Panel Paper:
Planning Evaluations of Interventions with Required and Optional Components: Instrumental Variable (IV) Estimation and Sample Size Requirements
*Names in bold indicate Presenter
To estimate the effects of the main and optional components, the authors propose a three-group randomization strategy: one group is randomized into a control condition, a second group is randomized into a treatment condition with the main component only, and a third group is randomized into a treatment group that included both the main component and, additionally, encouragement for the optional component.
Of course, not all members of the third group that are encouraged to take up the optional component would likely do so, and so to estimate the treatment effect of the optional component relative to the main treatment, the authors propose an instrumental variable (IV) method to instrument uptake of the optional component with assignment to the third group.
This paper considers the estimation technique and the sample size requirements of this design both with and without covariates. Sample size formulas are presented for each of the three effects of interest:
1) the effect of the main component relative to control:
n = 2M2(1-RW2) / δ12
2) the effect of the optional component relative to main component only:
n = 2M2(1-RW2) / C2δ22
3) the total effect of the program relative to control:
n = [2M2(1-RW2) / δ2 ][1 + (1/C2) - (1/C)]
Where n is the number of observations in each of the three groups, δ is a Cohen’s d like effect size, C is the compliance rate with the optional component, and R2 is the population squared correlation between the outcome and covariate. M is a factor based on the desired power and level of significance, which is about 2.8 for power of 0.8 and a two-tailed test with αlpha=0.05
Full Paper: