EBP Flashcards

1
Q

Five stages of evidence based practice

A

1 .convert the need for info in an answerable question
2 .find the best evidence to answer this question
3 . Critically appraise the evidence
4 . Apply evidence to the patient
5 . Evaluate your effectiveness and efficacy at step 1-4

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2
Q

Definition of EBP

A

EBP is the conscientious (careful) explicit and judicious use of current best evidence in helping individual patients make decision about their care in the light of their personal values and beliefs

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3
Q

What information can be found in guidelines

A
Usually based on 1 disease and describe :
Diagnostic criteria 
Investigations 
Immediate treatment 
Subsequent treatment 
Monitoring treatment 
Discharge policy
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4
Q

When to use guidelines

A

Good enough quality AND

Relevant to your patient

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5
Q

Who produces guidelines that i can trust

A

NICE

SIGN- Scottish intercollegiate guiltiness network

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6
Q

How do I apply that information to my patient?

A

Best external evidence: guidelines -the stronger the evidence recommendation, the more weight this should be given
Individual clinical expertise : think about co- morbidities (guidelines usually only consider one disease)
Patients values and expectations
EBP

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7
Q

Evidence can come from

A

RCT
Meta analyses
Cohort studies
Case control studies

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8
Q

What’s the purpose of clinical trails

A

Designed to determine efficacy

Collect efficacy and safety data on new drugs

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9
Q

After which point does patient irreversibly stay in clinical trail?

A

After they have given consent

Before allocate to trt

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10
Q

What’s parallel group design

A

Treatment gp and control gp run in parallel

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11
Q

What does inclusion and exclusion criteria affect?

A

They affect the extent to which the results of the trail can be generalised

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12
Q

Randomisation is viewed as gold standard because?

A

Possible error is just chance

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13
Q

Randomisation avoid … bias

Benefit

A

Avoid allocation bias
Comparable groups with respect to measures and unmeasured risk factors
Eliminates confounding- trt is independent of outcome
Equipoise

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14
Q

Chi square

A

How likely it is that an observed distribution is due to chance

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15
Q

Double blind is ideal cause

A

It protects against information bias

Neither patient nor/or(if single blind) researcher knows the trt being taken

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16
Q

Study power =

A

Probably of detecting a true difference (usually >80%)

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17
Q

What is primary outcome

A

The outcome that the trial is designed to investigate

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18
Q

What is secondary outcome

A

Other outcomes that are of interest for example symptom relief, adverse events,quality of life

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19
Q

What is clinical endpoint

A

It reflects survival or symptomatic status of patient

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20
Q

What is Surrogate endpoint

A

Associated with clinical endpoint but do not directly reflect survival or a clinical status
Example: BP, cholesterol, tumour size

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21
Q

Non randomised method

2 types of control

A

Historical control - use the control from literature /databank and compare it with new drug group
Concurrent control - control gp at one centre, trt gp at another / same centre

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22
Q

Pros and cons of crossover design

A

Pros - eliminates between subject (person) variation from trt comparisons
- make more use of each subject

Cons- more complex
Difficult to interpret carry over (left over trt A + trt B) is present
Consequence of drop outs more serious

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23
Q

Date collection (when? What for? Types? Other purpose

A

Baseline date - prior to start of trt
Efficacy
Safety data - non/ serious ADR
Follow up status

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24
Q

Intention to treat -?

A

All subjects inc regardless of adherence

All outcomes must be determined of whether the trt has been discontinued

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25
Q

Objections to ITT

And response to objections

A

Sub who discountinue no longer receive the benefit from the trt
ADR occurred after trt stopped bias analysis
Study may lack of power where nonadherance is significant
Non adherence can be beneficial in non inferiority or equivalence trail

Non adherends reflect real-life usage
Excluding subject would produce biased estimates

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26
Q

Per protocol analysis

A

Include only those events that occur while participant is complying with intervention
Vulnerable to bias

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27
Q

Non inferiority design is

A

To evaluate new trt is not inferior to stnd trt ( less toxic?)
Trail design is more challenging

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28
Q

Terms used to Describe disease frequency

A

Incidence

Prevalence

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29
Q

What’s incidence

A

Measure of occurrence of new cases of disease

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30
Q

Incidence rate is equation

A

No of new cases of disease / mid year population -only inc those “at risk” of getting the disease

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31
Q

How to calculate incidence rate that take changes in population into account?

