Health-related quality of life profiles in adolescents and young adults with chronic conditions.

PURPOSE: To assess health-related quality of life (HRQOL) among adolescents and young adults (AYAs) with chronic conditions. METHODS: AYAs (N = 872) aged 14-20 years completed NIH's Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, pain interference, fatigue, social health, depression, anxiety, and anger. Latent profile analysis (LPA) was used to group AYAs into HRQOL profiles using PROMIS T-scores. The optimal number of profiles was determined by model fit statistics, likelihood ratio test, and entropy. Multinomial logistic regression models were used to examine how LPA's HRQOL profile membership was associated with patient demographic and chronic conditions. The model prediction accuracy on profile membership was evaluated using Huberty's I index with a threshold of 0.35 for good effect. RESULTS: A 4-profile LPA model was selected. A total of 161 (18.5%), 256 (29.4%), 364 (41.7%), and 91 (10.4%) AYAs were classified into Minimal, Mild, Moderate, and Severe HRQOL Impact profiles. AYAs in each profile had distinctive mean scores with over a half standard deviation (5-points in PROMIS T-scores) of difference between profiles across most HRQOL domains. AYAs who were female or had conditions such as mental health condition, hypertension, and self-reported chronic pain were more likely to be in the Severe HRQOL Impact profile. The Huberty's I index was 0.36. CONCLUSIONS: Approximately half of AYAs with a chronic condition experience moderate to severe HRQOL impact. The availability of risk prediction models for HRQOL impact will help to identify AYAs who are in greatest need of closer clinical care follow-up.

Applying latent profile analysis to identify adolescents and young adults with chronic conditions at risk for poor health-related quality of life.

The impact of chronic diseases on health-related quality of life (HRQOL) in adolescents and young adults (AYAs) is understudied. Latent profile analysis (LPA) can identify profiles of AYAs based on their HRQOL scores reflecting physical, mental, and social well-being. This paper will (1) demonstrate how to use LPA to identify profiles of AYAs based on their scores on multiple HRQOL indicators; (2) explore associations of demographic and clinical factors with LPA-identified HRQOL profiles of AYAs; and (3) provide guidance on the selection of adult or pediatric versions of Patient-Reported Outcomes Measurement Information System® (PROMIS®) in AYAs. A total of 872 AYAs with chronic conditions completed the adult and pediatric versions of PROMIS measures of anger, anxiety, depression, fatigue, pain interference, social health, and physical function. The optimal number of LPA profiles was determined by model fit statistics and clinical interpretability. Multinomial regression models examined clinical and demographic factors associated with profile membership. As a result of the LPA, AYAs were categorized into 3 profiles: Minimal, Moderate, and Severe HRQOL Impact profiles. Comparing LPA results using either the pediatric or adult PROMIS T-scores found approximately 71% of patients were placed in the same HRQOL profiles. AYAs who were female, had hypertension, mental health conditions, chronic pain, and those on medication were more likely to be placed in the Severe HRQOL Impact Profile. Our findings may facilitate clinicians to screen AYAs who may have low HRQOL due to diseases or treatments with the identified risk factors without implementing the HRQOL assessment.

Determining a transitional scoring link between PROMIS® pediatric and adult physical health measures.

