Results Summary and Professional Abstract
|This project's final research report is expected to be available by December 2019.|
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:
- Reviewers raised questions about the structure and validity of the primary outcome of utility, a combination of efficacy and quit rate. One reviewer expressed concern that the measure had been biased because one of the medications tested had a much higher cost and therefore, higher quit rate that would affect it. The researchers noted that as a pragmatic trial, the study needed to include the available medication choices patients had. Other reviewers asked for a stronger rationale and explanation for how the researchers developed the utility function and what weighting they used. The researchers explained that they sought input from three clinical experts to determine the weighting between efficacy and quit rates, helping to establish the clinical meaning in the utility outcome.
- Reviewers suggested that a crossover design may have been better. The researchers agreed that in the future it could be helpful to use an adaptive crossover design where patients could be randomized a second time if they do not respond well to their initial treatment.
- Reviewers suggested that it would be useful to report patients’ prior experiences with the medications tested, or at least to note the medications they had used previously. The researchers said this information was not tracked, so they could not report on patients’ prior experiences with the tested medications.
Conflict of Interest Disclosures
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