John R. Ward, MD: Pioneer-Clinical Trials in Rheumatology.

John Robert Ward was one of the early academic rheumatologists in the United States. He was the founding father of rheumatology in the Intermountain West, the first Chief of the Division of Rheumatology in the Department of Internal Medicine at the University of Utah. Dr Ward became a national leader in the understanding and treatment of rheumatic disease. His foundational work established gold-standard techniques for the successful investigation of anti-rheumatic drugs. His leadership and scientific contributions clearly qualify him as a "giant in rheumatology."

Effect of Pulsed Low-Intensity Ultrasonography on Symptom Relief and Tibiofemoral Articular Cartilage Thickness Among Veterans Affairs Enrollees With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Osteoarthritis (OA) is a major cause of disability in the US, with no approved treatments to slow progression, but animal models suggest that pulsed low-intensity ultrasonography (PLIUS) may promote cartilage growth. Objective: To evaluate the efficacy of PLIUS in providing symptom reduction and decreased loss of tibiofemoral cartilage thickness in patients with knee OA. Design, Setting, and Participants: A phase 2A, sham-controlled, parallel, double-blind randomized clinical trial was conducted at 2 Veterans Affairs hospitals in Salt Lake City, Utah, and San Diego, California, from May 22, 2015, to January 31, 2019. Data were analyzed from June 27, 2020, to October 20, 2020. Participants recruited through the US Department of Veterans Affairs (N = 132) with clinical and radiographic evidence of early knee OA were randomly assigned to receive PLIUS or a sham device, self-administered for 20 minutes daily over the medial compartment of the knee. All enrollees participated in a 4-week prerandomization sham run-in period, followed by a 48-week treatment period. Randomization was stratified by study site and Kellgren-Lawrence grades 1 (n = 15), 2 (n = 51), and 3 (n = 66). Intervention: Participants either received 48 weeks of PLIUS or sham ultrasonography. Main Outcomes and Measures: The trial incorporated 2 coprimary outcomes: symptomatic improvement assessed by Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International Responder Criteria (ie, met if either >50% improvement in pain and function with at least a 20% absolute improvement of at least 2 of the following 3 factors: improvement by at least 20% [pain, function, and patient global assessment] with at least a 10-mm absolute improvement), and cartilage preservation assessed as change in central medial femoral condyle cartilage thickness by magnetic resonance imaging. Intention-to-treat analysis was used. Results: The mean (SD) participant age was 63.6 (10.7) years and 119 were men (90.2%). The mean (SD) duration of OA symptoms was 13.4 (12.3) years. In the PLIUS group, 70.4% (95% CI, 58.2%-82.6%) of the participants experienced symptomatic improvement, compared with 67.3% (95% CI, 54.9%-79.7%) of participants in the sham group (P = .84); there was no statistically significant difference in response rates between the treatment groups, and the between-group rate difference of 3.1% (95% CI, -14.3% to 20.5%) did not meet the predefined 10% threshold for clinically significant symptomatic improvement from application of PLIUS. At 48 weeks of treatment, central medial femoral condyle cartilage thickness decreased by a mean (SD) of 73.8 (168.1) µm in the PLIUS group and by 42.2 (297.0) µm in the sham group. This 48-week mean change between the 2 groups did not reach statistical significance (P = .44), and the between-group 48-week difference of -31.7 µm (95% CI, -129.0 µm to 65.7 µm) did not meet the predefined threshold. There were 99 nonserious adverse events in the PLIUS group and 89 in the sham group during the trial. No serious adverse events were deemed related to the study device. Conclusions and Relevance: PLIUS, as implemented in this study, demonstrated neither symptomatic benefit nor a decrease in loss of tibiofemoral cartilage thickness in knee OA. Trial Registration: ClinicalTrials.gov Identifier: NCT02034409.

Tumor necrosis factor inhibitor (TNFi) persistence and reasons for discontinuation in a predominantly male cohort with axial spondyloarthritis.

