Podcast
Questions and Answers
What is the primary purpose of a protocol in a Randomized Control Trial (RCT)?
What is the primary purpose of a protocol in a Randomized Control Trial (RCT)?
- To publish the results of the trial
- To prevent bias and reduce errors (correct)
- To select the experimental and control groups
- To analyze the data collected during the trial
What is the main difference between a pilot study and a full-scale RCT?
What is the main difference between a pilot study and a full-scale RCT?
- Duration of the study
- Objective of the study
- Sample size (correct)
- Type of intervention
What is the reference population in a RCT?
What is the reference population in a RCT?
- The population that is excluded from the trial
- The population that is randomly selected for the trial
- The population that participates in the trial
- The population to which the trial results are intended to be applicable (correct)
Why is randomization important in a RCT?
Why is randomization important in a RCT?
What is the primary criterion for selecting participants in a RCT?
What is the primary criterion for selecting participants in a RCT?
What is the purpose of a feasibility study?
What is the purpose of a feasibility study?
What is the term for the population that participates in a RCT?
What is the term for the population that participates in a RCT?
What is the goal of protocol development in a RCT?
What is the goal of protocol development in a RCT?
What is the primary purpose of randomized control trials in epidemiologic experiments?
What is the primary purpose of randomized control trials in epidemiologic experiments?
What is the key difference between randomized and non-randomized control trials?
What is the key difference between randomized and non-randomized control trials?
What is the first step in conducting a randomized control trial?
What is the first step in conducting a randomized control trial?
What is the purpose of the World Health Organization's (WHO) code of practice in connection with human trials?
What is the purpose of the World Health Organization's (WHO) code of practice in connection with human trials?
What is the main advantage of using animals in experimental studies?
What is the main advantage of using animals in experimental studies?
What is the purpose of the follow-up step in a randomized control trial?
What is the purpose of the follow-up step in a randomized control trial?
What is the term for the process of assigning participants to either a reference or experimental group in a randomized control trial?
What is the term for the process of assigning participants to either a reference or experimental group in a randomized control trial?
What is the primary goal of an epidemiologic experiment?
What is the primary goal of an epidemiologic experiment?
What is a major challenge in conducting epidemiologic experiments when the disease frequency is low and the natural history is long?
What is a major challenge in conducting epidemiologic experiments when the disease frequency is low and the natural history is long?
What is the purpose of allocation concealment in randomized control trials?
What is the purpose of allocation concealment in randomized control trials?
What type of bias occurs when there is a lack of blinding in a clinical trial?
What type of bias occurs when there is a lack of blinding in a clinical trial?
What is the term for non-randomized trials that are used when it is not possible to conduct randomized control trials on humans?
What is the term for non-randomized trials that are used when it is not possible to conduct randomized control trials on humans?
What is the primary reason why preventive measures can be applied only to groups or communities in some cases?
What is the primary reason why preventive measures can be applied only to groups or communities in some cases?
What is the term for the practice of dividing experimental subjects or specimens into different intervention groups?
What is the term for the practice of dividing experimental subjects or specimens into different intervention groups?
Why are randomized control trials not always possible to conduct on humans?
Why are randomized control trials not always possible to conduct on humans?
What is the purpose of protocol development in epidemiologic experiments?
What is the purpose of protocol development in epidemiologic experiments?
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Study Notes
The Protocol
- A crucial feature of any RCT, specifying the study's aims, objectives, and criteria for selection of the study and control groups, sample size, and treatment to be applied.
- The protocol aims to prevent bias and reduce sources of error.
Pilot Study
- Also known as a feasibility study, conducted on a small sample size to check whether the study is feasible under certain conditions and environment.
Selecting the Reference and Experimental Populations
- The reference population is the population to which the study's findings are expected to be applicable.
- The experimental population is derived from the reference population and should be randomly chosen from it.
Participants' Criteria
- Participants must give informed consent.
- They should be representative of the population.
- They should be qualified or eligible for the trial.
Randomization
- The "heart" of a controlled trial, ensuring the study's integrity.
Experimental Studies
- Involve some action, intervention, or manipulation of a variable to observe the outcome.
- Aims to provide "scientific proof" of etiological factors and measure the effectiveness of health services.
- Can be conducted on animals or human beings.
Types of Experimental Studies
- Randomized control trials
- Non-randomized control trials (quasi-experimental studies)
Randomized Control Trials
- An assessment method for new programs or therapies.
- Basic steps include: drawing up a protocol, selecting reference and experimental populations, randomization, manipulation/intervention, follow-up, and assessment of outcome.
Non-Randomized Trials
- Conducted due to ethical or administrative problems.
- Also called quasi-experimental studies.
Types of Bias
- Selection bias: occurs when experimental subjects or specimens are divided into different intervention groups.
- Assessment bias: occurs when bias in the assessment of the outcome exists.
Assessment Bias
- Also called ascertainment bias, diagnostic bias, or detection bias.
- Caused by lack of blinding (triple blinding).
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