What can we learn from developing medicines information for patients?
-
Upload
hlguk -
Category
Health & Medicine
-
view
154 -
download
4
Transcript of What can we learn from developing medicines information for patients?
School of HealthcareFACULTY OF MEDICINE AND HEALTH
Improving health information to promote health literacy
What can we learn from developing
medicines information for patients?
DK Theo RaynorProfessor of Pharmacy Practice, University of Leeds
and Co-founder & Academic Advisor, Luto Research
UK - 2015
Comprehensive patient leaflet supplied with every medicine
Readability testing of each leaflet through user testing with general public
Patient friendly summaries of: Public assessment report (EPAR) Risk management plan (RMP)
Meaningful consumer input to policy MHRA and EMA patient advisory groups
Background Consumer medicines information research group:
20 year programme, funded by Department of Health, DIA Expert advice to MHRA, EMA and FDA
Focus: Impact of EU legislation & User Testing Expressing risks and benefits to patients US & Australian leaflets – part of World Universities Network
collaboration: Sydney, Wisconsin, Utrecht
University Spin Out: Develops, refines & tests health information >20,000
participant interviews Patient information leaflets & Instructions for use
(IFUs) NHS medicines information e.g. Lithium booklet Health charities e.g. range of condition booklets
Medicine Label Wordings 1978
One to be taken every 6 hours• 53%: every 6 hours for 3 doses only
Complete the prescribed course• 40% misunderstood
Caution: this medicine may cause drowsiness• 33% misunderstood
Raynor &980
European Draft Readability Guideline: 1997
Guideline included: • a prescriptive “model” leaflet
• detailed structure & wording
• proposed 37 headings
pecmi tested model leaflet• performed poorly
• best practice version performed much better
Fred, Mary and Joan go to Brussels
As a result: Model leaflet amended Headings reduced to a manageable 7 Deviation from model allowed if
supported by consumer testing
Game Changer
European Directive in 2005
“The package leaflet shall reflect the results of consultations with target patient groups to ensure
that it is legible, clear and easy to use” No successfully tested leaflet – no licence
Implemented through process called User Testing• Process developed in Australia by Prof David Sless
Performance-based testing• Can potential users find and understand key points of information
for safe and effective use?
Two components:• Quantitative – how many can find & understand key points?• Qualitative – what do people find useful?
User Testing in brief
Select 15 key points
Relevant to safe and effective use
Design & pilot a questionnaire which tests:
Finding each piece of information
Understanding (express in own words)
Recruit 20 people from target group
Interviewed individually
Interview concludes with qualitative questions
What did they like and not like about the leaflet?
Try, Try and Try Again
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
Rebacsa
Rebastatin
“19 out of 20, I’d say it was a good pill.”
“I found [numerical information] a bit depressing ‘Oh it only improves in 1 in 20 in 5 years’, well, I won’t bother!“
• Identify patients with lower health literacy and then - develop special materials
or• Develop clear, well written and
designed information to benefit all patients - universal precautions
• Focus on patients is a ‘partial measure’
• ‘Health Literacy Questionnaire’
• Domains related to both individual and health system
School of HealthcareFACULTY OF MEDICINE AND HEALTH
Improving health information to promote health literacy
What can we learn from developing
medicines information for patients?
DK Theo RaynorProfessor of Pharmacy Practice, University of Leeds
and Co-founder & Academic Advisor, Luto Research