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Longitudinally collected outcomes are increasingly common in cell biology and gene therapy research.
Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results, and routinely collected outcomes should be prioritized.
The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) empowers surgeons and medical centers to reliably collect, analyze, and act on clinically collected outcomes data.
For studies that were published, not all collected outcomes were reported.
In addition to the main study outcomes, the pilot study collected outcomes to establish feasibility of the protocol and processes.
In order to improve internal validity (reliability of the result) outcomes were patient-centred and an independent assessor collected outcomes.
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We collected outcome measure data prospectively.
All patients had detailed, prospectively collected outcome data with primary outcome at 90 days.
The quality of routinely collected outcome data in the field could not be judged.
We collected outcome measures at 5, 12 and 24-weeks post baseline.
Field workers not involved in the implementation of the trial collected outcome data.
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