The Nine Circles of Burden Beyond COAs: Informed Consent, Information Sheets, IFUs and Wearables
Jan 7, 2026
UK
,
Spain
In earlier articles we showed how the Nine Circles of Burden explain why Clinical Outcome Assessments (COAs) are more cognitively demanding than they appear. At the centre sits the Core, which is what our Cognitive Burden Simulator (CBS) and where the parsing, recalling, attributing and mapping a response happens. Around it radiates nine layers of additional constraint: working memory limits, visual design, cultural and linguistic variation, delivery mechanisms, contextual stressors, wording and adaptation quality, entrenched formatting conventions, participant cognitive impairment and digital/technological offloading.
But COAs are not the only patient-facing materials that matter. Patients must also navigate informed consent forms, patient information sheets, instructions for use (IFUs) for medical devices and, increasingly, apps and wearables. These are every bit as central to the patient experience and every bit as prone to overloading the mind, in some cases much more so than with COAs.
This article shows how the Nine Circles transfer across these contexts, revealing how the same cognitive bottlenecks can undermine informed decision-making, safe device use and effective engagement with technology.
The Core Across Documents
At the centre of any patient-facing material is the act of cognitive processing:
Parsing the sentence of instruction.
Recalling relevant knowledge.
Mapping it to the patient’s own context.
Deciding on an action.
This is the core. Even without the outer circles, each step requires working memory, attention, a high degree of health literacy (and traditional literacy) and comprehension.
Consent Forms: parsing complex medical/legal sentences; mapping risks to personal circumstances.
Patient Information: parsing side-effect descriptions; mapping to “Do I need to act or tell my clinician?”
IFUs: parsing numbered steps; mapping them to the device in hand.
Wearables/apps: parsing notifications; mapping to “act now or later?”
This baseline burden is always present. But the outer circles magnify it in different ways across different formats.
Circle 1: Working Memory Limits
Human working memory is small: around four chunks at best and fewer under stress.
Consent: multiple risks, rights and procedures listed in dense blocks exceed span; patients cannot hold all clauses while evaluating.
Information sheets: dozens of side effects swamp memory, even when grouped by frequency.
IFUs: branching logic (“if error light flashes, then reset; else proceed.”) outstrips what can be retained without aids.
Wearables/apps: multiple concurrent notifications require priority decisions; juggling alerts exceeds span.
Lesson: any material assuming a patient can hold “seven ideas” is cognitively unrealistic.
Circle 2: Visual Processing
Design and layout are not cosmetics; they are central to burden.
Consent: long, unbroken paragraphs, tiny fonts, low contrast mean that readers carry half-decoded fragments while hunting for salient phrases.
Information sheets: dense columns and tables with poor hierarchy turn into walls of text.
IFUs and PILs: tiny folded leaflets, misaligned steps, unclear diagrams force constant cross-referencing.
Apps/wearables: small screens, sun glare, cluttered UI, cryptic icons increase error rates.
Visual burden magnifies cognitive burden. Clear structure offloads memory; clutter multiplies it.
Circle 3: Cultural and Linguistic Processing
Language and culture shape comprehension.
Consent: legal/ethical concepts, such as “withdrawal of consent”, may be unfamiliar; idioms and metaphors do not translate cleanly.
Information sheets: emotion/symptom words, such as gnawing pain, flashbacks, may lack equivalents; stigma around depression or loneliness impedes reporting.
IFUs: technical terms may not exist in target languages, forcing clumsy paraphrase.
Apps/wearables: interfaces assume LTR scanning and Western numeracy; RTL/logographic readers scan differently.
What feels “clear” to designers is often culturally specific.
Circle 4: Delivery Mechanisms
How information is delivered changes what must be remembered versus what stays invisible.
Consent: paper forces flipping; e-consent hides content behind links and accordions.
Information sheets: print versus PDF versus interactive web alters legibility and persistence.
IFUs: leaflets are physically awkward: app-based instructions split steps across screen and force scrolling.
Apps/wearables: haptic/light cues demand quick interpretation, often without text.
Delivery details quietly shift load from the page/screen onto memory.
Circle 5: Contextual Stressors
Patients rarely read material in calm conditions.