PURPOSE: Having independent versions of the PROMIS® scales (for Pediatric and Adults) is problematic as scores cannot be evaluated longitudinally as individuals move from childhood into adulthood. The primary aim of this research project is to use item response theory (IRT) to develop a transitional scoring link (or "crosswalk") between the PROMIS adult and pediatric physical health measures. SETTING: Sample 1 was collected at 6 rehabilitation hospitals in the U.S., and participants in Sample 2 were recruited from public health insurance programs and an online research panel. METHODS: PROMIS pediatric and adult physical function, mobility, upper extremity, fatigue, and pain measures were administered to a sample of 874 individuals aged 14-20 years old with special health needs and a sample of 641 individuals aged 14-25 years with a disability. IRT-based scores were linked using a linear approximation to calibrated projection. RESULTS: Estimated latent variable correlations ranged between 0.84 and 0.95 for the PROMIS pediatric and adult scores. Root Expected Mean Square Difference values were below the 0.08 threshold in all cases except when comparing genders on the Mobility (0.097) and Pain (0.10) scales in the special health care needs sample. Sum score conversion tables for the pediatric and adult PROMIS measures are presented. CONCLUSIONS: The linking coefficients can be used to calculate scale scores on PROMIS adult measures from pediatric measure scores and vice versa. This may lead to more accurate measurement in cross-sectional studies spanning multiple age groups or longitudinal studies that require comparable measurement across distinct developmental stages.

Assessing responsiveness over time of the PROMIS® pediatric symptom and function measures in cancer, nephrotic syndrome, and sickle cell disease.

PURPOSE: Previous studies provided evidence for the validity of the PROMIS Pediatric measures in cross-sectional studies. This study evaluated the ability of the PROMIS Pediatric measures to detect change over time in children and adolescents with cancer, nephrotic syndrome (NS), or sickle cell disease (SCD). METHODS: Participants (8-17 years) completed measures of fatigue, pain interference, anger, anxiety, depressive symptoms, mobility, upper extremity, and peer relationships at three or four time points (T1-T4). Between T1 and T2, children with cancer received chemotherapy and children with SCD experienced a pain exacerbation. Children with NS were first assessed during active disease (T2), with T3 and T4 conducted at disease remission. For the primary analysis of responsiveness, we expected better scores at T3 (recovery) compared to T2 (event) for all diseases. T1 and T4 are also expected to have better scores than T2. Linear mixed models were used and adjusted for time, gender, age, race/ethnicity, education, comorbid conditions, and disease. RESULTS: Enrolled were 96 children with cancer, 121 children with SCD, and 127 children with NS. Fatigue, pain interference, mobility, and upper extremity scores worsened from T1 (baseline) to T2 (event) (p < 0.01), and significantly improved from T2 to T3 and T4 (p < 0.01). Similarly, anxiety and depressive symptoms significantly improved from T2 to T3 and T4 (p < 0.01). CONCLUSIONS: This study provides evidence for the responsiveness of seven PROMIS Pediatric measures to clinical disease state in three chronic illnesses. The findings support use of PROMIS Pediatric measures in clinical research.

Reliability and validity of PROMIS measures administered by telephone interview in a longitudinal localized prostate cancer study.

PURPOSE: To evaluate the reliability and validity of six PROMIS measures (anxiety, depression, fatigue, pain interference, physical function, and sleep disturbance) telephone-administered to a diverse, population-based cohort of localized prostate cancer patients. METHODS: Newly diagnosed men were enrolled in the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study. PROMIS measures were telephone-administered pre-treatment (baseline), and at 3-months and 12-months post-treatment initiation (N = 778). Reliability was evaluated using Cronbach's alpha. Dimensionality was examined with bifactor models and explained common variance (ECV). Ordinal logistic regression models were used to detect potential differential item functioning (DIF) for key demographic groups. Convergent and discriminant validity were assessed by correlations with the legacy instruments Memorial Anxiety Scale for Prostate Cancer and SF-12v2. Known-groups validity was examined by age, race/ethnicity, comorbidity, and treatment. RESULTS: Each PROMIS measure had high Cronbach's alpha values (0.86-0.96) and was sufficiently unidimensional. Floor effects were observed for anxiety, depression, and pain interference measures; ceiling effects were observed for physical function. No DIF was detected. Convergent validity was established with moderate to strong correlations between PROMIS and legacy measures (0.41-0.77) of similar constructs. Discriminant validity was demonstrated with weak correlations between measures of dissimilar domains (-0.20--0.31). PROMIS measures detected differences across age, race/ethnicity, and comorbidity groups; no differences were found by treatment. CONCLUSIONS: This study provides support for the reliability and construct validity of six PROMIS measures in prostate cancer, as well as the utility of telephone administration for assessing HRQoL in low literacy and hard-to-reach populations.

