Final Research Report

This project's final research report is expected to be available by October 2022.

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 questioned the researchers’ approach to calculating their needed sample size, saying that sample size should be calculated based on the minimal effect of interest, or the minimal difference between groups that would be clinically important. The researchers clarified that there was no previous evidence of a reliable minimum clinical difference for the outcome measures that they could use to calculate the sample size.
  • Reviewers were particularly concerned that some study participants were not included in the analyses because they had not submitted any data from their activity monitors, questioning whether the researchers conducted their analyses based on the intention-to-treat principle or on how the participants were randomized.  The researchers pointed to a supplementary table where they had compared the demographic characteristics of the participants who provided some activity data to those who provided none. They also acknowledged that their analyses were completed with all available data, which is not intention-to-treat.
  • Reviewers noted that the authors’ description of their methods to account for missing data was written in future tense. The researchers explained that there was no agreed-upon method for controlling for missing data when data from an activity monitor were not even available at the baseline assessment. The researchers said they used future tense in this section because at the time of writing they had not yet performed all of the sensitivity analyses they planned to account for the missing activity data.

Conflict of Interest Disclosures

Project Information

Andrew A. Nierenberg, MD
Massachusetts General Hospital
$2,522,180
Healthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic Trial

Key Dates

March 2016
February 2022
2016
2021

Study Registration Information

Tags

Has Results
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
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: May 24, 2022