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 asked the researchers to provide information on the minimally clinically important differences for outcome measures to help readers understand what amount of difference between groups would be considered clinically significant. The researchers responded that they were not aware of standards for minimally clinically important differences for their outcome measures but said they will explore this idea further and potentially include such analyses in the future.
- The reviewers noted the inconsistencies in the description of the study design, which initially did not seem to take into account the lack of random assignment to the clinic intervention. The researchers revised the methods, especially for the analytic and statistical methods section of the report. The researchers acknowledged that they had not yet examined outcome differences by clinic site. However, in four previous trials, outcomes from the different clinic sites had not varied significantly, so the researchers did not expect that differences among clinic sites led to different outcomes but said they will examine the issue further.
- The reviewers asked for a discussion of why the researchers decided to include youth with mild persistent asthma in the study after initially not intending to include such patients. The researchers replied that they originally planned to recruit only youth with moderate-to-severe persistent asthma but modified eligibility criteria one month into recruitment for several reasons. First, immediately classifying the severity of asthma in youth was difficult because of discrepancies in the data available. Second, the researchers recognized that patients with mild persistent asthma could also benefit from the planned family and clinic interventions. Third, including youth with mild persistent cases simplified the process for healthcare providers in working with youth with persistent asthma symptoms. Also, the researchers anticipated that recruiting adequate numbers of patient participants might prove challenging if they did not recruit youth with mild symptoms as well as more severe symptoms, so the researchers decided to modify their approach to recruitment early enough to avoid potential biases.
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Training and Education Interventions