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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. [ABSTRACT FROM AUTHOR]

Background: The National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS) has developed several scales measuring symptoms and function for use by the clinical research community. One advantage of PROMIS is the ability to link other scales to the PROMIS metric.Objectives: The objectives of this research are to provide evidence of validity for one of the PROMIS measures, the Pediatric Asthma Impact Scale (PAIS), and to link the PedsQL™ Asthma Symptoms Scale with the metric of the PAIS.Methods: Descriptive statistics were computed describing the relationships among scores on the PAIS, the PedsQL™ Asthma Symptoms, Treatment, Worry, and Communication Scales, and the DISABKIDS Asthma Impact and Worry Scales for approximately 300 children ages 8-17. A novel linkage method based on item response theory (IRT), calibrated projection, was used to link scores on the PedsQL™ Asthma Symptoms Scale with the metric of the PAIS.Results: The PAIS exhibited strong convergent validity with the PedsQL™ Asthma Symptoms Scale, and less strong relations with the other five scales. The linkage system uses scores on the PedsQL™ Asthma Symptoms Scale to produce relatively precise score estimates on the metric of the PAIS.Conclusions: Results of this study provide evidence for the validity of the PAIS, and a method to use scores on the PedsQL™ Asthma Symptoms Scale to estimate scores on the metric of the PAIS, in partial fulfillment of the PROMIS goal to provide a lingua franca for health-related quality of life. [ABSTRACT FROM AUTHOR]

Abstract 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).

BACKGROUND:: An important part of examining the adequacy of measures for use in ethnically diverse populations is the evaluation of differential item functioning (DIF) among subpopulations such as those administered the measure in different languages. A number of methods exist for this purpose. OBJECTIVE:: The objective of this study was to introduce and demonstrate the identification of DIF using item response theory (IRT) and the likelihood-based model comparison approach. METHODS:: Data come from a sample of community-residing elderly who were part of a dementia case registry. A total of 1578 participants were administered either an English (n = 913) or Spanish (n = 665) version of the 21-item Mini-Mental State Examination. IRT was used to identify language DIF in these items with the likelihood-based model comparison approach. RESULTS:: Fourteen of the 21 items exhibited significant DIF according to language of administration. However, because the direction of the identified DIF was not consistent for one language version over the other, the impact at the scale level was negligible. CONCLUSIONS:: IRT and the likelihood-based model comparison approach comprise a powerful tool for DIF detection that can aid in the development, refinement, and evaluation of measures for use in ethnically diverse populations. [ABSTRACT FROM AUTHOR]

An item response theory (IRT) approach to test linking based on summed scores is presented and demonstrated by calibrating a modified 23-item version of the Center for Epidemiologic Studies Depression Scale (CES-D) to the standard 20-item CES-D. Data are from the Depression Patient Outcomes Research Team, II, which used a modified CES-D to measure risk for depression. Responses (N = 1,120) to items on both the original and modified versions were calibrated simultaneously using F. Samejima's (1969, 1997) graded IRT model. The 2 scales were linked on the basis of derived summed-score-to-IRT-score translation tables. The established cut score of 16 on the standard CES-D corresponded most closely to a summed score of 20 on the modified version. The IRT summed-score approach to test linking is a straightforward, valid, and practical method that can be applied in a variety of situations. [ABSTRACT FROM AUTHOR]

The concept of factorial invariance has evolved since it originated in the 1930s as a criterion for the usefulness of the multiple factor model; it has become a form of analysis supporting the validity of inferences about group differences on underlying latent variables. The analysis of differential item functioning (DIF) arose in the literature of item response theory (IRT), where its original purpose was the detection and removal of test items that are differentially difficult for, or biased against, one subpopulation or another. The two traditions merge at the level of the underlying latent variable model, but their separate origins and different purposes have led them to differ in details of terminology and procedure. This review traces some aspects of the histories of the two traditions, ultimately drawing some conclusions about how analysts may draw on elements of both, and how the nature of the research question determines the procedures used. Whether statistical tests are grouped by parameter (as in studies of factorial invariance) or across parameters by variable (as in DIF analysis) depends on the context and is independent of the model, as are subtle aspects of the order of the tests. In any case in which DIF or partial invariance is a possibility, the invariant parameters, or anchor items in DIF analysis, are best selected in an interplay between the statistics and judgment about what is being measured.

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., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

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.

