The IGNITE trial: Participant recruitment lessons prior to SARS-CoV-2
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Abstract
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SciScore for 10.1101/2020.05.19.20107458: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The script began with a description of the study design, and then study procedures, and request for verbal consent for data collection to determine eligibility. Randomization Enrollees passing all screening criteria are randomized to one of three groups: 150 min per week of light intensity stretching and toning condition exercise; 150 min per week of aerobic exercise; 225 min per week of aerobic exercise. Blinding not detected. Power Analysis not detected. Sex as a biological variable We anticipated approximately 60% of the final sample would be female. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did …
SciScore for 10.1101/2020.05.19.20107458: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The script began with a description of the study design, and then study procedures, and request for verbal consent for data collection to determine eligibility. Randomization Enrollees passing all screening criteria are randomized to one of three groups: 150 min per week of light intensity stretching and toning condition exercise; 150 min per week of aerobic exercise; 225 min per week of aerobic exercise. Blinding not detected. Power Analysis not detected. Sex as a biological variable We anticipated approximately 60% of the final sample would be female. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Though the IGNITE recruitment experience can inform this and other exercise trials, several limitations should be considered. First, our phone screen flow did not capture all demographics and medical history on every potential participant. We do not know, for example, if the individual who did not want to have an MRI would have been excluded anyway for heart disease. This limits our ability to fully assess the impact of inclusion criteria on study diversity. We have made the assumption that individuals who were not interested in completing the phone screening were balanced in their race, ethnicity, and gender. This is in part due to Institutional Review Board requirements that the study be explained prior to collection of demographics or screening information. Second, the trial is not fully enrolled. It does not capture the potential effect of any increased investment in enrollment of specific populations, nor any damaging effect of SARS-CoV-2. We have listed our plans to support enrollment of men and individuals identifying as URM. The success of these initiatives remains to be quantified. In conclusion, the IGNITE trial will provide essential information on the role of aerobic exercise in promoting sustained cognition and overall brain health as we age. The study team is making additional efforts to increase enrollment of men and URM to ensure the findings are generalizable to the broader American population of healthy older adults. Future studies in aging populations shoul...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT02875301 Recruiting Investigating Gains in Neurocognition in an Intervention Tri… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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