The Cycle of Patient Engagement

Patient engagement strategist, Olivia Kersey, takes the patient engagement conversation to the next level.

Thinking bigger in patient engagement

Many of us have heard patient engagement is a hot topic in pharma. But do you know how to scale up the benefits – or even what that means? It’s time to evolve the conversation; we know patient engagement brings a triple win for patients, pharma, and society, but we can think bigger – enter the cycle of patient engagement. Not only does patient engagement constitute each step in this cycle, but it is also the key to elevating to the respective next step. Read on to find out how!

Patient engagement can bring immediate benefits

Patient engagement… it’s in your blood! In 2016, research by Hermans et al.¹ found patient engagement activities to be a major determinant of glycaemic (blood sugar) outcomes. In the study, HbA1c levels of engaged patients decreased from 8.1% to 7.2% and controls’ rates rose from 7% to 43%. This just goes to show patient engagement really does have a tangible, positive impact on health in the short term, as well as wellbeing and patient-industry relations. If you want to see better clinical outcomes for your patients, patient engagement could well be your product’s missing ingredient. But that’s not all – we can think bigger! The potential for patient engagement reaches far beyond targeting individual clinical outcomes like HbA1c levels – indeed, engagement can empower patients to take matters into their own hands.

From engagement to activation

Patient activation is a measure of the knowledge, skills, and confidence a person has in managing their own care². Taking the form of, for example, lifestyle changes or obtaining preventative care, patient activation is easily assessed and quantified³, and is a useful way of measuring the impact of patient engagement. Described as “a vital sign”⁴, the importance of patient activation is only increasing. Why? Because long-term conditions – for which patient self-management contributes significantly to outcomes⁵ – underlie the greatest healthcare needs of the UK population⁶and are increasing in prevalence⁷, meaning the sheer volume of disease management patients are required to perform is huge and growing. As patient activation increases, this self-management becomes more effective, and outcomes are improved^8,9.

Patient engagement can directly promote activation¹⁰, for example by combining health literacy education with behavioural science, and indeed engagement success is often measured by change to activation scores¹¹. Increased activation from successful engagement may be reflected in patients’ improved health, reduced health service use, and greater ability to work, among other benefits. What’s more, activated patients are much more likely to collaborate with industry and take part in this next level of discussion surrounding their treatment – potentially even reshaping the medical landscape for their diagnosis by acting as advisors.

Care about patient safety? It’s time to step up engagement

From May to June 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) ran a consultation on their draft 2020-25 Patient Involvement Strategy. The Strategy outlined numerous objectives and methods in line with ‘adopting a more systematic approach to listening to and meaningfully involving patients and the public’. Particular points of interest in the strategy included:

Creating engagement opportunities for underrepresented and diverse patients, including non-White people, children, elderly patients, and those with learning disabilities or for whom English is not their first language
The MHRA also committed to overhauling their Patient Group Consultative Forum to improve its diversity and representativeness
Commissioning research on public understanding of risk and how risk may best be communicated (hello, COVID-19!)
Developing the use of patient-reported outcomes so they may be built into all MHRA licensing decisions
Improving transparency, for example by reporting on the impact of patient involvement
Introducing various internal measures to support an agency-wide, patient-centric culture change

This was a very positive step, especially reflecting on the MHRA’s own statement last year highlighting “a lack of responsiveness from the agency when concerns are raised, especially by patients, who say they often do not feel listened to and that the agency’s response is not always proportionate to the seriousness of patients’ issues”¹².

Indeed, the findings of the 2020 Independent Medicines and Medical Devices Safety (IMMDS) review into patient experiences of sodium valproate in pregnancy, pelvic mesh implants, and hormone pregnancy tests shone a damning light on how a lack of appropriate communication with patients from the MHRA led to serious and extensive avoidable harm to patients and their loved ones. Patients were more than willing to share their concerns with the healthcare industry, but sadly their voices were dismissed, and thus the opportunities to address significant safety threats early were lost – along with a great deal of trust in regulators and industry. This stain on the MHRA’s history is a prime example of how patients can not only offer insights that are not just merely useful, but also vital in the protection of patient safety. If the MHRA had committed to a systemic, consistent patient engagement program whereby patients had the opportunity to productively collaborate with the agency, a huge number of patients could have been spared life-changing disaster. Looking ahead, it will certainly be interesting to hear how the MHRA’s new Patient Involvement Strategy both evolves in response to the recent consultation and also effects long-term change within the agency. We’ll be keeping our eyes peeled!

Activated patients as an indispensable advisory resource

Evidently, the regulatory environment is evolving, and patient engagement is and will continue to be the catalyst for this change. Not only do regulators want to see improvements to patient outcomes, but they also want to see improvements to the outcomes that matter most to patients – and there are plenty of patients keen to guide industry in this patient-centric direction. Just recently, the FDA opened applications for eight new spaces within the Patient Engagement Collaborative (PEC), an initiative run by both the FDA and the Clinical Trials Transformation Initiative. The PEC panel includes patients, caregivers, and advocates, and has been described by FDA media relations director Stephanie Caccomo as “a forum for patients’ voices to be heard and to advocate for patients who are seeking different health outcomes”¹³. Caccomo has also stated that the FDA “listens closely to feedback from individuals in the PEC and uses the insight from patients to inform regulatory decision making”. In the past, the PEC has focused on making interactions with patients more systematic and transparent.

