Final Research Report
This project's final research report is expected to be available by January 2023.
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 noted that this trial comparing two techniques for inserting shunts to treat hydrocephalus in children found no significant difference in time to shunt failure, but the authors’ sensitivity analyses pointed to a higher failure rated in posterior shunt entry compared to anterior shunt entry. The reviewers suggested that the authors note this difference in their abstract conclusions but acknowledge that the difference could be due to chance. The researchers considered this suggestion but in their review of the data noted that the difference might be related more to the surgeons in the study rather than to shunt entry site. Therefore, the researchers felt that their original conclusion of no difference between groups was still the most accurate statement.
- The reviewers pointed out the high rates of missing information about patient quality of life at both the baseline and the one-year assessments. They did not agree with the researchers’ contention that data were missing at random and recommended that the researchers use multiple imputation in a sensitivity analysis to account for the factors that contributed to the missing data. The researchers noted that the factors they believed to contribute to missing data were not related to the assessment or the intervention and were concerned about the validity of the multiple imputation approach given the substantial amount of missing data in this study. However, the researchers did impute the missing data using several available patient characteristics and conducted the recommended sensitivity analysis. They reported that the results of the sensitivity analysis were similar to the main analyses and that there was no difference between treatment groups in patient quality of life.
- One reviewer asked the researchers to add a description of the valve types used in the surgeries and recommended that the researchers add valve type to their analyses. The researchers declined this addition because there is research evidence that valve type does not affect shunt survival in this population, and they preferred not to list the valve types so they would not appear to be endorsing a specific valve product.
Conflict of Interest Disclosures
- Has Results