Final Research Report
This project's final research report is expected to be available by August 2023.
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:
- Reviewers noted that the study found a statistically significant difference between the two treatments for Myasthenia Gravis, but the researchers did not consider that difference to be clinically meaningful. They asked the researchers to provide more support for this conclusion and postulate on the reasons for the smaller-than-expected difference between groups. The researchers added text to the report indicating that their difficulties with meeting their enrollment goals during the COVID-19 pandemic led to a loss of study power and was probably a main reason for the lack of a clinically meaningful difference between the two treatments.
- The reviewers asked for more information on the involvement of patients and stakeholders as research partners in the study. The researchers added details to the engagement section of the report describing how their three stakeholders were involved starting at the point of study development when they helped to identify the outcome measures. This advisory group continued to meet with the researchers every three months to discuss issues related to the study and to provide feedback on their study recruitment plans as well as on abstracts and papers stemming from the project.
- The reviewers questioned how the researchers could conclude that the study results were due specifically to the interventions for Myasthenia Gravis when patients might also be affected by the COVID-19 pandemic, either by contracting the illness or through side effects from the vaccinations. The researchers explained that the outcome measures they used were specific to Myasthenia Gravis. They did record occurrences of other medical illnesses during the study and no patients reported having COVID-19 in that time.
Conflict of Interest Disclosures
- Has Results