Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial

Table 3 Schedule of events

Trial procedures	Pre-screening	Screening Visit	Baseline	Week 1 (+ / −) 3 days	Week 6 (+ / −) 2 weeks	Month 6 (+ / −) 6 weeks	Month 12 (+ / −) 6 weeks	Month 18 (+ / −) 6 weeks	Month 24 (+ / −) 6 weeks	Month 30 (+ / −) 6 weeks	Month 36 (+ / −) 6 weeks	At variceal bleed	At trial completion (via notes)
Informed consent		X
Eligibility criteria		X	X
Randomisation			X
Demographics^a		X
Medical history^a		X
Targeted physical exam^a		X	X^c			X	X	X	X	X	X
Weight/height^a		X	X^c			X	X	X	X	X	X
Vital signs (BP/HR)^a		X	X	X		X	X	X	X	X	X	X
TE/APRI (FibroScan)^a	X
FBC, INR, liver, renal and bone profile^a			X^e			X	X	X	X	X	X	X
Liver prognostic scores^af			X^e			X	X	X	X	X	X	X
AUDIT-C/alcohol questionnaire^a			X			X	X	X	X	X	X
Variceal haemorrhage status						X	X	X	X	X	X	X
IMP dispensing			X^g			X	X	X	X	X
Commence IMP			X
Dose – titration				X	X	X	X	X	X	X	X	X
HCC surveillance US^a	X^d					X	X	X	X	X	X	(X)
Gastroscopy^a	X^e						X		X		X	X
Conmeds^a			X	X	X	X	X	X	X	X	X
Adverse events (AEs)^b				X	X	X	X	X	X	X	X		X
QoL questionnaire			X			X	X	X	X	X	X
Health care usage			X			X	X	X	X	X	X		X
Adherence to IMP				X		X	X	X	X	X	X	X
Telephone call					X

^astandard of care
^aAEs collected from baseline to 30 days post M36 visit/permanent IMP discontinuation (not including death)
^cnot repeated if screening and baseline are within 2 weeks
^dcompleted within 6 months of screening or last SOC surveillance for HCC-US [alternative imaging methods [CT and/or MRI] are permitted as long as the data needed is provided])
^ecompleted within 6 months of baseline
^fChild-Pugh, MELD, UKELD, CLIF-C AD
^gIMP to be allocated within 4 weeks of consent

ISSN: 1745-6215