Final Research Report

View this project's final research report.

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 a clearer picture of the depth and scope of feedback obtained from focus groups. Researchers said they did not record quantitative data from the focus groups nor did they perform a formal qualitative analysis of the discussions. The researchers revised the report to include more detail on the feedback obtained, and they noted the lack of quantitative analysis of focus group data as a study limitation.
  • Reviewers expressed curiosity about the fact that five people in the intervention group had leg revascularization treatment, while none of those in the control group did. The researchers responded that they did not anticipate this difference and agreed that this might have had the potential to bias the study in favor of the intervention group. Since the findings showed no benefit from the intervention, the researchers concluded that the different rates of lower extremity revascularization did not affect the conclusions.
  • Reviewers asked why the researchers added an accelerometer as a study outcome for Aim 2. The researchers explained that this decision was the result of two on-site stakeholder meetings, where participants decided to add a second objective outcome measure, in addition to the six-minute walk test.
  • Reviewers suggested that changing from a single-center study to a multicenter study should be noted as a limitation. The researchers addressed the issue in the revised report but disagreed that this change was a limitation, since they said multicenter trials are generally considered more generalizable and more valid than single-center trials. The researchers added that they discussed the switch with stakeholders, who agreed that it was important to reach the target sample size and complete the trial in a reasonable amount of time. Also, training was uniform across research sites.

Conflict of Interest Disclosures

Project Information

Mary McDermott, MD
Northwestern University
$2,090,661
10.25302/06.2020.CER.130602719
Patient-Centered Home Exercise Program for Peripheral Artery Disease

Key Dates

July 2014
April 2019
2014
2019

Study Registration Information

Tags

Has Results
Award Type
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 4, 2022