Results Summary and Professional Abstract
|This project's final research report is expected to be available by November 2021.|
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 the report presented a large number of subgroup analyses, which could increase the risk of identifying a false positive result. The researchers agreed and indicated that most of these analyses were exploratory. Therefore, the researchers focused their subgroup analyses on the primary outcomes only, removing some of the results and discussion related to the subgroup analyses on secondary outcomes.
- The reviewers noted that an individual patient might be prescribed additional medication more than once, so they asked whether one patient could contribute multiple times to the study, which lasted eight years. The researchers said individual patients could contribute more than one augmenting medication episode because polypharmacy is common in patients with posttraumatic stress disorder so patients might receive augmenting medication in more than one medication category. To make sure that including multiple episodes from the same patient would not bias their analyses, the researchers explained that they conducted sensitivity analyses that showed that restricting patients to contributing an episode to a single medication class did not lead to substantial differences in results.
- The reviewers suggested that a weakness of the study was the analysis of just three antipsychotic medications despite the large number of medications available in this category, and in particular the increasing use of medications that do not promote weight gain. The researchers agreed that it would be helpful to examine additional medications in future studies, but said they were asked to focus on a relatively small number of agents when they designed the study so they could better examine comparative effectiveness. The researchers said they chose to analyze the antipsychotic medications that were most widely used within the Veterans Health Administration during the study period and had the most clinical trial evidence for potential benefit for posttraumatic stress disorder.
- The reviewers noted that the researchers only counted episodes of adjunctive medication when the medication was taken for at least 60 days and would therefore, miss trials of medication that ended early due to side effects. The researchers acknowledged in the limitations section that their data collection missed these early discontinuation cases, but that this was because the researchers felt they needed at least 60 days of medication use to evaluate the impact of these medications on mental health and metabolic outcomes.
Conflict of Interest Disclosures
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