Mode effects between computer self-administration and telephone interviewer-administration of the PROMIS(®) pediatric measures, self- and proxy report.

OBJECTIVE: To test equivalence of scores obtained with the PROMIS(®) pediatric Depressive Symptoms, Fatigue, and Mobility measures across two modes of administration: computer self-administration and telephone interviewer-administration. If mode effects are found, to estimate the magnitude and direction of the mode effects. METHODS: Respondents from an internet survey panel completed the child self-report and parent proxy-report versions of the PROMIS(®) pediatric Depressive Symptoms, Fatigue, and Mobility measures using both computer self-administration and telephone interviewer-administration in a crossed counterbalanced design. Pearson correlations and multivariate analysis of variance were used to examine the effects of mode of administration as well as order and form effects. RESULTS: Correlations between scores obtained with the two modes of administration were high. Scores were generally comparable across modes of administration, but there were some small significant effects involving mode of administration; significant differences in scores between the two modes ranged from 1.24 to 4.36 points. CONCLUSIONS: Scores for these pediatric PROMIS measures are generally comparable across modes of administration. Studies planning to use multiple modes (e.g., self-administration and interviewer-administration) should exercise good study design principles to minimize possible confounding effects from mixed modes.

Linkage between the PROMIS® pediatric and adult emotional distress measures.

PURPOSE: Research studies that measure health-related quality of life (HRQOL) in both children and adults and longitudinal studies that follow children into adulthood need measures that can be compared across these age groups. This study links the PROMIS pediatric and adult emotional distress measures using data from participants with diverse health conditions and disabilities. METHODS: Analyses were conducted and compared in two separate samples to confirm the stability of results. One sample (n = 874) included individuals aged 14-20 years with special health care needs and who require health services. The other sample (n = 641) included individuals aged 14-25 years who have a physical or cognitive disability. Participants completed both PROMIS pediatric and adult measures. Item response theory-based scores were linked using the linear approximation to calibrated projection. RESULTS: The estimated latent-variable correlation between pediatric and adult PROMIS measures ranged from 0.87 to 0.94. Regression coefficients ß 0 (intercept) and ß 1 (slope), and mean squared error are provided to transform scores from the pediatric to the adult measures, and vice versa. CONCLUSIONS: This study used a relatively new linking method, calibrated projection, to link PROMIS pediatric and adult measure scores, thus expanding the use of PROMIS measures to research that includes both populations.

Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method.

OBJECTIVE: To assess minimally important differences (MIDs) for several pediatric self-report item banks from the National Institutes of Health Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)). METHODS: We presented vignettes comprising sets of two completed PROMIS questionnaires and asked judges to declare whether the individual completing those questionnaires had an important change or not. We enrolled judges (including adolescents, parents, and clinicians) who responded to 24 vignettes (six for each domain of depression, pain interference, fatigue, and mobility). We used item response theory to model responses to the vignettes across different judges and estimated MID as the point at which 50 % of the judges would declare an important change. RESULTS: We enrolled 246 judges (78 adolescents, 85 parents, and 83 clinicians). The MID estimated with clinician data was about 2 points on the PROMIS T-score scale, and the MID estimated with adolescent and parent data was about 3 points on that same scale. CONCLUSIONS: The MIDs enhance the value of PROMIS pediatric measures in clinical research studies to identify meaningful changes in health status over time.

Item-level informant discrepancies between children and their parents on the PROMIS(®) pediatric scales.

