Health Literacy, Medicines and Pharmacy: Setting the Scene School of Healthcare FACULTY OF MEDICINE AND HEALTH Health Literacy, Medicines and Pharmacy: Setting the Scene DK Theo Raynor Professor of Pharmacy Practice , University of Leeds & Director, Luto Research Ltd

30 years ago …………. What does this mean? “One to be taken every 8 hours” 53%: every 8 hours for 2 doses only “Avoid alcoholic drink” 61%: no alcohol 39%: drink a little

Two way street? “There was limited comprehension and understanding of medications; thus, functional health literacy of the study population was poor".  Only valid if sure that information presented was worded, designed and delivered appropriately You can't simply say that their health literacy was poor; rather their health knowledge was poor Did the information follow best practice? - simple words? Hence medication & health literacy is two-way street Need to meet patients half way by applying good practice in spoken and written information to make sure what is supplied actually meets patients' needs Raynor DK. Medication Literacy Is a 2-Way Street. Mayo Clinic Proceedings 2008

Over-view Overview of Leeds research Systematic review Expressing harm & benefit information Performance based testing and health literacy What is “User Testing”? Applying to the NPSA Lithium booklet Key messages

Leeds Research on Consumer Medicines Information School of Healthcare FACULTY OF MEDICINE AND HEALTH Leeds Research on Consumer Medicines Information Health Literacy, Medicines and Pharmacy: Setting the Scene d.k.raynor@leeds.ac.uk

Medicines Management Research Group Consumer medicines information Impact of EU legislation & User Testing Expressing risks and benefits to patients Medicines pictograms US & Australian patient leaflets Expert advice to MHRA, EMEA and FDA World Universities Network (WUN) Key collaborators Sydney & Wisconsin Also Universities of Utrecht & North Carolina University Spin Out: Patient information testing service for pharma >15,000 participant interviews

Systematic Review - Key Findings Most people do not value information they receive Patients do not want written information as substitute for spoken information Great concern about complex language & poor visual presentation of information Patients value the idea of information: set in the context of their particular illness contains a balance of benefit & harm information Raynor DK, Blenkinsopp A, Knapp et al. Systematic review of research on role & effectiveness of written information to patients about medicines. Health Technol Assess 2007;11:1-160

Information design principles Short familiar words and short sentences Short headings that stand out Type as large as possible Leave ‘white space’ Use bullets for lists Be conversational Use the ‘active voice’ Use non-justified text Use bold lower case for emphasis Pictures and graphs don’t necessarily help Raynor DK, Dickinson D. Key principles to guide development of consumer medicine information--content analysis of information design texts. Ann Pharmacother 2009;43:700-706 Knapp, P; Raynor, DK; Jebar, AH; Price, SJ,  Interpretation of medication pictograms by adults in UK. Ann Pharmacother,  2005;39:1227-1233

Expressing risk Side effect data using verbal descriptors Such as ‘common’ and ‘rare’ Overall gross overestimation of risk Percentages confuse many percentages less than 1? Natural frequencies work better Like ‘Affects less than 1 in a 100 patients’ Combining words & frequencies may have advantages Rare (affects less than 1 in 100 people) Berry, Raynor, Knapp. Provision of information about drug side effects. Lancet 2002 Knapp, Raynor et al.  Communicating risk of side effects to patients: an evaluation of UK regulatory recommendations. Drug Safety 2009;32:837-849

How to present benefit information?

Performance Based Testing and Health Literacy School of Healthcare FACULTY OF MEDICINE AND HEALTH Performance Based Testing and Health Literacy Health Literacy, Medicines and Pharmacy: Setting the Scene d.k.raynor@leeds.ac.uk

Do not exceed the stated dose Content or Performance based testing? Content Based Testing: Readability Formulae Do not take into account: layout or design of leaflet size of text or typeface sequence of words used Do not exceed the stated dose Guide a only are they Performance based testing: User Testing How does the information perform? Can people find and understand the information they need?

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 & their general comments Remedy problems Using research evidence & good practice in writing & design Test again Raynor DK. Testing, Testing: The Benefits of User-testing Package Leaflets Regulatory Affairs Focus 2008

User Testing during development of Lithium Booklet Two rounds of User Testing during development of Lithium Booklet Target not reached for many questions including: The need to carry Lithium Alert Card Causes of lithium levels going up Why need to take same brand When should you take during the day

Other User Testing Research

Key Messages Health and medication literacy is a two-way street Patients’ information needs are not necessarily met in the ways we think are best Presenting harm information is best provided using natural frequencies Presenting benefit information requires more research Performance based testing can significantly improve information