OVER 25 YEARS OF METHODOLOGICALLY RIGOROUS COA TRANSLATIONS
Patient perspective on effects of cancer treatment gain recognition
As part of increasing interest from the international clinical and research communities to assess the patient's perspective of his or her disease, David Cella, Ph.D. publishes the original manuscript on his development of the Functional Assessment of Cancer Therapy FACT-G.
Cella D.F., Tulsky D.S., Gray G., Sarafian B., Lloyd S., Linn E., Bonomi A., Silberman M., Yellen S.B., Winicour P., Brannon J., Eckberg K., Purl S., Blendowski C., Goodman M., Barnicle M., Stewart I., McHale M., Bonomi P., Kaplan E., Taylor S., Thomas C., Harris J. The Functional Assessment of Cancer Therapy (FACT) Scale: Development and validation of the general measure. Journal of Clinical Oncology 1993; 11(3): 570-579.
Clinicians request the FACT-G in Spanish
Careful consideration of equivalence and quality are at the forefront of this endeavor. The translation group that will become FACITtrans is born.
A call to quality within the PRO/HRQOL community
The initial manuscript on the translation and linguistic validation of the FACT scale is published.
Bonomi, A.E., Cella, D.D., Hahn, E.A., Bjordal, K., Sperner, B., Gangeri, L., Bergman, B., Willems, J., Hanquet, P., & Zittoun, R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Quality of Life Research 1996; 5: 309-320.
The translation group’s work gains recognition
The first requests to translate COAs by other developers begin.
The translation group publishes an article, and causes a stir
Our translation group develops the first iteration of an article in support of the universal translation approach, which 20 years later is still considered methodologically novel.
Advantages of the Universal Approach:
Enables comparisons across subgroups, assuming the scale applied is unbiased (e.g. Spanish speaking populations in the US).
Minimizes bias introduced by multiple translations in a survey or clinical trial.
Reduces logistical complexity in multinational clinical trials.
Facilitates survey administration in the case of migrating populations.
Eremenco S., Arnold B., Cella D. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions 2005; 28(2): 212-232.
Item banking translation begins
Item banking translation begins with the PROMIS into Spanish.
Our translation group contributes to landmark ISPOR translation and cultural adaptation guidelines
The result is the seminal manuscript, “Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient‐Reported Outcomes (PRO)”. Translation companies rush to adopt this methodology that is now accepted as industry standard.
The translation and formatting team formerly part of CORE becomes FACITtrans
The transition from academia to a business environment frees our group to be even more responsive and streamlined, permitting more effective response times and quicker turnaround for the deadline-driven pharmaceutical clinical trial industry. Under the scientific direction of Dr. Cella, the outcomes scientists at MSS and the translation and formatting team of FACITtrans have world-class experience and expertise in translation and linguistic validation, outcomes research design, database development, multicenter data collection and management, psychometrics and statistics.
Adapt FACIT measures for electronic administration
The FACIT Group starts to modify text for FACT and FACIT questionnaires’ use on tablets and other devices.
FACITtrans earns ISO 9001:2015 certification
Quality processes have always been central to our work, which is why we co-founded the ISPOR translations guidelines so many years ago. In 2017 we went a step further to seek recognition on an international level for how we work. This resulted in a very rewarding moment when we received praise from the auditing agency and our ISO 9001:2015 certification.
Collaboration is our strength
While most of our work is for top pharmaceutical companies, we regularly partner with Dr. Cella’s research program at Northwestern University - the largest academically-based outcomes research group in the world.
We also collaborate on NIH initiatives such as PROMIS, and with industry leaders like C-Path.
Our executive director, Benjamin Arnold, served as Co-Chair, and is now a permanent steering committee member of the ISOQOL Translation and Cultural Adaptation Special Interest Group.