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 questioned the choice of outcomes, including disease-specific survival and using mastectomy as a proxy for recurrence. The researchers explained that they focused on these patient-centered outcomes, along with local recurrence, based on discussions with patient and clinician stakeholders. The researchers used disease-specific survival to measure the impact of sentinel lymph node biopsy (SLNB) among patients with ductal carcinoma in situ (DCIS) to minimize selection bias because patients who had a SLNB procedure were likely to be healthier. The researchers also explained that they used mastectomy occurring nine months or more after DCIS diagnosis as a proxy for recurrence, which made it less likely that the mastectomy had been performed for clinical issues related to the initial diagnosis.
  • Reviewers asked why the researchers chose the age range of 67 to 94. The researchers responded that the age range was consistent with other analyses using the Surveillance, Epidemiology, and End Results (SEER) Medicare Database. Subjects were at least age 67, so data were available for two years in advance to assess comorbidity, since patients enroll in Medicare at age 65 typically. Patients were not older than 94 because of the short life expectancy and the small numbers of people in that age range.
  • Reviewers asked why the researchers used different cohorts for the study’s two aims. The researchers said the different cohorts reflected the SEER-Medicare data available to researchers at the time they conducted each portion of the study. For Aim 1, the most recent available data came from 2014. For Aim 2, they were able to use 2016 data.

Conflict of Interest Disclosures

Project Information

Shiyi Wang, MD, PhD
Yale University
$438,751
10.25302/06.2020.CER.150731630
Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

Key Dates

April 2016
June 2019
2016
2019

Study Registration Information

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Has Results
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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 26, 2022