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# Randomized Controlled Trials ppt.pptx

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# Randomized Controlled Trials ppt.pptx

epidemiology content for m.sc student first year

epidemiology content for m.sc student first year

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### Randomized Controlled Trials ppt.pptx

1. 1.  UNIT-4 EPIDEMIOLOGY Randomized Controlled Trials Submitted To, Dr. ANJALATCHI M.Sc(N)MD(AM)MBA(HA) ERA COLLEGE OF NURSING SARFARAJ GANJ LUCKNOW Submitted By, Mrs. MARY TEENA M.Sc(N) I YEAR ERA COLLEGE OF NURSING SARFARAJ GANJ LUCKNOW
2. 2.  At the end of the topic the learner will be able to, o Discuss about experimental epidemiology. o Define Randomized Controlled Trials. o Explain Randomized Controlled Trials. o Design the Randomized Controlled Trial. o Enlist the basic steps in conducting Randomized Controlled Trial. o List down the types of Randomized Controlled Trial. Learning Objectives
3. 3.   Random = Governed by chance  Randomization = Allocation of individuals to groups by chance  (Each sampling unit has the same chance of selection  Variables = It refers to a person, place, thing or phenomenon that you are trying to measure in some way. Terminology
4. 4.   Independent: It is the characteristic of a psychology experiment that is manipulated or changed by research.  Dependent: It is the variable that is being measured or tested in an experiment.  Field trial: It is a real life experiment which test directly whether proposed interventions actually works.  Community trial: The studies with whole community on experimental units.
5. 5.   Epidemiological experiment: It is the study of the relationships of various factors, determining the frequency and distribution of disease in a community.  Quantitative: It is research strategy that focuses on quantifying the collection and analysis of data.  Comparative: It is the act of comparing two or more things.  Controlled experiment: An independent variable (the cause) is systematically manipulated and the dependent variables (the effect) is measured.  Protocol: It is the guide book for research study .
6. 6.   Manipulation : It refers to control over the independent variables.  Intervention: Strategy and process designed to measure the change in a situation after a systematic modification.  Bias: It occurs when systemic error is introduced into sampling or testing by selecting one outcome or answer over others.  Attrition: The loss of follow up due to death or migration of an individual is called as attrition.
7. 7.   Blinding: It refers to a practice where study participants are prevented from knowing certain information that may somehow influence them.
8. 8.  EXPERIMENTAL EPIDEMIOLOGY RANDOMIZED CONTROLLED TRIAL (RCT)
9. 9.  Introduction:  It is mainly in the last 35-40 years, determined efforts have been made to use scientific techniques to evaluate methods of treatment and prevention.  It is really an epidemiologic experiment.  It is widely regarded as gold standard for evaluating health care technologies as it allows us to be confident that a difference in outcome can be directly attributed to a difference in the treatments and not due to some other factor. Randomized Controlled Trials
10. 10.   Definition:  Randomized Controlled Trials are quantitative, comparative, controlled experiments in which investigators study two or more receive them in random order.  The RCT is one of the simplest and powerful tools in clinical research.
11. 11.   Drawing up a protocol  Selecting reference and experimental population  Randomization  Manipulation and Intervention  Follow-up  Assessment of outcome Basic steps in conducting a RCT
12. 12.   Strict protocol  Aims and objectives  Questions to be answered  Criteria of selection 1. DRAWING UP A PROTOCOL
13. 13.   Reference or target population - population to which the findings of the trial, if found successful, are expected to be applicable (eg. drugs, vaccines, etc.) Experimental or study population - actual population that participates in the experimental study 2.Selecting reference and experimental population
14. 14.   Procedure: Participants are allocated into study and control groups  Eliminates bias and allows comparability  Both groups should be alike with regards to certain variables that might affect the outcome of the experiment  Best done by using table of random numbers 3.Randomization
15. 15.   Deliberate application or withdrawal or reduction of a suspected causal factor  It creates an independent variable 4.Manipulation and intervention
16. 16.   Implies examination of the experimental and control group subjects  -: at defined intervals of time,  -: in a standard manner, with equal intensity, under the same given circumstances. 5.Follow up
17. 17.   Positive results  Negative results  Biases: subject variation, observer bias, evaluation bias  Can be corrected by blinding 6.Assessment
18. 18.  • Single • (patient doesn’t know) • Double • (neither patient nor investigator knows) • Triple • (none of the patients, investigators or analysts know) Blinding masking
19. 19.  Randomization is a key feature And heart of RCT
20. 20.   The types of Randomized Controlled Trials:  Clinical trials  Preventive trials  Risk factor trials  Cessational experiment  Trial of aetiological agents  Evaluation of health services
21. 21.   Park’s text book of preventive and Social Medicine, Park. K, 23rd edition, Bhanot, Page no: 88-97.  Nursing Research statistics, Suresh K Sharma, ELESEVIER, 3rd Edition Page No: 162.  www.wikipedia.com REFERENCES
22. 22.  THANK YOU