Results Summary and Professional Abstract
|This project's final research report is expected to be available by October 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. The comments and responses included the following:
- Reviewers suggested that the study results were not surprising and may not help increase the use of N-of-1 trials. The researchers responded that they are confident that alerting trial designers to patient concerns about the time and cost of such trials will allow researchers to design better N-of-1 trials.
- Reviewers said that it was unclear how to deal with conflicts between patient preferences and scientific community recommendations for trial design. The researchers said their study only used conditions that are compatible with the needs of sound trial design. They said that the analysis they used provides a template for combining trial features in a way that could enhance patient acceptance. Also, their work can alert trial designers when they will need to be prepared to address patients’ concerns.
- Reviewers questioned how the researchers’ described blinding as a trial attribute in the second patient survey. They questioned whether respondents understood the concept correctly as not knowing the order of treatments, rather than also not knowing the nature of treatments. The researchers said the surveys underwent rigorous cognitive testing to ensure their comprehensibility and had further user testing. The researchers added the potential that blinding was misunderstood to their study limitations but also noted that the concept did not appear to drive patient preferences.
Conflict of Interest Disclosures
View the COI disclosure form.
^The original principal investigator of this project was Karina Davidson, PhD.