Results Summary and Professional Abstract
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.
Reviewers’ comments and the investigator’s changes in response included the following:
- The reviewers requested that the report better describe the study’s adherence to PCORI’s Methodology Standards. In response, the awardee added explanations of its work in patient and stakeholder engagement. The investigator also explained the relationship of the Lumbar Epidural Steroid Injections for Spinal Stenosis Extended Research (LESSER) study to the previously funded Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) study, including differences in the methods for patient recruitment. The investigator also explained their choices regarding the treatment of missing data.
- The awardee responded to reviewers’ recommendations for analyses of heterogeneity of treatment effects. The investigator described the analyses it conducted that compared lidocaine versus corticosteroid injections. The investigator added details about these analyses and noted that more detail could be found in its published paper.
- Given the long-term nature of the study, the reviewers questioned the awardee’s focus on findings related to three and six week outcomes. The awardees explained that there were three and six week limits to the predictors of outcome analysis due to the findings of no difference at six weeks and the lack of evidence for long-term benefits at 12 months.
- The awardee added a limitation, acknowledging that the design of the original LESS study, from which the current LESSER study came, addressed the effectiveness of corticosteroid versus lidocaine injections and was not powered for secondary analyses. Therefore, the awardee suggested considering those analyses tentative and hypothesis generating.
- The investigator clarified the conclusions, stating that although patients felt that the decision aid’s material was clear and helpful, there was no evidence that using the aid changed patient behavior.
Conflict of Interest Disclosures
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