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1.  Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items 
Quality of Life Research  2009;18(7):873-880.
Background
The use of global health items permits an efficient way of gathering general perceptions of health. These items provide useful summary information about health and are predictive of health care utilization and subsequent mortality.
Methods
Analyses of 10 self-reported global health items obtained from an internet survey as part of the Patient-Reported Outcome Measurement Information System (PROMIS) project. We derived summary scores from the global health items. We estimated the associations of the summary scores with the EQ-5D index score and the PROMIS physical function, pain, fatigue, emotional distress, and social health domain scores.
Results
Exploratory and confirmatory factor analyses supported a two-factor model. Global physical health (GPH; 4 items on overall physical health, physical function, pain, and fatigue) and global mental health (GMH; 4 items on quality of life, mental health, satisfaction with social activities, and emotional problems) scales were created. The scales had internal consistency reliability coefficients of 0.81 and 0.86, respectively. GPH correlated more strongly with the EQ-5D than did GMH (r = 0.76 vs. 0.59). GPH correlated most strongly with pain impact (r = −0.75) whereas GMH correlated most strongly with depressive symptoms (r = −0.71).
Conclusions
Two dimensions representing physical and mental health underlie the global health items in PROMIS. These global health scales can be used to efficiently summarize physical and mental health in patient-reported outcome studies.
doi:10.1007/s11136-009-9496-9
PMCID: PMC2724630  PMID: 19543809
Global health; PROMIS; Item response theory; EQ-5D
2.  PROMIS computerised adaptive tests are dynamic instruments to measure health-related quality of life in patients with cirrhosis 
Summary
Background
Cirrhotic patients have an impaired health-related quality of life (HRQOL), which is usually analysed using static paper-pencil questionnaires. The Patient Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CAT) are flexible, freely available, noncopyrighted, HRQOL instruments with US-based norms across 11 domains. CAT presents five to seven questions/domain depending on the patient's response, from large validated question banks. This provides brevity and precision equivalent to the entire question bank.
Aim
To evaluate PROMIS CAT tools against ‘legacy instruments’ for cirrhotics and their informal caregivers.
Methods
A total of 200 subjects: 100 cirrhotics (70 men, 53% decompensated) and 100 caregivers were administered the PROMIS and legacy instruments [Sickness Impact Profile (SIP), Beck depression/anxiety inventories, Pittsburgh Sleep-Quality Index (PSQI) and Epworth Sleepiness scale (ESS)] concurrently. Both legacy and PROMIS results for patients were compared with caregivers and US norms. These were also compared between compensated and decompensated patients. Preference for SIP or PROMIS was inquired of a selected group (n = 70, 50% patients). Test – retest reliability was assessed in another group of 20 patients.
Results
Patients had significant impairment on all PROMIS domains apart from anger and anxiety compared with caregivers and US norms (P < 0.02 to <0.0001). Decompensated patients had significantly worse sleep, pain, social and physical function scores compared with compensated ones, similar to legacy instruments. There was a statistically significant correlation between PROMIS and their corresponding legacy instruments. The majority (71%) preferred PROMIS over SIP. PROMIS tools had significant test – retest reliability (ICC range 0.759–0.985) when administered 12 ± 6 days apart.
Conclusion
PROMIS computerised adaptive testing tools had significant concurrent and discriminant validity, test – retest reliability and subject preference for assessing HRQOL in cirrhotic patients.
doi:10.1111/j.1365-2036.2011.04842.x
PMCID: PMC3989141  PMID: 21929591
3.  Measuring health-related quality of life in chronic obstructive pulmonary disease: properties of the EQ-5D-5L and PROMIS-43 short form 
Background
The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function.
Methods
We conducted a multi-center, cross-sectional study (“COPD Outcomes-based Network for Clinical Effectiveness & Research Translation” [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed.
Results
Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles.
Conclusions
Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients.
doi:10.1186/1471-2288-14-78
PMCID: PMC4072614  PMID: 24934150
COPD; EQ-5D-5L; PROMIS; Psychometric properties
4.  An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales 
Purpose
The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to develop self-reported item banks for clinical research. The PROMIS pediatrics (aged 8–17) project focuses on the development of item banks across several health domains (physical function, pain, fatigue, emotional distress, social role relationships, and asthma symptoms). The psychometric properties of the anxiety and depressive symptom item banks are described.
Methods
Participants (n = 1,529) were recruited in public school settings, hospital-based outpatient and subspecialty pediatrics clinics. The anxiety (k = 18) and depressive symptoms (k = 21) items were split between two test administration forms. Hierarchical confirmatory factor-analytic models (CFA) were conducted to evaluate scale dimensionality and local dependence. IRT analyses were then used to finalize item banks and short forms.
Results
CFA results confirmed that anxiety and depressive symptoms are separate constructs and indicative of negative affect. Items with local dependence and DIF were removed resulting in 15 anxiety and 14 depressive symptoms items. The psychometric differences between short forms and simulated computer adaptive tests are presented.
