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Table 1 SORTED A study assessments

From: Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial

  Pre-screening Screening Baseline Follow-up
Visit    1 2 3 4 (phone call only)
Assessmentsa Within 3 months of baseline visit Week −4 to −1 Day 0 Week 12 (+/− 7 days) Week 24 (+/− 7 days) Week 25 (+/− 3 days)
Identification and initial approach (including provision of PIS) X      
Eligibility criteria checked (as per routine clinical practice) X      
Written informed consent (including discussion of study in detail, questions answered)   X     
Physical examination (height,e weight, blood pressure, pulse)    X   X  
Venepuncture    X b X c Xd  
Clinical history (relevant medical history, medication list/history)    X    
Participant-completed questionnaires (ThyDQoL, ThySRQ, EQ-5D)    X   X  
Nurse-administered questionnaires (FRAT, TUG)    X   X  
Randomization (after all eligibility criteria checked and written informed consent obtained)    X    
Study medication prescribed and dispensed (following LT4 dose assessment at visit 2 only)    X X   
Study medication compliance checks     X X  
Concomitant medication    X X X  
Adverse events     X X  
Serious adverse events     X X X
  1. a Study-specific procedures must only be performed once written informed consent is obtained from the participant; b 10 ml blood: TSH, FT4, FT3, thyroid peroxidase antibodies, total cholesterol, HDL, triglycerides, serum CTX; c 5 ml blood: TSH, FT4, FT3 only; d 10 ml blood: TSH, FT4, FT3, total cholesterol, HDL, triglycerides, serum CTX; e height to be measured at the baseline visit only.
  2. FT3: free triiodothyronine (thyroid hormone); FT4: free thyroxine; HDL: high-density lipoprotein; serum CTX: serum collagen type-1 cross-linked C-telopeptide; TSH: thyroid stimulating hormone, PIS: participant information sheet.