ata 55 chicago 2014 - linguistic validation: understanding conceptual equivalence in the...

© 2014 Nova Language Services

Diana SanchezLanguage and Training Consultant07/11/2014

LINGUISTIC VALIDATION

UNDERSTANDING CONCEPTUAL EQUIVALENCE IN THE

HARMONIZATION PROCEDURE


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



CONTENTS

I. Background

II. Standard Linguistic Validation Process

III. Linguistic Validation Project Management

IV. Conclusions

V. References



BACKGROUND• Increasing regulatory

requirements

• Shortening product lifecycles

• Improving service provider and patient interactions


Life Sciences industry characterized by high regulatory and timing pressures:

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 ReportsValidation Protocols Software

Clinical Trial Recruitment and Retention

LIFE SCIENCEDOCUMENTS



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)


Implemented in the area of clinical trial documentation:


“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:


CLINICAL TRIAL DOCUMENTATION

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


The following stakeholders are typically involved in the linguistic validation of PRO / QoL instruments:


STANDARD LINGUISTIC

VALIDATION PROCESS


MAPI RESEARCH INSTITUTE PROCESS


CONCEPTUAL DEFINITION

CLINICAL RESEARCH ORGANIZATION The project manager (usually from a linguistic background) will perform the conceptual analysis.

HARMONIZATIONAND

CONCEPTUAL EQUIVALENCE

QUESTIONNAIRE VOCABULARYDetermine the concepts underlying the vocabulary found in each questionnaire item TRANSLATE INTO ITS CULTURAL EQUIVALENT

LSPLSP will verify conceptual analysis, forward information to the translators, revisers and back-translators.


Reference: A critique of the linguistic validation process for Patient-Reported Outcomes and Quality of Life Instruments (Mark Gibson)

HARMONIZATIONAND



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’’.

STANDARD LINGUISTIC

VALIDATION PROCESS



FT REPORT TEMPLATE



FT REPORT EXAMPLE


STANDARD LINGUISTIC

VALIDATION PROCESS




• […] 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 harmonizationbegan.


HARMONIZATION

Reference: The Role of Cognitive Debriefing and Linguistic Validation in Instrument Development and Modification. Dr. Bonnie Teschendorf – PRO Scientific Advisor.


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


Reference: The Role of Cognitive Debriefing and Linguistic Validation in Instrument Development and Modification. Dr. Bonnie Teschendorf – PRO Scientific Advisor.



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


Described as having four components (Anderson, 1996)


• 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


For more information:http://www.ispor.org/sigs/pro_translation.asp

STANDARD LINGUISTIC

VALIDATION PROCESS





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


01.XXXXXL01 NOVA PRONAME STEP 1 (FT A)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 1 (FT B)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 2 (Analysis and harmonization)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 3 (Consensus target language version 1)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 4 (Back‐translation)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 5 (Comparative review)_ES.doc01.XXXXXL01 NOVA PRONAME STEP 6 (Consensus target language version 2)_ES.doc


ADDITIONAL BENEFITS

• New international markets

• Linguistic validation is required in many countries



• 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.


SERVICES REQUIREMENTS



• Account Managers• Project Managers• Translators• Revisers• QA Supervisors



SERVICE MANAGEMENT


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)


WILL DIFFER FROM PROJECT TO PROJECT AND LARGELY DEPENDS ON THE FOLLOWING VARIABLES:


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

COMMUNICATIONRECRUITMENT

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.


CHALLENGES

CONSULTANCY

Determining language(s) when

target country is multilingual..


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.



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)



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ata 55 chicago 2014 - linguistic validation: understanding conceptual equivalence in the...

Health & Medicine

linguistic background

conceptual analysis

project manager

outcomes clinros observer

life sciences sector

regulatory requirements

translation company

outcome promeasures