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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

 

Taking a Real-Time Approach to Identifying and Enrolling Patients in the ADAPTABLE Study

The Duke Heart Center, the second highest enrolling site in the ADAPTABLE study, recently celebrated a milestone with more than 1,000 patients enrolled. In this article, the team shares how they leverage their electronic health record (EHR) system to streamline the screening process for this pragmatic study designed to answer what is the best daily dose of aspirin for patients with heart disease.

The ADAPTABLE Duke Heart Center Team

They start by designing a report based on ADAPTABLE’s eligibility criteria. From this customized report, study coordinators receive a list of patients who have been automatically screened for the upcoming clinic day. Designed to minimize coordinator effort in identifying eligible patients, study coordinators use the list to confirm eligibility, remove any patients who have previously declined, and take note of the patient’s clinic appointment time so that a “Golden Ticket” can be delivered to clinicians to pass on to their eligible patients. A golden ticket is in invitation to eligible study participants to further explore and enroll in ADAPTABLE.

How is this daily list created? The customized report is run against EHR data available at ADAPTABLE Column in a EHR Multi-Provider Schedulethat moment (real time) to identify potential patients – as opposed to the previous process of querying the PCORnet Common Data Model (CDM), which is a much more static process of organizing EHR data. Once the EHR identifies the patients and associates them to the ADAPTABLE protocol, a rule is implemented and a new field named “ADAPTABLE” (see image to the right) is populated in the multi-provider schedule column that providers see. This column is effectively a flag so providers can readily recognize when a patient is eligible for ADAPTABLE. This is especially helpful since many providers use this screen as their clinic ‘home’ screen.

Leveraging the EHR in this way has provided research staff with a near real-time view of eligible patients in their clinic and has allowed for better communication with providers and support staff. Patients identified as potential participants by coordinators can be evaluated for appropriateness by providers before the clinic visit begins, and nurses can remind providers which patients to approach during the day. Using this process has been a successful strategy to identify a larger pool of potential participants as well as providing a more consistent approach to recruitment.

The ADAPTABLE Duke Heart Center team started implementing this process in October 2017. Since then the team has seen an increase in eligible patients on the daily clinic lists compared to the former CDM system. Between November 2017 and March 2018, 65% of patients enrolled were a result of this process. This number reflects both enrollments in clinic and patients self-enrolling from home.

Effectively using EHRs as a recruitment strategy requires transparency and communication with clinicians. Before implementing a new EHR study identification and recruitment process, the team recommends that clinicians are informed about the study and process. Although pragmatic studies are intended to reduce clinician and coordinator effort, the role of clinicians and research staff in ADAPTABLE remains critical. Patients want to hear about study opportunities from their doctors and doctors welcome the opportunity to discuss participation in research with their patients.

Finding ways to make research more practical is what ADAPTABLE and pragmatic clinical research is all about. Using EHRs in ADAPTABLE integrates conversations about participation into the clinical work flow, helping both clinicians and patients become more aware of the research question, and better understand if participation is the right choice.

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.

Celebrating Your Heart and February

The ADAPTABLE Team is excited for February, a month-long celebration of heart-health awareness. This a great time to think about what is known about heart disease, how heart-healthy choices can make a difference, and the potential impact of the results from the ADAPTABLE Study for patients and their doctors.

Heart Disease

Heart disease is the leading cause of death for American women and men, responsible for one in four deaths in the U.S. According to the Centers for Disease Control and Prevention, someone in the U.S. has a heart attack every 40 seconds, and every year 790,000 Americans have a heart attack. For 210,000 people this is their second heart attack. Unfortunately, once you have had a heart attack, your chance of having another one increases.

The good news is that there are actions you can take to protect your heart. Making heart-healthy food choices, taking prescribed medications, starting or following a regular exercise routine, having regular check-ups, and working with your physician to achieve your heart health goals are all important steps to help prevent another heart attack. Check out the resources listed at the end of this artcle to learn more.

Joining Forces in the ADAPTABLE Study

Daily aspirin is one of the medications doctors often prescribe to patients who have heart disease. Doctors know that the anti-blood-clotting action of aspirin can help prevent the occurrence of a second heart attack. However, the best dose (81 mg or 325 mg) of aspirin is uncertain and is not specified by clinical practice guidelines. To help answer this aspirin-dose question, patients, clinicians, and researchers have joined forces in ADAPTABLE.

ADAPTABLE will enroll and follow approximately 15,000 participants with heart disease who are randomly assigned to take either 81 mg or 325 mg aspirin daily. In addition to determining the best aspirin dose, the study will evaluate the overall benefits and side effects of the different aspirin doses by gender, age, ethnicity, race, and the presence of additional medical conditions, such as diabetes.

