BEPH_lesson+13.pdf

Lesson 13 Experimental studies Biostatistics, Epidemiology and Public Health Prof. Eugenia García Zaragozá, PhD Bachelor in Dentistry ACADEMIC YEAR 2023-2024 ÍNDICE TABLE OF CONTENTS CONTENIDOS Experimental Studies 1. Clinical trials 2. Field Trials 3. Community Trials 4. Cluster Randomised Tri...

Lesson 13 Experimental studies Biostatistics, Epidemiology and Public Health Prof. Eugenia García Zaragozá, PhD Bachelor in Dentistry ACADEMIC YEAR 2023-2024 ÍNDICE TABLE OF CONTENTS CONTENIDOS Experimental Studies 1. Clinical trials 2. Field Trials 3. Community Trials 4. Cluster Randomised Trials 2 Types of studies in Epidemiology 3 1. Clinical Trials: Generalities 4 1. Clinical Trials: Generalities depending on the design of the clinical trial: ❖ RANDOMISED / NOT RANDOMISED TRIAL ❖ PARALLEL / CROSS-OVER TRIAL ❖ MASKED / OPEN TRIAL ❖CONTROLLED / NOT CONTROLLED ❖ UNICENTRIC / MULTICENTRIC 5 Generalities 6 1. Clinical Trials: Randomisation o Patients are randomly and simultaneously assigned to the experimental group or the control group with the same probability of entering (like rolling a die). o Both groups are similar in all but the intervention they receive. The distinguishing feature between observational and experimental studies is random assignment. 7 Randomisation o Systematic and reproducible procedure o Requirements: -Adequate sample size -Non-predictable random assignment method -Concealment of allocation RANDOMISATION METHODS: -Simple randomisation -Block randomisation - Stratified randomisation QUASI-RANDOMISATION -Next patient, Day of week, Date of birth, Medical record number, odd or even number.. 8 1. Clinical Trials: Design 9 Design 10 Flow diagram 11 Flow diagram 12 1. Clinical Trials: Concealment of allocation and Masking 13 1. Clinical Trials: Measures 14 1. Clinical Trials: Authorisation and Ethical issues REQUIREMENTS TO START A CT: , EMA Sponsor Trial investigator 15 Authorisation and Ethical issues 16 2. Field Trials: Generalities 17 2. Field Trials: Generalities 18 3. Community Trials: Generalities 19 3. Community Trials: Design 20 3. Community Trials: Design 21 3. Community Trials: Example 22 3. Community Trials: Example 23 https://youtu.be/Jd3gFT0-C4s?si=KoudUYMb1DmLMS1j 24 Remember ❑ ❑ ❑ ❑ In EXPERIMENTAL STUDIES the investigator randomly allocates experimental units (individuals or communities) to different exposures, providing strong evidence of a causal relationship. Main features of CLINICAL TRIALS are: randomisation methods, use of masking, allocation of concealment, parallel or cross-over design and use of control group. It is not easy to conduct well-designed clinical trials (as many biases can affect their design), and there are ethical issues to be taken into account. FIELD TRIALS are randomized healthy population-based trials COMMUNITY TRIALS are non randomized (quasi-experimental) population-based trials 25 REFERENCIAS BIBLIOGRAPHY BIBLIOGRÁFICAS - Gordis L., Epidemiology, 4th Edition. 2009. Saunders Elsevier -Somerville M., Kumaran K., Anderson R. Public Health and Epidemiology at a Glance, First Edition. 2012. John Wiley & Sons, Ltd - Deter R., Gulliford M., Karim Q.A, Tam C.C. Global Public Health. Sixth Edition. Oxford University Press. 2015 26 Prof. Eugenia García Zaragozá, PhD [email protected] UCAM Universidad Católica de Murcia © © UCAM UCAM