Conclusions
PROMIS pediatric item banks were developed to provide efficient assessment of health-related quality of life domains. This sample provides initial calibrations of anxiety and depressive symptoms item banks and creates PROMIS pediatric instruments, version 1.0.
doi:10.1007/s11136-010-9619-3
PMCID: PMC3158603  PMID: 20213516
PROMIS; Anxiety; Depressive symptoms; HRQOL; PRO; Scale development; Surveys; Pediatrics
5.  Application of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) to Mental Health Research 
Background
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative to develop item banks measuring patient-reported outcomes (PROs) and to create and make available a computerized adaptive testing system (CAT) that allows for efficient and precise assessment of PROs in clinical research and practice.
Aims of the Study
Based on the presentation from a symposium on “Evidence-based Outcomes in Psychiatry: Updates on Measurement Using Patient-Reported Outcomes (PRO)” at the 2011 American Psychiatry Association Convention, this paper provides an overview of PROMIS and its application to mental health research.
Methods
The PROMIS methodology for item bank development and testing is described, with a focus on the implications of this work for mental health research.
Results
Utilizing qualitative item review and state-of-the-art applications of item response theory (IRT), PROMIS investigators have developed, tested, and released item banks measuring physical, mental, and social health components. Ongoing efforts continue to add new item banks and further validate existing banks.
Discussion
PROMIS provides item banks measuring several domains of interest to mental health researchers including emotional distress, social function, and sleep. PROMIS methodology also provides a rigorous standard for the development of new mental health measures.
Implications for Health Care Provision
Web-based CAT or administration of short forms derived from PROMIS item banks provide efficient and precise dimensional estimates of clinical outcomes that can be utilized to monitor patient progress and assess quality improvement.
Implications for Future Research
Use of the dimensional PROMIS metrics (and co-calibration of the PROMIS item banks with existing PROs) will allow comparisons of mental health and related health outcomes across disorders and studies.
PMCID: PMC3705221  PMID: 22345362
6.  Gaining the PROMIS perspective from children with nephrotic syndrome: a Midwest pediatric nephrology consortium study 
Background and objectives
Nephrotic syndrome (NS) represents a common disease in pediatric nephrology typified by a relapsing and remitting course and characterized by the presence of edema that can significantly affect the health-related quality of life in children and adolescents. The PROMIS pediatric measures were constructed to be publically available, efficient, precise, and valid across a variety of diseases to assess patient reports of symptoms and quality of life. This study was designed to evaluate the ability of children and adolescents with NS to complete the PROMIS assessment via computer and to initiate validity assessments of the short forms and full item banks in pediatric NS. Successful measurement of patient reported outcomes will contribute to our understanding of the impact of NS on children and adolescents.
Design
This cross-sectional study included 151 children and adolescents 8-17 years old with NS from 16 participating institutions in North America. The children completed the PROMIS pediatric depression, anxiety, social-peer relationships, pain interference, fatigue, mobility and upper extremity functioning measures using a web-based interface. Responses were compared between patients experiencing active NS (n = 53) defined by the presence of edema and patients with inactive NS (n = 96) defined by the absence of edema.
Results
All 151 children and adolescents were successfully able to complete the PROMIS assessment via computer. As hypothesized, the children and adolescents with active NS were significantly different on 4 self-reported measures (anxiety, pain interference, fatigue, and mobility). Depression, peer relationships, and upper extremity functioning were not different between children with active vs. inactive NS. Multivariate analysis showed that the PROMIS instruments remained sensitive to NS disease activity after adjusting for demographic characteristics.
Conclusions
Children and adolescents with NS were able to successfully complete the PROMIS instrument using a web-based interface. The computer based pediatric PROMIS measurement effectively discriminated between children and adolescents with active and inactive NS. The domain scores found in this study are consistent with previous reports investigating the health-related quality of life in children and adolescents with NS. This study establishes known-group validity and feasibility for PROMIS pediatric measures in children and adolescents with NS.
doi:10.1186/1477-7525-11-30
PMCID: PMC3599189  PMID: 23510630
Patient reported outcomes; Quality of life; Nephrotic syndrome; Pediatrics
7.  Promising insights into the health related quality of life for children with severe obesity 
Background
Childhood obesity is a growing health concern known to adversely affect quality of life in children and adolescents. The Patient Reported Outcomes Measurement Information System (PROMIS) pediatric measures were developed to capture child self-reports across a variety of health conditions experienced by children and adolescents. The purpose of this study is to begin the process of validation of the PROMIS pediatric measures in children and adolescents affected by obesity.
