Outline: 1. What is a Systematic Review? 2. Hierarchy of Evidence in Research 3. Inclusion and Exclusion Criteria [IC/EC] 4. Rationale for IC/EC in a Systematic Review [SR] 5. Models/Frameworks used in Formulating IC/EC for a SR 6. Examples of Models/Frameworks for 7. Qualitative and Quantitative SR 8. Other Considerations for IC/EC

1. INCLUSION AND EXCLUSION
CRITERIA
innocentdc1@gmail.com
BY
DAVID CHINAECHEREM, INNOCENT, PhD (in view)

2. OUTLINE
• What is a Systematic Review?
• Hierarchy of Evidence in Research
• Inclusion and Exclusion Criteria [IC/EC]
• Rationale for IC/EC in a Systematic Review [SR]
• Models/Frameworks used in Formulating IC/EC for a SR
• Examples of Models/Frameworks for Qualitative and Quantitative SR
• Other Considerations for IC/EC
• Conclusion
• Take home Meal

3. What is a Systematic Review?
• Systematic reviews are a type of research review that follows a
structured methodology to identify, appraise, and synthesize all
available evidence on a specific research question or topic.
• Systematic reviews provide a rigorous and comprehensive
evaluation of the existing literature, which helps to identify
gaps in knowledge, identify areas for further research, and
inform clinical practice and policy decisions.

4. What is a Systematic Review? (Contd.)
• The process of conducting a systematic review involves
several steps, including developing a clear research question,
identifying relevant studies, assessing the quality of the
studies, synthesizing the findings, and interpreting the results.
• To ensure that the review is comprehensive and unbiased,
systematic reviews usually adhere to predefined protocols and
guidelines and involve multiple reviewers to minimize the risk
of errors or bias.

5. Hierarchy of Evidence in Research
• Source: Page et al. (2021).

6. INCLUSION AND EXCLUSION CRITERIA
• Inclusion and exclusion criteria are essential components of the study design for
research studies, particularly for systematic reviews.
• These criteria are used to define the characteristics that potential study participants
must possess or lack to be included or excluded from the study.

7. RATIONALE FOR IC/EC
• The rationale for inclusion and exclusion criteria in a
systematic review is to ensure that the review is focused
on answering a well-defined research question and that
the studies included in the review are relevant, valid, and
reliable.
• The criteria help to identify the studies that are most
likely to provide high-quality evidence and to minimize
bias in the selection process.

8. INCLUSION CRITERIA
• Inclusion criteria are the specific characteristics that potential
study participants must have to be eligible for the study.
• These may include age, gender, medical history, specific
symptoms or conditions, or other relevant factors.
• For example, in a clinical trial of a new drug for diabetes, the
inclusion criteria might specify that participants must have a
diagnosis of type 2 diabetes and be between the ages of 18 and
65.

9. EXCLUSION CRITERIA
• Exclusion criteria, on the other hand, are the specific
characteristics that would make potential study participants
ineligible for the study.
• These may include factors such as certain medical conditions,
allergies, pregnancy, or previous exposure to a particular
treatment.
• For example, in a clinical trial of a new drug for hypertension, the
exclusion criteria might specify that participants with a history of
heart disease or kidney disease would be excluded from the study.

10. Models/Frameworks used in Formulating IC/EC for
a SR
• There are several models and frameworks that can be used to formulate the IC/EC
of a systematic review, depending on the research question and the type of study
design.
• PICO (Population, Intervention, Comparison, Outcome).
• PICOS (Population, Intervention, Comparator, Outcome, Study design).
• SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, research type).
• PEO (Population, Exposure, Outcome) The PEO framework is similar to PICO but
is used specifically for observational studies, such as cohort and case-control studies).

