Linguistic Validation: Understanding Conceptual Equivalence in the Harmonization Procedure Diana Sánchez, Nova Language Services In addition to translation, multinational clinical trials must also undergo a strict linguistic validation process to ensure proper adaptation for the target languages and countries. This algorithm of checks and reviews requires intense and efficient management between project managers and translators, who will often times encounter unique challenges specific to this sector. In this session, we will explain a standard linguistic validation process, the different phases in which feedback is to be analyzed, validated and implemented, and the importance of harmonization in achieving optimum translation results.

1. © 2014 Nova Language Services
Diana Sanchez
Language and
Training Consultant
07/11/2014
LINGUISTIC VALIDATION
UNDERSTANDING CONCEPTUAL
EQUIVALENCE IN THE
HARMONIZATION PROCEDURE

2. © 2014 Nova Language Services
INTRODUCTION
• Multilingual communications and
translation company focused in the life
sciences sector since 1998
• Offices in Europe and the United States
• ISO 9001:2008 and EN 15038:2006
certified
• Over 1,500 in-country medical translators
LINGUISTIC VALIDATION

3. © 2014 Nova Language Services
CONTENTS
I. Background
II. Standard Linguistic Validation Process
III. Linguistic Validation Project Management
IV. Conclusions
V. References
LINGUISTIC VALIDATION

4. © 2014 Nova Language Services
BACKGROUND
• Increasing regulatory
requirements
• Shortening product
lifecycles
• Improving service
provider and patient
interactions
LINGUISTIC VALIDATION
Life Sciences industry
characterized by high regulatory
and timing pressures:

5. Clinical Trial Translations Regulatory Affairs Medical Devices
Patient Reported Outcomes
(PROs)
Summaries of Product
Characteristics (SmPC)
Instructions for use (IFU)
Quality of Life (QoL) Instruments
Patient Information Leaflets (PIL)
Structured Product Labeling (SPL)
Adverse and Serious Adverse
Events
Labeling updates and amendments
Patient Recruitment,
Questionnaires, Diaries and
Interpretations Labeling and Packaging
Product Information Leaflets (PIL)
Patient and Clinician Education
Materials
Patient handbooks
Patient Informed Consent Forms
(ICFs)
Marketing Authorization Dossiers
Data sheets
Patient Information Sheets (PIS)
Expert Reports
User guides
Protocols and Case Report Forms
(CRF)
Technical manuals
Site Documentation and Reports
Validation Protocols
Software
Clinical Trial Recruitment and
Retention
LIFE SCIENCE
DOCUMENTS
LINGUISTIC VALIDATION

6. © 2014 Nova Language Services
CLINICAL TRIAL
DOCUMENTATION
• Patient Reported Outcome (PRO)
measures and Clinical Outcomes
Assessments (COAs), as
pioneered by MAPI Research
Institute
• Quality of Life (QOL)
questionnaires
• Clinician Reported Outcomes
(ClinROs)
• Observer Reported Outcomes
(ObsROs)
LINGUISTIC VALIDATION
Implemented in the area of
clinical trial documentation:

7. © 2014 Nova Language Services
“That sponsors provide evidence
that the content validity and other
measurement properties are
adequately similar between all
versions used in the clinical trial.
We will review the process used to
translate and culturally adapt the
instrument for populations that will
use them in the trial.”
IN THE US, THE FDA RECOMMENDS:
LINGUISTIC VALIDATION
CLINICAL TRIAL
DOCUMENTATION

8. Source instrument
developer
Project sponsor Contract Research
Organizations
(CROs)
Typically, the
developer may be an
academic or team of
academics working
with a
pharmaceutical
company
A pharmaceutical
company or a
global health
organization
Coordinate all
project
management are
responsible for the
timely delivery of
the linguistic
validation process
STAKEHOLDERS
LINGUISTIC VALIDATION
The following stakeholders are
typically involved in the linguistic
validation of PRO / QoL instruments:
© 2014 Nova Language Services