Methods
The pediatric PROMIS instruments were administered to 138 children and adolescents in a cross-sectional study of patient reported outcomes in children aged 8–17 years with age-adjusted body mass index (BMI) greater than the 85th percentile in a design to establish known-group validity. The children completed the depressive symptoms, anxiety, anger, peer relationships, pain interference, fatigue, upper extremity, and mobility PROMIS domains utilizing a computer interface. PROMIS domains and individual items were administered in random order and included a total of 95 items. Patient responses were compared between patients with BMI 85 to < 99th percentile versus ≥ 99th percentile.
Results
136 participants were recruited and had all necessary clinical data for analysis. Of the 136 participants, 5% ended the survey early resulting in missing domain scores at the end of survey administration. In multivariate analysis, patients with BMI ≥ 99th percentile had worse scores for depressive symptoms, anger, fatigue, and mobility (p < 0.05). Parent-reported exercise was associated with better scores for depressive symptoms, anxiety, and fatigue (p < 0.05).
Conclusions
Children and adolescents ranging from overweight to severely obese can complete multiple PROMIS pediatric measures using a computer interface in the outpatient setting. In the 5% with missing domain scores, the missing scores were consistently found in the domains administered last, suggesting the length of the assessment is important. The differences in domain scores found in this study are consistent with previous reports investigating the quality of life in children and adolescents with obesity. We show that the PROMIS instrument represents a feasible and potentially valuable instrument for the future study of the effect of pediatric obesity on quality of life.
doi:10.1186/1477-7525-11-29
PMCID: PMC3598567  PMID: 23452863
Quality of life; Obesity; Patient Reported Outcomes Measurement Information System (PROMIS); Child; Depression
8.  The PROMIS Initiative: Examples of Applications in Rehabilitation 
In order to fully capture the impact of a disease or condition on the lives of individuals, patient-reported outcomes (PROs) are considered a necessary component of health measurement in rehabilitation. This article provides an overview of the involvement of rehabilitation stakeholders in the development of sound measurement tools for the Patient-Reported Outcomes Measurement Information System (PROMIS), a National Institutes of Health-funded initiative. PROMIS is a multi-site study that included many different populations. Here we focus on the involvement of people with several chronic conditions, including multiple sclerosis, spinal cord injury, and arthritis in the development of PROMIS measures. We describe both qualitative and quantitative methods used, including expert panels, focus groups, cognitive interviews and item response theory modeling, which resulted in enhanced utility of PROMIS measures in rehabilitation. The measures include a set of global health items and twelve item banks representing six domains. Scores are reported in the T-score metric (Mean = 50, SD=10) and centered on means from the U.S. general population. The PROMIS item banks measure quality of life and symptoms of people with chronic conditions and have the potential to enhance research and clinical practice by facilitating comparisons of scores across domains and populations.
doi:10.1016/j.apmr.2011.04.025
PMCID: PMC3668854  PMID: 21958918
Outcome Assessment (Health Care); rehabilitation; Disabled Persons
9.  Better assessment of physical function: item improvement is neglected but essential 
Arthritis Research & Therapy  2009;11(6):R191.
Introduction
Physical function is a key component of patient-reported outcome (PRO) assessment in rheumatology. Modern psychometric methods, such as Item Response Theory (IRT) and Computerized Adaptive Testing, can materially improve measurement precision at the item level. We present the qualitative and quantitative item-evaluation process for developing the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function item bank.
Methods
The process was stepwise: we searched extensively to identify extant Physical Function items and then classified and selectively reduced the item pool. We evaluated retained items for content, clarity, relevance and comprehension, reading level, and translation ease by experts and patient surveys, focus groups, and cognitive interviews. We then assessed items by using classic test theory and IRT, used confirmatory factor analyses to estimate item parameters, and graded response modeling for parameter estimation. We retained the 20 Legacy (original) Health Assessment Questionnaire Disability Index (HAQ-DI) and the 10 SF-36's PF-10 items for comparison. Subjects were from rheumatoid arthritis, osteoarthritis, and healthy aging cohorts (n = 1,100) and a national Internet sample of 21,133 subjects.
Results
We identified 1,860 items. After qualitative and quantitative evaluation, 124 newly developed PROMIS items composed the PROMIS item bank, which included revised Legacy items with good fit that met IRT model assumptions. Results showed that the clearest and best-understood items were simple, in the present tense, and straightforward. Basic tasks (like dressing) were more relevant and important versus complex ones (like dancing). Revised HAQ-DI and PF-10 items with five response options had higher item-information content than did comparable original Legacy items with fewer response options. IRT analyses showed that the Physical Function domain satisfied general criteria for unidimensionality with one-, two-, three-, and four-factor models having comparable model fits. Correlations between factors in the test data sets were > 0.90.