Introduction: In the Netherlands, the sentinel lymph node procedure protocol consists of preoperative lymphoscintigraphy combined with intraoperative blue dye for identifying sentinel lymph nodes in early vulvar squamous cell carcinoma. This study aimed at investigating the role of early and late lymphoscintigraphy., Material and Methods: From January 2015 to January 2019, early and late lymphoscintigraphies of 52 women were retrospectively analyzed. Lymphoscintigraphy was performed 30 minutes (early) and 2.5-4 hours (late) after vulvar injection of 99m Tc-labeled nanocolloid. We calculated the concordance correlation coefficient (CCC) between number of sentinel lymph nodes detected on both images using the Lins concordance coefficient and correlated with clinicopathological data., Results: Thirty-four women had a midline tumor and 18 had a lateral tumor. Detection rates with early and late scintigraphy were 88.5% and 98.1%, respectively. Median number of detected nodes was 1.0 (0-7) and 2.0 (0-7). Good statistical correlation between number of sentinel lymph nodes detected on early and late imaging was found (CCC = 0.76) in most patients. In 18 women (35%) a mismatch occurred: a higher number of nodes was detected on late imaging. In 11 of 18 women re-injection was performed because no sentinel lymph nodes were visualized on early images. Late imaging and intraoperative detection showed a good statistical correlation (CCC = 0.61). One woman showed an isolated groin recurrence despite negative sentinel lymph nodes., Conclusions: This study showed good statistical correlations between early and late scintigraphy in most patients. However, in 35% of women late scintigraphy detected more nodes. In case of poor visualization after the first scintigraphy, re-injection should be considered. Late scintigraphy is probably helpful in confirming successful re-injection and in showing deviating lymph flow in women with failed mapping after the first injection and successful re-injection. Because missing metastatic sentinel lymph nodes often leads to a poor prognosis, we prefer optimal correlations between imaging and intraoperative identification. Hence, late scintigraphy cannot be safely omitted., (© 2022 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Parenting is a critical mechanism contributing to child and adolescent development and outcomes. The Multidimensional Assessment of Parenting Scale (MAPS) is a new measure that aims to address gaps in the literature on existing self-report parenting measures. Research to date on the MAPS includes essential steps of scale development and validation; however, replicating scale dimensionality and examining differential item functioning (DIF) based on child age and a parent or child gender is a critical next step. The current study included 1,790 mothers and fathers of sons and daughters, spanning childhood to adolescence in the United States. Item response theory (IRT) confirmed initial factor-analytic work revealing positive and negative dimensions; however, the best-fitting multidimensional model included six nested dimensions from the original seven. A few notable items displayed DIF based on child age and parent gender; however, DIF based on child gender had minimal impact on the overall score. Future directions, clinical implications, and recommendations are discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Objective: To investigate the influence of a dedicated team on the success rate of external cephalic version and mode of delivery., Study Design: This prospective cohort study included 673 women with a singleton fetus in breech presentation who underwent external cephalic version between January 2013 and December 2017 at Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. In January 2014, a dedicated team consisting of six gynaecologists and six midwives was introduced at the study clinic. The success rate of external cephalic version and mode of delivery were analysed. In addition, predictors for success were examined by logistic regression analysis. Successful external cephalic version was defined as fetal cephalic presentation immediately following the procedure., Results: Following the introduction of a dedicated team in 2014, the success rate of external cephalic version increased from 39.8% in 2013 to 69.5% in 2017 (p < 0.001), with the greatest increase in nulliparous women (from 23.5% to 58.5%, p = 0.002). Over the 5-year study period, the vaginal delivery rate after external cephalic version increased from 43% in 2013 to 71% in 2017 (p < 0.05). The rate of caesarean section after external cephalic version decreased from 55% to 27% (p < 0.05). Anterior placenta [odds ratio (OR) 0.7, 95% confidence interval (CI) 0.48‒0.97] and complete breech (OR 0.2, 95% CI 0.07‒0.90) were significantly associated with a lower success rate., Conclusions: This study showed that introduction of a dedicated team led to a significant increase in the success rate of external cephalic version, and a significant decrease in the rate of caesarean section for women presenting with breech in pregnancy., (Copyright © 2019 Elsevier B.V. All rights reserved.)

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.

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.

Purpose To estimate cancer population-based reference values in the United States for eight PROMIS (Patient-Reported Outcomes Measurement Information System) domains by age and stage of disease. Patients and Methods For the Measuring Your Health (MY-Health) study, persons newly diagnosed with cancer (prostate, colorectal, non-small-cell lung, non-Hodgkin lymphoma, breast, uterine, or cervical) from 2010 to 2012 (N = 5,284) were recruited through the National Cancer Institute's SEER Program. Participants were mailed surveys 6 to 13 months after diagnosis. Raking by race/ethnicity, age, and stage generated weighted average PROMIS scores for pain interference, fatigue, anxiety, depression, sleep disturbance, physical function, ability to participate in social roles, and cognitive function. PROMIS measures are standardized to a T-score metric, with a score of 50 representing the general US population mean. Clinically meaningful differences were defined as a 3-point difference in scores. Results Several reference values (means) for patients with cancer were worse than the general United States population norms of 50. These include pain interference (52.4), fatigue (52.2), and physical function (44.1). Reference values were highest (ie, showed greatest symptom burden) in lung cancer (pain interference, 55.5; fatigue, 57.3; depression, 51.4) and cervical cancer (anxiety, 53.2; sleep disturbance, 53.4). Reference values for patients age 65 to 84 years reported lower sleep disturbance, anxiety, and depression, and better cognitive function than younger patients. Cancer reference values were poorer among those with advanced disease compared with patients with limited or no evidence of disease, specifically physical function (41.1 v 46.6, respectively), fatigue (55.8 v 50.2, respectively), and pain interference (55.2 v 50.9, respectively). Conclusion In a large, population-based sample of patients with recently diagnosed cancer, we observed symptom severity and functional deficits by age, stage, and cancer type consistent with the expected impact of cancer diagnosis and treatment. These United States cancer reference values can help facilitate interpretation of the PROMIS domain scores in research studies or in clinical applications that measure and evaluate the symptom and functional burden patients with cancer experience after initial treatment.

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.