This paper describes the psychometric properties of the PROMIS Pain Interference (PROMIS-PI) bank. An initial candidate item pool (n=644) was developed and evaluated based on review of existing instruments, interviews with patients, and consultation with pain experts. From this pool, a candidate item bank of 56 items was selected and responses to the items were collected from large community and clinical samples. A total of 14,848 participants responded to all or a subset of candidate items. The responses were calibrated using an item response theory (IRT) model. A final 41-item bank was evaluated with respect to IRT assumptions, model fit, differential item function (DIF), precision, and construct and concurrent validity. Items of the revised bank had good fit to the IRT model (CFI and NNFI/TLI ranged from 0.974 to 0.997), and the data were strongly unidimensional (e.g., ratio of first and second eigenvalue = 35). Nine items exhibited statistically significant DIF. However, adjusting for DIF had little practical impact on score estimates and the items were retained without modifying scoring. Scores provided substantial information across levels of pain; for scores in the T-score range 50-80, the reliability was equivalent to 0.96 to 0.99. Patterns of correlations with other health outcomes supported the construct validity of the item bank. The scores discriminated among persons with different numbers of chronic conditions, disabling conditions, levels of self-reported health, and pain intensity (p< 0.0001). The results indicated that the PROMIS-PI items constitute a psychometrically sound bank. Computerized adaptive testing and short forms are available.

Objective To report contemporary estimates of the prevalence of hip-related osteoarthritis (OA) outcomes in African-Americans and Caucasians aged ≥ 45 years. Methods Weighted prevalence estimates and their corresponding 95% confidence intervals for hip symptoms, radiographic hip OA, symptomatic hip OA, and severe radiographic hip OA were calculated using SUDAAN® for age, race, and sex subgroups among 3,068 participants (33% African-Americans, 38% men) in the baseline examination (1991–1997) of The Johnston County Osteoarthritis Project, a population-based study of OA in North Carolina. Radiographic hip OA was defined as Kellgren-Lawrence radiographic grade ≥ 2, moderate/severe radiographic hip OA as grades 3 and 4, and symptomatic hip OA as hip symptoms in a hip with radiographic OA. Results Hip symptoms were present in 36%; 28% had radiographic hip OA; nearly 10% had symptomatic hip OA; and 2.5% had moderate/severe radiographic hip OA. Prevalence of all 4 outcomes was higher in older individuals; most outcomes were higher for women and African-Americans. Conclusion These hip-related outcomes were common in this population, and African-Americans did not have a lower prevalence as previous studies have suggested. Increasing public and health system awareness of the relatively high prevalence of these outcomes, which can be disabling, may help to decrease their impact and ultimately prevent them.

The health literacy demands of the healthcare system often exceed the health literacy skills of Americans. This article reviews the development of the Health Literacy Universal Precautions (HLUP) Toolkit, commissioned by the Agency for Healthcare Research and Quality and designed to help primary care practices structure the delivery of care as if every patient may have limited health literacy. The development of the toolkit spanned 2 years and consisted of 3 major tasks: (1) developing individual tools (modules explaining how to use or implement a strategy to minimize the effects of low health literacy), using existing health literacy resources when possible, (2) testing individual tools in clinical practice and assembling them into a prototype toolkit, and (3) testing the prototype toolkit in clinical practice. Testing revealed that practices will use tools that are concise and actionable and are not perceived as being resource intensive. Conducting practice self-assessments and generating enthusiasm among staff were key elements for successful implementation. Implementing practice changes required more time than anticipated and some knowledge of quality improvement techniques. In sum, the HLUP Toolkit holds promise as a means of improving primary care for people with limited health literacy, but further testing is needed. KeywordsHealth literacy; Quality improvement * Corresponding author: Dr. Darren A. DeWalt, Division of General Internal Medicine, University of North Carolina, 5041 Old Clinic Building, CB#7110, Chapel Hill, NC 27599, dewaltd@med.unc.edu (D.A. DeWalt). Competing InterestsThe author(s) declare that they have no competing interests. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptThe complexity of the healthcare system makes it difficult for many Americans to receive the best possible care. More than one-third of U.S. adults have limited health literacy-the ability to understand and use health information to make decisions. 1 People with limited health literacy are less likely to engage in disease prevention behaviors, to know about their illness and medicines, and to manage and control a chronic disease. 2 Limited health literacy is associated with multiple adverse outcomes including rates of hospitalization and mortality. 2-4 Furthermore, the skills of patients, even those who have adequate health literacy skills, can decline when under the stress of illness or facing a new diagnosis.On the demand side, medical care is complex. Routine healthcare activities such as receiving instructions at the doctor's office, taking medication, preparing for a screening test, and choosing a treatment option require sophisticated skills. Health information is often presented in such a way that proficiency in literacy and numeracy is needed to make informed health decisions. Developing systems of care that do not require advanced health literacy skills could improve the delivery of safe, timely, efficient, effective, equitable, and patient-centered care. 5Pract...

