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 noted that although the goals of the study all involved comparisons of guideline-concordant care (GCC) versus active surveillance (AS) for ductal carcinoma in situ (DCIS), some patients were included in the AS group who had other types of high-risk lesions. Reviewers expressed concern that these patients were not comparable to those with DCIS because clinicians and patients tend to consider DCIS to be cancer, but that is not true for the other types of lesions included, and patient-reported outcomes would likely be different. The researchers acknowledged this, saying that very few women choose an AS approach for DCIS so they added women with other high-risk lesions as proxies since these patients would receive similar treatment under AS conditions. They also stated that if AS was accepted as a standard option for DCIS, it would likely also become a viable approach for women with these other conditions.  Moreover, they did not observe differences in patient-reported outcomes between women with DCIS and women with other types of lesions in the AS group.
  • The reviewers questioned the treatment category definitions in this study, since AS1, which is treatment after active surveillance, would seem to be the same as GCC, assuming both groups received treatment within the observation window. The researchers explained that women in the GCC group received treatment within one year of DCIS diagnosis, whereas women in the AS1 group initially refused treatment but received treatment after surveillance demonstrated cancer progression.
  • The reviewers noted that the report was missing a model of treatment choice which could explain patient choices of GCC versus AS. The researchers acknowledged that a more complete treatment choice model would have improved their conclusions, but they were limited to the data available for them to measure patients’ care choices. They could not, for instance, consider patient motivations in their analyses because this information was not available in the databases the researchers used.

Project Information

E. Shelley Hwang, MD, MPH
Duke University
$1,772,381
10.25302/07.2021.CER.150329572
PORTAL: Patient-reported Outcomes after Routine Treatment of Atypical Lesions

Key Dates

September 2015
January 2021
2015
2021

Study Registration Information

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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
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Last updated: March 4, 2022