Results Summary and Professional Abstract
|This project's final research report is expected to be available by July 2020.|
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 expressed concern that the report did not present enough information about the study methods, particularly the interventions, to satisfy standard reporting guidelines and PCORI Methodology Standards. The researchers added text to better explain their methods and revised the structure of the report to consolidate their description of the compared interventions, as well as to help the narrative flow more logically.
- The reviewers expressed concern about the inconsistency between the primary and secondary outcomes described in the report, which had one primary outcome and the rest secondary, and the outcomes described in the clinical trial registry, which included eight primary outcomes. They also stressed the necessity to report all of the results for preplanned outcomes and analyses, even for outcomes that showed no effect. The researchers revised the final report to include all of the preplanned outcomes. They also updated the primary outcomes listed in the clinical trial registry so that the final report and the registry information were consistent in describing 3 primary outcomes, with 12 more secondary outcomes.
- The reviewers asked the researchers to expand the background of the report to present the evidence of a need for a behavioral intervention, such as the one tested in the study. The researchers added text and references, noting that they had conducted a systematic review before conducting their study. They cited the Centers for Disease Control and Prevention in noting that healthy eating and physical activity are core clinical recommendations for managing type 2 diabetes.
- The reviewers suggested that a technology recall affecting a large number of participants and the addition of a third clinic to the trial because of slow recruitment should be considered setbacks and therefore, weaknesses of the study. The researchers disagreed that these two issues represented setbacks. The issues had been anticipated when designing the study, so the researchers had adopted a platform that would allow for evolving technology. Also, the researchers noted that the third clinic that was added was part of the same primary care network, and shared common systems and oversight. The researchers also disagreed that the study had a relatively high drop-out rate, saying that the attrition rate was below the average in clinical trials.
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Other Clinical Interventions
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Incentives for Behavior Change
Training and Education Interventions