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ADAPTABLE Team Finishes Enrollment, Reflects on Lessons Learned

ADAPTABLE, the first large, pragmatic clinical trial to be coordinated at the Duke Clinical Research Institute, DCRI, recently celebrated a milestone as the trial reached its goal of enrolling 15,000 patients.

Many individuals living with heart disease are instructed to take aspirin to prevent heart attacks and strokes. However, aspirin can cause bleeding in some individuals, and there is no data available that can help physicians decide on the optimal dose to prescribe. ADAPTABLE will compare two different doses—a high dose of 325 mg and a low dose of 81 mg—to determine which is more safe and effective.

 

 

 

 

 

 

 

 

 

 

 

 

Using Real World Data from EHRs

ADAPTABLE, which is funded by the Patient-Centered Outcomes Research Institute (PCORI), is a pragmatic clinical trial, meaning that research is integrated in patient care and leverages technology to alleviate burden on patients and site staff. ADAPTABLE is a demonstration project of PCORnet, the National Patient-Centered Clinical Research network. Forty healthcare systems and three health plans are participating in ADAPTABLE.

ADAPTABLE draws data from electronic health records (EHRs), patient-reported outcomes, and insurance claims data to capture primary endpoints.

“ADAPTABLE is a ground-breaking clinical trial for several reasons, including primarily remote recruitment of patients outside of traditional research clinic settings, direct-to-patient follow-up, and surveillance of EHRs to identify patients for potential enrollment and to ascertain potential endpoints during follow-up,” said Matthew T. Roe, MD, MHS, co-principal investigator for ADAPTABLE. “Via a web-based platform, we conduct outreach to potentially eligible patients to ask them if they’re willing to provide informed consent via an electronic, web-based consent module, which then allows patients to self-randomize into the study. These approaches have never been used before for a large-scale clinical trial the size of ADAPTABLE.”

Viewing Patients as Partners

ADAPTABLE provides a new model of engaging with patients. Patient partners also known Adaptors represent the patient voice at every stage of the study by providing input on study recruitment, contributing to participant newsletters, participating in working groups, and presenting on ADAPTABLE at scientific meetings.

Incorporating a group like the Adaptors is reflective of DCRI’s mission to engage all stakeholders with the goal of improving the study participant experience in clinical research. Get to know and learn more about the Adaptors.

“Patients themselves may be the most important and yet underutilized voice in research,” said Adaptor Greg Merritt, of Ann Arbor, Michigan. “The ADAPTABLE Study is a wonderful example of how patients can assist researchers in prioritizing and studying what matters most to a patient who lives with an illness or disease every day. Their insight and perspective can help to uncover new ways to look at old problems.”

Learning Logistics through a Pragmatic Approach

The ADAPTABLE team—researchers, clinicians, and patients alike—has learned many lessons through the enrollment period of the first large pragmatic clinical trial conducted at the DCRI.

First and foremost, the researchers learned that collaboration between diverse organizations is critical in reaching a goal as large as 15,000 participants.

“Using novel tools and techniques, we are transforming how patients are identified and recruited for clinical trials,” Holly Robertson, PhD, project leader for ADAPTABLE, said. “We also developed strategies for clinician and patient engagement which are important in supporting recruitment and retention for virtual trials.”

The study team also shared that when recruiting patients, it is beneficial to contact potential participants through multiple modes of communication: online, by phone, through the mail, and in person.

“The ADAPTABLE study has encouraged increased collaboration and inspired us to work together to solve new interesting research challenges using a pragmatic approach,” said Schuyler Jones, MD, co-investigator for ADAPTABLE.

Click here for the complete article on DCRI.

Cuando los pacientes se asocian con investigadores: Perspectiva de Kevin

Leer este artículo en inglés.

El socio de un paciente de ADAPTABLE, Kevin Edgley, comparte la forma en que comenzó a participar en ADAPTABLE y por qué este estudio y esta investigación centrada en el paciente es importante.

Como ingeniero, siempre me gustó trabajar con los clientes, y ya desde el principio fue evidente que las personas a las que les vendemos los equipos y que los usan todos los días, de alguna manera, saben más que los ingenieros que los diseñan. Siempre es bueno hablar con los clientes porque pueden ser sinceros acerca de lo que les gusta y no les gusta; esto ha sido muy útil para mí en mi profesión. Esta experiencia como adaptador es similar en este aspecto, es diferente y valioso.

¿Cómo comenzó a participar en una investigación centrada en el paciente?

Estaba sentado en mi hogar una noche y mi cardiólogo me llamó. Me dio un poco de miedo… Mencionó el estudio y me preguntó si me gustaría participar, y yo dije que sí. La mitad de mi vida estuve involucrado en la investigación y el desarrollo (desde la perspectiva de ingeniería mecánica) y, aunque esto es muy diferente, los principios son similares. Mis intereses y antecedentes se relacionan con este tipo de trabajo.