Conclusions
Item improvement must underlie attempts to improve outcome assessment. The clear, personally important and relevant, ability-framed items in the PROMIS Physical Function item bank perform well in PRO assessment. They will benefit from further study and application in a wider variety of rheumatic diseases in diverse clinical groups, including those at the extremes of physical functioning, and in different administration modes.
doi:10.1186/ar2890
PMCID: PMC3003539  PMID: 20015354
10.  Initial Adult Health Item Banks and First Wave Testing of the Patient-Reported Outcomes Measurement Information System (PROMIS™) Network: 2005–2008 
Journal of clinical epidemiology  2010;63(11):1179-1194.
Objective
Patient-reported outcomes (PROs) are essential when evaluating many new treatments in health care, yet current measures have been limited by a lack of precision, standardization and comparability of scores across studies and diseases. The Patient-Reported Outcomes Measurement Information System (PROMIS™) provides item banks that offer the potential for PRO measurement that is efficient (minimizes item number without compromising reliability) flexible (enables optional use of interchangeable items), and precise (has minimal error in estimate) measurement of commonly-studied PROs. We report results from the first large-scale testing of PROMIS items.
Study Design and Setting
Fourteen item pools were tested in the U.S. general population and clinical groups using an online panel and clinic recruitment. A scale-setting sub-sample was created reflecting demographics proportional to the 2000 U.S. census.
Results
Using item response theory (graded response model), 11 item banks were calibrated on a sample of 21,133, measuring components of self-reported physical, mental and social health, along with a 10-item global health scale. Short forms from each bank were developed and compared to the overall bank as well as with other well-validated and widely accepted (“legacy”) measures. All item banks demonstrated good reliability across the majority of the score distributions. Construct validity was supported by moderate to strong correlations with legacy measures.
Conclusion
PROMIS item banks and their short forms provide evidence they are reliable and precise measures of generic symptoms and functional reports comparable to legacy instruments. Further testing will continue to validate and test PROMIS items and banks in diverse clinical populations.
doi:10.1016/j.jclinepi.2010.04.011
PMCID: PMC2965562  PMID: 20685078
Outcome Measures; Quality of life; Chronic disease
11.  The Patient-Reported Outcomes Measurement Information System (PROMIS) 
Medical care  2007;45(5 Suppl 1):S3-S11.
Background
The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group program of research designed to develop, validate, and standardize item banks to measure patient-reported outcomes (PROs) relevant across common medical conditions. In this article, we will summarize the organization and scientific activity of the PROMIS network during its first 2 years.
Design
The network consists of 6 primary research sites (PRSs), a statistical coordinating center (SCC), and NIH research scientists. Governed by a steering committee, the network is organized into functional subcommittees and working groups. In the first year, we created an item library and activated 3 interacting protocols: Domain Mapping, Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we developed and initiated testing of item banks covering 5 broad domains of self-reported health.
Results
The domain mapping process is built on the World Health Organization (WHO) framework of physical, mental, and social health. From this framework, pain, fatigue, emotional distress, physical functioning, social role participation, and global health perceptions were selected for the first wave of testing. Item response theory (IRT)-based analysis of 11 large datasets supplemented and informed item-level qualitative review of nearly 7000 items from available PRO measures in the item library. Items were selected for rewriting or creation with further detailed review before the first round of testing in the general population and target patient populations.
Conclusions
The NIH PROMIS network derived a consensus-based framework for self-reported health, systematically reviewed available instruments and datasets that address the initial PROMIS domains. Qualitative item research led to the first wave of network testing which began in the second year.
doi:10.1097/01.mlr.0000258615.42478.55
PMCID: PMC2829758  PMID: 17443116
outcomes; patient reported outcomes; quality of life; health-related quality of life
12.  Development of six PROMIS pediatrics proxy-report item banks 
Background
Pediatric self-report should be considered the standard for measuring patient reported outcomes (PRO) among children. However, circumstances exist when the child is too young, cognitively impaired, or too ill to complete a PRO instrument and a proxy-report is needed. This paper describes the development process including the proxy cognitive interviews and large-field-test survey methods and sample characteristics employed to produce item parameters for the Patient Reported Outcomes Measurement Information System (PROMIS) pediatric proxy-report item banks.
Methods
The PROMIS pediatric self-report items were converted into proxy-report items before undergoing cognitive interviews. These items covered six domains (physical function, emotional distress, social peer relationships, fatigue, pain interference, and asthma impact). Caregivers (n = 25) of children ages of 5 and 17 years provided qualitative feedback on proxy-report items to assess any major issues with these items. From May 2008 to March 2009, the large-scale survey enrolled children ages 8-17 years to complete the self-report version and caregivers to complete the proxy-report version of the survey (n = 1548 dyads). Caregivers of children ages 5 to 7 years completed the proxy report survey (n = 432). In addition, caregivers completed other proxy instruments, PedsQL™ 4.0 Generic Core Scales Parent Proxy-Report version, PedsQL™ Asthma Module Parent Proxy-Report version, and KIDSCREEN Parent-Proxy-52.
