The issue is not whether blinding should be disregarded, but investigators need to carefully assess how much bias might ensue owing to absence of blinding, and to explore alternative methods of trial design to minimise the risk of bias in the trial.
The strengths of this study are the triangulation of methods and randomized trial design.
Major parts of the CopenHeartSF methods section and trial design in this article are similar to other randomised clinical trials, Copen HeartIE 50 CopenHeartRFA 51 and CopenHeartVR.
We analyzed our design and methods using the recently published 'Pragmatic Explanatory Continuum Indicatory Summary (PRECIS)' tool, a qualitative method to assess trial design across 10 domains.
The meta-regression may have identified the causes of heterogeneity as the intervention method, comparator and trial design.
Here we demonstrate impacts of PET measurement error and choice of quantification method on clinical trial design.
These include procuring the study agents, selecting appropriate study method and clinical trial design, navigating through regulatory obstacles, and obtaining funding.
This trial will utilise a mixed-methods, quasi-experimental trial design where an active Wii intervention will be compared to a control (wait condition) utilising aged care facility residents.
Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial.
These results indicate that usual-care treatment was not equivalent to targeted statin therapy, even in a trial conducted to minimize potential bias owing to traditional patient selection and trial design methods.
MJ, JG, and TG assisted in the statistical methods aspect of the trial design.
