Surveys of parents and clinicians concerning the minimally important difference of probiotic therapy for prevention of paediatric antibiotic-associated diarrhoea

OBJECTIVES: To establish the minimally important difference (MID) that would prompt parents and clinicians to use probiotics for prevention of paediatric antibiotic-associated diarrhoea (AAD) and to obtain parent and clinician opinion about the most important outcomes in clinical trials of AAD. METHODS: In this survey, parents of children presenting to the emergency department of a Canadian tertiary care children’s hospital and paediatricians working in that hospital were approached. A range of potential MIDs were presented and participants selected one that they would require to use probiotics for AAD prevention. In addition, participants were asked to rate a list of outcomes they would consider to be important in clinical trials of AAD. RESULTS: In total, 127 parents and 45 paediatricians participated. About 51% (64/125) of parents and 51% (21/41) of clinicians responding to the MID question reported they would use probiotics if it reduced the risk of AAD by 39% (ie, reduce the risk of AAD from 19% to 12%). The most important outcomes to parents, in descending order, were need for hospitalisation, prevention of dehydration, disruption of normal daily activities, diarrhoea duration and physician revisit. Paediatricians considered need for hospitalisation along with physician revisit as the most important outcomes. They rated prevention of dehydration, diarrhoea duration and stool frequency as important outcomes as well. CONCLUSION: There is good agreement between parents and clinicians regarding how effective probiotics would need to be in preventing AAD in order to warrant use. This information, along with outcomes perceived to be most important, will help in the design of future clinical trials.