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. Those comments and responses included the following:

  • The reviewers expressed concern that the goals of care GOC discussion appeared to be framed as a single event. The researchers responded that they were certainly aware that GOC discussions are not and should not be a single event. However, because the intervention had to be somewhat scripted and reliably implemented, they identified a suggested time for beginning these discussions. In interviews with oncologists, the researchers identified the visit to review imaging results after the first round of chemotherapy as an opportune time for a GOC discussion. While the researchers aimed to provide skills for improving ongoing conversations, the study needed a specific and measurable delivery method.
  • The reviewers wondered if the study lacked power especially given that fewer patients participated than planned. The researchers had proposed to follow 280 patients, but only followed 265. The researchers explained that this change reduced the study’s power only slightly, still providing more than 80 percent power to detect a difference in the prevalence and quality of GOC discussions.
  • The reviewers expressed concern that the primary outcome measure was a composite measure without previous psychometric testing. Thus, the validity and reliability of the measure could not be confirmed, and the items that went into the composite could be considered very different constructs: prevalence and quality. The researchers explained that most of questions making up the composite measure were taken from other validated instruments based on the questions’ coverage of specific focus areas (i.e., patient values, treatment preferences, and global assessment of communication quality). But in response to reviewer comments, the researchers said they refocused the primary outcome on value, which was the intended target of the intervention. The researchers dropped the components about treatment preferences and prognosis. Results of the revised analyses still showed no significant difference between the intervention and usual care groups.

Conflict of Interest Disclosures

Project Information

Nina Bickell, MD, MPH
Mount Sinai School of Medicine
$2,304,146
10.25302/05.2020.IHS.131006444
Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions

Key Dates

July 2014
August 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
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