Making patient leaflets more accessible and easier to understand: the case of Italian patients
Guendalina Graffigna is a Professor of Consumer Health Psychology and Psychology for Social Marketing at the Faculty of Agriculture, Food and Environmental Sciences of the Catholic University in Milan, Italy. She is also the Director of the EngageMinds HUB at the Consumer, Food & Health Engagement Research Center and is an expert in patient engagement, behavioural change and behavioural economics.
Guendalina is a member of Gravitate Health WP4 (the section of the project dedicated to ‘End-user tools’ aiming to access information & services) and WP6 (the section ‘Evaluation’ with the purpose to prove it works). She is involved in analysing data from the Italian scenario, showing what is the general attitude of Italians towards product information leaflets for patients (PLs) and how different levels of health literacy and patient engagement can predict different attitudes towards the patient leaflets.
Background and Context of the Italian scenario
Q: Could you provide a brief overview of the Italian scenario you analysed?
A: The Italian scenario is composed by 305 Italians representative of the Italian population and 206 participants, that we identified as patients, since they self-referred to have at least one chronic condition.
Q: What makes this scenario unique or particularly relevant to health literacy?
A: The analysis is being carried out with two different samples. Each sample includes the characteristics of the project personas, which are expected to present different health literacy levels, also due to their health needs. Specifically, in the present study, each sample provides a special understanding of how leaflets are used, in terms of their own medication usage and needs.
On the one hand, healthy citizens, who take over-the-counter medicines (OTCs), provide insights from the perspective of a person that does not need medicines on daily basis, but that wants to be informed for those occasions where taking them is expected.
On the other hand, patients, give us insights from the perspective of someone who requires a closer relationship with their medication and might see the leaflet as a supportive tool to navigate their medicines and support their understandings on their health.
Q: What were the primary objectives of your analysis?
A: The primary objectives of this study were to:
- Identify the orientation of Italians towards the use of ePLs or “electronic product information (ePIs).”
- Determine the orientation of Italians towards G-lens, depending on their health literacy, digital health literacy and patient engagement.
Were there specific questions or hypotheses you aimed to explore regarding health literacy and patient leaflets?
A: To address the primary objectives, we decided to orient our analysis in 4 domains. First, to explore the usage, then the frequency of consultation, third, the ability to find relevant information and fourth, to comprehend the understanding that participants had of the information presented on the leaflet. This served to have a clear overview of the relationship that the Italian population has (of OTCs consumers and patients) regarding leaflets.
For the second objective, we explored how attitudes, evaluations and intention to use G-lens varied according to the patients and citizens characteristics listed above.
Our Methodology
Q: What methods or tools did you use to assess Italians’ attitudes towards patient leaflets and their connection to health literacy and patient engagement?
A: We conducted an online survey. At the mid of the questionnaire we proposed to the sample a realistic video of the G-lens use with two realistic scenarios. Then, we asked the interviewees their opinions and evaluations. We also tested—before and after the video interviews—attitudes towards medical adherence.
Q: Were there any specific demographics or patient groups that you focused on during your research?
A: Explained above.
Key Findings on Italians’ behaviour towards Patient Leaflets
Q: What are the main insights or trends you have discovered so far regarding Italians’ attitudes toward patient leaflets?
- High leaflet consultation but low comprehension among healthy citizens: 16% of OTC users report reading the patient leaflet (PL), yet 42% of them struggle to comprehend the content, indicating a major gap between access and understanding.
- Patients demonstrate higher comprehension: Among individuals with chronic conditions, 4% read the PL, but only 10.19% report comprehension difficulties—significantly lower than OTC users.
- Sociodemographics do not predict understanding: Logistic regression results show that only 2% to 2.9% of the variance in comprehension difficulty can be attributed to age, education, or gender, indicating that comprehension barriers affect diverse groups.
- Limited impact of education: Despite 5% of respondents holding a university degree, comprehension issues persist, emphasizing the need for clearer, more accessible medical information.
Q: How do health literacy levels influence these attitudes? Are there notable differences among various groups?
- Health literacy impacts reliance on PLs: Individuals with higher health literacy (mean HLQ score = 3.59/5) are less likely to consult PLs and more likely to rely on alternative sources, such as digital health tools or healthcare providers.
>> Interesting finding resulting from frequency of consultation and dimension 8 and 9 from the HLQ: Dimension 8 (Finding Good Health Information) and Dimension 9 (Understanding Health Information):
The negative correlations here (-0.130 and -0.170, respectively) suggest that those who are adept at finding and understanding health information from other sources rely less on leaflets, which may be a sign of confidence in their capabilities and the perception of a lesser need of ePI use.
- Low health literacy correlates with leaflet dependence: Participants with lower health literacy scores (HLQ < 2.85/4) are 42% more likely to rely on PLs but also report greater difficulties in understanding them.
- OTC users have more comprehension issues than patients: Among OTC users, 38% of the total sample struggles with comprehension, compared to just 10.19% of patients.
