‫ نابل رامي عبدالحسيب‬-: ‫الاسم‬

Specialty :Oral and maxillofacial surgery

Biostatistics assignment

The outcome used :-

Main Result (Primary Outcome): The key outcome in a study that is of primary interest
and is usually the focus of the research.

Secondary Result (Secondary Outcome): Additional outcomes measured in a study

that provide supplementary information but are not the primary focus.

Proxy Endpoint (Surrogate Endpoint): An intermediate or substitute endpoint that is

used as a substitute for a true clinical endpoint in clinical trials. It may not directly
measure clinical benefit but is expected to predict it.

Authentic Endpoint (True Endpoint): The actual clinical outcome that is the ultimate
target of interest in a study, providing direct evidence of clinical benefit.

Flexible Endpoint (Soft Endpoint): An outcome measure that allows for some degree
of interpretation or flexibility in its assessment.

Rigorous Endpoint (Hard Endpoint): An outcome measure that is precise, well-

defined, and leaves little room for interpretation, providing a strict criterion for
assessment.
Type of data used for outcome :-
1. Qualitative Variable:
• Defined as a characteristic that cannot be measured in quantitative
form but can only be identified by name or categories.
• Examples include place of birth, ethnic group, type of drug, stages of
breast cancer, and degree of pain.
• Subtypes: A. Nominal Data: Represents categories or names. B.
Ordinal Data: Has order among the response classifications
(categories). C. Binary Data: Involves binary categories like Yes or
No.
2. Quantitative Variable:
• Defined as a variable that can be measured and expressed
numerically, and it can be either discrete or continuous.
• Subtypes: A. Numerical Discrete Data: Involves integers
corresponding to a count (e.g., number of bacteria colonies,
heartbeats). B. Numerical Continuous Data: Utilizes a continuous
scale for measurements (e.g., blood pressure, serum cholesterol,
height).

Entry 1: (mean difference between 2 groups, mean and

standard deviation of group 1, proportion 1 or estimated
prevalence):

The standard deviation, a statistical measure, assesses the spread of a

dataset concerning its mean and is computed as the square root of the
variance. It involves determining the deviation of each data point from
the mean.
 Entry 2: (standard deviation of control group, mean and
standard deviation of group 2, proportion 2 or clinically
important difference):

1. Alpha level of significance: is the probability of detecting a significant

difference when the treatments are equally effective or risk of false positive
findings.

2. Effect size used in calculation: is a statistical concept that measures the

strength of the relationship between two variables on a numeric
scale. Where the type used is standardized mean difference

3. Power of the study: is the probability of correctly rejecting the null

hypothesis that sample estimate does not statistically differ between study
groups in the underlying population.

4. Statistical test used:

Chi squared test: usually used for categorical data
Kolmogorov-Smirnov and Shapiro-Wilk tests: used for numerical data,
using mean and median values.
5. The calculated sample size: is the total number of subjects who are
required for the final study analysis.
6. Anticipated missing data: the expected absence of certain data points in a
study or dataset