Results Summary and Professional Abstract
|This project's final research report is expected to be available by January 2021.|
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 suggested that the improvements observed in both groups in the study may have resulted from regression to the mean, since the study recruited only people with poorly controlled asthma, and asthma severity fluctuates over time. The researchers said they had considered this possibility and ran analyses to evaluate whether participants had been recruited during asthma exacerbations. The researchers explained that patients were generally recruited from databases where symptoms of poorly controlled asthma were recorded months before they enrolled patients in the study. The researchers considered that patients may have been more likely to enroll in the study if they were struggling with their symptoms when contacted. So, the researchers examined the patients’ asthma control scores and spirometry data from baseline to the last follow-up to look for evidence of an exacerbation at study entry. The researchers did not find evidence that participants experiencing an exacerbation were more likely to enter the study, but the researchers said that in future studies they will assess this possibility at enrollment.
- The reviewers commented that when the researchers compare their results with those of other studies, they should note that other studies included patients who had less severe asthma. The researchers agreed that in general the severity of asthma in their patients allowed for greater improvement than would be expected in studies that recruited patients with mild asthma. They explained that their eligibility criteria allowed not only for patients with very poorly controlled asthma but also patients who had better control but suffered regular acute crises leading to hospitalizations or repeated emergency department visits. By reviewing enrollment information for the study participants, the researchers were able to ascertain that 92.4 percent of participants could be categorized as having very poorly controlled asthma based on accepted clinical criteria, and 6.5 percent of participants met criteria for not well-controlled asthma. Finally, the researchers identified three patients as having well-controlled asthma at baseline, and the researchers posited that these three participants were probably enrolled because their asthma was not well controlled at screening but by baseline had improved.
- The reviewers noted that the two study groups showed differences in baseline characteristics and asked the researchers to include any such differences in their multivariate models. The researchers responded by reanalyzing their outcomes after including emergency department use and employment status, two areas of significant difference between the study groups, in the models. The researchers reported that use of a portable heater was another characteristic that had significant baseline differences, but they did not include this variable in the model because it was not related to the primary outcome and had considerable missing data.
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