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
Huda Shalhoub and Ana Popielnicki
Donald Patrick, Katrin Conway, Mona Martin, Sonya Eremenco
Non-PRO COA Translation Method
Group Leader: Sonya Eremenco
Examples of Topics:
Examples of Topics:
Chair: Christelle Giroudet
Literature Review: Diane Wild
ClinRO: Mona Martin
ObsRO: Shawn McKown
PerfO: Christelle Giroudet
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 2018 TCA-SIG Annual Meeting on Saturday, 27 October from 12:35 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 ISOQOL 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.
Co-Chair: Ana A. Popielnicki, BA
Ms. Popielnicki is the Senior Director for Clinical Outcome Assessments Consulting for the Linguistic Validation group at TransPerfect, in an advisory role on best practices on translation and cultural adaptation, as well as industry standards. With a BA in Clinical Psychology and Psychometrics from the Universidad Nacional Pedro Henríquez Ureña (UNPHU) in the Dominican Republic, Ms. Popielnicki has extensive experience in questionnaire development, survey research analysis, and cognitive debriefing. She has been in the Linguistic Validation industry for over 13 years. In pursuing her passion for books and literature, Ms. Popielnicki currently serves as the Translations Manager for Evolved Publishing, a small press publisher, where she coordinates multi-language translations of fiction books. She is a member of the American Literary Translators Association (ALTA), the PROMIS Health Organization (PHO), the International Society for Quality of Life Research (ISOQOL), and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Co-Chair: Huda Shalhoub, PhD
Dr. Shalhoub is a Research Scientist at Evidera’s Patient-Centered Research division and an Adjunct Assistant Professor at Bentley University in the Boston area, USA. Prior to joining Evidera, she worked as a Clinical Outcomes Scientist at eResearch Technology (ERT) where she conducted research in a wide range of therapeutic areas across all clinical trial phases, including instrument development and validation, scientific literature and meta-reviews, electronic clinical outcome assessment (eCOA) validation, translation and cross-cultural adaptation, and rater training. In her past roles, she was Research Director and Chief Learning Officer at Nielsen Neuro where she spearheaded some of the most prominent international healthcare and customized consumer neuroscience research projects. Dr. Shalhoub has over a decade of expertise and passion in health outcome cross-cultural issues, electronic COAs, translation work and instrument validation. She holds a doctorate in Psychology Research from Brunel University, London, UK; an Applied Sociology master’s degree from the University of Massachusetts, Boston; and, an undergraduate degree with distinction in Applied Sociology from Concordia University, Montreal, Canada. Dr. Shalhoub is a member of ISPOR, PROMIS, DIA, and the American Psychological Association.
Benjamin Arnold (2014-2018)
Sonya Eremenco (2013 – 2017)
Mona Martin (2013 – 2016)
Donald Patrick (2005 – 2013)
Katrin Conway (2004 – 2013)