INCLUSION AND EXCLUSION CRITERIA session ACRM.pptx
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The document outlines the importance of inclusion and exclusion criteria (IC/EC) in systematic reviews, detailing their role in ensuring the relevance and quality of included studies. It explains various frameworks such as PICO, SPIDER, and PCC that assist in formulating these criteria for different research types. Additionally, the document provides examples and considerations for effectively applying IC/EC in systematic reviews.
![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](https://image.slidesharecdn.com/inclusionandexclusioncriteriasessionacrm-230430203652-0618988e/85/INCLUSION-AND-EXCLUSION-CRITERIA-session-ACRM-pptx-2-320.jpg)
INCLUSION AND EXCLUSION CRITERIA session ACRM.pptx
- 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