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Table 1 Trial outcomes

From: 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

Outcome Characteristics Assessment time Comparisonsa Null Hypothesisa
Primary outcome (Informed choice elements)
Knowledge Numeric scale Baseline 1 vs. 2 No difference
Numeric scale DifFollow-up-baselineb 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
Numeric scale DifFollow-up-baselineb 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
Numeric scale DifFollow-up-Baselineb 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
  1. H historic study arm
  2. aGroup 1 refers to the intervention group and group 2 refers to the control group
  3. bDifFollow-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