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By: Estelle Willems, Scientific Writer
As experts on what it is like to live with their conditions or to receive such a medicine or vaccine, patients are uniquely placed to provide accurate data on their needs, feelings and symptoms. Both clinical researchers and potential drug recipients are keen to understand the patient’s perspective on the risks and benefits of treatment. As evidenced by recently updated regulatory guidelines, collecting patient-reported outcomes (PROs) via questionnaires completed by patients and without interpretation by clinicians has become a key component of clinical trials. In the meantime, in a world where digital technologies have advanced faster than any innovation in our history, electronic patient-reported outcomes (ePROs) was no exception to the rule. The availability of new technologies has enabled the use of digital tools for collecting PRO, such as tablets and smartphones, interactive voice response systems and other web technologies. That being said, one can wonder about the real pros and cons of adopting ePRO in clinical research, both from the point of view of clinical researchers and patients.
Digital studies have the potential to make clinical research more inclusive, faster and more cost‑effective. One of the main benefits of using ePROs is the ease of recruiting and retaining a larger and more representative population, as patients report their outcomes at home and are not influenced by the hospital setting. The use of ePROs also allows prompt and automated reporting; for example, with color codes to signal severe complications, or with wearable devices to track patients in their daily life. In addition, compared to paper-and-pencil data, electronic data more easily meets the fundamental data quality requirements, i.e. attributable, legible, contemporaneous, original and accurate (also known as the ALCOA principles).
On the patient’s side, digital tools also improve patient’s quality of life by reducing time-consuming face-to-face consultations with their doctors. Remote patient monitoring is also useful for frail patients (e.g. elderly) or anyone else who encounters difficulty getting to the hospital. Where non-digital PROs fail to adapt to all patients (e.g. due to age, low literacy, language barriers, critical illness, etc.), ePROs offer cutting-edge solutions to tailor the digital system to each patient. For example, PRO items can be shared via text, but also via audio’s (for low literacy people, children or blind individuals), graphics (i.e., cartoons for children), videoconferences (for remote interviews) or adaptive questionnaires (depending on the therapeutic response or the disease evolution) and can be supported by instructions, reminders and contact support information made easily available.
Nevertheless, the many uses of these digital systems are only possible if patients are given adequate trainings on how to properly complete ePRO questionnaires. These trainings must be valued, adapted to each patient and include plain language instructions, reminders and strict monitoring. Therefore, there is a risk of selecting a patient population suitable for the use or rapid learning of digital tools. Patients should also be aware of the importance of ePRO reporting, as patient’s engagement can become an issue. For example, patients with no or very few symptoms may view their intervention as irrelevant and may prefer to engage in other activities. In addition, some patients may also be reluctant to use ePROs due to privacy concerns, as issues related to trust in digital devices and data security are increasingly widespread.
Another potential drawback of ePROs is the lack of social contact, with the fear that digital tools can affect the patient-doctor relationship. Additionally, some patients may find it difficult to rate their own symptoms levels over time (e.g. worsening of symptoms) and miss the opportunity to seek advice from their doctor in the moment. These concerns could however be mitigated by offering patients the option of using ePROs to prepare for telephone contacts or face-to-face consultations with their doctors (e.g. with questionnaires to be completed in waiting rooms). It should also be noted that ePROs are likely to generate emotional distress for users. Indeed, repeatedly answering health-related questions at home increases the attention paid to the disease and the digital system’s intrusion into daily life can also cause anxiety in some patients.
Finally, the development of ePRO systems is so rapid that new standards will be quickly required to ensure data quality and validity for PRO assessments. In principle, another advantage of collecting ePROs is their direct integration in databases or registers; however, the data linkage is currently not yet sufficiently optimized and also needs to be improved. In conclusion, although ePROs offer new avenues for improvement in clinical research in terms of effectiveness and patient orientation, the rapid progress of ePRO systems still poses a challenge for the research community.