The Nexus Narcolepsy Registry: methodology, study population characteristics, and patterns and predictors of narcolepsy diagnosis.

OBJECTIVE/BACKGROUND: The real-world experience of people with narcolepsy is not well understood. PATIENTS/METHODS: The Nexus Narcolepsy Registry (NCT02769780) is a longitudinal, web-based patient registry of self-reported data from adults with physician-diagnosed narcolepsy. Surveys were electronically distributed every 6 months; the current analysis reports registry population demographics, narcolepsy diagnosis journey, and predictors of diagnostic delays. RESULTS: The registry population included in this analysis (N = 1024) was predominantly female (85%) and White (92%), with a mean age of 37.7 years. Most participants had education/training beyond high school (93%). Mean (median) reported ages at narcolepsy symptom onset, first consultation for symptoms, and narcolepsy diagnosis were 18.1 (16), 26.4 (24), and 30.1 (28) years, respectively. A majority (59%) of participants reported ≥1 misdiagnosis, and 29% reported consulting ≥5 physicians before narcolepsy diagnosis. More than half (56%) of participants' first consultations for narcolepsy symptoms were with a general practitioner, whereas the diagnosing clinician was usually a sleep specialist (64%) or neurologist (27%). Pediatric symptom onset was associated with a longer mean interval to first consultation than adult symptom onset (10.7 and 4.6 years, respectively; P < 0.001) and a longer mean interval between first consultation and diagnosis (4.5 and 2.2 years, respectively; P < 0.001). Overall, mean (95% CI) time from symptom onset to diagnosis was 11.8 (11.1-12.5) years. CONCLUSIONS: The Nexus Narcolepsy Registry data indicate that onset of narcolepsy symptoms frequently occurs in childhood or adolescence. In many individuals, the diagnostic process is long and involves multiple physicians and frequent misdiagnosis.

Health care resource utilization and disease modifying treatment use in multiple sclerosis patients by age and insurance type.

OBJECTIVE: The objective of this study was to describe and compare health care resource utilization (HCRU) and disease modifying treatment (DMT) use among US adults <65 years with multiple sclerosis (MS), across commercial and Medicare Advantage plans. METHODS: Medical and pharmacy claims data from commercial and Medicare Advantage with Part D (MAPD) plans were extracted for MS patients age 18 - 64 identified between 1 January 2014 and 31 May 2017. Comparisons were made between commercial and MAPD enrollees for all-cause HCRU and DMT use over 1 year, overall and by 5 year age groups. RESULTS: A total of 28,427 MS patients were identified; two-thirds (67%) had commercial coverage. MAPD patients had statistically significantly higher mean counts of all-cause inpatient, emergency room (ER) and ambulatory visits compared to commercial patients. The significant differences were evident in all age groups ≥30 years, except for ER visits in the 40-44 and 60-64 age groups. MAPD patients had statistically significantly lower prevalence of DMT use compared to commercial patients in all age groups starting at ≥35 years. CONCLUSION: MAPD patients had a higher burden of medical HCRU compared to their commercially insured counterparts, most likely due primarily to their more advanced disease state and higher level of MS-related disability. Reasons for lower prevalence of DMT use among MAPD patients may include their more advanced disease state, older age and higher prevalence of comorbid conditions compared with commercially insured patients, as well as more restrictive formularies for MAPD vs. commercial plans. These findings suggest that there may be an opportunity for recently approved DMTs indicated for active secondary progressive MS to fulfill an unmet need for treatment among MS patients <65 years without contraindicated comorbid conditions who are enrolled in MAPD plans. Novel therapies under development to delay progression may help keep MS patients of working age in the work force.

Analysis of patient characteristics, health care costs by surgical venue, and opioid utilization for common orthopedic procedures in the United States.

