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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