ADAPTABLE

September 13, 2019: ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement (Kevin Haynes, PharmD, MSCE)

Posted on by Gina Uhlenbrauck

Speaker

Kevin Haynes, PharmD, MSCE
Principal Scientist
HealthCore, Inc.

Topic

ADAPTABLE Recruitment and Follow-up: Health Plan Research Network Engagement

Keywords

Real-world evidence; Real-world data; Study design; Claims data; ADAPTABLE; Patient recruitment; Pragmatic clinical trial; Electronic health record; Informed consent; Learning health system

Key Points

  • We need integrated EHR data and claims data in order to close evidence gaps in observational pharmacoepidemiology studies and comparative effectiveness trials.
  • The health plan claims data environment can be leveraged to support real-world evidence studies.
  • An integrated health plan network database can be a resource for data about eligibility, lab test results, and pharmacy claims. In a pragmatic clinical trial, using health plan data can provide a longitudinal electronic approach to endpoint ascertainment.

Discussion Themes

Have you had a chance to do any cost analysis of this high-volume, low-touch method of recruitment?

In the ADAPTABLE enrollment portal, it seems the biggest chunk of time (reading about the study) came before the screening questions. Do you think swapping the order might have improved enrollment?

Read more about the ADAPTABLE pragmatic trial.

Tags

#pctGR, @Collaboratory1, @HealthCoreRWE

August 28, 2018: ADAPTABLE Patient-Reported Health Data Codes Now Available

Posted on by Karen Staman

The ADAPTABLE pragmatic trial relies on patients to report key information at baseline and throughout follow-up. To capture these data, ADAPTABLE investigators developed a LOINC (Logical Observation Identifiers Names and Codes) patient-reported item set, which is now publicly available.

The development of the item set is part of the ADAPTABLE Supplement, an initiative funded by the Office of the Assistant Secretary for Planning and Evaluation to develop best practices for capturing patient-reported outcome data and optimal analytic approaches for using the data in a pragmatic clinical trial. Additional reference material can be found in the ADAPTABLE Supplement Roundtable Meeting summary, in a report describing the results of a literature review of data standards and metadata standards for variables of interest, and on GitHub. The project is expected to inform future efforts to integrate patient-reported data in the electronic health record and provide opportunities to streamline data for use in pragmatic trials. Information from the project is being added to the Living Textbook as it accumulates; learn more in the chapters on Using Electronic Health Record Data and Choosing and Specifying End Points and Outcomes.

ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) aims to identify the optimal dose of aspirin therapy for secondary prevention in atherosclerotic cardiovascular disease and is the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network (PCORnet).

February 28, 2018: New Meeting Summary Examines How to Integrate Patient‐Reported Health Data for Pragmatic Research

Posted on by Karen Staman

A recently released summary from the ADAPTABLE Roundtable Meeting explores ways to better understand the sets of circumstances and considerations that could guide when and how to gather and integrate patient-reported health data with other data sources in pragmatic trials.

For outcomes that represent subjective experiences, such as pain, symptoms, and physical functioning, the patient is the unique and privileged source of information. Other patient-reported health data may not have a clear source of truth, such as co-morbidities and hospitalizations. In such cases, patient-reported health data may supplement, contradict, or agree with EHR and claims data. For example, medication data reported by patients might be a more accurate reflection of what patients are actually taking than medication data in the EHR, especially for over-the-counter medications.

Patient-reported health data come from various sources and can be feasibly collected in the conduct of a pragmatic clinical trial, but the optimal approaches for capturing and analyzing these data are unclear. Questions include how to integrate this information with other data collected as part of a study, including data from the EHR.

To better understand patient-reported health data and how to use them in pragmatic trials, 18 experts from 8 institutions convened at the roundtable meeting, coming from a wide variety of backgrounds including biostatistics, epidemiology, oncology, nursing, psychiatry, health policy, and regulation. Representatives from the NIH Collaboratory included Drs. Lesley Curtis and Rachel Richesson from the EHR Core and Dr. Kevin Weinfurt from the Patient-Reported Outcomes Core.

In addition to the meeting summary, two white papers are forthcoming. For more information about using patient-reported data in pragmatic trials, see the Living Textbook Chapter on Endpoints and Outcomes.

This effort was funded by Office of the Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services through a supplement provided to the NIH Collaboratory Coordinating Center.

PCORnet Posts Aspirin Study Protocol for Public Review and Comment

Posted on by Gina Uhlenbrauck

PCORnetThe National Patient-Centered Clinical Research Network (PCORnet) has recently made a draft protocol for its first randomized clinical trial available for stakeholder review. Researchers, clinicians, patients and the public are all invited to read the current draft of the study protocol and provide comments and feedback.

The ADAPTABLE Study (PDF), which will investigate whether lower- or higher-dose aspirin is better for preventing heart attack and stroke in patients at risk for heart disease, is PCORnet’s first randomized pragmatic clinical trial. Designed to leverage PCORnet’s Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs), the trial will serve as twofold purpose: answering a clinical question of direct importance for patients, families, and healthcare providers, and serving as a demonstration of PCORnet’s capabilities in conducting clinical research on a national scale.

Links to the proposed study protocol, a survey tool for capturing feedback, and other information about ADAPTABLE Study, including press releases, fact sheets, and infographics, are available at the link below:

ADAPTABLE: The Aspirin Study

Follow PCORnet on Twitter @PCORnetwork for updates on the ADAPTABLE #ClinicalTrial

PCORI Announces First PCORnet NIH Collaboratory Trial: The ADAPTABLE Aspirin Study

Posted on by Gina Uhlenbrauck

The Patient-Centered Outcomes Research Institute (PCORI) has approved the first pragmatic clinical trial to be performed through the National Patient-Centered Clinical Research Network (PCORnet)—the ADAPTABLE study (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness).

Over the course of the trial, 20,000 study participants with cardiovascular disease will be randomly assigned to receive one of two commonly used doses of aspirin—a low dose of 81 mg per day versus a higher dose of 325 mg per day—in order to determine which provides the optimal balance between protecting patients with cardiovascular disease from heart attack and stroke, and minimizing bleeding events associated with aspirin therapy. The trial will also employ a number of innovative methods, including electronic health record (EHR)-based data collection and a patient-centered, web-based enrollment model in partnership with the Health eHeart Alliance Patient-Powered Research Network (PPRN).

The ADAPTABLE trial, which includes six of PCORnet’s Clinical Data Research Networks (CDRNs), will be led and coordinated through the Duke Clinical Research Institute (DCRI).

Read more about the ADAPTABLE Aspirin Trial here:
Fact Sheet (PDF)
Infographic (PDF)
DCRI Coordinating Center Announcement