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Evaluation of the Patient-Reported Outcomes Information System (PROMIS(®)) Spanish-language physical functioning items.

ABSTRACT: To evaluate the equivalence of the PROMIS(®) physical functioning item bank by language of administration (English versus Spanish).The PROMIS(®) wave 1 English-language physical functioning bank consists of 124 items, and 114 of these were translated into Spanish.Item frequencies, means and standard deviations, item-scale correlations, and internal consistency reliability were calculated. The IRT assumption of unidimensionality was evaluated by fitting a single-factor confirmatory factor analytic model. IRT threshold and discrimination parameters were estimated using Samejima's Graded Response Model. DIF by language of administration was evaluated.Item means ranged from 2.53 (SD = 1.36) to 4.62 (SD = 0.82). Coefficient alpha was 0.99, and item-rest correlations ranged from 0.41 to 0.89. A one-factor model fits the data well (CFI = 0.971, TLI = 0.970, and RMSEA = 0.052). The slope parameters ranged from 0.45 ("Are you able to run 10 miles?") to 4.50 ("Are you able to put on a shirt or blouse?"). The threshold parameters ranged from -1.92 ("How much do physical health problems now limit your usual physical activities (such as walking or climbing stairs)?") to 6.06 ("Are you able to run 10 miles?"). Fifty of the 114 items were flagged for DIF based on an R(2) of 0.02 or above criterion. The expected total score was higher for Spanish- than English-language respondents.English- and Spanish-speaking subjects with the same level of underlying physical function responded differently to 50 of 114 items. This study has important implications in the study of physical functioning among diverse populations.

SUBMITTER: Paz SH

PROVIDER: S-EPMC3683100 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Evaluation of the Patient-Reported Outcomes Information System (PROMIS(®)) Spanish-language physical functioning items.

Paz Sylvia H SH Spritzer Karen L KL Morales Leo S LS Hays Ron D RD

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation 20121103 7

<h4>Purpose</h4>To evaluate the equivalence of the PROMIS(®) physical functioning item bank by language of administration (English versus Spanish).<h4>Methods</h4>The PROMIS(®) wave 1 English-language physical functioning bank consists of 124 items, and 114 of these were translated into Spanish.<h4>Analysis</h4>Item frequencies, means and standard deviations, item-scale correlations, and internal consistency reliability were calculated. The IRT assumption of unidimensionality was evaluated by fi ...[more]

PMID: 23124505

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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: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.

Project description:BackgroundThe Patient-Reported Outcomes Measurement Information SystemⓇ (PROMISⓇ) is a dynamic system of psychometrically sound patient-reported outcome (PRO) measures. There has been a recent increase in the use of PROMIS measures, yet little has been written about the reporting of these measures in the field of orthopedics. The purpose of this study was to conduct a systematic review to determine the uptake of PROMIS measures across orthopedics and to identify the type of PROMIS measures and domains that are most commonly used in orthopedic research and practice.MethodsWe searched PubMed, Embase, and Scopus using keywords and database-specific subject headings to capture orthopedic studies reporting PROMIS measures through November 2018. Our inclusion criteria were use of PROMIS measures as an outcome or used to describe a population of patients in an orthopedic setting in patients ≥ 18 years of age. We excluded non-quantitative studies, reviews, and case reports.ResultsOur final search yielded 88 studies published from 2013 through 2018, with 57% (50 studies) published in 2018 alone. By body region, 28% (25 studies) reported PROMIS measures in the upper extremity (shoulder, elbow, hand), 36% (32 studies) reported PROMIS measures in the lower extremity (hip, knee, ankle, foot), 19% (17 studies) reported PROMIS measures in the spine, 10% (9 studies) reported PROMIS measures in trauma patients, and 6% (5 studies) reported PROMIS measures in general orthopedic patients. The majority of studies reported between one and three PROMIS domains (82%, 73 studies). The PROMIS Computerized Adaptive Test (CAT) approach was most commonly used (81%, 72 studies). The most frequently reported PROMIS domains were physical function (81%, 71 studies) and pain interference (61%, 54 studies).ConclusionOur review found an increase in the reporting of PROMIS measures over the recent years. Utilization of PROMIS measures in orthopedic populations is clinically appropriate and can facilitate communication of outcomes across different provider types and with reduced respondent burden.RegistrationThe protocol for this systematic review was designed in accordance with the PRISMA guidelines and is registered with the PROSPERO database (CRD42018088260).

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.

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Evaluation of the Patient-Reported Outcomes Information System (PROMIS(®)) Spanish-language physical functioning items.

Publications

Evaluation of the Patient-Reported Outcomes Information System (PROMIS(®)) Spanish-language physical functioning items.

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