In clinical research, the goal of understanding patients’ experiences, symptoms and treatment outcomes is more important than ever. Clinical Outcome Assessments (COAs), including Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs) and Performance Outcomes (PerfOs), play a crucial role in capturing that lived experience.

When a COA in English needs to be used in other languages, ensuring that concepts used in the COA are equivalent is vital. That is where concept elaboration comes in before the translation phase.

Concept elaboration is the foundational step in the linguistic validation process. It is not just leaning into linguistics. It is a cross-disciplinary effort that ensures we are measuring the right thing, for the right people, no matter the language or culture.

What Is Concept Elaboration?

Essentially, concept elaboration is the act of unpacking, clarifying and refining what each item in a COA is intended to measure. Before even thinking about translating the COA, the entire team needs to be sure that they understand the concept behind each item; what it really means, clinically, experientially and linguistically.

This means:

·       Defining the construct behind each item, such as is “tiredness” the same as “fatigue”?

·       Understanding how it is expressed in real-world language.

·       Thinking through how the concept might vary across cultures.

·       Providing guidance for translation that reflects this complexity.

If an item asks, “How often did you feel downhearted and blue?”, what does “downhearted” mean? Is it sadness? Depression? Disappointment? How do you explain “blue” to someone who does not use colour metaphors for emotion?

Concept elaboration makes sure that the intent of the item is not lost when it crosses linguistic or cultural barriers.

Standing At the Crossroads: The Interdisciplinary Nature of Concept Elaboration

Just as “Linguistic Validation” is not solely “linguistic” or “validation” - it is a form of Patient Voice research – neither is concept elaboration only a linguistic task. It sits at the intersection of language, health, science, culture and philosophy.

Semiotics and Semantics

Semiotics, the study of signs and symbols, and its subfield, semantics, play a vital role in uncovering the meaning behind an item. Consider expressions like “heavy heart”, “feeling flat” or “burned out”. These are figurative and emotionally rich in English, but their direct translations may fall flat, cause confusion or not mean anything at all in target languages.

Semiotic analysis helps bring to the surface where meaning is located. Is it in the cultural context? The metaphor? The word choice? This allows teams to decide whether to retain, adapt or replace such imagery when preparing a COA for cross-cultural use.

Philosophy of Language

Some concepts, like well-being, quality of life or functioning, seem simple on the surface but are philosophically complex. What does it mean to have “quality of life”? Is it defined by independence? By relationships? By economic freedom? Is it subjective contentment?

The philosophy of language pushes researchers to ask the deeper, more structural questions:

·       What exactly are we trying to measure with this item?

·       Why is this concept important?

·       Is this concept universal or culturally specific?

Clinical Science

Clinicians bring their expertise to bear on whether a concept is clinically relevant and whether the nuance matters. A word like “fatigue” might be clinically distinct from “tiredness” in a depression scale but might overlap entirely in the context of cancer treatment. A clinical look at the items might also distinguish whether “pain” refers to acute, chronic or neuropathic pain. These are distinctions that are easy to lose if the concept is flattened during translation or takes on additional “cultural coating”.

Sociolinguistics and Anthropology

No concept exists in a vacuum. Sociolinguistics and anthropology help make sure that the COA items are grounded in real-life, social and cultural realities. For instance, the idea of “independence” may be a prized quality in individualistic Western cultures, where managing one’s own affairs is a sign of health. However, in collectivist societies, reliance on family or community may be seen as expected, even virtuous. Without these perspectives, even a perfectly translated item can misfire in meaning, because the underlying values are not aligned.

Medical Sociology

Concept elaboration also draws on medical sociology. It helps unpack reporting of symptom experience. In some cultures, mental health symptoms are expressed through bodily complaints (somatically), rather than with emotional terms. Expressions of pain or fatigue may be minimised or exaggerated based on social roles, stigma or expectations of stoicism.

Medical sociology raises the important question: how does society shape the way patients describe, prioritise or suppress symptoms? And does this align with the item?

Applied Linguistics and Intercultural Communication

Applied Linguistics and Intercultural Communication bring in methodological rigour, offering tools and frameworks for understanding:

·       The limits of conceptual equivalence: when a term has no direct counterpart in the target language.

·       The role of pragmatics: how tone, context and intention influence interpretation of an item.

An Act of Care

Concept elaboration is an act of care; care for the clarity of research instruments, care for the voices of the patients and care for the diversity of cultures and languages that those voices will come from.

It ensures that what the items ask really reflects what it means and what patient answers reflects what they feel.

It is not a prelude to translation. It is a cultural and conceptual scaffolding that supports everything that follows. While the concept elaboration focuses on the source version, the task involves a great deal of thinking forward to possible equivalence (and, therefore, translation) issues. This is even before any translatability activity takes place.

The interdisciplinary approach is the work that should go into concept elaboration.

However, one common approach to this task is to oversimplify and the result is the concept elaboration is often done poorly.

For example,

·       Describing an item too vaguely: “This is a question about health”

·       Just adding in a load of synonyms: “Fatigue = tiredness, exhaustion, drowsiness” without defining what it is and why it appears in a given item.

·       Ignoring cultural framing: assuming that all cultures treat and describe pain, depression, for instance, in the same way.

·       Not calling out ambiguities and expecting the translation process to fix it.

·       Not bothering at all with concept elaboration and only worrying about it once serious linguistic issues arise.

When concept elaboration is superficial, the risk is that different language versions of the COA are not conceptually equivalent, making cross-language, cross-cultural comparisons unreliable or even invalid.

Meaning Engineering

Concept Elaboration could be thought of as “meaning engineering”. It is behind-the-scenes work that makes sure each item is:

·       Clear in intent

·       Accurately measurable

·       Culturally portable

·       Scientifically valid.

In a world of globalised studies, concept elaboration is not optional. It is essential.

Thank you for reading,

Mark Gibson

Leeds, United Kingdom, April 2025