Final Research Report
This project's final research report is expected to be available by January 2024.
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:
- The reviewers questioned how the researchers modified the study design to improve study power, particularly regarding prevalent user design and intent-to-treat (ITT) analysis. The researchers explained that the ITT analysis was always planned for aim 1 sensitivity analysis, and that ITT was always planned as the primary analysis for aim 2. The prevalent user design as well as time-varying exposure designs were added early in the project not to improve study power but because the researchers were interested the long-term impact of hypoglycemia from sulfonylureas and in the effect of taking concomitant diabetes medication. They also articulated the specific limitations of prevalent user designs and time-varying approaches in the discussion section.
- The reviewers suggested further that the researchers address their rationale for the study changes given the differences these changes caused for study interpretation. The researchers added a discussion about the rationale and potential for bias that changes to the study created, especially expansion of the study sample from only new users of the medication to including prevalent users. They noted that the two groups addressed very different questions.
- The reviewers asked about the use of ‘time-varying covariates’ because it was not clear what these were or how they were analyzed. The researchers explained that this referred to exposures to antidiabetic drugs during the follow-up period so that these changes could be incorporated into the statistical model. To reduce confusion, the researchers replaced the term time-varying covariates with more descriptive language in the text.
Conflict of Interest Disclosures
- Has Results