Wen Hung Chen

Development of a PROMIS item bank to measure pain interference

&NA; 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 the 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 0.96–0.99. 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.

Development and Psychometric Analysis of the PROMIS Pain Behavior Item Bank

ABSTRACT 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.

Predicting EuroQol (EQ-5D) scores from the patient-reported outcomes measurement information system (PROMIS) global items and domain item banks in a United States sample.

BackgroundPreference-based health index scores provide a single summary score assessing overall health-related quality of life and are useful as an outcome measure in clinical studies, for estimating quality-adjusted life years for economic evaluations, and for monitoring the health of populations. We predicted EuroQoL (EQ-5D) index scores from patient-reported outcomes measurement information system (PROMIS) global items and domain item banks.MethodsThis was a secondary analysis of health outcome data collected in an internet survey as part of the PROMIS Wave 1 field testing. For this study, we included the 10 global items and the physical function, fatigue, pain impact, anxiety, and depression item banks. Linear regression analyses were used to predict EQ-5D index scores based on the global items and selected domain banks.ResultsThe regression models using eight of the PROMIS global items (quality of life, physical activities, mental health, emotional problems, social activities, pain, and fatigue and either general health or physical health items) explained 65% of the variance in the EQ-5D. When the PROMIS domain scores were included in a regression model, 57% of the variance was explained in EQ-5D scores. Comparisons of predicted to actual EQ-5D scores by age and gender groups showed that they were similar.ConclusionsEQ-5D preference scores can be predicted accurately from either the PROMIS global items or selected domain banks. Application of the derived regression model allows the estimation of health preference scores from the PROMIS health measures for use in economic evaluations.

Exploratory and confirmatory factor analysis of the PROMIS pain quality item bank

PurposeThe assessment of pain sensation and quality is a key component in understanding the experience of individuals with chronic pain. This study evaluated the factor structure of the patient-reported outcome measurement information system (PROMIS) pain quality item bank.MethodsAs part of the PROMIS project, we developed a pool of 37 pain quality items, based on a review of existing pain questionnaires and development of new items. A web-based survey was designed and completed by 845 members of the general population and 967 individuals with different types of chronic pain. Exploratory factor analysis (EFA) was conducted on a random split-half sample of the data to examine the factor structure of the 37 PROMIS pain quality items in the general population and in a chronic pain sample. A confirmatory factor analysis was conducted in the holdout sample.ResultsThe EFA of the pain quality items resulted in comparable six-factor solutions for the general and chronic pain samples: (1) pulling/tugging pain; (2) tingling/numbness pain; (3) sharp/stabbing pain; (4) dull/aching pain; (5) pounding/pulsing pain; and (6) affective pain. The confirmatory factor analysis in the holdout sample supported this factor structure.ConclusionsFurther research is needed to evaluate the psychometric characteristics of the derived scales based on their factor scores.

Reduction in opioid-related adverse events and improvement in function with parecoxib followed by valdecoxib treatment after non-cardiac surgery: a randomized, double-blind, placebo-controlled, parallel-group trial.

AbstractBackground: Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. Methods: In this randomized, double-blind trial, patients (n=1062) undergoing major non-cardiac elective surgery received either parenteral parecoxib for 3 days or placebo then oral valdecoxib or placebo for a total of 10 days, with both arms being allowed additional opioid analgesia. Clinically meaningful opioid-related adverse events were assessed daily using the Opioid-Related Symptom Distress Scale (OR-SDS). Pain severity and interference with function were evaluated daily using the modified Brief Pain Inventory exploratory form (mBPI-e). Additional validation work was undertaken to understand the psychometric properties of the two PROs. Detailed clinical results were reported elsewhere. Results: Patients receiving parecoxib/valdecoxib achieved significantly better pain control and consumed 37% and 28% less opioid medication than the placebo group on day 2 and day 3, respectively. Over the 10-day treatment period, patients receiving parecoxib/valdecoxib consumed 31% less opioid medication. This coincided with significantly fewer (p < 0.0001) OR-SDS clinically meaningful events (CMEs) and lower mBPI-e scores from days 2–10 in the parecoxib/valdecoxib group compared with the placebo group. On day 3, the percentage of patients reporting one, two or three CMEs in the parecoxib/valdecoxib versus placebo group was 11.6% versus 13.0%, 2.3% versus 5.1%, and 0.8% versus 2.3%, respectively. The mean (± standard error) mBPI-e pain severity scores over days 2–10 were 2.47 ± 0.04 for the parecoxib/valdecoxib group and 3.01 ±0.04 for the placebo group, and the mean mBPI-e pain interference scores were 1.73±0.04 and 2.19 ± 0.04, respectively. Conclusions: Patients receiving parecoxib/valdecoxib had less pain interference on physical functioning, required less opioid medication and experienced fewer clinically meaningful opioid-related adverse events than patients receiving placebo.

