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

Table 1 Detailed schedule of assessments

Months of follow up	0 visit	6-8 wks	6m	12m	18m	24m	30m	36m	Final^a visit
Months of follow up	0 visit	visit	call/visit	visit	call/visit	visit	call/visit	visit	Final^a 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

^athe final visit assessments may substitute for any assessment time between 12 and a maximum of 42 months

ISSN: 1472-6823