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Table 1 Timing of data collection

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

Variable

Inclusion baseline

Follow-up 6 weeks ± 1 week

Follow-up 3 months ± 2 weeks

Follow-up 6 months ± 2 weeks

Follow-up 12 months ± 2 weeks

Follow-up 18 months ± 2 weeks

Visit

x

 

x

 

x

x

Weight

x v

 

x v

 

x v

x v

Medical treatment

x v

 

x v

 

x v

x v

ThyPRO

x r

x r

x r

x r

x r

x r

TSH, FT4, FT3

x s

 

x s

 

x s

x s

TPO-Ab

x s

 

x s

 

x s

x s,

LT4 dosage

x v

 

x v

 

x v

x v

Immunological and oxidative stress biomarkers

x s

 

x s

 

x s

x s

Selenium

x s

 

x s

 

x s

x s

Creatinine/iodine ratio in spot urine

x s

     

Tablet count

  

x v

 

x v

 

Consumption of additional selenium

x v

 

x v

 

x v

x v

Adverse reactions

  

x v

 

x v

x v

Serious adverse reactions and events (SARs, SUSARs and SAEs)

     

x p

  1. All assessments must be made at the time points specified above. If not possible at the specified time, the assessment shall still be conducted, and the time of assessment shall be noted in the specified electronic case report form (eCRF). x v , analyzed via data obtained in eCRFs at trial visits, administered through the trial data management system (TDMS); x r , analyzed via patient-reported outcomes, administered through the TDMS; x s , analyzed in blood or urine samples obtained at trial visits; x p , analyzed via public national registries at the end of the trial.