OBJECTIVE: The study objective was to describe the individual item-level discrepancies between children ages 8-17 years and their parents for the PROMIS(®) pediatric scales. Contextual effects on item-level informant discrepancies for the pediatric pain interference items were further analyzed conditional on whether the child, the parent, or anyone else in the household experienced chronic pain. METHODS: Parallel pediatric self-report and parent proxy-report items were completed by approximately 300 parent-child dyads depending on form assignment and individual nonresponse. Agreement between parent and child responses to individual items was measured using the polychoric correlation coefficient and weighted κ. The Chi-square test of symmetry was utilized for a comparison of the pattern of parent-child item discrepancies on the response scales, and the differences between the child and parent responses on the 1-5 item response scale are summarized . RESULTS: A continuum of higher item-level parent-child discrepancies was demonstrated starting with peer relationships, anger, anxiety, and depressive symptoms, followed by progressively lower parent-child discrepancies for energy, fatigue, asthma impact, pain interference, upper extremity, and mobility items. Parent-child discrepancies for pain interference items were lower in the context of chronic pain either in the child or in the parent. CONCLUSIONS: Parent-child item-level discrepancies were lower for more objective or visible items than for items measuring internal states or less observable items measuring latent variables such as peer relationships and fatigue. Future research should focus on the child and parent characteristics that influence domain-specific item-level discrepancies, and under what conditions item-level parent-child discrepancies predict child health outcomes.

PROMIS(®) pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions.

PURPOSE: To conduct a comparative analysis of eight pediatric self-report scales for ages 8-17 years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS(®)) in six pediatric chronic health conditions, using indicators of disease severity. METHODS: Pediatric patients (N = 1454) with asthma, cancer, chronic kidney disease, obesity, rheumatic disease, and sickle cell disease completed items from the PROMIS pediatric mobility, upper extremity functioning, depressive symptoms, anxiety, anger, peer relationships, pain interference, and fatigue self-report scales. Comparisons within the six pediatric chronic health conditions were conducted by examining differences in groups based on the disease severity using markers of severity that were specific to characteristics of each disease. A comparison was also made across diseases between children who had been recently hospitalized and those who had not. RESULTS: In general, there were differences in self-reported health outcomes within each chronic health condition, with patients who had higher disease severity showing worse outcomes. Across health conditions, when children with recent hospitalizations were compared with those who had not been hospitalized in the past 6 months, we found significant differences in the expected directions for all PROMIS domains, except anger. CONCLUSIONS: PROMIS measures discriminate between different clinically meaningful subgroups within several chronic illnesses. Further research is needed to determine the responsiveness of the PROMIS pediatric scales to change over time.

Using item response theory to enrich and expand the PROMIS® pediatric self report banks.

BACKGROUND: The primary objective was to enhance the content coverage of some of the pediatric self-report item banks for ages 8-17 years from the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS®), and extend the range of precise measurement to higher levels of physical functioning. METHODS: Data from 1,419 pediatric patients with cancer, chronic kidney disease, obesity, rehabilitation needs, rheumatic disease, and sickle cell disease were combined with item responses from the original standardization sample of 3,048 children to calibrate new items for the pediatric PROMIS Anger, Anxiety, Depressive Symptoms, Pain Interference, Fatigue, and physical functioning Upper Extremity and Mobility scales. Simultaneous or concurrent calibration using the graded item response theory model placed all of the items on the same scale. RESULTS: Twenty-two of 28 potential new items were added across the seven scales. A recommended short form was proposed for the Anger scale, and the recommended short forms for the Anxiety and Depressive Symptoms scales were revised. Unfortunately, we were not particularly successful at extending the range of measurement for the physical functioning banks. CONCLUSIONS: The present study expanded PROMIS pediatric item banks to add new content and to increase the range of measurement. Using item response theory, the banks were revised and expanded without changing the underlying scale of measurement. For Anger, Anxiety, and Depressive Symptoms, we successfully added new content that may render those banks more robust and flexible.

