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Cluster Randomization Trials Heidelberg
May 22 – 24, 2003
Places still available!
Goals and Contents
A cluster randomization trial (CRT) is a trial in which clusters of individuals, rather than
individuals themselves, are randomized to different intervention groups. CRTs have come to be
an important tool in the evaluation of non-therapeutic interventions, including lifestyle
modification, educational programmes and innovations in the provision of health care. The units
of randomization in such trials are diverse, ranging from relatively small clusters such as
households or families, to entire neighbour hoods or communities, but also including places of
work, hospital wards, classrooms and medical practices. The focus of this course is on primary
care trials, which are typically conducted to assess methods of health care delivery.
This course will consider the design and analysis of such trials. The primary outcome variable in
most cluster randomization trials is continuous or binary. Therefore, the statistical methods
discussed in our course will present approaches to handle both cases: Models for random
effects and generalized estimation equations (GEE). A short review of relevant theory as well
as hints how to use available software will be demonstrated on real data sets. The appropriate
interpretation of statistical outcome will play an important role.
With CRTs, there are two sample size issues: How many clusters and how many patients per
cluster? Sample size estimation is usually based on the ICC, the intra-cluster correlation. There
are problems related to the use of the ICC which depend - like the Pearson correlation
coefficient - on the choice of the independent variable. Issues discussed are the estimation and
range of values of the ICC found in general practice, and the associated sample size problems.
Practical aspects of CRTs like ethics, handling of drop-outs, formulation of the intervention,
and techniques in maximising compliance will be discussed. A critical review of the literature
and hints how to read a paper on performed CRTs will be given.
Schedule
Thursday
09.00 - 09.15
Introduction and Welcome
09.15 - 10.30
Introduction in CRT
11.00 - 12.30
Summary measures, Meta-Analysis
13.30 - 15.00
Sample size considerations and ICC
15.30 - 17.00
Classical Hierarchical Models for the analysis of gaussian outcome data
Friday
9.00 - 10.30
Classical Hierarchical Models for the analysis of binary outcome data
11.00 - 12.30
Critique of papers
13.30 - 15.00
Bayesian approach: theory and example
15.30 - 16.30
GEE approach: theory and example
16.30 - 17.00
Interpreting statistical outcome: comparison of marginal and cluster specific models
Saturday
9.00 - 10.30
Supervised studentwork
11.00 - 12.30
Practical aspects of CRTs: ethics, drop-outs, formulation of the intervention, maximising
compliance
13.30 - 15.00
Discussion of studentwork, Evaluation of the course
Teaching language is English
Lecturers
Rumana Omar, Department of Statistical Science, UCL, 1-19 Torrington Place, London
WC1E 6BT
Michael J. Campbell, Institute of General Practice, Community Sciences Centre, Northern
General Hospital, Sheffield S5 7AU
Ulrich Mansmann, Institut für Medizinische Biometrie und Informatik, INF 305, 69120
Heidelberg (Coordinator)
Organization
Venue
The course will take place in Heidelberg at the university campus “Im Neuenheimer Feld”. A
detailed description of how to get there as well as other pertinent information will be sent with
the confirmation of your registration.
Registration
Deadline for registration is May 01, 2003.
Course fee
The fee for the course is 450,- Euro; for univer sity employees 310,- Euro.
Cancellation
Cancellations after May 08, 2003 will be charged with 25 % of the course fee.
In case of cancellation after May 15, 2003 the total fee is due.
A substituting participant can be named.
Information
{ HYPERLINK "http://www.biometrie.uni-
heidelberg.de/postgraduate_education/postgrad1.html" }http://www.biometrie.uni-
heidelberg.de/postgraduate_education/postgrad1.html
Concept and Contents
Universität Heidelberg, Abt. Medizinische Biometrie
Coordination
Dr. Christine Wollermann
Tel: +49(0) 62 21/56–47 29, Fax: –41 95
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Organization
Academy for Postgraduate Education at the Universities of Heidelberg and Mannheim
Friedrich-Ebert-Anlage 22-24, D-69117 Heidelberg
Tel: +49(0) 62 21/54–78 10, Fax: –78 19
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Professor Mike Campbell
Medical Statistics Unit
Institute of Primary Care and General Practice
University of Sheffield
Community Sciences Centre
Northern General Hospital
Sheffield S5 7AU
Tel 0114 271 5919
Fax 0114 242 2136
e-mail [log in to unmask]
http://www.shef.ac.uk/michaelcampbell/
http://www.shef.ac.uk/medical-statistics/
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