I've been working with Merakoi now since early 2021, and I've worn quite a few hats in that time. Right now, I consider my core roles to be Engagement Manager and Moderator of patient sessions across different projects.

To me, wearing both these hats means I get to see a project from every angle. As an Engagement Manager, I’m the one holding the line between what the client needs and what our internal team can deliver - I'm basically translating a big strategy into a practical session plan. Then, when I step into the Moderator role, I’m the one in the room setting the tone. I decide which thread to follow when a conversation opens, because I know that the quality of what our experts share really depends on the quality of the questions I ask. Since I usually hold both roles, I can make sure the project stays connected to that real patient experience from the very first call to the final readout.

In simple terms, I help connect the dots between patients, clients, and internal teams.

I feel I have the most impact in the space I create for patients when they’re sharing their lived experience, which can be deeply personal. It is incredibly important to me that they feel respected and safe, so I work to create that psychological safety by asking the right follow-ups and balancing empathy with clarity. But creating that safe space is only the beginning; the real magic happens when that safety allows for a level of honesty that transforms the work itself.

From "Technically Correct" to "Actually Meaningful"

Patient experts make a project dramatically better, just by being there. They bring lived experiences which translate theory into reality; talking to them makes it really clear what truly matters when someone is navigating a chronic illness. It brings an "emotional truth" which often reveals what data alone cannot. In short, patient experts help move a project from being technically correct to being actually meaningful.

Editors note: On "emotional truth". The most accessible anchor for this kind of language is Brené Brown, a research professor at the University of Houston whose work on vulnerability has reshaped how leaders and clinicians think about authenticity. Her line "stories are data with a soul" describes exactly what Rebekka is reaching for: the lived, felt dimension of experience that quantitative data alone can't reach.

▶ Watch: Brené Brown, The Power of Vulnerability (TED, 2010). Editor's note: On the science of "strategic fuel". Rebekka's chocolate habit is actually backed by more than just a sweet tooth; research suggests that cocoa flavanols can enhance cerebral blood flow and sharpen cognitive performance during high-intensity mental work. When navigating a full day of deep, emotional patient sessions, that small boost becomes a vital tool for staying present and focused.

When we treat patients’ expertise as strategic expertise, not symbolic inclusion, projects become grounded, relevant, and far more likely to succeed in the real world. I believe patient experts are often misunderstood when they are seen merely as adding perspective; they are actually adding foresight. Patient expertise is most powerful when used "upstream," when direction is still flexible, and assumptions can be challenged. When they are brought in too late, they are asked to validate something that is already 90% there, and their role becomes reactive rather than creative. This shift from reactive validation to proactive foresight isn't just a theory; I’ve seen it completely save a project from missing its mark.

Recalibrating the Compass

I remember one project where we were refining patient communication materials for a healthcare initiative. The messaging was clinically accurate, the design was nice, and it all looked strong on paper. But during a session, one of the patient experts said something very simple:

"It just doesn't feel like it's written for us, the younger generation."

They didn't identify with the language or the images, which were all of aging, fragile people.

Up until that moment, the focus had been on clarity and completeness, but the person receiving the information hadn’t been truly centered. That one insight shifted the entire direction of the work. Moments like that reinforce why patient expertise is not decorative - it literally recalibrates the compass. Of course, finding those moments of clarity requires staying incredibly focused during a session and knowing when to steer the conversation back to what matters.

The "Gentle Reset Button"

When I’m in a session and notice we are drifting into "tactical weeds" or forgetting why we are here, I use my "gentle reset button" phrase: "Let’s zoom out for a second." I use it to help us reconnect to the purpose and focus on the questions we actually need answers to. I learned a lot of this by observing my colleagues, Debbie and Sandra, when I first joined as a patient coordinator. Watching how they didn't let momentum or stress get to them shaped me a lot.

Finally, if you want to know how I stay sharp during a long day of sessions, a double espresso is non-negotiable. I also always have dark chocolate on hand, because I'm a total chocoholic. I've decided that chocolate is strategic fuel, not an indulgence!

Editor's note: Rebekka isn't wrong about chocolate as "strategic fuel". There's real, if modest, evidence that the flavanols in cocoa support cerebral blood flow and short-term cognitive performance during demanding mental tasks. Over a long day of patient sessions, that's not nothing.

As someone who has lived with atopic dermatitis (AD), also commonly known as eczema, for over 30 years, I’ve navigated a wide range of treatments and therapies, both as a patient and as a professional consultant in healthcare. For the past seven years, I’ve worked with pharmaceutical companies, healthcare organizations, and patient advocacy groups to ensure that patient perspectives are front and center in medical research and communication. From this dual vantage point, I’ve seen firsthand the disconnect between complex scientific studies and the patients those studies aim to help. This is why I am a passionate advocate for lay summaries and, more importantly, for including patients in the creation, review, and dissemination of those summaries.

Breaking Down Medical Barriers

Medical research is evolving faster than ever before and cutting-edge treatments and diagnostics are emerging. For patients, understanding the research behind potential treatments can provide hope, reassurance, and empowerment. However, this understanding is often blocked by a wall of jargon-filled research papers, clinical trial reports, and medical terminology that is inaccessible to most patients.

That’s where lay summaries come in. A well-written lay summary translates dense, technical research into clear, concise, and accessible language that patients can understand. But it’s not just about simplifying; it’s about making the information meaningful to patients. Lay summaries can help patients make informed decisions about their care, track the progress of treatments, and advocate for themselves in conversations with healthcare providers.

As a patient advocate and content creator, lay summaries also enable me to share accurate, research-based information with my online community. In the era of rampant misinformation, this accessibility is more essential than ever. When research is accessible and written in terms I can grasp, I can then translate that information in a way that resonates with my community, offering them clarity and helping counter the flood of false information that circulates online. Without access to accurate, understandable summaries, I—and other advocates—are left unable to relay critical findings back to the communities we serve.

In my own journey with AD, I’ve experienced how empowering it is to understand the science behind my condition. When I can grasp how a treatment works or why a particular therapy was developed, it changes the way I approach my health. I’m not just a passive recipient of care; I’m an active participant. That’s the power of patient-friendly information, and it’s why lay summaries are critical.

Patient Voice in Research

While lay summaries are essential, they are only truly effective when patients are involved in their creation. Too often, these summaries are written by researchers, doctors, or—more recently—AI tools, with little input from the very people they are meant to serve. As a result, even "simplified" versions of studies can still miss the mark, failing to address the specific concerns or priorities of patients.

As someone with deep experience both as a patient and a consultant in the healthcare space, I know that patients bring a unique and invaluable perspective. We understand our conditions in ways that healthcare providers or researchers may not. We know what questions we need answered, what concerns keep us up at night, and how we interpret information. For example, when I consult with pharmaceutical companies on eczema-related projects, I often highlight issues that might seem minor from a medical perspective but are significant for patients—like the day-to-day burden of managing a chronic, visible skin condition or the anxiety that comes with flare-ups. These insights should inform not just the treatments themselves but also how those treatments are communicated to the patient community and the impact it has on a patient’s day-to-day activities.

Involving patients in the creation of lay summaries ensures that the language is not only clear but also resonates with our lived experience. It allows for a more compassionate and empathetic approach to medical communication. And when patients are involved in reviewing and disseminating these summaries, it builds trust between the research community and the patients they aim to serve.

Transforming Healthcare Communication

For pharmaceutical companies, this shift toward patient involvement in lay summaries is not just a "nice to have"—it’s a necessary evolution. As healthcare becomes more patient-centered, there is a growing expectation from both patients and regulators that medical information be accessible and transparent.

Pharma teams that prioritize patient input in the development of lay summaries are not only meeting this expectation but also gaining a competitive advantage. By involving patients, pharma can create materials that speak directly to the concerns of their target audience, improving patient engagement and adherence. It’s a win-win situation: patients feel more informed and empowered, and pharma companies can build stronger relationships with their patient communities, leading to better outcomes in clinical trials and product adoption.

Additionally, as AI becomes more integrated into medical communication, there is a temptation to rely on automated tools to generate lay summaries. While AI can be a useful tool, it cannot replace the nuanced insights and empathy that come from real patient experiences. Lay summaries generated solely by AI risk missing critical emotional and practical aspects of patient care. Pharma must recognize the irreplaceable value of involving patients directly.

