Final Research Report

View this project's final research report.

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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 confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not 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 how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, the PI made changes including

  • Clarifying the role that patients and other stakeholders played in the development of study aims and other processes before and during study implementation
  • Providing more details in the Methods to address reviewer concerns that the report lacked several reporting elements required by the CONSORT statement. This included describing modifications to the study eligibility criteria and sample size
  • Clarifying and describing their assumptions regarding missing data, and describing sensitivity analyses performed to determine whether results differed when including data from families who did not complete the study, or who did not use the Family Navigator intervention. The result was no change in the outcomes of the study, indicating that the intervention did not have a significant effect on most primary and secondary outcomes even when limiting the analysis to families who completed treatment
  • Revising the Results and Discussion sections of the report and the abstract to clearly state the primary and secondary outcomes, and acknowledge null findings. These were separated from the more positive post-hoc analyses

Conflict of Interest Disclosures

Project Information

Gloria Reeves, MD
University of Maryland Baltimore
$1,455,602
10.25302/3.2019.CER.997
The Family VOICE Study: A Randomized Trial of Family Navigator Services Versus Usual Care for Young Children Treated with Antipsychotic Medication

Key Dates

December 2012
May 2018
2012
2018

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
Funding Opportunity Type
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
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022