Published online Nov 21, 2021. doi: 10.3748/wjg.v27.i43.7572
Peer-review started: March 4, 2021
First decision: June 3, 2021
Revised: June 30, 2021
Accepted: October 31, 2021
Article in press: October 31, 2021
Published online: November 21, 2021
Of 25% of randomised controlled trials (RCTs) on interventions for inflammatory bowel disease (IBD) have no power calculation.
To systematically review RCTs reporting interventions for the management of IBD and to produce data for minimum sample sizes that would achieve appro
We included RCTs retrieved from Cochrane IBD specialised Trial register and CENTRAL investigating any form of therapy for either induction or maintenance of remission against control, placebo, or no intervention of IBD in patients of any age. The relevant data was extracted, and the studies were grouped according to the intervention used. We recalculated sample size and the achieved difference, as well as minimum sample sizes needed in the future.
A total of 105 trials were included. There was a large discrepancy between the estimated figure for the minimal clinically important difference used for the calculations (15% group differences observed vs 30% used for calculation) explaining substantial actual sample size deficits. The minimum sample sizes indicated for future trials based on the 25 years of trial data were calculated and grouped by the intervention.
A third of intervention studies in IBD within the last 25 years are underpowered, with large variations in the calculation of sample sizes. The authors present a sample size estimate resource constructed on the published evidence base for future researchers and key stakeholders within the IBD trial field.
Core Tip: This work has identified a large variation in the estimated minimal clinically important difference (MCID) between study groups in inflammatory bowel disease trials in the literature, with no standard to support study designers or reviewers. We have provided a resource to support sample size estimation based on observed MICD in the literature over the last 25 years.