BACKGROUND: Orthopedic surgery can be performed in hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs), as well as in traditional inpatient venues. Patients who undergo orthopedic surgery may be prescribed opioids for the management of postsurgical pain. However, the association between surgery venue, postsurgical opioid use, and health care costs remains unclear. OBJECTIVE: To compare postsurgical opioid use and health care costs associated with 6 different orthopedic surgical procedures performed at inpatient, ASC, and HOPD venues. METHODS: Using the Optum Research Database, this retrospective study analyzed commercial health care claims from adult patients in the United States undergoing specific orthopedic procedures (total knee arthroplasty, partial knee arthroplasty, total hip arthroplasty, total shoulder arthroplasty, rotator cuff repair, and lumbar spinal fusion) between April 1, 2012, and December 31, 2017. The date of the first procedure in that period was the index date; continuous insurance coverage for 12 months before the index date (baseline period) to 6 months following the index date (postsurgical period, which includes the index date) was required. Opioid use and all-cause costs were measured in the postsurgical period. Baseline patient characteristics included demographics, Quan-Charlson Comorbidity Index, and opioid use. Multivariable analysis identified factors influencing postsurgical costs and persistent opioid use (defined as ≥ 1 opioid fill within 3 days after surgery [or discharge for inpatient stay] and ≥1 additional opioid fill during the postsurgical period at least 90 days after the index date). RESULTS: The sample included 126,172 patients (mean age, 58 years; 49% female). Overall, most procedures were performed at inpatient venues (68%), followed by HOPDs (18%) and ASCs (14%); the percentage of procedures performed at ASCs increased from 12% to 17% from 2012 to 2017. Patients whose procedures were performed at ASCs reported the lowest adjusted percentage of persistent opioid use following the procedure (18%) compared with those with procedures performed at HOPDs (24%) or inpatient venues (26%). Adjusted 30-day costs were 14% and 27% lower for patients with procedures in HOPDs and ASCs, respectively, compared with inpatient venues (P < 0.001 for both), and adjusted costs over the first 90 days were similar. CONCLUSIONS: All-cause costs on the day of surgery through 30 days after surgery for these 6 orthopedic procedures were significantly lower in HOPDs and ASCs compared with inpatient venues, even after adjustment for cohort, surgery year, demographic characteristics, baseline Quan-Charlson Comorbidity Index, and any opioid use within 90 days before the procedure. Additionally, patients undergoing orthopedic surgery at ASCs had the lowest adjusted percentage of persistent opioid use compared with those undergoing surgery at HOPDs or inpatient venues. Migration of certain orthopedic procedures from inpatient venues to HOPDs or ASCs may reduce health care costs and decrease the potential for persistent opioid use. DISCLOSURES: This study and editorial support for the preparation of this manuscript was funded by Pacira BioSciences, which contracted with Optum to conduct the study. Cisternas, Korrer, and Wilson are employees of Optum. Waterman was employed with Pacira BioSciences at the time of the study. Portions of this work were presented at AMCP Nexus 2019; October 29-November 1, 2019; National Harbor, MD.

All-Cause Opioid Prescriptions Dispensed: The Outsized Role of Adults With Arthritis.

INTRODUCTION: Limited estimates of prescribed opioid use among adults with arthritis exist. All-cause (i.e., for any condition) prescribed opioid dispensed (referred to as opioid prescription in the remainder of this abstract) in the past 12 months among U.S. adults aged ≥18 years (n=35,427) were studied, focusing on adults with arthritis (n=12,875). METHODS: In 2018-2019, estimates were generated using Medical Expenditure Panel Survey data: (1) 2015 prevalence of 1 or more opioid prescriptions to U.S. adults overall and by arthritis status and (2) in 2014-2015, among adults with arthritis, multivariable-adjusted associations between 1 or more opioid prescriptions and sociodemographic characteristics, health status, and healthcare utilization characteristics. RESULTS: In 2015, the age-standardized prevalence of 1 or more opioid prescriptions among adults with arthritis (29.6%) was almost double of that for all adults (15.4%). Adults with arthritis represented more than half of all adults (55.3%) with at least 1 opioid prescription; among those with 1 or more prescriptions, 43.2% adults had 4 or more prescriptions. The strongest multivariable-adjusted associations with 1 or more opioid prescriptions were ambulatory care visits (1-4: prevalence ratios=1.9-2.0, 5-8: prevalence ratios=2.5-2.7, 9 or more: prevalence ratios=3.4-3.7) and emergency room visits (1: prevalence ratios=1.6, 2-3: prevalence ratios=1.9-2.0, 4 or more: prevalence ratios=2.4); Ref for both: no visits. CONCLUSIONS: Adults with arthritis are a high-need target group for improving pain management, representing more than half of all U.S. adults with 1 or more opioid prescriptions. The association with ambulatory care visits suggests that providers have routine opportunities to discuss comprehensive and integrative pain management strategies, including low-cost evidence-based self-management approaches (e.g., physical activity, self-management education programs, cognitive behavioral therapy). Those with multiple opioid prescriptions may need extra support if transitioning to nonopioid and nonpharmacologic pain management strategies.

Walking and the 2-year risk of functional decline: An observational study of US adults with arthritis.

