Results Summary and Professional Abstract
|This project's final research report is expected to be available by December 2021.|
|Article Highlight: Fatigue is one of the most common problems among patients living with multiple sclerosis (MS). Three drugs—amantadine, modafinil, and methylphenidate—are commonly prescribed for reducing fatigue in patients with MS, but conclusive evidence for their effectiveness is lacking. As published in Lancet Neurology, this PCORI-funded study found that these three drugs were no more effective in reducing fatigue in a group of nearly 170 patients with MS than a placebo pill.|
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 there are medications often prescribed for patients with multiple sclerosis that could affect patient fatigue and thereby interact with the study treatments. The researchers acknowledged that other medications could affect the severity of patient fatigue but there were no changes in concomitant medications during the study period, so there would be no effect of changes from other medications on study results.
- The reviewers noted that patients ending medications at the beginning of their study participation might not have had sufficient time to wash out of those medications and asked the researchers to discuss how they accounted for these carry-over effects in their analyses. The researchers added information to the report about medication half-life and their reasoning for a two-week washout period. They explained that two weeks should have been enough time to wash out of the medications that participants were taking and that analyses looking for carry-over effects found none. The researchers concluded that variation in the washout period did not affect the results.
Conflict of Interest Disclosures
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Other Stakeholder Partners
^Bardia Nourbakhsh, MD, was affiliated with The Regents of the University of California when this project was initially awarded.