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Chapter 6

The document discusses key concepts in randomized controlled trials including randomization, selection criteria, comparability between groups, and ensuring data quality. Randomization is presented as the ideal method for reducing bias and determining treatment efficacy by assigning participants to treatment or control groups in a non-predictable manner. The goal of randomization is to eliminate subjective biases and produce comparable groups for accurate evaluation of outcomes.

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23 views4 pages

Chapter 6

The document discusses key concepts in randomized controlled trials including randomization, selection criteria, comparability between groups, and ensuring data quality. Randomization is presented as the ideal method for reducing bias and determining treatment efficacy by assigning participants to treatment or control groups in a non-predictable manner. The goal of randomization is to eliminate subjective biases and produce comparable groups for accurate evaluation of outcomes.

Uploaded by

X And Z
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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1.

What is the main objective of assessing the efficiency of preventive therapeutic


measures?
Answer: The main objective is to modify the natural history of a disease in order to
prevent or delay death or disability, improve the health of the patient or the
population, and select the best available preventive or therapeutic measure.

2. What are the challenges in selecting the best preventive or therapeutic measures?
Answer: The challenges include the need to evaluate the effectiveness and side
effects of new interventions, the selection of the most appropriate preventive or
therapeutic measure, and the assessment of new drugs and treatments, including
health and medical care technologies.

3. What is the ideal design for evaluating the effectiveness and side effects of new
interventions?
Answer: The randomized trial is considered the ideal design for evaluating both the
effectiveness and side effects of new interventions.

4. In what types of trials is randomization applicable?


Answer: Randomization is applicable in both clinical trials and community-based
trials.

5. What is the focus of presentations on randomized trials?


Answer: Presentations on randomized trials typically focus on the evaluation of the
efficacy and side effects of treatment and drugs.

6. How does a randomized trial work in assessing the effectiveness of a new


treatment compared to the current treatment?
Answer: In a randomized trial, a defined population is randomly assigned to
receive either the new treatment or the current treatment. The subjects in each
group are then followed to determine how many show improvement. If the new
treatment group shows better outcomes compared to the current treatment group, it
can be concluded that the new treatment is more effective.

7. What criteria should be spelled out for determining who will be included or not
included in a study?
Answer: The criteria for determining who will or will not be included in the study
should be spelled out with great precision and in writing. There should be no
element of subjective decision-making on the part of the investigator in deciding
who is included or not included.
8. Why is it important for a study to be replicable by others?
Answer: A study must be replicable by others to ensure the validity and reliability
of the findings. Replicability allows other researchers to verify and build upon the
results, increasing confidence in the study's conclusions.

9. Are there any alternatives to randomization in study design?


Answer: Yes, there are alternatives to randomization in study design. Some
alternatives include case studies or case series, historical controls, and non-
randomized simultaneous controls.

10. What is the case study or case series design, and what are its limitations?
Answer: The case study or case series design involves studying individuals without
comparison to an untreated group or a group receiving a different treatment. Its
limitations include the inability to derive causal inferences and the lack of a
comparison group to assess treatment outcomes.

11. Why is comparison important in inferring a causal relationship in treatment


studies?
Answer: Comparison is important in inferring a causal relationship because it
allows researchers to assess the relationship between treatment and outcomes.
Without a comparison group, it is difficult to determine whether the observed
improvement is due to the treatment or other factors.

12. Can a causal relationship be inferred without a comparison group?


Answer: It is challenging to infer a causal relationship without a comparison group.
Without a comparison group, it is difficult to isolate the effects of the treatment
from other factors that may impact the outcomes.

13. What are the problems with using historical controls in a study?
Answer: The problems with using historical controls include the lack of control in
data collection from past patients, the possibility of changes in factors other than
treatment over time, and the inability to determine whether observed differences in
outcomes are due to the treatment or other factors.

14. What is the alternative approach to historical controls?


Answer: An alternative approach to historical controls is the use of simultaneous
controls. Simultaneous controls involve selecting a control group at the same time
as the treatment group, reducing the confounding effects of changes over calendar
time.
15. What is the problem with selecting non-randomized simultaneous controls?
Answer: The problem with selecting non-randomized simultaneous controls is the
potential for selection bias. If the selection of controls is predictable or influenced
by the investigator, it introduces the possibility of biased results.

16. What are the challenges in selecting controls in a non-randomized fashion?


Answer: The challenges in selecting controls in a non-randomized fashion include
the potential for selection bias, the need to ensure comparability between treatment
and control groups, and the difficulty in ruling out confounding factors that may
affect the outcomes.

17. What is the goal of randomization in study design?


Answer: The goal of randomization in study design is to achieve non-predictability
of treatment assignment and eliminate the possibility of subjective biases on the
part of the investigator. Randomization helps ensure that the treatment and control
groups are comparable.

18. How does proper randomization eliminate subjective biases in selecting


treatment groups?
Answer: Proper randomization eliminates subjective biases by assigning treatment
groups in a non-predictable manner. This means that the investigator cannot
influence or know the assignment of the next patient, reducing the potential for
bias in treatment group selection.

19. What are the advantages and limitations of randomization in ensuring


comparability between treatment groups?
Answer: The advantages of randomization in ensuring comparability between
treatment groups include reducing selection bias, balancing known and unknown
confounding factors, and allowing for more reliable statistical analysis. However,
the limitations include the need for a sufficient sample size to achieve balance, the
potential for chance imbalances in small samples, and the inability to control for
unmeasured confounding factors.

20. How does the process of randomization using numbered envelopes work?
Answer: In the process of randomization using numbered envelopes, each
participant is assigned a unique number. The numbers are then placed in envelopes,
and the envelopes are shuffled or mixed. When it's time to assign participants to
treatment groups, the envelopes are sequentially opened, and the treatment
assignment corresponding to the number inside is applied to the participant.
21. What are the benefits of stratification in randomization?
Answer: Stratification in randomization helps ensure balance and comparability
between treatment groups within important subgroups. By stratifying participants
based on certain characteristics (e.g., age, gender), randomization can be
performed within each stratum, reducing the potential for confounding and
improving the validity of the study.

22. Why is it important for the data collected in each study group to be of the same
quality?
Answer: It is important for the data collected in each study group to be of the same
quality to ensure the validity and reliability of the study's findings. If there are
differences in data quality between the treatment and control groups, it may
introduce bias or confounding, making it difficult to draw accurate conclusions.

23. How do researchers determine which treatment each patient received?


Answer: In a randomized trial, researchers determine which treatment each patient
received through the randomization process. This could involve using methods
such as numbered envelopes, computer-generated randomization lists, or other
randomization techniques. The treatment assignment is typically concealed from
both the researchers and the participants until after randomization to maintain
blinding and reduce bias.

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