Impact of ADAPTABLE Study Results

The ADAPTABLE Team is committed to providing study participants, individuals living with heart disease, clinicians, and the public with study updates and results. These results will help patients with heart disease and their doctors answer questions about aspirin therapy such as:

  • How much aspirin should I take each day to reduce my risk for a heart attack or stroke?
  • Do the benefits of taking aspirin every day differ based on the dose?
  • Do the risks, such as bleeding, differ based on the dose?
  • Based on my health, age, and presence of other medical conditions, what is the best dose to protect my health?

We hope that your February is filled with heart-healthy choices and activities. Follow ADAPTABLE on Twitter @ADAPTABLEstudy and on Facebook where we will share heart-healthy recipes and tips for healthy living.

Heart-Healthy Resources

American College of Cardiology CardioSmart

American Heart Association (AHA)

AHA Go Red for Women

AHA Support Network

Centers for Disease Control and Prevention

The Heart Foundation

 

 

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).

ADAPTABLE’s Patient-Researcher Partnership Serves as a Model of Engagement

The ADAPTABLE Study is featured as a model of patient engagement in Applied Clinical Trials.

As patients take more active roles in decision-making about health, healthcare, clinical trials, and regulatory activities, their influence has changed how sponsors and researchers view patient involvement in clinical research.Once regarded as “subjects” who had research performed on them, patients are now contributing across the spectrum of clinical development. Patients are asked to weigh in on the design and planning of research protocols, selection of outcomes and endpoints, development of recruitment and retention strategies, and dissemination of research results.

ADAPTABLE integrates patient partners (the Adaptors) into the study team to provide patient voices and perspectives in all aspects of the trial. By participating in ongoing study meetings, Adaptors hear firsthand about recruitment challenges and barriers to enrolling up to 15,000 patients in the ADAPTABLE study. Working with their local network researchers, Adaptors play a key role in tailoring the recruitment messages. Adaptors help develop and review recruitment materials, anticipating questions and identifying potential points of confusion. They offer input on study materials that facilitates understanding and enhances appeal to a broad audience, such as incorporating graphics and white space, reducing jargon and legalese, and using language that emphasizes the importance of clinical trials, the role of patients in the process, and the value of the patient voice in transforming healthcare. Adaptors have also contributed as authors in peer-reviewed literature.

Read the complete article to explore more models of patient engagement in research.

Heart Patients Help Doctors Determine Best Aspirin Dose

Doctors have known for decades that taking aspirin can reduce the risk for future heart attacks and strokes in people with cardiovascular disease. What is less clear is which dose is best. Participants in a new kind of clinical trial are helping them find out.

Which Aspirin Dose Is Best?

Some doctors prescribe a “baby aspirin” (81mg) once a day, while others recommend a full-strength (325mg) aspirin tablet. The difference is important because taking aspirin daily can potentially increase your risk of bleeding. Until now, there hasn’t been enough good-quality data to guide doctors’ decisions.

That’s where the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) study comes in. Duke Clinical Research Institute is coordinating the study, one of the first to make patients key partners in an effort to gather vast amounts of data quickly and efficiently. People with heart disease and who are at high risk of having a heart attack or stroke are randomly assigned to take an 81mg or 325mg aspirin daily and are followed for up to 30 months. Eventually, as many as 15,000 people around the U.S. will participate.

Patients Appreciate Opportunity to Advance Medical Knowledge

Retiree John Turk started having shortness of breath and chest tightness while juggling the stresses of selling his Cleveland, OH, home and buying a new one in Raleigh to be near his daughter. He hadn’t had symptoms before.

“My general practitioner immediately referred me to Duke to get checked out,” Turk said. “Within a few weeks, I had bypass surgery.” Duke interventional cardiologist Schuyler Jones, MD, worked with Turk during his post-surgical recovery period and encouraged him to get involved in the ADAPTABLE study.

“If this helps, I’m glad to be part of it,” Turk said. “Makes me feel good to help with the research.”

For full story from Duke Health Blog: https://www.dukehealth.org/blog/heart-patients-help-doctors-determine-best-aspirin-dose-new-clinical-trial

2017: Year in Review

The ADAPTABLE Study team reflects on the many accomplishments and milestones throughout 2017 — a year of record enrollment, new network collaborations, and actively engaging with and sharing the voice of study participants. We wish you the best in 2018 and look forward to continuing to build a community where participants, researchers, and clinicians partner together to improve cardiovascular health.