Title: Risk of Clostridioides difficile infection in inflammatory bowel disease patients
undergoing vedolizumab treatment: a systematic review and meta-analysis
Version: 1 Date: 17 Jul 2024
Reviewer's report:
This is a meta-analysis of the incidence of Clostridioides difficile in patients with inflammatory
bowel disease being treated with vedolizumab. This is an important question however there are
concerns with this study in its current form.
1) The authors need to update the title to reflect the updated nomenclature.
2)  Under results in the abstract, the authors need to indicate what the range indicates. This is
assumed to be a 95% confidence interval, however this should be labeled.
3) In the background section, the authors indicate that "vedolizumab posed an increased risk
of gastrointestinal infections compared to the placebo group" however the cited article findings
state: "the exposure-adjusted incidence rates of any infection were lower among patients
receiving vedolizumab (63.5/100 PYs; 95% CI 59.6 to 67.3) than placebo (82.9/100 PYs; 95%
CI 68.3 to 97.5)" and  "The exposure-adjusted incidence rates of serious infections were similar
for vedolizumab and placebo ". Therefore, the authors' statement is incorrect.
4)  The authors included low quality studies in this analysis, such as case series and included
studies that were only published in abstract form. Using low quality studies decreases the
strength of the findings.  Further, it appears that the authors included at least 1 cohort twice
(Kochar - once in abstract form and once full publication).
5) Many of the results either showed a 95% CI that crosses 1 or have a very high i2 score
supporting a finding of a high level of heterogeneity between the studies.  Despite these results,
the authors report a "potentially lower risk of c. difficile infection with vedolizumab" however
this cannot be concluded when the 95% CI crosses 1.
Title: Risk of Clostridioides difficile infection in inflammatory bowel disease patients
undergoing vedolizumab treatment: a systematic review and meta-analysis
Version: 1 Date: 17 Jul 2024
Reviewer's report:
This is a meta-analysis of the incidence of Clostridioides difficile in patients with inflammatory
bowel disease being treated with vedolizumab. This is an important question however there are
concerns with this study in its current form.
1) The authors need to update the title to reflect the updated nomenclature.
2)  Under results in the abstract, the authors need to indicate what the range indicates. This is
assumed to be a 95% confidence interval, however this should be labeled.
3) In the background section, the authors indicate that "vedolizumab posed an increased risk
of gastrointestinal infections compared to the placebo group" however the cited article findings
state: "the exposure-adjusted incidence rates of any infection were lower among patients
receiving vedolizumab (63.5/100 PYs; 95% CI 59.6 to 67.3) than placebo (82.9/100 PYs; 95%
CI 68.3 to 97.5)" and  "The exposure-adjusted incidence rates of serious infections were similar
for vedolizumab and placebo ". Therefore, the authors' statement is incorrect.
4)  The authors included low quality studies in this analysis, such as case series and included
studies that were only published in abstract form. Using low quality studies decreases the
strength of the findings.  Further, it appears that the authors included at least 1 cohort twice
(Kochar - once in abstract form and once full publication).
5) Many of the results either showed a 95% CI that crosses 1 or have a very high i2 score
supporting a finding of a high level of heterogeneity between the studies.  Despite these results,
the authors report a "potentially lower risk of c. difficile infection with vedolizumab" however
this cannot be concluded when the 95% CI crosses 1.
Please review this paper.
user
Title: Risk of Clostridioides difficile infection in inflammatory bowel disease patients
undergoing vedolizumab treatment: a systematic review and meta-analysis
Version: 1 Date: 17 Jul 2024
Reviewer's report:
This is a meta-analysis of the incidence of Clostridioides difficile in patients with inflammatory
bowel disease being treated with vedolizumab. This is an important question however there are
concerns with this study in its current form.
1) The authors need to update the title to reflect the updated nomenclature.
2)  Under results in the abstract, the authors need to indicate what the range indicates. This is
assumed to be a 95% confidence interval, however this should be labeled.
3) In the background section, the authors indicate that "vedolizumab posed an increased risk
of gastrointestinal infections compared to the placebo group" however the cited article findings
state: "the exposure-adjusted incidence rates of any infection were lower among patients
receiving vedolizumab (63.5/100 PYs; 95% CI 59.6 to 67.3) than placebo (82.9/100 PYs; 95%
CI 68.3 to 97.5)" and  "The exposure-adjusted incidence rates of serious infections were similar
for vedolizumab and placebo ". Therefore, the authors' statement is incorrect.
4)  The authors included low quality studies in this analysis, such as case series and included
studies that were only published in abstract form. Using low quality studies decreases the
strength of the findings.  Further, it appears that the authors included at least 1 cohort twice
(Kochar - once in abstract form and once full publication).
5) Many of the results either showed a 95% CI that crosses 1 or have a very high i2 score
supporting a finding of a high level of heterogeneity between the studies.  Despite these results,
the authors report a "potentially lower risk of c. difficile infection with vedolizumab" however
this cannot be concluded when the 95% CI crosses 1.
assistant