Category Archives: News

Conozca un adaptador: Greg Merritt

Lee este artículo en inglés.

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

Lee este artículo en español.

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!

Cada participante cuenta desde la inscripción hasta completar el estudio

Lee este artículo en inglés.

En estudios de investigación como ADAPTABLE, los investigadores inicialmente se concentran en inscribir pacientes en el estudio. Todo estudio clínico tiene un número de inscripción “objetivo”, que es el número de participantes que los investigadores esperan inscribir en el estudio. Para ADAPTABLE ese número es 15,000 participantes. Alcanzar este número es importante para que los investigadores puedan tener la seguridad de que el estudio representa a la población que más se beneficiará de conocer la dosis preferida de aspirina.

Igualmente importante que la inscripción en un estudio de investigación es la retención. La retención es el número de pacientes que permanece en el estudio hasta que se completa. Los participantes bien intencionados ocasionalmente se retiran antes por una serie de motivos y, por supuesto, tienen este derecho. Un principio rector de la investigación clínica es que los participantes del estudio pueden discontinuar la participación en cualquier momento por cualquier motivo.

¿Por qué es importante la retención?

La retención es importante por varios motivos claves.

En primer lugar, los investigadores tienen una obligación ética de realizar un seguimiento de la salud de cada participante del estudio hasta el final del estudio, incluso si el participante ha dejado de tomar el fármaco del estudio. Para cumplir con esta obligación, es esencial que los investigadores puedan comunicarse con los participantes del estudio y recopilar información sobre su salud y la ocurrencia de eventos, como hospitalizaciones, infarto de miocardio o accidentes cerebrovasculares.

En segundo lugar, una elevada tasa de deserción de los participantes significa que los investigadores podrían no tener datos suficientes para evaluar si el tratamiento funciona o no para todas las personas. La Administración de Medicamentos y Alimentos (Food and Drug Administration, FDA) es el organismo de Estados Unidos que aprueba nuevos fármacos o tratamientos. La FDA considera como información del participante incompleta a los datos faltantes, y esto puede comprometer los hallazgos del estudio.

Finalmente, existe un principio fundamental que motiva a los investigadores a retener participantes en un estudio. Tanto los investigadores como los pacientes desean aprender lo más posible sobre un estudio. Para lograr esto, los investigadores desean comprender el viaje de todos y cada uno de los pacientes a través del estudio. Cada uno de esos viajes individuales nos enseña algo. La historia y experiencia de cada paciente necesita salir a la luz y ser parte de los resultados finales de un estudio.

Daniel Munoz ,MD, MPA

El investigador principal de ADAPTABLE Daniel Munoz de Vanderbilt Medical Center dice,

El estudio ADAPTABLE solo es posible porque cada participante ha elegido unirse, para contribuir a la ciencia y ser parte de algo más grande que ellos mismos. Todos nosotros estamos en esto para ayudar a los pacientes acercándonos a la verdad de si puede existir la mejor dosis de aspirina. Solo podemos llegar allí comprendiendo y siguiendo la experiencia de todos y cada uno de los participantes en el estudio. Todo el equipo de ADAPTABLE agradece a los miles de participantes cuyo compromiso hasta el final del estudio ayudará en última instancia a los pacientes alrededor del mundo.”

Retención en ADAPTABLE

El objetivo de la retención es asegurar que la mayor cantidad posible de participantes elije permanecer en el estudio hasta que finaliza. En ADAPTABLE, una participación completa significa continuar tomando la dosis asignada de aspirina y completar una encuesta cada 3 a 6 meses. Para superar algunas barreras que los participantes en ADAPTABLE enfrentan, estos pueden cambiar su dosis de aspirina de ser necesario por motivos de salud, modificar su nivel de participación y cambiar cómo completan las encuestas del estudio.

El gráfico informativo a continuación presenta ideas sobre cómo los investigadores y los participantes del estudio pueden trabajar para ayudar a mejorar la retención en ADAPTABLE.

Recuerde, si tiene preguntas o inquietudes sobre su participación en ADAPTABLE, o cualquier otro estudio de investigación, puede comunicarse con el equipo del estudio para analizar las opciones disponibles que podrían hacer que la participación sea más confortable para usted.

Los miembros del equipo de investigación de ADAPTABLE comprenden que las circunstancias o la motivación para participar de una persona pueden cambiar y afectar la decisión de permanecer en el estudio. Los miembros del equipo siempre honrarán la elección del participante de cambiar la participación o abandonar el estudio.

Every Participant Counts from Enrollment to Study Completion

Lee este artículo en español.

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

 

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