Although tumor necrosis factor inhibitors (TNFi) have favorably altered the treatment landscape for patients with axial spondyloarthritis (axSpA), there is limited data regarding TNFi persistence and reasons for discontinuation. This is an observational time-to-event study utilizing data collected for a prospective multiple-disease registry of US Veterans with axSpA treated with TNFi therapies and recruited over a 10 year period. Clinical, serological, and comorbid parameters were collected. Corporate Data Warehouse Pharmacy files provided courses of the 5 TNFi agents, and response to treatment was documented. Individual TNFi persistence was established utilizing univariate and multivariate Cox proportional models, and reasons for discontinuation were obtained by physician chart review. Two-hundred and fifty-five axSpA patients received 731 TNFi courses. A majority of patients (84.3%) had TNFi persistence at 12 months; 63.5% and 47.1% at 24 and 36 months, respectively. Compared to adalimumab, infliximab demonstrated greater persistence, certolizumab the least. Age, smoking status, BMI, comorbidity burden, inflammatory markers and HLA-B27 did not predict TNFi persistence or discontinuation. Stroke and peripheral arterial disease increased the probability of TNFi discontinuation. Secondary non-response (SNR) was the most common reason for discontinuation (46% of all courses); non-adherence (6%) and clinical remission (2%) were uncommon. Pain score at enrollment, myocardial infarction, African American race and inflammatory bowel disease (IBD) predicted TNFi response. While initial persistence of TNFi treatment was high, a large proportion of the patients discontinued initial TNFi therapy by 3 years, primarily due to loss of efficacy. While further research identifying potential predictors of TNFi discontinuation in axSpA is warranted, access to alternate disease-modifying therapies is needed.

Identifying Patients With Axial Spondyloarthritis in Large Datasets: Expanding Possibilities for Observational Research.

OBJECTIVE: Observational research of axial spondyloarthritis (axSpA) is limited by a lack of methods for identifying diverse axSpA phenotypes in large datasets. Algorithms were previously designed to identify a broad spectrum of patients with axSpA, including patients not identifiable with diagnosis codes. The study objective was to estimate the performance of axSpA identification methods in the general Veterans Affairs (VA) population. METHODS: A patient sample with known axSpA status (n = 300) was established with chart review. For feasibility, this sample was enriched with veterans with axSpA risk factors. Algorithm performance outcomes included sensitivities, positive predictive values (PPV), and F1 scores (an overall performance metric combining sensitivity and PPV). Performance was estimated with unweighted outcomes for the axSpA-enriched sample and inverse probability weighted (IPW) outcomes for the general VA population. These outcomes were also assessed for traditional identification methods using diagnosis codes for the ankylosing spondylitis (AS) subtype of axSpA. RESULTS: The mean age was 54.7 and 92% were male. Unweighted F1 scores (0.59-0.74) were higher than IPW F1 scores (0.48-0.65). The full algorithm had the best overall performance (F1IPW 0.65). The Early Algorithm was the most inclusive (sensitivityIPW 0.90, PPVIPW 0.38). The traditional method using ≥ 2 AS diagnosis codes from rheumatology had the highest PPV (PPVIPW 0.84, sensitivityIPW 0.34). CONCLUSION: The axSpA identification methods demonstrated a range of performance attributes in the general VA population that may be appropriate for various types of studies. The novel identification algorithms may expand the scope of research by enabling identification of more diverse axSpA populations.

Identification of Axial Spondyloarthritis Patients in a Large Dataset: The Development and Validation of Novel Methods.

