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Lay Summaries How to make them fit-for-purpose Dr DK Theo Raynor - - PowerPoint PPT Presentation
Lay Summaries How to make them fit-for-purpose Dr DK Theo Raynor - - PowerPoint PPT Presentation
Risk Management Plan Lay Summaries How to make them fit-for-purpose Dr DK Theo Raynor Professor of Pharmacy Practice University of Leeds, UK and European Medical Academic Advisor, Luto Research Information and Communications Conference
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2014
Comprehensive patient leaflet
- supplied with every medicine
Readability testing of each leaflet
- through user testing with real people
Patient friendly summaries of:
- Public Assessment Report (EPAR)
- Risk Management Plan (RMP)
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Risk Management Plan Summaries
Legislation
- Member States & EMA to 'make public RMP summaries
for all medicines authorised in the EU'. Target audience
- ‘Lay reader' (no scientific knowledge)
- HCPs, patients & consumers with
particular interest Content
- Clear, concise summary
- Risk put in context of the benefit, but
avoid being alarming
- Consistent and complementary with EPAR summary,
package leaflet - with minimal duplication
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Over-view
- 1. How we User Tested RMP Summaries
- 2. What RMP Summary User Testing tells us
- 3. Preparing a revised Summary using
learnings from User Testing
- 4. Findings from testing the revised Summary
- 5. What is the way forward?
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- 2. How we User Tested
RMP Summaries
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User Testing in Brief
Select key points of information Recruit 10 people from target group
- Interviewed individually
(a) Quantitative aspect
Design & pilot a questionnaire which tests:
- Finding each piece of information
- Understanding (express in own words)
(b) Qualitative aspect
- Interview then moves to qualitative questions
- What did they like and not like about the document?
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User Testing is an iterative process
- Test material
- Identify problems
- the points people struggled with
and their general comments
- Remedy problems
- using research evidence & good
practice in writing & design
- Test again
Raynor DK. User testing in developing patient medication information in Europe. Research in Social and Administrative Pharmacy 2013
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Which Summaries to test?
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Main headings
Overview of disease epidemiology Summary of treatment benefits Unknowns related to treatment benefits Summary of safety concerns Summary of additional risk minimisation measures by safety concern Planned post-authorisation development plan Summary of changes to the risk management plan over time
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Original Latuda RMP Summary
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- 3. What RMP Summary
User Testing told us about the original Preliminary data – subject to confirmation
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Quantitative findings: Problems with finding and understanding
- Who is document written for?
- What are 3 types of safety concerns listed?
- What did long-term studies already
completed show about benefits of Latuda?
- In what 2 documents can you find routine risk
minimisation measures for Latuda?
- What particular groups of patients will the PASS
study include?
- Can you find the patient leaflet for Latuda?
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Qualitative findings: what participants said
Who is it written for?
- They [patients] wouldn't understand it ……… by the time
they've gone through that, I don't think they'd have time to take a tablet. It should be broken down into layman's terms.
- Nowhere at the beginning does it clearly say that's who it's
intended for. Language
- “Strong CYP 3A4 inhibitors” - a lot of words that just seem to
be thrown in for the fun of it.
- “In vitro” - I haven't got a clue - some sort of medicine?
Could be something in Italian. Index
- On the leaflet you have an index ....and you just went
straight to where you needed to go ...it ‘s more difficult here.
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What participants said
Layout
- Possibly break up the "summary of safety concerns“ …..
start them on different pages .... make it more obvious there's 3 different sections. Tables It's good that they have the side-effects in tables X They absolutely make no sense to anybody, apart from a doctor ... they really are confusing Later sections
- From page 5 you could just get rid of those 4 pages.
- [It is] complicated and confusing "metabolite ID 14823",
I don't know if you really need that as a patient.
- Some bits are fairly clear and then when you get bits at the
bottom about Japanese trials, that's very confusing.
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EPAR Summary findings from User Testing
Need clear signposting
- main headings (numbered) and sub-
headings which work for lay people
Clarify the purpose
- who it is for - why is it useful?
Should it be aimed at a different audience?
- is it for lay people?
Clarify relationship with the patient leaflet
- are they inter-dependent?
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- 4. Preparing a revised
version using learnings from the User Testing
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Revised Headings
Introduction 1. What is schizophrenia? 2. How many people have the illness?
[ex Overview of disease epidemiology]
3. What have completed studies shown about the benefits of Latuda
[ex Summary of treatment benefits]
4. Groups of people where we have less information about lurasidone
[ex Unknowns relating to treatment benefits]
5. Summary of safety concerns 6. Summary of actions to minimise the risk to patients
[ex Summary of additional risk minimisation measures by safety concern]
7. Studies happening now and in future
[ex Planned post authorisation development plan]
8. Summary of changes to the risk management plan over time
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Original Revised
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- 4. Findings from User
Testing of revised version
Preliminary data – subject to confirmation
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What the participants said
Layout
- It's really well laid out. The tables are good and the sub-
headings and the bullet point all worked really well … you can find what you need to find really easily.
- I really like the tables, the way the risks are laid out because
there's the ‘a’, ‘b’ and ’c’ at the top.
Contents list
- I like the way it's laid out and the contents that tells you
exactly where you going to find each section - makes it quite easy to skip around.
- I like the summary at the beginning that helps you to find
what you're looking for
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- 5. What is the way
forward?
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General improvements to current template
Layout
- Clear signposting with main headings (numbered) and sub-
headings which work for lay people
- Contents list
- Simplify tables – minimise number of columns – start each
- n a new page
- Greater use of bullets, including in tables
Content
- Clarify purpose - who it is for - why useful?
- Simplify language e.g. in vitro, epidemiology
- Improve links to the patient leaflet
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What is ‘transparency’?
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Major changes to current template
Does it work to retain structure and headings of the full RMP?
- Should a more lay friendly structure be used
Do lay readers want / need all of the current content?
- “Summary of additional risk minimisation measures
by safety concern”?
- “Planned post-authorisation development plan”?
Could document be split into 2 sections?
- Place later sections in an appendix?
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Is the concept & approach right?
Concept You want information like that, then you can make an informed decision yourself, am I going to risk it, or not? xI don’ t think it would be wise to let patients see all this stuff at this stage, because there are so many imponderables Approach
- Is straightforward translation of the sections of the full RMP
appropriate? Same headings, same sequence, same content?
- Is this approach a form of information dumping –rather than
transparency?
- Is it cost-effective – would the time and money be better
spent on other approaches to transparency?
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