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Additional File 1. CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trialAdditional File 2 Appendix 1: COMPASSND procedures by visit Visit 1: Screening and demographics
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Feasibility refers to the assessment of whether a proposed project or study can be conducted successfully, considering the resources, time, and other constraints. Preliminary efficacy refers to the initial evaluation of how effective a proposed treatment or intervention may be, based on early data or small-scale studies.
Researchers, sponsors, or organizations proposing new medical treatments, clinical trials, or health interventions are typically required to file feasibility and preliminary efficacy evaluations.
Filling out feasibility and preliminary efficacy typically involves completing specific forms or documents that outline the study design, population, expected outcomes, and methods of data collection and analysis, as well as considering ethical and regulatory requirements.
The purpose of feasibility is to ensure that a study can be conducted effectively within the available resources and constraints, while preliminary efficacy aims to provide initial insights into the potential success of an intervention, guiding further research and development.
Information to be reported typically includes study objectives, methodology, population characteristics, intervention details, expected outcomes, preliminary results, and any identified risks or challenges.
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