Results Summary and Professional Abstract
|This project's final research report is expected to be available by February 2020.|
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 whether the researchers collected baseline characteristics for participants that may have affected their adherence to the behavior change intervention. The researchers responded that they did not collect demographic characteristics, such as education and income that might have provided such information. However, they did add some discussion of potential factors that may have contributed to participants’ compliance with the diet, backing up their postulations with previous research.
- Because researchers enrolled far fewer patients in the study than planned, reviewers asked whether that compromised statistical power to detect clinically important differences. Reviewers suggested conducting another power analysis to determine small-to-medium effects in the primary outcome measure. The researchers said they did not feel the need to conduct the additional power analysis because they detected a difference between groups on the primary outcome. For secondary aims, the researchers acknowledged the study was underpowered to detect small-to-moderate clinically important differences between groups. The researchers addressed the limitations in identifying small-to-moderate differences within treatment group due to smaller-than-expected sample size also.
- Reviewers asked for additional detail on how researchers assigned study subjects to groups, noting the unequal number assigned to the two interventions. The researchers added details about the randomization process to the methods. Because of the low recruitment levels and because when assigning subjects to different protocols, factors such as subjects’ age and gender were taken into consideration, allocations became uneven.
- Reviewers questioned the use of symptoms instead of histology to score the primary outcome. The researchers noted that PCORI had asked that changes in symptoms be the primary outcome in the initially approved research plan, perhaps because symptoms are of greater interest to patients. The researchers added information about this to the background and methods sections. They also noted that a larger sample size would have been needed to detect differences between the two diets if they had used both histology and symptoms as measures, instead of either alone.
Conflict of Interest Disclosures
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