Results Summary and Professional Abstract
|This project's final research report is expected to be available by November 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. Those comments and responses included the following:
- The reviewers expressed concerns about how the report described the methods and results for aim 1 of the study, which focused on developing a survey that could be used to determine what clinical trial participants and clinicians thought about clinical trial participation. The reviewers asked for more information about this aim and the eventual results. The researchers expanded their discussion of changes made to the study related to the aim. First, because they had difficulty reaching more than six participants from one previous trial they hoped to survey, they decided to recruit their sample from a different trial that was in its early stages. This resulted in a participant sample of 53 and the participants were surveyed before they had experienced the intervention in the clinical trial. Therefore, the researchers completed the aim with a small sample and with little difference between groups on feelings about participation in clinical trials. At the recommendation of the peer reviewers, the researchers presented this background information but did not include the results of this aim in their report, since the aim could not be accomplished as anticipated.
- The reviewers asked for more explanation of how the approximation methods for non-inferiority trials developed in this study differ from the fully Bayesian statistical approach. The researchers said the fully Bayesian approach is exact and expected to yield better power but is computationally intensive. The researchers explained that their approximation methods can be used when one cannot afford the computational cost and complexities of fully Bayesian methods. The researchers noted that they explain the pros and cons of different approximation approaches in their published papers.
Conflict of Interest Disclosures
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^This project was previously titled: Developing Statistical Methods to Compare Multiple Treatments