Results
Item content was well understood by proxies and did not require item revisions but some proxies clearly noted that determining an answer on behalf of their child was difficult for some items. Dyads and caregivers of children ages 5-17 years old were enrolled in the large-scale testing. The majority were female (85%), married (70%), Caucasian (64%) and had at least a high school education (94%). Approximately 50% had children with a chronic health condition, primarily asthma, which was diagnosed or treated within 6 months prior to the
interview. The PROMIS proxy sample scored similar or better on the other proxy instruments compared to normative samples.
Conclusions
The initial calibration data was provided by a diverse set of caregivers of children with a variety of common chronic illnesses and racial/ethnic backgrounds. The PROMIS pediatric proxy-report item banks include physical function (mobility n = 23; upper extremity n = 29), emotional distress (anxiety n = 15; depressive symptoms n = 14; anger n = 5), social peer relationships (n = 15), fatigue (n = 34), pain interference (n = 13), and asthma impact (n = 17).
doi:10.1186/1477-7525-10-22
PMCID: PMC3312870  PMID: 22357192
PROMIS; HRQOL; PRO; Scale development; Parent Proxy; Pediatrics
13.  Development and Psychometric Analysis of the PROMIS Pain Behavior Item Bank 
Pain  2009;146(1-2):158-169.
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.
doi:10.1016/j.pain.2009.07.029
PMCID: PMC2775487  PMID: 19683873
Pain behavior; item response theory analysis; patient reported outcomes; psychometric analysis; chronic pain; item banks
14.  PROMIS Pediatric Anger Scale: An Item Response Theory Analysis 
Quality of Life Research  2011;21(4):697-706.
Purpose
The Patient Reported Outcomes Measurement Information System (PROMIS) aims to develop patient-reported outcome (PROs) instruments for use in clinical research. The PROMIS pediatrics (ages 8–17) project focuses on the development of PROs across several health domains (physical function, pain, fatigue, emotional distress, social role relationships, and asthma symptoms). The objective of the present study is to report on the psychometric properties of the PROMIS Pediatric Anger Scale.
Methods
Participants (n=759) were recruited in public school settings, hospital-based outpatient and subspecialty pediatrics clinics. The anger items (k=10) were administered on one test form. A hierarchical confirmatory factor analytic model (CFA) was conducted to evaluate scale dimensionality and local dependence. Item response theory (IRT) analyses were then used to finalize the item scale and short form.
Results
CFA confirmed that the anger items are representative of a unidimensional scale and items with local dependence were removed resulting in a six-item short form. The IRT-scaled scores from summed scores and each score’s conditional standard error were calculated for the new six-item PROMIS Pediatric Anger Scale.
Conclusions
This study provides initial calibrations of the anger items and creates the PROMIS Pediatric Anger Scale, version 1.0
doi:10.1007/s11136-011-9969-5
PMCID: PMC3245753  PMID: 21785833
PROMIS; Anger; HRQOL; PRO; Scale Development; Surveys; Pediatrics
15.  Evaluation of Item Candidates: The PROMIS Qualitative Item Review 
Medical care  2007;45(5 Suppl 1):S12-S21.
One of the PROMIS (Patient-Reported Outcome Measurement Information System) network's primary goals is the development of a comprehensive item bank for patient-reported outcomes of chronic diseases. For its first set of item banks, PROMIS chose to focus on pain, fatigue, emotional distress, physical function, and social function. An essential step for the development of an item pool is the identification, evaluation, and revision of extant questionnaire items for the core item pool. In this work, we also describe the systematic process wherein items are classified for subsequent statistical processing by the PROMIS investigators. Six phases of item development are documented: identification of extant items, item classification and selection, item review and revision, focus group input on domain coverage, cognitive interviews with individual items, and final revision before field testing. Identification of items refers to the systematic search for existing items in currently available scales. Expert item review and revision was conducted by trained professionals who reviewed the wording of each item and revised as appropriate for conventions adopted by the PROMIS network. Focus groups were used to confirm domain definitions and to identify new areas of item development for future PROMIS item banks. Cognitive interviews were used to examine individual items. Items successfully screened through this process were sent to field testing and will be subjected to innovative scale construction procedures.
doi:10.1097/01.mlr.0000254567.79743.e2
PMCID: PMC2810630  PMID: 17443114
patient-reported outcomes; cognitive interviews; qualitative methods; questionnaire development
16.  Development of the NIH PROMIS® Sexual Function and Satisfaction Measures in Patients with Cancer 
The journal of sexual medicine  2013;10(0 1):43-52.
Introduction
We describe the development and validation of the PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 for cancer populations.
Aim
To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS® Network.
Methods
Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient reported outcome (PRO) measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item response theory and evaluated for reliability and validity.
Main Outcome Measures
The PROMIS Sexual Function and Satisfaction (PROMIS SexFS) measures version 1.0 include 79 items in 11 domains: interest in sexual activity, lubrication, vaginal discomfort, erectile function, global satisfaction with sex life, orgasm, anal discomfort, therapeutic aids, sexual activities, interfering factors, and screener questions.
