Results Summary and Professional Abstract
|This project's final research report is expected to be available by July 2021.|
Related PCORI Dissemination and Implementation Project
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 the odds ratios of several outcomes that were based on whether or not patients were able to make informed, patient-centered (IPC) decisions using the patient decision aids used in this study. The reviewers noted that the odds for surgery, and for less hip pain and knee pain seemed unusually high for the IPC group versus the non-IPC group, and suggested that there was an unaccounted-for bias in the analyses. The researchers refuted the claim of bias but acknowledged that risk ratios would be more appropriate measures for these outcomes than odds ratios. The researchers changed the results in the report to provide the risks of surgery, hip pain, and knee pain related to IPC decisions rather than the odds of these outcomes.
- The reviewers raised questions about the use of an existing patient advisory committee, whose members appeared to have varying levels of experience with orthopedic conditions. The reviewers also questioned how engaged the patient advisors were in various aspects of the research study. The researchers said the patient advisory committee had been created by their institution specifically to support the development of patient decision aids for orthopedic research. The patient advisors they worked with all had experience with orthopedic conditions, either osteoarthritis or low back pain, and were involved in developing the research proposal, designing aspects of the project, selecting outcomes, supporting patient recruitment efforts, and interpreting the data. The researchers added that they invited the patient advocates to participate as authors on publications but the patient advocates asked to be acknowledged instead after reviewing authorship requirements for peer-reviewed reports.
- The reviewers had questions about the study’s primary outcome, which was the proportion of IPC decisions. The researchers explained that the IPC measure was a composite measure of two key elements that patient advocates had emphasized: whether patients are informed and whether they receive their preferred treatment. The study found a lack of concordance between these two elements in some patients, and the researchers said they plan to explore the reasons for this discordance in future studies.
- The reviewers challenged the researchers’ statement advocating the use of either of the two tested patient decision aids, since there was no evidence in this study that either decision aid produced better outcomes than usual care. The researchers responded that while their study did not include a usual care arm, past studies show that patients in usual care had about half the level of IPC decision-making levels as observed in this study. The researchers agreed that including a usual care arm would be helpful in future, similar studies.
Conflict of Interest Disclosures
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