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Table 2 Elements of primary outcomes

From: Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial

Domain

Specific measurement

Specific metric

Method of aggregation

Time point

Anxiety (aim 1)

State anxiety subscale of the State-Trait Anxiety Inventory (STAI)

Percent change in STAI score from T1 to T2, and also from T1 to T3

The distribution of the percent change in STAI will be summarized by the mean and standard deviation

Comparisons of percent change from T1 between the groups will be made at T2 and T3

MBD knowledge (aim 1)

3 survey items assessing knowledge of MBD as a risk factor, MBD as a masking effect, and mammography screening intervals

Knowledge score will be calculated as the number of the three knowledge items that are answered correctly (possible range 0–3)

The distribution of the knowledge score will be summarized with frequencies and percentages (i.e., N (%) of participants with all 3 items correct, N (%) with 2 items correct, N (%) with 1 item correct, and N (%) with no items correct)

Comparisons of knowledge score between the groups will be performed at T2 and T3

Continued adherence to mammography (aim 2)

For each participant, we will assess whether they were adherent to their next annual mammogram. This information will be captured via self-report in the T3 survey, corroborated with the electronic health record (EHR) at T3, and assessed via EHR again at T4

Participants will be classified as adherent if there is evidence of having had the next annual mammogram, and will otherwise be classified as non-adherent

Frequency and percentage of participants who were adherent

Comparisons of adherence between the groups will be performed at T3 and T4

  1. T1 = enrollment; T2 = 2–4 weeks post-randomization; T3 = 1-year post-randomization; T4 = 2-years post-randomization