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Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale.

ABSTRACT: Although multinational clinical trials frequently use patient-reported outcomes to measure efficacy, measurement equivalence across cultures and languages, a scientific requirement, is rarely tested. Clinically accessible accounts are rare; exemplars are needed.To develop and test a Turkish version of the Multiple Sclerosis Walking Scale (MSWS-12v2) as a clinical exemplar for examining measurement equivalence.The MSWS-12v2 Turkish (MSWS-12v2T) was developed using recognised methods for linguistic equivalence. Rasch measurement theory was used to examine measurement performance (multiple tests of targeting, scale performance, and person measurement) and measurement equivalence (differential item functioning). UK data (n?=?3310) were used for comparisons and differential item functioning testing.One hundred and twenty-four people from two Turkish centres completed the MSWS-12v2T. Rasch measurement theory evidence supported MSWS-12v2T as reliable (person separation?=?0.96) and valid (thresholds ordered; no concerning item misfit, bias, or person misfit). However, four items demonstrated significantly different performance between UK and Turkish samples. These item differences significantly affected scores (person measurements) at the group-level (p?

SUBMITTER: Dib H

PROVIDER: S-EPMC5613845 | biostudies-other | 2017 Jul-Sep

REPOSITORIES: biostudies-other

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Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale.

Dib Hussein H Tamam Yusuf Y Terzi Murat M Hobart Jeremy J

Multiple sclerosis journal - experimental, translational and clinical 20170701 3

<h4>Background</h4>Although multinational clinical trials frequently use patient-reported outcomes to measure efficacy, measurement equivalence across cultures and languages, a scientific requirement, is rarely tested. Clinically accessible accounts are rare; exemplars are needed.<h4>Objective</h4>To develop and test a Turkish version of the Multiple Sclerosis Walking Scale (MSWS-12v2) as a clinical exemplar for examining measurement equivalence.<h4>Methods</h4>The MSWS-12v2 Turkish (MSWS-12v2T) ...[more]

PMID: 28975038

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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.

Dataset Information

Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale.

Publications

Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale.

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