11. Models/Frameworks used in Formulating IC/EC for a SR (Contd.)
• SPICE (Setting, Perspective, Intervention, Comparison, Evaluation): The SPICE
framework is often used for health services research or economic evaluations.
• PCC (Population, Concept, and Context). The PCC framework is a helpful tool for
formulating inclusion criteria in a scoping review.
• PICOT (Population, Intervention, Comparison, Outcome, Timeframe): This is similar
to PICO but includes a timeframe component, which is particularly useful for studies
evaluating the duration or timing of interventions.
• ECLIPSE (Exposure, Comparator, Outcome, Population, Setting, Eligibility): The
framework is often used for studies evaluating the safety or effectiveness of drugs or
medical devices.

12. Examples of Models/Frameworks for IC/EC in a SR
• PICO (Mostly for Quantitative Studies)
Criteria Inclusion Criteria Exclusion Criteria
Population
Adult patients (18 years or older)
diagnosed with hypertension
Patients with severe or unstable hypertension
(systolic blood pressure >180 mmHg or
diastolic blood pressure >110 mmHg)
Intervention New medication for hypertension
Patients with a history of drug allergy to any
of the components of the new medication
Comparison
Placebo or existing medication for
hypertension
Patients who are pregnant or breastfeeding
Outcome Reduction in blood pressure
Patients with a history of significant
cardiovascular disease, such as myocardial
infarction or stroke, within the past 6 months

13. Examples of Models/Frameworks for IC/EC in a SR (Contd.)

14. Examples of Models/Frameworks for IC/EC in a SR (Contd.)
• For SPIDER (Mostly Qualitative Studies)
Criteria Inclusion Criteria Exclusion Criteria
Sample
Adult cancer patients (18 years or older)
currently undergoing chemotherapy
treatment
Cancer patients who have not undergone
chemotherapy
Phenomenon of
Interest
Experiences of cancer patients undergoing
chemotherapy
Patients who have not received
chemotherapy in the past 3 months
Design
Qualitative study using interviews or focus
groups
Quantitative or mixed-methods study
design
Evaluation
Patients' subjective experiences and
perceptions of chemotherapy treatment,
including physical and emotional effects,
coping mechanisms, and interactions with
healthcare providers
Studies that primarily focus on clinical
outcomes or objective measures of
treatment response
Research Type Primary qualitative research studies Review articles, case reports, or editorials

15. Examples of Models/Frameworks for IC/EC (Contd.)
• PCC- for Scoping Reviews
Criteria Inclusion Criteria Exclusion Criteria
Population/Participant
s
Adults diagnosed with fibromyalgia
Pediatric patients or patients with other
chronic pain conditions
Concept/Phenomena
Exercise interventions to manage symptoms
of fibromyalgia, including aerobic exercise,
strength training, or mind-body practices
such as yoga or tai chi
Pharmacological interventions or non-
exercise-based interventions such as
cognitive-behavioral therapy
Context
Studies conducted in any setting, including
inpatient or outpatient rehabilitation
programs, community centers, or home-
based programs
Studies conducted exclusively in the
workplace or school settings

16. OTHER CONSIDERATIONS FOR IC/EC
• Publication date (Studies published earlier than 2010 OR all studies from antiquity?)
• Study setting (Where?)
• Publication status (Preprints? OR original published articles?)
• Publication type (Opinions?, case studies?, observational studies?, editorials,
commentaries?, short communications?).
• Language Status (Studies published in English? OR French? OR ALL?)

17. CONCLUSION
• In conclusion, inclusion and exclusion criteria are essential components of a
systematic review that help to ensure the review is focused on answering a
well-defined research question using high-quality evidence.
• The criteria should be designed to identify studies that are relevant, valid,
reliable, and generalizable.
• Different models and frameworks, such as PICO, SPIDER, PEO etc, can be
used to develop these criteria for quantitative and qualitative studies.

18. TAKE HOME MEAL
Generate IC/EC for the following Systematic Review research topics.
• Experiences of Nurses towards workplace violence in Sub Saharan Africa
• Comparative effectiveness of different types of exercise for improving cardiovascular
health
• Patient preferences for telehealth vs. in-person healthcare services
• Effectiveness of cognitive-behavioral therapy (CBT) for treating insomnia in older
adults

19. THANK YOU!!!!!!!!!!!!!!!!!!!!!