Dataset Information

The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS).

ABSTRACT: BACKGROUND:The Patient-Reported Outcomes Measurement Information System® (PROMIS) includes a Physical Function (PF) item bank and an Upper Extremity (UE) item bank, which is composed of a subset of items from the PF bank. The UE item bank has few items and known ceiling effects. Therefore, this study aimed to expand the item bank to assess a wider range of functioning. With the additional content, other psychometric properties-improved content validity, item bank depth, range of measurement, and score reliability-were also evaluated. We convened an expert panel to review potential items, and then conducted psychometric analyses on both extant and newly-collected data. RESULTS:Expert focus groups reviewed the PF item bank for items that were "sufficiently" related to upper extremity functioning for inclusion in the expanded UE item bank. The candidate item bank was quantitatively evaluated in a new sample of 600 people. The final items were calibrated in an aggregated dataset (n?=?11,635) from two existing datasets, and the newly collected sample. The original UE item bank included 15 items. After expert review and quantitative evaluation, 31 items were added. The combined 46 items were calibrated using item response theory (IRT). Then computer adaptive tests (CATs) were simulated based off of the psychometric results. These indicated that the new UE item bank has an extended measurement range compared to the original version. CONCLUSIONS:The expanded PROMIS UE item bank assesses a wider range of upper extremity functioning compared to the initial UE item bank. However, ceiling effects remain a concern for unimpaired groups. The new UE item bank is recommended for individuals with known or suspected upper extremity limitations.

SUBMITTER: Kaat AJ

PROVIDER: S-EPMC6879697 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS).

Kaat Aaron J AJ Buckenmaier Chester Trip CT Cook Karon F KF Rothrock Nan E NE Schalet Benjamin D BD Gershon Richard C RC Vrahas Mark S MS

Journal of patient-reported outcomes 20191126 1

<h4>Background</h4>The Patient-Reported Outcomes Measurement Information System® (PROMIS) includes a Physical Function (PF) item bank and an Upper Extremity (UE) item bank, which is composed of a subset of items from the PF bank. The UE item bank has few items and known ceiling effects. Therefore, this study aimed to expand the item bank to assess a wider range of functioning. With the additional content, other psychometric properties-improved content validity, item bank depth, range of measurem ...[more]

PMID: 31773413

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Project description:BACKGROUND:The Dutch-Flemish PROMIS® Upper Extremity (DF-PROMIS-UE) V2.0 item bank was recently developed using Item Response Theory (IRT). Unknown for this bank are: (1) if it is legitimate to calculate IRT-based scores for short forms and Computerized Adaptive Tests (CATs), which requires that the items meet the assumptions of and fit the IRT-model (Graded Response Model [GRM]);(2) if it is legitimate to compare (sub) groups of patients using this measure, which requires measurement invariance; and (3) the precision of the estimated patients' scores for patients with different levels of functioning and compared to legacy measures. Aims were to evaluate (1) the assumptions of and fit to the GRM, (2) measurement invariance and (3) (comparative) precision of the DF-PROMIS-UE v2.0. METHODS:Cross-sectional data were collected in Dutch patients with upper extremity disorders. Assessed were IRT-assumptions (unidimensionality [bi-factor analysis], local independence [residual correlations], monotonicity [coefficient H]), GRM item fit, measurement invariance (absence of Differential Item Functioning [DIF] due to age, gender, center, duration, and location of complaints) and precision (standard error of IRT-based scores across levels of functioning). To study measurement invariance for language [Dutch vs. English], additional US data were used. Legacy instruments were the Disability of the Arm, Shoulder and Hand (DASH), the QuickDASH and the Michigan Hand Questionnaire (MHQ). RESULTS:In total 521 Dutch (mean age?±?SD?=?51?±?17?years, 49% female) and 246 US patients (mean age?±?SD?=?48?±?14?years, 69% female) participated. The DF-PROMIS-UE v2.0 item bank was sufficiently unidimensional (Omega-H?=?0.80, Explained Common Variance?=?0.68), had negligible local dependence (four out of 1035 correlations >?0.20), good monotonicity (H?=?0.63), good GRM fit (no misfitting items) and demonstrated sufficient measurement invariance. Precise estimates (Standard Error?<?3.2) were obtained for most patients (7-item short form, 88.5%; standard CAT, 91.3%; and, fixed 7-item CAT, 87.6%). The DASH displayed better reliability than the DF-PROMIS-UE short form and standard CAT, the QuickDASH displayed comparable reliability. The MHQ-ADL displayed better reliability than the DF-PROMIS-UE short form and standard CAT for T-scores between 28 and 50. For patients with low function, the DF-PROMIS-UE measures performed better. CONCLUSIONS:The DF-PROMIS-UE v2.0 item bank showed sufficient psychometric properties in Dutch patients with UE disorders.

