The ISOQOL Translation and Cultural Adaptation Special Interest Group was created in 2004 with the following objectives:
Translation and Cross-Cultural Adaptation (TCA) SIG Chairs
Sonya Eremenco and Benjamin Arnold
Donald Patrick, Katrin Conway, Mona Martin, Sonya Eremenco
COA Translation Methods
Group Leader: Sonya Eremenco
Examples of Topics:
Examples of Topics:
Writing Team Members:
TCA-SIG members are professionals working on translation of patient-reported outcome (PRO) measures and other COAs, instrument developers and all ISOQOL members interested in the linguistic and cultural issues relating to COAs. They represent academia, industry, languages service providers, consulting firms, etc.
The TCA-SIG’s current and past research interests include projects include:
Michael Koller, Valeska Kantzer, Isabelle Mear, Katie Zarzar, Mona Martin, Eva Greimel, Andrew Bottomley, Maria Arnott, Dagmara Kuliś D, on behalf of the ISOQOL TCA-SIG. The process of reconciliation in translating quality of life questionnaires. Evaluation of existing translation guidelines and a set of recommendations. Expert Rev Pharmacoeconomics Outcomes Res. 12(2), 189-197 (2012).
Antoine Regnault, Jean-François Hamel, Donald L. Patrick, on behalf of the ISOQOL TCA-SIG. Pooling of cross-cultural PRO data in multinational clinical trials: How much can poor measurement affect statistical power? Qual Life Res. 2015 Feb;24(2):273-7.
Papers in Progress
Catherine Acquadro, Donald L. Patrick, Sonya Eremenco, Mona Martin, Dagmara Kuliś, Helena Correia, Katrin Conway, on behalf of the ISOQOL TCA-SIG. Emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures (working title).
Caroline Anfray, Benjamin Arnold, Mona Martin, Sonya Eremenco, Donald L. Patrick, Katrin Conway, Catherine Acquadro on behalf of the ISOQOL Translation and Cultural Special Interest Group (TCA-SIG). Reflection paper on copyright, patient-reported outcome measures and their translations.
TCA-SIG Annual Meeting and Presentation
Come join us at the 2016 TCA-SIG Annual Meeting on Thursday, 20 October from 12:25 pm – 1:30 pm.
Is there something you would like to see discussed at this year’s SIG meeting? Please contact the co-chairs so this can be added to the agenda.
Workshops at Annual ISOQL Conferences
TCA-SIG Workshop in 2016 Copenhagen
2016 Joint workshop: WK08 Clinical Outcomes Assessment in a Multi-Cultural Context: Measurement Challenges and Recommendations
Workshop conducted in Collaboration between the Translation and Cultural Adaptation (TCA) SIG and the Psychometric SIG
Workshop Organized and Presented by: Stacie Hudgens, Antoine Regnault, Lori McLeod (Psychometric SIG), Mona Martin and Sonya Eremenco (TCA-SIG)
Description: Clinical Outcome Assessment (COA) in multi-cultural studies requires particular caution due to differences in language, culture, education, and differing standards of care. Each of these aspects presents a potential source of variability in measurement outcomes. If not adequately managed, this variability can jeopardize the accurate capture of the targeted concepts, and make demonstration of treatment benefit more difficult. Cross-cultural equivalence of COAs being used in multi-cultural studies is, therefore, of particular importance. This workshop will present the challenges and discuss possible solutions related to this question including qualitative methods to minimize cross-cultural variability in measure development, quantitative methods for exploration of cross-cultural equivalence of COAs, methods to assess whether a difference is a translation issue or cross-cultural difference, and suggestions for managing imperfect cross-cultural equivalence when using clinical trial data for treatment comparisons. This workshop is for researchers having an interest in the impact of multiple cultures on research data.
TCA-SIG Workshop in 2014 Berlin
Translation Methodology for Clinical Outcome Assessments in Global Trials
Workshop conducted by the TCA-SIG.
Catherine Acquadro; and Katrin Conway, BA, Mapi Research Trust, France; Sonya Eremenco, MA, Evidera, United States; Valeska Kantzer; and Mona Martin, RN MPA, Health Research Associates, Inc., United States; Donald Patrick, PhD MSPH, Seattle Quality of Life Group, United States
Description: An update on the role of translation in instrument development, translation and linguistic validation methodologies, and addressing new issues such as translation for eCOA technologies.