Building Better Patient Resources

In my work as a patient consultant, I’ve had the privilege of seeing the impact of patient involvement firsthand. Whether it’s advising on the language used in educational materials or sharing my lived experience in roundtable discussions with healthcare leaders, I’ve seen how much value patients can bring to the table. Recently, I participated in a project with Merakoi focused on ocular surface diseases, and once again, the importance of patient insights was clear. My background in eczema and AD gave me a unique perspective on chronic, inflammatory conditions, which is something that resonates with many OSD patients as well.

When I share my story with pharma teams, I often highlight how being able to fully understand my treatment options transformed my care. Lay summaries were a key part of that transformation, but only because they were crafted with the patient in mind. That’s why I continue to advocate for not just better communication, but for patient-driven communication.

Shaping the Future of Patient Communication

If pharma teams are serious about improving patient outcomes, they must commit to creating lay summaries that are accessible, meaningful, and patient-centered. But more than that, they need to involve patients in the process—from creation to review to dissemination. As someone who has lived the reality of a chronic condition and worked professionally in patient advocacy, I can attest to the transformative power of patient involvement. Let’s build a future where medical research doesn’t just talk about patients but talks with us.

Merakoi commentary

What else you need to know

« The UK's Health Research Authority (HRA) has taken a groundbreaking step by implementing new Participant Information Quality Standards and Design Review Principles, effective December 1, 2023. This mandate requires all patient-facing documents, including Informed Consent Forms, to undergo patient review to ensure content relevance and comprehensibility. This progressive approach aligns perfectly with what patient experts like Ashley have been advocating for – making clinical trial information more accessible and meaningful for participants.

This UK requirement serves as a model for the future of lay summaries globally. By mandating patient involvement in document review, it acknowledges that effective healthcare communication isn't just about simplifying complex information – it's about creating materials that truly resonate with patients' needs and experiences. The requirement for British English usage, clear explanation of acronyms, and structured study summaries demonstrates a practical commitment to patient-centered communication that other regions would do well to emulate. »

About Merakoi
At Merakoi, we're passionate about harnessing the power of mini-communities to bridge the information gap and empower patients to take control of their health journeys. By fostering ongoing collaboration between patients, healthcare providers, and pharma companies, we're creating a future where every patient has access to the knowledge and support they need to thrive.

Together, we can build a world where no patient is left in the dark, searching for answers. If this sounds like the kind of healthcare innovation you want to participate in, let's chat!

In the battle against obesity, new medications have emerged as powerful allies, offering hope to millions struggling with weight loss. However, as patient expert Melanie Bahlke reveals, these medications are just one piece of a much larger puzzle. Melanie, who leads the obesity surgery self-care association in Germany, paints a picture of obesity treatment that goes far beyond simply prescribing medication.

Melanie Bahlke is the Chairperson of Adipositaschirurgie Selbsthilfeverein Deutschland, focusing on obesity prevention and patient engagement, particularly for children and adolescents facing obesity challenges.

Promising Yet Limited

"For everyone (including physicians), this is a huge step," Melanie says, referring to the new obesity medications. "And for the patient, that's a new way to handle obesity." There's no doubt that these treatments have generated excitement and hope among patients, many of whom have struggled with weight loss for years.

However, Melanie is quick to point out a crucial limitation: "When you receive the medication, that's brilliant. But you have only changed your body and not your mind." In other words - while medications can be effective tools for weight loss, they don't address the psychological and lifestyle factors that contribute to obesity.

Holistic Approaches

Both Melanie and Merakoi strategist Debbie Denison emphasize that medication alone is not enough to tackle obesity effectively. As Debbie notes, even the websites for these medications recommend combining treatment with diet and lifestyle changes. But Melanie goes further, advocating for a much more comprehensive program:

"The medication then can work better when patients have a good psychologist and nutritionist and somebody who will teach you to go out and have fun and make friendships."

Mental health support, nutrition guidance, and finding joy in activity - all these are the essential components for sustainable weight management.

Rethinking Exercise

Interestingly, Melanie challenges the use of the word "sport" (also meaning exercise), which can be intimidating for many living with obesity. Instead, she suggests focusing on "mobility":

"Mobility! I think there should be more mobility for your bones and for your muscles. The thing is we do not have a good build and core strength. I only have the muscles in the legs that can hold my weight."

This shift in perspective from "athletics" to "mobility" could be key in making physical activity more approachable and less daunting for those beginning their weight loss journey. It's a reminder that effective obesity treatment must be tailored to the specific needs and capabilities of each individual.

Psychological Impact

A recurring theme in Melanie's insights is the critical role of mindset and mental health in obesity treatment. She emphasizes that obesity often affects a person's entire outlook:

"So many people that are so affected from obesity that their whole mindset is confused. They have no structure and they need help."

This underscores the need for comprehensive support that goes beyond just physical interventions. Mental health resources, community support, and strategies for developing healthy habits are all crucial elements of a successful obesity treatment plan. Building supportive communities can play a vital role in managing chronic conditions like obesity.

Numbers Don't Tell the Whole Story

Melanie challenges the traditional focus on weight as the primary measure of success in obesity treatment. She points out a crucial flaw in this approach:

"Instead of speaking about losing weight, we should speak about becoming healthy. When you are concentrated on your kilos, the circle starts again and again, and you lose motivation."

Obsessing over kilos lost can be counterproductive, potentially leading to cycles of frustration and demotivation. Instead, Melanie advocates for celebrating other indicators of progress, such as increased mobility, improved mental health, or enhanced quality of life. This views aligns with modern understanding of health, where factors beyond weight - such as metabolic health, cardiovascular fitness, and emotional well-being - define overall wellness.

Digital Integration

Digital health apps like Zoe and Noom have revolutionized weight management by focusing on behavioral psychology and lifestyle modifications. These apps use evidence-based techniques to help users reframe their relationship with food, develop healthier habits, and make sustainable changes.

While these digital solutions have proven effective for many users, they have yet to be fully integrated with breakthrough pharmacological treatments for obesity. The opportunity lies in connecting these two powerful interventions to create a seamless user experience.

Melanie highlighted the potential of this integration: "You can have digital apps in your pocket, in your hand, and that is something that is not visible. And you can have it all the time." For people with mobility limitations, traveling to frequent in-person appointments or classes can be difficult, uncomfortable, or even impossible. Yet, apps are just an arms length away.

By combining the behavioral support of digital apps with the physiological effects of medication, patients could benefit from a more comprehensive and personalized approach to weight management. This integration could help address the limitations of medication-only treatments by providing ongoing support, education, and motivation.

The challenge now is for pharmaceutical companies and digital health providers to collaborate and create solutions that seamlessly blend medication management with proven behavior change techniques.

Comprehensive Care

Melanie proposes an intriguing model for initiating obesity treatment - a dedicated clinic or program where patients can start their journey:

"My wish is for a program, maybe two weeks, where you go to a clinic. They teach you, they give you the medication, and they provide knowledge about nutrition, mental health care, and all the other important aspects. It's not just about the medication - it's about learning how to manage your health."

This concept of a "kickstart" program that combines medication initiation with education and comprehensive support could be a game-changer in helping patients set themselves up for long-term success. It embodies the holistic approach that Melanie advocates for throughout her discussion.

Debbie's Takeaway

Tipping the Scales ...of Innovation

Melanie’s message is straightforward: while new obesity medications offer valuable tools in weight management, they are not a silver bullet. To truly address this complex condition, we need a collaborative and innovative approach that brings together pharmaceutical innovations, digital health solutions, mental health support, and lifestyle interventions.

What stands out to me is the opportunity for cross-industry collaboration. Pharma, digital health, mental health, and even the fitness industry could create groundbreaking solutions by working together. Imagine a care platform that integrates medication management, psychological support, tailored mobility programs, and community engagement. This interview with Melanie has reinforced my belief that the next big breakthrough in obesity treatment won't come from a single sector, but from innovative partnerships that address the a spectrum of patient needs.

About Merakoi
At Merakoi, we're passionate about harnessing the power of mini-communities to bridge the information gap and empower patients to take control of their health journeys. By fostering ongoing collaboration between patients, healthcare providers, and pharma companies, we're creating a future where every patient has access to the knowledge and support they need to thrive.

Together, we can build a world where no patient is left in the dark, searching for answers. If this sounds like the kind of healthcare innovation you want to participate in, let's chat!

If you watched the recent conversation between our digital strategist, Debbie, and eczema patient advocate, Ashley Lora, you’ll know many important and interesting topics were brought to light. One key topic was the lack of information and knowledge sharing, which is something patient communities are really crying out for. It’s something I’m personally really passionate about, so I wanted to expand on the problems and some potential solutions a little further.

