A small, optional usability pilot

Version 1.0.1 · 22 September 2026 · Proposed plan, not an enrolled study

Purpose and scale

Find out whether people can understand and use the blank pack, which parts they skip, and what could cause confusion. Proposed scale: 5 to 8 adults over 2 to 4 weeks, with one optional real appointment use. This is not a test of treatment, clinical outcomes or error prevention. No participants or partner have been recruited.

Before inviting anyone

An interested host names a facilitator and provides a written contact route on the consent sheet. The host checks its own requirements for a usability activity, including whether service, data-protection or research review applies. This document does not determine the activity's legal classification. Agree an accessible format and a private place for feedback. Do not recruit through a treating clinician in a way that could make participation feel required.

First session: about 15 minutes

Explain the purpose and limits in plain language. Give the participant the information/consent sheet and time to decide. Use a completely fictional scenario first: someone wants to clarify the next appointment date and where an expected letter will arrive. Ask the participant to find the right section and write one question. Do not introduce real diagnoses, medicines, names or records into this demonstration.

Check understanding by asking the participant to describe what the sheet does, whether it is an official record, and whether a clinician must sign it. If the wording causes confusion, stop and explain; do not treat misunderstanding as a participant failure. Offer a supporter, reading aloud, larger print or extra time. Do not exclude someone merely because writing is difficult.

Optional use between sessions

If the participant wants, they may use the folder at their next routine visit. It is entirely optional to tell a service they are trying it; a service is not being asked to certify the folder. The participant retains every completed sheet. If no appointment happens during the period, a fictional walk-through is enough. Do not delay care or arrange a medical visit for the pilot.

Consent and privacy

Use the separate one-page information/consent sheet. A participant chooses a random code, with no initials or date of birth. They keep the consent sheet and code. The facilitator records only that consent was given, the code and the date; no signature or name is needed for this proposed anonymous usability approach. Do not keep a code-to-name lookup, audio/video recordings, completed folders or health histories. If a host needs identifiable consent records, design and explain that separate process before recruitment; this pack does not authorise it.

Only the facilitator holds coded feedback, locally and privately. Do not email feedback sheets containing health details. Ask people to leave names, diagnoses, services, appointment dates and identifying stories out of comments. If such details are accidentally provided, do not copy them into project reports; arrange removal with the person and the host's privacy lead where applicable. Do not promise absolute anonymity for free-text responses.

The participant can skip questions or stop without affecting care. They may ask the facilitator to remove their feedback using their code until 14 days after their feedback session. The facilitator then combines responses into a summary without codes or identifying quotes, and deletes individual responses within 30 days of that summary. Explain that feedback cannot be removed from a combined anonymous summary afterwards. These are proposed retention limits; explain any agreed change before consent.

Feedback and observations

Use the one-page feedback sheet. Record whether someone could find current information, add a question, locate the next step, and explain the lack of sign-off. Count “not tried” separately from “could not do”. Ask about burden, privacy and access needs. Do not ask whether symptoms or treatment improved. Facilitators record design problems without personal health information.

Stop, fix, decide

Pause use and revise the relevant wording if anyone thinks the sheet changes treatment, verifies an official record, requires a clinician signature, replaces result follow-up, or makes participation compulsory. If a health concern comes up, direct the person to their usual care route; the facilitator does not interpret records or give treatment advice.

At the end, report the number invited, consenting, trying each task, giving feedback and withdrawing. Report missing responses honestly. Describe which barriers were fixed and which remain. Success means the next revision is easier to use and less open to misunderstanding, not that the pack is clinically proven. Agree any larger evaluation separately.