Title: Effect of Diabetes Mellitus Type 2 and Sulfonylurea on Colorectal Cancer Development:
A Case-Control Study
Version: 6 Date: 16 Oct 2024
Reviewer:  Ehab Elmongui
Reviewer's report:
Dear Author,
The sample size calculation should be clearly outstated in the methods section including all the
parameters used in the formula for case-control studies:
1- Odds Ratio (OR): The estimated effect size you aim to detect between the cases and controls
regarding the exposure (e.g., T2D or sulfonylurea use). This value could be based on previous
studies, pilot data, or a a defined value assuming a medium effect size.
2- Prevalence of Exposure in Controls (p0): The proportion of control subjects who are exposed
to the risk factor (e.g., having T2D or using sulfonylureas)
3- Desired Power (1 – #)
4- Significance Level (#)
5- Ratio of Controls to Cases (m)
6- Adjustment for Multiple Covariates: If multivariate analysis is planned, adjustments might
be needed to maintain adequate power considering potential confounders. For instance you may
use the Rule of Thumb commonly used in regression analyses to have at least 10 events per
variable (EPV). This means you should aim for at least 10 cases for each confounder you plan
to include in the model.
Best Regards
Ehab Elmongui, BPharmSC, PharmD, MSc, PhD(c) (Medical Statistics)
Title: Effect of Diabetes Mellitus Type 2 and Sulfonylurea on Colorectal Cancer Development:
A Case-Control Study
Version: 6 Date: 16 Oct 2024
Reviewer:  Ehab Elmongui
Reviewer's report:
Dear Author,
The sample size calculation should be clearly outstated in the methods section including all the
parameters used in the formula for case-control studies:
1- Odds Ratio (OR): The estimated effect size you aim to detect between the cases and controls
regarding the exposure (e.g., T2D or sulfonylurea use). This value could be based on previous
studies, pilot data, or a a defined value assuming a medium effect size.
2- Prevalence of Exposure in Controls (p0): The proportion of control subjects who are exposed
to the risk factor (e.g., having T2D or using sulfonylureas)
3- Desired Power (1 – #)
4- Significance Level (#)
5- Ratio of Controls to Cases (m)
6- Adjustment for Multiple Covariates: If multivariate analysis is planned, adjustments might
be needed to maintain adequate power considering potential confounders. For instance you may
use the Rule of Thumb commonly used in regression analyses to have at least 10 events per
variable (EPV). This means you should aim for at least 10 cases for each confounder you plan
to include in the model.
Best Regards
Ehab Elmongui, BPharmSC, PharmD, MSc, PhD(c) (Medical Statistics)
Please review this paper.
user
Title: Effect of Diabetes Mellitus Type 2 and Sulfonylurea on Colorectal Cancer Development:
A Case-Control Study
Version: 6 Date: 16 Oct 2024
Reviewer:  Ehab Elmongui
Reviewer's report:
Dear Author,
The sample size calculation should be clearly outstated in the methods section including all the
parameters used in the formula for case-control studies:
1- Odds Ratio (OR): The estimated effect size you aim to detect between the cases and controls
regarding the exposure (e.g., T2D or sulfonylurea use). This value could be based on previous
studies, pilot data, or a a defined value assuming a medium effect size.
2- Prevalence of Exposure in Controls (p0): The proportion of control subjects who are exposed
to the risk factor (e.g., having T2D or using sulfonylureas)
3- Desired Power (1 – #)
4- Significance Level (#)
5- Ratio of Controls to Cases (m)
6- Adjustment for Multiple Covariates: If multivariate analysis is planned, adjustments might
be needed to maintain adequate power considering potential confounders. For instance you may
use the Rule of Thumb commonly used in regression analyses to have at least 10 events per
variable (EPV). This means you should aim for at least 10 cases for each confounder you plan
to include in the model.
Best Regards
Ehab Elmongui, BPharmSC, PharmD, MSc, PhD(c) (Medical Statistics)
assistant