Dataset Information

Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

ABSTRACT: Two item banks for substance use were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): severity of substance use and positive appeal of substance use.Qualitative item analysis (including focus groups, cognitive interviewing, expert review, and item revision) reduced an initial pool of more than 5300 items for substance use to 119 items included in field testing. Items were written in a first-person, past-tense format, with 5 response options reflecting frequency or severity. Both 30-day and 3-month time frames were tested. The calibration sample of 1336 respondents included 875 individuals from the general population (ascertained through an internet panel) and 461 patients from addiction treatment centers participating in the National Drug Abuse Treatment Clinical Trials Network.Final banks of 37 and 18 items were calibrated for severity of substance use and positive appeal of substance use, respectively, using the two-parameter graded response model from item response theory (IRT). Initial calibrations were similar for the 30-day and 3-month time frames, and final calibrations used data combined across the time frames, making the items applicable with either interval. Seven-item static short forms were also developed from each item bank.Test information curves showed that the PROMIS item banks provided substantial information in a broad range of severity, making them suitable for treatment, observational, and epidemiological research in both clinical and community settings.

SUBMITTER: Pilkonis PA

PROVIDER: S-EPMC4633351 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

Pilkonis Paul A PA Yu Lan L Dodds Nathan E NE Johnston Kelly L KL Lawrence Suzanne M SM Hilton Thomas F TF Daley Dennis C DC Patkar Ashwin A AA McCarty Dennis D

Drug and alcohol dependence 20150921

<h4>Background</h4>Two item banks for substance use were developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): severity of substance use and positive appeal of substance use.<h4>Methods</h4>Qualitative item analysis (including focus groups, cognitive interviewing, expert review, and item revision) reduced an initial pool of more than 5300 items for substance use to 119 items included in field testing. Items were written in a first-person, past-tense forma ...[more]

PMID: 26423364

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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:The Patient-Reported Outcomes Measurement Information System (PROMIS) Smoking Initiative has developed item banks for assessing six smoking behaviors and biopsychosocial correlates of smoking among adult cigarette smokers. The goal of this study is to evaluate the performance of the Spanish version of the PROMIS smoking item banks as compared to the original banks developed in English.The six PROMIS banks for daily smokers were translated into Spanish and administered to a sample of Spanish-speaking adult daily smokers in the United States (N = 302). We first evaluated the unidimensionality of each bank using confirmatory factor analysis. We then conducted a two-group item response theory calibration, including an item response theory-based Differential Item Functioning (DIF) analysis by language of administration (Spanish vs. English). Finally, we generated full bank and short form scores for the translated banks and evaluated their psychometric performance.Unidimensionality of the Spanish smoking item banks was supported by confirmatory factor analysis results. Out of a total of 109 items that were evaluated for language DIF, seven items in three of the six banks were identified as having levels of DIF that exceeded an established criterion. The psychometric performance of the Spanish daily smoker banks is largely comparable to that of the English versions.The Spanish PROMIS smoking item banks are highly similar, but not entirely equivalent, to the original English versions. The parameters from these two-group calibrations can be used to generate comparable bank scores across the two language versions.In this study, we developed a Spanish version of the PROMIS smoking toolkit, which was originally designed and developed for English speakers. With the growing Spanish-speaking population, it is important to make the toolkit more accessible by translating the items and calibrating the Spanish version to be comparable with English-language scores. This study provided the translated item banks and short forms, comparable unbiased scores for Spanish speakers and evaluations of the psychometric properties of the new Spanish toolkit.

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: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.

Dataset Information

Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

Publications

Item banks for substance use from the Patient-Reported Outcomes Measurement Information System (PROMIS(®)): Severity of use and positive appeal of use.

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