CLINICAL RESEARCH METHODS

SHE Level 3
SCQF Credit Points 10.00
ECTS Credit Points 5.00
Module Code M3B526457
Module Leader Simon Jeon
School School of Health and Life Sciences
Subject Vision Sciences
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 Methods - Research process. - Accuracy vs. precision in measurement. - Levels of measurement. - Correlation vs. causation. - Components of experimental design - controls, repeated measurement, and randomisation. - Principles and definitions of epidemiology. - General distribution of eye disease in the population. - Epidemiological research designs: Case reports. Case series. Cross sectional surveys. Case-control design. Cohort studies. Clinical trials. - Principles of screening vs. diagnostic tests. Data Analysis - Contextual data analysis related to study design. - Exploratory data analysis - Normal distribution. - Concepts of inferential statistics. - Null and experimental (alternative) hypotheses. - Significance Testing - Comparing two samples: paired vs. independent samples. - Introduction to ANOVA - Correlation & regression analysis. - Assumptions behind parametric tests and how to check them. - How to proceed with non-parametric alternative tests.

Learning Outcomes

On successful completion of this module students should be able to:1. define the appropriate research methodology for investigations in clinical research and visual science.2. design a research study.3. critically evaluate study designs employed in the ophthalmic literature.4. understand the methods of study of the distribution of eye disease in the population5. perform and interpret the outcomes of a range of data analysis scenarios.6. 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, 4th Ed. Wiley-Blackwell. [eBook] Field, A. (2012) Discovering Statistics with SPSS, 4th 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: Evaluation and Application. Butterworth-Heinemann. Hicks, C. M. (2009) Research Methods for Clinical Therapists: Applied Project Design and Analysis, 5th Ed. Churchill Livingstone. Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D., Hearst, N. & Newman, T. B. (2001) Designing Clinical Research, 2nd 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, 6th 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
Independent Learning (FT) 60.00
Assessment (FT) 16.00
Lectures (FT) 16.00
Practicals (FT) 8.00

Assessment Methods

Component Duration Weighting Threshold Description
Exam (Dept) 01 2.00 50.00 35% Open book, computer-based exam organised by Dept
Course Work 01 n/a 50.00 35% Data analysis report (1500-2000 words)