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 commented that a limitation of the report is that it excluded observational studies, especially ones considering subgroups and neurodevelopmental outcomes. The researchers said they did not try to collect data from observational studies because of budget and time constraints but agreed that a future review of observational studies would be a useful addition to the evidence already collected. The researchers also revised the report to acknowledge that other trials of preterm birth preventive treatments have ended since they completed the current meta-analysis. However, these newer trials have not provided the individual patient data necessary for inclusion in the type of analysis described in this report. Once this information is available, the researchers hope to include the additional trials in an update to the current report.
- The reviewers noted that there did not appear to be much patient and stakeholder engagement in this study, as is typical for PCORI-funded research. The researchers acknowledged that it was difficult to incorporate patient and stakeholder feedback in the study. They stated that given that this project was a meta-analysis combining data from already-completed clinical trials, there was little relevant support and guidance patient and stakeholder partners could provide. Instead, the researchers added a qualitative component to the study to gain information about patient perspectives related to treatment options for preterm birth, to help put the study results into perspective.
- The reviewers questioned the presentation of the qualitative substudy, stating that the researchers presented the results in a way that made them seem like a minor portion of the work. The researchers said they tried to strengthen the patient voice in the study by conducting a small-scale qualitative analysis, which they believe provided insights that were integral to the report’s conclusions and recommendations. The researchers restructured the report so that a summary of the qualitative study methods is in the main report and much more detailed information is in an appendix.
- The reviewers asked for a clearer explanation of how the researchers handled missing data. The researchers said they did not need to infer missing data since sets of variables were generally provided in their entirety or were completely missing in any one trial.
Conflict of Interest Disclosures
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