Patient-facing documents are important contact points between the organisation and the patient. Some equip patients with the information needed to make significant health decisions. This could vary from agreeing to take part in a study based on an Informed Consent Form to adhering to a treatment regimen influenced by a medication guide. This information is unidirectional: from organisation to patient.

Other materials are designed to gain important insights from patients, such as Clinical Outcomes Assessments, which need to be as precise as possible. This information is bi-directional: from organisation to patient and back – just like a boomerang.

In other articles linking face work and interaction points with the medical establishment, we argued that patients do the most face work. In medical encounters, face maintenance serves to uphold the doctor’s authority. The same dynamics could apply in Patient Voice encounters in the drug development cycle: are some patients telling researchers what they want to hear because of subconscious face maintenance work? Where else might this apply? Clinical study visits involving key data points, such as study diaries or outcomes assessments? Could some patients provide insights in real-world evidence (RWE) studies in a way that attends to the face of the research team or institution?

What if this happens in study sites worldwide, in cultures where face work is consciously attended to? What if this is undetected and contaminates outcomes data? Could differences in Korean real-world data be explained by face work? This might have an effect on both qualitative and quantitative data from patients. Researchers could find themselves stumped by pronounced differences between international study sites, and face work might be the reason why.

What if face-sensitivity towards patients’ needs was part of the design of patient-facing documents? When planning an eCOA or a consent form, a team could brainstorm the potential impact of face of the intended patient audience. Better still, include patients in this brainstorming. It does not have to be many: three to five at most. To maintain consistent input, it would be advisable to consult each individually rather than in a panel, as better insights arise in one-to-one settings (a topic for another discussion).

The first step is to examine past and current document weaknesses. Patients should be involved from this early stage. Insights could emerge through simple health literacy testing, comprehension testing, cognitive debriefing, or a blend of all three. Patient feedback may include:

• Too much jargon, where consent forms prioritise regulatory and legal needs over patient comprehension.

• Complex language that discourages questions and engagement.

• Poor design, such as cluttered text, small fonts, and complex layouts that reduce readability.

• Consent processes that feel bureaucratic, not as dialogues, and discourage discussion.

• Or eConsent that may be too simplified, leading to improper consent.

The digital dimension is important. The shift from COA to eCOA, and from Consent to eConsent, has been ongoing for years now. Has much thought been given to usability and access? Or has it all proceeded based on assumptions that this is the future, that everyone should use technology, and that it saves paper? What about those on the other side of the digital divide?

Then, there are simple human-factor issues: if patients receive a consent form on a tablet or a phone, isn’t the temptation to skip through screens the same as with Terms and Conditions on social media? These are notorious for being unread, with no care for better information design. Some eConsent forms resemble these Ts&Cs. Are patients reading them properly when delivered digitally compared to paper-based versions? The paper versions are just as deficient in design, but at least patients physically handle each page, allowing more time to process the text and think about their decision.

Considering all these points unearthed during this hypothetical consultation, what impact would they have on the patient’s face? In other words, how would patients feel when they are given them? And what are the repercussions from these feelings?

• Content, format, and presentation may intimidate patients and discourage questions.

• Confusing materials make patients feel lost and dependent.

• The consent process may make patients feel pressured and reluctant to opt-out.

In this scenario, the development team would then conclude:

• This is the opposite of informed consent.

• This does not foster engagement or empowerment.

• Their corporate messaging around the Patient Voice may be hollow if patient-facing documents are like these.

eCOA and eConsent should engage patients while respecting autonomy. This requires clear information, plain language, visual aids, and summaries, all designed to enable comprehension.

So, considering patients’ face, simple fixes include:

• Use plain language, bullet points, and glossaries.

• Train staff in face-sensitive communication and use visual decision aids.

• Use clear headings, images, step-by-step instructions, and accessible formats.

• If consent is digital, ensure users cannot skip ahead without reading, perhaps by requiring confirmation: “I confirm I have read and understood this page.” Then, a follow-up message: “If you have questions, please ask a study team member.”

Giving patients poorly produced documentation that erodes engagement is an act of hostility. By contrast, informed consent is an act of empowerment. The content must be concise, transparent, and include clear risk-benefit explanations. It should encourage questions to promote understanding. Face considerations in consent could mean using polite, respectful language to reduce pressure on the patient.

Thank you for reading!

Mark Gibson

Boston, USA, November 2024