Results Summary and Professional Abstract
|This project's final research report is expected to be available by July 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 drop-out rate was high in the study and particularly high in the intervention group, where 45.5 percent dropped out before the outcome assessment compared with 27.7 percent of the control group. This difference in drop-out rates could lead to inaccurate estimates of the effects of the intervention. The reviewers suggested comparing people across several variables to see if there were any systematic demographic or clinical differences between study participants and those who dropped out. The researchers added a statement to the limitations section about the high level of loss to follow-up and mentioned that possible differences between those who dropped out and those who did not were study limitations. They also described future analyses they planned to conduct about the impact of the intervention among individuals they identified as attenders and their plans to report these analyses in future manuscripts and presentations. The researchers stated that they are still working on the best way to define attenders, but it is likely that they will compare three groups of participants: those who attended no sessions, those who attended some sessions, and those who attended most or all of the sessions.
- The reviewers asked about the unexpected result that perceived stress scores rose for participants in the intervention group compared to the control group. The researchers added discussion to their report to explain this finding. They said that they attributed the increased scores to intervention participants becoming more aware of and acknowledging their own stress.
- The reviewers commented that the analyses for the large number of secondary outcomes, about 50, did not include statistical controls for multiple comparisons. The number of secondary outcomes reflected all of the outcomes that PCORI had funded the researchers to assess, but the lack of correction for multiple comparisons could lead to false positive results where an outcome was found to be significantly different between groups when the result was due to measurement error. The reviewers recommended adding a sentence to the analysis section about interpreting significant findings cautiously since the analyses did not control for multiple comparisons. The researchers added this language at the end of the analytical and statistical approaches subsection of the report methods. They added it again when describing baseline analyses in the results.
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