ISOQOL Webinar December 2015
Webinar conducted in Collaboration between the Translation and Cultural Adaptation (TCA) SIG and the Psychometric SIG
Organized and Presented by: Stacie Hudgens, Antoine Regnault, Lori McLeod (Psychometric SIG), Mona Martin and Sonya Eremenco (TCA-SIG)
Clinical Outcome Assessment (COA) in an international study requires particular caution due to the differences in language, culture, education, and differing standards of care. These differences are likely to be sources of variability in measurement outcomes. If not adequately managed, this variability can potentially jeopardize the accurate capture of the targeted concepts, and make the demonstration of treatment benefit more difficult. Cross-cultural equivalence of COAs used in international studies is, therefore, of particular importance. The webinar will present the challenges and discuss possible solutions related to this question.
A certain amount of cross-cultural variation can be prevented using qualitative methods during the development and translation of a COA. Content can be considered from a cross-cultural perspective using multi-cultural patient interviews and techniques such as Translatability Assessment. Evaluation of cross-cultural equivalence of a measure has traditionally been accomplished using quantitative methods. These methods include investigation of differential item functioning and measurement invariance. Once data have been collected and evaluated quantitatively, further investigation can be conducted qualitatively to focus on specific areas of variability that raise questions about equivalency or comparability. Once the cross-cultural equivalence of a COA used in a multicultural study has been tested and variability addressed using both qualitative and quantitative methods, a more clear demonstration of a treatment benefit can be ascertained with confidence in the results.
These topics and methods for early qualitative and quantitative evaluation will be described, using examples, during the webinar by speakers from both the Translation and Cultural Adaptation and Psychometrics Special Interest Groups of ISOQOL. The presentation will be followed by an interactive Q&A session during which the speakers will address questions from the audience.
Watch Teamwork for announcements of upcoming webinars.
Our first “brainstorming call” was initiated in 2015 and resulted in support for and participation in the COA translation writing group.
Watch Teamwork for announcements of upcoming brainstorming calls
We encourage active communication between members.
From the very beginning of the TCA-SIG, we have organized ourselves into a structure of Co-Chairs, a Steering Committee, and Project Leads. The Steering Committee consists of current Co-Chairs and past Co-Chairs. In 2016, we will begin elections of a new Co Chair each year so terms can alternate, and we will also be adding an official position of TCA-SIG Secretary in the election process. Each Co-Chair will serve for a period of two years and the Secretary will serve for a period of 3 years.
Benjamin Arnold, MA, With over 17 years’ experience, Benjamin Arnold, MA has a strong background in multilingual translations and cross-cultural health outcomes assessment. Mr. Arnold serves as the Director of FACITtrans, providing high quality COA translations for pharma and international health researchers, in addition to several large federally-sponsored NIH research initiatives. Mr. Arnold is a member of the American Translators Association (ATA), the International Society for Quality of Life Research (ISOQOL) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). He has conducted workshops in multiple languages on translation and cross-cultural issues at conferences worldwide and is the Latin American presence for FACITtrans, residing in Fortaleza, Brazil. Mr. Arnold holds an MA in Multicultural and Corporate Communication from DePaul University, Chicago and a BA in Spanish (Linguistics) with a minor in Portuguese from the University of Arizona.
Sonya L. Eremenco, BA, MA, is Associate Director for the Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute, which provides a collaborative framework of stakeholders to develop qualified and publicly available PRO and COA instruments for use in clinical trials in order to support labeling claims. Sonya has over 20 years of experience in PRO (and other COA) instrument development, with a focus on multicultural development, linguistic validation, and electronic implementation. Prior to joining the Critical Path Institute, Sonya was Director, ePRO New Products, for Evidera’s Outcomes Research practice area in Bethesda, MD, where she led Evidera’s initiative to combine technology and PRO expertise into a science-driven ePRO service. Prior to joining Evidera in 2008, she served as Director of Translation and Formatting Services at the Center on Outcomes, Research and Education (CORE) at the Evanston Northwestern Healthcare Research Institute, which is now FACITtrans.org. In addition to overseeing the translation and linguistic validation of PRO measures, she also participated in cross-cultural instrument development projects including FACT-Leukemia and FACT-Gastric cancer questionnaires. She has served as Chair of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Special Interest Group’s Task Force on Mixed Modes of Data Collection, and as co-Chair of International Society for Quality of Life Research (ISOQOL)’s Translation and Cultural Adaptation Special Interest Group.
Ms. Eremenco is well published in the field of cross-cultural communication and linguistic validation and translation methodology and is regarded as an expert in these important arenas of patient-reported outcomes research. Ms. Eremenco received her MA in Multicultural Communication from DePaul University in Chicago, Illinois, and she received her BA in Cultural Anthropology with a concentration in linguistics from Duke University.
Past and Current Co-Chairs
Katrin Conway (2004 – 2013)
Donald Patrick (2005 – 2013)
Sonya Eremenco (2013 – 2017)
Mona Martin (2013 – 2016)
Benjamin Arnold (2016 – 2018) (Chair-Elect)
Dagmara Kuliś (2016-2019) (Secretary-Elect)