Results Summary and Professional Abstract
Chronic Pain Treatment without Opioids
This research project explores nonpharmacological alternatives for managing pain to help patients in low-income areas.
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:
- The reviewers said that the report was unclear on whether the per-protocol analyses were preplanned, and what reported analyses were exploratory. This affected the reviewers’ comfort with the study’s original conclusions regarding the success of the integrated medical group visits (IMGV) compared to standard primary care visits. The researchers revised their analyses descriptions to specify what was pre-planned and what was exploratory. The researchers noted that they conducted much of the exploratory analyses based on the advice of patient and scientific advisors. The researchers also tempered their conclusions regarding the success of the IMGV since there was no significant difference in primary outcomes between the two treatment arms.
- Reviewers commented that it was unclear whether different components of the IMGV intervention, including mindfulness techniques and group visits, were meant to work independently, additively, or synergistically. The researchers replied that Figure 2 demonstrates the proposed mechanism of how different aspects of the intervention work, but the study was not designed to assess how well individual components work or whether they work in synergy.
- Reviewers noted that the study provided no information on the range of treatmentsthe usual care participants received and suggested that without better-defined mechanisms for treatment components, any differences observed could be due to the amount of attention participants received in the study. The researchers agreed that they did not collect important information on the control group, such as time spent with clinicians. They expanded on this in the limitations section.
- Reviewers noted that the researchers collected several measures of intervention uptake for the IMGV group, as well as measures on use of non-pharmacological treatments in the usual care group but did not use these data in analyses to help identify reasons for the null study findings. The researchers explained that they did not factor in non-pharmacological treatment changes because so many participants in the usual care group were already using non-pharmacological treatments when they started the study.
Conflict of Interest Disclosures
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Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
Low Health Literacy/Numeracy