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41 Cards in this Set
- Front
- Back
EBM = integration of:
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1. Individual clinical experience
a. Vital for determining whether the evidence applies to pt AT ALL and if so, how? 2. Best available external clinical evidence a. From clinical research among intact pts. b. Short doubling time (10 yrs) c. Replace current tests and treatments with new ones that are more accurate, powerful and safer 3. Patient’s values and expectations a. Getting better at quantifying |
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Ideas Behind New Medical Practice
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• Many aspects of clinical practice cannot, or will not, ever be adequately tested
• Study of basic diseases is necessary but not sufficient • Understand certain rules of evidence is necessary to correctly interpret literature |
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How can clinical performance be kept up to date??
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1. Learning how to practice EBM
2. Seeking and applying EBM 3. Applying EBM for changing our clinical behavior |
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Desirable characteristics of research:
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1. The study addresses specific clinical question of the PT
2. Study participants are similar to your pt. 3. The study was published in a **peer-reviewed format** 4. The context of the study is consistent with **contemporary** healthcare |
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What is Bias
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Systematic deviation from the truth that occurs as a result of uncontrolled influences during the study
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Research Design Types (1-4)
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1. Experimental
2. Quasi-experimental 3. Observational 4. Case Reports |
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Research Design Types
1. Experimental |
Classic design approach (RCT); most control you can have in a study!
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Research Design Types
2. Quasi-experimental |
Not as controlled, but still has some elements of experimental design
(Ex: all pt get same tx but objectively look at results) |
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Research Design Types
3. Observational |
Non-experimental; just observing over time, but in a systematic way (same outcome measures)
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Research Design Types
4. Case Reports |
Descriptive studies; documenting what happens with pt; may be about diagnostic process, intervention, etc.
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Three Factors that make Research Difficult
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- Research with small or "rare" populations
- Topics that are hard to define (fatigue, endurance, etc) - If there's not enough funding |
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PICO
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Population
Intervention Comparison Outcome |
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Levels of Evidence (best to worst)
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1. Randomized Control Trial (RCT)
2. Lesser quality RCT 3. Case Control or Retrospective Study 4. Case Series 5. Expert Opinion |
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Levels of Evidence (best to worst)
1. Randomized Control Trial (RCT) |
a. Systematic review of RCT
b. Individual RCT (high quality) |
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Levels of Evidence (best to worst)
2. Lesser quality RCT |
a. Systematic review of cohort studies
i. Cohort = studying one specific group of people over time b. Individual cohort study i. Including lesser quality RCT c. Outcomes Research |
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Levels of Evidence (best to worst)
3. Case Control or Retrospective Study |
a. Systematic review of case-control studies
b. Individual case-control studies c. Case = people with disease of interest d. Control = people without disease of interest |
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Levels of Evidence (best to worst)
4. Case Series |
a. More than one pt.
b. Stronger evidence than case report |
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Levels of Evidence (best to worst)
5. Expert Opinion |
a. Includes textbooks
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Primary Ethical Issues (that should be considered when designing a research study)
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• Safety
• Informed consent • Confidentiality • How adverse events will be handled |
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Belmont Report – set 3 ethical principles
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1. Autonomy = obligation of investigator to respect each subject as a person capable of making informed decisions regarding participation in study
a. Subjects receive full disclosure 2. Beneficence = obligation of investigator to attempt to maximize benefits for subject which minimizing risk of harm a. Honest risk/benefit analysis should be performed 3. Justice = equitable selection of subjects (avoiding coercion of prisoners, poor people, institutionalized people, etc) |
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5 Components of Informed Consent
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1. Disclosure
2. Understanding 3. Volunteerism 4. Competence 5. Consent |
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P of PICO
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Population-details about pt, i.e. gender, dx, severity
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I of PICO
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Intervention-could be a dx test, risk factor or outcome
- "Indicator" in diagnostic or prognostic studies (talking about risk factor) |
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C of PICO
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Comparison-if appropriate
Ex: pt has shoulder impingement, trying to find dx test. Learned about Neer and Hawkin. Comparison may be "Is te Neer test better than Hawkin for identifying impingement?" Ex2: Diagnositic "Is TxA more effective for shoulder impingement than TxB", and then Outcome can change and be whatever you'd like or what the pt is intereested in |
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O of PICO
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Outcome-consequence of interest for Rx, Dx or
outcome - This is what will change in your search |
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What are the 3 most important factors in a Diagnostic Question
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tests or measures that give ...
1) the best information 2) in the least amount of time 3) with the least amount of cost and risk |
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Questions about Prognosis
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• Social factors affect prognosis
• Predicted optimal level of importance through intervention and amount of time needed to reach that level |
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Questions about Interventions
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• Is intervention in line with pt. goals?
• Cost vs. benefit • Practical intervention for pt.? |
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Questions about Outcomes
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• Validity for population (does it measure what you want it to measure?)
• Reliable • Standardized • Sensitive to change (if a pt. gets better, will the outcome measure show that?) |
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Concept vs. Construct:
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Concept = mental image of an observable phenomenon expressed in words (i.e. fatigue, pain, flexibility, age)
Construct = non-observable abstraction created for research purpose and defined by observable measures (i.e. motivation, patient satisfaction, health related QOL) |
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Hypothesis:
Null Hypothesis (Ho) |
1. Null hypothesis (Ho)
a. Aka “statistical hypothesis” b. No difference or no relationship everything related to statistical testing falls into these 2 categories c. Tests are designed to challenge the null and attempt to reject the null |
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Hypothesis:
Alternative hypothesis (Ha or H1) |
a. Aka “research hypothesis”
b. There is a difference or there is a relationship c. Best if directional language is used |
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Theory
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Organized set of relationships among concepts and constructs that is proposed to systematically explain a phenomenon or interest (Darwin’s Theory of Evolution, Nagi’s Disablement Model)
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Research Design Features & Components:
• Philosophical Perspective |
o Quantitative - Objective reality, measured in
numbers o Qualitative - Subjective reality, measured in words |
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Research Design Features & Components:
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o Experimental
o Quasi-experimental o Non-experimental |
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Research Design Features & Components:
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o Cross-sectional (Data collected from one point
in time) o Longitudinal |
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Research Design Features & Components:
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o Retrospective
o Prospective |
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Research Design Features & Components:
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o Within groups
o Between groups (this is always the best to use!) |
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Prognosis – one of the following 3 designs is usually used:
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1. Prospective cohort
2. Retrospective cohort 3. Case-control study |
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In a prognostic study, Causality can only be inferred when:
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• Exposure clearly precedes the outcome
• A dose-response relationship between exposure and outcome was demonstrated • Findings are consistent with previous, well-designed studies (contemporary) • Results are biologically plausible |
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RCT: Efficacy vs Effectiveness
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- Efficacy = performed under ideal conditions (in vitro)
- Effectiveness = performed in real world circumstances (in vivo) |