Recent studies of middle age and older adults with, or at risk for, arthritis demonstrate that engaging in physical activities like walking - even at levels below the current aerobic physical activity guideline of ≥150 min of moderate-intensity activity - can protect against onset of functional limitations. Using a large nationally representative sample of US adults ≥18 years with arthritis, we investigated whether, among those not meeting the aerobic activity guideline, walking ≥10 min/week vs. <10 min/week reduced the risk of six outcomes (fair/poor health and five physical limitations) over 2 years. We conducted a prospective cohort study among adults with arthritis in the 2010 National Health Interview Survey who participated in the 2011-2012 Medical Expenditure Panel Survey (n = 1426). Among adults not meeting the guideline, we examined the effect of walking on risk of developing each of six outcomes using hazard ratios (HRs) estimated from multivariable Cox regression models. Among adults with arthritis not meeting the guideline, compared to walking <10 min/week, walking ≥10 min/week was associated with a statistically significant decreased risk for all five limitations: walking three blocks (HR: 0.3 [95% CI = 0.2-0.6]), climbing 10 stairs (HR: 0.5 [95% CI = 0.3-0.8]), stooping/kneeling (HR: 0.4 [95% CI = 0.2-0.8]), reaching overhead (HR: 0.5[95% CI = 0.5-0.8]), and grasping (HR: 0.4 [95% CI = 0.2-0.7]). The decrease in risk was not significant for fair/poor health. Even limited walking may prevent the onset of physical limitations among adults with arthritis of all ages not meeting the aerobic activity guideline.

Health Care Provider Counseling for Weight Loss Among Adults with Arthritis and Overweight or Obesity - United States, 2002-2014.

In the United States, 54.4 million adults report having doctor-diagnosed arthritis (1). Among adults with arthritis, 32.7% and 38.1% also have overweight and obesity, respectively (1), with obesity being more prevalent among persons with arthritis than among those who do not have arthritis (2). Furthermore, severe joint pain among adults with arthritis in 2014 was reported by 23.5% of adults with overweight and 31.7% of adults with obesity (3). The American College of Rheumatology recommends weight loss for adults with hip or knee osteoarthritis and overweight or obesity,* which can improve function and mobility while reducing pain and disability (4,5). The Healthy People 2020 target for health care provider (hereafter provider) counseling for weight loss among persons with arthritis and overweight or obesity is 45.3%.† Adults with overweight or obesity who receive weight-loss counseling from a provider are approximately four times more likely to attempt to lose weight than are those who do not receive counseling (6). To estimate changes in the prevalence of provider counseling for weight loss reported by adults with arthritis and overweight or obesity, CDC analyzed National Health Interview Survey (NHIS) data.§ Overall, age-standardized estimates of provider counseling for weight loss increased by 10.4 percentage points from 2002 (35.1%; 95% confidence interval [CI] = 33.0-37.3) to 2014 (45.5%; 95% CI = 42.9-48.1) (p<0.001). Providing comprehensive behavioral counseling (including nutrition, physical activity, and self-management education) and encouraging evidence-based weight-loss program participation can result in enhanced health benefits for this population.

Medical Expenditures and Earnings Losses Among US Adults With Arthritis in 2013.

OBJECTIVE: We estimated the economic impact of arthritis using 2013 US Medical Expenditure Panel Survey (MEPS) data. METHODS: We calculated arthritis-attributable and all-cause medical expenditures for adults age ≥18 years and arthritis-attributable earnings losses among those ages 18-64 years who had ever worked. We calculated arthritis-attributable costs using multistage regression-based methods, and conducted sensitivity analyses to estimate costs for 2 other arthritis definitions in MEPS. RESULTS: In 2013, estimated total national arthritis-attributable medical expenditures were $139.8 billion (range $135.9-$157.5 billion). Across expenditure categories, ambulatory care expenditures accounted for nearly half of arthritis-attributable expenditures. All-cause expenditures among adults with arthritis represented 50% of the $1.2 trillion national medical expenditures among all US adults in MEPS. Estimated total national arthritis-attributable earning losses were $163.7 billion (range $163.7-$170.0 billion). The percentage with arthritis who worked in the past year was 7.2 percentage points lower than those without arthritis (76.8% [95% confidence interval (95% CI)] 75.0-78.6 and 84.0% [95% CI 82.5-85.5], respectively, adjusted for sociodemographics and chronic conditions). Total arthritis-attributable medical expenditures and earnings losses were $303.5 billion (range $303.5-$326.9 billion). CONCLUSION: Total national arthritis-attributable medical care expenditures and earnings losses among adults with arthritis were $303.5 billion in 2013. High arthritis-attributable medical expenditures might be reduced by greater efforts to reduce pain and improve function. The high earnings losses were largely attributable to the substantially lower prevalence of working among those with arthritis compared to those without, signaling the need for interventions that keep people with arthritis in the workforce.

