The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial

Table 1 Trial outcomes

Outcome	Characteristics	Assessment time	Comparisons^a	Null Hypothesis^a
Primary outcome (Informed choice elements)
Knowledge	Numeric scale	Baseline	1 vs. 2	No difference
	Numeric scale	Dif_{Follow-up-baseline}^b	1 vs. 2	1 > 2
	Numeric scale	Follow-up	1 vs. 2 vs H	1 > 2 and 1 > H
Attitudes	Numeric scale	Baseline	1 vs. 2	No difference
Attitudes	Numeric scale	Dif_{Follow-up-baseline}^b	1 vs. 2	No difference
Uptake	Dichotomous	Follow-up	1 vs. 2 vs H	1 > 2 and 1 > H
Secondary outcomes
Decisional conflict	Numeric scale	Follow-up	1 vs. 2 vs H	1 < 2 and 1 < H
Worry	Numeric scale	Baseline	1 vs. 2 vs H	No difference
Worry	Numeric scale	Dif_{Follow-up-Baseline}^b	1 vs 2	1 < 2
Effect modifiers and confounders
Health literacy	Numeric scale	Baseline	1 vs. 2 vs. H	No difference
Background data
Family income	Categorical	Post survey	1 vs. 2 vs. H	No difference
Occupation	Categorical	Post survey	1 vs. 2 vs. H	No difference
Marital status	Dichotomous	Post survey	1 vs. 2 vs. H	No difference
Ethnicity	Categorical	Post survey	1 vs. 2 vs. H	No difference

H historic study arm
^aGroup 1 refers to the intervention group and group 2 refers to the control group
^bDif_{Follow-up-Baseline}: The mean increase or decrease in knowledge, attitude, and worry-score from baseline to follow-up will be estimated. Means will be compared between the two study arms

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