Face-Sensitive Patient Documentation Across Cultures: Can One Size Fit All?
24 feb 2025
Mark Gibson
,
UK
Health Communication Specialist
In the last article, we covered how cultural differences shape patient engagement and why pharmaceutical companies must tailor their communication strategies accordingly. Collectivist cultures prioritise group harmony, leading patients to defer decisions to family or doctors, while individualist cultures value autonomy and expect direct, data-driven communication. Similarly, high-context cultures rely on implied meaning and intermediaries, while low-context cultures expect explicit, structured information. In high power distance cultures, patients defer to medical authority, whereas in low power distance cultures, shared decision-making is expected. Pharma companies must adapt patient materials to these realities, using indirect, reassuring language in collectivist and high-context cultures while providing clear, detailed guidance for individualist and low-context cultures. Failing to integrate face-sensitive communication risks patient disengagement and misunderstanding, which will have an impact on health outcomes.
The one-size-fits-all challenge
Given vast cultural differences in healthcare communication, a one-size-fits-all approach risks overlooking key nuances in how patients process and act upon medical information. A direct, data-driven approach may work well in individualist, low-context cultures, where patients expect autonomy and transparency. Yet, the same approach could alienate patients in collectivist, high-context cultures, where indirect communication and deference to authority are the norm. In the same way, in high power distance societies, patients may prefer guidance framed as expert recommendations, whereas in low power distance cultures, shared decision-making is expected. If trust and comprehension are key to patient engagement and adherence, should pharma companies localise their communication strategies? Is it possible to develop universally effective materials without sacrificing cultural sensitivity?
The reality of standardised documentation
The one-size-fits-all approach has dominated the pharma sector for decades. Despite cultural differences, certain patient-facing documents are standardised across regions to ensure regulatory compliance and consistency. However, these uniform formats can create barriers to comprehension and engagement in diverse cultural settings.
Examples of Standardised Pharma Documents
Informed Consent Forms (ICFs): Used worldwide in clinical trials to explain risks, benefits, and procedures. However, they are often dense, legalistic, and difficult to navigate, especially for high-context or collectivist cultures, where patients expect indirect explanations or family involvement. Within a clinical trial, the ICF is translated from English but remains identical across sites, regardless of local cultural expectations.
Clinical Outcomes Assessments (COAs): Standardised to ensure data consistency across trials, but they often reflect Western cultural assumptions. Linguistic validation forces potentially alien concepts into diverse settings—such as ski-related questions in tropical regions.
Patient Information Leaflets (PILs) in the EU: Readability testing assumes that if a leaflet is clear in English, its translation into other EU languages will be equally readable. This ignores cultural differences in how text is processed across the Member States.
The cultural impact on Patient Engagement
Most Patient Engagement initiatives originate in individualist cultures and have an emphasis on autonomy. Does this alienate patients in societies that prioritise harmony, both through engagement strategies and culturally mismatched materials? Trying to force through communication strategies that fall flat in a given culture causes dissonance. Pharma materials originate from a small subset of the world, meaning many regions have long experienced a disconnect that may have gone unnoticed, unreported, or unaddressed. Does pharma ever acknowledge or research this disconnect? Do they know about it? Surely, clinical researchers on the ground must encounter this.
Regulatory pressures and the need for change
Regulatory bodies such as the MHRA, FDA, EMA, and ICH enforce strict guidelines for standardising patient-facing documents to ensure safety, comparability, and compliance. However, this approach often disregards cultural and linguistic differences in how patients engage with medical information. Localised adaptations or supplementary materials may be needed to bridge these gaps and enhance comprehension and adherence.
Cultural adaptations for specific pharma materials: How it might work
Pharma Document | High-Context, Collectivist, High Power Distance (e.g., China, Middle East, Latin America) | Low-Context, Individualist, Low Power Distance (e.g., UK, Germany, Australia) |
Informed Consent Forms (ICFs) | Use indirect, respectful language. Frame decisions as collective. Use case studies rather than direct instructions. | Use clear language with bullet points, risks, and direct disclosures. |
Clinical Outcomes Assessments (COAs, eCOAs) | Present results through clinical consultations rather than direct patient access. Include cultural context in outcome interpretation. | Allow patients direct access to raw data and customised digital dashboards. |
Patient Information Sheets | Use narratives, testimonials, and analogies. Emphasise the doctor’s recommendations. | Use straightforward, factual content with visual aids: charts, infographics, and decision trees. |
Medication Guides and Package Leaflets | Do not use alarming language about side effects. Frame guidance as gentle recommendations. | Be direct and precise about risks, ensuring full transparency. |
Patient Engagement Strategies | Rely on doctor-pharma collaborations and community-based education programmes. | Use self-service digital resources, online Q&As, and mobile health apps. |
The future of face-sensitive communication
Face-sensitive communication in pharma must be flexible and culturally adaptive. Western patients value autonomy, transparency, and directness, while collectivist and high-power distance cultures prioritise trust, respect, and doctor-led decision-making.
Pharmaceutical companies must recognise these differences to create truly patient-centred materials. Informed consent forms, clinical outcomes assessments, and medication guides should not be designed in isolation from cultural realities.
By integrating cultural awareness into patient engagement strategies, pharma companies can enhance trust, adherence, and participation, ensuring patients worldwide feel respected, understood, and empowered to make informed healthcare decisions.
Thank you for reading.
Mark Gibson
Boston, USA, November 2024.
Originally written in
English