## ST2MS-Medical Statistics

Module Provider: Mathematics and Statistics
Number of credits: 10 [5 ECTS credits]
Level:5
Terms in which taught: Autumn / Summer term module
Pre-requisites:
Non-modular pre-requisites:
Co-requisites:
Modules excluded: ST2EPI Epidemiology ST2CT Clinical Trials
Module version for: 2016/7

Module Convenor: Dr Karen Ayres

Summary module description:
This module covers statistical methods for medical studies that involve human subjects. Broadly speaking, such studies can be divided into two groups: observational and experimental. Methodology for the design and analysis of both types of studies will be presented. In both cases ethical considerations prompt the use of special techniques.

Aims:
Epidemiology is concerned with the health of human populations. Observational studies known as case-control and cohort studies are used to investigate patterns of health and disease occurence and the factors that influence these patterns. In contrast, clinical trials are planned experiments involving humans. Important and controversial issues include patient randomisation, blinding, sequential experimentation and the use of meta-analysis.

The aims of this course are to provide students with:

• an understanding of the role of statistics in medical research;
• familiarity with ethical issues relevant to medical studies;
• a grounding in the different types of epidemiological and clinical studies most commonly used;
• skills in the practical implementation of simple statistical methods appropriate to particular study types.

Assessable learning outcomes:
At the end of the module students will be able to:

• calculate and interpret summary statistics commonly used in epidemiology;
• analyse data from a medical study, using simple statistical methods, and be able to interpret the results;
• discuss the ethical issues involved in conducting medical studies;
• prepare a study protocol;
• implement simple randomisation methods;
• calculate the required sample size for a study.

Outline content:
Introduction to epidemiology.
Epidemiological study designs: cross-sectional, cohort, case-control.
Methods of analysis for epidemiological studies: hypothesis testing, relative risk, odds ratio.
Problems with interpretation: confounding, interaction.
Sample size calculations.
Introduction to clinical trials.
Randomisation, blinding and ethical considerations.
Study design and analysis.
Special topics in clinical trials: cross-over trials, adaptive designs, meta-analysis, bio-equivalence.

Brief description of teaching and learning methods:
Lectures, supported by problem sheets and tutorials.

Contact hours:
 Autumn Spring Summer Lectures 20 2 Tutorials 10 Guided independent study 68 Total hours by term 98.00 2.00 Total hours for module 100.00

Summative Assessment Methods:
 Method Percentage Written exam 80 Set exercise 20

Other information on summative assessment:
Two assignments and one examination.

Formative assessment methods:
Problem sheets.

Penalties for late submission:
The Module Convenor will apply the following penalties for work submitted late, in accordance with the University policy.

• where the piece of work is submitted up to one calendar week after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for the piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of five working days;
• where the piece of work is submitted more than five working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

• The University policy statement on penalties for late submission can be found at: http://www.reading.ac.uk/web/FILES/qualitysupport/penaltiesforlatesubmission.pdf
You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Length of examination:
2 hours.

Requirements for a pass:
A mark of 40% overall.

Reassessment arrangements:
One examination paper of 2 hours duration in August/September - the resit module mark will be the higher of the exam mark (100% exam) and the exam mark plus previous coursework marks (80% exam, 20% coursework).

1) Required text books:
2) Specialist equipment or materials:
3) Specialist clothing, footwear or headgear:
4) Printing and binding:
5) Computers and devices with a particular specification:
6) Travel, accommodation and subsistence:

Last updated: 21 December 2016