Results Summary and Professional Abstract
Final Research Report
View this project's final research report.
|Article Highlight: Chronic Hepatitis C virus (HCV) can lead to liver failure, liver cancer, and death. In 2013, the Food and Drug Administration approved a new type of HCV treatment called direct-acting antiviral medicine. This PCORI-funded study examined short- and long-term effects on patients treated by this newer medicine. As reported in Liver International, three months after completing treatment, patients reported less fatigue, better sleep quality, and better ability to do daily tasks than before treatment. These improvements held over 12 months.|
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 how the researchers administered the surveys and whether the researchers considered the health literacy level of the patient population in developing the surveys. The researchers explained that they used multiple ways to collect survey results, which they characterized as a strength of their study, leading to high retention and data collection rates. The researchers added that past research has shown that different methods of collecting survey responses obtain similar results except when addressing sensitive data, such as drug use, which was a small component of this study. The researchers responded that they did not evaluate the health literacy of the study cohort, but 95 percent of the cohort had an education level of eighth grade or higher. They noted also that some of the survey measures had been developed to target a sixth-grade reading level, but the reading level for other measures was not known.
- The reviewers asked for clarification on the group of patients with cirrhosis, since the report only stated that the patient-reported outcomes measures were similar for patients with and without cirrhosis. The researchers said that they started off considering patients with and without cirrhosis as distinct subgroups but de-emphasized this focus after observing minimal differences between the groups. But in response to the reviewers’ request, they added a new figure (Figure 14: Change in PROs one-year post-treatment (T5) after SVR by CIRRHOSIS-MELD STATUS) with results comparing patients without cirrhosis and those with less- and more- advanced cirrhosis.
- The reviewers suggested that the analysis on treatment adherence seemed superfluous to the rest of the study and could be dropped from the report. The researchers agreed that the analysis of medication adherence was not well integrated with other aims in the report and that self-reporting on medication use can be subject to recall bias. However, they explained that they included this as an aim because this was found to be an important outcome to stakeholders. The reviewers also objected to the use of self-reported medication adherence to measure this outcome but acknowledged that nonadherence was unlikely to be a major issue in this population. The researchers agreed with reviewers regarding the limitations of self-reported adherence, but they used their available resources to collect this information once it was clear that stakeholders were interested in the results.
- Reviewers had difficulty understanding how the study handled missing data posttreatment related to sustained virological response (SVR) and asked for more detail, as this outcome has typically been key to determining treatment success or failure in hepatitis C (HCV) studies. The researchers explained that for the primary outcomes they used the full sample, regardless of whether they had SVR status on all patients posttreatment. They excluded patients with missing SVR measures when SVR status was necessary for the analysis. The researchers acknowledged that most HCV studies would not have 10 percent missing SVR data. They speculated that the higher than expected incidence of missing SVR status was related to patients’ expectations of cure and greater psychosocial instabilities.
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