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15-05-2018

Translation and cross-cultural adaptation of eight pediatric PROMIS® item banks into Spanish and German

Auteurs: J. Devine, F. Klasen, J. Moon, M. Herdman, M. P. Hurtado, G. Castillo, A. C. Haller, H. Correia, C. B. Forrest, U. Ravens-Sieberer

Gepubliceerd in: Quality of Life Research | Uitgave 9/2018

Abstract

Purpose

The Patient-Reported Outcome Measurement Information System (PROMIS®) is a National Institutes of Health (NIH)-funded initiative to develop reliable, valid, and normed item banks to measure health. We describe the first large-scale translation and cross-cultural adaptation effort to German and Spanish of eight pediatric PROMIS item banks: Physical activity (PAC), subjective well-being (SWB), experiences of stress (EOS), and family relations (FAM).

Methods

We utilized methods outlined in the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Translation Task Force recommendations. Ten professional translators performed a translatability assessment and generated forward translations. Forward Translations were compared within a country and cross-culturally to identify problems and to produce a consensus-derived version, which was then back translated, evaluated, and revised where necessary. Reconciled versions were evaluated in cognitive interviews with 126 children before finalization.

Results

Eight resulting pediatric PROMIS® item banks were translated: Two PAC banks (22 total items), three SWB banks (125 total items), two EOS banks (45 total items), and one FAM bank (47 total items). Up to 92% of all items raised no or only minor translation difficulties, 0–5.6% were difficult to translate. Up to 20% item revisions were necessary to ensure conceptual equivalence and comprehensibility. Cognitive interviews indicated that 91–94% of the final items were appropriate for children (8–17 years).

Conclusions

German and Spanish translations of eight PROMIS Pediatric item banks were created for clinical trials and routine pediatric health care. Initial translatability assessment and rigorous translation methodology helped to ensure conceptual equivalence and comprehensibility. Next steps include cross-cultural validation and adaptation studies.

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In the following, we will use the term “child” or “children” whenever referring to children and/or adolescents.

An example for an item revision in the 7th step is that the German translation of the PA item “I felt pleased” (FT) was “war ich gut gelaunt,” which translated back to “I was in a good mood” (BT). The reviewer noticed the different concepts between FT and BT and talked to the translators, who then suggested the item revision to “war ich glücklich und zufrieden.” (This was then tested fine within the following CIs with children, i.e., the original concept was covered.)

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Titel: Translation and cross-cultural adaptation of eight pediatric PROMIS® item banks into Spanish and German
Auteurs: J. Devine
F. Klasen
J. Moon
M. Herdman
M. P. Hurtado
G. Castillo
A. C. Haller
H. Correia
C. B. Forrest
U. Ravens-Sieberer
Publicatiedatum: 15-05-2018
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 9/2018
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-018-1874-8

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