I am that patient. I am the patient who has been left with many unanswered questions. I am the patient who’s had to do lots of my own research - allowing me to try treatments for my ulcerative colitis that weren’t offered by my inflammatory bowel disease (IBD) team, and diagnosing my own skin condition. I am the patient who has been sent away with a printed sheet to learn about the new treatment I’m starting because the gastroenterologist (GI) didn’t have time to go through any of it with me. I am the patient who ultimately lost all faith in the healthcare system because of my repeated experiences of invalidation and a lack of a good standard of care.

Knowledge gaps filled by the World Wild Web

Many patients want to understand medication decisions and be able to be part of the decision-making process about what goes into their body. They want to understand why treatment X might work better for them than treatment Z. They want to understand what the latest research is saying and how that could impact future treatment options. They want to know if there’s a clinical trial they can get involved in. But all too often, no one is telling them these things.

In an ideal world, patients would know exactly where they can look at their treatment options more closely. They would be able to look at the research and outcomes in layman's terms and understand which treatment might work best for them and why, as well as preferences such as route of administration (rectal, oral, subcutaneous, or intravenous). With this knowledge, patients could view their options and make an informed choice depending on what best suits their lifestyle.

Newly diagnosed patients or those with lower health literacy skills often only know what the doctor tells them. They trust that the healthcare professional looking after them knows best. But, when one, two, or three, of the treatment options haven’t helped or have stopped helping, or tests haven’t highlighted a cause for symptoms, those patients begin asking questions, often outside of their healthcare team. They start asking Dr Google and other patients on social media and in groups. This is concerning because, without good health literacy skills, the World Wide Web is a confusing, and often scary, place. There’s conflicting information, misinformation, and people and companies looking to pray on the vulnerable and sick.

Filling gaps as an advocate and what the life science industry has to offer

I’m an IBD advocate, and I’m lucky enough to be able to read and join in with, a very active online community of GIs. Each week, on X, MondayNightIBD engages GIs around the world in conversations that are useful for patients like me to read. It helps me understand how the people sitting on the other side of the table think and prioritise. It also helps me understand what their pain points are!

I utilise lists to keep an eye on what’s going on in GI and I follow GI event coverage on social media to learn about breakthroughs in science and technology. During COVID, I was regularly scrolling through a list I’d created of UK gastroenterologists, colorectal surgeons, and IBD specialist researchers, to stay up to date on what the recommendations were so I could feed it back to my community.

I have access to this information, and for that I am grateful, but most people living with IBD or raising awareness of IBD don’t go to the nerdy lengths I go to. They won’t read journal papers because they do not understand them, so they have no idea what treatments, therapies, apps etc. are being developed until someone like me or a charitable organisation picks it up and starts to talk about it. And I don’t have all the time in the world to keep myself up to date and the community apprised. In fact, I often feel like I have no time to invest in that side of things; it’s dependent on how much support has been necessary elsewhere in the community each week, as there’s only so much of my time I am able to give freely.

I understand the issues around pharma directly engaging with patients and sharing their research. However, patients should, at the very least, be able to access this information or know it exists.

Reimagining the doctor-patient relationship

The doctor-patient relationship has the potential to be a wonderful source of knowledge, inspiration, and hope, but as it stands, it regularly falls far short of that. The time I get with my GI is mainly taken up by her running through standard questions about the frequency, urgency, and consistency of my bowel movements and the medications I’m taking. Imagine if that time were instead used to talk about the results of my latest tests, what this might mean going forward, and what options I might have in the future based on the newest research. That is a conversation I’d like to be part of!

Why should health companies care about the patient information gap

At this point, you might be wondering why pharma, device, or diagnostic teams should even concern themselves with addressing the information gap faced by patients. After all, their primary focus is on developing and delivering innovative treatments and diagnostics. However, there's a compelling value proposition for health companies to invest in patient education and engagement.

When patients feel informed and engaged, they're more likely to get tested, adhere to treatment plans, participate in clinical trials, and become advocates for better care within their communities. This, in turn, can lead to improved patient outcomes, increased brand loyalty, and ultimately, better business results for pharma companies.

Moreover, by collaborating with patients to create accurate, understandable educational materials, health companies can demonstrate their commitment to patient well-being and build trust with the very people they aim to serve. This trust is essential in an era where patients are increasingly skeptical of the pharmaceutical industry and seeking greater transparency.

Investing in patient education and engagement is not just a nice-to-have – it's a strategic imperative for health companies looking to thrive in a patient-beneficial healthcare landscape.

Mini-communities are a great way to make change in healthcare

Small collaborative groups of healthcare stakeholders can create solutions. At Merakoi, we call these "mini-communities" and they offer a powerful way to address the current lack of information sharing between healthcare providers, pharma companies, and patients. By bringing together diverse groups of patients, physicians, specialists, and pharma or health tech innovators, mini-communities enable the co-creation and dissemination of accurate, understandable educational materials that meet the needs of all stakeholders.

So, how would this work in practice? Let's use IBD as an example. An IBD mini-community could be segmented based on factors like patient activation measurements (PAM), disease type, professional skills, clinical trial experience, and influence. Highly activated patients with content creation skills would be ideally suited for the co-creation phase, as they understand the language and informational needs of other patients. Physicians could provide medical expertise and ensure accuracy, while pharma companies could share their latest research and developments.

To ensure the co-created materials are truly accessible and understandable, additional mini-community cohorts could be involved in the review process. For example, patients with lower health literacy levels could provide feedback on the clarity and comprehensibility of the content. If the materials focus on clinical trial information, a cohort of patients with trial experience should be engaged to offer their unique insights.

Given the constantly evolving nature of medical research and treatment advancements, mini-community partnerships should be ongoing, allowing for the timely updating of educational materials. This continuous engagement not only ensures that patients have access to the most current information but also fosters a sense of trust and collaboration between all parties involved.

Co-created content can then be disseminated through various channels, including patient advocacy groups, influential patient leaders, healthcare providers, and specialists. By involving mini-communities of influential patients in the creation and sharing of these materials, we can amplify their reach and impact.

Ready to bridge knowledge gaps in your therapy area?

At Merakoi, we're passionate about harnessing the power of mini-communities to bridge the information gap and empower patients to take control of their health journeys. By fostering ongoing collaboration between patients, healthcare providers, and pharma companies, we're creating a future where every patient has access to the knowledge and support they need to thrive.

Together, we can build a world where no patient is left in the dark, searching for answers. If this sounds like the kind of healthcare innovation you want to participate in, let's chat!

About Merakoi
Merakoi partners with health and life sciences companies to build mini-communities that guide product development through continuous user insights. Our network of patients/advocates and proprietary community platform enable engaging, longitudinal co-creation between users and developers. The result is human-centered solutions that resonate powerfully in the real world.

The Complexity of Patient Journeys

As projects progress from insights to solution co-design, we look to collaboratively address unmet needs with continuous input from patients, physicians and industry stakeholders. One of the key challenges when designing solutions is tailoring the experience to each person’s needs. Building mini-communities of patients and other stakeholders with shared experiences around a specific condition can provide valuable support and understanding. 

Given the complexity of patient journeys, there is no one-size-fits-all approach that will work for everyone. Solution design often utilises a modular approach to deliver a personalised experience through self-segmentation. However, these modules need to incorporate behaviour change goals and the diverse needs of those adopting the solution. Failing to address this early on in the process leads to challenges in recruitment and retention, ultimately missing the opportunity to positively impact the lives of patients.

Segmentation: A Challenging Endeavor

Let’s look into an example from an ongoing project to illustrate the complexity around segmenting patients for solution co-design. For this project, we are developing a digital therapeutic for people at moderate to high risk of stroke. We mapped hypertension across various disease pathways - from essential hypertension to comorbid conditions where hypertension is present and diseases where acute hypertensive episodes are likely.

Collaborating with a diverse mini-community representing potential conditions associated with hypertension, we focused primarily on the clinical journey while also incorporating areas where patients seek support and information outside the clinical setting. Utilising a train map analogy, we identified areas of moderate and high stroke risk to understand the points in the journey where a solution could benefit patients and their care teams.

After mapping the patient journey, we moved to segmentation, to better understand those patients who were at the highest risk of stroke. We segmented by disease, number of comorbidities, access to specialist Centres of Excellence of Comprehensive Stroke Center, age, smoking status, treatment type and history of stroke. After aligning on the priority segments, we needed to understand their needs and concerns around disease management and uncontrolled hypertension.

