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PMP 103 - Clinical Pharmacy > Evidence-Based Medicine (EBM) > Flashcards

Evidence-Based Medicine (EBM) Flashcards

1
Q

What is the definition for Evidence-based medicine (EBM) ?

A

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. (Sackett DL et al, 1996)

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2
Q

What are two examples of experimental study design ?

A
  • Animal and laboratory studies
  • Randomised controlled trial (RCT) – Gold standard
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3
Q

What are three examples of observational study designs ?

A
  • Cohort studies
  • Case-control studies
  • Cross-sectional studies
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4
Q

What does animal research use and what does it test for ?

A

Animal research uses animals to test potential pharmaceuticals prior to human trials

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5
Q

What are some disadvantages of animal and laboratory studies ?

A
  • Its application is limited considering the difference between human and animal physiology
  • Experiments are undertaken in a highly controlled environment
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6
Q

What are the 5 levels of evidence ?

A

1) randomised controlled trial - prospective, tests treatment. (Secondary, pre-appraised or filtered studies)
2) cohort studies
3) case control studies
4) case report or case series
5) animal and laboratory studies

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7
Q

Why is EBM an important concept for pharmacists ?

A
  • Ensure medicines sold are of high quality, safety and efficacy
  • Basis for the recommendations we make to patients and other health professionals through pharmacy services

(It is essential that pharmacists are available to retrieve, appraise and apply research evidence as the basis for clinical decision making)

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8
Q

What does a randomised controlled trial consist of ?

A

Clinical practice guidelines, meta-analysis, systemic reviews, is prospective and tests treatments.

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9
Q

What do cohort studies involve ?

A

It is prospective; the cohort has be exposed to a risk. Observe for outcome of interest.

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10
Q

What does case control studies involve ?

A

It is retrospective ; the subjects have the outcome of interest - you are then looking for the risk factor.

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11
Q

What do case reports and case series contain ?

A
  • narrative reviews
  • expert opinions
  • editorials
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12
Q

What are the secondary / pre-appraised or filtered studies ?

A

-clinical practice guidelines
-meta-analysis systemic reviews

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13
Q

What are the primary studies ?

A

-randomised controlled trial
-cohort studies
-case control studies

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14
Q

Define cross-sectional studies …
How are participants selected ?

A
  • An observational study design where outcomes and exposures are measured concurrently.

Participants are selected based on set inclusion and exclusion criteria.

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15
Q

When is cross-sectional study mainly used ?

A

In population based research

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16
Q

What is data collected on in a schematic representation of a typical cross-sectional study ?

A

The data is collected on both outcomes and exposure of the individuals at a given point in time.

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17
Q

What is the case-control study DESIGN ?

A

Retrospective in nature

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18
Q

What are advantages of a case-control study design ?

A
  • Less expensive
  • Easier to do and take less time
  • Useful when obtaining follow-up data that is difficult to obtain due to the nature of population being studied
  • More efficient if the disease is rare
  • This design may be the only ethical way to evaluate something
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19
Q

What are disadvantaged of a case-control study design ?

A
  • Potential recall bias
  • Subject to selection bias
  • Generally do not allow investigators to calculate an incidence or absolute risk
20
Q

Is a cohort study prospective or retrospective ?

A

It is almost always prospective but sometimes can be retrospective cohort studies.

21
Q

What are the advantages of a cohort study ?

A
  • Can more clearly show the time of exposure and development of the outcome because the subjects are without the disease at baseline.
  • Allows for evaluation of more than one outcome as it relates to an exposure
  • Allows for the calculation of the incidence
22
Q

What are the disadvantages of a cohort study ?

A
  • Can be expensive and time consuming because of needing to follow a large number of people
  • Loss of follow up can begin to introduce bias
  • May not be good for rare diseases
23
Q

Is a randomised controlled trial (RCT) a prospective study or a retrospective study ?

A

A prospective study

24
Q

What are the advantages to a randomised controlled trial (RCT) ?

A
  • Considerers the gold standard
  • This design allows for washout of most population bias
  • Reduced influence by confounders
  • Reduced variability in the outcome(s)
  • Easier to blind patients than observational studies
25
Q

What are the 2 disadvantages of a randomised controlled study ?