Consent: high-stakes decision points heighten anxiety; stress narrows attention.
Information sheets: often read while ill, fatigued or distressed.
Information sheets: read while ill, fatigued, or distressed.
IFUs: used in urgency (e.g., injections, inhalers) when load is already high.
Apps/wearables: alerts interrupt ongoing tasks in busy environments.
Context shrinks effective working memory. What seems “reasonable” in review is unmanageable in reality.
Circle 6: Adaptation and Wording Quality
Text quality can add or reduce burden.
Consent: ambiguity in “may/might”; overlap between “serious/severe”; passive voice hides agency.
Information sheets: regulatory jargon instead of plain speech.
IFUs: vague steps (“press firmly until click”( mislead
IFUs: vague steps (“press firmly until click”) mislead; missing conditions/actions.
Apps/wearables: prompts like “activity low” are too vague; patients need specific, actionable guidance.
Plain language, testing with real users, reduces cognitive work.
Circle 7: Presentation Conventions and Formatting Habits
Entrenched habits that persist despite evidence.
Consent: ALL CAPS (“YOU MAY WITHDRAW…”) reduces legibility, readability and feels hostile, particularly when translated; underlining looks like links online.
Information sheets: semicolon-separated risk lists with no hierarchy.
IFUs: non-standard symbols, superscripts, footnotes in tiny print.
Apps/wearables: long pop-ups, flashing alerts, legal boilerplate that users ignore.
These are institutional habits, not best practice and they had unnecessary burden.
Circle 8: Participant Cognitive Impairment
Many patients live with cognitive vulnerabilities that reduce attention, working memory and executive control.
Consent: mild cognitive impairment, stroke history, Parkinson’s, depression, ADHD, all reduce the ability to juggle clauses and weight risks.
Information sheets: memory and attention deficits lead to misclassification, such as missing a serious side-effect they actually experienced.
IFUs: executive dysfunction increase sequencing and branching errors; psychomotor slowing amplifies timing mistakes, such as inhaler actuation.
Apps/wearables: alert fatigue is compounded; prioritisation and inhibition are harder.
Design that ignores impairment systematically excludes those who most need clarity.
Circle 9: Digital and Technological Offloading
Modern habits shift cognition from content to location (search) and from reasoning to fluency (LLMs).
Consent: readers conditioned to rely on summarisation may skim dense content, expecting “the gist”, unaided comprehension plummets.
Information sheets: patients used to AI paraphrase may not wrestle with fuzzy terms; they disengage instead.
IFUs and PILs: reliance on video/AI instructions can help in training but without built-in checks, it breeds dependency and fragile recall.
Apps/wearables: users expect “smart” prioritisation; when alerts lack context or are not personalised, trust erodes and compliance drops.
Acknowledging offloading means scaffolding recall and guiding action rather than punishing forgetting.
Case Studies
Informed Consent Forms
A cancer patient with mild cognitive impairment faces Core, Circle 1, Circle 2, Circle 3, Circle 5, Circle 7, Circle 8 and Circle 9. In practice, comprehension is minimal without scaffolds.
Patient Information Sheets
A leaflet listing 40 side effects, is full of jargon and has tiny print overwhelms Core, Circle 1, Circle 2, Circle 6. A patient accustomed to AI summaries (Circle 9) skims or discards it.
IFUs for Devices
A patient with diabetes learning a new pen injector faces branching instructions (Circle 1), tiny diagrams in thin fold-out paper (Circle 2), vague verbs (Circle 6), self-injection anxiety (Circle 5), tremor/cognitive slowing (Circle 8) and expectation of video guidance instead of paper-based (Circle 9). Errors are predictable without better design.
Wearables and Apps
A smartwatch vibration for low heart rate engages Circle 1; decoding icons (Circle 2), interruption in a busy setting (Circle 5), vague prompts (Circle 6), generic formatting (Circle 7), attention deficits (Circle 8) and reliance on “smart” triage (Circle 9). Dismissals and missed actions are common.
What We Learn
Across COAs, consent, information sheets, IFUs and apps:
Working memory is smaller than designers assume. Four chunks at best; two or three in practice under stress or impairment.
Burdens are additive. Visual, cultural, delivery, context, word9ing, impairment and presentation layers multiply.
