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

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A Correction to this article was published on 25 August 2018

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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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Change history

  • 25 August 2018

    In the original publication of the article, two of the author names “L. A. Schröder, F. Metzner” and email address of the authors “J. Devine, J. Moon, A. C. Haller” were missed out. The correct author group with affiliations are provided in this correction.

Notes

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

  2. 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.)

Abbreviations

BT:

Backward translation

CAT:

Computerized Adaptive Test

CI:

Cognitive interview

DIF:

Differential item functioning

EMEA:

European agency for the evaluation of medicinal products

EORTC:

European Organisation for Research and Treatment of Cancer

EuroQol:

European Quality of Life Group

EOS:

Experience of stress

EOS-P:

Experience of stress—subdomain: psychological stress responses

EOS-S:

Experience of Stress—subdomain: somatic (physical) stress responses

FAM:

Family relations

FAM-FB:

Family relations—subdomain: family belonging

FAM-FI:

Family relations—subdomain: family involvement

FDA:

Food and Drug Agency

FT:

Forward translation

ISPOR:

The International Society for Pharmacoeconomics and Outcomes

IQOLA:

The International Quality of Life Assessment Project

MOS:

Medical outcome trust

PAC:

Physical Activity

PAC-M:

Physical Activity—subdomain mobility

PAC-S:

Physical Activity—subdomain strength

PRO:

Patient-reported outcome

PROMIS:

Patient-reported outcome measurement information system

RFT:

Reconciled forward translation

SWB:

Subjective well-being

SWB-PA:

Subjective well-being—subdomain positive affect

SWB-LS:

Subjective well-being—subdomain life satisfaction

SWB-MP:

Subjective well-being—subdomain meaning and purpose

WHOQOL:

World Health Organization Quality of Life

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Acknowledgements

The authors thank Joanie Jean for her extensive contributions in summarizing the data and Veronika Ottová-Jordan for her help in editing the manuscript. Furthermore, we thank the translation team, the experts, and all children/adolescents participating in the translation process.

Funding

This PROMIS work was funded by the National Institutes of Health through the NIH Roadmap for Medical Research, 1 U01 AR057956-02.

Author information

Authors and Affiliations

  1. Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University Medical Center Hamburg-Eppendorf, Martinistr. 52, W29, 20246, Hamburg, Germany

    J. Devine, F. Klasen, A. C. Haller & U. Ravens-Sieberer

  2. Children’s Hospital of Philadelphia, Philadelphia, PA, 19104, USA

    J. Moon

  3. Insight Consulting & Research, Cami Ral 266, 2nd floor, 7a, 08301, Mataro, Barcelona, Spain

    M. Herdman

  4. MPH Consulting, Columbia, MD, USA

    M. P. Hurtado

  5. American Institutes for Research (AIR), 1000 Thomas Jefferson Street, NW, Washington, DC, 20007, USA

    G. Castillo

  6. Feinberg School of Medicine, Department of Medical Social Science, Northwestern University, Chicago, IL, USA

    H. Correia

  7. University of Pennsylvania School of Medicine/Children’s Hospital of Philadelphia, Philadelphia, PA, USA

    C. B. Forrest

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  1. J. Devine
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  10. U. Ravens-Sieberer
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Contributions

The Principal Investigators of this study were Prof. C. Forrest (U.S.) and Prof. U. Ravens-Sieberer (Germany) leading the translation process. Researchers overseeing and conducting the translation process were J. Moon, F. Klasen, J. Devine (German team), and M. Herdman, M.P. Hurtado, and G. Castillo, (Spanish team). The first and second authors wrote this manuscript. All co-authors read, revised, added their comments, discussed, and finally approved the manuscript.

Corresponding author

Correspondence to U. Ravens-Sieberer.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study. More Information on the Patient-Reported Outcomes Measurement Information System (PROMIS) can be found at http://nihroadmap.nih.gov/ and http://www.nihpromis.org.

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Devine, J., Klasen, F., Moon, J. et al. Translation and cross-cultural adaptation of eight pediatric PROMIS® item banks into Spanish and German. Qual Life Res 27, 2415–2430 (2018). https://doi.org/10.1007/s11136-018-1874-8

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