Results Summary and Professional Abstract
Improving Methods for Studying Chronic Disease
A narrative on how researchers are creating an easy-to-use statistical toolkit to help researchers study treatments that vary over time.
|This project's final research report is expected to be available by June 2019.|
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 questioned the researchers’ use of a target trial—a hypothetical trial structure used to test causal inference—in testing their CERBOT instrument. The reviewers noted that consensus is lacking about the need for a target trial to establish causal inference in observational data. Moreover, this framework does not fit all causal questions, like those involving safety or less easily manipulated exposures. The researchers added to their justification for using a target trial. They also confirmed that the CERBOT instrument’s design enables it to measure comparative effectiveness and test safety.
- Reviewers identified several areas where the description of the CERBOT tool itself was difficult to understand. The researchers made extensive revisions based on these comments. They also added examples and a video tutorial to the CERBOT website to help users implement the tool.
- Reviewers expressed concern that without a well-defined causal question, the tool would not be useful in developing the components of a target trial. The researchers agreed and revised the report to say that a well-defined question would be one for which an investigator could specify a hypothetical research trial.
- Reviewers asked for clarification of the makeup of the study’s advisory committee which the researchers claimed to include stakeholders and patient representatives. The researchers noted that the committee included clinicians working with patients but acknowledged that it lacked members that represented a patient perspective.
Conflict of Interest Disclosures
View the COI disclosure form.