Usage data or KPIs from existing digital solutions or patient support programmes would also need to be layered into the segmentation data. As you can see, this process can become quite overwhelming. Is there a simpler way to segment which could deliver equally effective results

PAM: A Simpler Segmentation Approach

It is widely accepted that people who have the knowledge, confidence and skills to manage their disease have better health outcomes than those who take a more passive approach. Highly activated patients living with long term conditions are more likely to engage in positive health behaviours and manage their disease, and their health, more effectively than those who have low levels of activation. 

The Patient Activation Measure (PAM) is a framework is one of the foundations of personalised care adopted by healthcare systems in Germany, Denmark, Japan, the UK, Canada and others.

Benefits of the PAM Framework

It’s easy to see how the PAM framework could be useful in moving patients from lower levels of activation to higher ones by empowering them with the knowledge and confidence they need to self-manage their disease. Roughly half of all people living with a disease could be in PAM levels 2 and 3, enabling you to address larger segments through your digital solution, PSP or digital therapeutic.

PAM in Practice: Solution co-design

In a recent oncology project, where detailed patient data was lacking, we swiftly adapted by employing the PAM framework to create personas based on actual cancer patients. Engaging in sessions with mini-communities of cancer patients enabled us to gain valuable insights into the unique needs and challenges of people in each activation level. Insights were utilised to drive content planning and improve experience design , and create additional modules that had not been previously considered by the client team.

Olivia (not her real name) was a PAM level 1 patient living with Non-Hodgkin’s lymphoma. Everyone in the mini-community could empathise with Olivia - she was overwhelmed, disconnected from her disease management, had low levels of knowledge and few coping skills. People who are diagnosed with cancer typically start here, and it is very difficult to recruit or retain them onto digital solutions, apps, or patient support programmes in this stage. 

During our sessions, we explored what Olivia would need in terms of resources, support / connection, appointment and side effect management. But we also looked at how that information could be presented in easy to digest formats that would help Olivia understand her disease at a time when she is ready to learn. We explored mental health concerns and how peers her own age who had been through a similar journey might be needed to help Olivia come to terms with her cancer and accept it.

We repeated the process for our other personas in levels 2 to 4, taking the mini-community through each and asking them to walk in the shoes of each person to identify gaps and opportunities for the client team to meet the needs of each patient segment.

Enhancing Insights with Additional Cohorts

In this example, the cross-indication mini-community was able to walk in the shoes of other patient segments, providing valuable insights into their needs and challenges. Many members of the mini-community had been in similar situations throughout their own patient journeys or knew and interacted with peers in their communities who fit the specific segments and personas being explored. This shared experience allowed for a deeper understanding of the unique perspectives of each patient segment.

While the cross-indication community provided a strong foundation for understanding patient needs, including additional cohorts in the mini-community would allow for further exploration as the client moves from concept into solution design. These additional cohorts could include people with a specific tumour type, those on a specific treatment or type of treatment, those with an oncogene mutation, or those in a specific cancer stage.

By incorporating these specific cohorts, the team can gather targeted insights around the particular challenges the solution aims to address, ensuring a better fit for the intended patient population. For example, people living in rural areas who do not have access to a multidisciplinary team may struggle to share knowledge with physicians located in different clinics or hospitals. To address this challenge, the team could create a cohort that includes nurses from multiple specialisms involved in the patient's care, allowing them to understand the complexities patients face when being managed by both an oncologist and a nephrologist.

These additional cohorts would provide valuable feedback on the solution design, user experience, and content, enabling the team to make informed decisions and adjustments that improve the overall fit and effectiveness of the solution. By engaging with patients who closely match the target audience, the team can ensure that the final product addresses the specific needs and preferences of the intended users, ultimately leading to better adoption and outcomes.

Evidence shows that if we don’t address the levels of activation in people living with a disease, they are unlikely to benefit from the interventions we provide; they may not take their medications as prescribed, they may miss appointments, their conditions may progress faster, and they may develop additional comorbidities that could have been prevented. By focusing on activation as a driver for the solutions we create, we can provide a personalised experience that empowers them to better manage their health, and get better outcomes.

Ready to deliver a more personalised experience that meets the needs of patients? Contact us to learn how PAM plus mini-communities can elevate your patient interactions.

About Merakoi
Merakoi partners with health and life sciences companies to build mini-communities that guide product development through continuous user insights. Our network of patients/advocates and proprietary community platform enable engaging, longitudinal co-creation between users and developers. The result is human-centered solutions that resonate powerfully in the real world.

Related reading: our primer on patient co-design

Seven years after being diagnosed with ulcerative colitis, a form of inflammatory bowel disease (IBD), I finally opened up about it online. I found my disease difficult to talk about openly due to what I perceived to be the embarrassing nature of it. I had been using Twitter under a pseudonym to engage with the IBD community before that, so I was already aware that many people with IBD had an unmet need for support and understanding.

My post went viral. People with IBD from all over the world were commenting on my post. I had hundreds of friend requests from the same people, and more besides.

Building IBDSuperHeroes, an organic mini-community

It was a very organic journey from that first post to patient advocacy. I’d already acknowledged the need for support and understanding, so I started writing blogs and raising awareness online. That was a pretty easy manoeuvre because I was working in social media marketing at the time. 

I set up IBDSuperHeroes with a small team of other people affected by IBD. We were essentially building a mini-community, bringing together people with shared experiences around a specific condition. We aimed to raise awareness and funds for IBD research. The need for a private group became apparent pretty quickly, so we set one up on Facebook. It was a beautiful sight. People were excited to have a space where they didn’t feel they needed to censor themselves. They didn’t have to tell a huge backstory to add context to a current situation like one might when talking to friends or family.

More and more people began advocating in the IBD space. Many people told me I had inspired them and given them the confidence they needed to make that leap. Over the years, I’ve seen many advocates come and go. I’ve also seen advocates come and stay.

Activating patient superheroes

Some advocates stick to story sharing and awareness raising. Others, like me, prioritise education. We learn as much as we can about disease management and disseminate information that we believe can help others. They might run communities, host podcasts, or just use social media. We’re the type of people who actively seek and get involved with IBD-related projects, from new digital health solutions to PPIE groups for IBD research or patient organisations. These people, who for merakoi are patient experts, have become respected and trusted contacts.

Harnessing mini-communities and cohorts at merakoi

As someone deeply engaged with the IBD online community, I've seen how it organically functions like the mini-communities merakoi builds, with different patient segments forming natural cohorts.

At merakoi, I get to apply my experience building IBDSuperHeroes to create purposeful patient communities for health innovators. I'm responsible for recruiting members, vetting them, getting them contracted, and scheduling all the interactions. Our digital platform makes this process seamless and efficient. I work closely with our partners to define the right cohorts for their needs, whether that's by treatment type, disease severity, online influence - you name it.

Essentially, I get to be a matchmaker, connecting the right patient voices to the right projects at the right time. And let me tell you, watching mini-community insights shape better health solutions never gets old.

It’s easy for me, as someone who is continually engaged with the online IBD community, to divide it into mini-communities. These mini-communities can be split in many different ways, such as:

From one-off input to continuous co-creation

I came to know merakoi early in its inception. I was a pharmaceutical company's lead patient consultant for an IBD project. They made the most of my marketing skills and disease experience. I was involved from the start, with everything from market research to survey design.

When the time came to dip into the aforementioned cohorts within my mini-communities, I’d got them ready-made. Lucky Pharma! I recruited patient experts for focus groups and patients and caregivers for surveys easily, because I knew my community and I had their trust. However, a great opportunity was potentially missed here.

Nearly all of the patients who got involved with the focus groups and patient survey were interested in doing more.

They asked me to let them know about future opportunities, whether they were part of the same project or unrelated. This was a lightbulb moment for me. These patients were eager to stay engaged, but the typical one-off project model didn't allow for that.

I know from working in patient recruitment for merakoi, that patients in all disease areas really do want to be involved as much as possible. Highly activated patients are keen to change the future of healthcare and patient support. They get involved with things like patient advisory groups, grant reviews, reading panels, or steering committees, which are usually a long-term commitment. But when Pharmaceutical or Biotech companies involve them, it’s usually a one-off project with a particular task, goal, and outcome. Once that has been achieved, the project is over and they have no idea what happens from there unless the drug hits the market several years later or the solution they worked on is released. 

