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In clinical trials, agreement on outcomes is of utmost importance for valid estimation of intervention effects.
Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects.
This can lead to biased estimation of intervention effects, both within and between patient groups.
An estimation of intervention effect on outcome measures will be obtained at each follow-up observation (2, 12, & 24 months post-baseline) on an intention to treat basis.
Due to the large number of stratifier categories, there will be no adjustment for stratifiers in order to ensure that estimation of intervention effects is stable.
A comparison of different caliper widths found that this width was superior to others at reducing conditional bias in the estimation of intervention effects [ 51].
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However, we had not taken into account stratification of GPs according to CVR knowledge for the estimation of the intervention effect, and the power of the study was insufficient to demonstrate an intervention effect in a specific subgroup.
In economic evaluation alongside clinical trials, estimation of direct intervention costs, i.e. the value of the resources used in the provision of the intervention, is normally straightforward in well-defined interventions.
The use of Bayes factor might, therefore, be an incentive for a more realistic and smaller estimation of anticipated intervention effects, leading to more trials with sufficient power and less trials either overestimating or underestimating intervention effects.
In addition to estimation of crude intervention effects, multivariable linear regression analysis will be used to compare infant mean weight gain between intervention groups, while adjusting for baseline covariates that were a priori determined to be important confounders in the published literature.
This could, then, result in either under- or over estimation of the intervention effects [ 14, 15].
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