Category Archives: Patient Engagement

When Patients Partner with Researchers: Kevin’s Perspective

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ADAPTABLE patient partner, Kevin Edgley, shares how he became involved in ADAPTABLE and why this study and patient-centered research is important.

“As an engineer I’ve always enjoyed working with customers, it was obvious early on that the people we sell the equipment to and who use it every day, know more in some ways than the engineers who design it. It is always humbling to talk with customers because they can be frank about what they like and do not like– this has been very constructive for me in my career. This experience as an Adaptor is similar in this respect — it is different and valuable.”

How did you get involved in patient-centered research?

I was sitting at home one night and my cardiologist called me. A little frightening….!  He mentioned the study and asked if I would participate, and I said yes. Half of my life I have been involved in research and development (from a mechanical engineering perspective), and while this is very different, the principles are similar. My interests and history appeals to this type of work.

Why do you think the ADAPTABLE study is important?

I do not have a whole lot of experiences to compare this to in terms of medical research. From what I know, getting the voice of the patient in a study is important as opposed to a bunch of academic professionals making assumptions. This is a unique and important opportunity!

What do you enjoy most from your involvement in the ADAPTABLE study?

I have enjoyed doing something different and separate from my own profession and thinking about research differently. Adaptable has been a great change of pace for me. I enjoy the interaction with the other Adaptors and hearing their different points of view that I would not normally consider on my own. As an engineer I’ve always enjoyed working with customers, it was obvious early on that the people we sell the equipment to and who use it every day, know more in some ways  than the engineers who design it. It is always humbling to talk with customers because they can be frank about what they like and do not like– this has been very constructive for me in my career. This experience as an Adaptor is similar in this respect — it is different and valuable.

Why is patient-centered research important?

I think patient centered approach is important and communication to the public is one of the most difficult things to do. When I mention this project to people, they are surprised. To the public this question about aspirin dose is an already a closed case. It is ingrained that 81 mg is the right way to go! People are not always willing to consider there may be another answer.

The way studies are presented in mainstream news is almost a joke. The say coffee is good for you one year and the next year it is bad for you! I’m not sure the general public (which I am more a member of) takes these findings seriously, and sometimes study results are discounted since you get so much conflicting information.

The public does not read medical journals or in-depth study results, we need to think about ways to share research back that is not conflicting and incorporates the patient perspective.

Top Lessons Learned from ADAPTABLE Patient Partners

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ADAPTABLE patient partners, also known as Adaptors, provide input to the study team at every critical step in the research process. Adaptors are passionate about patient-centered research and draw on their personal work and life experiences to improve the study participant experience for current and future research participants. In this issue, we asked the Adaptors to share their top lessons learned from their experiences in ADAPTABLE.

  1. Mutual respect between patient leaders and researchers has helped build an engaged & caring community that improves the research experience for all involved.
  2. Our involvement as patient advisors in research is important because it can help our friends and family in the future.
  3. It is harder than we realized to recruit patients for studies like ADAPTABLE. That is why personal involvement from study participants is so important.
  4. We are encouraged by the participants who share their personal reasons for enrolling in ADAPTABLE and enjoy reading their stories.
  5. Patients have valuable insights about study procedures and how to address challenges. ADAPTABLE is truly an authentic patient-centered study!
  6. We learned researchers can be fun and are real people.
  7. Patient involvement in the beginning of a study can make a friendlier and better study.
  8. Patients shaping study communications has helped to engage our study community.
  9. Being involved in Adaptable has made us feel more empowered and proactive with our own healthcare. We hope this is also true for study participants.
  10. Patients and researchers need to be connected. Patient advisors can help researchers keep patients at the center of research by refining the research questions. The answers to these questions may help improve your quality of life.
  11. A good facilitator or liaison is crucial in helping guide and direct communications between the patient advisors and researchers. Study research budgets should account for the role of a facilitator.

Conozca un adaptador: Greg Merritt

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El socio del paciente de ADAPTABLE, Greg Merritt, comparte su perspectiva sobre el valor que los pacientes aportan a la investigación clínica y cómo los pacientes y los investigadores pueden trabajar juntos en la investigación y el tratamiento.

Greg Merritt

“Cuando se invita a las personas a involucrarse con la investigación y a compartir todas sus experiencias, podemos estudiar un interrogante desde una perspectiva verdaderamente colaborativa, creando una cultura de curiosidad y la posibilidad de innovación. ¡El mantra aquí es la fuerza en nuestras diferencias!”

