Randomisedcontrolledtrials(RCTs).pptVIP

* * * * * * * * * Allocation Concealment Centralised 24 hour telephone hotline (e.g. group assignment by an independent central office) or statistician-controlled randomisation On-site computer system combined with group assignments in a locked unreadable computer file that can be accessed only after entering characteristics of an enrolled subject Sequentially numbered, sealed, opaque envelopes Allocation v. Blinding Allocation concealment refers to the process of recruitment and assignment to groups and occurs before and during the enrollment process Blinding refers to the knowledge of practitioners, staff, patients, etc. to the actual assignment (i.e. it occurs during and after enrollment) Blinding Safeguards the assignment sequence after allocation Users Practitioners/Clinicians Assessors Not always possible Financial burden (often requires more staff) Blinding Consider importance with respect to outcome-level bias Subjective outcomes (satisfaction) Objective outcomes (death) Control Groups What is the control group for? Time Attention ‘Placebo Effect’ Inappropriate control group may threaten blinding e.g. Active anti-psychotic versus placebo Types of Comparison Superiority Non-Inferiority Measuring Outcomes Usually easy! Continuous Means and SDs ANOVA Dichotomous T-test (Effect sizes) You should be familiar with ConSORT Checklist Elaboration paper Extensions Cluster trials Non-inferiority Etc. See also The EQUATOR Network More on Bias… Delgado 2004 Critical Appraisal Sheets from the Centre for Evidence-Based Medicine /index.aspx?o=1157 * * * * * * * * * * * * * * * * * * * * * Randomised controlled trials (RCTs) Methodologies for a new era summer school School of Applied Social Studies, University College Cork 22 June 2011 Dr Paul MontgomeryJennifer Burton Aims Questions RCTs might answer Main strengths and weaknesses How to conduct them Different types of RCTs Analysing their results Questions for RCTs Efficacy Effectiveness (including multiple treatm