OBJECTIVE: Observational axial spondyloarthritis (axSpA) research in large datasets has been limited by a lack of adequate methods for identifying patients with axSpA, because there are no billing codes in the United States for most subtypes of axSpA. The objective of this study was to develop methods to accurately identify patients with axSpA in a large dataset. METHODS: The study population included 600 chart-reviewed veterans, with and without axSpA, in the Veterans Health Administration between January 1, 2005, and June 30, 2015. AxSpA identification algorithms were developed with variables anticipated by clinical experts to be predictive of an axSpA diagnosis [demographics, billing codes, healthcare use, medications, laboratory results, and natural language processing (NLP) for key SpA features]. Random Forest and 5-fold cross validation were used for algorithm development and testing in the training subset (n = 451). The algorithms were additionally tested in an independent testing subset (n = 149). RESULTS: Three algorithms were developed: Full algorithm, High Feasibility algorithm, and Spond NLP algorithm. In the testing subset, the areas under the curve with the receiver-operating characteristic analysis were 0.96, 0.94, and 0.86, for the Full algorithm, High Feasibility algorithm, and Spond NLP algorithm, respectively. Algorithm sensitivities ranged from 85.0% to 95.0%, specificities from 78.0% to 93.6%, and accuracies from 82.6% to 91.3%. CONCLUSION: Novel axSpA identification algorithms performed well in classifying patients with axSpA. These algorithms offer a range of performance and feasibility attributes that may be appropriate for a broad array of axSpA studies. Additional research is required to validate the algorithms in other cohorts.

Treatment Patterns with Disease-Modifying Antirheumatic Drugs in U.S. Veterans with Newly Diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis.

BACKGROUND: Delays in treatment for inflammatory arthritis (IA) are associated with unfavorable outcomes, including impaired quality of life, irreversible joint damage, and disability. OBJECTIVE: To characterize treatment initiation patterns in veterans with newly diagnosed rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS). METHODS: ICD-9/10-CM codes and natural language processing were used to identify incident cases of RA, PsA, or AS between January 1, 2007, and December 31, 2015, in patients enrolled in the Veterans Health Administration. Patterns of treatment initiation and nontreatment with disease-modifying antirheumatic drugs (DMARDs) were assessed in the 12-month follow-up period after the incident diagnosis. Outcomes included the percentage of veterans treated with a DMARD, the mean time to the initial DMARD after diagnosis, and the percentage of veterans who accessed rheumatology care before DMARD initiation. To assess outcomes over time, veterans were grouped by year of initial IA diagnosis. Additionally, outcomes were compared between nonbiologic and biologic DMARDs and among IA subtypes (RA, PsA, and AS). Groups were statistically compared with 95% confidence intervals. RESULTS: The population consisted of 12,118 IA veterans (9,711 RA, 1,472 PsA, and 935 AS), with 91.3% males and a mean age of 63.7 years. The percentage of veterans treated with ≥ 1 DMARD (nonbiologic or biologic) during the 12-month follow-up period increased from 48.8% in 2007 to 66.4% in 2015. In veterans diagnosed with IA in 2015, DMARD treatment was more common for PsA patients (72.9%) and RA patients (68.6%) than for AS patients (28.9%). In the subset treated with a DMARD within 12 months after diagnosis, the mean time to the initial DMARD after diagnosis did not change throughout the observation period (35.5 days for RA, 43.9 days for PsA, and 59.5 days for AS). Rheumatology specialty care was accessed by 87.4% of veterans treated with a nonbiologic DMARD and 92.2% of veterans treated with a biologic DMARD, in patients diagnosed in 2015. CONCLUSIONS: DMARD treatment rates during the initial 12 months after diagnosis increased between 2007 and 2015, but nontreatment remained common, particularly in veterans with AS. The time to treatment after diagnosis was stable over time; it was shortest for RA, intermediate for PsA, and longest for AS. DMARD treatment was uncommon in veterans who did not access rheumatology specialty care. DISCLOSURES: AbbVie Pharmaceuticals and Marriott Daughters Foundation funded this study via investigator-initiated grants. Data analyses were completed by investigators independent of AbbVie and Marriott Daughters Foundation. Walker, Clewell, and Douglas are employed by, and stockholders in, Abbvie. Halwani reports grants from BMS, Kyowa Hakko Kirin, Seattle Genetics, Roche-Genentech, Miragen, Immunedesign, Takeda, Amgen, Pharmacyclics, and Abbvie. The other authors have nothing to disclose.

