Abstract
Inflammatory bowel disease is a collection of disorders of the gastrointestinal tract, characterised by relapsing and remitting inflammation. Studies have reported several pharmacological or non-pharmacological interventions being effective in the management of the disease. Sample size estimation with power calculation is necessary for a trial to detect the effect of an intervention. This project critically evaluates the sample size estimation and power calculation reported by randomised controlled studies of inflammatory bowel disease management to effectively conclude appropriateness of the studies results.
We conducted a literature search in the Cochrane database to identify systematic literature reviews. Their reference lists were screened, and studies were selected if they met the inclusion criteria. The data was extracted based on power calculation parameters and outcomes, results were analysed and summarised in percentages, means and graphs.
We screened almost all trials about the management of inflammatory bowel disease published in the past 25 years. 232 studies were analysed, of which 167 reported power calculation. Less than half (48%) of these studies achieved their target sample size, needed for them to accurately conclude that the interventions were effective. Moreover, the average minimal difference those studies were aimed to detect was 30%, which could be not enough to prove the effect of an intervention.
To conclude inaccurate power calculations and failure to achieve the target sample sizes can lead to errors in the results on how effective an intervention is in the management of inflammatory bowel disease.
Minimum sample size estimates for trials in inflammatory bowel disease: A systematic review of a support resource