A
  • Generally more time consuming
  • Tend to be more expensive
26
Q

What is as systematic review ?

A

A systematic review is a literature review that is designed to locate, appraise and synthesize the best available evidence relating to a specific research question to provide informative and evidence-based answers. This information can then be combined with professional judgment to make decisions about how to deliver interventions or to make changes to policy.

27
Q

What is meta-analysis ?

A

The use of statistical methods to summarize the results of independent studies. By combining information from all relevant studies, meta-analysis can provide more precise estimates of the effects of health care than those derived from the individual studies included within a review.

28
Q

What is an Advantage of meta-analysis ?

A

Objective evaluation of research findings

29
Q

What is the disadvantage of meta-analysis ?

A

Not all topics have sufficient research evidence to allow a meta-analysis to be conducted

30
Q

What are some advantages of having guidelines in place ?

A
  • Are on topic of relevance to population (usually determined by NHS England or the Department of Health and Social Care). 
  • Thorough and transparent development process to ensure fairness. 
  • Representative stakeholders involved in the process.  
  • Guidelines are developed using thorough literature reviews of many RCTs and other forms of evidence. 
  • Directly applicable to patients. 
  • Often take into account a huge number of potential treatments and drug classes, e.g. type 2 diabetes guidelines. 
  • Complex issues simplified. 
  • Regularly reviewed.  
  • Take into account cost considerations. 
31
Q

What are the two disadvantages of having guidelines put into place ?

A
  • very resource intensive
  • May course Conflict of interest?
32
Q

What are the key terms in epidemiological calculations ?

A
  • Endpoints
  • Absolute risk reduction (ARR)
  • Relative risk reduction (RRR)
  • Number needed to treat (NNT)
  • Number needed to harm (NNH)
33
Q

What is and endpoint ad what should it be ?

A
  • An endpoint is an event or outcome that can be objectively measured in a study.
  • Endpoints should be pre-defined and, ideally, sufficiently powered.
34
Q

What is a primary endpoint ?

A

Primary endpoint/s: the main result/s that is measured at the end of a study to see if a given intervention was effective – needs to be clinically relevant and must always be powered

35
Q

What is a secondary endpoint ?

A

Secondary endpoints: these are additional events of interest, but which the study may not be specifically powered to assess

36
Q

What is a patient-oriented endpoint (POEs) ?

A
  • An ideal endpoint should be a valid and applicable measure of how a patient feels, functions or survives.

POEs measure this directly (e.g. number f fractures, deaths, pain levels, number of migraines)

37
Q

What is an advantage of POEs ?

A
  • considers measures of true patient benefit
  • is clinically meaningful
  • has clinical certainty
38
Q

What is the disadvantages of POEs ?

A
  • large sample sizes needed
  • has a longer trial duration
  • expensive
  • has a delay in potentially beneficial medicines coming to market.
39
Q

What are disease oriented endpoints (DOEs) ?

A

DOEs – also known as “surrogate” endpoints: do not directly measure how a person feels, functions or survives, but which should be so closely associated with a clinically meaningful endpoint that they are taken to be a reliable substitute for them, e.g. blood sugar, blood pressure, cholesterol levels, bone mineral density.

40
Q

Advantages of DOEs …

A
  • uses smaller sample size
  • has a shorted trial duration
  • less expensive
  • expedites medicines to market
41
Q

Disadvantages of DOEs …

A
  • may not relate to clinically meaningful outcomes
  • may not change at all staged of disease
  • may not predict that harmful treatments are effective
42
Q

Examples of DOEs vs POEs

A

DOE: Beta-carotene and vitamin E are good antioxidants
POE: Neither vitamin prevents cancer or cardiovascular disease

DOE: Anti-arrythmic drug X decreases the incidence of premature ventricular contractions on ECGs
POE: Anti-arrythmic drug X is associated with an increase in mortality

43
Q

What is ARR ?

A
  • Absolute risk reduction
  • a straightforward process, is the difference between event rates
44
Q

What is RRR ?

A

-Relative risk reduction

  • the difference in event rates expressed relative to what you started with
45
Q

What does the NNT estimate ?

A

The number of patients we need to treat for one patient to benefit.

PMP 103 - Clinical Pharmacy (24 decks)

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