Final Research Report
This project's final research report is expected to be available by February 2023.
Results of This Project
Related Journal Citations
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:
- This final report was a combined description of the main research study and the COVID-19 enhancement project. Peer reviewers were asked to assess both parts of the work.
- The statistical reviewer advised the researchers to provide more information on how they calculated sample size for the study, and in particular to clarify what the researchers meant in stating that their sample size could detect “very small effect sizes.” The researchers expanded their sample size justification by describing how they estimated the sample sizes in the planning stage of the study. In addition the researchers specified that they calculated that their sample size would have 90% power to detect an effect as small as 0.026 units of change in the main outcomes.
- Reviewers noted that the COVID-19 enhancement project (aim 3 in the report) was unclear on whether the aim was focused on telemedicine access or telemedicine use. The researchers edited the report to clarify that the study focused telemedicine use and identified additional limitations to making conclusions about the relationship between telemedicine use and the severity of COVID-19 infection. The reviewers cautioned the researchers to also avoid any language in the report that might lead readers to think that telemedicine use had a causal link to COVID-19 severity as opposed to having an association based on the study results.
- The reviewers suggested that the researchers provide more justification for comparing a single intensive behavioral therapy visit to no visit, asking whether going to one visit would be likely to have a clinically significant effect on weight loss. The researchers responded that since there is no evidence of how many sessions are associated with clinically significant weight loss, they analyzed the study participants based on how many treatment visits participants made. Since more than half of participants had only one session and there was no evidence that more sessions were associated with greater weight loss, the researchers decided to use one visit as the threshold.
Conflict of Interest Disclosures
- Has Results