¿Por qué es importante una investigación centrada en el paciente?

¡El mayor valor de una investigación centrada en el paciente es incorporar pacientes! Esto puede sonar obvio dado que los pacientes se encuentran exclusivamente calificados para comprender la importancia de la investigación. Cuando los investigadores trabajan largas horas, tienen la opción de irse a su hogar y dejar de pensar en la enfermedad en estudio. Sin embargo, los pacientes nunca dejan de pensar ni vivir con su enfermedad. Los pacientes se acuestan y se levantan con su afección. Cuando las respuestas a los interrogantes de la investigación son positivas o pueden derivar en una mejora significativa en la calidad de vida, tiene sentido que los pacientes se involucren de manera importante en la investigación desde el principio.

En una reunión de investigación reciente, auspiciada por Health eHeart Alliance, vi de antemano el valor de tener pacientes en la sala analizando y priorizando los interrogantes de la investigación. Saber qué preguntas hacer es clave y los pacientes deben formar parte de este proceso de priorización, especialmente cuando los recursos y la financiación son limitados.

En el caso de ADAPTABLE, al menos para mí, he tomado aspirina como medida preventiva durante aproximadamente 16 años. Si me preguntaban si sabía lo que hacía la aspirina, más allá de prevenir un infarto de miocardio, no hubiese podido contestarle. Si me preguntaba por qué tomaba la dosis que tomaba o por qué esa dosis era correcta, tampoco hubiese podido responder eso. Al hablar sobre ADAPTABLE y el interrogante sobre la dosis de aspirina con otros pacientes cardíacos, generalmente escucho, “¡Debemos averiguarlo!” Es grandioso saber que ADAPTABLE ayudará a responder qué dosis es la correcta para los pacientes cardíacos e incluye a estos pacientes en el diseño del interrogante y el estudio.

¿Cómo pueden los pacientes e investigadores trabajar juntos como socios en la investigación y el tratamiento?

La participación del paciente necesita ser bienvenida y deseada. Los investigadores y médicos de la atención de la salud necesitan ver esto como una oportunidad, no un inconveniente. En la investigación, los pacientes usan dos sombreros. El primer sombrero es su “sombrero de paciente”: Me encuentro aquí para el tratamiento o participando en un proyecto de investigación porque me interesa lo que sucede. Mejoraré o empeoraré o el interrogante de la investigación presentado podría mejorar mi vida o la de mi familia en el futuro. El segundo sobrero que el paciente usa es el sombrero de su “experiencia de vida”. Al usar este sombrero, los pacientes recurren a experiencias de su campo profesional, educación, antecedentes de salud, etc. Los investigadores pueden aceptar estas perspectivas diferentes que los pacientes traen y observar el problema o interrogante con un nuevo lente.

Es muy importante dar valor a la experiencia de asociarse con los pacientes en la investigación. ¡Es posible que los investigadores se sorprendan con los comentarios de los pacientes y se topen con la innovación! Cuando se invita a las personas a involucrarse con la investigación y a compartir todas sus experiencias, podemos estudiar un interrogante desde una perspectiva verdaderamente colaborativa, creando una cultura de curiosidad y la posibilidad de innovación. ¡El mantra aquí es la fuerza en nuestras diferencias!

When Patients Partner with Researchers: Greg’s Perspective

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ADAPTABLE patient partner, Greg Merritt, shares his perspective on the value patients bring to clinical research and how patients and researchers can work together in research and treatment.

Greg Merritt

“When people are invited to get involved with research and bring all their experiences, we can study a question from a truly collaborative perspective, creating a culture of curiosity, and the prospect of innovation. The mantra here is strength in our differences!”

Why is patient-centered research important?

The biggest value of patient-centered research is incorporating patients! This may sound obvious as patients are uniquely qualified to understand why the research matters. When researchers work long hours, they have the option to go home and turn off thinking about the disease under study. However, patients never get to turn off thinking about or living with their disease. Patients go to bed with and wake up with their condition. When answers to research questions are positive or can lead to a significant improvement in quality of life, it makes sense that patients should be meaningfully involved in the research from the beginning.

At a recent research meeting, hosted by Health eHeart Alliance, I saw first hand the value of having patients in the room discussing and prioritizing research questions. Knowing what questions to ask is key and patients should be part of this prioritization process, especially when resources and funding are limited.