Project description:PurposeThis study aimed to validate the PROMIS Pediatric item bank v2.0 Peer Relationships and compare reliability of the full item bank to its short form, computerized adaptive test (CAT) and the social functioning (SF) subscale of the Pediatric Quality of Life Inventory (PedsQL™).MethodsChildren aged 8-18 (n = 1327), representative of the Dutch population completed the Peer Relationships item bank. A graded response model (GRM) was fit to the data. Structural validity was assessed by checking item-fit statistics (S-X2, p < 0.001 = misfit). For construct validity, a moderately strong correlation (> 0.50) was expected between Peer Relationships and the PedsQL SF subscale. Cross-cultural DIF between U.S. and NL was assessed using logistic regression, where an item with McFadden's pseudo R2 > 0.02 was considered to have DIF. Percentage of participants reliably measured was assessed using the standard error of measurement (SEM) < 0.32 as a criterion (reliability of 0.90). Relative efficiency ((1-SEM2)/nitems) was calculated to compare how well the instruments performed relative to the amount of items administered.ResultsIn total, 527 (response rate: 39.7%) children completed the PROMIS v2.0 Peer Relationships item bank (nitems = 15) and the PedsQL™ (nitems = 23). Structural validity of the Peer Relationships item bank was sufficient, but one item displayed misfit in the GRM model (S-X2 < 0.001); 5152R1r ("I played alone and kept to myself"). The item 733R1r ("I was a good friend") was the only item that displayed cross-cultural DIF (R2 = 0.0253). The item bank correlated moderately high (r = 0.61) with the PedsQL SF subscale Reliable measurements were obtained at the population mean and > 2SD in the clinically relevant direction. CAT outperformed all other measures in efficiency. Mean T-score of the Dutch general population was 46.9(SD 9.5).ConclusionThe pediatric PROMIS Peer Relationships item bank was successfully validated for use within the Dutch population and reference data are now available.

Project description:BackgroundLimitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs).MethodsPubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach.ResultsEleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments.ConclusionsThe first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.

Project description:This is the first study of the measurement equivalence of the Patient Reported Outcomes Measurement Information System® (PROMIS®) Anxiety short forms in a large ethnically diverse sample. The psychometric properties and differential item functioning (DIF) were examined across different racial/ethnic, educational, age, gender and language groups. METHODS:These data are from individuals selected from cancer registries in the United States. For the analyses of race/ethnicity the reference group was non-Hispanic Whites (n = 2,263), the studied groups were non-Hispanic Blacks (n = 1,117), Hispanics (n = 1,043) and Asians/Pacific Islanders (n = 907). Within the Hispanic subsample, there were 335 interviews conducted in Spanish and 703 in English. The 11 anxiety items were from the PROMIS emotional disturbance item bank. DIF hypotheses were generated by content experts who rated whether or not they expected DIF to be present, and the direction of the DIF with respect to several comparison groups. The primary method used for DIF detection was the Wald test for examination of group differences in item response theory (IRT) item parameters accompanied by magnitude measures. Expected item scores were examined as measures of magnitude. The method used for quantification of the difference in the average expected item scores was the non-compensatory DIF (NCDIF) index. DIF impact was examined using expected scale score functions. Additionally, precision and reliabilities were examined using several methods. RESULTS:Although not hypothesized to show DIF for Asians/Pacific Islanders, every item evidenced DIF by at least one method. Two items showed DIF of higher magnitude for Asians/Pacific Islanders vs. Whites: "Many situations made me worry" and "I felt anxious". However, the magnitude of DIF was small and the NCDIF statistics were not above threshold. The impact of DIF was negligible. For education, six items were identified with consistent DIF across methods: fearful, anxious, worried, hard to focus, uneasy and tense. However, the NCDIF was not above threshold and the impact of DIF on the scale was trivial. No items showed high magnitude DIF for gender. Two items showed slightly higher magnitude for age (although not above the cutoff): worried and fearful. The scale level impact was trivial. Only one item showed DIF with the Wald test after the Bonferroni correction for the language comparisons: "I felt fearful". Two additional items were flagged in sensitivity analyses after Bonferroni correction, anxious and many situations made me worry. The latter item also showed DIF of higher magnitude, with an NCDIF value (0.144) above threshold. Individual impact was relatively small. CONCLUSIONS:Although many items from the PROMIS short form anxiety measures were flagged with DIF, item level magnitude was low and scale level DIF impact was minimal; however, three items: anxious, worried and many situations made me worry might be singled out for further study. It is concluded that the PROMIS Anxiety short form evidenced good psychometric properties, was relatively invariant across the groups studied, and performed well among ethnically diverse subgroups of Blacks, Hispanic, White non-Hispanic and Asians/Pacific Islanders. In general more research with the Asians/Pacific Islanders group is needed. Further study of subgroups within these broad categories is recommended.

