What were the OR and 95 CI of variable place of recidence? Explain, what does

26- 30 20 50 3 19 92 21 86 3 49 159 31- 35 7 12 1 3 23 4 21 1 26 Tota l 66 181 59 209 515 55 257 17 412 741 Learning Tasks 2: After you examined the above table, please calculate the following: 1. What is the CRUDE OR? Please provide an interpretation 2. Calculate 95 CI confidence interval of the CRUDE OR using below formula: 3. After it is controlled for age variable, what is its SPECIFIC OR? What is the interpretation? 4. What is the SPECIFIC OR after being controlled for obstetric history variable? What is the interpretation? Case 3: Carefully read the article entitles: “Risk factors for psoriasis: a case control study” Learning Tasks 3: Based on the above case, please answer the following questions: 1. What is the dependent or response variable of this study? 2. What are the objectives of this study? 3. What are risk factors investigated or what are independent variables of this study? 4. Was this study hospital based or population based? 5. How long the cases were collected? 6. Who was the control group? 7. Regarding which variables cases and control was comparable? a Regarding which variables cases and control was not comparable? bWhat must be done to control these confounding variables? 8. See Table-3. How do you determine the most dominant risk factors? 9. See Table-3. Which risk factor had the highest OR? What was the 95 CI for this risk factor? 10. What were the OR and 95 CI of variable place of recidence? Explain, what does it mean? Self Assessments: 1. What are the advantages and disadvantages of case-control study in determining risk factors of diseases? 2. Explain what is mean by control by design and control by analysis in a case-control study Udayana University Faculty of Medicine, DME 95 CI = OR exp [+ 1.96 1a+1b+1c+1d] 93 M O D U L E ~ 16 Reference Greenberg, p.91-113 Gordis, 131-163 Epidemiology Study Design: Clinical Trial dr. Anak Agung Sagung Sawitri, MPH Dr. dr. Gd Indraguna Pinatih, MSc., Sp.GK AIMS: To be able to describe the application of clinical trials to determine the effectiveness of intervention, prevention, and treatment of diseases. LEARNING OUTCOMES: 1. To describe and to draw clinical communitytrial design 2. To explain the advantages and disadvantages of clinical community trial to determine the effectiveness of intervention, prevention, and treatment of diseases 3. To explain the definition, aims, subject determination enrolment, inclusionexclusion criteria, and randomization of intervention and control group 4. To explain statistical calculation and consideration in clinical trial 5. To explain outcome evaluation strategy blinding and how to calculate outcome 6. To explain the interpretation of study outcome 7. To explain ethical consideration in certain clinical trial 8. To explain the differentiation between clinical and community trial CURRICULUM CONTENTS: Udayana University Faculty of Medicine, DME 94 1. The clinical trial design and its attributes 2. Definition of intervention and control group 3. Enrolment, Inclusion and exclusion criteria and randomization strategy 4. Blinding strategy in clinical trial 5. Statistical calculation and its parameters 6. Data analysis in clinical trial and its interpretation 7. Ethical consideration 8. Differentiation of clinical and community trial ABSTRACTS Evidence-based medicine can be defined as the integration of current best evidence with clinical expertise, pathophysiological knowledge and patient preferences to make health care decisions. Although there are barriers to the practice of evidence-based medicine, such as the skills and time required in appraising the literature, this approach encourages effective management of diseases. It can serve to optimize health outcomes and promote cost-effective management. Fundamental practice of evidence-based medicine is the ability to critically assess the design, conduct and analysis of clinical studies. For the purpose of assessing the comparative benefits of alternative treatment, the randomized controlled clinical trial is the “gold standard” approach. The evidence-based practitioner, therefore, must be thoroughly familiar with this research method. The principal strength of this approach derives from assigning treatment to patients by randomization, thereby tending to balance the study groups with respect to both known and unknown prognostic factors. Before enrolling patient in a clinical trial, the investigation can determine the baseline and follow-up information that will be required to all subjects. Procedures can then be put in place to enable the researches to collect data in a fairly complete and accurate manner. The investigator can also allocate subjects to desire dose level rather than relying on physicians or patients preference. When blinding of the evaluation or patients is feasible, the assessment of clinical outcomes is less likely to be influenced by knowing which treatment was used. Randomized controlled clinical trial is subject to certain constraints, however. Restrictive criteria for inclusion of subjects may produce a very homogenous study population, which may restrict the ability to extrapolate