Results
In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different), convergent validity (strong correlations between scores on PROMIS and scores on conceptually-similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (inter-class correlations from 2 administrations of the instrument, 1 month apart).
Conclusions
The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study.
doi:10.1111/j.1743-6109.2012.02995.x
PMCID: PMC3729213  PMID: 23387911
patient-reported outcome measures; sexual function; satisfaction; cancer; quality of life; male and female sexual dysfunction
17.  Reliability and Validity of PROMIS Cognitive Abilities and Cognitive Concerns Scales Among People with Multiple Sclerosis 
Background: Cognitive impairment is among the most debilitating outcomes of multiple sclerosis (MS). Although several neuropsychological tests and self-report cognitive measures have been used to assess cognitive impairment, they may not be sensitive to change over time, or may not be feasible to administer in a clinical setting. The purpose of this study was to assess the reliability and validity of the 8-item PROMIS Cognitive Abilities and Cognitive Concerns Scales in a large community-based sample of people with MS. The PROMIS Cognitive Abilities and Cognitive Concerns Scales derive from the National Institutes of Health–funded Patient Reported Outcomes Measurement Information System (PROMIS), an item repository that capitalizes on recent psychometric advances to produce short, psychometrically sound health measures.
Methods: Mailed survey data were collected from 322 individuals recruited from two National Multiple Sclerosis Society chapters in a southwestern state.
Results: Both cognitive scales demonstrated high internal consistency reliability and were moderately correlated with self-reported depressive symptoms, self-efficacy, barriers to health promotion, health, and functional status (all correlation coefficients >0.35). In hierarchical regression analysis, the PROMIS Cognitive Concerns score added significant unique variance to the prediction of MS Incapacity Status after controlling for self-reported depressive symptoms, exercise, spiritual growth, and global health. Those who were unemployed owing to their disabilities had significantly lower PROMIS Cognitive Abilities scores and higher Cognitive Concerns scores than those who were working or those who were retired or not working for other reasons.
Conclusions: The PROMIS Cognitive Abilities and Cognitive Concerns Scales are short, psychometrically sound measures that assess an important dimension of functioning and health for people with MS.
doi:10.7224/1537-2073.2012-047
PMCID: PMC3967698  PMID: 24688349
18.  Feasibility and Construct Validity of PROMIS and Legacy Instruments in an Academic Scleroderma Clinic—Analysis from the UCLA Scleroderma Quality of Life Study 
Background
The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative is a cooperative group program of research designed to develop, evaluate, and standardize item banks to measure patient-reported outcomes relevant across medical conditions. For adults, 11 domains have been developed in physical, mental, and social health.
Purpose
The objective of the current study was to assess feasibility and construct validity of PROMIS item banks versus legacy measures in a observational study in systemic sclerosis (SSc).
Methods
Patients with SSc in a single academic center completed computerized adaptive technology (CAT) administered PROMIS item banks during the clinic visit and legacy domains (using paper-and-pencil). The construct validity of PROMIS items was evaluated by examining correlations with corresponding legacy measures using multitrait-multimethod analysis.
Results
Participants consisted of 143 SSc patients with an average age of 51.5 years; 71% were female and 68% were Caucasian. The average number of items completed for each CAT-administered item bank ranged from 5 to 8 (69 CAT items per patient), and the average time to complete each CAT-administered item bank ranged from 48 seconds to 1.9 minutes per patient (average time= 11.9 minutes/per patient for 11 banks). All correlations between PROMIS domains and respective legacy measures were large and in the hypothesized direction (ranged from .61 to .82).
Conclusion
Our study supports the construct validity of the CAT-administered PROMIS item banks and shows that they can be administered successfully in a clinic with support staff. Future studies should assess the feasibility of PROMIS item banks in a busy clinical practice
doi:10.1016/j.jval.2011.08.006
PMCID: PMC3457915  PMID: 22264980
Systemic sclerosis; PROMIS; health-related quality of life; construct validity
19.  Sampling plan and patient characteristics of the PROMIS pediatrics large-scale survey 
Purpose
This paper describes a large-scale administration of the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric items to evaluate measurement characteristics.
Methods
Each child completed one of seven test forms containing items from a pool of 293 PROMIS items and four legacy scales. PROMIS items covered six domains (physical function, emotional distress, social role relationship, fatigue, pain, and asthma).
Results
From January 2007 to May 2008, 4,129 children aged 8–17 were enrolled. The sample was 51% female, 55% aged 8–12, 42% minority race and 17% were Hispanic ethnicity. Approximately, 35% of the children participating in the survey consulted a clinician for a chronic illness diagnosis or treatment within 6 months prior to study enrollment.