Project description:AIMS:The goals of these analyses were to examine the psychometric properties and measurement equivalence of a self-reported cognition measure, the Patient Reported Outcome Measurement Information System® (PROMIS®) Applied Cognition - General Concerns short form. These items are also found in the PROMIS Cognitive Function (version 2) item bank. This scale consists of eight items related to subjective cognitive concerns. Differential item functioning (DIF) analyses of gender, education, race, age, and (Spanish) language were performed using an ethnically diverse sample (n = 5,477) of individuals with cancer. This is the first analysis examining DIF in this item set across ethnic and racial groups. METHODS:DIF hypotheses were derived by asking content experts to indicate whether they posited DIF for each item and to specify the direction. The principal DIF analytic model was item response theory (IRT) using the graded response model for polytomous data, with accompanying Wald tests and measures of magnitude. Sensitivity analyses were conducted using ordinal logistic regression (OLR) with a latent conditioning variable. IRT-based reliability, precision and information indices were estimated. RESULTS:DIF was identified consistently only for the item, brain not working as well as usual. After correction for multiple comparisons, this item showed significant DIF for both the primary and sensitivity analyses. Black respondents and Hispanics in comparison to White non-Hispanic respondents evidenced a lower conditional probability of endorsing the item, brain not working as well as usual. The same pattern was observed for the education grouping variable: as compared to those with a graduate degree, conditioning on overall level of subjective cognitive concerns, those with less than high school education also had a lower probability of endorsing this item. DIF was also observed for age for two items after correction for multiple comparisons for both the IRT and OLR-based models: "I have had to work really hard to pay attention or I would make a mistake" and "I have had trouble shifting back and forth between different activities that require thinking". For both items, conditional on cognitive complaints, older respondents had a higher likelihood than younger respondents of endorsing the item in the cognitive complaints direction. The magnitude and impact of DIF was minimal. The scale showed high precision along much of the subjective cognitive concerns continuum; the overall IRT-based reliability estimate for the total sample was 0.88 and the estimates for subgroups ranged from 0.87 to 0.92. CONCLUSION:Little DIF of high magnitude or impact was observed in the PROMIS Applied Cognition - General Concerns short form item set. One item, "It has seemed like my brain was not working as well as usual" might be singled out for further study. However, in general the short form item set was highly reliable, informative, and invariant across differing race/ethnic, educational, age, gender, and language groups.

Project description:BackgroundPatient-Reported Outcomes provide an opportunity for patients to establish dialogue with pharmaceutical or biotechnology companies about their health conditions without interpretation by a clinician or anyone else. However, Patient-Reported Outcomes that can be widely applicable for use in patient-focused drug development or clinical trial designs are not yet validated for all diseases. The aim of this study report was to provide supportive evidence of the construct and content validity of selected Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaires compared with other disease-relevant clinical outcome measures, including the 6-Minute Walk Distance, forced vital capacity, and Manual Muscle Test, in late-onset Pompe disease and to provide supportive evidence that the selected PROMIS measures are relevant and important to these patients.MethodsThirty patients with late-onset Pompe disease completed five PROMIS questionnaires that were chosen based on patient and provider feedback, along with discussion with key opinion leaders who are experts in Pompe disease. The Amicus Pompe Patient Advisory Board also provided patient experience feedback using the PROMIS questionnaires. Clinical outcome measures (6-Minute Walk Distance, forced vital capacity, and Manual Muscle Test) were collected at the Duke University Pompe Disease Clinical Research Program during a single visit.ResultsThe Patient Advisory Board rated the questionnaires as representative of an unmet need. Correlation data demonstrated moderate to strong correlations of PROMIS questionnaires with the specified clinical outcome measures (6-Minute Walk Distance, forced vital capacity, and Manual Muscle Test). These data supported the construct and content validity of the PROMIS questionnaires because they confirmed the motor signs and symptoms of functional disability observed in patients with Pompe disease.ConclusionsThe correlations indicate that the clinical outcome measures assess important concepts related to patient-reported experiences. The Patient Advisory Board findings suggest that the selected PROMIS questionnaires are meaningful and address important concepts to patients with Pompe disease. The data were collected from a small number of patients at a single time point; further studies are needed with additional PROMIS questionnaires, which should include measures of motor function and health-related quality of life, in a larger number of patients followed up longitudinally.

Dataset Information

The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS).

Publications

The expansion and validation of a new upper extremity item bank for the Patient-Reported Outcomes Measurement Information System® (PROMIS).

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