Results Summary and Professional Abstract
|This project's final research report is expected to be available by May 2020.|
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 noted that an important limitation of this study was the failure to blind outcome assessors from knowledge of the treatment arm to which participants were assigned. The researchers acknowledged that not blinding data collectors was a limitation and added this point to their discussion of the study’s limitations, but they explained that those who collected outcome data were not necessarily aware of participants’ treatment assignments. They also said that any bias would have been in the direction of favoring group over individual acupuncture. Since group acupuncture was not found to be as effective as individual acupuncture, they believed that the bias, if any, was small.
- The reviewers said the report seemed to imply that both individual and group interventions were both effective, but a conclusion could not be made since the study did not include an arm with no treatment. Therefore, the improvements seen in both individual and group intervention conditions could be the result of changes over time rather than intervention effects. The researchers changed the language throughout the report to focus on differences between the two treatment groups.
- Some of the reviewers suggested that subgroup analysis would be helpful to sort patients by pain level, since pain reduction is not as meaningful for those with minimal pain. The researchers agreed that baseline pain scores can influence the magnitude of change in pain scores. However, dividing participants into subgroups would reduce the sample size for evaluating treatment effects, so instead they used other analytical methods to try to adjust for baseline pain scores.
Conflict of Interest Disclosures
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