Final Research Report
View this project's final research report.
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. The comments and responses included the following:
- Reviewers did not find the comparison of person-centered care (PCC) versus management-based care (MBC) compelling. They asked for more justification for this comparison based on theoretical and empirical evidence. The researchers expanded their description of the two interventions and added a conceptual framework comparing PCC, MBC, and a typical visit.
- Reviewers expressed concern about the problems in the study design created when several clinics dropped out postrandomization, and the researchers replaced the clinics without randomization. The researchers acknowledged these limitations, noting that this was a notable example of the problems in conducting research in the real world. They also added information about why clinic sites dropped out of the study and included analyses demonstrating that the new sites did not differ significantly from the dropped-out sites.
- Reviewers further questioned why the researchers did not use propensity score weighting or similar measures to account for the lack of randomization when completing their outcome analyses. The researchers noted that given their large number of participants and few significant baseline differences between the sites in the two intervention groups, they felt there was no need to seek additional precision through propensity scoring. The researchers went on to say that the small magnitude of the significant differences between PCC and MBC groups, and the results from sensitivity analyses looking at the effects of non-random site assignment both supported this decision.
- Reviewers asked why the researchers had completed subgroup analyses for Aim 3 given the problems with site randomization, substantial missing data, and the lack of differences between intervention groups. The researchers explained that along with these analyses being a part of their contracted work, they conducted the analyses with the assumption that the results would be exploratory or hypothesis generating rather than confirmatory or hypothesis testing. The researchers stated that they were cautious in their interpretation of the results.
- Reviewers commented that the assessment of side effects was simplistic and that unmeasured differences might appear and be the result of selection bias given the lack of true randomization. The researchers agreed that collecting more-detailed information about side effects would have been helpful, but said they wanted to minimize the number of survey questions so as to limit the burden on participants. The researchers felt that a single question on side effects would provide adequate information and prompt discussion between prescribers and patients. They went on to say that the single item provided the information that patient stakeholders identified as most important to them.
Conflict of Interest Disclosures
- Has Results