Calibration and Validation of the Dutch-Flemish PROMIS Pain Interference Item Bank in Patients with Chronic Pain

Abstract

The Dutch-Flemish PROMIS Group translated the adult PROMIS Pain Interference item bank into Dutch-Flemish. The aims of the current study were to calibrate the parameters of these items using an item response theory (IRT) model, to evaluate the cross-cultural validity of the Dutch-Flemish translations compared to the original English items, and to evaluate their reliability and construct validity. The 40 items in the bank were completed by 1085 Dutch chronic pain patients. Before calibrating the items, IRT model assumptions were evaluated using confirmatory factor analysis (CFA). Items were calibrated using the graded response model (GRM), an IRT model appropriate for items with more than two response options. To evaluate cross-cultural validity, differential item functioning (DIF) for language (Dutch vs. English) was examined. Reliability was evaluated based on standard errors and Cronbach’s alpha. To evaluate construct validity correlations with scores on legacy instruments (e.g., the Disabilities of the Arm, Shoulder and Hand Questionnaire) were calculated. Unidimensionality of the Dutch-Flemish PROMIS Pain Interference item bank was supported by CFA tests of model fit (CFI = 0.986, TLI = 0.986). Furthermore, the data fit the GRM and showed good coverage across the pain interference continuum (threshold-parameters range: -3.04 to 3.44). The Dutch-Flemish PROMIS Pain Interference item bank has good cross-cultural validity (only two out of 40 items showing DIF), good reliability (Cronbach’s alpha = 0.98), and good construct validity (Pearson correlations between 0.62 and 0.75). A computer adaptive test (CAT) and Dutch-Flemish PROMIS short forms of the Dutch-Flemish PROMIS Pain Interference item bank can now be developed.

Differential item functioning of the patient-reported outcomes information system (PROMIS®) pain interference item bank by language (Spanish versus English)

“…In addition, the study reported here and previous PROMIS ® Pain Interference analyses assume normality of the latent trait distribution. 25 Finally, the results of this study should be replicated in other samples before final conclusions can be reached about the validity of comparisons between Spanish and English speaking groups.…”

Language‐related differential item functioning between English and German PROMIS Depression items is negligible

“…For the assessment of potential language DIF in PROMIS measures, to date researchers have used DIF analysis in an ordinal regression framework (Crane et al, 2006) and its implementation in the lordif-package (Choi, Gibbons, & Crane, 2011) with a criterion of R 2change of 0.02 (Crins et al, 2015;Hahn et al, 2014;Oude Voshaar et al, 2014;Paz et al, 2013). In case of absence of language DIF, parameters from the US calibration sample have been simply used in other languages as well (Hahn et al, 2014;Paz et al, 2013) For all items we unconstrained item parameters from the baseline model one at a time in the German sample.…”

“…Some PROMIS item banks have already been evaluated regarding language DIF, in particular Physical Functioning between US and Latino (Paz, Spritzer, Morales, & Hays, ) as well as US and Dutch samples (Oude Voshaar et al, ), Pain Interference between US and Dutch samples (Crins et al, ), and Social Health between US and Spanish‐speaking samples (Hahn et al, ). While a substantial impact of language related DIF was found in Physical Functioning between US and Latino (Paz et al, ), in others language‐related DIF was negligible (Crins et al, ; Oude Voshaar et al, ) or even absent (Hahn et al, ).…”

“…Some PROMIS item banks have already been evaluated regarding language DIF, in particular Physical Functioning between US and Latino (Paz, Spritzer, Morales, & Hays, ) as well as US and Dutch samples (Oude Voshaar et al, ), Pain Interference between US and Dutch samples (Crins et al, ), and Social Health between US and Spanish‐speaking samples (Hahn et al, ). While a substantial impact of language related DIF was found in Physical Functioning between US and Latino (Paz et al, ), in others language‐related DIF was negligible (Crins et al, ; Oude Voshaar et al, ) or even absent (Hahn et al, ). In studies investigating language DIF of depression measures, DIF has been found with various impact on scale scores (Azocar, Areán, Miranda, & Muñoz, ; Arthurs, Steele, Hudson, Baron, & Thombs, ; Hirsch, Donner‐Banzhoff, & Bachmann, ; Kwakkenbos et al, ) and authors emphasize that assessment of language DIF should be conducted when pooling different language data (Kwakkenbos et al, ; Arthurs et al, ).…”

PROMIS® tools as endpoints in clinical trials: what should you know? A review of PROMIS® capabilities and the current regulatory space

“…For pediatric populations, there are PROMIS-25, PROMIS-37, and PROMIS-49, each assessing anxiety, depressive symptoms, fatigue, pain intensity and interference, mobility and peer relationships. They can either be self-completed (ages [8][9][10][11][12][13][14][15][16][17] or completed by a parental proxy (ages [5][6][7][8][9][10][11][12][13][14][15][16][17]. Distinct from the Profiles, there is also a PROMIS global instrument which serves as a brief (10 item adult, 7/9 item pediatric) measure of physical and mental health.…”