Even lesser activated patients want to help where they can. I don’t doubt that money can be a driving factor in that, particularly because poor health can impact a person's ability to hold down a full-time job. But, some patients just enjoy feeling seen and heard. They want to tell their story and are keen to highlight gaps in the system or solutions designed for them. For some, there’s a genuine interest in the product, clinical trial, solution, app etc. They want to be involved further, but they are not given the opportunity. Others just love feeling like they’re contributing to the changes they want to see, whether it be in healthcare, diagnostics, digital health solutions, or disease management. It's an opportunity to be more than just a patient.

Ready to unleash the superpowers of patients?

It’s great that healthcare companies are recognising the value patients bring in product and service design. I love that more and more companies are involving patients during the design concept phase, rather than bringing them in to tick boxes once the design is complete. However, not continually engaging with potential users throughout the whole design phase results in the final product or service being unsuccessful. 

Patient insights being considered in the initial phases of product, service, or clinical trial design is great, but as it progresses, those insights get diluted. Ideally, there should be a continuous engagement and feedback loop. This ensures that when it’s time to release whatever the solution is, it’s real-world ready. Tried and tested, and then tried and tested again!

This engagement and feedback loop builds trust within the patient community, and if done right, will highlight to the community that you have a shared goal of improving healthcare. If members of the mini-community feel like valued and respected stakeholders, that positively impacts how the wider community sees you, and your product or service, long-term. 

At merakoi, we've seen the transformative power of continuous patient engagement through mini-communities and cohorts time and again. From clinical trials and digital therapeutics to medical devices, our partners have been able to create solutions that truly resonate with their target users by making patient input an integral part of the process from start to finish.

If you're ready to harness the superpowers of patients and create health solutions that hit the mark every time, we've got you. Contact me to learn more about building a mini-community for your next project. Together, let's unleash the potential of patient-partnered innovation!

About Merakoi
Merakoi partners with health and life sciences companies to build mini-communities that guide product development through continuous user insights. Our network of patients/advocates and proprietary community platform enable engaging, longitudinal co-creation between users and developers. The result is human-centered solutions that resonate powerfully in the real world.

Imagine a world where clinical trials prioritize the needs of patients, not solely focus on testing new treatments. Co-designing with patients should be the starting point for clinical trial design, but sometimes their voices get lost in the shuffle. As the people who stand to benefit the most from new therapies, patients have a lot to say about what works and what doesn't. That's why it's so important to involve them from the very beginning.

When we invite patients to be active co-designers in clinical trials, we're doing more than just checking a box. We're recognizing that their experiences, opinions, and concerns are valuable and can shape the way a trial is run. By having open and honest conversations with patients, we can tackle issues that might make it tough for them to join or stay in a study. This could be anything from transportation problems to worries about the trial procedures or unknown results. By understanding each patient's perspective, we can make the trial experience better for everyone. When patients feel good about participating, it can lead to faster enrollment and better retention throughout the study.

But patient engagement is about more than just making trials run smoothly. It's also about building trust and creating a shared goal of improving healthcare. When patients feel like their voices are heard and valued, they're more likely to become champions for clinical research in their communities. This can greatly impact how the public sees clinical trials, breaking down misconceptions and encouraging more people to get involved.

Redefining Insights: Embracing Next-Generation Methodologies

Traditional market research and advisory board methods have long been the foundation of insight gathering for clinical trials. However, as technology and data rapidly evolve, it's crucial to recognize the limitations of these approaches and explore next-generation methodologies.

Market Research:

• Expensive and time-consuming
• One-off, snapshot views of patient experiences
• Limited ability to iterate and adapt based on ongoing patient feedback

Advisory Boards:

• Stale and commoditized audiences
• Lack of genuine diversity and representation of trial-specific target populations
• Tendency for the same voices to be heard repeatedly

While these methods have served us well, they may not be leveraging the full potential of advances in software, big data, and AI. It's time to embrace new approaches that address these limitations and unlock the power of continuous patient insights.

Imagine a solution that offers:

• Cost-effective, iterative processes
• Ongoing engagement with diverse patient segments
• The ability to shape and validate designs for specific patient populations

By adopting next-generation methodologies, we can revolutionize the way we conduct clinical research, leading to more effective, efficient, and engaging trials. 

Mini-Communities: Your Direct Line to Patient Insights

So, how can we make patient engagement easier and more effective? Enter the idea of mini-communities for your clinical programme. At Merakoi, our mini-communities bring together diverse patients who are the perfect fit for a specific trial, giving researchers a direct line to the people who matter most.

Let's say a research team is planning a trial for a new treatment for multiple sclerosis (MS). They could create a mini-community of MS patients with different experiences and backgrounds. This could include patients who have participated in trials before, those who are new to the process, and even patients from different geographic regions or with different types of MS.

By engaging with this mini-community, the research team can get valuable insights at every stage of the trial design process. They can ask patients for feedback on the trial protocol, making sure it's feasible and patient-friendly. They can test different recruitment materials and strategies to see what resonates best with patients. And they can even involve patients in designing the trial itself, getting their input on everything from the number of visits required to the types of assessments used.

Cohorts: Unlocking the Power of Segmentation

One of the most powerful features of mini-communities is the ability to create cohorts, or subgroups, within the larger community. In our MS trial example, the research team could create cohorts based on patients' previous trial experience. They could compare insights from trial-savvy patients to those who are new to the process, identifying potential barriers and concerns for each group. This information can help the team tailor their approach to meet the needs of different patient populations.

Cohorts can also be used to gather insights on specific aspects of the trial experience. For example, the research team could create a cohort of patients who have used wearable devices in previous trials. By learning about these patients' experiences and preferences, the team can make informed decisions about incorporating wearables into their own trial design.

The value of cohorts in patient engagement cannot be overstated. By segmenting patients based on key characteristics or experiences, study teams can gain a more nuanced understanding of patient needs and preferences. This, in turn, allows for more targeted and effective trial design, ultimately leading to better recruitment, retention, and overall trial success.

Case Study: Enhancing a Skin Disease Trial through Patient Mini-Communities

Recently, I had the opportunity to work with a global clinical study team on enhancing a skin disease trial. As someone who has seen firsthand the challenges of patient recruitment and retention, I was excited to put the power of mini-communities and cohorts to the test.

We began by creating a mini-community of patients with the specific skin disease. Within this community, we established three main cohorts: patients who had previously participated in clinical trials and those who were new to the process, as well as a panel of patient advocates and expert. This allowed us to compare insights from trial-experienced patients with those who were trial-naive, giving us a more comprehensive understanding of patient perspectives.

One of the key issues we uncovered through our interviews with these cohorts was the impact of certain invasive procedures, such as skin biopsies, in the trial protocol. Trial-experienced patients were able to share their past experiences and concerns, while trial-naive patients expressed apprehension about these procedures. Patient advocates, though not necessarily the target population for the study, provided vital information on ensuring informed consent. By listening to these groups, we were able to work with the study team to refine the protocol, making it more patient-friendly without compromising scientific integrity.

Another crucial aspect of our mini-community was its ethnic and geographic diversity. We made sure to include patients of different skin colors and from various national healthcare systems. This diversity proved invaluable, as we discovered that patients with darker skin tones often faced delays in diagnosis due to the difficulty in visually identifying symptoms. Patients from countries with more robust healthcare systems reported having better access to information and support networks, while those from regions with less developed infrastructure struggled to find the help they needed. This knowledge allowed the study team to tailor our recruitment materials and patient support programs to better meet the needs of patients from different backgrounds.

For patients in the mini-community around this clinical study, the experience is extraordinarily rewarding:

"You have to make the process comfortable for participants. They're spending their time doing this not only to help themselves but really to advocate for others because there's a lot of people that have this condition that don't have a voice. And what we are trying to do is help them come out of that. They don't have to be an advocate themselves, but they should advocate for themselves at least. And that's so important. You want the process to be smooth sailing and change from the way it has been, and it can change."

Ashley Wall, Merakoi Patient Expert

At the end of the day, a successful clinical trial isn't just about the scientific results. It's also about making a real difference in patients' lives. By putting patients at the center of the process and working together to design better trials, we can unlock the full potential of clinical research. This means faster development of life-changing treatments and a brighter future for healthcare, one trial at a time.

For a comprehensive guide on patient engagement in clinical trial co-design, check out this valuable resource from PFMD: Patient Engagement in Clinical Trial Protocol Design (Merakoi is a contributor)

Ready to change the way we do clinical research? Contact us for more information about mini-communities.