A

Number of new case / disease- free person-time at risk

2 case/ 24person- years

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32
Q

For dynamic population how to calculate incidence rate

A

The no of new case of disease within a specific time period (person-years: add up the years that each person lived for, when the test is carried out

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33
Q

Comparing incidence rates between calendar years can be misleading if the population structure has changed (ppl get old) What are the ways to overcome it

A

Standardisation -reduce distortion in the rate comparison
Compare rates by categories e.g. Age
Stratify -form into groups

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34
Q

Incidence is new case of disease but prevalence is focused on

A

Disease status

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35
Q

What’s point prevalence

A

The proportion of ppl who have a disease at a specific POINT in ti
time

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36
Q

Period prevalence

A

The number of ppl who gave the disease in a time period divided by the population at mid- point of the period

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37
Q

What’s the equation for prevalence

A

Number of cases / number of people in the population

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38
Q

Prevalence will always be between .. and …

A

0 and 1

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39
Q

Prevalence depends on two factors

A

Disease incidence

Duration

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40
Q

Prevalence may change over time with

A

Changes in incidence
Changes in disease duration
Intervention programmes
Changing classifications

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41
Q

What’s relative risk

How to calculate it

A

The ratio of risk between incidence (exposed gp) and incidence (unexposed gp)

Exposed outcome/(EO+exposed no outcome-total population)
Divide by
Unexposed outcome/ (UO+UNO)

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42
Q

What’s is risk?

A

Probability that individual WILL BE diagnosed with outcome over follow up period

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43
Q

What does it mean when RR=1

A

There is no difference in incidence exposed and unexposed

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44
Q

Measures of variability
Standard deviation qualifies…
Used for …

A

Quantified spread of a set of individuals in population

Used for description

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45
Q

Stand error quantifies…
Describes
Used for…

A

Spread of sample means
Precision of means
Estimating and calculate confidence interval

46
Q

How are populations selected in a cohort study

A

People WITHOUT the disease being studied

47
Q

2 ways to measure an effect give examples for
Absolute
Relative

A

Absolute risk difference, Attributable risk , NNT, NNH

Relative risk, risk ratio, hazard ratio, odd ratio

48
Q

How to calculate attributable risk

A

=absolute risk reduction

Incidence exposed - incidence unexposed

49
Q

What does NNH measures?

A

The ADR impact of a trt

The no of ppl who when treated results in one additional harmful outcome

50
Q

How to calculate NNH?

Results should be round up/ down?

A

1/ absolute risk difference

Always round down the nearest while number

51
Q

what’s NNT

A

No of ppl who must be treated with new trt to achieve one more success than an old trt

52
Q

What does it mean when NNT=1

A

New trt always effective

53
Q

How to calculate NNT

A

1/ absolute risk difference

54
Q

Hazard means

A

The risk of getting outcome in following short time interval (given that outcome has not already occurred)

55
Q

Hazard can quantify …

A

Differences in survival

56
Q

What’s hazard ratio?

Will it be constant over time?

A

Compare hazards bw gps over follow up time

Hazard may change but hazard ratio is constant

57
Q

What’s confidence interval

A

A range of values which we can be confident includes the true value (e.g. Point estimate

58
Q

How to calculate 95% confidence interval

A

Mean+- (1.96x SE)

59
Q

What does SE represent

SD?

A

The variability of sample MEANS

Variability of a population

60
Q

Definition of 95% confidence jntervak

A

If you repeated the study 100 times, on 95 of those times the point estimate (mean) will be within the confidence interval

61
Q

Point of no difference for absolute and relative difference when value is no difference to interval

A

Absolute =subtraction so 0

Relative division so 1

62
Q

Definitions for null hypothesise

Alternative hypothesis

A

Null: there is NO DIFFERENCE in outcomes comparing treatment with no treatment
Alternative: there is A DIFFERENCE

63
Q

Definition of p value

A

Probability of HAVING OBSERVED our data or more extreme data when the NULL HYPOTHESIS IS TRUE

64
Q

P=…. is usually the value to compare p values against

A

0.05

65
Q

How to work out SD

A
Root mean square 
Work out mean 
Mean - value , square it
Add up the square values 
Divide by no of values - mean 
Square root the mean
66
Q

