Results Summary and Professional Abstract
Results of This Project
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 said the report needed to appropriately emphasize all assessed outcomes and not overstate significant findings or downplay null results. Specifically, the reviewers told the researchers to first report the results for their primary outcomes, even if those were less interesting than the secondary results. In response, the researchers revised the abstract and added a table to present the differences for all primary and secondary outcomes between the two study arms. The researchers also commented on the clinical importance of the differences observed, not only the statistical importance, as the reviewers requested. The researchers noted that they had analyzed all primary and secondary outcomes as as planned in their PCORI award, but they had conducted additional analyses to clarify asthma control and quality of life results.
- The reviewers asked for a description of the qualitative research methods and results. The researchers added this material, which was previously published.
- The reviewers expressed concern about the methods used in analyzing results from the randomized trial, specifically questioning the methods used to handle missing data and covariates. The researchers said that they involved a statistician in the project from the outset, and they are confident about how they handled missing data. They explained that they did not use multiple imputation with primary outcomes, which had very few missing values. The majority of missing covariates resulted from participants skipping a question on a survey, and they used single imputation for these missing values. The researchers added that the results did not drive the selection of covariates, but that the covariates followed the original analysis plan.
- The reviewers noted that they included many participants in analyses even when participants missed their six-month study visits. The researchers explained that they planned to do the six-month visits at participants’ homes, but that the study was seriously disrupted by a hurricane so many of these visits were not possible.
Conflict of Interest Disclosures
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