Results Summary and Professional Abstract
| This project's final research report is expected to be available by August 2021. |
Peer-Review Summary
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 relevant the data were for pregnant women with latent herpes infection, not currently exhibiting symptoms. The researchers stated that the herpes virus is a continuous infection even when patients are asymptomatic, and that asymptomatic infection may still present a risk for fetal health. In the dataset it was not possible to distinguish women with symptoms from those without symptoms, so the researchers included both in the study cohorts and distinctions were not made in the results between the two groups.
- The reviewers asked for an explanation for why the study found treatment to be associated with reduced risk of preterm delivery (PTD) but did not find an association with low birthweight (LBW), even though the two often go together. The researchers said PTD may lead to LBW, but many other causes lead to LBW as well. They said they did not know why herpes treatment did not seem to affect LBW in this study, but this was not an unexpected finding since previous studies have seen different impacts of interventions on PTD versus LBW.
- The reviewers asked for clarification on the possible side effects of antiherpes drugs in pregnant women and asked why the researchers did not also look at material health outcomes, along with infant outcomes. The researchers responded that antiherpes medications consistently have been found to be quite safe and have been classified by the United States Food and Drug Administration in the same category of safety as prenatal vitamins. Moreover, the focus of this study was on preterm birth and low birthweight in infants, so the researchers were not looking at other outcomes such as maternal health or infant birth defects.
- The reviewers asked whether women with herpes who received antiviral medications were at the same risk of preterm delivery as women without infection and why maternal outcomes and the effects of race, age, and weight were not considered. The researchers replied that they observed only a very small difference in preterm delivery rates among women who received medications compared with women without infection, but the primary aim of the study was to compare treated and untreated women with herpes, not to compare them with women without infection, so that finding was not part of the PCORI study.
- The reviewers asked how underdiagnosis of herpes may have affected the study, for example in affecting the study’s power to detect an association between medication use and LBW. The researchers said that while herpes infection may have gone unrecognized in some women, herpes infection rates have gone down substantially in the United States in recent decades, so the researchers did not expect that a very large proportion of women in the comparator group had undetected herpes. In addition, the researchers emphasized that such misclassification would only have reduced the strength of any observed associations, not suggested associations that do not exist.
Conflict of Interest Disclosures
View the COI disclosure form.
Project Details
Principal Investigator
De-Kun Li, MD, PhD Project Status
Completed; PCORI Public and Professional Abstracts Posted Project Title
Comparative Effectiveness of Treatment Options for Genital Herpes Infection in Pregnant Women to Reduce Adverse Pregnancy Outcomes Board Approval Date
July 2016 Project End Date
February 2021 Organization
Kaiser Foundation Research Institute Year Awarded
2016 State
California Year Completed
2020 Project Type
Research Project Health Conditions
Infectious Diseases
HPV and other Sexually Transmitted Infections
Reproductive and Perinatal Health
Pregnancy and Birth Outcomes
Intervention Strategies
Drug Interventions Other Health Services Interventions
Populations
Racial/Ethnic Minorities Women
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options Project Budget
$2,402,605 Partners
Patient/Caregiver Partners
Other Stakeholder Partners
Page Last Updated:
January 12, 2021