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Table 2 Outcome measures

From: The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial

Outcome (priority)

Times of measurements

Mathematical type of quantity (analytical category)

ThyPRO composite scale score (P)

Time sequence of six measurementsa

Numerical (1 + 2)

ThyPRO hypothyroid symptoms (S)

Time sequence of six measurementsa

Numerical (1 + 2)

ThyPRO goitre symptoms (S)

Time sequence of six measurementsa

Numerical (1 + 2)

LT4 dosage (S)

Time sequence of four measurementsb

Numerical (1 + 2)

Serum TPO-Ab (S)

Time sequence of four measurementsb

Numerical (1 + 2)

Serum FT3/FT4 Ratio (S)

Time sequence of four measurementsb

Numerical (1 + 2)

Plasma selenium (S)

Time sequence of four measurementsb

Numerical (1 + 2)

Biomarkers of immunology and oxidative stress (S)

Time sequence of four measurementsb

Numerical (1 + 2)

Adverse reactions (S)

End of trial

Rate (3)

Serious adverse events (S)

End of trial

Rate (3)

  1. Outcomes with priorities, times of measurement and mathematical types of quantity with analytical categories. P, primary outcome measure; S, secondary outcome measure. Analytical categories 1 to 3 are defined in the main text. a, includes five measurements relative to the reference time (6 weeks, 3 months, 6 months, 12 months and 18 months after randomization); b, includes three measurements relative to the reference time (3 months, 12 months and 18 months after randomization).