CLINICAL RESEARCH METHODS

SHE Level 3
SCQF Credit Points 10.00
ECTS Credit Points 5.00
Module Code M3B526753
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. - 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 in a blended format using mostly online delivery approaches within a Virtual Learning Environment (GCU Learn). The VLE will provide flexible access to a range of relevant learning resources and materials through appropriate multimedia sources. This will enhance the teaching strategy and provide an opportunity for students to structure their learning to suit their developmental needs. Online resources will include exercises involving appropriate statistical analysis and writing the results. Online drop-in sessions will be available for the students to ask questions or who are in need of help. The learning strategy will build upon the students' maturity, and workplace experience and environment. The use of statistical packages such as Jamovi will be a key feature. A range of practical exercises will be used to consolidate the student's software skills and aid their understanding of how to prepare, summarise, and present research data for the purpose of data analysis.

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
Tutorials (FT) 5.00
Lectures (FT) 15.00
Assessment (FT) 15.00
Independent Learning (FT) 65.00

Assessment Methods

Component Duration Weighting Threshold Description
Exam (Dept) 01 1.00 50.00 35% Open book, computer-based exam organised by Dept
Course Work 01 n/a 50.00 35% Online Quiz and Data Analysis Report