The Physician Global Assessment and Body Surface Area composite tool is a simple alternative to the Psoriasis Area and Severity Index for assessment of psoriasis: post hoc analysis from PRISTINE and PRESTA.

BACKGROUND: The product of Physician Global Assessment and Body Surface Area (PGA × BSA) is a new outcome measure for psoriasis severity and response to therapy. The objective of this study was to evaluate PGA × BSA as an alternative to Psoriasis Area and Severity Index (PASI) for psoriasis assessments. METHODS: The relationship between PASI and PGA × BSA was assessed in a post hoc analysis of pooled data from the PRISTINE (NCT00663052) and PRESTA (NCT00245960) trials in patients with moderate-to-severe psoriasis who received etanercept 50 mg/week. Data were analyzed using Spearman and intra-class correlation coefficients, effect sizes, scatterplots, Bland-Altman plots, and Kappa statistics. RESULTS: Spearman correlations at baseline, week 12, and week 24 were strong for PGA × BSA versus PASI (r=0.78, 0.87, and 0.90, respectively; all P<0.0001) as were intra-class correlations (0.76 [95% confidence interval 0.73-0.80], 0.80 [0.76-0.83], and 0.85 [0.82-0.87], respectively). The effect size was -1.53 for PASI and -0.94 for PGA × BSA (baseline to week 24). Scatterplots and Bland-Altman plots detected a trend across the range of measurement. Kappa statistics (at 12 and 24 weeks) between PASI50/75/90 and 50/75/90% improvement in PGA × BSA showed good agreement (0.58-0.69 at week 12 and 0.63-0.67, respectively; all P<0.0001). At baseline, the Spearman correlation coefficients were 0.96, 0.51, 0.19, and 0.17 for PGA × BSA versus BSA, PGA, Patient Global Assessment, and Dermatology Life Quality Index, respectively (all P<0.001). CONCLUSION: PGA × BSA has advantages over PASI for measuring moderate-to-severe psoriasis; it is intuitive, sensitive, and easy to use.

Cohort identification of axial spondyloarthritis in a large healthcare dataset: current and future methods.

BACKGROUND: Big data research is important for studying uncommon diseases in real-world settings. Most big data studies in axial spondyloarthritis (axSpA) have been limited to populations identified with billing codes for ankylosing spondylitis (AS). axSpA is a more inclusive concept, and reliance on AS codes does not produce a comprehensive axSpA study population. The first objective was to describe our process for establishing an appropriate sample of patients with and without axSpA for developing accurate axSpA identification methods. The second objective was to determine the classification performance of AS billing codes against the chart-reviewed axSpA reference standard. METHODS: Veteran Health Affairs clinical and administrative data, between January 2005 and June 2015, were used to randomly select patients with clinical phenotypes that represented high, moderate, and low likelihoods of an axSpA diagnosis. With chart review, the sampled patients were classified as Yes axSpA, No axSpA or Uncertain axSpA, and these classification assignments were used as the reference standard for determining the positive predictive value (PPV) and sensitivity of AS ICD-9 codes for axSpA. RESULTS: Six hundred patients were classified as Yes axSpA (26.8%), No axSpA (68.3%), or Uncertain axSpA (4.8%). The PPV and sensitivity of an AS ICD-9 code for axSpA were 83.3% and 57.3%, respectively. CONCLUSIONS: Standard methods of identifying axSpA patients in a large dataset lacked sensitivity. An appropriate sample of patients with and without axSpA was established and characterized for developing novel axSpA identification methods that are anticipated to enable previously impractical big data research.

An initiative using informatics to facilitate clinical research planning and recruitment in the VA health care system.

