Assignment

RCT & Quazi experimental designs

1- Explain why RCTs are described as the design that has the
highest degree of evidence?

1- Because RCTs ensure that known and unknown person and

environment characteristics that could affect the outcome of interest are
evenly distributed across conditions, so we minimize the bias and
variables.

2- Equalize the influence of nonspecific processes not integral to the

intervention whose impact is being tested. Nonspecific processes might
include effects of participating in a study, being assessed, receiving
attention, self-monitoring, positive expectations, etc.
3- Random assignment and the use of a control condition ensure that any
unnecessary variation not due to the intervention is either controlled
experimentally or randomized. That allows the study's results to be
causally attributed to differences between the intervention and control
conditions.
 2- Determine the characteristics of RCTs?

• participants are assigned to study groups (intervention/control,

study arms, or treatment /no treatment arms) randomly, they have
an equal probability of being assigned to any group).
• Assignment to treatment conditions occurs randomly (i.e.,
Procedures are controlled (have robust rules) to ensure that all
participants in all study groups are treated the same except for the
factor that is unique to their group.

3- What is the main purpose for conducting cluster RCTs?

To test association and prove causation.

4- How to minimize internal validity bias?

1- Random assignment to equalize selection bias across the treatment
and control conditions
2- Equally distributing the subjects to groups with same rate of
maturation.
3- Ensure that intervention must occur before the outcome.
4- Ensuring that drop-out rate is equal in all groups
5- Ensur that measurement and testing are standardized for all subjects
in both groups.
 5- Sampling bias, selection bias, what is the difference between
them? And what is the effect of each on your study outcome?
Sampling bias undermines the external validity of a test (the ability of its
results to be generalized to the rest of the population), while selection
bias mainly addresses internal validity for differences or similarities
found in the sample at hand.

6- Determine the main purposes for randomization in RCTs?

Maximize validity and minimizing bias

7- Why do you think that concealed allocation is necessary for a

valid RCT?
Because knowledge of the patient's assignment could introduce bias,
If allocation is not concealed, research staff is prone to assign "better"
patients to intervention rather than control, which can bias the
treatment effect upward by 20-30%

8- What is the main advantage of blocked randomization over

simple randomization procedure?
In small studies this may not be the case. Block randomisation and
stratification are strategies that may be used to help ensure balance
between groups in size and patient characteristics
 9- You calculated a sample of 451 person from 3450 individual
for your clinical trial, and you found two important variables
in your study that could distort your results: gender and age
(young/old), you will conduct a parallel RCT design and will
use permuted blocks in your randomization. Explain how will
you conduct the randomization procedure?

Stratified blocked randomization

1- Identify the significant strata (gender and age)
2- blocked randomization schedule is developed for each stratum.
3- Use randomly permuted blocks within stratification groups
We use the method of randomly permuted blocks (vary block length at
random: use blocks of length six (3t) as well as 4 (2t)), and keeping
research staff blind to the randomization process, and hide the block
size. Be blind to A and B. Be blind to the size of the block. Be blind to
the block if fixed or permuted

10- What are the main characteristics of quasi experimental

design?
1- quasi-experiment does not have randomly assigned groups
2- control is lacking in quasi-experiments