About Merakoi
Merakoi partners with health and life sciences companies to build mini-communities that guide product development through continuous user insights. Our network of patients/advocates and proprietary community platform enable engaging, longitudinal co-creation between users and developers. The result is human-centered solutions that resonate powerfully in the real world.

Related reading: what patient co-design really means

Imagine you're a master chef. You've spent months crafting the perfect dish, a combination of exotic flavors that will revolutionize the culinary world. You're about to present it to a room full of eager foodies. But wait, you skipped the taste tests, and now, as the first bites are taken, you realize the dish isn't resonating. Panic sets in. Your masterpiece isn't a hit because you didn't understand your audience's palate.

This common scenario - perfecting the product without truly understanding the user - is exactly what we see happening in healthcare. Companies are often so focused on the endgame that they forget who they're playing for. The rush to reach significant milestones like regulatory approval or market launch can overshadow the key process of user research.

Teams become so consumed by these critical goals that they overlook the profound importance of involving patients and clinicians early and continuously throughout product development. Instead of integrating user research as a core element from conception through post-launch, it's often relegated to the final stages. This is particularly concerning because by the time the product is nearly ready to hit the market, opportunities for meaningful and cost-effective iterations are vastly reduced.

The result: solutions that may be clinically sound but don't fully meet the nuanced needs of the end-users they aim to serve.

A new perspective is essential—one that places continuous user research at the heart of creating healthcare solutions. This ensures those who the products are meant to help have a voice in the process every step of the way. In this article, we'll show how user research is not just about ticking boxes, but about connecting deeply with patient needs and experiences.

The User Research Journey

User research steers products via formative insights early on and summative validation later.

1. In the formative stages, research focuses on discovery. Deep user interviews and observation provide fundamental insights into user challenges, current workarounds, and context. These learnings form the basis for solutions designed to map to real user needs.
2. As concepts develop into prototypes, formative research continues through usability testing. Researchers gather user feedback, especially around pain points, to enable iterative UX refinement grounded in user models and expectations.
3. In the final stages, research becomes more summative, validating product readiness. User journey mapping and testing communication strategies reveal potential adoption barriers. Feedback-driven tweaks maximize clarity and accessibility for the target audience.
4. Post-launch, research returns to a formative role, powering ongoing enhancement. Quantitative usage data and qualitative insights directly from users fuel innovation rooted in real-world experience.

Integrating both formative, exploratory and summative, evaluative research allows products to evolve aligned with user perspectives throughout the development journey. Prioritizing these human-centered learnings helps ensure solutions resonate powerfully with the lives they aim to improve.

User Research Vs. Market Research: What's the Real Deal?

Let’s differentiate user research from two common tactics—market research and advisory boards.

Market research analyzes demographics, competitors, trends—crucial for positioning.

Advisory boards offer valuable but limited perspectives. Unless well provisioned, they likely represent the industry more than your users.

User research gets personal with real users. It uncovers deep insights into their everyday reality and what they truly need. This nitty-gritty understanding is impossible to glean from surface-level research or semi-removed advisors. You need boots-on-the-ground user research to create products that fit seamlessly into your customers’ lives. No amount of indirect data can replace or replicate the insight derived from engaging directly with users and prospective users themselves.

Seeing Results: How User Research Pays Off

Incorporating user research into product development is essential for achieving key performance indicators like adoption and adherence. But how exactly does it pay off? Here are a couple examples:

• A global clinical study team sought to improve patient recruitment and protocol adherence for a rare skin disease trial. By interviewing trial naive and trial experienced patients and their caregivers, they uncovered insights that informed a more patient-friendly study design and recruitment materials.

• A commercial pharma team struggled with 50% medication adherence dropoff after launch. Ethnographic research into prescribed patients' lives identified confusion around proper dosage and communication with clinicians as a key driver.

Products designed collaboratively with end users are more intuitive, more convenient, and ultimately more impactful. The solution that emerges is not just built for users but built with them.

Mini-Communities for User Research

If you're sold on the value of user research, you might think of hiring a consultancy. But let me propose an alternative approach that harnesses the collective power of users.

At Merakoi, we run mini-communities -- small pools of patients that provide ongoing insights and feedback. Unlike sporadic focus groups, mini-communities persist over months or years as integral partners in product development. And, unlike standing advisory boards, turnover is encouraging to bring fresh voices.

Mini-communities may consist of several different cohorts of users, such as:

• Experienced users already familiar with a product or condition
• Naive users new to a product or condition
• Champions or influencers who can promote the product
• Specific demographics like newly diagnosed, fit vs. unfit, healthcare system, or age/gender

This diversity of perspectives ensures feedback represents the full spectrum of stakeholders.

Let's see how this worked for one promising digital health startup. The startup had secured regulatory approval in German (DiGa) and early commercial success with their digital solution for heart failure management. However, they knew that to achieve their vision of empowering patients worldwide, they needed to expand beyond a high-touch personal monitoring model.

The startup turned to Merakoi for mini-communities to continually guide development of a self-management program. Here's how it went:

1. Recruited a cohort of experienced users who had used the digital therapeutic for over 6 months. This gave insights into the high-touch monitoring model.
2. Also recruited a second cohort of naive users - those newly diagnosed with a less severe grade of heart failure. This represented their target expansion demographic.
3. Conducted remote interviews with both cohorts to understand their different needs and perspectives on managing their condition daily.
4. As the self-management software was built, both cohorts tested prototypes and provided feedback from their distinct vantage points.
5. Reviewed marketing ideas and messaging with each group. Experienced users valued interoperability of devices while newer users wanted more education.
6. After launch, the standing mini-communities continued providing insights into real-world usage and enhancement ideas.

My final takeaway: the future of human-centered healthcare is bright when we embrace user research not as an obligation, but as an opportunity to meaningfully connect with and empower the people we seek to help.

About Merakoi
Merakoi partners with health and life sciences companies to build mini-communities that guide product development through continuous user insights. Our network of patients/advocates and proprietary community platform enable engaging, longitudinal co-creation between users and developers. The result is human-centered solutions that resonate powerfully in the real world.

Ready to create health solutions that resonate? Contact us for more information about mini-communities.

  VALUE_Patient  = (HEALTH OUTCOMES_Patient) / (BURDEN_Patient)

In the first part of this article, the focus was on increasing patient value by improving health outcomes.  Five drivers were highlighted:

• Better wellness care
• Better access to treatment
• Early detection
• Find an excellent doctor
• Pursue the best treatment plan

Technology has served as a key catalyst to achieving greater outcomes, but education is necessary, so patients and caregivers appreciate what is possible. The other lever to influence overall patient value is patient burden – if we can reduce the denominator, value can be increased.  What specific opportunities exist to minimize the patient burden as we attempt to execute the Personalized Treatment Plan – a holistic, tailored treatment plan designed to meet the unique needs of the individual patient?  Consider the challenge of gathering all the existing patient data as input into the multidisciplinary meeting to establish the Personalized Treatment Plan.  If there was no previous screening or testing, then it is straightforward – order a complete set of tests at the Multi-Disciplinary Clinic (MDC); or if previous testing was done within this health network, then the information is readily available.  But often, patients are referred to MDCs from outside the network.  Previous scans and tests need to be sent and often these may not be specific enough now that the patient has been diagnosed.  New tests may be needed and would need to be scheduled, and of course, patients need to understand potential cost implications.  Patients want to make sure the MDC has all the information it requires to develop the Personalized Treatment Plan the first time – no rework or delay because there is missing data.  This should be seamless and painless for patients.  

When considering burden, it is not just patient burden but should include patient and caregiver/family burden.  It should be noted upfront that the chosen treatment plan by its nature has an associated level of burden.  If chosen, a clinical trial carries a degree of burden, whether it is limited sites executing the trial or the need to gather and track very detailed information beyond that which might be required if undergoing standard of care treatment.  The question is how we can best meet the requirements of a clinical trial or the Personalized Treatment Plan while trying to minimize the burden on the patient and caregiver.  How can we reduce patient burden?

1. Easier access to healthcare – This factor was also highlighted in the first part of this article – improving health outcomes, but it is an important factor in reducing patient burden and needs to be improved, particularly in underserved communities. Healthcare access should be:
   • Convenient, with pharmacies, doctors, and health clinics in the neighborhood.  
   • Affordable, with help provided to make sure the costs to patients are not burdensome.
   • Trusted.  Medical professionals need to be trusted partners in the community, providing high quality care, but also helping patients navigate the complexities of the healthcare system, particularly when referring to specialty doctors or medical centers.  
   • Timely and available when needed.

