Designing patient self-reporting tools to improve clinical trial experiences for diverse populations

By Ben James , Chief Design Officer and Co-founder of uMotif and Syed Mustafa Ali, Research Associate in Health Informatics at the Centre for Health Informatics at the University of Manchester. 

Featured In: International Clinical Trials, November 2023

As clinical trials rely increasingly on self-reporting, the methods in which they are expected to do this must be improved upon to avoid participant drop-out.

Patient engagement is the lifeblood of a clinical trial. However, sustaining this engagement is a perennial challenge. Approximately 30% of people who enter a trial drop out, and data capture compliance rates in real-world studies hover around 50%.

The challenges are even more urgent and complex when it comes to increasing diversity in clinical trial participation and retention. Historically, diverse populations, including ethnic
and racial minorities, have been underrepresented in clinical research, which can hinder overall efforts to improve healthcare and outcomes.

In 2018, racial and ethnic minority representation in cancer clinical trials was approximately 20% compared with 80% of white counterparts, representing only a 2% increase over the last two decades.

An urgent focus on retention

Participant retention is a critical priority in clinical trials, as attrition adds considerable disruption, time and costs to studies. It is even more imperative with diverse participants
given their underrepresentation. On average, it costs $6,533 to recruit one patient to a clinical study, and the cost of replacing patients is even higher – averaging $19,533.

Because drop-out rates are high and overall compliance can be low, study
timelines are routinely prolonged to meet data volume requirements. This can add to the patient burden and fuel further attrition.

Many factors that drive attrition apply universally across non-minority and minority participants. In addition to financial barriers, the most common reasons patients cite for attrition include inconvenience, time commitments, poor communication and feeling underappreciated. And there are additional impediments to participation and factors that contribute to attrition among ethnic and racially diverse groups, including mistrust based on
historical events, fear of unintended outcomes and limited access to information.

Technology as a tool to make it personal

The proliferation of mobile technology has opened the door to eClinical innovation. However, the technologies have not progressed at the same pace. Since the early 2000s, we have seen rapid innovation and adoption of mobile technology.

While mobile devices have become profoundly powerful, sophisticated and technologically complex, they also have become easier to use and more intuitive. The reason behind this apparent paradox is that these devices have been designed from the ground up with the user at the centre of the experience.

eClinical applications have followed a different trajectory. While they have proliferated and the industry has paid considerable lip service to patient- centricity, most eClinical applications – like trial protocols themselves – have been designed from the perspective of sponsors and investigators, not participants. This tends to push the key stakeholders in a clinical trial apart versus bringing them together around a common goal, resulting in a negative impact on participant engagement and trial outcomes. A large proportion of clinical trial technology can be cumbersome to use, confusing, and require specific terminology.

There is no question that eClinical technology, especially electronic clinical outcome assessment (eCOA) solutions, can play an important role in improving engagement and retention across all participants.

Their effectiveness, however, depends on their ability to ‘make it personal’ – to acknowledge patients’ contributions and sacrifice and understand the individual, their needs and how to engage with them most effectively to get the best possible data.

Digital technology is most effective when it starts with human relationships and behaviours, and then introduces technology into the equation to enhance and advance outcomes.

To achieve this goal, it is important to seek patients’ input at the early stages of design and development, and incorporate that feedback in a way that optimises the user
experience while ensuring effective data collection.

Without this commitment to truly understanding the needs of patients as individuals, technology – including eCOA platforms – will struggle to fulfill its full potential.

Configurability, flexibility and convenience are key

No human participant processes information in the same way, and each of us seeks experiences that are as individual as we are. This also applies in clinical trials.

Consideration of culture, ethnicity and terminology and notes to better describe
other personal characteristics when their symptoms also help to make developing health technologies is an the experience more personalised, important factor in making it possible
engaging and meaningful to extend adoption of such tools at a larger scale.

To meet these requirements, eCOA, solutions must support extreme configurability and flexibility to align the clinical trial experience to individuals or groups of individuals. Flexibility and configurability can take many forms, including the ability to deliver
individualised interfaces to patients that match their unique language preferences, such as cultural-specific terminology. It can include tailored visual diagrams and cues; the ability
to choose what additional information participants might want to provide to make the experience more meaningful and useful to them; and the type of feedback or reports patients receive.

The ability for users to add in their own terminology and notes to better describe
their symptoms also helps to make the experience more personalised, engaging and meaningful.

