P062 A SYSTEMATIC REVIEW ON POWER ESTIMATION TO SUPPORT SAMPLE SIZE CALCULATION FOR RANDOMISED TRIALS IN INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S9-S9
Author(s):  
Svetlana Lakunina ◽  
Zipporah Iheozor-Ejiofor ◽  
Morris Gordon ◽  
Daniel Akintelure ◽  
Vassiliki Sinopoulou
Keyword(s):  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Bowel Disease ◽  
Sample Size Calculation ◽  
Sample Size Estimation ◽  
Power Calculation ◽  
Size Estimation ◽  
Target Sample ◽  
Inflammatory Bowel ◽  
Randomised Controlled

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.

scholarly journals Sample-size estimation is not reported in 24% of randomised controlled trials of inflammatory bowel disease: A systematic review

2020 ◽  
pp. 205064062096789
Author(s):  
Zipporah Iheozor-Ejiofor ◽  
Svetlana Lakunina ◽  
Morris Gordon ◽  
Daniel Akintelure ◽  
Vasiliki Sinopoulou ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Systematic Reviews ◽  
Bowel Disease ◽  
Randomised Controlled Trials ◽  
Sample Size Estimation ◽  
Controlled Trials ◽  
Size Estimation ◽  
Inflammatory Bowel ◽  
Randomised Controlled

Background Sample-size estimation is an important factor in designing a clinical trial. A recent study found that 65% of Cochrane systematic reviews had imprecise results. Objective This study set out to review the whole body of inflammatory bowel disease (IBD) randomised controlled trials systematically in order to identify the reporting of sample-size estimation. Methods We conducted a comprehensive hand search of the Cochrane Library and Cochrane IBD Specialized Trials Register. We extracted information on relevant features and the results of the included studies. We produced descriptive statistics for our results. Results A total of 242 randomised controlled trials were included from 44 Cochrane systematic reviews. About 25% of the studies failed to report on sample-size estimation. Of those that did report on sample-size estimation, 33% failed to recruit their target sample size. Conclusions Around half of the randomised controlled trials in IBD either do not report sample-size estimation or reach their recruitment target with the level of detail in reporting being limited.

P062 A SYSTEMATIC REVIEW ON POWER ESTIMATION TO SUPPORT SAMPLE SIZE CALCULATION FOR RANDOMISED TRIALS IN INFLAMMATORY BOWEL DISEASE

2020 ◽  
Vol 158 (3) ◽  
pp. S14-S15
Author(s):  
Svetlana Lakunina ◽  
Zipporah Iheozor-Ejiofor ◽  
Morris Gordon ◽  
Daniel Akintelure ◽  
Vassiliki Sinopoulou
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Bowel Disease ◽  
Sample Size Calculation ◽  
Power Estimation ◽  
Randomised Trials ◽  
Inflammatory Bowel

Application of Ultrasound Elastography for Assessing Intestinal Fibrosis in Inflammatory Bowel Disease: Fiction or Reality?

2020 ◽  
Vol 21 ◽  
Author(s):  
Roberto Gabbiadini ◽  
Eirini Zacharopoulou ◽  
Federica Furfaro ◽  
Vincenzo Craviotto ◽  
Alessandra Zilli ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Sample Size ◽  
Bowel Disease ◽  
Small Sample Size ◽  
Shear Wave Elastography ◽  
Small Sample ◽  
Ultrasound Elastography ◽  
Invasive Technique ◽  
Intestinal Fibrosis ◽  
Inflammatory Bowel

Background: Intestinal fibrosis and subsequent strictures represent an important burden in inflammatory bowel disease (IBD). The detection and evaluation of the degree of fibrosis in stricturing Crohn’s disease (CD) is important to address the best therapeutic strategy (medical anti-inflammatory therapy, endoscopic dilation, surgery). Ultrasound elastography (USE) is a non-invasive technique that has been proposed in the field of IBD for evaluating intestinal stiffness as a biomarker of intestinal fibrosis. Objective: The aim of this review is to discuss the ability and current role of ultrasound elastography in the assessment of intestinal fibrosis. Results and Conclusion: Data on USE in IBD are provided by pilot and proof-of-concept studies with small sample size. The first type of USE investigated was strain elastography, while shear wave elastography has been introduced lately. Despite the heterogeneity of the methods of the studies, USE has been proven to be able to assess intestinal fibrosis in patients with stricturing CD. However, before introducing this technique in current practice, further studies with larger sample size and homogeneous parameters, testing reproducibility, and identification of validated cut-off values are needed.

scholarly journals Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036400
Author(s):  
Jérémy Vanhelst ◽  
Stéphanie Coopman ◽  
Julien Labreuche ◽  
Claire Dupont ◽  
Valérie Bertrand ◽  
...  
Keyword(s):  
Physical Activity ◽  
Inflammatory Bowel Disease ◽  
Randomised Controlled Trial ◽  
Bone Health ◽  
Bowel Disease ◽  
Controlled Trial ◽  
Whole Body ◽  
Paediatric Patients ◽  
Inflammatory Bowel ◽  
Randomised Controlled

IntroductionLow bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.Methods and analysisThis trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.Ethics and disseminationThe study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union’s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.Trial registration numberNCT03774329.

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