Final Research Report
View this project's final research report.
The KIDCARE Study compared treatment strategies for resistant Kawasaki disease. The research team assessed the effectiveness of a medicine called infliximab compared to giving a second dose of IVIG. More than 100 children who had resistant disease and received care at 30 health centers across the United States were evaluated. The team found that children who received infliximab had shorter hospital stays and experienced fewer side effects, including anemia, than those given a second dose of IVIG. This is one of few trials to evaluate therapies for a rare group of patients experiencing the already rare condition of Kawasaki disease. These study findings were published in The Lancet Child & Adolescent Health.
Results of This Project
Related Journal Citations
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 confirm their statements regarding the amount of missing data in the study, in particular whether each participant had seven days of follow-up outcomes for analyses. The researchers included that information in their participant flow diagram, noting that three patients did not have those outcomes available for seven days. The reviewers also commented on the substantial missing data in the secondary outcomes of symptom reporting, which the researchers acknowledged in their limitations section.
- The reviewers questioned the generalizability of the study results given the apparent exclusion of more severely affected children who would be taking steroids. The researchers noted that in some clinic sites included in this study, the standard of care for children who have had one round intravenous immunoglobulin (IVIG) and aspirin treatment and who then become febrile is immediate treatment with IVIG again. Only children in clinics that did not apply this automatic second round of IVIG were included in the study and randomized to IVIG or infliximab. The researchers acknowledged that the study recruitment might have therefore been biased toward lower-risk patients, reducing the generalizability of the results.
- Reviewers noted that fever after IVIG treatment could be a side effect of the treatment or an indication of disease activity, and asked whether the researchers were able to identify the cause of the fever. The researchers explained that fever caused by IVIG treatment usually manifests within a few hours after administration, but the outcome of fever reduction was measured 24 hours after administration. If fever persisted at that point, patients would be switched to the other treatment condition.
Conflict of Interest Disclosures
Patient / Caregiver Partners
- Greg Chin, KD Foundation
Other Stakeholder Partners
No information provided by awardee.
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