In the case of ADAPTABLE, at least for me, I have taken aspirin as a preventative measure for approximately 16 years. If you asked me if I knew what aspirin did, beyond preventing a heart attack, I would not be able to tell you. If you asked me why I was on the dose I was or why that dose was right, I would not be able to tell you that either. When talking about ADAPTABLE and the aspirin dose question to other heart patients, I often hear, “We should figure this out!” It is great that ADAPTABLE will help answer what dose is right for heart patients and includes these patients in the design of the question and study.

How can patients and researchers work together as partners in research and treatment?

Patient involvement needs to be welcomed and wanted. Healthcare researchers and practitioners need to see this as an opportunity not an inconvenience. In research, patients wear two hats. The first hat is their “patient hat:” I am here for treatment or involved in a research project because I have a stake in what happens. I will either get better or worse or the research question asked could improve my life or my family’s down the line. The second hat patients wear is their “life experience” hat. In wearing this hat, patients draw on experiences from their professional field, education, health history, etc. Researchers can embrace these different perspectives that patients bring and look at the same problem or question with a new lens.

It is incredibly important to give value to the experience of partnering with patients in research. Researchers may be surprised by patient input and stumble upon innovation! When people are invited to get involved with research and bring all their experiences, we can study a question from a truly collaborative perspective, creating a culture of curiosity, and the prospect of innovation. The mantra here is strength in our differences!

Every Participant Counts from Enrollment to Study Completion

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In research studies like ADAPTABLE, researchers initially focus on enrolling patients in the study.  Every clinical study has a “target” enrollment number, which is the number of participants researchers hope will enroll in the study. For ADAPTABLE that number is 15,000 participants. Reaching this number is important so that researchers can be certain that the study is representative of the population who will benefit most from knowing the preferred dose of aspirin.

Equally important to enrollment in a research study is retention. Retention is the number of patients who remain in the study until it is completed. Well-intentioned participants occasionally drop out early for a variety of reasons and, of course, they have this right. A guiding principle of clinical research is that study participants can discontinue participation at any time for any reason.

Why is Retention Important?

Retention is important for several key reasons. First, researchers have an ethical obligation to follow the health of every study participant until the end of the study, even if the participant has stopped taking the study drug. To meet this obligation, it is essential for researchers to be able to communicate with study participants and collect information on their health and the occurrence of events, such as hospitalizations, heart attacks, or strokes.

Second, a high participant dropout rate means that researchers might not have enough data to evaluate whether or not the treatment works for everyone. The Food and Drug Association (FDA) is the U.S. agency who approves new drugs or treatments. The FDA considers incomplete participant information as missing data, which can compromise the findings of the study.

Finally, there is a fundamental principal that motivates researchers to retain participants in a study. Researchers and patients alike want to learn as much as possible from a study. To accomplish this, researchers want to understand each and every patient’s journey through a study. Each of those individual journeys teaches us something. Every patient’s story and experience needs to come through and be part of the final results of a study.

ADAPTABLE Principal Investigator Daniel Muñoz with Vanderbilt Medical Center says,

Daniel Muñoz, MD, MPA

“The ADAPTABLE study is only possible because each participant has chosen to join, to contribute to science, and to be part of something bigger than themselves. All of us are in this to help patients by getting closer to the truth about whether there might be a best dose of aspirin. We can only get there by understanding and following the experience of each and every participant in the study. The entire ADAPTABLE team is grateful to the thousands of participants whose commitment through the end of the study will ultimately help patients around the world.”


Retention in ADAPTABLE

The goal of retention is to make sure as many participants as possible choose to remain in the study until it ends. In ADAPTABLE, full participation means continuing to take your assigned dose of aspirin and completing a survey every 3 – 6 months. To overcome some of the barriers that participants in ADAPTABLE face, participants are able to switch their dose of aspirin if needed for health reasons, modify their participation level, and change how they complete the study surveys.

The infographic below presents ideas on how researchers and study participants can both work to help improve retention in ADAPTABLE.

Remember, if you have questions or concerns about your participation in ADAPTABLE, or any other research study, you can contact the study team to discuss available options that would make participation more comfortable for you.

 ADAPTABLE research team members understand that a person’s circumstances or motivation to participate can change affecting their decision to remain in the study. Team members will always honor a participant’s choice to change participation or leave the study.

Making Sense of it all: A Review of Recent Studies on the Role of Aspirin in Preventing Heart Disease and how ADAPTABLE fits in the Picture

Aspirin is a drug that has been used for decades to prevent the occurrence of a heart attack or stroke by thinning blood so clots do not form. Doctors recommend either high-dose (325 mg) or low-dose (81 mg) aspirin and its use across the United States is fairly balanced between high-dose and low-dose aspirin.