Conclusions
The final PROMIS pediatric item banks include physical function (n = 52 items), emotional distress (n = 35 items), social role relationships (n = 15 items), fatigue (n = 34 items), pain (n = 13 items), and asthma (n = 17 items). The initial calibration data were provided by a diverse set of children with varying health states (e.g., children with a variety of common chronic illnesses) and racial/ethnic backgrounds.
doi:10.1007/s11136-010-9618-4
PMCID: PMC3157238  PMID: 20204706
PROMIS; HRQOL; PRO; Scale development; Surveys; Pediatrics
20.  The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative 
Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.
PROMIS is a U.S.-based cooperative group of research sites and centers of excellence convened to develop and standardize PRO measures across studies and settings. If extended to a global collaboration, PROMIS has the potential to transform PRO measurement by creating a shared, unifying terminology and metric for reporting of common symptoms and functional life domains. Extending a common set of standardized PRO measures to the international community offers great potential for improving patient-centered research, clinical trials reporting, population monitoring, and health care worldwide. Benefits of such standardization include the possibility of: international syntheses (such as meta-analyses) of research findings; international population monitoring and policy development; health services administrators and planners access to relevant information on the populations they serve; better assessment and monitoring of patients by providers; and improved shared decision making.
The goal of the current PROMIS International initiative is to ensure that item banks are translated and culturally adapted for use in adults and children in as many countries as possible. The process includes 3 key steps: translation/cultural adaptation, calibration, and validation. A universal translation, an approach focusing on commonalities, rather than differences across versions developed in regions or countries speaking the same language, is proposed to ensure conceptual equivalence for all items. International item calibration using nationally representative samples of adults and children within countries is essential to demonstrate that all items possess expected strong measurement properties. Finally, it is important to demonstrate that the PROMIS measures are valid, reliable and responsive to change when used in an international context.
IRT item banking will allow for tailoring within countries and facilitate growth and evolution of PROs through contributions from the international measurement community. A number of opportunities and challenges of international development of PROs item banks are discussed.
doi:10.1186/1477-7525-11-210
PMCID: PMC3879205  PMID: 24359143
Patient-reported outcomes; Health-related quality of life research; Patients’ experiences; Questionnaires; Cross-cultural equivalence; Health information systems; Clinical decision making; Comparative effectiveness research; Patient empowerment; Cross-national comparisons
21.  Development of A Promis Item Bank to Measure Pain Interference 
Pain  2010;150(1):173-182.
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.
doi:10.1016/j.pain.2010.04.025
PMCID: PMC2916053  PMID: 20554116
Quality-of-life outcomes; quality-of-life measurement; pain
22.  Validity of Two New Patient Reported Outcome Measures in Systemic Sclerosis: the PROMIS-29 Profile and the FACIT-Dyspnea 
Arthritis care & research  2011;63(11):1620-1628.
Objective
Many patient-reported outcome (PRO) instruments used in systemic sclerosis (SSc) trials are limited by lack of validation, licensing fees, and complicated scoring systems. We assessed the construct validity for discriminative purposes of two new PRO instruments-the Patient Reported Outcomes Measurement Information System 29-item Health Profile (PROMIS-29) and the Functional Assessment of Chronic Illness Therapy-Dyspnea short form (FACIT-Dyspnea), measuring health status and dyspnea in SSc patients.
Methods
Seventy-three patients participated in a cross-sectional study at a tertiary SSc program. PROMIS-29, FACIT-Dyspnea, and legacy PRO instruments used in clinical trials (Medical Research Council [MRC] Dyspnea Score, St. George’s Respiratory Questionnaire [SGRQ], Health Assessment Questionnaire-Disability Index [HAQ-DI] and Short-Form 36 [SF-36]) were administered. Composite severity scores using an adaptation of the Medsger Disease Severity Index were generated using clinical, diagnostic and laboratory information. PROMIS-29 and FACIT-Dyspnea scores were compared with legacy PRO measures and composite severity scores.
Results
The mean (range) patient age (84% women) was 51 years (22–72). The mean (range) SSc disease duration from the onset of the first non-Raynaud symptom was 7 years (0–45). Spearman correlation coefficients across FACIT-Dyspnea and PROMIS Physical Functioning scores with legacy PRO instruments were generally high (range=0.64–0.86); those between PROMIS and FACIT-Dyspnea with composite disease severity scores were more modest, but statistically significant (range=0.33–0.48, p<0.01).
Conclusion
PROMIS-29 and FACIT-Dyspnea are valid instruments to measure the health status of SSc patients. PROMIS-29 and FACIT-Dyspnea may be preferable to legacy instruments because they are freely available in multiple languages, and simple to administer, score and interpret.
doi:10.1002/acr.20591
PMCID: PMC3205420  PMID: 22034123
23.  Construction of the Pediatric Asthma Impact Scale (PAIS) for the Patient-Reported Outcomes Measurement Information System (PROMIS) 
Background
Recently, the National Institutes of Health Roadmap for Medical Research initiative led a large-scale effort to develop the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS’s main goal was to develop a set of item banks and computerized adaptive tests for the clinical research community. Asthma, as the most common chronic childhood disease, was chosen for a disease-specific pediatric item bank.
