Planning patient education for a pharmaceutical sponsor
A pharmaceutical company commissions patient education across a product's life, from trial participation to living with a chronic condition. Planning it within a regulated, fast-paced industry means settling where the patient stands on their journey, the insights the content rests on, the objectives agreed with the sponsor, the format and channel, and the client's review.
Constraints of the industry setting
Writing patient education in the highly regulated, fast-paced pharmaceutical industry is challenging on several fronts: a wealth of new healthcare communication technologies, patients more involved in decisions about their health, different national and international guidelines and legislation to adhere to, and the complexity of meeting the needs of both diverse populations of patients and specific individuals. Multiple pieces of legislation, industry codes of practice and guidelines govern the various stages of the product lifecycle, and they vary by country.
Patient education has evolved, particularly with the rise of digital media as a tool in healthcare and pharmaceuticals. Patients are now more informed and more likely to seek education actively. Use of the internet for health information has risen dramatically, and greater possibilities now exist for delivering healthcare solutions digitally through technologies such as e-learning and apps. These technologies are becoming more commonly accepted and used in the industry, and they are valuable additions to the patient educator's toolkit.
The need for personalisation in patient education is broadly recognised. To that end, two things contribute to an engaging and understandable end product: knowing the target audience well, on the basis of robust insights, and making the content, the technology or delivery method and the creative aspects all work together. Translating complex medical and scientific information into language a lay audience can understand takes a specific skillset.
The patient's journey
From clinical trials through product approval and launch to use in routine clinical practice, there are always good reasons to inform and engage the relevant patients. For any initiative, it is prudent to consider where the patient is on their own journey with the disease. The information a patient needs changes from diagnosis through the course of treatment and depends on factors such as age and education. Patients may also change behaviour over time, as the stages of change model (the transtheoretical model of behaviour change) describes, and that model can be a useful tool to help understand, predict and influence their behaviour.
Before diagnosis, disease awareness campaigns play an important role, with the overall aim of an earlier diagnosis that enables earlier treatment and potentially better outcomes. The primary purpose of such a campaign must be to increase awareness of a disease and to provide health educational information about the disease and its management. Regulations such as those in the UK stipulate that a campaign should not promote the use of a particular medicinal product, and that its emphasis should be on the condition and its recognition.
The point of diagnosis matters for patient education because it sets the foundation for motivation and empowerment. It is vital that patients receive sufficient information to understand the condition fully, including its prognosis, the treatment pathway and the potential risks and benefits of the different therapy options. When treatment starts, whether at diagnosis or later, patients should be told about the available choices so that they can take an active part in the decision.
Patients are more in control of their own health and treatment decisions than ever. With a vast array of health information websites and healthcare apps, they are able to access more relevant health information. The practice is less widespread among elderly patients, who often prefer verbal communication from their regular doctor; studies have shown that they also appreciate brief written information in clear language.
Decision aid tools that provide evidence-based information about options and outcomes are another useful way to help patients make informed choices. It is essential that healthcare professionals are receptive to shared decision making. Involving patients in decision making is generally becoming more widespread and more accepted. Patients are becoming more empowered, by their own initiative and the growing resources available to them, and by changes in practice driven by the industry and by campaigns such as the European Patients' Forum Patient Empowerment Campaign.
For chronic conditions, patient education can help patients with their own long-term management, such as managing medications and self-care. Patient support programmes, for example, can bridge the gap between scheduled appointments and the daily management of the condition. Personalising them is important because every patient needs a different level of support and has a different preferred method and frequency of receiving information and support. Where complete personalisation is not possible, perhaps because of complexity or scale, it can be advantageous to offer patients a variety of options so that they can choose the tools they prefer. Useful delivery channels include nurse-led support by helpline or face to face, which offers personalisation, credibility and accessibility, and, increasingly, multimedia technologies such as apps, emails that link to videos, and text messages.
Safety is a priority in a patient support programme, and the pharmaceutical company must be able to meet its pharmacovigilance requirements as well as its other ethical, legal and regulatory obligations. Patients must sign informed consent to enrol in a programme in which they will be directly contacted.
Patient insights
Patient education programmes are often driven by the perceptions of healthcare providers who have not walked in a patient's shoes. To truly engage patients, programme planners and writers must understand the motivators, barriers, attitudes, beliefs, misperceptions and educational needs that patients and family caregivers bring. It is critical that patients and family caregivers understand the benefits and risks of these programmes. Some core patient barriers to health literacy and learning are cognitive challenges, stress related to disease burden, low motivation, poor adherence, lack of a supportive environment, complex healthcare systems and treatment regimens, lack of support, and denial about the need for and benefits of treatment.
Understanding the cultural beliefs and the language that patients are most comfortable with is also critical. One approach to understanding them is immersion in the advocacy space. Advocacy organisations live and work with patients every day and best represent the tone and language of their target patients. Other channels for patient insights are social listening, end-user interviews, channel analytics and a review of the peer-reviewed literature. The core insights are those that rise to the top across all of these channels and prove timely, relevant, actionable and accurate. They should serve as the foundation of patient education offerings.
Agreeing objectives with the sponsor
Educating patients is a delicate balance between addressing what patients or their carers want and meeting the objectives of the initiative from the point of view of the healthcare provider or the pharmaceutical sponsor. A mismatch can render the initiative of limited value. It is imperative that appropriate objectives are defined and agreed with the invested parties at the start, and it is often down to the medical writer to represent and defend the patients' perspective, on the basis of insights.
Format and channel
When patients are educated about their disease and treatment options, health literacy can play a significant role in helping them understand and weigh the benefits and risks of treatment. Patient materials should also enhance the dialogue between patients and their healthcare providers.
Beyond clear writing and communication, the format and channel of education can greatly affect how critical health information is processed and retained. Patients bring a variety of learning styles to patient education, so multi-modal educational strategies drive optimal learning and outcomes. Most patient education offerings provide only the opportunity to see, read and hear health information. True learning and retention occur when patients have an opportunity to interact with the material, for example through simulation, demonstrations, discussion, or space to write in their printed materials. The most engaging space for multi-modal learning is digital communication. However, many patients, particularly older adults, may not have access to digital communications or be comfortable with them, so programme planners need to make sure that offline learning opportunities are always present.
Client review
Managing client feedback and expectations is one of the most challenging aspects of writing for patients. Most pharmaceutical clients, clinical trial study teams and other invested parties are not experts in patient communication. It is common for materials to come back from review with proposed changes to the language that are overly complex or scientific, or that contain complex medical terms without explaining their meaning. In these circumstances, it is always best to explain respectfully that the proposed language is not likely to be understood by patients, and to suggest an alternative, patient-friendly wording that conveys the same message. Medical writers and communications experts are employed for their expertise, so they should have the confidence to advise.
What effective patient education requires
Effective patient education requires well-defined objectives; compliance from ethical and regulatory standpoints; personalisation; appropriate language and design based on health literacy principles; and the right channels for delivery, at the right time. For long-term programmes, it is advisable to build in ways to measure outcomes along the way and to be flexible enough to adjust the approach accordingly.