Results Summary and Professional Abstract
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. The comments and responses included the following:
- Since the primary outcomes of the study did not show group differences but the secondary outcomes did, reviewers asked for greater detail on some of the secondary outcome measures. Reviewers also asked for additional discussion of the clinical relevance of the observed improvements in secondary outcomes. The researchers added details about the secondary outcomes and clarified how they used measures, such as medication use in Table 1. They also expanded the discussion section to address clinical relevance of the secondary outcomes.
- Reviewers asked about self-reported pain and whether researchers verified patient reports of pain by reviewing medical charts. The researchers said they followed consensus guidelines for the assessment of pain in clinical trials and added that these guidelines recognize self-reporting as a valid method of measuring pain. The researchers did not review medical charts when assessing pain.
- Reviewers noted that telehealth delivery systems are not widely reimbursed and so they are not accessible to many patients. The researchers agreed that this is an important point and added it to their discussion section but said that payers are increasingly covering telehealth.
- Reviewers noted that the measures included two separate measures of depression and asked for the rationale to have two measures rather than one. The researchers explained that one of the measures, the Patient Health Questionnaire, is routinely used as a screening tool in medical offices because it is brief, easy to use, and has good specificity and sensitivity for current depressive episode. Their depression outcome measure, the Hopkins Symptom Checklist, is the gold standard used in depression clinical trials that include participants with multiple sclerosis
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