Final Research Report
View this project's final research report.
Results of This Project
Related Journal Citations
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 pointed out that in the first study involving children with inflammatory bowel disease, “usual diet” was not a randomized intervention arm but more of a baseline condition; thus comparisons between usual diet and the other two diet interventions had some limitations. The researchers added a comment to their study limitations on this subject and changed their terminology in the paper from “usual diet” to “baseline diet.”
- The reviewers noted that less than half of the study participants fully completed the interventions, which the researchers partially dealt with by conducting separate analyses based on intervention completion. Given the apparent differences in the group of people who did complete the interventions fully, the reviewers asked the researchers to discuss how their analytic model differed from intention to treat principles and other limitations to the generalizability of the results. The researchers added additional pooled or aggregate analyses to the report that would be more in line with an intention-to-treat model. The researchers also commented that the N-of-1 study methods at the core of this research emphasizes individual differences that are important to understand effect heterogeneity rather than effect generalizability.
- The reviewers suggested that the researchers soften their very positive statements about the utility of N-of-1 study designs given the limitations the researchers faced in implementing these studies. The researchers also acknowledged that it was difficult to determine whether the challenges of the dietary interventions or the feasibility of N-of-1 trial designs was associated with their problems with participant recruitment and high drop out.
- Reviewers asked the researchers to add to their presentation of limitations for study 2 about individual-level triggers of atrial fibrillation, especially related to the high rate of missing data in this study. The researchers clarified that their analyses used complete cases and therefore could not be considered intention-to-treat.
- The reviewers asked why study 2 seemed to emphasize alcohol use as a potential trigger for atrial fibrillation. The researchers explained that alcohol use is currently the only potential trigger of atrial fibrillation with prior evidence in the literature and alcohol has some biological plausibility as a trigger.
Conflict of Interest Disclosures
- Has Results