BACKGROUND: Randomized clinical trials are the gold standard for evaluating healthcare interventions and, more generally, add to the medical knowledge related to the treatment, diagnosis and prevention of diseases and conditions. Recent literature continues to identify health informatics methods that can help improve study efficiency throughout the life cycle of a clinical trial. Electronic medical record (EMR) data provides a mechanism to facilitate clinical trial research during the study planning and execution phases, and ultimately, can be utilized to enhance recruitment. The Department of Veterans Affairs (VA) has a strong history of clinical and epidemiological research with over four decades of data collected from Veterans it has served nationwide. The VA Informatics and Computing Infrastructure (VINCI) provides VA research investigators with a nationwide view of high-value VA patient data. Within VA, the Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine sites that are part of an embedded clinical research infrastructure intended to provide systematic site-level solutions to issues that arise during the conduct of VA CSP clinical research. This paper describes the collaboration initiated by the Salt Lake City (SLC) node site to bring informatics and clinical trials together to enhance study planning and recruitment within the VA. METHODS: The SLC VA Medical Center physically houses both VINCI and a node site and the co-location of these two groups prompted a natural collaboration on both a local and national level. One of the functions of the SLC NODES is to enhance recruitment and promote the success of CSP projects. VINCI supports these efforts by providing VA researchers access to potential population pools. VINCI can provide 1) feasibility data during study planning, and 2) active patient lists during recruitment. The process for CSP study teams to utilize these services involves regulatory documentation, development of queries, revisions to the initial data request, and ongoing communications with several key study personnel including the requesting research team, study statisticians, and VINCI data managers. RESULTS: The early efforts of SLC NODES and VINCI aimed to provide patient lists exclusively to the SLC CSP study teams for the following purposes: 1) increasing recruitment for trials that were struggling to meet their respective enrollment goals, and 2) decreasing the time required by study coordinators to complete chart review activities. This effort was expanded to include multiple CSP sites and studies. To date, SLC NODES has facilitated the delivery of these VINCI services to nine active CSP studies. CONCLUSION: The ability of clinical trial study teams to successfully plan and execute their respective trials is contingent upon their proficiency in obtaining data that will help them efficiently and effectively recruit and enroll eligible participants. This collaboration demonstrates that the utilization of a model that partners two distinct entities, with similar objectives, was effective in the provision of feasibility and patient lists to clinical trial study teams and facilitation of clinical trial research within a large, integrated healthcare system.

Use of Disease-modifying Antirheumatic Drugs for Inflammatory Arthritis in US Veterans: Effect of Specialty Care and Geographic Distance.

OBJECTIVE: To evaluate the effect of access to and distance from rheumatology care on the use of disease-modifying antirheumatic drugs (DMARD) in US veterans with inflammatory arthritis (IA). METHODS: Provider encounters and DMARD dispensations for IA (rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis) were evaluated in national Veterans Affairs (VA) datasets between January 1, 2015, and December 31, 2015. RESULTS: Among 12,589 veterans with IA, 23.5% saw a rheumatology provider. In the general IA population, 25.3% and 13.6% of veterans were exposed to a synthetic DMARD (sDMARD) and biologic DMARD (bDMARD), respectively. DMARD exposure was 2.6- to 3.4-fold higher in the subpopulation using rheumatology providers, compared to the general IA population. The distance between veterans' homes and the closest VA rheumatology site was < 40 miles (Near) for 55.9%, 40-99 miles (Intermediate) for 31.7%, and ≥ 100 miles (Far) for 12.4%. Veterans in the Intermediate and Far groups were less likely to see a rheumatology provider than veterans in the Near group (RR = 0.72 and RR = 0.49, respectively). Exposure to bDMARD was 34% less frequent in the Far group than the Near group. In the subpopulation who used rheumatology care, the bDMARD exposure discrepancy did not persist between distance groups. CONCLUSION: Use of rheumatology care and DMARD was low for veterans with IA. DMARD exposure was strongly associated with rheumatology care use. Veterans in the general IA population living far from rheumatology sites accessed rheumatology care and bDMARD less frequently than veterans living close to rheumatology sites.

Identifying Axial Spondyloarthritis in Electronic Medical Records of US Veterans.

