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Table 1 Characteristics of trials included in the DelibeRATE study a

From: Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials

Trial characteristics Trial 1 Trial 2 Trial 3
Clinical condition Vaginal prolapse Haemorrhoids Ureteric stones
Trial design RCT and comprehensive cohort Simple parallel design Simple parallel design
Sample size, N (n) 4,500 (2,250 randomised) 800 1,200
Recruitment rate (%) 49 74 56
Arms 3 in each repair arm (4 different interventions) 2 3
Intervention Surgery (RCT split by primary or secondary repair Surgery Drug
  Primary repair randomisation 1. Traditional excisional haemorrhoidectomy 1. Calcium channel blocker
  1. Standard repair 2. Stapled haemorrhoidopexy 2. α blocker
  2. Standard repair with biological mesh   3. Placebo
  3. Standard repair with nonabsorbable mesh   
  Secondary repair randomisation   
  1. Standard repair   
  2. Standard repair with nonabsorbable mesh   
  3. New repair with mesh kit   
Blinding Participants and outcome assessors (for patient-reported outcomes) Participants and outcome assessors (for patient-reported outcomes) Participants, caregivers and outcome assessors
Number of sites 15 31 24
Primary outcome (clinical or patient-reported and timing) Patient-reported at 2 years postrandomisation Patient-reported at 2 years postrandomisation Clinical at 4 weeks and patient-reported at 12 weeks postrandomisation
Parent trial participant characteristics
Median age (IQR) 61 (52 to 68) 49 (20 to 40) 44 (34 to 52)
Sex (% females) 100 48 19
  1. aRCT, Randomised controlled trial.