The advent of digital health solutions is transforming how healthcare takes place, giving patients the chance to receive truly bespoke care that matches precise individual needs, while enabling healthcare providers (HCPs) to secure the best possible results.

As we continue to shift towards an increasingly patient-centred and personalised approach to healthcare, however, the importance of patient-reported outcomes (PROs) will increase.

PROs supplement the traditional ‘hard clinical outcomes’ conventionally relied on by healthcare to provide a more accurate, holistic picture of patient well-being – as long as they are used and designed correctly.

Pharmaceutical companies already recognise the value of asking patients directly about their experience of a condition and its treatment. But more can be done to ensure pharma gathers valuable, timely and clinically valid data on patient well-being that enables HCPs to make sound decisions that result in better care and outcomes for patients.

From paper forms handed to patients in doctors’ waiting rooms, or questionnaires given to take home and fill in before the next visit, the concept of PROs has long been part of healthcare.

But there is untapped potential in collecting PROs digitally. A 2021 study by Richter et al, for example, reveals that patients and physicians highly value the use of an app for patient-physician interaction: 87% of patients in the study reported that it was easier for them to document the course of their rheumatoid arthritis using an app compared with answering questions during routine outpatient visits alone. App use also saw an increased adherence to therapy in 11.7% of the cohort, according to physicians in the study.

Taking advantage of today’s technology can therefore go a long way in ensuring PROs are gathered accurately and efficiently. Collecting PROs electronically (ePROs) via smartphone apps, for instance, means the process can fit more easily into the patients’ schedules, filling in responses when it is convenient for them.

It also makes it far simpler and quicker to get the data back to the clinician. Rather than a static collection of data – on the day of a doctor’s appointment, for example – using a device that’s already part of the patient’s life means that PROs can be collected regularly and repeatedly, accounting for the clinician’s preferred cadence of responses, if necessary, tracking symptoms and experiences on any given day in real time. That creates a more comprehensive picture of patient health and quality of life in between healthcare visits.

ePROs can also be used as screening tools to detect disease complications, or as clinical monitoring tools to assess the impact of treatment. They can also facilitate patient involvement, support patients in self-managing chronic conditions and increase patients’ awareness and activation in their own healthcare.

In the course of our work, we’ve seen that pharma companies are interested in using digital tools to monitor patient well-being and measure their health in a more holistic way.

However, it needs to be done in the right way. Not all questions about patients’ well-being can unlock scientifically useful data which HCPs can use to make clinical decisions; a PRO measure must be developed robustly, and the tool used must demonstrate adequate reliability, construct validity, and content validity, to ensure they have the ability to measure meaningful changes as they occur over time.

It’s important, therefore, to consider which factors are most important to collect.

To aid in this process, pharma should think about how questions to patients are framed to ensure the data and information collected are actually meaningful for both clinicians and patients. HCPs are used to using medical data, like blood tests, for example, so that when they’re trying to understand further aspects of a patient’s lived experience, they seek data that’s clinically valid and provides meaningful insights. Short, top-level questionnaires simply aimed at getting patients to interact with a tool, app or device that make them feel looked-after simply aren’t sufficient to gather meaningful information for the patient, HCP, app developer or even pharma companies themselves.

It’s exciting to see pharmaceutical companies strive to build apps to complement their treatments that focus on patient engagement. That said, the opportunity to uncover meaningful, clinically relevant data on their symptoms, well-being and experience, and drive better patient outcomes is too valuable to be missed and should be the priority here. After all, there are existing design strategies aimed at engaging patients across all types of apps; ePROs themselves don’t need to contribute to engagement.

It’s worth noting, however, that there’s no need to create new ePROs from scratch with every new project, nor is it necessary to try to reinvent the wheel. There are clinically valid, robust ePROs already developed and validated that can be used as part of new digital solutions, as long as the ePRO is used in line with the usage policy and licensed accordingly (if required).
That may avoid the burden for pharma of having to do a lot of preliminary work upfront in creating and validating a tool from scratch. Piloting combinations of different existing tools to meet the needs of a specific patient population is also an option.

Once it’s been established which PROs need to be collected, it’s important to consider how to collect the PROs.

Ultimately, patients and HCPs will only benefit from PROs if they are used – and many patients don’t engage with any digital interventions at all. That can be a major problem and may contribute to inequality in the healthcare system, effectively ostracising patients with low digital literacy.
Therefore, digital tools that collect ePROs must be designed carefully to mitigate any risk of isolating some patient populations.

This includes conducting user-testing to ensure ePROs are perceived to be useful to patients, as well as easy and intuitive to use by the target patient population. It also means considering the patient demographic and doing qualitative research to explore specific needs linked to their health condition. Having guidance and support available to address any issues that present challenges to patients as they fill in their answers can be a huge help.

More generally, the process of sharing information shouldn’t be a burden for patients and must be designed in a way that causes minimal disruption to their lives. For example, it is important to think about how frequently patients should be asked to fill in ePROs, therefore balancing gathering as much relevant data as possible while not taking up too much of their time.

It’s also worth considering how many questions to ask; ensuring the data is robust and trustworthy might mean asking similar questions multiple times, framed in different ways, to verify the validity of the information, but burdening patients with lengthy questionnaires is not ideal. It’s about striking the right balance.

Pharma should also think carefully about patients’ health conditions and how this can impact their ability to share information. If patients have dexterity challenges, for example, asking them to type in a smartphone app might not be appropriate.

With a myriad of variables at play, it’s impossible to create a solution that works for everyone. What pharma companies can do to reap the benefits of PROs is to start small.

Select a sample of the target market and test, analyse and adjust. Piloting with a sample of patients before launching a tool means pharma won’t fall into the trap of imposing its own assumptions of what might work on users, and can therefore make informed decisions based on real-world patient data.

This process can continue once a given solution is on the market; as usage data is gathered and outcomes are measured, the solution can be improved.

Starting small can also be a beneficial approach when it comes to how the data is analysed, interpreted and shared with patients and HCPs. A simple digital PRO has a low barrier to entry and can be scaled later as part of the overall project roadmap, which would also consider any required regulatory approval.

Improving patient outcomes has taken centre stage in the healthcare conversation, and ePROs offer pharma companies a clear opportunity to make treatments and care more patient-centred.

By designing processes with the patient in mind, collecting clinically valid data in an efficient and evidence-based manner, and using the right technology and tools, pharma can put patients at the heart of their own treatment and make a real difference to their care from day one.

‘Tracking symptoms and experiences on any given day in real time creates a more comprehensive picture of patient health and quality of life in between healthcare visits’