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 said it was difficult to identify which recommendations and guidelines resulted from the study’s case studies and simulations and which were previously known. The researchers said the guidelines document that they were finalizing provides a detailed explanation of the basis for recommendations along with citations to relevant literature. The final report now refers extensively to the guidelines, which were in the finalization process during the completion of peer review.
  • The reviewers asked the researchers to discuss the potential for bias in the results their focus group participants produced because those participants are unlikely to represent a random sample of the population. The researchers stated that while it is never possible to guarantee that study participants are a random sample of the population, the researchers could state positively that the patients who participated in the study focus groups came from a wide cross section of an urban population.
  • The reviewers recommended considering quality-of-life outcomes, not only safety and efficacy, and different subgroups. The researchers said their guidelines are agnostic about types of outcomes and subgroups, so investigators are free to choose different types as they see fit.
  • The reviewers commented that the software developed for this study is coded only in SAS and not available to all researchers. The researchers responded that they are trying to secure funding to release software in SAS, R, and Python.

Conflict of Interest Disclosures

Project Information

Miguel Hernán, MD, DrPH
Harvard University School of Public Health
Causal Inference Guidelines for Pragmatic Clinical Trials^

Key Dates

September 2015
September 2020

Study Registration Information

^This project was previously titled: Developing Guidelines to Choose Ways to Analyze Results from Real-World Studies


Has Results
Award Type
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022