OBJECTIVE: Large database research in axial spondyloarthritis (SpA) is limited by a lack of methods for identifying most types of axial SpA. Our objective was to develop methods for identifying axial SpA concepts in the free text of documents from electronic medical records. METHODS: Veterans with documents in the national Veterans Health Administration Corporate Data Warehouse between January 1, 2005 and June 30, 2015 were included. Methods were developed for exploring, selecting, and extracting meaningful terms that were likely to represent axial SpA concepts. With annotation, clinical experts reviewed sections of text containing the meaningful terms (snippets) and classified the snippets according to whether or not they represented the intended axial SpA concept. With natural language processing (NLP) tools, computers were trained to replicate the clinical experts' snippet classifications. RESULTS: Three axial SpA concepts were selected by clinical experts, including sacroiliitis, terms including the prefix spond*, and HLA-B27 positivity (HLA-B27+). With supervised machine learning on annotated snippets, NLP models were developed with accuracies of 91.1% for sacroiliitis, 93.5% for spond*, and 97.2% for HLA-B27+. With independent validation, the accuracies were 92.0% for sacroiliitis, 91.0% for spond*, and 99.0% for HLA-B27+. CONCLUSION: We developed feasible and accurate methods for identifying axial SpA concepts in the free text of clinical notes. Additional research is required to determine combinations of concepts that will accurately identify axial SpA phenotypes. These novel methods will facilitate previously impractical observational research in axial SpA and may be applied to research with other diseases.

Mortality in American Veterans with the HLA-B27 gene.

OBJECTIVE: To compare survival in American veterans with and without the HLA-B27 (B27) gene. METHODS: Mortality was evaluated in a national cohort of veterans with clinically available B27 test results between October 1, 1999, and December 31, 2011. The primary outcome was the mortality difference between B27-positive and B27-negative veterans, adjusted for age, sex, race, and diagnoses codes for diseases that may have influenced both B27 testing and mortality, including psoriasis, inflammatory bowel disease, spondyloarthritis (SpA), and other types of inflammatory arthritis. The secondary outcomes were the adjusted mortality HR for B27+ and B27- veterans, in subgroups with and without SpA. RESULTS: Among veterans with available B27 test results, 27,652 (84.7%) were B27- and 4978 (15.3%) were B27+. The mean followup time was 4.6 years. Mortality was higher in the B27+ group than in the B27- group (HR 1.15, 95% CI 1.03-1.27). Mortality was also higher in the B27+ subgroups with SpA (HR 1.35, 95% CI 1.06-1.72) and without SpA (HR 1.11, 95% CI 0.99-1.24), but the difference was significant only in the subgroup with SpA. CONCLUSION: B27 positivity was associated with an increased mortality rate in a cohort of veterans clinically selected for B27 testing, after adjustment for SpA. In the subgroup with SpA, the mortality rate was associated with B27 positivity, and in the subgroup without SpA, there was a nonsignificant association between B27+ and mortality.

Rapidly Fatal Internal Carotid Artery Mycotic Aneurysm Rupture in a Rheumatoid Patient Taking a TNF-α Inhibitor: Case Report and Literature Review.