The ADAPTABLE study aims to provide patients and doctors with information on the best dose of aspirin to prevent another heart attack or stroke in people living with heart disease. Doctors refer to this as secondary prevention. Recently, four major studies contributed to our understanding of aspirin’s role in preventing a heart attack or stroke for individuals who do not have known cardiovascular disease and have not experienced a heart attack or stroke. Doctors refer to this as primary prevention. Working with ADAPTABLE patient partner, Greg Merritt, we provide a summary of the results for each of these studies below.

Schuyler Jones, MD

“We all deeply believe in the work required to finish the ADAPTABLE study, and we’re excited to maintain momentum over the fall and winter months. Please take a look of our thoughts on the recent aspirin studies and their applicability to ADAPTABLE.”

The ASCEND Trial: Aspirin in Primary Prevention of Vascular Events in Patients with Diabetes

The ASCEND study included patients with diabetes, a major risk factor for developing heart disease and stroke, but without known heart disease. In this study, approximately half of the 15,480 patients took a low-dose (100 mg daily) of aspirin, and the other half took a placebo pill. A placebo is a substance that does not contain an active drug.

After an average of 7.4 years, patients who took aspirin experienced 11 percent fewer cardiovascular problems, including heart attacks, strokes or mini-strokes, and even death due to a cardiovascular cause. This benefit was stronger in patients weighing 70 kg (154 lbs) or more. Researchers estimated one cardiovascular problem was prevented for every 91 patients who took aspirin. Since aspirin is a blood-thinner, it is also associated with more bleeding problems. For every 112 patients who took aspirin, one more bleeding event occurred compared to patients who did not take aspirin. The increase in bleeding events did not lead to death or a stroke.

The ARRIVE Trial: Aspirin in Primary Prevention in Non-Diabetic Patients at Moderate-Risk of Cardiovascular Diseases

The ARRIVE study was similar to the ASCEND trial (by including patients without known heart disease) but did not include patients with diabetes. This study included patients with a moderate risk for developing heart disease based on factors such as high blood pressure, smoking, or high blood levels of cholesterol. Half of the 12,546 patients took 100 mg of aspirin each day, but this time, aspirin did not prevent cardiovascular problems when compared to a placebo pill. After an average of 5 years, whether or not they took aspirin, approximately 4 percent of all patients experienced either a heart attack, stroke or mini-stroke, unstable chest pain, or death due to a cardiovascular cause. Although bleeding from the stomach or intestines was rare and occurred in less than 1 percent of the patients in both groups, patients who took aspirin were more likely to experience this type of bleeding.

Greg Merritt

“It continues to be an honor and privilege to be a patient partner in the ADAPTABLE Study.As a patient, I often see a wealth of information in the media about the role of aspirin in preventing or treating heart disease. However, my friends, fellow heart patients, and I are often confused by this influx of information. I love having ‘experts that I trust’ put into context these reports. Putting results from these studies in a language lay people can understand helps a great deal, so we don’t spread information that has not been scientifically proven.”

The ASPREE Trial: Aspirin in Primary Prevention of Dementia or Disability

The ASPREE study also included exclusively patients with no previous heart disease or stroke, but only if they were considered healthy and at least 65 to 70 years old. Half of the 19,114 participants took 100 mg of aspirin each day, and the other half took a placebo. After an average of almost 5 years, the study did not show benefits of aspirin in preventing death, dementia, or chronic physical disability, but the risks of major bleeding problems increased. In addition, aspirin did not prevent heart attacks, strokes, and other cardiovascular events. The ASPREE study raises concern for a potentially higher risk of death with aspirin in elderly patients without previous heart disease or stroke. The study found a higher rate of cancer deaths in the participants who took aspirin. This finding should be interpreted with caution because it was not the main focus of the study, and most importantly because previous studies demonstrated the opposite: a protective effect of aspirin on death related to cancer.

Meta-Analysis on the Interaction between Aspirin Dose and Body Weight

The fourth study was a meta-analysis, which combines and evaluates the results from multiple studies. This analysis looked at the results from nine studies involving nearly 103,000 patients (but did not include any of the results from the three studies above). The purpose of the analysis was to decide if aspirin dosing should be different for heavier people compared to people with lower body weights. The authors found that only patients weighing less than 70 kg (154 lbs) benefited from a daily dose of aspirin of 70-100 mg. This benefit (prevention of a heart attack or stroke) decreases as the weight of the patient increases. Patients weighing 70 kg or more benefited from daily doses of aspirin greater than or equal to 300 mg. Patients with lower body weights did not benefit from this higher dose of aspirin in general. Of note, these nine studies did not set out to research an association between body weight and aspirin dose, so results from this analysis should be interpreted with caution.

