Inclusion and Exclusion criteria for Clinical Research

2. Presented to
Dr. Shahbaz
Ahmad Zakki
Presented by:
Muhammad Junaid
Department of Public Health &
Nutrition UOH

3. criteria &
primary and
secondary
outcome
measures

4. Introduction:
• Identify the criteria that will be used to determine which research
studies will be included.
• The inclusion and exclusion criteria must be decided before you start
the review.
• Inclusion criteria is everything a study must have to be included.
• Exclusion criteria are the factors that would make a study ineligible
to be included.
• Defining inclusion and exclusion criteria increases the
likelihood of producing reliable and reproducible results,
minimizes the likelihood of harm to the subjects, and guards
against exploitation of vulnerable persons.

5. Continue
• In practice, there is a delicate balance between internal and external
validity.
• It is important to select articles with an appropriate study
design for the research question.
• Dates for the studies and a timeline of the problem/issue being
examined may need to be identified

6. Continue
• Inclusion and exclusion criteria may include factors
such as age, gender, race, ethnicity, type and stage of
disease, the subject’s previous treatment history, and
the presence or absence (as in the case of the “healthy”
or “control” subject) of other medical, psychosocial, or
emotional conditions.
• Healthy, or control, subjects may be defined as those
individuals who are free of certain specified attributes of
non-health.

7. Inclusion criteria
• Inclusion criteria are characteristics that the prospective
subjects must have if they are to be included in the
study.
• Inclusion criteria ensure that the study includes participants most
likely to be relevant to the study and outcomes for reporting.
• They help balance between-participant variability.
• They include the disease or condition under study, demographic
criteria, such as age, gender, geographic area and recent
hospitalization.
• Thus, they help to define and formulate the question of interest.

8. The following things must
consider in inclusion criteria
• Type of studies:
• It is important to select articles with an appropriate study
design for the research question.
• Dates for the studies and a timeline of the problem/issue being
examined may need to be identified.
• Type of participants:
• Identify the target population characteristics. It is important to
define the target population's age, sex/gender, diagnosis, as
well as any other relevant factors

9. Continue
• Types of intervention:
• Describe the intervention being investigated. Consider whether to
include interventions carried out globally or just in States. Eligibility
criteria for interventions should include things such as the dose,
delivery method, and duration of the investigated intervention. The
interventions that are to be excluded may also need to be described
here.
• Types of outcome measures:
• Outcome measures usually refer to measurable outcomes or ‘clinical
changes in health’. For example, these could include body structures
and functions like pain and fatigue, activities as in functional abilities,
and participation or quality of life questionnaires.

10. Exclusion criteria
• Exclusion criteria are those characteristics that disqualify
prospective subjects from inclusion in the study.
• Exclusion criteria should be considered as being applicable to participants
fulfilling the eligibility criteria, but who are not ‘included’ because of safety,
confounding or feasibility considerations, thus minimizing missing data.
• They serve to increase internal validity by decreasing participant variability.
Some participants are excluded because they are on concurrent
medications, or other interventions that are disallowed during the ongoing
trial because of concerns of drug-drug interventions,

11. Primary outcome measures
• Primary outcome measures are those that define the primary
question of interest.
• The primary outcome measure is the outcome that an
investigator considers to be the most important among the
many outcomes that are to be examined in the study.
• The primary outcome needs to be defined at the time the study
is designed.

12. The benefit of primary outcome
measures
• It reduces the risk of false-positive errors resulting from the
statistical testing of many outcomes.
• It reduces the risk of a false-negative error by providing the
the basis for the estimation of the sample size necessary for an
for an adequately powered study.

13. Secondary outcome measures
• Secondary outcome measure refers to a planned outcome
measure that may provide supportive information about a
therapy's effect on the primary endpoint or demonstrate
additional effects on the disease or condition.
• Secondary outcomes will often feed directly into the overall
interpretation of a clinical trial and facilitate an understanding of
the scope of any potential intervention effect.

14. Hip attack trial
• It included “ages 45 years or older, diagnosed during regular working
hours with a low energy mechanism hip fracture that required
surgery”.
• Exclusion criteria were “if patients were taking a therapeutic dose of
an anticoagulant for which no antidote drug was available to reverse
its effects, history of heparin-induced thrombocytopenia or taking a
therapeutic dose of vitamin K antagonist.
• Those with a peri-prosthetic or open fracture, bilateral fractures and
those requiring emergency surgery for another reason (e.g., subdural
hematoma) were also excluded. Those previously enrolled in HIP
ATTACK trial were also excluded.

15. Primary outcomes
• Primary (coprimary) outcomes were “mortality, composite of major
complications (mortality and nonfatal myocardial infarction, stroke,
venous thromboembolism, sepsis, pneumonia, life-threatening
bleeding, and major bleeding) at 90 days after randomization”.

16. Secondary outcomes
• Secondary outcomes were “vascular mortality, non-vascular mortality,
myocardial infarction, myocardial injury not fulfilling the definition of
myocardial infarction, congestive heart failure, new clinically
important atrial fibrillation, stroke, venous thromboembolism,
pulmonary embolism, proximal deep venous thrombosis, infection,
sepsis, pneumonia, life-threatening bleeding, major bleeding, new
residence in a nursing home, and pressure ulcer at 90 days after
randomization and delirium within 7 days of randomization”.