Final Research Report

View this project's final research report.

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Journal Citations

Article Highlight: Surgically implanting a left ventricular assist device (LVAD) can prolong the lives of people with end-stage heart failure. But the surgery and device carry significant risk for harms, such as infections and stroke, according to researchers in an article in JAMA Internal Medicine. Using a shared decision making tool improved patients’ knowledge about the potential benefits and risks of an LVAD compared with typical educational pamphlets. The aid also helped them make initial decisions better aligned with their values.

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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. The comments and responses included the following:

  • Reviewers asked for more information about the type of educational materials provided to the usual care control group across sites, so that readers could more easily compare the control group to their own usual care practices. The researchers added details about this, including a table listing the educational materials used at each site.
  • Reviewers asked if the intervention materials were available so that other centers could use them. The researchers said the materials have been online and freely available for many years. They added information to the report about where to find the materials. The researchers also added a recommendation to the report that, based on the study’s results, other left ventricular assist device (LVAD) programs should consider using their educational intervention.
  • Reviewers asked for clarification about sample size and whether the actual number of people completing the study affected the ability to detect differences. The researchers said the study was adequately powered to detect meaningful differences in the primary outcome, since they enrolled substantially more patients and caregivers than required in the study plans. However, the study was not adequately powered for subanalyses. They also noted that missing data were more common among patients who did not receive an LVAD and their caregivers.  
  • Reviewers asked whether the effectiveness study results were consistent with the widely accepted RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework for dissemination research. The researchers clarified in the study overview section that the primary endpoints of the effectiveness study specifically targeted the effectiveness and implementation components of RE-AIM and explained how they evaluated these components.

Conflict of Interest Disclosures

Project Information

Larry A. Allen, MD, MHS
University of Colorado Denver
$2,097,085
10.25302/04.2020.CDR.131006998
A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for End-Stage Heart Failure: The DECIDE-LVAD Trial

Key Dates

July 2014
May 2019
2014
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: April 20, 2022