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Biostats/EBM > Lecture 1 - Principles of EBM > Flashcards

Lecture 1 - Principles of EBM Flashcards

1
Q

What is the “big question” of EBM?

A

How do you, as a medical provider, make the BEST decision for your patients?

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2
Q

Define EBM.

A

“The integration of best research evidence with clinical expertise and patient values”.

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3
Q

Who is the “Father” of EBM?

A

David Sackett

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4
Q

What are the 3 components of EBM?

A
  1. Best practices (Gold Standard) - I.e., National Comprehensive Cancer Network Guidelines
  2. Individual Clinical Experience - your experience caring for patients with similar situations/conditions/diagnoses
  3. Patient values & expectations - What does the patient want out of their care? (I.e. longer life, quality of life, time with family)
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5
Q

What do the 3 components of EBM provide ultimately?

A

Improved patient outcomes

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6
Q

What is evidence-based practice?

A

“Making a conscientious effort to base clinical decisions on research that is most likely to be free from bias, and using interventions most likely to improve how long or well patients live”.

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7
Q

Explain the difference between clinical research and clinical practice.

A

Gap between “best” clinical research (big questions involving lots of people) vs. what might be best for your patient
- Broadly applied, research will likely be right most of the time
- BUT clinical medicine is about individuals
Clinical research = broad vs clinical practice = about the patients as individuals

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8
Q

What are the 3 types of medical knowledge?

A
  1. Clinical research (clinical trials (RCTs) => meta-analyses (quantitative) => systemic reviews (qualitative)
  2. Clinical experience - personal/expert
  3. Physiologic principles/rationale - basic science/mechanistic reasoning (I.e. mRNA vaccines)
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9
Q

What are the examples of clinical research?

A
  1. clinical trials (typically RCTs) - research study in which one or more human subject is prospectively assigned to an intervention (or placebo or control) to evaluate effects of an intervention
  2. meta-analysis (Quantitative) - formal study design used to systematically assess previous research studies to derive conclusions about that body of research; combines results from many smaller studies to evaluate relationships
  3. systematic reviews (Qualitative) - attempts to collect and analyze all evidence that answers a specific question. More broad and thorough search of literature
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9
Q

What are the examples of clinical research?

A
  1. clinical trials (typically RCTs) - research study in which one or more human subject is prospectively assigned to an intervention (or placebo or control) to evaluate effects of an intervention
  2. meta-analysis (Quantitative) - formal study design used to systematically assess previous research studies to derive conclusions about that body of research; combines results from many smaller studies to evaluate relationships
  3. systematic reviews (Qualitative) - attempts to collect and analyze ALL evidence that answers a specific question. More broad and thorough search of literature
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10
Q

What are the strengths to clinical research?

A
  1. Potential to minimize bias
  2. Power to discern small, but significant effects
  3. Easy to share
  4. Subject to peer review
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11
Q

What are the weaknesses of clinical research?

A
  1. No direct application to individuals
  2. Knowledge is narrow
  3. Fixed in place and time
  4. Fallible, not always trustworthy (funding involved?)
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12
Q

What are the strengths to clinical experience?

A
  1. Accommodates individual variability
  2. Ability to compare to others (with deep experience)
  3. Allows recognition of new situations
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13
Q

What are the limitations to clinical experience?

A
  1. Subject to a variety of cognitive biases
  2. Small numbers
  3. Variable responses
  4. “This is how we’ve always done it”
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14
Q

What are the strengths to physiologic principles/rationale medical knowledge?

A
  1. Accommodates individual variability
  2. Early recognition of efficacy/futility
  3. Safeguard against incorrect findings from clinical research
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15
Q

What are the limitations to physiologic principles/rationale?

A
  1. Does not always predict relevant outcomes (I.e. CAST Trial (1980s)
  2. Only as good as current physiologic understanding
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16
Q

List the 5 steps of the EBM process model.

A
  1. Ask - Define the clinical question
  2. Acquire - Locate pertinent information
  3. Appraise - Evaluate for validity and relevance
  4. Apply - Make decision with patient
  5. Assess - Evaluate the process (OR, if at beginning, assess the clinical problem)
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17
Q

List and define the 4 elements of developing well-formed clinical questions.

A
  1. P - patient(s) (or problem)
  2. I - intervention
  3. C - Comparison
  4. O - Outcome
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18
Q

List the 4 different domains/types of clinical questions and associate these questions with the type of evidence that will best answer the question.

