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 asked for more information about any power calculations the researchers performed to determine the study’s sample size. The researchers responded that their initial power calculations showed that they would have the power to detect a 10-percent difference between study arms. However, they stated that greater than expected sample sizes at the two hospitals increased their power to detect clinically meaningful differences in participants’ responses to different models of informed consent procedures.
  • Reviewers expressed concern about the researchers’ decision to collapse the Likert-scale values on two of the outcome measures and about how that affected the measures’ validity. The researchers acknowledged that they did not conduct additional psychometric evaluations to determine the overall validity of the outcome measures when used this way, but they believed that the measures maintained face validity based on their cognitive interviews and feedback from their patient advisory groups. The researchers also did revise their results by reporting all categories on the Likert scale rather than collapsing categories.
  • Reviewers asked about subgroup analyses and the completeness of reporting. The researchers added analyses of primary outcomes by study arm as well as summary statistics for basic demographic data by study arm and site. The researchers said they plan to conduct further subgroup analyses in the future.
  • Reviewers wondered about the likelihood of substantial selection bias, noting that participants were almost certainly predisposed to have favorable attitudes about participating in research because they had to indicate willingness to participate in this study. Reviewers suggested the report discuss this limitation at length. The researchers added text about limitations. They noted that they believe this limitation applies more to the online sample than for participants recruited at medical clinics who were coming in for routine care.

Conflict of Interest Disclosures

Project Information

Nancy Kass, ScD^
Johns Hopkins University
Demonstrating Respect and Acceptable Consent Strategies: What Matters to Patients in PCOR?

Key Dates

July 2014
June 2019

Study Registration Information

^Ruth Faden, PhD, MPH was the original principal investigator for this project.


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Last updated: March 4, 2022