Results Summary and Professional Abstract
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 suggested that participants’ perception of regret about enrolling in a research study may be hard to distinguish from potential regret or conflict related to the treatment they receive. The researchers added a sentence about this to the limitations section but also commented that in most of the trials examined, treatment was begun almost immediately after enrollment. Therefore, there was really a single decision made rather than two separate ones.
- The reviewers expressed concern that the report did not contain the results of aim 3 interviews. The report instead stated that the interviews at the end of the study did not reflect exposure to the novel consent process and were similar to interviews conducted in aim 1. Reviewers noted that the aim 3 interviews took place after participants may have undergone surgery, which could be an important factor in understanding the informed consent process. The researchers acquiesced to this concern and clarified in the report what themes overlapped between the aim 1 and aim 3 interviews, and the little new information obtained from the latter.
- The reviewers asked how the results of this study could translate to the real world of clinical trial research, since most researchers conducting such trials would not have the resources to develop a highly trained and motivated patient advisory panel to develop their informed consent process. The researchers agreed that this could be a problem and added language to their discussion section suggesting that institutions could create such panels as a resource for several projects.
- The reviewers suggested that the study would have been improved by the addition of non-English-speaking participants. The researchers acknowledged the lack of non-English speakers as a limitation of the study but explained that they had not been able to conduct or analyze the long and highly interactive interviews in other languages. The researchers added that a Spanish-language version of the survey is being used in a follow-up study.
Conflict of Interest Disclosures
The Conflict of Interest Disclosures for this project will be posted here soon.