Results Summary and Professional Abstract
|This project's final research report is expected to be available by May 2021.|
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 asked why the study design chosen, a cluster randomized trial with a stepped-wedge design, was well suited to address the study’s aims. They suggested that it was a flaw in the study that the Teachable Moments Communication Process (TMCP) was used at clinicians’ discretion and that intervention uptake was inconsistent across sites. The researchers explained that the participating health system wanted all clinics to eventually receive the intervention rather than some just serving as control clinics. The stepped-wedge design allowed the researchers to start each clinic with the control condition and then implement the TMCP intervention in each clinic at randomly assigned time points. The researchers said they did not view the variability in clinicians’ communication styles or the site uptake of the intervention as faults of the study. They noted that this was a pragmatic trial, and the site variability in uptake and use of the TMCP intervention demonstrated the need for future research to provide performance feedback to clinicians. The researchers did acknowledge that they could have improved the study by proactively and systematically collecting site-level data to help explain the observed variability.
- The reviewers asked for clarity about whether the researchers performed intent-to-treat analyses on the data. The researchers explained that they analyzed the data in three ways: (1) intent-to-treat analyses based on when the clinic site should have received the TMCP training, regardless of whether the clinicians attended the training; (2) per-protocol analyses using only the sample of clinicians who attended the training; and (3) analyses comparing when trained clinicians used and did not use the intervention.
- The reviewers noted that very small numbers of patients who were referred to the two smoking cessation programs that the study used as interventions, completed those programs. The reviewers asked how these rates compared with what was seen in past studies and to what extent participation in such programs is associated with successfully quitting smoking. The researchers said their study focused on success in improving the referral process to such programs, not engagement with the programs after referral. They chose to include the data on intervention engagement because few studies presented these data, but they could be useful for future studies. However, this was not the focus of the study.
Conflict of Interest Disclosures
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Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
^This project was originally affiliated with Case Western Reserve University.