Final Research Report

View this project's final research report.

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Audio Interview

JAMA Neurology Author Interviews
In an interview as part of the journal's "Author Interviews" series, Adrian F. Hernandez, MD, MHS, discusses what prompted him to launch the study, and what’s new and additive about this study. He notes that it’s one of the largest studies with its focus, and that it enrolled many older patients who have not traditionally been enrolled in studies with this focus.

Journal Citations

Article Highlight: This study compared outcomes of older adults who have atrial fibrillation and have had a stroke. In a new paper published in JAMA Neurology, the research team reports that patients who were prescribed direct oral anticoagulants when discharged from the hospital following a stroke had relatively better outcomes—including more days at home and fewer adverse events—than patients prescribed the blood thinner warfarin. This reinforces findings from prior research on the subject.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers noted that aim 3 of the study, involving the development and testing of a novel decision aid for stroke survivors, originally was not reported in the draft report. The researchers added information about the decision aid they created in the methods, results, and discussion sections of the report.
  • The reviewers were unclear on how the retrospective and prospective study cohorts aligned with the aims, and how the two populations differed in characteristics and in what outcomes the researchers measured. The researchers explained that they designed the prospective cohort to evaluate the patient-reported outcomes that are typically not available in registry data. They noted that depression and antidepressant use are likely to affect these outcomes, so these factors were specifically examined in the prospective group. Similarly, they investigated statin and oral anticoagulant use in the retrospective cohort because subsets of the stroke survivor population used those medications.. Therefore, they needed the larger sample size that the registry-based population provided in order to detect a meaningful effect.
  • The reviewers wondered how clinically meaningful some of the observed associations were, since the study’s large sample size allowed for differences of relatively small magnitude to be statistically significant. The researchers agreed this was a good point and explained that they used methods to help minimize false positives and overly strong conclusions based on multiple comparisons. They added that they felt that differences they described, like a 9-13 percent reduction in major adverse cardiovascular events, were clinically meaningful. 
  • The reviewers asked for more information on the background of patient coinvestigators and how the researchers  selected them. The researchers said they used American Heart Association resources to identify stroke survivors within their network of volunteers. All patient coinvestigators turned out to be women who had strokes between their 20s and their 50s. Despite the homogeneity in this group, these patient coinvestigators, as active members of stroke support groups, tried to speak from the perspective of a wide range of stroke survivors rather than only from personal experience.
  • The reviewers requested more detail on the study’s use of focus groups, their demographic makeup, and the methods used to survey them. The researchers said that the focus groups were a small part of the project and did not contribute to the project’s aims, so the researchers did not formally record the information the reviewers requested. The researchers explained that their goals for the focus groups were to confirm that the project’s aims were meaningful to a wide range of stroke patients and to inform subgroup analyses.

Conflict of Interest Disclosures

Project Information

Adrian F. Hernandez, MD, MHS
Duke University
$2,106,499
10.25302/09.2020.CE.13047073
Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER)

Key Dates

September 2013
March 2020
2013
2019

Study Registration Information

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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 15, 2022