Results Summary and Professional Abstract
|This project's final research report is expected to be available by November 2021.|
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 requested additional background information in the report, particularly about how gaming and virtual reality methods have affected medical care. The researchers expanded the introduction in the report but said that they did not expand on gaming and virtual reality methods much because they felt this would distract from the focus of the report. The researchers explained that the goal of the study was to affect access barriers in the delivery of constraint-induced movement therapy (CIMT), and the gaming technology they used was meant to be a vehicle for testing their efforts to improve access.
- The reviewers asked whether the sizeable number of individuals who consented to participate in the study but did not start treatment were included in the analyses. The researchers said that in fact, they did not analyze data from the people who never started treatment because almost no data were collected about them. If they were to interpolate the data as necessary to include these individuals, the researchers felt that the results were more likely to be biased. The researchers noted that many of the patients that withdrew so early from the study did so because of challenges like transportation rather than because of the treatment they had been assigned, and the researchers felt that it would be appropriate to exclude those cases.
- Reviewers suggested the study did not have enough statistical power to accurately assess differences among the four treatment arms and that the study should have been stopped or more subjects should have been recruited. The researchers said budget and time constraints did not allow for enrolling more participants to account for the higher-than-expected attrition, but the researchers did work to increase recruitment, for example by adding a study site. The researchers noted that they openly discussed their failure to achieve the desired sample size in the report and qualified their conclusions accordingly. The researchers said they still detected statistically significant comparative treatment effects despite the smaller than expected number of participants.
- One reviewer felt the researchers overstated the known value of CIMT as an approach to stroke rehabilitation and stated that the researchers did not consider past literature demonstrating that CIMT was as effective as standard care for motor rehabilitation after stroke. This reviewer questioned whether the study conclusions were appropriate given the lack of sufficient power to test the primary outcome and comparable changes in motor improvement across all conditions. The researchers refuted the reviewer’s statement regarding lack of efficacy in CIMT, providing additional literature that demonstrated the superiority of CIMT over standard care. The researchers acknowledged that the results did not differ based on CIMT delivery methods. However, the researchers noted that their advisory board found the results to be encouraging because the findings show that engaging in rehabilitation of any type even long after a stroke leads to improvements in motor function and gives patients a choice of treatments administered remotely when it may not be feasible for them to obtain treatments in a clinic.
Conflict of Interest Disclosures
The COI disclosure form for this project will be posted here soon.
Other Clinical Interventions
Other Health Services Interventions
^Lynne Vonda Gauthier, PhD, was the original principal investigator on this project.