|This project's final research report is expected to be available by March 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.
Reviewers’ comments and the investigator’s changes in response included the following:
- The awardee justified the study design, in which patients were able to review study materials at their own convenience, outside the context of a doctor’s visit, factors which might have improved internal validity. The investigator explained that it did not feel appropriate to add the burden of viewing study materials when patients with noncurable cancer are in an emotionally charged doctor’s visit. By allowing patients to view materials on their own time, the investigator felt the study would better reflect real-world implementation of the intervention.
- The awardee revised its presentation of results to clarify that although some comparisons reached statistical significance, most would not be considered significant because the p-value did not reach the conventional threshold of p<0.05.
- The reviewers expressed concern that the research moved too quickly from developing the intervention to becoming a large effectiveness study, particularly given a lack of pilot data that would have helped establish what to consider as a clinically meaningful effect. The awardee countered that it estimated an appropriate effect size based on previous studies with similar populations. The investigator considered this practice an acceptable substitute for piloting the intervention in a feasibility study.
Conflict of Interest Disclosures
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