The PAAD study was designed as a two-stage study. PAAD stage 1 was a prospective observational cohort study in care homes in South Wales with up to 12 months’ follow-up for each resident. It aimed to:
(1) prospectively describe antibiotic prescribing in care homes
(2) determine the incidence of C. difficile carriage and AAD (including C. difficile-associated diarrhoea)
(3) to consider implementation challenges and establish the basis for a sample size estimation for an RCT of probiotic administration with antibiotics to prevent AAD in care homes.
If justified by PAAD stage 1, the RCT would be implemented in PAAD stage 2. However, as a result of new evidence regarding the clinical effectiveness of probiotics on the incidence of AAD, a decision was taken not to proceed with PAAD stage 2.