¿Por qué cree que el estudio ADAPTABLE es importante?

No tengo muchas experiencias para comparar esto en términos de investigación médica. Por lo que conozco, tener en cuenta la opinión del paciente en un estudio, en lugar de simplemente hablar con profesionales académicos y hacer suposiciones, es importante. ¡Esta es una oportunidad única e importante!

¿Qué es lo que más le gusta de participar en el estudio ADAPTABLE?

Disfruté hacer algo distinto y que no esté relacionado con mi profesión; también me gustó pensar acerca en la investigación de manera diferente. ADAPTABLE ha sido un gran cambio de ritmo para mí. Disfruto interactuar con los otros adaptadores y escuchar sus diferentes puntos de vista, que normalmente no consideraría por mi cuenta. Como ingeniero, siempre me gustó trabajar con los clientes, y ya desde el principio fue evidente que las personas a las que les vendemos los equipos y que los usan todos los días, de alguna manera, saben más que los ingenieros que los diseñan. Siempre es bueno hablar con los clientes porque pueden ser sinceros acerca de lo que les gusta y no les gusta; esto ha sido muy útil para mí en mi profesión. Esta experiencia como adaptador es similar en este aspecto, es diferente y valioso.

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

Creo que un enfoque centrado en el paciente es importante y la comunicación con el público es uno de los aspectos más difíciles. Cuando les menciono este proyecto a distintas personas, se sorprenden. Para el público, la cuestión acerca de la dosis de aspirina es un caso cerrado. Ya está arraigado que la dosis de 81 mg es la dosis correcta. Las personas no siempre están dispuestas a pensar que puede haber otra respuesta.

 

Es ridícula la forma en que los estudios se presentan en los principales medios de comunicación. Se dice que el café es bueno un año y, el próximo año, se dice que es dañino. No estoy seguro de que el público general (del que formo parte) tome estos hallazgos con seriedad y, en ocasiones, los resultados del estudio se minimizan debido a que se recibe mucha información contradictoria.

 

El público no lee revistas médicas ni los resultados de los estudios en profundidad, necesitamos pensar en maneras de compartir información sobre investigaciones que no sean contradictorias e incorporar la perspectiva del paciente.

Lecciones fundamentales aprendidas por parte de los socios de los pacientes de ADAPTABLE

Leer este artículo en inglés.

Los socios de los pacientes de ADAPTABLE, también conocidos como adaptadores, proporcionan información al equipo del estudio en cada paso crítico en el proceso de investigación. A los adaptadores les interesa mucho la investigación centrada en el paciente y recurren a experiencias de su trabajo y vida personal para mejorar la experiencia de los participantes de estudios de investigación actuales y futuros. En este asunto, les pedimos a los adaptadores que compartan las lecciones fundamentales aprendidas en ADAPTABLE.

  1. El respeto mutuo entre los directores e investigadores del paciente ha ayudado a construir una comunidad comprometida y solidaria que mejora la experiencia de investigación para todas las personas involucradas.
  2. Nuestra participación como asesores de los pacientes en investigación es importante porque puede ayudar a nuestros familiares y amigos en el futuro.
  3. Reclutar pacientes para estudios como ADAPTABLE es más difícil de lo que pensamos. Este es el motivo por el cual el compromiso personal de los participantes del estudio es tan importante.
  4. Nos gusta que los participantes compartan sus motivos personales para inscribirse en ADAPTABLE y disfrutamos leer sus historias.
  5. Los pacientes brindan aportes valiosos sobre los procedimientos del estudio y sobre cómo abordar desafíos. ¡ADAPTABLE es verdaderamente un auténtico estudio centrado en el paciente!
  6. Hemos aprendido que los investigadores pueden ser divertidos y que son personas comunes.
  7. La participación del paciente al comienzo de un estudio pueda ayudar a que el estudio sea mejor y más amigable.
  8. El diseño de las comunicaciones del estudio por parte de los pacientes ha ayudado a comprometer a nuestra comunidad del estudio.
  9. Participar en Adaptable ha hecho que nos sintamos más empoderados y proactivos en cuanto a nuestra propia atención médica. Esperamos que esto también les haya pasado a los participantes del estudio.
  10. Los pacientes y los investigadores necesitan estar conectados. Los asesores de los pacientes pueden ayudar a los investigadores a mantener a los pacientes en el centro de la investigación y, así, mejorar las preguntas de la investigación. Las respuestas a estas preguntas pueden ayudar a mejorar su calidad de vida.
  11. Un buen facilitador o enlace es crucial para ayudar a guiar y orientar la comunicación entre los investigadores y asesores del paciente. Se debe tener en cuenta el rol de un facilitador en los presupuestos de los estudios de investigación.

When Patients Partner with Researchers: Kevin’s Perspective

Leer este artículo en español.

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

Leer este artículo en español.

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

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.