Results Summary and Professional Abstract
|This project's final research report is expected to be available by May 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 noted that the report cited a few studies that supported the need for further research but no systematic reviews. They asked what methods the researchers used to review the literature. The researchers replied that they conducted a thorough review of the literature spanning 20 years when developing their grant application. They said their search focused on medical decision making and especially female-cancer decision making.
- Reviewers recommended that the researchers should give more attention to patients who received additional therapy before surgery, as this could significantly affect the study outcomes. The researchers explained that they did examine these factors as possible confounders in the analyses but did not observe a significant effect on the outcomes. They did add more discussion of the patient subgroup receiving previous therapy to the report.
- The reviewers said that outcomes should represent concerns of the population of interest and suggested that quality of life was not sufficiently emphasized in the report. The researchers added text and a new figure (Figure 3) to describe trends in quality of life. They said their primary interest was in how quality of life might influence participants’ satisfaction with their treatment decisions.
- The reviewers asked for an analysis of inconsistencies between original plans and how the researchers carried out the study, and specifically the switch from a final follow-up time from one year to nine months. They asked how the researchers managed the missing data. The researchers responded that they conducted statistical analyses as planned. They said the reason for changing the final follow-up time point from one year to nine months was because of unexpected time constraints with the PCORI contract. They also changed it because the study team wanted to stay close to the planned 80 percent retention rate for the study. Due to the seriousness of the disease, retention was only 62 percent at 12 months but 81 percent at 9 months.
- The reviewers asked how the decision aid could be improved and, if shown to be effective, how it could be disseminated and implemented among patients. The researchers said the educational module of their decision aid was very well received and considered useful in describing treatment options and side effects. They noted that technical misunderstandings (e.g., needing to swipe on an iPad) may have impeded the gathering of some data, but that many participants liked the gaming feature. The researchers also acknowledged that some aspects of the educational module may have overwhelmed patients with more information than they wanted, but many clinicians said they would like to see the decision aid adapted for use with patients who have recurrent ovarian cancer. The researchers said they foresee the aid being useful in the context of other advanced cancer types and other treatment choices.
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Training and Education Interventions