Design and Analysis of Randomised Controlled Trials

IIDS68112 Design and Analysis of Randomised Controlled Trials 15 Semester 2 Postgraduate Taught Level 6 Jack Wilkinson Unit coordinator 1 FHEQ level (Framework for Higher Education Qualifications) ' Masters/Integrated Masters P4 ' European Credit Transfer & Accumulation System Rating : 7.5 This unit aims to introduce the application of statistical ideas and methodology to randomised controlled trials. This unit aims to introduce the application of statistical ideas and methodology to randomised controlled trials. This unit aims to introduce the application of statistical ideas and methodology to randomised controlled trials. Recognise, choose and apply statistical methods appropriate to a trial, based on its design, objectives and outcome measures. Critically appraise the design, analysis and interpretation of results of randomised controlled trials (RCTs), with specific reference to minimising bias. Analyse data from RCTs of various designs (including: parallel, crossover or cluster; superiority, non-inferiority or equivalence), including the meta-analysis of several RCTs, and interpret the findings in the relevant context Choose, with justification, the design, including calculation of the sample size, for a RCT (parallel, crossover or cluster; superiority, non-inferiority or equivalence) with a continuous or binary outcome. <ul><li>Introduction to the application of statistics to randomised controlled trials (RCTs) RCTs: historical background and ethical issues concerning randomised experimentation on human participants.</li><li>Design and organisation of RCTs. Types of bias and methods for controlling bias in RCTs, including blinding and placebo treatments.</li><li>Critical reviewing publications of RCT – key issues.</li><li>Sample size estimation for continuous and binary outcome measures.</li><li>Methods of treatment allocation including simple randomisation, random permuted blocks, stratification and minimisation.</li><li>Statistical methods for the analysis of parallel group trials including methods for the adjustment for baseline data.</li><li>Implications of protocol deviations and the motivation for the intention-to-treat principle</li><li>Use of R statistical software to design and analyse RCT's  </li></ul> A blended learning approach will be used throughout the 11 weeks delivering the new content. Self-directed learning:Student review of approximately 1.25 hours of online lecture materials per week. Additionally, students are expected to review lecture slides, including attempting accompanying exercises/ examples (including reading journal papers set for review), and reviewing supplementary notes. Face-to-face contact:Review session, complementing online lecture material (additional examples); group tutorial, supporting students working through solutions to an exercise sheet. There will additionally be one revision week (with two hours of face-to-face contact). 1 Written exam 60% 2 Written assignment (inc essay) 40% MSc Health Data Science PT MSc Health Data Science PGDT Taught Component Optional MSc Health Data Science PT MSc Health Data Science (ACF) PGDT Taught Component Optional PG Dip Health Data Science PT PG Diploma Health Data Science PGDT Taught Component Optional PG Cert Health Data Science PT PGCert Health Data Sci (18) PGDT Taught Component Optional PG Cert Health Data Science PT PGCert Health Data Sci (12) PGDT Taught Component Optional Health Data Science - CPD Health Data Science - CPD PGDT Taught Component Optional MSc Health Data Science FT MSc Health Data Science FT PGDT Taught Component Optional PG Dip Health Data Science FT PG Dip Health Data Science FT PGDT Taught Component Optional PG Cert Health Data Science FT PG Cert Health Data Science FT PGDT Taught Component Optional N Primary TextJohn Matthews. An Introduction to Randomised Controlled Trials. Taylor and Francis London (2nd edition, 2006; 1st edition, 2001).Supplementary TextsMichael Campbell, David Machin, Stephen Walters. Medical Statistics. John Wiley London (5th edition, 2021).Brian Everitt, Andrew Pickles. Statistical Aspects of the Design and Analysis of Clinical Trials. Imperial College Press (Revised edition, 2004). Examples of journal reports of RCTs that may be used for critical appraisal exercises: Quist-Paulsen P, Gallefoss F. Randomised controlled trial of smoking cessation intervention after admission for coronary heart disease BMJ 2003; 327:1254. Melchart D, Streng A et al. Acupuncture in patients with tension-type headache: randomised controlled trial.  BMJ 2005; doi:10.1136/bmj.38512.405440.8F. 0 0 0