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. 

Reviewers’ comments and the investigator’s changes in response included the following:

  • The awardee justified the study design, in which patients were able to review study materials at their own convenience, outside the context of a doctor’s visit, factors which might have improved internal validity. The investigator explained that it did not feel appropriate to add the burden of viewing study materials when patients with noncurable cancer are in an emotionally charged doctor’s visit. By allowing patients to view materials on their own time, the investigator felt the study would better reflect real-world implementation of the intervention.
  • The awardee revised its presentation of results to clarify that although some comparisons reached statistical significance, most would not be considered significant because the -value did not reach the conventional threshold of p<0.05.
  • The reviewers expressed concern that the research moved too quickly from developing the intervention to becoming a large effectiveness study, particularly given a lack of pilot data that would have helped establish what to consider as a clinically meaningful effect. The awardee countered that it estimated an appropriate effect size based on previous studies with similar populations. The investigator considered this practice an acceptable substitute for piloting the intervention in a feasibility study.

Conflict of Interest Disclosures

Project Information

Deborah Schrag, MD, MPH
Dana-Farber Cancer Institute
$1,063,122
10.25302/7.2019.CE.13046517
Improving Informed Consent for Palliative Chemotherapy: Development of a Regimen-Specific Multi-Media Informed Consent Library to Promote Patient-Centered Decision Making about Treatment of Advanced Gastrointestinal Cancers

Key Dates

September 2013
June 2018
2013
2018

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
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: March 4, 2022