Objectives
The primary objective of this research is to present the details of the psychometric analyses of the asthma domain items.
Methods
Item response theory (IRT) analyses were conducted on a 34–asthma item bank. Test forms containing PROMIS Pediatric Asthma domain items were completed by 622 children ages 8 to 12. Items were subsequently evaluated for local dependence, scale dimensionality, and differential item functioning.
Results
A 17-item pool and an 8-item short form for the new PROMIS Pediatric Asthma Impact Scale (PAIS) were generated using IRT. The recommended 8-item short form contains the item set that provides the maximum test information at the mean (50) on the T-score metric. If more score precision is required, the complete 17-item pool is recommended and may be used in toto or as the basis of a computerized adaptive test (CAT). A shorter test form can also be created and scored on the same scale.
Conclusions
The present study presents the PROMIS Pediatric Asthma Impact Scale (PAIS) developed with IRT, and provides the initial calibration data for the items.
doi:10.3109/02770900903426997
PMCID: PMC3098738  PMID: 20394514
asthma; pediatric; quality-of-life; item response theory
24.  PROMIS Pediatric Pain Interference Scale: An Item Response Theory Analysis of the Pediatric Pain Item Bank 
An aim of the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) initiative is to develop item banks and computerized adaptive tests (CAT) that are applicable across a wide variety of chronic disorders. The PROMIS Pediatric Cooperative Group has concentrated on the development of pediatric self-report item banks for ages 8-17 years. The objective of the present study is to describe the Item Response Theory (IRT) analysis of the NIH PROMIS pediatric pain item bank and the measurement properties of the new unidimensional PROMIS Pediatric Pain Interference Scale. Test forms containing pediatric pain items were completed by a total of 3,048 respondents. IRT analyses regarding scale dimensionality, item local dependence, and differential item functioning were conducted. A pain item pool was developed to yield scores on a T-score scale with a mean of 50 and standard deviation of 10. The recommended 8-item unidimensional short form for the PROMIS Pediatric Pain Interference Scale contains the item set which provides the maximum test information at the mean (50) on the T-score metric. A simulated CAT was computed that provides the most information at five possible score locations (30, 40, 50, 60, and 70 on the T-score metric).
doi:10.1016/j.jpain.2010.02.005
PMCID: PMC3129595  PMID: 20627819
Pain; pediatrics; PROMIS; pain interference; Item Response Theory
25.  HD-PRO-TRIAD™ Validation: A Patient-reported Instrument for the Symptom Triad of Huntington's Disease 
Background
Few valid, disease-specific measures of health-related quality of life (HRQOL) capture the spectrum of symptoms associated with Huntington's disease (HD). The HD-PRO-TRIAD™ is a new, HD-specific, patient-reported outcome (PRO) instrument of the HD symptom triad (cognitive decline, emotional/behavioral dyscontrol, and motor dysfunction) designed for clinical research and practice. The objective was to validate the HD-PRO-TRIAD™ through a cross-sectional sample of individuals with HD and caregivers.
Methods
Development of the HD-PRO-TRIAD™ has been described elsewhere. A total of 132 individuals with HD and 40 HD caregivers, comprising 29 dyads, participated in the cross-sectional psychometric validation of this instrument. Participants provided responses to the HD-PRO-TRIAD™ and other HRQOL and disease severity instruments (EuroQOL 5D, Short Form 12, Neuro-QOL Item Banks, PROMIS Global Health, and self-reported Unified Huntington's Disease Rating Scale Total Functional Capacity and Independence Scales). Internal consistency, construct validity, and patient–caregiver proxy consistency were evaluated.
Results
Internal consistency of the three domains and overall HD-PRO-TRIAD™ instrument was supported by Cronbach's alpha values ≥0.94. Construct validity was supported by significant correlations between HD-PRO-TRIAD™ domain scores and other measures of the same domains (e.g., significant positive correlations between HD-PRO-TRIAD™ Anxiety with Neuro-QOL Anxiety), as well as slightly weaker but still strong correlations with other HRQOL instruments (e.g., HD-PRO-TRIAD™ Anxiety and UHDRS Independence; all p<0.01). Consistency between patient self-report and caregiver proxy report was supported by an intra-class correlation coefficient ≥0.92 for all three domains and the overall instrument.
Discussion
These data indicate that HD-PRO-TRIAD™ is a reliable and valid HRQOL instrument that captures the typical triad of HD symptoms.
doi:10.7916/D8PN93NZ
PMCID: PMC3990832  PMID: 24761312
Huntington's disease; quality-of-life scale; psychometric validation; patient-reported outcome; health-related quality of life; HD-PRO-TRIAD™

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