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Table 1 Schedule of assessments

From: Clinical trial readiness to solve barriers to drug development in FSHD (ReSolve): protocol of a large, international, multi-center prospective study

Visits

Visit 1

Visit 2

Visit 3

Visit 4

Day 1

Day 2

Time (Month)

0

3

12

18

+/− 1 Week

+/− 2 Weeks

+/−  2 Weeks

Obtain Consent

X

    

Confirm Eligibility

X

    

Urine Pregnancy Testa

X

 

X

X

X

History and Physical Exam

X

 

X

X

X

Blood for FSHD DNA Testing

X

 

X

  

Blood for Serum Extraction

X

 

X

X

X

Blood for RNA (PAX gene tube)

X

 

X

  

Blood for Plasma (EDTA tube)

X

 

X

X

X

PROs: FSHD-HI, PROMIS57, UEFI, and FDI physical score

X

 

X

 

X

Electrical Impedance Myography

X

X

X

X

X

FSHD-COM / MFM Domain 1

X

X

X

X

X

Strength Testing: QMT and MMT

X

 

X

X

X

Bedside spirometry

X

 

X

X

X

DEXA

X

  

X

 

Clinical Severity Scores

X

 

X

X

X

Iowa Oral Performance Instrument

X

X

X

X

X

Reachable Workspace

X

X

X

X

X

Fall/Exercise Questionnaire

X

 

X

X

X

Fall Assessmentb

  

X

  

“Domain-delta” questionnaire

  

X

X

 
  1. aUrine pregnancy test for women of childbearing age, b weekly × 12 weeks after the month 3 visit
  2. Assessments occur at baseline, 3, 12, and 18 months. The FSHD-COM, electrical impedance myography, MFM Domain 1, Iowa Oral Performance Instrument, and Reachable Workspace are performed on Day 1 and Day 2 of the baseline visit in order to establish intra-rater reliability