9. STANDARD
LINGUISTIC
VALIDATION
PROCESS
LINGUISTIC VALIDATION
MAPI RESEARCH
INSTITUTE PROCESS

10. © 2014 Nova Language Services
CONCEPTUAL DEFINITION
CLINICAL RESEARCH ORGANIZATION
The project manager (usually from a linguistic background) will
perform the conceptual analysis.
HARMONIZATION
AND
CONCEPTUAL
EQUIVALENCE
QUESTIONNAIRE VOCABULARY
Determine the concepts underlying the vocabulary found in
each questionnaire item TRANSLATE INTO ITS
CULTURAL EQUIVALENT
LSP
LSP will verify conceptual analysis, forward information to the
translators, revisers and back-translators.
LINGUISTIC VALIDATION
Reference: A critique of the linguistic validation process for Patient-Reported
Outcomes and Quality of Life Instruments (Mark Gibson)

11. HARMONIZATION
AND
CONCEPTUAL
EQUIVALENCE
LINGUISTIC VALIDATION
THE UNDERLYING CONCEPT
Reference: A critique of the linguistic validation process for Patient-Reported
Outcomes and Quality of Life Instruments (Mark Gibson)
ORIGINAL TEXT (US ENGLISH) POTENTIAL PROBLEM IN FT UNDERLYING CONCEPT
“I feel anxious about my
wounds”
In French ‘anxious would not
translate as it is intended in US
English. In French, possible
translations ‘angoissant’ or
‘nerveux’ conveys the sense of
‘being neurotic’ about something
. None of these convey the
intended meaning of the original
text.
The underlying concept of
‘anxious’ is ‘worried’, therefore,
target translations should reflect
this.
“I am confident that the wounds
I have will heal”
One possible translation of
‘confident’ in French could be
‘self‐assurance’. This is not the
intended meaning of the original
text.
The underlying concept of
‘confident’ is ‘optimistic’
“I am comfortable in the
presence of food”
There is risk of misinterpretation
based on the ambiguity of the
original wording.
The underlying concept of
‘comfortable’ in this context
should be ‘feeling at ease’’.

12. STANDARD
LINGUISTIC
VALIDATION
PROCESS
LINGUISTIC VALIDATION
MAPI RESEARCH
INSTITUTE PROCESS

13. FT REPORT
TEMPLATE
LINGUISTIC VALIDATION
© 2014 Nova Language Services

14. FT REPORT
EXAMPLE
LINGUISTIC VALIDATION

15. STANDARD
LINGUISTIC
VALIDATION
PROCESS
LINGUISTIC VALIDATION
MAPI RESEARCH
INSTITUTE PROCESS

16. © 2014 Nova Language Services
• […] Some of the original writings
on linguistic validation are
chapters in Quality of Life and
Pharmacoeconomics in Clinical
Trials, Lippincott-Raven (1996).
• At the time of these writings there
was an attempt to agree on a
process and create
harmonization among
researchers who had begun to
use their instruments in
international studies.
• In order to pool data across
multinational studies it is
essential to be assured that the
items in questionnaires mean the
same thing to all subjects.
• Thus, an effort to create a
standard for harmonization
began.
LINGUISTIC VALIDATION
HARMONIZATION
Reference: The Role of Cognitive Debriefing and Linguistic Validation in Instrument Development and
Modification. Dr. Bonnie Teschendorf – PRO Scientific Advisor.

17. © 2014 Nova Language Services
HARMONIZATION
(CONT.)
Linguistic validation uses the original
instrument as the source document, yet
considers the target language in the
resulting reconciliation of words, phrases,
and sentences in the items and instruction
statements for the language, tone,
translation, and meaning of items or
semantics in the final version
LINGUISTIC VALIDATION
Reference: The Role of Cognitive Debriefing and Linguistic Validation in Instrument Development and
Modification. Dr. Bonnie Teschendorf – PRO Scientific Advisor.

18. © 2014 Nova Language Services
CONCEPTUAL
EQUIVALENCE
CONSTRUCT OR SCALE
EQUIVALENCE
Not simply the literal translation of
words but rather the understanding of
native speakers that phrases are
equivalent.
Similarity in the cultural adaptation
and translated versions of the
instrument and how they perform
psychometrically (psychological
measurement i.e. skills, knowledge,
attitudes, etc.)
OPERATIONAL
EQUIVALENCE
METRIC
EQUIVALENCE
Refers to the capacity of the instrument
to result in similar outcomes despite
being administered in more than one
format.
The ability to find the same level of
intensity or severity within the scale
among subjects with the same disease
state.
CROSS-
CULTURAL
EQUIVALENCE
LINGUISTIC VALIDATION
Described as having four
components (Anderson, 1996)