Linking pain items from two studies onto a common scale using item response theory.

This study examined two approaches to linking items from two pain surveys to form a single item bank with a common measurement scale. Secondary analysis of two independent surveys: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Survey with Main Survey (959 chronic pain patients; 42 pain items) and Pain Module (n=148; 36 pain items), and Center on Outcomes, Research and Education Survey (400 cancer patients; 43 pain items). There were common items included among the three data sets. In the first approach, all items were calibrated to an item response theory (IRT) model simultaneously, and in the second approach, items were calibrated separately and then the scales were transformed to a common metric. The two approaches produced similar linking results across the two sets of pain interference items because there was sufficient number of common items and large enough sample size. For pain intensity, simultaneous calibration yielded more stable results. Separated calibration yielded an unsatisfactory linking result for pain intensity because of a single common item with small sample size. The results suggested that a simultaneous IRT calibration method produces the more stable item parameters across independent samples, and hence, should be recommended for developing comprehensive item banks. Patient-reported health outcome surveys are often limited in sample sizes and the number of items owing to the difficulty of recruitment and the burden to the patients. As a result, the surveys either lack statistical power or are limited in scope. Using IRT methodology, survey data can be pooled to lend strength to each other to expand the scope and to increase the sample sizes.

Prevalence and impact of pain in adults aging with a physical disability: Comparison to a US general population sample:

Objectives:To describe rates of pain and pain interference in a large sample of adults aging with long-standing physical disabilities, relative to a normative US population sample. Methods:Self-report survey data was collected for a sample of 1877 individuals with spinal cord injury, neuromuscular disease, postpolio syndrome, or multiple sclerosis. Rates of pain severity and pain interference in these samples were then compared with those taken from a large normative sample (>20,000) collected through the NIH Patient Reported Outcomes Measurement Information System (PROMIS). Results:Individuals with long-standing physical disabilities reported higher levels of pain and pain interference across the lifespan as compared with individuals in the normative sample. In general, individuals with disability did not experience an age-related decrease in pain and pain impact in contrast to those in the normative sample. For 3 disability groups (neuromuscular disease, postpolio syndrome, and multiple sclerosis), pain interference remained elevated and significantly higher than national norms in the “postretirement” period (ie, age 65 to 74). Discussion:Results from this study provide a large scale data on prevalence rates of pain and pain interference in this population. Findings underscore the prevalence and impact of pain in persons with disabilities and suggest that individuals with disability may not experience the same degree of decrease in pain interference in later life that is typical of the US population. Those aging with disability may be especially at risk for pain-related impairment in later life.

Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro/SS) diary

BackgroundThe clinical course of ulcerative colitis (UC) and the effects of treatment are assessed through patient-reported signs and symptoms (S&S), and endoscopic evidence of inflammation. The Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS) measure was developed to standardize the quantification of gastrointestinal S&S of UC in clinical trials through direct report from patient ratings.DesignThe UC-PRO/SS was developed by collecting data from concept elicitation (focus groups, and individual interviews), then refined through a process of cognitive interviews of 57 UC patients. Measurement properties, including item-level statistics, scaling structure, reliability, and validity, were evaluated in an observational, four-week study of adults with mild to severe UC (N = 200).ResultsFindings from qualitative focus groups and interviews identified nine symptom items covering bowel and abdominal symptoms. The final UC-PRO/SS daily diary includes two scales: Bowel S&S (six items) and Abdominal Symptoms (three items), each scored separately. Each scale showed evidence of adequate reliability (α = 80 and 0.66, respectively); reproducibility (intraclass correlation coefficient = 0.81, 0.71) and validity, including moderate-to-high correlations with the Partial Mayo Score (0.79; 0.45) and Inflammatory Bowel Disease Questionnaire (IBDQ) total score (− 0.70; − 0.61). Scores discriminated by level of disease severity, as defined by the Partial Mayo Score, Patient Global Rating, and Clinician Global Rating (p < 0.0001).ConclusionsResults suggest that the UC-PRO/SS is a reliable and valid measure of gastrointestinal symptom severity in UC patients. Additional longitudinal data are needed to evaluate the ability of the UC-PRO/SS scores to detect responsiveness and inform the selection of responder definitions.