OBJECT: Tumor necrosis factor (TNF)-α inhibitors are effective at treating certain inflammatory and autoimmune disorders. They are generally safe; potential adverse events include infections (bacterial, fungal, and viral), congestive heart failure exacerbations, and the potential for demyelinating diseases and possibly certain malignancies. We present the first documented case of fungal internal carotid artery (ICA) mycotic aneurysm in a patient being treated with a TNF-α inhibitor. We also review the literature on infections with TNF-α inhibition and the management of previously reported fungal ICA mycotic aneurysm cases. CASE DESCRIPTION: A 76-year-old woman with rheumatoid arthritis, treated with etanercept and methotrexate, presented with a 2-week history of left temporal headaches. She was treated empirically for giant cell arteritis (GCA) with oral prednisone, which provided no symptom relief. She was subsequently hospitalized for a superficial temporal artery biopsy, which was negative for GCA. She returned 2 weeks later after experiencing a left thromboembolic ischemic stroke. She had an acute neurologic decline, and a head computed tomography scan showed diffuse subarachnoid hemorrhage from a ruptured left fusiform paraclinoid ICA aneurysm. She was taken emergently for a craniotomy for clip-wrapping of the aneurysm, but intraoperative ultrasound revealed poor flow in the left anterior cerebral circulation and a complete infarct of the left-sided anterior circulation. The family withdrew care and the patient died. Postmortem analysis demonstrated fungi consistent with Aspergillus invading the necrotic left ICA. CONCLUSIONS: Although fungal mycotic aneurysms of the ICA are rare, their incidence may increase with the expanded use of immunosuppressive medications. Patients with rheumatoid arthritis who take potent immunosuppression regimens may be prime candidates for mycotic aneurysms because they often have two favoring conditions: atherosclerosis and immunosuppression. These ICA aneurysms carry a high mortality rate, so early diagnosis and aggressive therapy, potentially by endovascular trapping/vessel occlusion coupled with long-term antifungal therapy, is essential.

Work productivity loss and fatigue in psoriatic arthritis.

OBJECTIVE: To explore the relationship between fatigue and work productivity loss (WPL) in people with psoriatic arthritis (PsA). METHODS: Data were collected from participants in the Utah Psoriasis Initiative Arthritis registry between January 2010 and May 2013. WPL was measured with the 8-item Work Limitations Questionnaire. Fatigue was assessed with question 1 from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI#1), "How would you describe the overall level of fatigue/tiredness you have experienced?" and with question 1 from the Psoriatic Arthritis Quality of Life Questionnaire (PsAQOL#1) "I feel tired whatever I do." Psoriatic activity was evaluated with tender joint count (TJC), swollen joint count (SJC), dactylitis count, enthesitis count, inflammatory back pain (IBP), physician global assessment, body surface area, and psoriasis pain and itch. RESULTS: Among 107 participants, work productivity was reduced by 6.7%, compared to benchmark employees without limitations. Fatigue was reported by 54 patients (50.5%) on PsAQOL#1, and 64 (60.0%) were classified as high fatigue by BASDAI#1. TJC, SJC, enthesitis count, IBP, and depressed mood were highest or most frequent in participants reporting fatigue. After adjustments for psoriatic activity and depressed mood, WPL was associated with fatigue, as measured by PsAQOL#1 (p = 0.01) and BASDAI#1 (p = 0.002). CONCLUSION: WPL was associated with fatigue, and the association was not entirely explained by the evaluated musculoskeletal, cutaneous, or psychiatric manifestations of PsA.

New population-based reference values for spinal mobility measures based on the 2009-2010 National Health and Nutrition Examination Survey.

OBJECTIVE: To report population-based percentile reference values for selected spinal mobility measures in a nationally representative sample of 5,001 US adults ages 20-69 years who were examined in the 2009-2010 US National Health and Nutrition Examination Survey (NHANES). METHODS: Occiput-to-wall distance (OWD), thoracic expansion (TE), and anterior lumbar flexion (ALF; by modified Schober test) were measured by trained examiners in a standardized manner. TE was measured at the xiphisternal level, while the lower reference point for ALF was a line marked at the level of the superior margin of the lateral iliac crests. We report reference values based on the 95th percentile for the OWD and the 5th percentile for TE and ALF, as well as other summary statistics for these measures, in the study population. RESULTS: An OWD of >0 was present in 3.8% of the participants, while 8.8% of them had out-of-range values for TE based on the commonly used threshold of 2.5 cm. The 95th percentile of the OWD measurement was 0, while the 5th percentile for TE and ALF were 1.9 cm and 2 cm, respectively. The spinal measures were significantly associated with sex, age, ethnicity, height, and body mass index (BMI). Exclusion of individuals with severe obesity (BMI >35 kg/m(2) ) changed the proposed reference values for TE and ALF to 2.2 cm and 1.9 cm, respectively. CONCLUSION: We verified a reference value of 0 for the OWD in the general population. Using the reported population-based percentile values, new reference values for TE and ALF can be derived.

