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Download RANDOMISED CLINICAL TRIALS
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BY: Shirin Maghsoud Randomised Controlled Trial (RCT) RCT is a trial in which subjects are randomly assigned to two groups: one (the experimental group) receiving the intervention that is being tested, and the other (the comparison group or controls) receiving an alternative treatment. The two groups are then followed up to see if any differences between the result. This helps in assessing the effectiveness of the intervention. Source: Cochrane Collaboration Glossary CASP Strength of evidence Experimental Systematic Review RCT Observationa P l rospective Retrospective Anecdote Cohort study Case-control study Case series Study population (participant) treatment / control Investigators Clinical intervention (medical surgical ,regimn ,hygiene) Outcome CASP Randomised controlled trial new treatment population group 1 Outcome group 2 Outcome inclusion/ exclusion control treatment RANDOMIZATION definition advantages vit A in measles main goal (laser in wound healing) methods Pseudo randomization( quasi –R) disadvantages All RCTs are controlled clinical trial BUT Not all controlled trials are RCTs Ascertainment selection BIAS publication Inappropriate handling of withdrawals • SELECTION BIAS Inclusion & exclusion Intervention New drug on MS and depression concealment • Ascertainment bias • treatment of Blood pressure • double blinding Double blinding prevents ascertainment bias and protects randomization after allocation and during study Allocation concealment prevents selection bias and protects randomization during selection Trial design Study execution Reporting Publication RCT IS NOT suitable for: * ETIOLOGY AND CLINICAL COURSE smoking and cancer * RARE & PROLONGED OUTCOME ethics • • • • Phase 1 Phase 2 Phase 3 Phase 4 20-80 100-200 Example: • Effect of laser therapy on mouse ulcer CASP RCTs - a checklist • • • • • Good randomisation procedures patients blind to treatment clinicians blind to treatment all participants followed up all participants analysed in the groups to which they were randomised (intention to treat)