Although aspirin can prevent cardiovascular events in some patients, these studies show that it comes at a cost in terms of risk of bleeding. Some patients might fear heart attacks and strokes more than bleeding, but some patients might worry more about bleeding. The choice to use aspirin or not must be a joint decision made by a patient and their doctor, using scientific information as well as personal preferences. 


 Take-home Messages

  •  In diabetic people without cardiovascular disease, the overall benefits of aspirin is low to moderate.
  • In people at moderate risk of developing a cardiovascular disease, but without diabetes, aspirin doesn’t seem to protect people from a first cardiovascular problem.
  • In people at least 65 to 70 years old without cardiovascular disease, aspirin does not protect against death, dementia, or persistent disability, and neither does it protect from heart attacks or strokes, but it increases the risk of bleeding.
  • The effectiveness of low-dose (70-100 mg) and high-dose aspirin (at least 300 mg) to prevent cardiovascular complications has not been researched in a study specifically designed for this purpose, particularly in patients who have experienced previous heart attacks or strokes. It is expected that benefits of aspirin are higher for this group versus patients who have not experienced these events.
  • A relationship between weight and aspirin dose may exist, but a future study designed specifically to research this association is needed.
  • ADAPTABLE is the largest study comparing two doses of aspirin in patients who have cardiovascular disease. This is a different population than the recent studies, which was comprised of study participants with no known heart disease.
  • The benefit of aspirin to prevent future events in people who have heart disease is established, but the optimal dose is not known. Results from ADAPTABLE will provide information to help doctors and patients answer this question.

When Patients Partner with Researchers: Desiree’s Perspective

In ADAPTABLE, patients are more than study participants, they are partners with researchers and clinicians to improve cardiovascular health for all patients and those who care for them. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. The Adaptors team works alongside the study team, participating in team meetings and providing review and input to the protocol, consent form, study portal, and study materials.

We talked with one of the Adaptors, Desiree Davidson, who provided her perspective on the value patients bring to clinical research, the importance of patient-centered research, and the ADAPTABLE experience.

How can patients inform researchers in clinical trials?

Goodness, how did we do research before? After participating as an Adaptor in Adaptable, I wonder how research could be done any other way.  There are plenty of patients that do not feel comfortable relaying their concerns to their physician.  When we have a doctor’s appointment we are going to see a physician or a nurse, not a guy in a lab coat! We do not see our care providers as researchers and it feels like there has been a barrier between patients and researchers, that is concerning to me.  This model of patient-centered research is an opportunity to advance medicine, in my opinion.

What activity do you appreciate most from your work on the ADAPTABLE Study?

If are worried about talking to your doctor, you might feel it is easier to talk to a researcher. There is some fear once you get to a certain age, especially if you have been healthy all your life. The fear is related to not wanting to face the challenges of aging and being open to accepting what the physician may have to say. This comes back to education, you need to educate yourself about what can happen—to be able accept that somewhere along the line, you are fallible. For example, high blood pressure doesn’t hurt, it causes no pain. When I went to the doctor, the nurse told me my BP was high. I thought OK—the severity of having high BP for years is my responsibility to know. If I knew this back when I was 40, it would have made a difference to me, knowing what I know now, it matters! This is the kind of information you can get from a researcher. So now I have begun to educate myself. This role of clinician/ researcher is so important. A doctor may see 25 people a day, let’s say 18 of them have high blood pressure, and this conversation will not happen with the doctor. For the patient they think it is someone else who will have high BP, someone else will get diabetes. You do not think it will be you, maybe the doctor thinks this conversation has happened already. Ultimately the patient needs to have this conversation with their doctor, but the other hand, the patient needs to be willing to hear what the doctor tells them and take it upon themselves to get educated.

We have to learn to be comfortable asking questions, because an uncomfortable conversation today about a life-threatening condition, down the road in a certain context, is not really that uncomfortable.

What activities or hobbies do you enjoy outside of your clinical research activities?

