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The efficacy aim of our study is to determine the reduction in CMV disease and the safety aim is to determine the risks of neutropenia, opportunistic infections, late-onset CMV disease, and death among patients receiving valganciclovir versus other preventive therapies (i.e. ganciclovir, valacyclovir, and high-dose acyclovir), or approaches (i.e. prophylaxis and preemptive).
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Patient barriers also contribute to the lack of counselling efficacy aimed at increasing PA levels.
Self-efficacy aims at a broad and stable sense of personal competence which can deal effectively with a variety of stressful situations [ 15].
However, given that efficacy trials aim to address if interventions work under ideal circumstances, secondary analyses using a per-protocol approach may be informative.
Efficacy studies aim to produce results with high internal validity by reducing both bias (e.g. using blinding) and variation (e.g. narrow eligibility criteria and a standardized treatment protocol) to increase the likelihood of detecting the hypothesized difference.
The frequent use of BDI can be theoretically justified as an efficacy study aiming at the efficacious maximisation of intervention.
The third step, called efficacy assessment, aims to investigate the quality of programs.
In addition to evaluating the program's efficacy, we aimed to identify whether girls would benefit equally when it was delivered as a universal intervention to a whole class including both boys and girls (co-educational delivery), or delivered as a selective intervention to girls only (single-sex delivery).
Another recommendation is that additional relevant measures be included, such as the application of self-efficacy scales, aiming at the analysis of associations with illness perception, as well as biological measures.
The sample size was determined to provide adequate power to test EDI treatment efficacy, the primary aim of BRAIN-HIT.
Second, we are conducting an effectiveness trial rather than an efficacy trial; our aim is to maximise generalisability of our findings to usual clinical practice and we therefore have maximised external validity.
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CEO of Professional Science Editing for Scientists @ prosciediting.com