The Incidence and Prevalence of Systemic Lupus Erythematosus in San Francisco County, California: The California Lupus Surveillance Project.

OBJECTIVE: Estimates of the incidence and prevalence of systemic lupus erythematosus (SLE) in the US have varied widely. The purpose of this study was to conduct the California Lupus Surveillance Project (CLSP) to determine credible estimates of SLE incidence and prevalence, with a special focus on Hispanics and Asians. METHODS: The CLSP, which is funded by the Centers for Disease Control and Prevention, is a population-based registry of individuals with SLE residing in San Francisco County, CA, from January 1, 2007 through December 31, 2009. Data sources included hospitals, rheumatologists, nephrologists, commercial laboratories, and a state hospital discharge database. We abstracted medical records to ascertain SLE cases, which we defined as patients who met ≥4 of the 11 American College of Rheumatology classification criteria for SLE. We estimated crude and age-standardized incidence and prevalence, which were stratified by sex and race/ethnicity. RESULTS: The overall age-standardized annual incidence rate was 4.6 per 100,000 person-years. The average annual period prevalence was 84.8 per 100,000 persons. The age-standardized incidence rate in women and men was 8.6 and 0.7 per 100,000 person-years, respectively. This rate was highest among black women (30.5), followed by Hispanic women (8.9), Asian women (7.2), and white women (5.3). The age-standardized prevalence in women per 100,000 persons was 458.1 in blacks, 177.9 in Hispanics, 149.7 in Asians, and 109.8 in whites. Capture-recapture modeling estimated 33 additional incident cases and 147 additional prevalent cases. CONCLUSION: Comprehensive methods that include intensive case-finding provide more credible estimates of SLE in Hispanics and Asians, and confirm racial and ethnic disparities in SLE. The disease burden of SLE is highest in black women, followed by Hispanic women, Asian women, and white women.

Psychological well-being among US adults with arthritis and the unmet need for mental health care.

PURPOSE: Mental health conditions can increase the risk of disability among adults with arthritis. The objective of this analysis was to compare the prevalence of serious psychological distress (SPD), depression, and anxiety among US adults with arthritis vs. those without; characterize adults with arthritis with and without SPD; and determine correlates of seeing a mental health professional during the year for adults with arthritis and SPD. MATERIALS AND METHODS: Cross-sectional analysis of adults in the 2011-2013 National Health Interview Survey. RESULTS: Higher proportions of adults with arthritis had SPD (6.8% vs. 2.4%), depression (19.4% vs. 7.3%), and anxiety (29.3% vs. 16.3%) compared to those without. Of the estimated 3.5 million adults with arthritis and SPD, only 39% saw a mental health professional during the year. Adjusted analyses identified the following statistically significant relationships: those who were older (45-64 and ≥65 [vs.18-44], prevalence ratio [PR]=0.8 and 0.4, respectively), less educated (PR=0.5 and 0.7 for high school or less vs. college degree, respectively), and without health insurance coverage (vs. any private, PR=0.7), were less likely to see a mental health professional, whereas the disabled or unemployed (vs. employed, PR=1.6 and 1.5, respectively), and those unable to afford mental health care throughout the year (PR=1.3) were more likely. CONCLUSION: The high prevalence of SPD, anxiety, and depression in adults with arthritis suggests the need for increased mental health screening, with subsequent referral to mental health professionals or other treatment programs, in that population.

Defining Arthritis for Public Health Surveillance: Methods and Estimates in Four US Population Health Surveys.