Last month, the PEC met with the European Medicines Agency (EMA) Patients and Consumers Working Party to discuss not only involving patients in regulatory decision making, but also specifically incorporating perspectives from young patients – a demographic who tend to be underrepresented in the world of patient engagement.

The overarching aim of the PEC – to gain meaningful patient input into medical product development and regulatory decision making – is a great example of the potential that can be unlocked by facilitating patient activation through engagement; by giving patients the tools to understand, manage and discuss their healthcare, pharma and regulators can expect to develop/approve better products and services as they learn from these patients in years to come.

Hopes and aspirations

We hope the continued work of the PEC results in a consistent spotlight on currently underserved patient challenges, with investigators consequently required to include patient-reported outcome measures and empirical data in line with PEC-identified priorities as part of regulatory submissions. Although expert patients are of course well suited to participation in such collaborations, we must all remain mindful of the fact that other patients may benefit from more accessible forms of collaboration. Indeed, industry and regulators must be careful to not let their insight gathering focus on an overly narrow subset of patients, thus slipping into unfair and unrepresentative territory. After all, patients who may not immediately seem able to provide input of interest may well in fact hold useful insight that could significantly shape decisions made. For instance, while patients who are elderly, not digitally savvy, or are even reluctant to use modern devices may not immediately appear an appropriate consulting group for digital innovation testing, such patients can offer very useful and potentially influential perspectives on accessibility, consequently paving the way for new technologies to be adopted by a wider range of patients than could have previously been reached. As another example, a treatment may have effects or implications specific to certain type of patient who might not otherwise have their voice heard by industry and regulators – for example, side effects that are tolerable for a mentally able patient may not be acceptable for a patient with an intellectual disability. Speaking more broadly, if industry and regulators make the effort to activate and learn from all patients, not just “the usual suspects”, that more realistic and representative lens will equip companies with the perspective to make those meaningful changes we all want and need in such a way that no patients are left behind.

The cycle of engagement will keep pharma turning

It is clear that if patients are engaged, the benefits extend far beyond improvements to specific aspects of individual patients’ health. Engagement brings immediate benefits and is a key step towards patient activation, through which patients are empowered to not only effectively manage their own condition, but also act as valuable advisors to industry and regulators – and as we’ve seen through the aforementioned IMMDS review, the consequences of not listening to patients can be dire.

The cycle of elevating patient engagement continues; the more patients are equipped with the tools to share their perspectives, the better-informed industry and regulators will be to develop the best possible patient engagement initiatives moving forward, empowering and activating patients yet further. The more patients are empowered in this way, the richer the insights they will be able to provide, enabling pharma to develop better treatments sooner – and who wouldn’t want that?

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References

Hermans M, Van Gaal L, Rézette I, Daci E, MacDonald K, Denhaerynck K et al. Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study). Primary Care Diabetes. 2016;10(6):425-433.
Hibbard J, Mahoney E, Stockard J, Tusler M. Development and Testing of a Short Form of the Patient Activation Measure. Health Services Research. 2005;40(6p1):1918-1930.
Heath S. What is the Patient Activation Measure in Patient-Centered Care? [Internet]. Patient Engagement Hit. 2017 [cited 16 August 2021]. Available from: https://patientengagementhit.com/news/what-is-the-patient-activation-measure-in-patient-centered-care
O’Shea L. Is the NHS missing a vital sign? [Internet]. 2014 [cited 16 August 2021]. Available from: https://www.england.nhs.uk/blog/luke-oshea-2/
Grady P, Gough L. Self-Management: A Comprehensive Approach to Management of Chronic Conditions. American Journal of Public Health. 2014;104(8):e25-e31.
Moore C. Do group consultations help promote self-management? | Nursing Times [Internet]. Nursing Times. 2021 [cited 16 August 2021]. Available from: https://www.nursingtimes.net/clinical-archive/long-term-conditions/do-group-consultations-help-promote-self-management-12-07-2021/
Chronic diseases and conditions are on the rise [Internet]. PwC. [cited 16 August 2021]. Available from: https://www.pwc.com/gx/en/industries/healthcare/emerging-trends-pwc-healthcare/chronic-diseases.html
Hibbard J, Greene J. What The Evidence Shows About Patient Activation: Better Health Outcomes And Care Experiences; Fewer Data On Costs. Health Affairs. 2013;32(2):207-214.
Greene J, Hibbard J. Why Does Patient Activation Matter? An Examination of the Relationships Between Patient Activation and Health-Related Outcomes. Journal of General Internal Medicine. 2011;27(5):520-526.
Heath S. Patient Engagement Strategies for Improving Patient Activation [Internet]. Patient Engagement Hit. 2019 [cited 16 August 2021]. Available from: https://patientengagementhit.com/features/patient-engagement-strategies-for-improving-patient-activation
Hibbard J, Gilburt H. Supporting people to manage their health: an introduction to patient activation [Internet]. The King’s Fund; 2014 [cited 16 August 2021]. Available from: https://www.kingsfund.org.uk/sites/default/files/field/field_publication_file/supporting-people-manage-health-patient-activation-may14.pdf
Medicines & Healthcare products Regulatory Agency. How should we engage and involve patients and the public in our work | Response: What we will do differently. www.gov.uk; 2020.
Schneider M. FDA seeks new members for Patient Engagement Collaborative [Internet]. Raps.org. 2021 [cited 16 August 2021]. Available from: https://www.raps.org/news-and-articles/news-articles/2021/7/fda-seeks-new-members-for-patient-engagement-colla