Use of the Pain Assessment Screening Tool and Outcomes Registry in an Army Interdisciplinary Pain Management Center, Lessons Learned and Future Implications of a 10-Month Beta Test.

INTRODUCTION: The U.S. Army Comprehensive Pain Management Campaign Plan was launched in 2010 to improve pain outcomes in military populations. Interdisciplinary Pain Management Centers (IPMCs) were established at every Army medical center, each offering a robust array of treatment options including conventional and complementary and integrative medicine (CIM) pain management therapies. The Pain Assessment Screening Tool and Outcomes Registry (PASTOR) was developed to assess and track biopsychosocial aspects of pain management and to identify best treatment practices. METHODS: During a 10-month pilot test of PASTOR at one Army IPMC, active duty patients completed PASTOR at baseline and at significant junctures during their therapeutic course. RESULTS: 322 IPMC patients completed baseline and follow-up PASTOR assessments. The PASTOR outcomes were analyzed for patients who completed a 3- to 6-week CIM program, a 3-week functional restoration program, or both. For most PASTOR domains, a greater proportion of patients who completed both programs reported important improvement compared with patients who completed either program alone. CONCLUSIONS: This pilot test demonstrated the utility of using PASTOR in a military IPMC to track biopsychosocial treatment outcomes. These preliminary data will inform future comparative effectiveness analyses of pain therapies among military and veteran populations.

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

BACKGROUND: The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population. METHODS: We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients. RESULTS: Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r ≥ 0.65) and depression (Beck Depression Index-II, r = 0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r = -0.73) and physical health (Short-Form 36 Physical-Component Summary, r = -0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r = 0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r = 0.79) than with scores on other legacy measures. CONCLUSION: The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidenced in correlations with legacy measures. PROMIS Anxiety and Depression target general mental health (e.g., stress, depression), and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis. Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes. TRIAL REGISTRATION: Clinicaltrials.gov NCT01258985. Registered 10 December 2010.

Report of the National Institutes of Health task force on research standards for chronic low back pain.

OBJECTIVES: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed nonspecific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. The purpose of this article is to disseminate the report of the National Institutes of Health (NIH) task force on research standards for cLBP. METHODS: The NIH Pain Consortium charged a research task force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel developed a 3-stage process, each with a 2-day meeting. RESULTS: The panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research subjects (drawing heavily on the Patient Reported Outcomes Measurement Information System methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved these recommendations, which investigators should incorporate into NIH grant proposals. CONCLUSIONS: The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of cLBP. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. We expect the RTF recommendations will become a dynamic document and undergo continual improvement.

Having a fit: impact of number of items and distribution of data on traditional criteria for assessing IRT's unidimensionality assumption.

PURPOSE: Confirmatory factor analysis fit criteria typically are used to evaluate the unidimensionality of item banks. This study explored the degree to which the values of these statistics are affected by two characteristics of item banks developed to measure health outcomes: large numbers of items and nonnormal data. METHODS: Analyses were conducted on simulated and observed data. Observed data were responses to the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Impact Item Bank. Simulated data fit the graded response model and conformed to a normal distribution or mirrored the distribution of the observed data. Confirmatory factor analyses (CFA), parallel analysis, and bifactor analysis were conducted. RESULTS: CFA fit values were found to be sensitive to data distribution and number of items. In some instances impact of distribution and item number was quite large. CONCLUSIONS: We concluded that using traditional cutoffs and standards for CFA fit statistics is not recommended for establishing unidimensionality of item banks. An investigative approach is favored over reliance on published criteria. We found bifactor analysis to be appealing in this regard because it allows evaluation of the relative impact of secondary dimensions. In addition to these methodological conclusions, we judged the items of the PROMIS Pain Impact bank to be sufficiently unidimensional for item response theory (IRT) modeling.