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 23-24 September 2014 London UK

UK 1970s “The Tablets” “The Capsules” “The Liquid”

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)

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

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?

2. How we User Tested RMP Summaries

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?

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

Which Summaries to test?

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

Original Latuda RMP Summary

3. What RMP Summary User Testing told us about the original Preliminary data – subject to confirmation

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?

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.

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.

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?

4. Preparing a revised version using learnings from the User Testing

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

Original Revised

4. Findings from User Testing of revised version Preliminary data – subject to confirmation

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

5. What is the way forward?

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 on 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

What is ‘transparency’? 32

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?

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? x I 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?

Risk Management 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 23-24 September 2014 London UK