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Table 3 Study assessment schedule

From: Autologous stem cell transplantation in refractory Crohn’s disease – low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study

  Screening1 Baseline   Week 4 (HSCT only) Week 8 Week 14 Week 24 Week 32 Week 40 Week 48
Assessments
 Eligibility assessment ✓ ✓ HSCT procedure (intervention) or continuation on current treatment (control)        
 Consent ✓         
 Standard Pre-HSCT work (including chest x-ray and MUGA scan) ✓         
 Serology for HBV, HCV, HIV ✓         
 Demographics ✓         
 Medication history ✓         
 Concomitant medications ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
 Adverse events    ✓ ✓ ✓ ✓ ✓ ✓ ✓
 General Medical History ✓         
 History of CD ✓         
 General Physical Examination ✓ ✓   ✓ ✓ ✓ ✓ ✓ ✓
 Urinalysis ✓ ✓        
 Pregnancy test ✓ ✓        
 Smoking History ✓         
 Crohn’s Disease Activity Index (CDAI) ✓ ✓   ✓ ✓ ✓ ✓ ✓ ✓
 Harvey Bradshaw Index ✓ ✓   ✓ ✓ ✓ ✓ ✓ ✓
 Karnofsky Performance Status ✓         ✓
 Patient Reported Outcome 2 questionnaire (PRO2) ✓    ✓ ✓ ✓ ✓ ✓ ✓
 Ileo-colonoscopy (Simple Endoscopic Score for Crohn’s Disease (SES CD)) / endoscopic assessment ✓      ✓    ✓
 Biopsies2 ✓      ✓    ✓
 MRI Intestine ✓   ✓    ✓    ✓
 MRI Pelvis ✓         
 Routine Clinical Care blood test   ✓   ✓ ✓ ✓ ✓ ✓ ✓
 Serum3   ✓   ✓ ✓ ✓ ✓ ✓ ✓
 Whole Blood3   ✓   ✓ ✓ ✓ ✓   ✓
 Peripheral Blood mononuclear cells (PBMCs)3   ✓   ✓ ✓ ✓ ✓   ✓
 Stool sample3   ✓   ✓ ✓ ✓ ✓   ✓
 Inflammatory Bowel Disease Questionnaire (IBDQ) ✓    ✓ ✓ ✓ ✓ ✓ ✓
 Inflammatory Bowel Disease Control Questionnaire (IBD-Control) ✓    ✓ ✓ ✓ ✓ ✓ ✓
 100 day safety (collection of Adverse Events for transplant endpoint)      ✓     
 EQ-5D-5 L ✓    ✓ ✓ ✓ ✓ ✓ ✓
 Work Productivity and Activity Impairment questionnaire (WPAI) ✓    ✓ ✓ ✓ ✓ ✓ ✓
 Health Care Resource Use Questionnaire ✓    ✓ ✓ ✓ ✓ ✓ ✓
 Patient Global Impression of Change (PGIC)          ✓
For participants in HSCTlite arm only:
 JACIE and HTA recommended routine tests   ✓ HSCT procedure (intervention) or continuation on current treatment (control)        
 Anti-TNF therapy initiated (if required)       ✓    
 Adherence to re-vaccination policy      ✓ ✓ ✓ ✓ ✓
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BMC Gastroenterology

ISSN: 1471-230X

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