- Stronger self-management in patients: Patients score higher in active health management (HLQ = 2.81/4) and appraisal of health information (HLQ = 2.85/4) than OTC consumers, reflecting their stronger engagement with medical information.
How does patient engagement impact the way Italians perceive and use patient leaflets?
- Patients with chronic conditions utilise leaflets more effectively: While 85.4% of patients read PLs, their lower comprehension difficulty rate (10.19%) suggests they can better navigate medical information compared to OTC users.
- Active health engagement reduces leaflet reliance: Individuals scoring high in active management of health (HLQ = 2.81/4) and finding good health information (HLQ = 3.42/5) rely less on PLs and more on healthcare professionals and digital resources.
- Lower health engagement leads to greater confusion: Participants with lower health literacy scores (HLQ < 2.85/4) are 29% more likely to find PLs confusing, suggesting the need for better health education strategies.
Implications and Next Steps
Q: What do your findings suggest about improving the design or content of patient leaflets to better support health literacy?
- Clearer, simpler language is necessary: 42% of OTC users struggle with comprehension, indicating that medical terminology should be simplified to improve accessibility.
- Better organization and readability: Difficulty in finding relevant information correlates negatively with overall understanding (p = 0.003), suggesting that PLs should include color-coded sections, bullet points, and simplified headers to enhance usability.
- Visual and digital enhancements needed: Participants who struggled with comprehension (HLQ = 2.85/4) also scored lower in digital engagement (HLQ = 2.77/4), indicating that integrating visual aids, infographics, and digital navigation tools (such as QR codes or interactive ePIs) could improve accessibility.
- Customisation based on user type: Given that 42% of OTC users struggle with comprehension compared to only 10.19% of patients, leaflets should provide tailored content based on medication use frequency and patient needs.
Q: How can these insights help enhance patient engagement and healthcare outcomes in Italy and beyond?
A: By encouraging proactive health management: Participants with stronger health literacy (HLQ = 3.59/5) report higher confidence in managing their health, reinforcing the need for targeted health literacy programs to promote proactive engagement. Also, pharmacist and physician involvement is key: Healthcare professionals should actively guide the 42% of OTC users who struggle with comprehension, providing verbal explanations or alternative educational materials.
Digital health integration can bridge the gap: Since individuals with higher eHealth literacy (HLQ = 2.92/4) rely less on PLs, incorporating digital solutions (such as ePIs, interactive videos, and AI-driven assistants) can enhance patient comprehension and adherence.
Q: Are there any specific recommendations you have for healthcare providers or policymakers based on your analysis?
- Develop digital patient leaflets: Given that 38% of total respondents struggle to find relevant information, ePIs with searchable text, multimedia content, and AI chat support could improve accessibility.
- Standardise leaflet formatting: Consistent use of summaries, infographics, and decision trees can improve navigation, especially for the 42% of OTC users who struggle with comprehension.
- Integrate health literacy training into clinical practice: Physicians and pharmacists should be trained to assist patients and OTC consumers with lower health literacy (HLQ < 2.85/4) in understanding their medication instructions.
- Promote G-lens and digital health tools: Given that higher digital literacy (HLQ = 2.92/4) correlates with reduced reliance on PLs, policymakers should encourage wider adoption of eHealth solutions to support those who struggle with traditional leaflets.
- Social interventions must be done in 2 ways. First, they need to attend the comprehension needs of leaflets’ users, who, despite of consulting this material, do not easily comprehend the information presented. Second, they should address the digital health literacy impairments of users who identify the need to retrieve relevant information inside this tool, but who also have shown to be the less engaged with technology, less understanding of health concepts, and less motivated to engage with digital services.
>> Strong negative correlations with all dimensions of eHLQ (1, 2, 3, 5, and 7) and the need to find relevant information inside the leaflet
Broader Perspective and Takeaways
Q: How do your findings align with or differ from trends in other countries participating in the Gravitate Health project?
- Comprehension challenges are a common issue across Europe: results from other testing scenarios have not been fully received, yet from the feedbacks gathered until now, low comprehension of patient leaflets remains a major barrier, therefore, solutions to facilitate the comprehension of the information presented and the ease by which content is appraised, are needed.
- On the Italian testing scenario, it was found that Digital Health Literacy plays a crucial role: we hypothesize that countries with higher digital engagement (HLQ > 3.0/4) will show lower reliance on ePI, indicating that expanding digital health education could improve comprehension in Italy and that digital tools that reimagine the vision of ePI’s will be needed to satisfy the needs of more digitally health-literate users
- Italy shows a stronger divide between OTC users and patients: The 42% comprehension difficulty rate in OTC users vs. 10.19% in patients suggests that Italy’s general population may require additional support in health literacy compared to some other European nations. To confirm the latter, further studies might need to take place.
>> Yet, the shorter gap on ePI comprehension coming from the patient sample, places patients as a resource to support the health literacy formation on general population.
