|This project's final research report is expected to be available by June 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 asked whether researchers met key statistical assumptions given the large number of patients and caregivers who did not complete outcomes assessments at six months. The researchers explained that they had to close recruitment to meet study time limits, and they assumed data were missing at random because the drop-out rates were similar to the researchers’ previous experiences with this population.
- Reviewers criticized enrollment criteria that excluded those who did not speak and read English and were unwilling to use a smartphone. The researchers explained that they did not exclude any participants for refusing to use a smartphone. Researchers also explained that they excluded fewer than 16 percent of potential participants from the study because of a language barrier. More common barriers involved clinical issues. Ultimately, the demographics of those recruited for the study matched those for stem cell transplant recipients nationally.
- Given past studies that found benefits to caregivers who received support, reviewers suggested that randomly assigning some participants to treatment as usual may no longer be ethically acceptable. The researchers agreed and explained that although the control group did not receive one-on-one counseling sessions, the group received the same written materials as those in the intervention group. Based on reviewers’ suggestions, the researchers changed the name of this comparison condition to enhanced treatment as usual.
- Reviewers wondered whether the patient outcome measures used were well chosen. The researchers said that in retrospect they would have used a different measure for patient quality of life, one that was more sensitive to psychological effects. But once the researchers registered the clinical trial publicly, restrictions prevented them from changing the primary outcome measure. The researchers emphasized the limitations of the patient outcome measure in their report, and they plan to complete exploratory analyses of the measure’s subscales to determine if there are other effects of caregiver distress.
- Reviewers asked whether a conceptual model could be used to guide interpretation of the findings and better support the concept of caregiver distress affecting patient quality of life, as well as a post-hoc conceptual model for ongoing analyses. The researchers added a conceptual model to the revision but did not feel it was appropriate to develop a post-hoc conceptual model since they were still going through extensive exploratory analyses.
Conflict of Interest Disclosures
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