atient engagement is becoming increasingly embedded in the healthcare sector. While it is understood that patient engagement is “the right thing to do” and benefits all stakeholders involved, a clear way of measuring its value remains to be determined. Here, we discuss the importance of standardizing the measurement of the value of patient engagement. It is hoped that a unified approach will ensure that patient engagement remains a key driver for the success of new healthcare developments.

What Constitutes Value?

Value is inherently personal and subjective. In the healthcare sector, what constitutes value in patient engagement will be different for different people. For patients, it might be more support for shared decision-making. For the pharmaceutical industry (pharma), it might be better understanding of the patient experience to aid recruitment and retention in clinical trials. For healthcare professionals (HCPs), it might be the availability of credible disease information to give to their patients. This subjectiveness can make the value of patient engagement difficult to measure.

Those who work in patient affairs understand that patient engagement is a valuable endeavour, which can ultimately lead to treatments that better meet the needs of patients and their caregivers. However, thus far, pharma has struggled to prove the value of patient engagement to more skeptical stakeholders.

The reasons for this are myriad: many of the metrics used to assess these projects are qualitative, not quantitative; existing metrics are not being applied consistently; and, as mentioned, what constitutes value differs between different stakeholders. As a result, much of the proof of the impact of patient engagement is in the form of case studies, anecdotes, and cautionary tales. Quantitative, large-scale data on this topic are scant, although they are starting to emerge. A unified approach to measuring the impact of patient engagement activities has never been agreed upon between different stakeholders.

At this time, 15 frameworks and conceptual models are available to measure the impact of patient engagement projects. Each has its strengths, but inconsistencies between the different frameworks and models mean that they cannot be compared directly. Furthermore, just 4 out of the 15 frameworks include metrics to measure the impact, which can in turn demonstrate the value of patient engagement. The rest use key performance indicators, which largely measure operational aspects of projects—did the project run on time and within budget, for example—rather than the impact of the project on the success of different parts of the drug development process.

Recently, two studies have conducted literature reviews of current practices to propose a comprehensive toolkit for measuring the impact of patient engagement projects on clinical research and development (R&D) in the future. However, while the literature reviews provided insights into the range of metrics valuable in R&D, the resulting toolkit is not extensive and has not yet been validated for standardized use by pharmaceutical companies.

A recent study assessed the perspectives of patients on impact measures across five categories:

• medicines R&D priorities
• clinical trial design
• regulatory and market access submissions
• product support and information
• disease support and information.

This was the first study of its kind that was global, therapy area agnostic, and included a mix of patients and advocates. Patients and advocates reported feeling ownership and a deep sense of accomplishment when working with pharma. However, they highlighted that patient feedback on involvement needs to be collected throughout the drug development process to ensure that patient experiences are fully understood. They defined impact as “positive, tangible, and useful outcomes” and provided insights that led to the revision of 23 candidate patient-engagement impact measures. For example, they explained the benefit of not only reporting the number of changes made to the research plan but of also describing the nature of changes alongside patient quotes about their involvement. The need for detail in the nature and context of changes as well as the inclusion of patient quotes was a common theme through most revised impact measures in the study.

A Standardized Method of Measuring Value is Sorely Needed

In late January 2022, Ipsen and Oxford PharmaGenesis led a roundtable at the Patients as Partners EU meeting titled How to Measure the Success of Patient Engagement – Key Performance Indicators (KPIs) vs Key Impact Indicators (KIIs)?

The roundtable had 30 attendees who were a mix of pharma representatives, as well as some patients and HCPs. While most pharma attendees worked in patient engagement in some capacity, there were also representatives from clinical development, operations, and marketing functions.

Although the session was only able to skim the surface of this topic, what quickly became clear was the universal need for a standardized set of validated metrics to measure the value of patient engagement. These metrics would allow patient engagement teams to consistently and quantifiably demonstrate the impact of their activities on research programs across the breadth of stakeholders.

A new set of metrics should be based on existing frameworks, which could be combined and updated to form a comprehensive suite of KIIs, rather than building a new set from scratch. This could ensure greater consistency and comparability of patient engagement impact assessments. The new set of metrics should be piloted across the biopharmaceutical industry to gain real-life insights on its effectiveness.

Quote 1 (patient): “One of the main reasons why this is important to me as a patient is that patients need to know who they can trust when it comes to patient engagement best practice. Having an industry standard [would] give us that indication [of who to trust and work with].”

Quote 2 (pharma representative): [Deciding] what [and] how [to best] measure [a KII] can take very long. It can be more impactful to just start measuring [what you can]. [This] sends a message that [patient engagement] is important and [likely] to have impact. I would encourage [stakeholders] to start [measuring any KIIs] that fulfill [key] criteria [such as being] measurable, consistent, and meaningful for patients.

Quote 3 (pharma representative, paraphrased): We don’t engage patients only in clinical trials; they also drive the strategy in pharma, plans, and disease awareness programs. In such activities, the value of patient engagement can be measured by changes in patients’ awareness of a disease or their satisfaction with patient support programs, for example.

Transparency and Collaboration are Key

It is vital for stakeholders to be open, transparent, and collaborative across pharma, academia, and healthcare systems to help demonstrate the value of patient engagement. All future patient engagement activities and programs should have tangible outputs that can be measured by KIIs. Only then will patient engagement be fully embraced, embedded within the culture of pharma, and funded accordingly, rather than the level of activities ebbing and flowing with changing company priorities.

We encourage all stakeholders who are committed to the growth of patient engagement in the healthcare sector to collaborate on initiatives measuring the impact of patient engagement. A unified approach is important to increase the reach and impact of such initiatives and in turn support the long-term integration of patient engagement in the healthcare sector. Specific initiatives could include focused roundtables, awareness campaigns, and working groups. We recommend that such initiatives be led by independent consultancies, industry boards, or patient organizations, which can establish a balanced set of metrics that represents the views of multiple stakeholders and can be adopted across the healthcare sector.