Skip to main content

Advertisement

Table 3 Outcome measures

From: A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol

Primary outcomes 1. the occurrence of AAD
  2. the occurrence of CDAD
  1. severity1 and duration of AAD
  2. severity1,2 and duration of CDAD and incidence of recurrence within the 8-12 weeks follow-up period
  3. abdominal symptoms (abdominal pain, bloating, flatus, nausea)
Secondary outcomes 4. well-being and quality of life assessed using the generic measures EQ-5D and the York SF12 (Iglesias 2001) at recruitment and 4 and 8 weeks
  5. duration of hospital stay
  6. serious adverse effects
  7. acceptability of the probiotic preparation
  8. viability of the probiotic at point of administration
  9. cost-effectiveness
  1. 1Frequency and consistency of stools. 2Additional information extracted from the clinical records (e.g. laboratory parameters, findings at sigmoidoscopy, pseudomembraneous colitis, colectomy, death).