A
  1. Treatment/therapy - questions of treatment in order to achieve some outcome (I.e. drugs, surgical intervention, change in diet, counseling)
    - RCTs
  2. Diagnosis - questions of identification of a disorder in a patient presenting with specific symptoms (I.e. diagnostic testing, imaging studies)
    - RCTs
  3. Prognosis - questions of progression of a disease or likelihood of a disease occurring
    - Cohort studies
  4. Etiology/harm - questions of negative impact from an intervention or other exposure
    - Cohort studies
19
Q

Which study design/level of evidence would you use to help answer prognosis questions?

A

Cohort studies

20
Q

Which which study design/level of evidence would you use to help answer etiology/harm questions?

A

Cohort studies

21
Q

Which study design/level of evidence do you use if you cannot find a cohort study to answer prognosis and etiology/harm questions?

A

Case control study

22
Q

Which study design/level of evidence do you use if you cannot find a cohort study or case-control study to answer prognosis or etiology/harm questions?

A

Case series & case reports

23
Q

Which study design/level of evidence should you use to answer treatment/therapy or diagnosis questions?

A

RCTs (randomized control trials)

24
Q

If you cannot find a RCT to answer treatment/therapy or diagnosis question, which study design/level of evidence should be used?

A

move down the pyramid to the next best option

25
Q

What are the items on asking clinical questions checklist?

A
  1. Do I ask a well-formulated question using PICO?
  2. Are my questions answerable?
  3. Do I have a working method to save my questions for later answering?
26
Q

What are the 3 types of medical literature (including examples)?

A
  1. Primary (unfiltered) - original studies/reports of journals and published conference proceedings and symposia (I.e. RCTs, Cohort & case-control studies)
  2. Secondary (filtered)* - PubMed searches, systematic reviews, meta-analyses, clinical guidelines)
  3. Tertiary - Textbooks, handbooks, online databases (UpToDate, DynaMed)
27
Q

Which type of medical literature is “the basic foundation of evidence based practice”?

A

primary literature (RCTs & cohort studies)

28
Q

What are the positives to primary literature?

A
  1. Evaluate research and original study
  2. Includes reference sources, funding sources or affiliations, and locations of study
  3. Often is peer-reviewd
29
Q

What are the negatives to primary literature?

A
  1. Requires additional skills to interpret results
  2. May not have access to article
30
Q

What type of medical literature connects you to primary literature?

A

Secondary literature

31
Q

Which type of medical literature involves indexing and abstracting databases?

A

Secondary literature

32
Q

In what case would review articles be classified as secondary literature?

A

if they are used to find references

33
Q

In what case would review articles be classified as tertiary literature?

A

if they are used for information

34
Q

What are the positives to secondary literature?

A
  1. Can search for primary literature across wide range of publications
  2. Read abstract before retrieving article
35
Q

What are the negatives to secondary literature?

A
  1. Defining proper search term
  2. Not all journals indexed in each service
  3. Sometimes need to go to primary literature after searching
36
Q

Term for “massive listing of citations and abstracts from all health science disciplines”

A

PubMed

37
Q

What are the 4 types of secondary literature examples?

A
  1. PubMed
  2. Practice guidelines
  3. Systematic reviews
  4. Evidence-based summaries
38
Q

Which type of medical literature is the most widely used source of information?

A

Tertiary literature

39
Q

Medical literature that is the “Gold standard” for diagnostic studies

A

tertiary literature

40
Q

What are the 3 well-established principles of tertiary literature?

A
  1. Common clinical presentation
  2. Gold-standard diagnostic studies
  3. Common treatment options
41
Q

What are the positives (6) of tertiary literature*?

A
  1. Easy access
  2. Fast
  3. User friendly
  4. Familiarity
  5. Reputation
  6. Answer provided
42
Q

What are the negatives (4) to tertiary literature*?

A
  1. Dated print materials
  2. Trusting that author interpretation is correct
  3. Not all inclusive
  4. May leave unanswered questions
43
Q

What are the examples of tertiary literature?

A
  1. Reference books - CURRENT Medical Diagnosis and Treatment (CMDT), Harrison’s Principles of Internal Medicine
  2. Online databases - UpToDate, Micromedex, Lexi-Comp
  3. Handbooks - Tarascon Pocket Pharmacopoeia, Sanford Guide (antibiotics)
  4. Other - web pages, package inserts
44
Q

What are the factors (6) influencing the internal and external validity of a study (tertiary literature)?

A
  1. Author/editorial board
  2. Sponsorship/Appropriate advertising
  3. Goal/focus
  4. Date published/update frequency
  5. Citations
  6. Cross-check accuracy of data
45
Q

What are the factors needed (4) to develop a recommendation?

A
  1. Quality of evidence
  2. Results
  3. Clinical judgement
  4. Patient’s values

Biostats/EBM (4 decks)

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