What fixed/ open cohort studies

A

Fixed- exposures are defined
New subjects not included
No movement bw gps
Open- movement can occur in and out of the cohort

67
Q

Hills aspects of association (for causation of disease)

A

CSS -consistency strength of association specificity
BBC -biological gradient and plausibility coherence
EAT - experimental evidence analogy temporality

68
Q

Limitation and use of large simple trails

A

Reduced the info collected to the minimum required to test hypothesis
Used to test the risk of ADR

69
Q

Is observation studies experimental or non experimental
Are there any control over exposures/ population
Can confounding occur

A

Non experimental - no risk to patients
No control over exposures assigned but can select subjects included
Confounding can occur

70
Q

Steps in the design process of case control study

A
Define research question
Design study 
To find - group of interest (cases)
- comparison group (controls) 
Take histories (identify exposures) 
Analyse results 
Draw conclusions
71
Q

RCT- 4 aspects of measuring outcomes

A
Unequivocal (no doubt) death 
Measured BP, hba1c
Clinical assessment (objective) swollen joints, X-ray results
Patient opinion (subjective) pain, s/e
72
Q

In parallel group design for non randomised trail -may have a run-in period
Patient presents - eligibility - consent -run in then -(irreversibly) allocate to trt

A

Test tolerance to cardiac suppression drugs
Determine disease stability e.g. Copd
Test patient adherence to intervention
Ensure zero plasma level of old trt

73
Q

Case control study-what cases should be included

A

Cases with outcomes of interest

74
Q

CCS- controls - are there any req?

A

Controls should be found from hopstial neighbourhood community

75
Q

CCS- match and unmatched studies can be used to

Often match on .. and …

A
Overcome confounding ( males more likely to have MI)
Match on age and sex
76
Q

Odds:

A

Probability of event occurring divided by probability of event not occurring

77
Q

Odds ratio:

How to calculate:

A

Compares odds that an outcome will occur, between exposed and absence of exposure groups
Odds of exposure in case and control gps

OR= odds of CASES having exposed/ odds of CONTROLS having exposed

A/C (a- cases exposed, c- cases unexposed)
Divided by
B/D (b- control exposed, d- control unexposed)

78
Q
Cohort vs case control studies 
Population sampling- 
How to obtain data -
Exposure / event status known or unknown-
Compare results -
Analytic calculation-
A

Cohort: Take a gp from population who do NOT have the outcome of interest / case control: take a gp WITH outcome of interest (cases)

Follow them forward in time see what happens/ retrospectively (consider past exposure) identify an appropriate comparison group

EXPOSURE is known / EVENT STATUS is know

Compare OUTCOMES in exposed and unexposed gps/ compare EXPOSURES in case and control

Calculate RELATIVE RISK/ calculate ODD RATIOS

79
Q

What is p value

A

Probility of finding the observed, or more extreme, results when the null hypothesis is true (results is due to chance)

80
Q

What tools help you to critically appraise?

How many other tools are there?

A

CASP- critical appraisal skills program

7

81
Q

What does PICO stand for

A

Population
Intervention
Comparator
Outcomes

82
Q

What is alpha level

A

Is the significance level - probability of making wrong decision when the null hypothesis is true
Usually use alpha level 5%

83
Q

What’s bias
It can be in terms of
Can result in … risks

A

Systemic error in data/ study
At the pint of study design
Cannot be eliminated at point of analysis

In terms of selection of study subjects, exposure classification, outcome classification

Over/ underestimated risks

84
Q

Misclassificarion have 2 gps

A

Non differential - misclassification to same degree for all groups

Differential- misclassifcation different between groups

85
Q

Confounding

A

The distortion of RISK ESTIMATE due to the mixture of the ppl in the study population

86
Q

Confounder

A

A confounder is a RISK FACTOR for the disease and is CORRELATED with the EXPOSURE INDEPENDENT OF DISEASE

87
Q

How to control confounding?

