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Clinical & Medical Affairs
Kate O’Brien

Low literacy issues and the Patient Information Leaflet

Posted by on 15 May 2019
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In this series - The Pain Clinic - Kate O’Brien, formerly a senior research nurse and now a site consultant, examines the most common problems facing clinical trials today and what the potential solutions to them are (read the previous posts here). This week she looks at how low literacy levels in the UK present a challenge to effective Patient Information Leaflets.


This alarming statistic has a dramatic impact on patient engagement in clinical trials. Clinical trials have become increasingly complex, involving more procedures and collecting data using different technologies. A recent survey by Informa Connect found trial complexity was felt to be the biggest challenge facing clinical trial professionals, so how much more does this impact on patients and their willingness to participate in a trial? Low health literacy is now widely recognised, but this issue cannot be tackled until low literacy has been addressed.

Part of the patient recruitment process is ensuring that a patient fully understands all aspects of the trial to enable them to comply with the requirements. To support this, they are provided with the Patient Information Leaflet (PIL), however, these documents are lengthy, use technical terms and can be intimidating. Patients are reluctant to admit that they do not understand the information and the easier option is to not be involved.

How can we change this?

The first step is to simplify the process. Ensure that sites are provided with a letter to send to potential recruits informing them that they may be eligible to take part in a study and some basic information about what is involved, in language easy to understand. This needs to include a reply slip for patients to enter their contact information. A telephone call prior to sending this out enables the site to initiate a relationship with patient and personalise communication. If this call can come from someone that they are already familiar with at the Practice this helps to reassure the person. This also enables them to expect the letter and increases the likelihood of a response.

A face to face discussion about the trial enables the research team to use a language format that the patient can easily understand. One method I used was to invite potential participants in for a group talk with myself and an investigator. The doctor would give some information about the condition and current treatment options, I would explain what being in a trial involved and the investigator then would discuss some of the specifics of the study. I would try to have a patient involved who had previously taken part in a trial to give that perspective. At the end of the talk we would book a one to one appointment for those that were interested, and give out the Patient Information Leaflet. The whole session was relaxed and informal with plenty of tea and coffee. I wanted those attending to feel comfortable and be able to ask questions. Family members were welcome as we were aware that often it was their fears that deterred patients from enrolling in a trial.

Olivia Neely at Dr Ainsworth’s site in Leamington has a similar approach. She will often invite patients in to talk about the trial three or four times prior to signing Informed Consent to ensure that they feel fully informed and comfortable with all aspects of the trial. This results in a high retention rate and compliance with the Protocol. She likens this to decorating – the more time spent in preparation, the better the outcome!

However, these talks and visits are often not included in the costings for the study. Experienced site staff recognise the value of dedicating this time to ensure the best outcome for both patients and Sponsors. Perhaps it is time that this knowledge is recognised, and funding is allocated to recompense the time spent in preparation. After all, sites with a high retention rate ultimately lower the cost to the Sponsor.

What can Sponsors do?

Sponsors could also help sites by providing the Patient Information Leaflet in a more acceptable format to patients. Provide the information in smaller chunks, perhaps enable sites to tailor this to the patients’ requirements. As an example, often there is a whole page focussing on pregnancy, this could be removed for post-menopausal women or men. More care needs to be taken with how the information around side effects is communicated. Regularly patients told me that they didn’t want to take part because of getting ALL these problems. At an appointment I was able to reassure them that they were highly unlikely to have all these problems and may not experience any side effects. I used a Patient Information Leaflet for Paracetamol to demonstrate the requirement of informing those taking a product of possible side effects. Listing pancreatitis and hepatitis did not mean that all patients would be afflicted if they took Paracetamol. However, I was unable to do this for those patients receiving the PIL by post, or for their family members.

As an industry it is easy for familiarity with what we do to cause us to become blasé about the understanding of those outside the profession. Employing a specialist company to design information leaflets with low literacy in mind is one solution, another is to involve patients in providing feedback. A trap companies fall into is using “professional” patients which then distorts the relevance of their contribution.

It is recognised that literacy and numeracy issues affect a patient’s ability to comply with routine appointments, planning journeys to arrive at the correct time and generally understanding what is required of them. Assistance with this is vital, not only providing reimbursement for taxi costs, but booking the transport and confirming this with the patient. Most patients find text appointment reminders useful. These could also include prompts to fast prior to their appointment, return IMP, return diaries etc. However, all this takes up more of the sites’ time so the Sponsor could consider using a company that provides a concierge service to relieve this burden.

Six ways to improve patient understanding

- Ensure all language used is low literacy compatible
- Provide information in smaller, easy to digest sections
- Recognise and reward sites that are committing extra time, visits, phone calls to ensure full patient understanding
- Utilise specialist companies to design the PIL
- Enable sites to tailor the PIL to individual needs
- Employ a concierge service to aid appointment attendance as per Protocol

RELATED ARTICLE: Increasing research awareness and changing public perception of clinical trials

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