Gaining the Patient Reported Outcomes Measurement Information System (PROMIS) perspective in chronic kidney disease: a Midwest Pediatric Nephrology Consortium study.

BACKGROUND AND OBJECTIVES: Chronic kidney disease is a persistent chronic health condition commonly seen in pediatric nephrology programs. Our study aims to evaluate the sensitivity of the Patient Reported Outcomes Measurement Information System (PROMIS) pediatric instrument to indicators of disease severity and activity in pediatric chronic kidney disease. METHODS: This cross sectional study included 233 children 8-17 years old, with chronic kidney disease from 16 participating institutions in North America. Disease activity indicators, including hospitalization in the previous 6 months, edema, and number of medications consumed daily, as well as disease severity indicators of kidney function and coexisting medical conditions were captured. PROMIS domains, including depression, anxiety, social-peer relationships, pain interference, fatigue, mobility, and upper extremity function, were administered via web-based questionnaires. Absolute effect sizes (AES) were generated to demonstrate the impact of disease on domain scores. Four children were excluded because of missing glomerular filtration rate (GFR) estimations. RESULTS: Of the 229 children included in the final analysis, 221 completed the entire PROMIS questionnaire. Unadjusted PROMIS domains were responsive to chronic kidney disease activity indicators and number of coexisting conditions. PROMIS domain scores were worse in the presence of recent hospitalizations (depression AES 0.33, anxiety AES 0.42, pain interference AES 0.46, fatigue AES 0.50, mobility AES 0.49), edema (depression AES 0.50, anxiety AES 0.60, pain interference AES 0.77, mobility AES 0.54) and coexisting medical conditions (social peer-relationships AES 0.66, fatigue AES 0.83, mobility AES 0.60, upper extremity function AES 0.48). CONCLUSIONS: The PROMIS pediatric domains of depression, anxiety, social-peer relationships, pain interference, and mobility were sensitive to the clinical status of children with chronic kidney disease in this multi-center cross sectional study. We demonstrated that a number of important clinical characteristics including recent history of hospitalization and edema, affected patient perceptions of depression, anxiety, pain interference, fatigue and mobility. The PROMIS instruments provide a potentially valuable tool to study the impact of chronic kidney disease. Additional studies will be required to assess responsiveness in PROMIS score with changes in disease status over time.

Psychometric properties of the PROMIS ® pediatric scales: precision, stability, and comparison of different scoring and administration options.

OBJECTIVES: The objectives of the present study are to investigate the precision of static (fixed-length) short forms versus computerized adaptive testing (CAT) administration, response pattern scoring versus summed score conversion, and test-retest reliability (stability) of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) pediatric self-report scales measuring the latent constructs of depressive symptoms, anxiety, anger, pain interference, peer relationships, fatigue, mobility, upper extremity functioning, and asthma impact with polytomous items. METHODS: Participants (N = 331) between the ages of 8 and 17 were recruited from outpatient general pediatrics and subspecialty clinics. Of the 331 participants, 137 were diagnosed with asthma. Three scores based on item response theory (IRT) were computed for each respondent: CAT response pattern expected a posteriori estimates, short-form response pattern expected a posteriori estimates, and short-form summed score expected a posteriori estimates. Scores were also compared between participants with and without asthma. To examine test-retest reliability, 54 children were selected for retesting approximately 2 weeks after the first assessment. RESULTS: A short CAT (maximum 12 items with a standard error of 0.4) was found, on average, to be less precise than the static short forms. The CAT appears to have limited usefulness over and above what can be accomplished with the existing static short forms (8-10 items). Stability of the scale scores over a 2-week period was generally supported. CONCLUSION: The study provides further information on the psychometric properties of the PROMIS pediatric scales and extends the previous IRT analyses to include precision estimates of dynamic versus static administration, test-retest reliability, and validity of administration across groups. Both the positive and negative aspects of using CAT versus short forms are highlighted.

