Expert–Non-expert Communication: Writing & Translation Essentials

Definition of Expert vs Non-expert

An expert is defined as an academically trained, experienced professional operating within a shared knowledge community, according to Bromme et al. Conversely, a non-expert is someone outside that specific community, though they may be an expert in other contexts and often hold divergent "lay theories."

Core Features of Expert–Non-expert Communication

Expert–non-expert communication is characterized by significant knowledge asymmetry, encompassing differences in factual understanding, conceptual structures, and problem-solving methodologies. Expert knowledge is inherently "situated" and "encapsulated," meaning it must be “unpacked” and recontextualized for lay readers. To facilitate effective communication, the expert must anticipate and adapt their language by gauging common ground and explicitly introducing new terms. External factors such as authority, power dynamics, and time constraints particularly influence verbal exchanges in this context.

Text Typologies & Networks

Göpferich describes a continuum of texts ranging from highly domain-specific to more didactic or instructive materials designed for broader audiences. Gläser further differentiates between domain-internal (expert–expert) and domain-external (expert–non-expert) texts, acknowledging some overlapping categories like directive texts. From a network perspective, documents are interlinked; for instance, European Public Assessment Reports (EPARs), which contain scientific discussions, inform the Summary of Product Characteristics (SmPC), which in turn leads to the Patient Information Leaflet (PIL) and labelling. Therefore, expert–non-expert texts are essentially inter-generic adaptations of expert documents, with labelling serving as an abridged version of the PIL.

Translation Methods for Patient Information Leaflets (PIL)

Writing a Patient Information Leaflet (PIL) functions as an inter-generic translation from the Summary of Product Characteristics (SmPC) and also serves as a source for subsequent inter-lingual translations. Key requirements for a translated PIL include being instrumental, as defined by Nord, meaning it fulfills the target-culture purpose; it should also be covert, per House’s theory, reading as an original document after cultural filtering; and it must be indirect, following Gutt’s principle, where clarity is prioritized and implicit information is made explicit. The writer or translator acts as a crucial mediator, necessitating a blend of domain, communication, and language competences.

Regulatory Framework Affecting PIL Production

The production of Patient Information Leaflets (PILs) is governed by a robust regulatory framework, notably Directive $(2004/27/EC)$, which mandates specific requirements for structure, clarity, legibility, and multilingual parity. The Readability Guideline $(2009)$ offers detailed advice on various aspects, including layout (e.g., font size $\ge$ $9$ pt, use of bullet lists), syntax (e.g., short words and sentences, active voice), and style (e.g., instructions presented before reasons, medical terms clearly translated). For translation, the guideline stresses the need for fidelity while allowing regional flexibility, explicitly discouraging literal translation. Furthermore, Quality Review of Documents (QRD) templates provide fixed headings and standardized sentences applicable across all EU languages.

Quality Assessment: User Testing

User testing is a legally mandated method for quality assessment of PILs, as per Directive Article $(59(3))$ and $(61(1))$. The preferred approach is face-to-face user testing, although alternative methods may be used if justified. The recommended protocol outlined in the Guideline involves a pilot phase with $3$–$6$ participants, followed by iterative rounds until satisfactory data is obtained from $10$ users, and then a final $10$ users, totaling approximately $20$ participants. Each test session should last no more than $45$ minutes and include $12$–$15$ questions covering key safety and usage points. Success is achieved when at least $90\%$ of users find the information AND at least $90\%$ of those understand it, which roughly translates to $16/20$ successful participants.

Practical Issues Identified

Despite guidelines, companies largely adhere to the protocol but sometimes reduce the sample size or question count, or accept lower success thresholds. Service providers, meanwhile, often critique the guidelines for being vague or contradictory and express frustration that authorities neglect feedback on terminology. Additionally, the high cost of user testing, which can reach up to $\text{€}(35,000)$, is perceived to offer limited gains in quality.

Overall Challenges & Needs

Overall, compliance in PIL production appears to be driven more by regulatory checklists than by a genuine orientation towards the audience's needs. Writers, often scientists, and translators tend to focus on templates and regulations rather than on maximizing communicative effectiveness. True improvement requires a multi-faceted approach, including feeding user-test insights back to experts, writers, translators, and regulators; providing comprehensive training in plain-language writing and adaptive translation; and fostering ongoing collaboration among domain experts, language professionals, and patient representatives.