Convenience in the form of the digital delivery method also is important to support engagement and retention. Participants respond best to technology that is familiar and intuitive. The ability to deliver the eCOA solution on an individual’s own device can help to
support a consumer-grade experience and speed data entry, easing the burden on participants.

“People from non-White ethnic backgrounds had different beliefs and perceptions about pain compared to those from White backgrounds.”


Building trust through meaningful communication

Mistrust in clinical research studies based on past events is a significant impediment to participation and retention among minority patients. Active communication throughout the
recruitment and study process can be an important factor in establishing trust. eCOA solutions can be a powerful tool for building trust by delivering meaningful information about the study and how data is used, in the format and via the channel preferred by the participant. eCOA platforms should have the capability to deliver this information directly to participants on devices they already own and are proficient at using.

New insight into cross-cultural acceptability of digital tools

A recent study published in JMIR Human Factors, “Exploring the Cross-cultural Acceptability of Digital Tools for Pain Self-Reporting: Qualitative Study”, expands insight into real-world considerations for more effective use of eCOA technology across diverse
audiences. The aim of the study was to inform the development of cross-culturally acceptable digital pain self-report tools by better understanding individuals’ pain experiences and reporting behaviours across ethnic backgrounds.

An individual’s cultural and ethnic background may affect the way they perceive, experience and communicate pain, and people from different ethnic groups often give different meanings to pain. In turn, this may impact the quality and content of patient-provided communication on pain. Previous studies have found that digital pain self-report and self-management apps seldom offer culturally tailored capabilities, and that smartphone-based pain mannequins could seldom be culturally personalised.

The research team conducted three workshops, each consisting of a focus group discussion and a user requirement exercise. The team found many similarities in how the participants described their experience of living with pain, how pain management is
suboptimal and how it is challenging to communicate about their pain. They also identified differences. People from non-White ethnic backgrounds had different beliefs and perceptions about pain compared to those from White backgrounds. This resulted in
internalising stigma and developing a negative attitude toward medication and
pain reporting.

Despite these differences, participants across ethnic backgrounds agreed on which aspects of pain reporting were important to self-report, such as pain quality, pain causes, feedback of previous pain reports and availability of a digital device for pain management. However, the team also found differences in requirements related to language (eg, translated in-app
instructions, culturally appropriate pain terminologies) and that people did not always agree on how best to translate requirements into reporting functionality (eg, pain layers/depth).

Addressing these differences when developing digital pain self-report tools will enhance their cross-cultural acceptability and contribute to more equitable pain management and
outcomes by reducing pain reporting barriers across ethnic groups.

Digital pain self-report tools such as smartphone-based pain mannequins
showed potential in overcoming challenges of communicating pain with healthcare professionals, especially for people from non-White ethnic backgrounds, which suggests that pain drawings may have clinical utility. However, this requires cultural (eg, culturally appropriate pain terminologies) and linguistic (eg, translated instructions in users’ native language or use of audio/video instead of text) compatibility across a wide range of ethnic backgrounds.

Dynamic development builds stronger tools

Rigorous user testing is critical to ensuring that eClinical approaches and solutions are human-centred. For the work on the Pain Mannequin and specifically the workshops around ethnicity, a personalised approach to user testing was pioneered. When
testing user interfaces and concepts, a participant often is presented with a design and asked to comment or interact to help developers understand how to iterate and improve. This is an effective method, but the team was conscious that it was important to individualise the experience when testing interfaces around subjective pain measures.

This is particularly important when testing around ethnicity and individualised pain triggers and treatments. To support this requirement, a dynamic testing environment was created that presented the same set of designs to participants, but captured personalised pain triggers and treatments. This meant that when it was testing an interaction flow, the data and labels around pain were person-specific allowing a much more authentic and targeted set of user tests.

Furthermore, this approach created better engagement with testing and removed barriers and conceptual leaps often required if data or specifics of pain and health measurement do not relate to the individual. The method of using a human-centred approach to design
the user testing and workshops also ensured that the team reduced some of the unconscious biases present when using non-personalised data for testing.

Individuals power clinical research and the results it yields. More engaged patients – both minority and non-minority – are less likely to drop out of studies and are more likely to be
compliant, which can drive better data and faster clinical trials.

Digital solutions including eCOA that consider the individual first and deliver the flexibility, configurability and convenience to enable highly personalised, culturally applicable experiences can be an efficient means of data collection and a powerful tool for boosting retention and compliance across all participants.