2. Make it easier for patients to find clinical trials – Should a patient participate in a clinical trial or not?  This is a difficult decision for many as patients consider the alternative treatment options available – will the current standard of care address my disease, or should the patient consider another option that may not be currently approved by regulators but offers a promising path forward?  

Patients still face hurdles after establishing clinical trials as a viable treatment option -   how do they find appropriate clinical trials, let alone the ‘best’ clinical trial to meet their needs?  How do patients navigate the very complicated landscape of clinical trials – unfamiliar medical terminology?  Confusing inclusion/exclusion criteria to most people?  What exactly is required of the patient if they participate in a clinical trial?  And importantly, what can be done to reduce the patient burden?

Tools that help patients find appropriate, actively recruiting clinical trials would be incredibly helpful.  Clinicaltrials.gov can be difficult to navigate, however, new tools are available to help patients find appropriate clinical trials where the patient meets the inclusion/exclusion criteria, that are actively recruiting new patients and identifies clinical trial sites.

In addition, clinical trials sponsors can reduce patient burden by improving the Informed Consent Form (ICF).  These forms can be difficult for patients to review as the information is often presented in a technically dense, legalistic manner.  Materials should be presented in patient-friendly language, so patients understand what the trial entails.  Each patient is different and may seek a different level of understanding.  I recently reviewed patient-facing clinical trials materials that used QR codes that allowed the patient to better understand the underlying science, if interested.  By scanning the QR code, the patient was taken to a video describing the mechanism of action in a simple, streamlined manner.  Only some patients might be interested in understanding this, but it is available for those who are and allows patients to easily find the information that they might need to make an informed decision on whether to participate in the trial.  

3. Improve clinical trial design through co-creation - Sponsors should work with patient experts to proactively identify patients’ concerns.  Have telehealth options been considered to reduce the number of trips to the clinic?  Are all of these biopsies required….because these procedures can be painful?  Patient experts should be engaged and engaged early.  These patient experts provide unique insights into the design process based on their personal history of disease (PhD).  After all, they have lived the patient journey.  

Many companies have established Patient Councils to gather patient input, but all councils are not created equally (I described Patient councils in greater detail in a previous post). Some councils are tasked to function primarily as ‘review boards’ as teams bring their patient facing materials, be it an ICF or patient brochure or website design to a group of patient experts who provide feedback.  These review boards allow companies to ‘check the box’ – yes patients have reviewed our materials.  The impact of these review boards is quite limited and there is no partnership with patients.  

Some councils are a bit more engaged.  There is an iterative collaboration between the patient council and teams.  A robust engagement occurs throughout the process as materials are developed.  It might be via workshops or prototype development, but the level of engagement is much more collaborative.

I serve as a patient peer and am engaged very early by my teammates.  As an example, this asset was preparing to enter the clinic, and I participated in a monitor training session.  It was a unique perspective brought to this conversation as my concerns were not so much around the operational execution of the trial or a debate of the underlying scientific rationale, but rather representing potential patient concerns.  Ultimately, is the proposed trial and associated information being presented in a way that will allow patients to make an informed decision on participation?  As the patient peer, I always have the flexibility to bring one of my council colleagues who might be better positioned to address a specific question – e.g. – a patient with experience in a CAR-T study.  

Some companies have expanded this patient partnership even further, where a patient serves as an ad-hoc team member as well as serving on the council.  This ‘patient peer’ provides the team with direct access to the patient voice whenever it might be needed.  Some specific examples include:

• Piloting a calendar app in support of a clinical trial;
• Reviewing a disease education website for newly diagnosed patients;
• Participating in clinical site training for monitors and investigators;
• Designing and testing different device delivery prototypes;
• Simplifying patient reported outcomes and questionnaires
• Enabling decision making – e.g. – what does the patient/caregiver need to know to make an informed decision and its impact on improved retention rates;

Early input by the patient peer has proven invaluable to project teams in capturing the patient perspective early in the process.

4. Leverage wearables/digital devices to provide timely data and insight:  The digital revolution provides many opportunities to reduce patient burden.  It’s easy today to capture health data on wearables – e.g. – heart rate, blood oxygen levels, sleep time and skin temperature are readily available.  We can track our physical activity – distance walked, flights climbed, minutes exercised, and calories burned, but we can also trend this data over time, providing our doctors with additional information and insight on our health.  Most individuals would not find this overly invasive or burdensome and would be willing to share this information with their medical teams if the data was useful.  However, if patients are asked to take their temperatures every day with a thermometer and then write it down in a diary, that might be seen as too burdensome relative to the value it would provide.

Let me provide a more specific example.  One of the key concerns associated with pancreatic cancer is patient weight loss.  Often this is associated with an inability to effectively process food.  I was told early in my treatment to focus on consuming calories, preferably ‘healthy’ calories in small meals throughout the day, but when in doubt, choose ice cream over salad (for some reason, my doctors don’t tell me that anymore).  It was important for me to weigh myself daily and call if I noticed a fluctuation in weight.  To be honest, it was a bit of a hassle to write it down and then bring that information to my appointments.  Alternatively, I could use a digital scale at home that would automatically upload my daily weight to the clinic.  My medical team would have this information available immediately.  In fact, they can spot changes that might warrant a check-in of some sort.  My burden is minimal and my only concerns are to take my weight consistently (same time of day, with or without shoes) and whether I am comfortable to share my information in this way.

But we can extend this analogy a bit further.  What if I took a picture of my food at each meal?  And there was an app available to capture what I was eating (we would need to ensure that patients had access to the technology to make this possible).  I now have information on what I am eating and my weight – could this information be useful to my medical team?  Maybe I add one more piece to the puzzle – one question each day on how I feel and what side effects I am currently experiencing.  A little more effort here, but still manageable.  As a patient, am I willing to spend the time and effort to provide my weight, a picture of what I eat and how I feel?  Technology makes it as easy as possible, but is it worth it?

This is the challenge – how much value does the patient get by doing this?  And is that value for this individual patient or value to improve the understanding of the disease?  Just because it is easy to gather more information, does not mean that we are adding overall value to the patient.    First, it is important for patients to receive feedback on the information being provided – that it is actually useful for them or other patients.  Otherwise, I am spending time and effort to provide this information but with no visible benefit.  Close the communication loop and be transparent with the patients.  

Second, there is insight to be gained from timely data capture.  If I am provided with a questionnaire to complete on my monthly visit to the clinic, the quality of my data may be suspect.  How did I feel since my last visit?  Well, I did experience a bit of nausea during the month and had some GI issues, but I don’t recall anything specific.  However, in the technology scenario above – where I captured my weight, my food intake and how I felt – I am reminded that I ate a spicy Mexican meal the day before I was feeling nauseous.  Perhaps my experienced nausea has little to do with my treatment or medication and everything to do with the fact that I just can’t handle spicy food anymore?

The opportunity to deliver transformative, improved patient care and value has never been greater.  Technology serves as the catalyst to both pursue and achieve this potential.  Outcomes can be dramatically improved by driving early detection, identifying excellent doctors, and developing personalized treatment plans.  Leveraging technology, be it genetic testing, improving access to healthcare for all patient populations, using advanced gene editing or immunotherapies or harnessing continuous data from wearables, serves as the flashlight on our smartphone that allows us to see in the dark park at night.  

Technology alone, however, is not the complete solution.  Healthcare – industry, physicians, payers, and regulators - must better engage patients and reduce the patient and caregiver burden.  Industry must co-collaborate with patient experts.  The goal must be to allow patients to make better, informed decisions on their treatment plans – through education, improved access to care/clinical trials and communicating effectively in understandable language.

“the measured improvement in a person's health outcomes for the cost of achieving that improvement”

This needs to be considered in the broadest context, through a holistic, multi-disciplinary approach to the delivery of healthcare.  It’s not just the treatment of disease but encompasses improving patients’ overall health and reducing the incidence and effects of chronic disease.  Ultimately, providers are rewarded for helping patients live healthier lives.

As seen through the patient lens, 

VALUE_Patient  = (HEALTH OUTCOMES_Patient) / (COST_Patient)

But the patient ‘cost’ is really the patient burden, so 

               VALUE_Patient  = (HEALTH OUTCOMES_Patient) / (BURDEN_Patient)

…where patient burden consists of physical burden, emotional (or pyscho-social) burden, financial/cost burden and time/effort burden.