19. © 2014 Nova Language Services
• Patient-Reported Outcomes
Translation and Linguistic Validation
Task Force Reports
• Principles of Good Practice for the
Translation and Cultural Adaptation
Process for Patient-Reported
Outcomes (PRO) Measures: Report
of the ISPOR Task Force for
Translation and Cultural Adaptation
• Multinational Trials—
Recommendations on the
Translations Required, Approaches
to Using the Same Language in
Different Countries, and the
Approaches to Support Pooling the
Data (2009)
ISPOR
TASKFORCES
LINGUISTIC VALIDATION
For more information:
http://www.ispor.org/sigs/pro_translation.asp

20. STANDARD
LINGUISTIC
VALIDATION
PROCESS
LINGUISTIC VALIDATION
MAPI RESEARCH
INSTITUTE PROCESS

21. © 2014 Nova Language Services
LINGUISTIC
VALIDATION
PROJECT
DELIVERY
• All files are delivered at the end of the project,
unless otherwise stated by the client
• Files names should clearly and accurately reflect
the contents of each document and the linguistic
validation step they belong to
• File names should allow the client to see the files
in chronological order, according to the different
steps of linguistic validation
LINGUISTIC VALIDATION
01.XXXXXL01 NOVA PRONAME STEP 1 (FT A)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 1 (FT B)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 2 (Analysis and harmonization)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 3 (Consensus target language version 1)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 4 (Back‐translation)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 5 (Comparative review)_ES.doc
01.XXXXXL01 NOVA PRONAME STEP 6 (Consensus target language version 2)_ES.doc

22. © 2014 Nova Language Services
ADDITIONAL
BENEFITS
• New international
markets
• Linguistic
validation is
required in many
countries
LINGUISTIC VALIDATION

23. © 2014 Nova Language Services
• Experience
• Specialized team
• Minimize the time
and effort required to
complete the entire
process
• Some LSPs solely
take part in the FT
part of the process,
while others act as a
single point of
contact for the entire
linguistic validation
process.
LINGUISTIC
VALIDATION
SERVICES
REQUIREMENTS
LINGUISTIC VALIDATION

24. © 2014 Nova Language Services
• Account Managers
• Project Managers
• Translators
• Revisers
• QA Supervisors
LINGUISTIC VALIDATION
LINGUISTIC
VALIDATION
SERVICE
MANAGEMENT

25. © 2014 Nova Language Services
PAYMENT
TERMS AND
CONDITIONS
a) The number of
words contained in
the instrument
b) The number of
languages required
c) The number of
translations needed
(2 FTs as well as
back-translation)
LINGUISTIC VALIDATION
WILL DIFFER FROM PROJECT TO
PROJECT AND LARGELY DEPENDS ON
THE FOLLOWING VARIABLES:

26. © 2014 Nova Language Services
LENGTHY PROCESS
DEADLINES
LINGUISTIC ISSUES
Difficult to get providers to
commit to the entire project,
several comments are sent at
random from different parties.
Short turnaround requirements,
time-to-market pressures
There isn’t always an exact
equivalent in target language, or
grammar/semantic rules obstacle
to total equivalence.
RATES
COMMUNICATION
RECRUITMENT
Client, LSP and translator
concerns regarding rates and fees
for validation process.
Chains of emails, written
comments, language barriers.
Great demand for medical
translators specialized in this
product, with advanced
knowledge, tools, skills and know-
how.
LINGUISTIC VALIDATION
CHALLENGES
CONSULTANCY
Determining language(s) when
target country is multilingual..

27. © 2014 Nova Language Services
CONCLUSIONS
• Strict linguistic validation
process
• Intense management
• Challenges very specific to
this sector
• Different from traditional
Quality Assurance workflow
• Close collaboration
between project managers,
quality assurance
managers and linguists
• High demand for medical
translators specialized in
this service.
LINGUISTIC VALIDATION

28. © 2014 Nova Language Services
REFERENCES
• http://mapigroup.com
• http://www.ispor.org/
• FDA Guidance for Industry Patient-Reported
Outcome Measures: Use in Medical Product
Development to Support Labeling Claims
• The Role of Cognitive Debriefing and Linguistic
Validation in Instrument Development and
Modification (Bonnie Teschendorf, PhD)
• A critique of the linguistic validation process for
Patient-Reported Outcomes and Quality of Life
Instruments (Mark Gibson)
LINGUISTIC VALIDATION

29. © 2014 Nova Language Services
Thank you
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diana@nova-transnet.com
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