Translating Clinical Trial Outcomes Measures

An Overview

Sergiy Tyupa, Diane Wild

• Publisher: SEEd Medical Publishers
• Year: 2016
• ISBN:
  9788897419723
• Topic: Medicine
• Subtopic: Medical Education

The purpose of this book is to provide a general overview of the translation and cultural adaptation process of clinical research survey instruments with a focus on the linguistic aspects of the process. Survey instruments here refer to any text, printed or electronic, prepared in order to collect information in a clinical research setting. This broad definition covers patient-reported, clinician-reported, and caregiver-reported outcomes measures, as well as patient diaries, indexes, scales, symptom checklists, etc. The first part of the book offers a brief introduction to selected linguistic aspects of translation in order to provide definitions of key linguistic concepts and to set a tentative theoretical framework for the translation and cultural adaptation process. The second part describes the main steps used in the translation process. The discussion of each step includes the definition of its most important component, a list of key professional involved in implementing the step, a detailed critical description of the process involved in the implementation of the step, as well as a brief overview of areas where more research is needed. The last chapters cover the translation of electronic versions of clinical research survey instruments, with a brief discussion of the necessary modification of each step in order to meet the needs of an electronic instrument translation.

Section II. Translation and Cultural Adaptation Process

Preparation

Successful preparation may ensure success at later stages of any complex project, including translation and cultural adaptation. The preparation step involves both linguistic and non-linguistic aspects. The latter include seeking the permission to use and translate the chosen instrument from its developers or copyright holders, as well as selecting teams of translation professionals for respective target languages. These processes will not be discussed here. The linguistic aspects of the preparation step are the following:

• Preparation of source files;
• Concept elaboration;
• Translatability assessment.

The key players involved in this step are: project managers, linguistic consultants, clients, and instrument developers. Project managers are coordinators of a translation project who work for a Language Service Provider (LSP). An LSP can be an in-house translation department of a Contract Research Organization (CRO) or an individual translation agency. Linguistic consultants are professional translators with extensive experience in the translation of clinical research survey instruments. Clients are pharmaceutical companies or other entities that sponsor the translation of the instrument; they may participate in the process directly or through a CRO. Instrument developers are individuals or organizations that developed the respective instrument.

Preparation of source files

The preparation of source files does not comprise only technical issues, such as converting the original instrument into the file format that translators will be working on. More importantly, the source files need to be analyzed from the linguistic perspective before they are split into segments that will be used during the translation workflow. The splitting of the source text into segments is practically inevitable today since the translation of survey instruments is almost never done in the original document format. However, this has to be done very carefully in order to avoid possible problems during the following steps of the translation process.

The source text can be split into segments either manually or automatically. The former approach, currently almost obsolete, is used when the translation is carried out only in simple text editors (such as MS Word). The latter approach comes into play when Computer-Aided Translation (CAT) software tools are used, such as SDL Trados, MemoQ, Memsource, etc. So why is it necessary to analyze the source files first and only then carry out the segmenting or improve the automatic CAT segmentation? The answer lies in the special structure of clinical research survey instruments. Since they are used as measurement tools, there is little plain text (i.e. simple sentence-after-sentence, paragraph-based structure). Instead, survey instruments often contain incomplete question stems, multiple response options, graphic elements, visual analogue scales, illustrations, lists and many other special features. Poor segmenting is likely to cause translation errors or at least increase the amount of time and effort spent during the following translation steps.

Another important aspect to consider while preparing source files is the use of a so-called ‘legacy translation’. Legacy translation refers to previous translated versions of an instrument that are used as the basis for producing the translations of an updated instrument. It is natural that clients and developers insist that no changes can be made in the legacy translation, as in most cases the translation has already gone through an expensive linguistic validation process and may have already been used in a research setting. Changing the legacy translation would, in the clients’ and developers’ opinion, compromise the comparability and validity of data. However, we believe there should always be a possibility to allow translators to introduce changes to the legacy translation. The most important reasons for this are the following:

• Errors. Even the most thorough translation processes cannot guarantee an absolutely error-free translation, not to mention translations that were done many years ago, when there were no or few translation quality assurance tools in place and no standard translation methodology.
• Linguistic changes. These changes may take a radical form of an orthography reform (e.g. in German-speaking countries in 1996), or of slower and less noticeable natural changes in vocabulary, grammar, language users’ preferences, acceptable degree of formality, etc.
• Extra-linguistic changes. A lot of instruments, especially those that collect demographic information, refer to referents in the real world, such as medical and educational institutions, names of professions, types of employment, etc. Such referents may change with time, e.g. an institution of a family physician may be introduced in a country where previously there was no family medicine.

It is impossible to foresee all potential segmenting and legacy translation issues since every instrument is unique. The Table III presents only the most common structuring elements of survey instruments and legacy translation features that have to be taken into account when reviewing the source documents prior to segmenting, as well as possible solutions that may help to avoid translation problems.

