in Linguistic Validation
Since 1987 Health Outcomes Group has been a leader in
establishing the methodology for translating and
linguistically validating Patient Reported Outcomes instruments
We created the
first Standard Operating Procedures for translation and
linguistic validation of health related quality of life
instruments in 1992 and these standards
foundation of the ISPOR Guidelines that are the industry’s
quality standard today.
CEO of Health Outcomes Group, was a member of the ISPOR Task
created those SOP’s - the Principles of
Good Practice for the Translation and Cultural Adaptation
Process for Patient-Reported Outcomes (PRO) Measures in
Using the Natural Language of
communication begins by understanding the background,
culture and educational level of your audience. We avoid
DOC talk used by physicians and draw upon the natural language with simple terms that the
audience understands in the same manner you intended.
It is not
sufficient to communicate concepts that are conceptually
equivalent. Equivalent experiences must yield equivalent
data in every language translated. This an essential
requirement in order to pool data from multinational
clinical trials for a single statistical analysis.
Patients Really Understand
validation replicates the setting in which the instrument
is intended to be used. Our linguists are more than
translators, they are experienced in a range of qualitative
techniques, including conducting personal interviews
and focus groups in a culturally sensitive manner.
and Linguistic Validation Methods
use accepted methods and provide
certification of translations that guarantees a level of quality
that meets and exceeds the standards
required by FDA, EMA and other international regulatory
We insure that the data collected
from different countries by patients speaking different
languages are linguistically equivalent and can be
for a pooled statistical analysis.
Health Outcomes Group
works to the standards of the ISO 17100
Standard (replaces EN 15038) for quality assurance.
Published by the European Committee for Standardization,
ISO 170100 provides standards for measuring the quality of translation services, and also
defines requirements for service delivery, quality control
and creates a framework for customer interaction.
Maintaining High Professional Standards
Our attitude toward
operational excellence is that quality is a continuous
effort that permeates every action by each employee for every
activity. We are members of the American Translators Association, the Northern California Translators Association and collaborate with many other international translation societies.