778 infection control & hospital epidemiology july 2018, vol. 39, no. 7


figure 3. Incidence of serious adverse events. table 3. Summary of Findings Table Based on Adjusted Analysisa


Control Group


No. of Participants Outcomes CDI defined by: cytotoxin and/or culture (No. of Studies)


Relative Effect, Odds Ratio (95% CI)


Serious adverse events defined by author report and/or IPD 4,714 (11) 1.06 (0.89–1.28) 122 5,074 (13) 0.35 (0.23–0.55)


Assumed Risk per 1,000b


27


Probiotic Group


Comparative Risk


per 1,000 (95% CI)b


12 (8–16)


Quality of Evidence (GRADE)c


Moderated 123 (110–136) Moderatee NOTE. CI, confidence interval; OR, odds ratio; GRADE, working group grades of evidence; CDI, Clostridium difficile infection; SAE, severe adverse


event; IPD, individual participant data; RCT, randomized controlled trial. aPatient or population: adults and children exposed to antibiotics. Settings: inpatient and outpatient. Intervention: probiotics. bRisk for the control group represents mean rate across studies. Risk for probiotics group is calculated by applying the relative effect rate to the


control risk. cHigh quality: further research is very unlikely to change our certainty in the estimate of effect. Moderate quality: further research is likely to have


an important impact on our certainty in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our certainty in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the


estimate. dWe rated CDI down for imprecision because of a low number of total events (<300). eWe rated SAEs down for risk of publication bias as we were only able to obtain IPD for 18 of 32 RCTs and among the IPD trials only 11 trials (n=4,718) could be included in our adjusted analysis.


find a dose effect may represent the variability in dose admi- nistered (viable organisms per capsule) as well as the potential variability between studies with respect to whether the


consumed dose survived gastric passage (viable organisms arriving in small and subsequently large bowel). Both are important areas of inquiry for future studies.


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