Product of the Physician Global Assessment and body surface area: a simple static measure of psoriasis severity in a longitudinal cohort.

BACKGROUND: The Psoriasis Area and Severity Index (PASI) is considered the gold standard assessment tool for psoriasis severity, but PASI is limited by its complexity and insensitivity in people with mild psoriasis. OBJECTIVE: We sought to evaluate the product of a Physician Global Assessment (PGA) and Body Surface Area (BSA) (PGAxBSA) as an alternative to PASI. METHODS: Psoriasis severity was evaluated at 6-month intervals in participants of the Utah Psoriasis Initiative registry. Correlation coefficients were used to compare PGAxBSA with PASI and the Simplified PASI (SPASI). RESULTS: Between August 2008 and November 2010, 435 assessments were completed in 226 participants. The median PASI score was 3.2 (interquartile range 1.8-5.4) and the median BSA was 3.0% (interquartile range 1.0%-5.0%). PGAxBSA had higher correlations with PASI than SPASI (0.87 vs 0.76, P < .001). PGAxBSA also had higher correlations with a Global Patient Assessment of psoriasis severity (0.65) than both PASI (0.59, P < .001) and SPASI (0.51, P < .001). LIMITATIONS: The use of PGAxBSA for measuring severe psoriasis and response to therapy is unclear, because most participants had mild to moderate psoriasis and data were not collected at predefined intervals in relation to therapy initiation. Interrater reliability was not assessed. CONCLUSIONS: PGAxBSA is a simple and sensitive instrument for measuring psoriasis severity.

Ankylosing spondylitis clinical registries: principles, practices and possibilities.

The need for a rigorously developed longitudinal registry of patients with spondyloarthritis (SpA) is clear and urgent. Like randomized controlled trials, registries rely on a prospective, systematic protocol-driven approach to data acquisition to assess outcomes for a prescribed cohort of patients. Registries seek to capture large numbers of patients across large geographic zones and can serve as a valuable resource for patient advocacy, patient education and support, incidence and prevalence, and broad demographic profiles. Building on 3 existing registries--the Prospective Study of Outcomes in Ankylosing Spondylitis, the Program to Understand the Longterm Outcomes of Spondyloarthritis (PULSAR) and the University Health Network Spondyloarthritis Program--these registries and the Spondylitis Association of America propose to form a combined registry of North American SpA patients. The combined registry would, ideally, complement ongoing clinical goals and improve patient care.

Comparing nebulized water versus saline after laryngeal desiccation challenge in Sjögren's Syndrome.

OBJECTIVES/HYPOTHESIS: This study examined the effects of a laryngeal desiccation challenge and two nebulized hydration treatments on phonation threshold pressure (PTP), vocal effort, and throat dryness in patients with chronic airway dryness. STUDY DESIGN: Double-blind, within-subjects crossover design. METHODS: Eleven individuals with Primary Sjögren's Syndrome received a 15-minute laryngeal desiccation challenge (breathing dry air-<1% relative humidity-transorally), followed by nebulized isotonic saline or nebulized water treatments (3 mL) on 2 consecutive weeks. PTP, as well as self-perceived vocal effort, mouth, and throat dryness were assessed before and after the desiccation challenge, and at 5, 35, and 65 minutes after the nebulized treatment. RESULTS: The laryngeal desiccation challenge produced statistically significant increases in PTP, vocal effort, and mouth and throat dryness (P < 0.05). Nebulized saline produced greater-but not statistically significant-treatment effects than water. PTP was more correlated with throat dryness than vocal effort. CONCLUSION: Patients with chronic airway dryness experienced phonatory changes following dry air exposure. Nebulized isotonic saline may offset this effect. Future research should explore dose-response relationships among dry air exposure, nebulized treatments, voice change, and self-perceived throat dryness.