CLINICAL RESEARCH METHODS (14)

SHE Level 3
SCQF Credit Points 10.00
ECTS Credit Points 5.00
Module Code M3B522376
Module Leader Simon Jeon
School School of Health and Life Sciences
Subject Vision Science
Trimester
  • A (September start)

Summary of Content

This half module has three inter-linked components: clinical research methodology, epidemiology and data analysis. The research methodology component will introduce the student to methods commonly used for clinical research together with the philosophy and application of study design thinking and planning to ensure study can provide clinical answers . The epidemiology component will introduce the student to general principles with a focus on the distribution of eye disease in the population. The data analysis component will introduce the student to the philosophy and application of statistical reasoning and statistical analysis methods commonly used to convert clinical data into meaningful knowledge.

Syllabus

Clinical Research Study Methods -567b7 Research methods: Case reports. Case series. Surveys. Case controlled studies. Cross sectional studies. Cohort studies. Clinical trials methodology. Single subject design. b7 Study organisation: Selection of subjects (aspects of selection bias and lack of comparability). Measurement of results (including appropriateness of measurement techniques, precision of measurements, effect of reporting and recall errors). Investigator errors (including incompleteness of assessment in precise measurements, observation errors). Analysis of study results (including aspects of data adjustment, confounding variables, prior matching). b7 Randomisation of subjects: Comparison of sampling schemes. Random allocation of subjects to treatment groups. Epidemiology -567b7 Principles and definitions of epidemiology. General distribution of eye disease in the population. Data Analysis b7 Relation of study design to data analysis. Null and experimental hypotheses. Inferential evidence measure concepts. Significance level. Power. Sample size estimation. Choosing the right test. b7 Two Sample Studies: Paired and independent samples studies. Parametric and nonparametric tests. Point and interval estimation of treatment effect. b7 Correlation: Introduction. Concept of cause and effect. Parametric and nonparametric tests. b7 Linear Regression: Model building. Model concepts and least squares estimation. Statistical validity checks. Practical validity of model fit. Diagnostic checking.

Learning Outcomes

On completion of this module the student should be able to:" define the appropriate research methodology for investigations in clinical research and visual science." design a research study." critically evaluate study designs employed in the ophthalmic literature." understand the methods of study of the distribution of eye disease in the population" perform and interpret the outcomes of a range of data analysis scenarios." use statistical software to aid the presentation, analysis and interpretation of clinical data.

Teaching / Learning Strategy

The module will be presented using a range of teaching and learning strategies. These will include traditional classroom sessions, IT sessions and directed reading elements. The learning strategies will build upon the students' maturity and their ability to reflect on their own learning experiences. Students will also be advised to consolidate their knowledge of the content via directed texts and articles, both paper based and electronic. Statistical software, such as IBM SPSS Statistics, will be used for data evidence creation. Appropriate formative exercises will be used to consolidate the students' skills in terms of presentation, analysis and reporting of results. This approach will provide the student with the opportunity to experience how a software package aids clinical data presentation and analysis and to have feedback on their development of data analysis skills.

Indicative Reading

Greenhalgh, T. (2010) How to Read a Paper: The Basics of Evidence Based Medicine , 4 th Ed. Wiley-Blackwell. [eBook] Field, A. (2012) Discovering Statistics with SPSS , 4 th Ed. Sage. Friedman, L. M. (2010) Fundamentals of Clinical Trials . Springer. [eBook] Hackshaw, A. K. (2009) A Concise Guide to Clinical Trials . Wiley-Blackwell. [eBook] Hatch, S. W. (1998) Ophthalmic Research and Epidemiology: E valuation and Application . Butterworth-Heinemann. Hicks, C. M. (2009) Research Methods for Clinical Therapists: Applied Project Design and Analysis , 5 th Ed. Churchill Livingstone. Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D., Hearst, N. & Newman, T. B. (2001) Designing Clinical Research , 2 nd Ed. Lippincot, Williams & Wilkins. Kestenbaum, B. (2009) Epidemiology and Biostatistics: An Introduction to Clinical Research . Springer. [eBook] Ott, L. & Longnecker, M. (2010) An Introduction to Statistical Methods and Data Analysis , 6 th Ed. Duxbury Press. Spilker, B. (1991) Guide to Clinical Trials . Lippincott, Williams & Wilkins. Tomlinson, A. & DeLand, P. N. (2005) Clinical Research Methodology and Statistics. In: Bennett, E. S. & Weissman, B. A. (Eds) (2005) Clinical Contact Lens Practice . Lippincott, Williams & Wilkins, p 917 - 962.

Transferrable Skills

Critical thinking and problem solving Cognitive/intellectual skills Knowledge and understanding in the context of the subject Time management: organising and planning work Independent working Planning, monitoring, reviewing and evaluating own learning and development Self-presentation skills Information retrieval skills IT Skills Communication skills, written, oral and listening Numeracy skills

Module Structure

Activity Total Hours
Assessment (FT) 16.00
Practicals (FT) 8.00
Independent Learning (FT) 60.00
Lectures (FT) 16.00

Assessment Methods

Component Duration Weighting Threshold Description
Exam (Exams Office) 1.00 50.00 35% Unseen written paper
Course Work 01 n/a 50.00 35% Data analysis report