Rheumatoid arthritis (RA) is an autoimmune/inflammatory disorder with a complex genetic component. We report the first major genomewide screen of multiplex families with RA gathered in the United States. The North American Rheumatoid Arthritis Consortium, using well-defined clinical criteria, has collected 257 families containing 301 affected sibling pairs with RA. A genome screen for allele sharing was performed, using 379 microsatellite markers. A nonparametric analysis using SIBPAL confirmed linkage of the HLA locus to RA (P < .00005), with lambdaHLA = 1.79. However, the analysis also revealed a number of non-HLA loci on chromosomes 1 (D1S235), 4 (D4S1647), 12 (D12S373), 16 (D16S403), and 17 (D17S1301), with evidence for linkage at a significance level of P<.005. Analysis of X-linked markers using the MLOD method from ASPEX also suggests linkage to the telomeric marker DXS6807. Stratifying the families into white or seropositive subgroups revealed some additional markers that showed improvement in significance over the full data set. Several of the regions that showed evidence for nominal significance (P < .05) in our data set had previously been implicated in RA (D16S516 and D17S1301) or in other diseases of an autoimmune nature, including systemic lupus erythematosus (D1S235), inflammatory bowel disease (D4S1647, D5S1462, and D16S516), multiple sclerosis (D12S1052), and ankylosing spondylitis (D16S516). Therefore, genes in the HLA complex play a major role in RA susceptibility, but several other regions also contribute significantly to overall genetic risk.

Objective. To provide an indication of the economic, social, and psychological impact of musculoskeletal conditions in the United States.Methods. Review of the literature combined with estimates of data concerning health care utilization and acute and chronic disability due to musculoskeletal conditions, from the 199&1992 National Health Interview Survey.Results. The cost of musculoskeletal conditions was $149.4 billion in 1992, of which 48% was due to direct medical care costs and the remainder was due to indirect costs resulting from wage losses. This amount translates to -2.5% of the Gross National Product, a sharp rise since the prior studies, even if part of the increase is an artifact of improved accounting methods. Each year, persons with musculoskeletal conditions make 315 million physician visits, have more than 8

NCT02312713.

The measurement of pain behavior is a key component of the assessment of persons with chronic pain; however few self-reported pain behavior instruments have been developed. We developed a pain behavior item bank as part of the Patient Reported Outcome Measurement Information System (PROMIS). For the Wave I testing, because of the large number of PROMIS items, a complex sampling approach was used where participants were randomly assigned to either respond to two full item banks or to multiple 7-item blocks of items. A web-based survey was designed and completed by 15,528 members of the general population and 967 individuals with different types of chronic pain. Item response theory (IRT) analysis models were used to evaluate item characteristics and to scale both items and individuals on the pain behavior domain. The pain behavior item bank demonstrated good fit to a unidimensional model (Comparative Fit Index = 0.94). Several iterations of IRT analyses resulted in a final 39 item pain behavior bank, and different IRT models were fit to the total sample and to those participants who experienced some pain. The results indicated that these items demonstrated good coverage of the pain behavior construct. Pain behavior scores were strongly related to pain intensity and moderately related to self-reported general health status. Mean pain behavior scores varied significantly by groups based on pain severity and general health status. The PROMIS pain behavior item bank can be used to develop static short-form and dynamic measures of pain behavior for clinical studies.

Objective. A number of non-HLA loci that have shown evidence (P < 0.05) for linkage with rheumatoid arthritis (RA) have been previously identified. The present study attempts to confirm these findings.Methods. We performed a second genome-wide screen of 256 new multicase RA families recruited from across the United States by the North American Rheumatoid Arthritis Consortium. Affected sibling pair analysis on the new data set was performed using SIBPAL. We subsequently combined our first and second data sets in an attempt to enhance the evidence for linkages in a larger sample size. We also evaluated the impact of covariates on the support for linkage, using LODPAL.Results. Evidence of linkage at 1p13 (D1S1631), 6p21.3 (the HLA complex), and 18q21 (D18S858) (P < 0.05) was replicated in this independent data set. In addition, there was new evidence for linkage at 9p22 (D9S1121 [P ‫؍‬ 0.001]) and 10q21 (D10S1221 [P ‫؍‬ 0.0002] and D10S1225 [P ‫؍‬ 0.0038]) in the current data set. The combined analysis of both data sets (512 families) showed evidence for linkage at the level of P < 0.005 at 1p13 (D1S1631), 1q43 (D1S235), 6q21 (D6S2410), 10q21 (D10S1221), 12q12 (D12S398), 17p13 (D17S1298), and 18q21 (D18S858). Linkage at HLA was also confirmed (P < 5 ؋ 10 ؊12 ). Inclusion of DRB1‫40ء‬ as a covariate significantly increased the probability of linkage on chromosome 6. In addition, some linkages on chromosome 1 showed improved significance when modeling DRB1‫40ء‬ or rheumatoid factor positivity as covariates.