Minimum sample size estimates for trials in inflammatory bowel disease: A systematic review of a support resource

Abstract

Background: Of 25% of randomised controlled trials (RCTs) on interventions for inflammatory bowel disease (IBD) have no power calculation.

Aim: To systematically review RCTs reporting interventions for the management of IBD and to produce data for minimum sample sizes that would achieve appropriate power using the actual clinical data.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Crohn’s disease; Gastroen- terology; Inflammatory bowel disease; Sample size; Statistics; Ulcerative colitis.

Figure 1

Study flow diagram. UC: Ulcerative colitis; CD: Crohn’s disease.