PROMIS® Parent Proxy Report Scales for children ages 5-7 years: an item response theory analysis of differential item functioning across age groups.

OBJECTIVE: The objective of the present study is to describe the extension of the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS(®)) pediatric parent proxy-report item banks for parents of children ages 5-7 years, and to investigate differential item functioning (DIF) between the data obtained from parents of 5-7-year-old children with the data obtained from parents of 8-17 year-old children in the original construction of the scales. METHODS: Item response theory (IRT) analyses of DIF were conducted comparing data from the 5-7 age group with data from the established scales for ages 8-17 across 5 generic health domains (physical functioning, pain, fatigue, emotional health, and social health) and asthma. RESULTS: IRT DIF analyses revealed that the majority of the items functioned similarly with responses from parents of younger and older children. A small number of items were removed from the item bank for younger children, and a few items that exhibited statistical DIF were retained in the pools with the caveat that they should not be used in studies that involve comparisons of younger children with older children. CONCLUSIONS: The study confirms that most of the items in the PROMIS parent proxy-report item banks can be used with parents of children ages 5-7. It is anticipated that these new scales will have application for younger pediatric populations when pediatric self-report is not feasible.

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.

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.

Development and psychometric properties of the PROMIS(®) pediatric fatigue item banks.

PURPOSE: This paper reports on the development and psychometric properties of self-reported pediatric fatigue item banks as part of the Patient-Reported Outcomes Measurement Information System (PROMIS). METHODS: Candidate items were developed by using PROMIS qualitative methodology. The resulting 39 items (25 tiredness related and 14 energy related) were field tested in a sample that included 3,048 participants aged 8-17 years. We used confirmatory factor analysis (CFA) to evaluate dimensionality and differential item functioning (DIF) analysis to evaluate parameter stability between genders and by age; we examined residual correlations to evaluate local dependence (LD) among items and estimated the parameters of item response theory (IRT) models. RESULTS: Of 3,048 participants, 48 % were males, 60 % were white, and 23 % had at least one chronic condition. CFA results suggest two moderately correlated factors. Two items were removed due to high LD, and three due to gender-based DIF. Two item banks were calibrated separately using IRT: Tired and (Lack of) Energy, which consisted of 23 and 11 items, respectively; 10- and 8-item short-forms were created. CONCLUSION: The PROMIS assessment of self-reported fatigue in pediatrics includes two item banks: Tired and (Lack of) Energy. Both demonstrated satisfactory psychometric properties and can be used for research settings.

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 theinterview. 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).

PROMIS® Parent Proxy Report Scales: an item response theory analysis of the parent proxy report item banks.

OBJECTIVE: The objective of the present study is to describe the item response theory (IRT) analysis of the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS(®)) pediatric parent proxy-report item banks and the measurement properties of the new PROMIS(®) Parent Proxy Report Scales for ages 8-17 years. METHODS: Parent proxy-report items were written to parallel the pediatric self-report items. Test forms containing the items were completed by 1,548 parent-child pairs. CCFA and IRT analyses of scale dimensionality and item local dependence, and IRT analyses of differential item functioning were conducted. RESULTS: Parent proxy-report item banks were developed and IRT parameters are provided. The recommended unidimensional short forms for the PROMIS(®) Parent Proxy Report Scales are item sets that are subsets of the pediatric self-report short forms, setting aside items for which parent responses exhibit local dependence. Parent proxy-report demonstrated moderate to low agreement with pediatric self-report. CONCLUSIONS: The study provides initial calibrations of the PROMIS(®) parent proxy-report item banks and the creation of the PROMIS(®) Parent Proxy-Report Scales. It is anticipated that these new scales will have application for pediatric populations in which pediatric self-report is not feasible.

PROMIS Pediatric Anger Scale: an item response theory analysis.

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 was to report on the psychometric properties of the PROMIS Pediatric Anger Scale. METHODS: Participants (n = 759) were recruited from 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.