Source document element	Possible issues	Solutions
Headers and footers	Some text in headers or footers, such as the acronym of an instrument or the names of companies and organizations, is not intended for translation. Other elements, such as the date, the word ‘page’ etc. have to be translated.	Place the portion of text that has to be translated into a different segment. If this is not possible for technical reasons, clearly mark the text not intended for translation with the help of the respective tag functions in CAT tools.
Incomplete question stems	Clinical research survey instruments often contain questions with an incomplete stem followed by a number of response options. Example: How often over the past 7 days have you felt... a. upset? b. tired? The possible issue is that the choice of an equivalent for a response option depends on the preceding question stem (e.g. some response options may have to be rendered as adjectives, and others as nouns, etc.). This issue is also relevant for Translation Memories (TMs) used by CAT tools: even though a memory may indicate a 100% match, the response option may not be suitable for a new question stem. This is particularly dangerous when such segments are marked as ‘perfect match’ or ‘context match’ in CAT tools and are locked by project managers as legacy translation.	Add the question stem in square brackets before each response option and tag it as text not intended for translation. Example: [How often over the past 7 days have you felt]... tired? Disable the automatic propagation function or its equivalent in a CAT tool. Avoid locking legacy translation segments in a CAT tool.
Response options	Even if questions in a PRO instrument are complete, identical response options may need to be changed depending on the question that they refer to. Example: 1. How would you describe your health over the past 7 days? a. Excellent b. Good c. ... 2. How would you describe your mood over the past 7 days? a. Excellent b. Good c. ... In many languages, the response options will have to be different as ‘health’ and ‘mood’ may be of a different grammatical gender.	Add segments with response options after each question, even if the response options are identical. Disable the automatic propagation function or its equivalent in a CAT tool.

Table III. Preparation of source documents: issues and solutions

Concept elaboration

Concept elaboration refers to a detailed explanation of terms and concepts used in the source document. A concept elaboration may also include background information on the instrument, the study where it is to be used, the target population, etc. Its primary purpose is to ensure that translators interpret the concepts according to the original intention of the instrument developers. To put it into simple words, concept elaboration helps translators to correctly understand the source document. This immediately implies that whoever prepares the concept elaboration must, in their turn, fully understand the source document items. In most contexts this presupposes direct communication with instrument developers. Overall, there are three main stages in preparing concept elaboration documents:

1. Selecting items and/or concepts that need to be elaborated;

2. Preparing draft definitions;

3. Validating draft definitions with instrument developers.

As will be argued below, we believe that concept elaboration has to be closely connected with translatability assessment. Concept elaboration definitions can be verified and improved during the translatability assessment process. Therefore, this introduces an additional stage:

4. Updating concept elaboration definitions based on translatability assessment results.

Selection of items

There are different approaches to selecting items for concept elaboration. Some LSPs prefer to develop extensive definitions for all items, whereas others select only the most complicated ones. Besides, concept elaboration definitions may explain an item as a whole or just define individual words. Respective decisions are made on the basis of company policies, client preferences, budget constraints, and many other factors. Nevertheless, some general recommendations applicable to most situations can be identified.

First of all, it seldom pays off to prepare definitions for all items in an instrument. This is especially true for clear and unambiguous items asking for basic information or instructions on filling in the instrument. For example, such items as ‘Today’s date’ or ‘Please check one box for each statement’ are very unlikely to be misinterpreted by a translator.

Besides, providing holistic definitions for an item as a whole is usually more helpful for translators than elaboration of only one, albeit very complicated, concept. For instance, exhaustive background information and a clear explanation of an item ‘How much have you been bothered by back pain over the past two weeks’ in the context of the instrument will be of much more value for translators than providing a definition of the term ‘bother’ alone. However, this doesn’t mean that there shouldn’t be definitions of individual concepts, especially when an item or a response option is actually comprised of only one word or a short phrase, such as ‘severe’ or ‘superficial pain’.

Special attention needs to be paid to compound nouns, i.e. a group of words made up of two or more nouns and/or other parts of speech. Their meaning may be ambiguous as it is not always immediately clear which word modifies (gives the property to) which word. For example, an instrument title ‘General Behavior Inventory’ may be interpreted as ‘a general inventory of behaviour’ and ‘an inventory of general behaviour’. Instrument developers will not see any ambiguity here as they know precisely what they wanted to say, but translators, who do not have the same educational and professional background as developers, may have problems with understanding this title. Therefore, compounds should always be explained in concept elaboration.

Moreover, specialist medical terms in most cases do not require any concept elaboration. Initially this may sound counterintuitive, but in fact specialist vocabulary tends to be much less ambiguous than concepts referring to emotions or mental states, which are abundant in clinical research survey instruments. Therefore, it would be superfluous to provide definitions for such terms as ‘stethoscope’, ‘peak flow meter’, ‘dialysis’, as direct equivalents for these words can be found in most languages. This, however, does not apply to the names of healthcare institution and healthcare providers, as these terms vary greatly among countries and languages (e.g. the concept of ‘family physician’ has no correspondences in many countries and has to be translated descriptively, depending on the context, so a concept elaboration for this term would be extremely helpful).

Finally, items that need to be explained in the concept elaboration may be identified with the help of translatability assessment (please see section “Translatability assessment”).

Preparing draft definitions

Concept elaboration i...

Table of contents

• Cover
• Colophon
• Introduction
• Section I. Linguistic Aspects of Translation
• Section II. Translation and Cultural Adaptation Process
• References
• The Authors
• Glossary
• Notes