Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 5 Date: 01 May 2024
Reviewer's report:
This work aimed to combine clinical trial data and real-word evidence using statistical
methodologies to predict long-term effectiveness of Darvadstrocel versus standard of care in
patients with complex Crohn’s perianal fistulas.
Major comments:
- Table 3: let median and IQR only. I'm not sure there's any point in leaving mean and median.
- The paragraph on the statistical model on page 12 (line 253) could be clearer. Its place in the
results section is unclear. The results section could begin by describing what the article aims to
study, and therefore the clinical outcomes.
- The fact that the data relating to the statistical model is mixed with the clinical data (line
285-292 for example) makes it difficult to read the manuscript (particularly for a clinician). A
section dedicated to the analysis of the models, separate from the clinical data, would perhaps
make it easier to read.
- The place of MSC versus SoC strategy in clinical practice in the light of these results could
be discussed.
Minor comments:
- Line 94: SoC/placebo
Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 5 Date: 01 May 2024
Reviewer's report:
This work aimed to combine clinical trial data and real-word evidence using statistical
methodologies to predict long-term effectiveness of Darvadstrocel versus standard of care in
patients with complex Crohn’s perianal fistulas.
Major comments:
- Table 3: let median and IQR only. I'm not sure there's any point in leaving mean and median.
- The paragraph on the statistical model on page 12 (line 253) could be clearer. Its place in the
results section is unclear. The results section could begin by describing what the article aims to
study, and therefore the clinical outcomes.
- The fact that the data relating to the statistical model is mixed with the clinical data (line
285-292 for example) makes it difficult to read the manuscript (particularly for a clinician). A
section dedicated to the analysis of the models, separate from the clinical data, would perhaps
make it easier to read.
- The place of MSC versus SoC strategy in clinical practice in the light of these results could
be discussed.
Minor comments:
- Line 94: SoC/placebo
Please review this paper.
user
Title: Predictive modeling to evaluate long-term treatment effectiveness of darvadstrocel in
patients with complex perianal fistulas in Crohn’s disease
Version: 5 Date: 01 May 2024
Reviewer's report:
This work aimed to combine clinical trial data and real-word evidence using statistical
methodologies to predict long-term effectiveness of Darvadstrocel versus standard of care in
patients with complex Crohn’s perianal fistulas.
Major comments:
- Table 3: let median and IQR only. I'm not sure there's any point in leaving mean and median.
- The paragraph on the statistical model on page 12 (line 253) could be clearer. Its place in the
results section is unclear. The results section could begin by describing what the article aims to
study, and therefore the clinical outcomes.
- The fact that the data relating to the statistical model is mixed with the clinical data (line
285-292 for example) makes it difficult to read the manuscript (particularly for a clinician). A
section dedicated to the analysis of the models, separate from the clinical data, would perhaps
make it easier to read.
- The place of MSC versus SoC strategy in clinical practice in the light of these results could
be discussed.
Minor comments:
- Line 94: SoC/placebo
assistant