OBJECTIVE: To determine the variability of arthritis prevalence in 4 US population health surveys. METHODS: We estimated annualized arthritis prevalence in 2011-2012, among adults age ≥20 years, using 2 definition methods, both based on self-report: 1) doctor-/health care provider-diagnosed arthritis in the Behavioral Risk Factor Surveillance Survey (BRFSS), National Health and Nutrition Examination Survey (NHANES), National Health Interview Survey (NHIS), and Medical Expenditure Panel Survey (MEPS); and 2) three arthritis definitions based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) criteria in MEPS (National Arthritis Data Workgroup on Arthritis and Other Rheumatic Conditions [NADW-AORC], Clinical Classifications Software [CCS], and Centers for Disease Control and Prevention [CDC]). RESULTS: Diagnosed arthritis prevalence percentages using the surveys were within 3 points of one another (BRFSS 26.2% [99% confidence interval (99% CI) 26.0-26.4], MEPS 26.1% [99% CI 25.0-27.2], NHIS 23.5% [99% CI 22.9-24.1], NHANES 23.0% [99% CI 19.2-26.8]), and those using ICD-9-CM were within 5 percentage points of one another (CCS 25.8% [99% CI 24.6-27.1]; CDC 28.3% [99% CI 27.0-29.6]; and NADW-AORC 30.7% [99% CI 29.4-32.1]). The variation in the estimated number (in millions) affected with diagnosed arthritis was 7.8 (BRFSS 58.5 [99% CI 58.1-59.1], MEPS 59.3 [99% CI 55.6-63.1], NHANES 51.5 [99% CI 37.2-65.5], and NHIS 52.6 [99% CI 50.9-54.4]), and using ICD-9-CM definitions it was 11.1 (CCS 58.7 [99% CI 54.5-62.9], CDC 64.3 [99% CI 59.9-68.6], and NADW 69.9 [99% CI 65.2-74.5]). Most (57-70%) reporting diagnosed arthritis also reported ICD-9-CM arthritis; respondents reporting diagnosed arthritis were older than those meeting ICD-9-CM definitions. Proxy response status affected arthritis prevalence differently across surveys. CONCLUSION: Public health practitioners and decision makers are frequently charged with choosing a single number to represent arthritis prevalence in the US population. We encourage them to consider the surveys' purpose, design, measurement methods, and statistical precision when choosing an estimate.

Alternative Methods for Defining Osteoarthritis and the Impact on Estimating Prevalence in a US Population-Based Survey.

OBJECTIVE: Provide a contemporary estimate of osteoarthritis (OA) by comparing the accuracy and prevalence of alternative definitions of OA. METHODS: The Medical Expenditure Panel Survey (MEPS) household component (HC) records respondent-reported medical conditions as open-ended responses; professional coders translate these responses into International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for the medical conditions files. Using these codes and other data from the MEPS-HC medical conditions files, we constructed 3 case definitions of OA and assessed them against medical provider diagnoses of ICD-9-CM 715 (osteoarthrosis and allied disorders) in a MEPS subsample. The 3 definitions were 1) strict = ICD-9-CM 715; 2) expanded = ICD-9-CM 715, 716 (other and unspecified arthropathies) OR 719 (other and unspecified disorders of joint); and 3) probable = strict OR expanded + respondent-reported prior diagnosis of OA or other arthritis excluding rheumatoid arthritis. RESULTS: Sensitivity and specificity of the 3 definitions, respectively, were 34.6% and 97.5% for strict, 73.8% and 90.5% for expanded, and 62.9% and 93.5% for probable. CONCLUSION: The strict definition for OA (ICD-9-CM 715) excludes many individuals with OA. The probable definition of OA has the optimal combination of sensitivity and specificity relative to the 2 other MEPS-based definitions and yields a national annual estimate of 30.8 million adults with OA (13.4% of US adult population) for 2008-2011.

Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort.

OBJECTIVE: There is a need to determine which response measures in lupus nephritis trials are most predictive of good long-term renal function. We used data from the Euro-Lupus Nephritis Trial to evaluate the performance of proteinuria, serum creatinine (Cr), and urinary red blood cells (RBCs) as predictors of good long-term renal outcome. METHODS: Patients from the Euro-Lupus Nephritis Trial with proteinuria, serum Cr, and urinary RBC measurements at 3, 6, or 12 months and with a minimum of 7 years of followup were included (n = 76). We assessed the ability of these clinical biomarkers at 3, 6, and 12 months after randomization to predict good long-term renal outcome (defined as a serum Cr value ≤1.0 mg/dl) at 7 years. Receiver operating characteristic curves were generated to assess parameter performance at these time points and to select the best cutoff for individual parameters. Sensitivity and specificity were calculated for the parameters alone and in combination. RESULTS: A proteinuria value of <0.8 gm/day at 12 months after randomization was the single best predictor of good long-term renal function (sensitivity 81% and specificity 78%). The addition of serum Cr to proteinuria as a composite predictor did not improve the performance of the outcome measure; addition of urinary RBCs as a predictor significantly decreased the sensitivity to 47%. CONCLUSION: This study demonstrates that the level of proteinuria at 12 months is the individual best predictor of long-term renal outcome in patients with lupus nephritis. Inclusion of urinary RBCs as part of a composite outcome measure actually undermined the predictive value of the trial data. We therefore suggest that urinary RBCs should not be included as a component of clinical trial response criteria in lupus nephritis.