I have always fallen into the role of teaching people. My first job was in a manufacturing company, my job was to explain insurance benefits to a labor force. This was something I fell into, and it was easy for me. This role as a patient leader feels natural to me. I was in personnel management for 37 years, and it was the easiest thing in the world to talk to people and teach them something new. I guess I have never had to work hard, this role is the easiest thing for me to do!

Importance of Diversity in Clinical Research

The main phases of a clinical research study include: 1) identification and recruitment of study participants, 2) data collection and monitoring, 3) analysis of study results, and 4) distribution of study findings. ADAPTABLE team members are currently focused on the first two phases. In this article, we explore why it is important that people of different ages, races, ethnic groups, and genders are included in clinical trials.

How Does Who you are Impact Your Risk for Disease?

Sex, age, race, and ethnicity all play an important role in how different diseases, medicines, and treatments affect people. For example, the American Heart Association (AHA) states that the prevalence of high blood pressure in African-Americans is the highest in the world. African-Americans are disproportionately affected by obesity and more likely to have diabetes than non-Hispanic whites. The Centers for Disease Control and Prevention (CDC) estimates that for American Indians/Alaska Natives and Asian Americans/Pacific Islanders, heart disease is second only to cancer. Heart disease affects women as much as men, but symptoms and the warning signs for women aren’t the same as in men.

Despite what is known about how certain groups of people may respond differently to disease; traditionally, the majority of cardiovascular clinical research study participants are white men. Increasing diversity in clinical research studies is a priority for the Food and Drug Administration and the ADAPTABLE team in making sure results provide evidence that is relevant and helpful to a wide range of people. Diversity in clinical research studies helps ensure that the results will have an impact on the people the study is intended to help.

How Can Researchers Work to Improve Diversity in Clinical Research?

So how do researchers work to ensure representation from a range of participants in clinical research studies? The short answer is education, trust, partnership, and access.

Providing Education: Too often people who choose not to participate in trials say that they lack information. Providing educational resources about clinical research—what it is, why it is important, and how to participate—is a good first step to filling this information gap and increasing participation of underrepresented groups. To be effective these resources must be written in plain language, culturally appropriate, and available in local languages.

Establishing and Building Trust in Communities: Lack of trust in clinical research by minority groups continues as a reason individuals decline participation in trials. PCORnet, the National Patient-Centered Clinical Research Network, is leading a shift in its approach to clinical research from the traditional sense of work that is done to the community to work that is done with the community. PCORnet has hosted events focused on fostering trust in clinical research and provides patients, caregivers, and others opportunities to partner with researchers to improve the clinical research process.

Involving patients as partners: By sharing their experiences on what it’s like to live with a disease, thoughts on treatments, and what research topics are most important, patients can make a significant impact on all aspects of clinical research, from the design of the study to the dissemination or sharing of the results.  In ADAPTABLE, a diverse group of patient partners called the Adaptors are integral team members who are passionate about representing and reflecting the best interests, concerns, and welfare of potential, current, and future clinical research participants.

ADAPTABLE team members frequently participate in community health fair events to provide information about clinical research, the ADAPTABLE study, and heart-health awareness. These events provide opportunities to engage with people, to make personal connections, and build trust with community members.

Jacqueline at a local health event talking about ADAPTABLE and heart health.

As a woman of color and a heart disease patient, Adaptor Jacqueline Alikhaani, is passionate about using her personal health experiences to not only heighten awareness of patient-centered research, but to enhance diversity in clinical trials. “One of the biggest advantages we have with ADAPTABLE is the diversity of the Adaptors team. We have women, men, and people from different races, ethnic, and socioeconomic backgrounds. We are bringing a wealth of experiences to help shape the design and direction of the study,” says Jacqueline. You can learn more about Jacqueline and how she serves as an architect of change in spreading the word about the role of patients in research and increasing minority participation in clinical research.

 Providing access to research: When designing a clinical trial, researchers plan to have study sites spread across the country and located in racially diverse communities to increase participation from everyone. ADAPTABLE enrolls participants from large health systems that are part of PCORnet’s Clinical Data Research Networks.

Want to learn more?

 If you are looking for general information about clinical research or resources about diversity in clinical research, check out the following resources:

Center for Information & Study on Clinical Research Participation

Minorities in Clinical Trials Fact Sheet

Engagement in Research


ADAPTABLE Study Team Shares Patient Engagement Experiences in CardioSmart Pavilion at American College Cardiology Conference

Jacqueline Alikhaani, a rare disease heart patient and partner on the ADAPTABLE Study, is passionate about the value and impact of novel clinical research studies. Alikhaani is especially passionate about studies that leverage electronic health records and common data resources, and includes patient input at every critical step in the process. “One of the special things about the ADAPTABLE Study is that everything is laid out on the table for patients to see. We touch every part of the trial. I think we’re going to be a great model for other clinical trials,” said Alikhaani.