Can be implemented at design and analysis stage

A
1 randomisation 
2 restriction 
3 matching 
4 statified analysis 
5 multivariate analysis 
RRMSM
88
Q

Two ways of analysis of data to control confounding

A

Stratified analysis- separate out factors, so any mixture of their effect is removed, used for 1-2 factors
Multivariate analysis - take into acc of annulled of factors

89
Q

Methods to search a paper for systemic review

A
1 define the question PICO
2 identify search terms 
3 use literally searching 
4 review papers 
5 summarise results 
- descriptively for systemic review 
- quantitatively for meta analysis ( check for heterogeneity
90
Q

Define a standard method for extracting data from a paper in systemic review

A
Need study details (type: cohort/ case control/ RCT)
Location 
No of patient included 
Patient demographics 
Exposure 
Covariates 
Overall result
91
Q

When to do a systemic review when to do a meta analysis?

A

Descriptive summary - systemic

Results can be combined and quantified - meta analysis

92
Q

What type of Meta analysis to use when variation is due to sample variation only?
If there is heterogeneity

A

Fixed effect meta analysis
Examine this assumption using a test of heterogeneity
Then use a Random effect meta analysis

93
Q

What is marginal utility?

A

In economics, decisions are made at the margins i.e. At the point when the utility (satisfaction) not ‘worth’ the 80p you spend
Marginal utility- at the margin of your satisfaction (about to become unsatisfied)

94
Q

What is opportunity costs

A

You have less resources (money, time) to do things (opportunity)

95
Q

What is health economics

A

The study of attempts to allocate limited health care resources among unlimited wants and needs to achieve the max health benefit for society

96
Q

What is pharmacoeconomics

A

The application of the theories, techniques and concepts of health economics to the study of pharmaceutical interventions (treatment)

97
Q

Medicine regulations QSEC

A

Quality
Safety
Efficacy
Cost effectiveness

98
Q

What’s is economic evaluation (in term of pharmacoeconomics)

A

Comparison of two or more alternative treatments in terms of costs and consequences
Quantify the differences
Ensure max utility from scares resources

99
Q

What’s QALY

A

Quality- adjusted life-years

Number of years lived x utility

100
Q

What can be used to measure the QOL for all health conditions?

A

EQ-5D scores
Compare with state values
Gives a utility scores between 0 (worst state) and 1

101
Q

Different types of economics analysis CMA

A

1 cost minimisation analysis - assume effectiveness is equal,

compares cost of trt with two or more drugs/ interventions

Whichever gives desired outcome at the LOWEST price is preferred

102
Q

Different types of economics analysis CEA

A

Cost effectiveness analysis
- NO assumption on equal effectiveness
-Benefit = non monetary terms (usually QALY)
-the greatest effectiveness for the lowest cost
- only consider NHS costs
- main measure in CEA is the ICER
ICER= C1-C0/ E1-E0
C1,E1 the cost and effect in study trt group
C0,E0 the cost and effect in study control group

103
Q

how to calculate ICER

A

Compare two different trts
Diff in treatment costs/ diff in effectiveness
Additional cost for each additional patient effectively treated

104
Q

Different types of economics analysis CBA

A

Cost -benefit analysis
To compare the outcomes of a medical intervention expressed in monetary terms - not easy so use
Willingness to pay approach (assign monetary value to health consequences)
How much you like to pay for additional 2 yrs of life? (Depends on the age)

105
Q

Economics is about how to make choices …

A

Make choices in the context of scare resources

106
Q

Economic decision are made at the …..? What the outcome of interest

A

Margin

The incremental cost effectiveness

107
Q

Incremental analysis

A

Assessment of the relative cost and the benefit of each marginal addition or reduction in production or consumption

108
Q

What’s the CEBM levels of evidence

A

The centre for evidence based medicines

109
Q

CEBM - does this trt help?

A
Level 1 (best) systematic review of RCT
2 RCT OR observational study with dramatic effect 
3 non Randomised controlled cohort/ follow up study
4 case series, CCS, historically controlled studies 
5 mechanism- based reasoning
110
Q

CEBM - what are the common harms?

A

1 systematic review of RCT or Observational study with dramatic effect
2 RAndomised trail or ob study with effect
3 non randomised CT/ follow up study
4 case control studies, historically CS
5 mechanism- based reasoning

111
Q

CEBM- graded may go down on basis of :

Grade may go up if

A

Study quality
Imprecision of result ( large 95CI)
Indirectness (study PICO not question PICO)
Absolute effect size is small

  • there is a large effect size