Annual average ambient particulate matter exposure estimates, measured home particulate matter, and hair nicotine are associated with respiratory outcomes in adults with asthma.

BACKGROUND: While exposure to outdoor particulate matter (PM) has been associated with poor asthma outcomes, few studies have investigated the combined effects of outdoor and indoor PM (including secondhand tobacco smoke). OBJECTIVE: To examine the associations between PM and asthma outcomes. METHODS: We analyzed data from a cohort of adults with asthma and rhinitis (n=302; 82% both conditions; 13% asthma only; 5% rhinitis alone) including measures of home PM, tobacco smoke exposure (hair nicotine and self-report), ambient PM from regional monitoring, distance to roadway, and season (wet or dry). The outcomes of interest were frequent respiratory symptoms and forced expiratory volume in 1 second (FEV1) below the lower limit of normal (NHANES reference values). Multivariable regression analyses examined the associations (Odds Ratio [OR] and 95% Confidence Interval [95%CI]) between exposures and these outcomes, adjusted by sociodemographic characteristics. RESULTS: In adjusted analyses of each exposure, the highest tertile of home PM and season of interview were associated with increased odds for more frequent respiratory symptoms (OR=1.64 95%CI: [1.00, 2.69] and OR=1.66 95%CI: [1.09, 2.51]). The highest tertile of hair nicotine was significantly associated with FEV1 below the lower limit of normal (OR=1.80 95%CI: [1.00, 3.25]). In a model including home PM, ambient PM, hair nicotine, and season, only two associations remained strong: hair nicotine with FEV1 below the lower limit of normal and season of measurement (dry, April-October) with increased respiratory symptoms (OR=1.85 95%CI: [1.00, 3.41] and OR=1.54 95%CI: [1.0, 2.37]). When that model was stratified by sex, the highest tertiles of ambient PM and hair nicotine were associated with FEV1 below the lower limit of normal among women (OR=2.23 95%CI: [1.08, 4.61] and OR=2.90 95%CI: [1.32, 6.38]), but not men. The highest tertile of hair nicotine was also associated with increased respiratory symptoms in women but not men (OR=2.38 95%CI: [1.26, 4.49]). When stratified by age, the middle quartile of ambient PM and the highest hair nicotine tertile were associated with increased respiratory symptoms (OR=2.07 95%CI: [1.01, 4.24] and OR=2.55 95%CI: [1.21, 5.36]) in those under 55 but not in the older stratum. CONCLUSIONS: Exposure to PM from both home and ambient sources is associated with increased symptoms and lower lung function in adults with asthma, although these associations vary by type of PM, the respiratory outcome studied, sex and age.

Hospitalization and mortality in hemodialysis patients: association with hemoglobin variability.

BACKGROUND/AIMS: Hemodialysis patients show complications associated with low or high hemoglobin (Hb), which occur frequently in clinical practice. We sought to determine the clinical importance of these changes in Hb levels. METHODS: From our clinic cohorts, we identified 1,634 who met inclusion criteria for analysis of hospitalization frequency and 1,953 analysis of mortality; many patients were in both groups. Hb excursions outside the target range (11-12.5 g/dl) were studied in relation to patient outcomes. RESULTS: Hb measures below range were associated with more frequent hospitalization (p < 0.001), increased length of stay (p < 0.001), and increased mortality (p < 0.01), whereas Hb above range was associated with a reduced frequency of hospitalization (p < 0.01) and shorter length of stay (p < 0.01), and tended to be associated with reduced mortality. CONCLUSIONS: Excursions below range were associated with negative outcomes, but excursions above range were either beneficial or neutral. Our findings indicate that clinicians should focus on low Hb as a negative indicator of patient status, whereas transient Hb above range is a marker for patient health and well-being.

Higher environmental relative moldiness index values measured in homes of adults with asthma, rhinitis, or both conditions.

