Results Summary and Professional Abstract
|This project's final research report is expected to be available by January 2021.|
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 asked why the researchers did not use statistical methods to estimate missing data, such as multiple imputation, or to try to account for co-occurring variables that might have affected outcomes using propensity scores. The researchers explained that they decided against using propensity scores because the data presented a small number of covariates to use, resulting in limited utility for the propensity scores. They said this was particularly true because they were already stratifying analyses using the most important difference between children: the presence or absence of a complex chronic condition. The researchers said they decided against using multiple imputation because the most likely missing variable would be antibiotic use, the exposure condition. For the outcome of body mass index (BMI), the researchers restricted their sample to the children who had a measure to include. This was because they would not be able to easily sort out whether missing BMI data were due to incomplete reporting or due to the child being too young to have BMI recorded.
- The reviewers questioned the researchers’ approach to heterogeneity of treatment effects (HTE) analyses in aim 3 of the study. The researchers added text to their methods section that they completed HTE analyses on fewer potential confounding variables than originally planned, focusing only on those variables hypothesized to present different outcomes from children’s antibiotic use. The reviewers also noted that these analyses focused only on changes in outcomes within each stratum but did not present interaction analyses demonstrating the effects of the strata on the relationship between antibiotic use and outcomes. The researchers explained that they had initially left some of this information out because the results were not clinically meaningful. They also did not test for interaction effects of complex chronic conditions on antibiotic use because they chose to stratify the analyses by this potential confounder throughout the study.
- The reviewers asked about potential misclassification of children’s antibiotic exposure, commenting that the report suggests that only 58 percent of prescribed antibiotics were filled at a pharmacy. The researchers clarified that past research showed that 58 percent of children 0-24 months of age received antibiotic prescriptions. Based on past literature, the researchers expected that a large proportion of those prescriptions are filled. They noted that in additional analyses they found prescription fill rates exceeded 90 percent.
Conflict of Interest Disclosures
View the COI disclosure form.
^Matthew Gillman, MD, MS, was the original principal investigator on this project, which had originally been titled "PCORnet Obesity Observational Study: Short- and Long-term Effects of Antibiotics on Childhood Growth."