Skip to main content

Table 1 Detailed schedule of assessments

From: Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

Months of follow up 0 visit 6-8 wks 6m 12m 18m 24m 30m 36m Finala visit
visit call/visit visit call/visit visit call/visit visit
Participant characteristics & medical history x         
Weight, height, waist circumference and BMI x    x      x
Concomitant medication x x   x   x   x x
Home support x         x
Safety and monitoring
Morbidity, mortality, hospitalisation and GP contacts   x x x x x x x x
Serious Adverse Events   x x x x x x x x
Single-lead ECG (for AF) x    x   x   x x
Drug adherence   x x x x x x x x
Outcomes
Thyroid related quality of life (ThyPRO) x x   x      x
Generic quality of life (EQ-5D-3L) x x   x      x
Cognitive function
 MMSE x         
 Letter Digit Coding Test x         x
Functional ability
 ADL (BI), IADL (OARS), falls questionnaire x         x
 Handgrip strength & 6-meter gait speed x    x      x
Blood pressure x    x      x
Fatal and non-fatal cardiovascular events   x x x x x x x x
Arthritis complaints          x
Treatment Satisfaction (TSQM vII)          x
Laboratory analysis
Thyroid function x x   x   x   x x
Haemoglobin x    x      
Blood samples for biobank x    x      
  1. athe final visit assessments may substitute for any assessment time between 12 and a maximum of 42 months