The report
Proof of what patients changed.
The report is what you get at the end. It's written so that someone who wasn't involved can see exactly what happened.
What's in it
- What was asked. The documents or product, their version numbers, the stage, and the questions members were asked.
- Who took part. How many were asked and answered, how fast, and their breakdown by age, sex, ethnicity, deprivation, where they live and other conditions, compared with who has the condition. Never names, and never anything that could identify a member.
- How they took part. What they saw, what they signed, and whether it was a survey, a video diary, a voice note, an on-screen review or an interview.
- Every point raised. How many raised it, which groups, a quote, and your response: changed, partly changed, or not changed.
- What changed and what didn't. Two tables. Every "not changed" has your reason next to it.
- What members said about your changes, if you asked them to look again.
- Where it goes. Which of your documents it feeds, and which section answers which question.
- What it doesn't show. Its limits, stated so nobody has to find them.
- Sign-off. Your clinical trial or product lead, our delivery lead, and the date members received their summary.
Why "what didn't change" matters
A report that only lists agreement is a testimonial. The "not changed" table, with your reasons, is what makes it evidence.
Where it goes
The report is written to feed documents you already have to produce.
| If you're… | It feeds… |
|---|---|
| Running a clinical trial in the UK | The IRAS public involvement questions, read by the research ethics committee |
| Running a clinical trial with EU sites | The CTIS application: the Part I protocol section on patient involvement in the design, and the Part II participant materials |
| Developing a device | Your usability engineering file, as a design input to formative evaluation (not a formative evaluation record) |
| Running a device clinical investigation | Your clinical investigation plan and participant information sheet under ISO 14155; your PMCF plan and evaluation report under the MDR |
| Building a digital health product | The user involvement sections of the NICE evidence standards framework and your DTAC submission |
| An NHS organisation or supplier | Your equality impact assessment, tender responses and health inequalities reporting |
| A researcher | Your NIHR involvement and inclusion sections, as one part of your involvement plan |
Your report is yours
Client reports belong to the client and are never published. That's why the sample patient involvement report is a worked example.