Higher values of the environmental relative moldiness index (ERMI), a DNA-based method for quantifying indoor molds, have been associated with asthma in children. In this study, settled dust samples were collected from the homes of adults with asthma, rhinitis, or both conditions (n=139 homes) in Northern California. The ERMI values for these samples were compared to those from dust collected in homes from the same geographic region randomly selected as part of the 2006 American Healthy Home Survey (n=44). The median ERMI value in homes of adult with airway disease (6) was significantly greater than median ERMI value (2) in the randomly selected homes (p<0.0001). In this study in Northern California, the homes of adults with asthma had ERMI values consistent with a heavier burden of indoor mold than that measured in other homes from the same region.

Both pulmonary and extra-pulmonary factors predict the development of disability in chronic obstructive pulmonary disease.

BACKGROUND: Although chronic obstructive pulmonary disease (COPD) is a major cause of disability worldwide, its determinants remain poorly defined. OBJECTIVE: We hypothesized that both pulmonary and extra-pulmonary factors would predict prospective disablement across a hierarchy of activities in persons with COPD. METHODS: Six hundred and nine participants were studied at baseline (T0) and 2.5 years later (T1). The Valued Life Activities (VLA) scale quantified disability (10-point scale: 0 = no difficulty and 10 = unable to perform), defining disability as any activity newly rated 'unable to perform' at T1. Predictors included pulmonary (lung function, 6-minute walk distance and COPD severity score) and extra-pulmonary (quadriceps strength and lower extremity function) factors. Prospective disability risk was tested by separate logistic regression models for each predictor (baseline value and its change, T0-T1; odds ratios were scaled at 1 standard deviation per factor. Incident disability across a hierarchy of obligatory, committed and discretionary VLA subscales was compared. RESULTS: Subjects manifested a 40% or greater increased odds of developing disability for each predictor (baseline and change over time). Disability in discretionary activities developed at a rate 2.2-times higher than observed in committed activities, which was in turn 2.5-times higher than the rate observed in obligatory activities (p < 0.05 for each level). CONCLUSIONS: Disability is common in COPD. Both pulmonary and extra-pulmonary factors are important in predicting its development.

Evaluating quality of life in patients with asthma and rhinitis: English adaptation of the rhinasthma questionnaire.

BACKGROUND: Separate health-related quality of life (HRQL) instruments exist for asthma and rhinitis. The Rhinasthma questionnaire, originally developed in Italian, is a unique measure designed for use where both conditions coexist. OBJECTIVE: We sought to assess the performance and validity of a new adaptation of the Rhinasthma questionnaire for use in English-speaking populations. METHODS: We analyzed cross-sectional data from an ongoing study of adults with asthma and rhinitis (n = 450), asthma alone (n = 75), or rhinitis alone (n = 20). Subjects were administered an English translation of the original 30-item Rhinasthma questionnaire. Health status measures simultaneously assessed include the Short Form (SF)-12, EuroQol (EQ)-5D, and Marks Asthma Quality-of-Life. RESULTS: Variable cluster analysis of the original 30-item instrument identified 5 discrete item clusters corresponding to the following domains: nasal (5 items), eye (4 items), respiratory (5 items), activity restriction (9 items), and treatment burden (5 items). Two other items were removed because of poor item-cluster correlations. Subjects with concomitant asthma and rhinitis had greater HRQL impairment, as measured by the Rhinasthma, than subjects with either asthma or rhinitis alone. The Rhinasthma correlated significantly (P < .05) with the SF-12, EQ-5D, and Marks Asthma Quality-of-Life in the anticipated direction consistent with the underlying constructs. In multiple logistic regression, poorer Rhinasthma HRQL was associated with significantly (P < .05) increased odds of both asthma- and rhinitis-related disability even after taking into account physical health status as measured by the SF-12. CONCLUSION: The 28-item English adaptation of Rhinasthma performs well in assessing HRQL in patients with asthma, rhinitis, or both conditions combined.

Identification of biomarkers that predict response to treatment of lupus nephritis with mycophenolate mofetil or pulse cyclophosphamide.