results to patients with other characteristics. Clinical trial—particularly those involving chronic processes—may require years of follow-up to determine the outcome of the treatment. A prolonged observation period leads to higher costs, increases the likelihood that patient will be lost to follow-up, and delays the time at which a treatment recommendation can be made. The use of intermediate end points, such as measurement blood glucose levels Udayana University Faculty of Medicine, DME 95 glycosylated hemoglobin in the diabetes therapy trial, can help limit the length of required follow-up. Nevertheless, a definitive conclusion about treatment benefit often requires years of observation. Large sample sizes typically are required in clinical trial when the magnitude of differences in responses between study groups is small. Furthermore, large numbers of subjects are likely to be required to demonstrate differences between study groups when there is wide variability in responses to treatment. Increasing the size of the study population not only raises the cost of a trial but may also lead to pragmatic difficulties in locating a sufficiently large pool of eligible patients. Ethical concern may arise in clinical trial if one or more of the treatment options has serious potential effects or if early suggest-but do not establish- a therapeutic advantage for one of the treatments. In this situation, a decision must be made about whether the trial should be continued until a definitive conclusion is reached or should be terminated early so that all patients have the opportunity to receive the apparently superior treatment. To minimize the possible influence of real or perceive conflicts of interests, and external advisory group should review these ethical questions. An investigator cannot control the behaviour of subjects enrolled in clinical trial. Even after initial informed consent has been given to participate in clinical trial, a subject has the right withdraw at any time. Some subject may elect to remain in the trial but not comply with the assigned regimen. Noncompliance can reduce the statistical power of clinical trial and thereby lead to a false-negative conclusion. Accordingly, every effort must be made to achieve maximal compliance with assigned treatment without infringing on the patients’ right to refuse therapy. Ultimately, treatment decisions should be best on the best evidence available concerning therapeutic benefit. The standard approach to gathering this evidence is the randomized controlled clinical trial. Although this type of investigation labour intensive, time consuming, and expensive it can provide the most convincing evidence of the superiority of one treatment over another. Through the use of randomized control clinical trial such as the diabetes therapy study, decisions concerning patient treatment and care can be based on rigorous scientific information. SELF DIRECTING LEARNING: Basic knowledge and its application that students must know include: 1. Clinical trial design and its attributes 2. The procedures of a clinical trial 3. The concept of subject selection, restriction and randomization 4. Statistical calculation and its parameters 5. Findings and its interpretation SCENARIO LEARNING TASKS Case 1. Please carefully study the article entitles “Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial” Udayana University Faculty of Medicine, DME 96 Learning Tasks 1: After you carefully read through the article above, please discuss the following questions: 1. What is the study intervention? 2. What is the expected outcome its dependent variable? 3. Why did the researcher consider to do this study, or in other words, what is the problem in the community? 4. Based on clinical trials definition, describe the purpose of this trial. 5. Describe how researchers design the study, the period, and selected the sites for study. What considerations were put in place when selected the sites? 6. Describe how the researcher selected the subjects of this study. What are the inclusion and exclusion criteria? What are the purposes of defining these criteria? 7. Which type of randomization has been done? What is the purpose in doing this? 8. See the Figure 1. Trial Profile. What is the purpose to describe this figure? 9. Describe how the method of intervention was performed? 10. What are the outcomes dependent variables? Describe the operational definitions. 11. Based on measurement scale, that dependent variable is part of which type? 12. Is this study using a blind design? What is the purpose to use blind design? 13. What is one limitation for this longitudinal study with regard to study subjects? 14. Look at Table 1. Baseline Characteristics of the Participants. What is the purpose of researchers for showing the table? 15. What is the main result of this study? Which intervention was more effective? 16. What other outcomes were also resulting from this study? 17. How you interpret the vaccine efficacy of primary analysis per protocol? 18. How you compare the vaccine efficacy for the dengue serotype? Udayana University Faculty of Medicine, DME 97 19. What are ethical aspects you see from the study? Case 2.