Final Research Report
This project's final research report is expected to be available by June 2022.
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. Those comments and responses included the following:
- The reviewers expressed concern about the conclusions presented in the report, which they saw as overly positive and not well supported by the study results. The reviewers also stressed that the report should consider the clinical importance of the results, rather than only the statistical significance, in assessing the impact of the findings. The researchers revised the report to a more conservative interpretation of the results.
- The reviewers identified problems in the study design that could not be addressed now that the study was completed. In particular, the reviewers felt that the study used inadequate measures of opioid use. The researchers explained that during the study, the use of prescription opioid medications to treat patients presenting with pain in the emergency department declined as U.S. population became more aware of the growing opioid crisis. This, along with new state policies regarding opioid use reporting, created significant challenges in measuring opioid use and opioid-free days based on prescriptions and electronic medical records. The researchers acknowledged that their eventual opioid use measure, using patient-reported use, was weak, and revised the report to acknowledge this weakness as a study limitation.
- The reviewers also questioned the use of risk recall, or patient recall of personal risk related to opioid use, as the primary trial outcome when this variable is more a predictor of health than a health-related outcome itself. The researchers explained that risk recall was a predetermined outcome based on discussions with their patient collaborators, experts in risk communication, and study reviewers. They did acknowledge that the fact that risk recall could only be measured in two of the three groups was also a disadvantage, and that this added a limitation to the findings of the study.
- The reviewers noted that the interventions used in this study had not previously been validated and seemed at face value to vary a great deal in the quality of their stimuli (for instance, a general risk information sheet versus a color-coded thermometer displaying probable risk). The researchers responded that both visual risk communication tools used in this project had been studied in other settings but acknowledged that there were limitations to these interventions that had not previously been studied.
Conflict of Interest Disclosures
Patient / Caregiver Partners
- Jeffrey Bell
- Rachel Graves
- Michael Zyla
- Sharon Mccollum
- Melissa Rogers
Other Stakeholder Partners
- Carolyn Cutilli, PHD, RN/Patient and Family Education Specialist, Hospital of the University of Pennsylvania
- Lewis Nelson, MD/New York City Poison Control Center
- Donald M. Yealy, MD/University of Pittsburgh, Department of Emergency Medicine
- Nicole Thomas, Hospital of the University of Pennsylvania
- Leslie Dye MD, American College of Medical Toxicology
^This project was previously titled: The Comparative Effectiveness of Probabilistic versus Patient Narrative: Enhanced Risk Communication for Pain Management Following Acute Care
- Has Results