What can be done to increase the value from the patient perspective?  Simple math indicates there are two ways to enhance patient value - by either increasing the numerator (Health Outcomes) and/or reducing the denominator (Burden).  Both levers must be considered and pursued.

How can people improve their health outcomes?  

1. Better Wellness Care can lead to a happier, healthier, more productive life -   eating a balanced diet, regular exercise, sufficient sleep every night, keeping mentally active are all important elements of preventive care;

2. Better Access to Treatment for all – As witnessed during the Covid pandemic, disparity in access to quality healthcare is a significant issue confronting society.  Without access, underserved communities will continually struggle to improve their health outcomes.  

At a macro/societal level, both the WHO (World Health Organization) and CDC (Center for Disease Control and prevention) consider the Social Determinants of Health (SDOH) primarily responsible for health inequities – the unfair and avoidable differences in health status seen within and between countries.  These determinants include:

• Healthcare access and quality 
• Education access and quality
• Social and community context
• Economic stability
• Neighborhood and built environment

At the patient level, these socioeconomic barriers manifest in a variety of ways:

• Limited trust in medical professionals and the pharmaceutical industry
• Limited availability of proximate health clinics, neighborhood pharmacies and state-of-the-art treatment options
• Limited awareness and understanding of complex medical terminology, diagnoses, and treatment decisions
• Inadequate healthcare payer coverage
• Concerns with good housing, environmental considerations, quality food, and safety
• Limited access to broadband and other fundamental technologies.

Until these challenges are addressed, improving health outcomes in these underserved communities will lag, but there is a significant opportunity to greatly improve outcomes across a broad population by reaching out to these underserved in a more proactive manner.  

3. Early detection.  The words ‘early detection’ are very empowering to patients.  For cancer patients, it means having a fighting chance as there are likely more treatment options available than if the disease had been detected later.  But how is this best achieved?  Can it be achieved without creating additional anxieties and concerns?  How can healthcare practitioners and health systems better enable early detection?  

One obvious answer is that patients must act and fulfill their responsibility of seeking medical attention in a timely manner when things just don’t feel right.  Many ignore the warning signs or just can’t make time in their busy schedules for a checkup or a test.  It's too inconvenient, and they fear what they may discover.  

However, the healthcare landscape must be viewed through a different light.  In the past, if a person lost her keys at night in a park, what did she do?  Her initial instinct is to retrace her steps and look closely under the lampposts.  Why?  Because that’s where the light is, and she can actually see the ground.  

There are many ‘early detection’ lampposts available throughout the park.  Patients often provide family history as this can help healthcare practitioners identify people with a higher-than-usual chance of having a particular disorder, and with this early warning, doctors can initiate early intervention.  Screening tests can be valuable tools in detecting potential issues via clear and simple results, particularly when performed at appropriate times as recommended by the healthcare provider. Many standard screening tests are embedded in mainstream healthcare:

• Cholesterol testing for cardiovascular disease;
• Pap smears for cervical cancer
• Diabetes screening
• Mammography for breast cancer
• Prostate Specific Antigen (PSA screening) for prostate cancer
• Colonoscopy for colon cancer and colon polyps 
• Hearing and eyesight tests…

…and we readily search under these well-established lampposts.  However, the world has moved on and the paradigms of yesterday are constantly challenged.  If we lose our keys today in a dark park, we are not limited to only searching near lampposts.  We carry our own light – the flashlights on our smartphones and this enables us to search anywhere, at any time.  What are the newer ‘early detection points of light’ that are unleashed by technology?

Genetic testing is a powerful medical test that identifies changes in genes, chromosomes, or proteins. At a macro level there are several genealogy and family history research companies like AncestryDNA and 23andMe which help people trace their family history, but this is based on DNA testing and can serve as a risk screener for several genetic conditions and diseases.  Using a cell-free DNA (cfDNA) test, the healthcare company Grail claims its early cancer detection product Galleri can detect fifty different types of cancer from a single blood draw.  These tests can highlight predisposition to specific diseases.  With this, individuals and their doctors could better track health around those ‘future risk diseases’ of that individual and stay aggressively ahead of it.  This can be achieved relatively easily, though there are other patient burdens that could likely surface like anxiety of discovering that you have a predisposition to a disease in your future.  Some patients are keen to have as much information as possible – if they know they have a predisposition for a particular disease, they can take steps to closely monitor or adopt a healthier lifestyle.  However, some patients prefer not to know as many of these tests are not definitive and certainly can’t predict when a patient might be afflicted; they choose to deal with it when they must.

At the patient diagnosis level, results of a genetic test can confirm or rule out a suspected genetic condition or help determine a person’s chance of developing or passing on a genetic disorder.  For example, the Pancreatic Cancer Action Network (Pancan) started a program - “Know Your Tumor” – to understand the underlying biology of the tumor.  Pancan encourages all pancreatic cancer patients to get genetic testing for inherited mutations as soon as possible after diagnosis and biomarker testing of their tumor tissue to help determine the best treatment options.  The genetic makeup of the tumor can guide patients and their doctors to ‘better’ treatment options, which is known as precision medicine.  Precision medicine leads to better health outcomes.  In 2020, Pancan reported that patients with actionable alterations who were treated on ‘matched’ therapies had a survival of 2.58 years vs 1.51 years for patients who were not on matched therapies.

Technology affords even greater opportunities for early detection beyond testing.  As an example, in an episode of the television show Billions, management provided their employees with a finger ring, which monitored some basic medical information continuously (for now, ignore the privacy issues that management was monitoring their employee’s health without their knowledge – a different topic).  One of the senior managers was exercising on his stationary bike and an abnormality was detected by the ring and transmitted this information to the monitoring station.  There was then a knock at the employee’s door by the paramedics saying that a person at this location was having a heart attack.  Privacy aside, the burden on the subject was very low, but the benefit was enormous resulting in a significant value through pre-detection of a significant medical incident. 

Finally, it is important to note an underlying patient benefit associated with clinical trial participation.  By being closely monitored while participating on a clinical trial, patients are more likely to discover medical issues or complications more quickly.  This form of early detection will lead to faster interventions by medical experts in the disease area.  Companies should highlight this benefit to patients as part of its clinical trials documentation.

4. Find an excellent doctor - Once patients receive a diagnosis of a disease, how do they choose a doctor?  Is their primary physician trained in this disease?  Is there anyone locally who has expertise in this disease and is current on the available treatment options?  Obviously, this depends on the complexity of the disease diagnosis, but clearly overall health outcomes can be improved by having the best medical team.  Most patients rely on their primary physician to serve as the Hogwarts ‘Sorting Hat' – to match the patient with the ‘right’ specialist as required.  Sometimes, however, the primary physician may not know or may be inclined to refer the patient to another doctor within their health system – a good doctor but maybe not the best doctor.  Advocacy groups are a good source when looking for a disease specialist or finding leading physicians..  Ultimately, patients need to be comfortable selecting their medical team and seek advice from people they trust.  

5. Pursue the best treatment plan, whether it is standard of care or a clinical trial, to achieve the best health outcomes.  This is not a trivial challenge for patients as they are often entering foreign territory.  Usually, patients receiving a new diagnosis may have limited knowledge of the disease – what is it?  How did I get it?  What are the treatment options?  Are there side effects, and if so, how impactful might they be?  Will I be able to work?  Can I afford this?  And often, this information is presented in a technical morass.  

The best treatment plan should be holistic and comprehensive.  This is best achieved with a medical team that takes a multidisciplinary approach.  For a cancer patient, the oncologist, radiation oncologist, surgeon, pain management, nutritionist need to consider the unique medical circumstance of each patient and develop an integrated ‘Personalized Treatment Plan.’  The full medical team must align to this common plan and coordinate its execution seamlessly.  And just like a good financial plan, the Personalized Treatment Plan should be constantly adjusted as more data is obtained, everyone aligned to a common goal.  Only then is it possible to achieve the best health outcomes for this patient.

Our ability to influence health outcomes has never been greater.  Technology advances, both medical and non-medical, offer patients the opportunity to find and pursue treatment options that are better targeted to them as individuals.  Improved health outcomes are attainable, however, the promise of better health wellness and precision medicine can only be fully attained if it is accessible, affordable, and available to all patients. 

In part 2 of this article, we will take a closer look at patient burden and consider opportunities to increase patient value by reducing patient burden.