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RESEARCH PRODUCT
Methodological Problems in RCTs on IBD
Irene ModestoCriscuoliA. OrlandoMario Cottonesubject
Pharmacologymedicine.medical_specialtySettore MED/09 - Medicina InternaRandomizationbusiness.industryGold standardAlternative medicineGeneral Medicinecontrolled clinical trials.inflammatory bowel disease.methodologyInflammatory Bowel Diseasesmedicine.diseasePlaceboInflammatory bowel diseasedigestive system diseaseslaw.inventionTreatment OutcomeRandomized controlled trialEnvironmental risklawmedicineHumansPopulation studyIntensive care medicinebusinessRandomized Controlled Trials as Topicdescription
Abstract: Randomized controlled trials (RCTs) are the gold standard method for developing evidence-based medicine in inflammatory bowel disease (IBD). Methodological problems in RCTs in IBD concern different aspects such as the definition of the study population due to the extreme variability of patients with IBD, the indices of disease activity, a clearly defined outcome, the environmental risk factors (i.e smoking behaviour) that may influence the randomization, the heterogeneous placebo rate of remission and the different statistical methods used to analyze the results. It is important that trials are designed efficiently, done well and complement clinical practice with a careful subject selection, standardization of disease activity indices, and precise outcome measurement in order to continue the improvement of the IBD research process.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2012-11-01 | Reviews on Recent Clinical Trials |