In contemporary clinical research, patient voice and patient-centredness have become slogans. Regulatory agencies, sponsors and trial designers alike now emphasise the need to include the patient voice in drug development, through qualitative research and Clinical Outcome Assessments (COAs). Yet beneath the surface of this well-intentioned shift lies a problem: much of what defines patient experience remains unseen, unspoken and unmeasured.

Culture is deep, embedded and emotionally charged. It is often treated as a variable to manage, a difference to translate or a risk to mitigate. COA items are designed wholly within Western biases and measured through a Western lens.

But translation is not enough. Culture is not surface detail. It is the submerged iceberg of meaning, identity and worldview that shapes how people experience illness, coping and care. And in most COA research and patient voice initiatives, this sublime depth is never reached and largely overlooked.

Above and Below the Waterline

The iceberg model of culture distinguishes between the visible and the invisible. What we often notice: language, clothing, food, music, makes up just the tip. Below the waterline lie the far more influential forces: values, social roles, emotional codes, beliefs about time, suffering and healing. This is what the philosopher Edmund Burke describes as the sublime: not just majestic and beautiful, but overwhelming, beyond rational and awe-inducing.

In healthcare, the sublime goes beyond poetic metaphor to being lived reality. It shows up in the patient who insists on family agreement before treatment, in the one who calls pain a “curse” or illness a “burden from God”, or the one who does not want to “rate their pain on a scale of 0 to 10”. These constitute the patient voice, not deviations. But they are expressed in ways COA tools are never equipped to deal with.

The Patient Voice, Barely Heard

Patient voice research aims to foreground lived experience in clinical development, but it often does so in constrained and orchestrated ways. Structured interviews, cognitive debriefing and validated questionnaires are the norm. These methods favour patients who:

·       Are fluent and literate in the dominant language.

·       Are comfortable with introspection and emotional disclosure.

·       Are aligned with biomedical logic (and language).

·       Correspond to the ideal of the ‘empowered patient’, which is a Western notion and utterly alien elsewhere.

In effect, patients who understand the language of the Western, biomedical model are rewarded. Those patient voices are heard. But someone who speaks metaphorically, indirectly or within a spiritual framework may be seen as digressing or misunderstood. If a patient says, “My illness is a punishment”, how is that coded within patient voice research? More often than not, it would be scrapped.

Tools like COAs are designed for clarity, consistency and comparability. But the risk is that researchers may miss the full texture of human experience, particularly the cultural, existential and symbolic dimensions that give suffering its meaning and healing its depth.

Clinical Outcome Assessments: A tool designed for the visible part of the iceberg

COAs are meant to standardise how we measure symptoms, functioning and quality of life. But these instruments are usually built with cultural assumptions embedded in the design:

·       Pain is personal and can be numerically measured

·       Independence is inherently good

·       Time is linear

·       Urgency is shared

·       Disclosure equals truth.

All of these reflect specific Western biomedical worldviews. In other contexts, pain is relational, interdependence is normal, time is event-driven, vertical or circular and silence is a sign of dignity, not denial.

Most COAs are not designed to measure those understandings. When we translate them into multiple languages, we may improve access, but we rarely uncover the submerged meaning behind the words, which we have previously referred to as cultural coating and its opposite - cultural stripping. COAs are focused on the tip of the iceberg and never dive into the deep waters below.

What is missing?

In many COA and patient voice initiatives, what is missing is the recognition that:

·       In some cultures, health is moral and spiritual, not just physical

·       Suffering is interpreted and not just endured

·       Recovery is social, not just individual.

For example, in some cultures, expressing pain is discouraged to avoid burdening others. Meanwhile, in other cultures, being seen to suffer openly is a form of social and spiritual validation. In addition, ‘quality of life’ may depend more on the ability to participate in community life or fulfil a family role than on physical capability alone.

A Sublime Mismatch

The discomfort or dissonance researchers sometimes feel when patient feedback doesn’t “fit” their expected categories is itself a sign of the sublime. When a patient’s logic seems elusive, or when a metaphor resists translation, we are brushing up against the deep part of the cultural iceberg.

And yet, instead of sitting with that discomfort, leaning into it, it is often flattened, rejected, deleted. Responses are reframed into analysable fragments or dismiss them as “noncompliant”, “hard to interpret” or “out of scope”.

This is a loss of the patient voice. It is a loss of human meaning.

Designing for Depth

What would it take to acknowledge and to take seriously the sublime in patient voice research and COA design?

It would mean:

·       Including narrative-based methods alongside structured surveys, to give space for expression that does not fit categories.

·       Valuing cultural and spiritual frameworks as valid dimensions of health and suffering. These are not beliefs “to be corrected”.

·       Partnering with cultural insiders: patients, caregivers, linguists, community members, traditional healers, who can help translate not just the words, but the worldview

·       Viewing nonstandard responses as signals that something deeper is at play and not just ‘noise’.

All this would mean slowing down, making room for reflection, for misalignment, for dialogue – in other words, exactly how qualitative research is supposed to take shape.

Listening Beneath

If researchers only engage with the tip of the cultural iceberg, then they misunderstand what matters to patients. They build interventions that may well succeed statistically but fail humanly. If they ignore how culture shapes expression and the experience of health, they may misread or erase the views of the people we most need to understand.

To make room for the sublime in patient voice research is not to abandon rigour, but to broaden its scope. It is to accept that not all knowledge is neatly categorised and not all experience of health and pain is fluently expressed. Some things are metaphorical, symbolic, spiritual and they are no less real.

The iceberg below is not a problem to solve. It is the context that makes the surface meaningful.

Thank you for reading,

Mark Gibson

Leeds, United Kingdom, May 2025