Concepedia

Abstract

study protocolThe methods section in a protocol should provide a description of the intervention(s) (whether active, usual practice, or placebo) that is sufficiently detailed to enable people with appropriate expertise to reproduce them.This should include:• What were the "contents," including all constituent components, materials, and resources and their quality • Who delivered the intervention, including their expertise, additional training, and support • Where the intervention was delivered (the setting) • How and when the intervention was delivered: the dose, the schedule (intensity, frequency, duration), and interaction • The degree of flexibility permissible, including options and decision points. 3 This list is readily adaptable for interventions beyond clinical treatments and encounters-for example, to health systems and other complex interventions.Attention should be paid to the different meanings that terms such as counselling or physical therapy may have in different settings.Space constraints in trial registration databases and

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