Many burdens are avoidable. Outdated formatting, jargon, cluttered layouts and careless digital splits add needless strain.
What feels “normal” to professionals is often hostile to patients. Caps, underlining, dense blocks, small screens reflect institutional habits and not best practice.
Digital habits change the baseline. Expecting summarisation and automation means unaided recall tasks need scaffolds to be fair and effective.
Conclusion
Whether it is signing consent, reading a leaflet, following an IFU or responding to a wearable, patients face the same layered burdens. The core, involving nothing more than parsing, recalling, mapping, is fragile enough. The Nine Circles add limits, distortions and obstacles until comprehension and compliance collapse.
We cannot change biology. The four-chunk limit is real and we must respect impairment. But we can change design: plain language, uncluttered layouts, cultural adaptation, delivery that keeps anchors visible, patient-friendly formatting, recall scaffolds and options tuned for cognitive vulnerability.
The imperative is simple: patient-facing materials should measure understanding and support action, not test memory resilience. If we reduce unnecessary burden, we free patients to do what matters: make informed decisions, use devices safely and engage meaningfully with their care.
Nine Circles of Burden Across Patient-Facing Documents
Circle of Burden | Informed Consent Forms | Patient Information Sheets | Instructions for Use (IFUs) | Apps & Wearables |
CBS Core (parsing, recall, mapping) | Parse complex sentences; map risks/benefits to personal decision. | Parse side effects; map to own symptoms/next steps. | Parse steps; map actions to device handling. | Parse notifications; map to “act now/later.” |
1. Working Memory Limits | Dense rights/risks exceed 4±1 chunks. | Dozens of side effects swamp span. | Branching “if/then” steps exceed WM without aids. | Multiple alerts/metrics compete for span. |
2. Visual Processing | Long blocks, tiny fonts, low contrast. | Non-hierarchical risk lists/tables. | Tiny leaflets, unclear diagrams, misaligned steps. | Small screens, glare, cluttered UI, cryptic icons. |
3. Cultural & Linguistic | Legal concepts/idioms don’t translate; unfamiliar rights. | Metaphors/stigma in emotion terms. | Technical terms lack equivalents. | LTR/RTL/TBR assumptions; numeracy/icon differences. |
4. Delivery Mechanisms | Paper flipping; e-consent hides content behind links. | Print vs PDF vs web alters visibility. | Leaflet vs app splits steps; scrolling hides anchors. | Haptics/lights with little text; scrolling hides context. |
5. Contextual Stressors | High anxiety at decision time. | Illness/fatigue reduce attention. | Urgency during setup/use (e.g., injections). | Alerts interrupt busy tasks. |
6. Adaptation & Wording | Ambiguity (may/might); overlap (serious/severe). | Regulatory jargon vs plain speech. | Vague verbs (“press firmly until click”). | Vague prompts (“activity low”); need clear actions. |
7. Presentation Conventions | ALL CAPS, underlining; hostile tone online. | Comma/semicolon chains; no hierarchy. | Non-standard symbols; tiny footnotes. | Long pop-ups; flashing alerts; boilerplate. |
8. Participant Impairment | MCI/attention deficits reduce comprehension/retention. | Memory/attention limits cause misclassification. | Executive dysfunction increases sequencing errors. | Alert priority/inhibition harder; more misses. |
9. Digital Offloading | Expect summarisation; unaided recall skimmed. | Expect paraphrase; disengage from fuzzy terms. | Dependence on videos/AI guidance; fragile recall later. | Expect smart triage; generic alerts lose trust. |
What The Matrix Shows
Same circles, different manifestations across different patient-facing documents. The framework applies across contexts; the surface changes, the cognitive load does not.
Consent and information sheets overload through density and regulatory habits.
IFUs overload through sequential branching and poor diagrams.
Apps/wearables overload through delivery quirks, small screens, interruptions and modern offloading expectations.
The outer circles 6 to 9 reveal avoidable design burdens, vulnerabilities due to impairment and cultural-tech shifts that designers must now plan for.
Thank you for reading,
Mark Gibson, Madrid, Spain
Nur Ferrante Morales, Ávila, Spain
September 2025
Originally written in
English