OBJECTIVE: There is a need to identify clinical characteristics and/or biomarkers that can predict treatment outcome in lupus nephritis. To this end, we utilized data from the Aspreva Lupus Management Study to identify possible baseline and early predictors of renal response to mycophenolate mofetil (MMF) or intravenous (IV) cyclophosphamide (CYC). METHODS: Patients with class III-V lupus nephritis were randomized to MMF or IV CYC. We assessed predictors of renal response, including baseline demographic, clinical, laboratory, and histologic characteristics, as well as early clinical and laboratory data, obtained within the first 2 months of therapy. Odds ratios (ORs) and 95% confidence intervals for renal response were calculated for each putative predictor. RESULTS: Normalization of C3, C4, or both by week 8 was strongly predictive of renal response at week 24 (ORs 2.5, 2.6, and 2.9, respectively; P < 0.05). Reduction in proteinuria by ≥25% by week 8 was predictive of renal response at week 24 (OR 3.2, P < 0.05). Reduction in anti-double-stranded DNA (anti-dsDNA) by week 8 was not predictive of renal response. Only 3 baseline characteristics (C4 level, time since diagnosis of lupus nephritis, and estimated glomerular filtration rate [GFR]) were predictive of renal response; the remaining characteristics (age, age at lupus nephritis onset, time since diagnosis of systemic lupus erythematosus, sex, histopathologic class, anti-dsDNA antibody level, C3 level, level of proteinuria, and use of angiotensin-converting enzyme inhibitors, statins, or hydroxychloroquine) were not. CONCLUSION: This study demonstrates that baseline C4 level, time since diagnosis of lupus nephritis, baseline estimated GFR, early normalization of complement, and reduction in proteinuria independently predict renal response to therapy at 6 months.

The role of physical inactivity in increasing disability among older adults with obstructive airway disease.

PURPOSE: : The independent contribution of physical inactivity to disability in obstructive lung disease (OLD) is difficult to study, partly because inactivity may reflect disease severity. We examined the relationship of physical inactivity to disability progression over a 1-year period among a group of older adults with OLD. METHODS: : A population-based cohort with self-reported physician-diagnosed emphysema, chronic obstructive pulmonary disease, or chronic bronchitis (n = 206) completed baseline interviews and in-person spirometry, with 1-year followup interviews. The Community Health Activities Model Program for Seniors physical activity questionnaire provided estimates of energy expenditure; we defined inactivity as no expenditure in moderate- or vigorous-intensity activities. Disability was measured with the Valued Life Activity (VLA) disability scale; increased disability was defined as a 10% or greater increase in VLA disability score over 1-year followup. Logistic regression tested the relationship between baseline inactivity and disability increase, controlling for age, sex, baseline VLA disability, comorbidities, smoking, and pulmonary function (forced expiratory volume in 1 second, % predicted). RESULTS: : Of 206 subjects, 48 (27%) were physically inactive at baseline; 42.9% of individuals whose disability increased were inactive at baseline compared with 23.4% of those who did not experience a disability increase. With adjustment for covariates, increased disability after 1 year was significantly (P = .04) more likely among individuals who were inactive at baseline (Odds Ratio =2.4; 95% confidence interval, 1.02-5.9). CONCLUSIONS: : Physically inactive individuals with OLD had more than double the odds of an increase in disability, even after controlling for baseline disability, lung function, and other covariates. These results provide strong support for the importance of maintaining physical activity among individuals with OLD.

Impact of knee osteoarthritis on health care resource utilization in a US population-based national sample.

OBJECTIVE: We sought to estimate the impact of knee osteoarthritis (OA) on health care utilization. RESEARCH DESIGN: Using the 2003 Medicare Current Beneficiary Survey, a population-based survey of Medicare beneficiaries linked to Medicare claims, we selected a national cohort of community-dwelling persons aged 65 and older with knee OA and a sex- and age-matched comparison cohort without any form of OA. We distinguished following 4 components of health care utilization: physician (MD) office visits, non-MD office visits, inpatient hospital stays, and emergency department visits. We built multiple regression models to determine whether knee OA affects utilization, controlling for comorbidity count, obesity, functional limitation, education, race, and working status. RESULTS: A total of 545 Medicare Current Beneficiary Survey participants with knee OA were matched with 1090 OA-free individuals. Mean age in both cohorts was 76 years; approximately 70% were female. Knee OA and OA-free subjects differed significantly in obesity (Knee OA: 37%, OA-free: 20%), % with >or=2 comorbidities (Knee OA: 69%, OA-free: 43%), and functional limitation (Knee OA: 42%, OA-free: 26%). In multivariable regression models, the knee OA cohort had on average 6.0 more annual MD visits (95% confidence interval [CI]: 4.7, 7.4) and 3.8 more non-MD visits (95% CI: 2.8, 4.7) than the OA-free cohort. The knee OA cohort also had 28% more hospital stays (odds ratio [OR] = 1.3, 95% CI: 1.0, 1.6), a difference attributable to total joint replacements. CONCLUSIONS: This first national, population-based study of health care utilization in persons with knee OA documents considerable excess utilization attributable to knee OA, independent of comorbidity, and other patient characteristics.