Results Summary and Professional Abstract
|Article Highlight: Earlier this decade, the use of direct-acting antivirals—which stop a virus from making copies of itself—was a breakthrough in the treatment of hepatitis C virus. But little research exists on possible side effects of the antivirals, especially among large, real-world populations. This study, which used PCORnet data, found that patients who took the antivirals were no more likely to experience adverse events than those who didn’t take them. The researchers published their findings in JAMA Network Open.|
|This project's final research report is expected to be available by May 2020.|
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 for the extent of missing data in the study and how the researchers handled missing data. They also asked what analyses the researchers performed to determine that missing data did not influence the conclusions. The researchers responded that the three health systems that participated in the study are highly experienced in using data for research and routinely consider the appropriate use of data. The researchers noted that the patterns of data availability were a result of system use, rather than failure to capture data. The researchers also explained how they conducted sensitivity analyses to account for missing data.
- The reviewers expressed concern about the possibility of bias in the study sample that could be created if the different exposure groups were followed for different lengths of time on average. This could occur because the health outcomes the researchers were following might vary over the course of the disease. The researchers referred to Appendix 7, where they detailed their sensitivity analyses looking at length of follow-up time for the study participants in different groups. The researchers noted that they also truncated observations after 365 days for both those treated with direct acting antivirals (DAAs) and those not receiving DAAs to produce comparable exposure periods. They found that this adjustment made little difference in the adverse event rate estimates.
- The reviewers asked that the report include a distribution list of the specific DAAs prescribed for the exposed group of patients, and what restrictions existed related to patient access to specific medications. The researchers responded that their data systems did not permit disclosure of specific medications within a drug class, so they were unable to estimate the number of each medication prescribed. They did, however, include a list of all medications that they had included in this class and noted that there were almost no restrictions on patient access to these medications.
Conflict of Interest Disclosures
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^This project was previously titled: Rapid-Cycle Research: Hepatitis C (Observational Study)