For the second consecutive year at the American College of Cardiology annual conference, patient partners, clinicians, and researchers discussed the patient-researcher partnership in the ADAPTABLE Study. ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and long-Term Effectiveness) is a pragmatic clinical trial that compares the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease.

The panel presentation supported by CardioSmart included Alikhaani as well as another patient partner Bill Larsen; researchers Eileen Handberg and Daniel Munoz; and project leader Holly Robertson. Principal investigator Schulyer Jones moderated the session.

Eileen Handberg, Dan Munoz, Bill Larsen, Jacqueline Alikhaani, Holly Robertson, and Schuyler Jones

Larsen was introduced to ADAPTABLE through his work as a citizen scientist at the University of Florida. Larsen is most interested in reviewing study materials through the lens of a potential study participant. “I try to beat the drum of educating the general population about the importance of participating in clinical research,” said Larsen of his role in ADAPTABLE. Larsen is also looking forward to the day when results will be available and he and his fellow patient partners can help create result summaries using language easily understandable by patients.

Jones reinforced the immense contributions of the patient partners from the beginning of the trial and at every step along the way. He then turned the microphone to Munoz who said, “A lot of assumptions that we come in with as researchers and clinicians have been challenged, corrected, and improved upon by our Adaptors, the ADAPTABLE patient partner team.”

Handberg, who works closely with Larsen at the University of Florida site, explained that ADAPTABLE patient partners are embedded in the clinical research process and hold the research team accountable. “Bill [Larsen] and I are on a weekly call and without fail, Bill will inquire about enrollment and what can we do differently to improve our numbers.” Handberg also described how a successful recruitment postcard (see image at right) came about. “It was a patient-inspired and created piece that has resulted in a positive trend in enrollment.”

ADAPTABLE is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is the first demonstration study of PCORnet, the National Patient-Centered Clinical Research Network. The study employs a wide range of digital and social media channels including a website, Twitter handle, and Facebook page to engage with study participants and the public at large. ADAPTABLE sends out a quarterly newsletter to study participants to introduce team members, provide study progress updates, and seek insights from participants on why they joined ADAPTABLE and the importance of patient-centered research.

“When I think of ADAPTABLE, I think of community,” said Robertson. “We are building a cardiovascular research community that not only includes the patient-partner voice but those of the study participants. Once the ADAPTABLE Study is complete, we’ll have a community of participants who we can engage with for future research projects to find out what’s important to them and what questions do they want answered by research. This community will be the legacy of ADAPTABLE.”

To learn more about the panel presentation, watch this video recap.

When Patients Partner with Researchers: Bill’s Perspective

In ADAPTABLE, patients are more than study participants, they are partners with researchers and clinicians to improve cardiovascular health for all patients and those who care for them. Adaptors are patient representatives who have been involved in ADAPTABLE from the beginning. The Adaptors team works alongside the study team, participating in team meetings and providing review and input to the protocol, consent form, study portal, and study materials.

We talked with one of the Adaptors, Bill Larsen, who provided his perspective on the value patients bring to clinical research, the importance of patient-centered research, and the ADAPTABLE experience.


How can patients inform researchers in clinical trials?

I find it useful to think of medical research as a team effort. There are roles best suited for researchers and those best filled by patient representatives.

On the research side, there are leadership, operations (day-to-day research activities), and clinician roles. In addition, there is oversight by the Institutional Research Board (IRB) that reviews all proposed research to ensure that patient privacy and security concerns are addressed. An even wider net would include roles filled by the research funding sources and the health plan providers.

On the patient side, there are participants who are directly involved in the research study, the larger community who suffers from the condition being researched, and someone like me, the patient representative, or as we are known in ADAPTABLE, the Adaptor, who provide the patient perspective. There are seven individuals who comprise the Adaptors team. Although, we each bring varied experiences, we share a common thread of having heart disease or caring for a loved one who does.

As an Adaptor, I fit somewhere in the middle of the research team. It’s my responsibility to understand the various perspectives of the researcher, the study participant, the heart patient, and the views of my fellow Adaptors.

