnosis codes, and exclusions for potentially mimicking pulmonary conditions. Positive predictive values (PPV) of several ILD algorithm variants for both prevalent and incident ILD were evaluated. RESULTS: We identified 234 linkable RA patients with sufficient data to evaluate for ILD. Overall, 108 (46.2%) of suspected cases were confirmed as ILD. Most cases (64%) were diagnosed in the outpatient setting. The best performing algorithm for prevalent ILD had a PPV of 77% (95% CI 67-84%) and for incident ILD was 96% (95% CI 85-100%). CONCLUSION: Case finding in administrative data for both prevalent and incident interstitial lung disease in RA patients is feasible and has reasonable accuracy to support population-based research and real-world evidence generation.

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

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.

Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus.

BACKGROUND: The Multidimensional Health Assessment Questionnaire (MDHAQ) is a patient-reported outcome (PRO) tool that includes the Routine Assessment of Patient Index Data 3 (RAPID3), an index that can be calculated at the point of care. The objective of this study was to perform psychometric analyses of MDHAQ/RAPID3 to study its measurement properties in systemic lupus erythematosus (SLE). METHODS: The MDHAQ was completed by 161 SLE patients in routine care, along with LupusPRO (a disease-specific PRO). The SLE disease-specific activity index (SELENA-SLEDAI) and damage (SDI) were assessed. Data from 70 patients with rheumatoid arthritis who had completed MDHAQ during their routine medical care were used as controls to compare the results of Physical Function (FN) domain exploratory factor analysis. Internal consistency reliability (ICR) for FN items was calculated using Cronbach's α. Validity of MDHAQ/RAPID3 was evaluated for content validity and construct validity. Responsiveness of the RAPID3 to changes in disease activity anchors was assessed. RESULTS: The ICR of the 10 physical function items on Cronbach's α was 0.88. Exploratory factor analysis revealed cross-loadings of three FN items. RAPID3 showed a strong correlation with LupusPRO health-related quality of life score (rho -0.68 (p < 0.001)), indicating convergent validity. RAPID3 scores did not correlate with disease activity indices or SDI. After adjustment for fibromyalgia status, a weak correlation with the Physician's Global Assessment (PGA) (rho = 0.31, p = 0.008) was noted. RAPID3 could differentiate between SLE patients based on flare status. RAPID3 was not responsive to changes in PGA, SELENA-SLEDAI or SELENA-Flare Index. CONCLUSIONS: MDHAQ/RAPID3 has fair reliability and validity in SLE.

Patient-reported outcomes in lupus clinical trials with biologics.

Therapeutic advances in systemic lupus erythematosus (SLE) are greatly needed. Despite advances in our knowledge of pathogenesis of the disease and targets, treatment remains a significant challenge. Finding effective and relatively safe medications remains one of the top priorities. SLE significantly impairs quality of life (QoL), and patient-reported outcomes (PROs) measure a unique aspect of the disease not captured by disease activity. Inclusion of PRO measurements is encouraged in SLE clinical trials, as they allow capturing benefits of a proposed intervention in language patients can relate to and in areas deemed pertinent and important to and by patients. Availability of patient-reported and patient-centric clinical trials data may facilitate patients in informed and shared decision making, and allow for comparative cost-effectiveness evaluation for future resource allocation and reimbursements. Herein we review clinical trials with biologic therapies wherein PRO tools were included in the study design.

Dialysis-requiring acute kidney injury among hospitalized adults with documented hepatitis C Virus infection: a nationwide inpatient sample analysis.

Chronic hepatitis C virus (HCV) infection may cause kidney injury, particularly in the setting of cryoglobulinemia or cirrhosis; however, few studies have evaluated the epidemiology of acute kidney injury in patients with HCV. We aimed to describe national temporal trends of incidence and impact of severe acute kidney injury (AKI) requiring renal replacement 'dialysis-requiring AKI' in hospitalized adults with HCV. We extracted our study cohort from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project using data from 2004 to 2012. We defined HCV and dialysis-requiring acute kidney injury based on previously validated ICD-9-CM codes. We analysed temporal changes in the proportion of hospitalizations complicated by dialysis-requiring AKI and utilized survey multivariable logistic regression models to estimate its impact on in-hospital mortality. We identified a total of 4,603,718 adult hospitalizations with an associated diagnosis of HCV from 2004 to 2012, of which 51,434 (1.12%) were complicated by dialysis-requiring acute kidney injury. The proportion of hospitalizations complicated by dialysis-requiring acute kidney injury increased significantly from 0.86% in 2004 to 1.28% in 2012. In-hospital mortality was significantly higher in hospitalizations complicated by dialysis-requiring acute kidney injury vs those without (27.38% vs 2.95%; adjusted odds ratio: 2.09; 95% confidence interval: 1.74-2.51). The proportion of HCV hospitalizations complicated by dialysis-requiring acute kidney injury increased significantly between 2004 and 2012. Similar to observations in the general population, dialysis-requiring acute kidney injury was associated with a twofold increase in odds of in-hospital mortality in adults with HCV. These results highlight the burden of acute kidney injury in hospitalized adults with HCV infection.

Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus.

OBJECTIVE: To evaluate the responsiveness of Lupus Impact Tracker (LIT) to changes in physician and patient disease activity assessments over time. METHODS: Available longitudinal data from routine patient care visits on LIT, physician assessed disease activity (physician global assessment (PGA), SELENA-SLEDAI score, SELENA Flare Index (SFI)), and patient-reported changes in systemic lupus erythematosus (SLE) health status were analyzed. Significant, clinically important change (worsening or improvement) in physician disease activity assessment or patient-reported SLE health status were judged using the following criteria: change of 0.3 on PGA, 4 on SELENA-SLEDAI, change in SFI status over time, and change of 2 in either direction in patient-reported SLE health status. Mixed model regression analysis was used to compare changes in LIT using the above criteria. RESULTS: There were 1184 observations with significant changes in physician disease activity or patient-reported measure for 182 patients' data across 1364 visits. Patients' mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) years and 6.4 (7.3) respectively. LIT mean scores decreased by more than 3 with improvement in PGA (standardized response mean -0.26, p < 0.05), while it increased by more than 5 with worsening in SELENA-SLEDAI (standardized response mean 0.42, p = 0.01). Mean change in LIT of greater than ±3 was noted with change in SFI status (p < 0.05). Mean LIT score decreased by greater than 4 and increased by greater than 2 with patient-reported improvement and worsening in SLE health status respectively (p < 0.05). CONCLUSIONS: LIT is responsive to physician-assessed and patient-assessed changes in disease status. A mean LIT change of 2-4 may represent a significant clinical change in LIT. It is an effective tool that may be used by patients and physicians in tracking disease impact in SLE patients.

The Austrian syndrome: a case report and review of the literature.

A 61-year-old man presented with fever and altered mental status. He was intubated for respiratory distress and was found to have multilobar pneumonia for which antibiotic therapy was instituted. However, his mental status continued to deteriorate despite appropriate antibiotic therapy for his pneumonia. The results from lumar puncture revealed meningitis and endocarditis was evident on a trans-esophageal echocardiogram. His blood and respiratory cultures grew Streptococcus pneumoniae. The patient was diagnosed with Austrian syndrome. After appropriate changes to his antibiotic regimen and an aortic valve replacement, he recovered and was discharged.

The association of the Friesinger score and estimated glomerular filtration rate in an urban South Asian patient population.

AIM: The correlation between kidney function and coronary artery disease (CAD) severity as assessed by an angiographic score has not yet been studied in the South Asian population. We sought to estimate the association by performing a single-center, cross-sectional study. PATIENTS AND METHODS: The estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation and the Friesinger score to quantify the severity of CAD were the primary endpoints in patients undergoing coronary angiograms. RESULTS: The mean eGFR was significantly lower in participants with a Friesinger score of > 5 compared to participants with a score of < 5 (73 vs. 86 ml/min/1.73 m(2) by MDRD). In univariate analysis, an eGFR of < 55 ml/min/1.73 m(2) was associated with a 9.5-fold increased odds of a higher Friesinger score compared to an eGFR >= 55 ml/min/1.73 m2 (p = 0.043), which was unchanged in multivariate analysis. In multivariate analysis, a 10 ml/min/1.73 m(2) decrease in eGFR was associated with a 1.63-fold increased odds of a higher score (95% CI 1·10 - 2.37, p = 0.042). Traditional risk factors such as a history of previous CAD, hypertension, and dyslipidemia remained predictors of a higher Friesinger score. CONCLUSION: Our study demonstrates that kidney function as assessed by eGFR is a significant independent predictor of severity of CAD as determined by the Friesinger score.