I view my role to be that of a communicator, asking questions that are sensitive to the roles of each player and of interest to those represented in the research study, and providing relevant information and feedback to the concerned parties. Active dialogue among all concerned is what enriches the conversation and leverages the contributions of each individual to best achieve the research goals of the team.

Here are a few of the questions that I have raised in ADAPTABLE, and continually review, as the project proceeds:

  • Is the proposed research really important to those most affected by the disease being studied?
  • Does the recruitment approach present any obstacles to the study participants?
  • Are the written recruitment materials clear and appealing?
  • Do follow-up calls to initial inquiries cover the points I believe are most important?
  • Are expectations for patient participation realistic?
  • Are safety and security issues satisfactorily addressed?
  • How will the participant be kept informed during the research process?
  • In reporting the final results, are there at least some that will be written in lay language?
  • Will results be distributed for maximum coverage to the affected population?

Patient representative can help ensure that the answers to these, and other, questions fully reflect the interests, concerns, and welfare of the entire patient population.

Why is patient-centered research important?

Until recent years, the focus of medical research has been heavily weighted toward basic science. This is understandable and undeniably important. It is essential for the development of new medications and procedures designed to benefit the patient.

But before the findings of basic science can be implemented, they must be tested in a real-world setting. The branch of medical research devoted to this stage is called “translational.” In order to translate the findings of basic scientific discoveries into actual solutions, they need to be tested in a controlled environment, typically in a clinical setting where the doctor and patient interact. How to achieve this is more complex than meets the eye. The concerns of both the doctor and patient must be addressed by the translational research team before success can be achieved.

Until recently, the voices of the researcher and the clinician were paramount, with only peripheral attention given to the concerns of the patient. One of the most significant provisions of the Affordable Care Act was the creation of the Patient-Centered Outcomes Research Institute. As its name suggests, this organization places primary emphasis on the PATIENT. It gives the patient an equal voice along with the researcher and clinician in the conduct of translational research. The ADAPTABLE study is a paradigm example of how this process has been put into practice.

From the very outset of the ADAPTABLE study, we Adaptors have provided the patient perspective in all aspects. We represent all areas of the country and bring great diversity of gender, race, ethnicity, and age. We work side by side with the research team and the other parties at every stage and throughout the endeavor. We raise key questions and will continue to do so throughout the duration of the project.

What activity do you appreciate most from your work on the ADAPTABLE Study?

It is the complete immersion in the whole research process, the opportunity to view it from the inside out and feel empowered to have an impact on a study with results that may potentially benefit so many people. From this, I have gained a greater appreciation of the complex environment of medical research, and the underappreciated importance of the expanded role the patient must play for the benefit of all.

Before my involvement in ADAPTABLE, I regret to say that I was a somewhat passive follower of medical research. Like many people, I am dealing with multiple health issues. I have surveyed the literature pertaining to these issues and have been frustrated by the difficulty of understanding and assessing these findings in their technical jargon, and even more frustrated at the slow pace of the findings. Why can’t they speak my language and why can’t they produce useful results faster?

Since ADAPTABLE, I have come to realize that THEY is US, and WE (patients) are being given the power and the voice to make a difference; we can accelerate the process by being more receptive to participating in research. We can no longer remain passive. We must get more involved. You might ask, “How?” There are many ways. You can participate in a research study or, similar to the role of the Adaptor, provide your perspective in a study. Other ways to get involved include participating in focus groups to help advise researchers on issues pertaining to your health condition during the formative stages of a project, or simply raising awareness within your communities of the importance of patient involvement in the research process.

I can personally attest to the benefits I have gained through participation in ADAPTABLE. Primarily, I can say unreservedly that the entire research team, from interactions with study leadership to the operations staff, we patient representatives participate on a peer-to-peer basis. They not only welcome our input, they seek it out. Secondly, I value greatly the interactions with my fellow Adaptors. We have only met twice in person, but we talk by teleconference biweekly. Although our common denominator is heart disease, we have personal implications that affect our lives in different ways. I am the richer for knowing the many ways in which each of us copes. The bond we have developed will last beyond ADAPTABLE.

What activities or hobbies do you enjoy?

I play duplicate bridge (competently but not expertly), participate in a twice-a-month Great Books Discussion group, listen to music (mostly classical, with a preference for live performances), love great movies, travel (summer music festivals are a special treat), do a little birding (with my wife, the real birder—600+ species on her life list), and follow my hometown Chicago sports teams (Go Cubs Go—please do not make me wait another 108 years for a World Series crown; I might not be around).