Evidence based dentistry Flashcards

1
Q

risk

A

What are the chances…?

Good (positive) or bad (negative)

  • …having a heart attack
  • …surviving prostate cancer
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2
Q

outcome

A

“something” that might happen, what you are measuring

  • Death, heart attack, cancer diagnosis (bad)
  • Tooth decay/ periodontitis/ TMJD (bad)
  • Caries free (good)
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3
Q

what are statistics?

A

Numbers that summarize information

  • Based on observations of large numbers people
  • Useful in predicting what is likely to happen in the future
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4
Q

what are risk statistics?

A

The chance that an outcome will happen – risk of an outcome

- Fractions or differences between 2 numbers

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5
Q

numerator in risk statistics

A

top number in fraction)

= number of people who actually experience the outcome

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6
Q

denominator in risk statistics

A

(bottom number in fraction)

= the number of people who could potentially experience the outcome

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7
Q

risks and odds in binary events

A

express the chance of being in one of the two states.

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8
Q

binary events

A

one or another outcomes

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9
Q

risk =

A

number of events of interest /

total number of observations

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10
Q

odds =

A

number of events of interest /

number without the event

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11
Q

ways of expressing risk

A

can be asked in exam, numbers and words

  • The chances of falling were one in four,
  • 25%.
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12
Q

ways of expressing odds

A

can be asked in exam, numbers and words

  • The chances of falling were one third of the chances of not falling;
  • One person fell for every three that didn’t fall;
  • The chances of falling were 3 to 1 against.
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13
Q

questions to ask when interpreting risk (4)

A

Risk of what?
- What is the outcome?
(Getting a disease? Dying from a disease? Developing a symptom? Surviving a disease?)

How big is the risk?
- What are the chances of experiencing the outcome?
(Out of how many? Need baseline/total)
- What is the timeframe? (Next year? Next 10 years? Lifetime?)
e.g. Out of 1000 people in the last 10 years

Does the risk information reasonably apply to me or my patient?
- Age/sex/lifestyle similar enough to apply results, need to dissect paper

How does this risk compare with other risks?
- Perspective- which risk should I do something about? Personal decision

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14
Q

questions to ask when you see messages about risk reduction (5)

A

Reduced risk of what?

  • What outcome?
  • How much do you care about it?

How big is the risk reduction?

  • What are my chances if I don’t get treatment?
  • Starting and modified risks

Does the risk reduction information reasonably apply to me?
- Is the study based on people like you (or your patients)?

Any downsides?

  • Life threatening side effects? (Mental health. Need to think of other side for patient)
  • Time/cost/hassle

Is the benefit (risk reduction) worth the downsides?

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15
Q

starting and modified risks in drug studies

A

are the chances of the outcome in the untreated and treated groups

those who did not take the drug and those that did

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16
Q

2 by 2 - contingency tables

A

Putting numbers into table

Rows – groups

  • Both groups got a placebo pill
  • group 1 had normal brushing
  • group 2 had perio treatment

Modified risk – is given treatment, what we are interested in (group 2)

need total for each group

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17
Q

issue with relative risk reductions

A

Makes even small risk reductions sound big

  • We then overestimate the benefit
  • Relative Risks that seem large might not mean much if starting risk is small

absolute risk reduction is more representative
FRAMING

i. e. 4.9% down to 0.8% = 84% reduction in risk of premature birth
4. 9% - 0.8% = 4.1% is the absolute risk reduction (difference)

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18
Q

(absolute) Risk difference

A

Difference in risk between groups

good outcome measure

  • Risk in paracetamol group= 40/63= 63%
  • Risk in placebo group=5/27= 18%
  • Risk Difference = 63% - 18% = 45% more patients experienced pain relief in the paracetamol group
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19
Q

(absolute) Risk difference when there is no difference in modified and control group

A

0

  • No benefit between the 2 conditions (take away from each other – no difference)
  • cannot straddle as unsatisfied of evidence
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20
Q

Number Needed to Treat (NNT)

A

The number of patients you would need to treat to prevent one patient from developing the disease/ condition/ outcome
- Numerically: 1/ Absolute Risk Difference

e. g. NNT for paracetamol = 1/ 0.45 = 2.22 (round up, measured in people)
- Would need to treat 3 people with paracetamol post-operatively to have one person experience pain relief of >50% in 4 hours

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21
Q

risk ratio/relative risk

A

How many times more likely is a participant in the paracetamol group to experience pain relief than a participant in the placebo group?
The risk of 50% pain relief after 4 h in placebo group = 5/27 = 18%
The risk of 50% pain relief after 4h in paracetamol group = 40/63 = 63%

Risk in paracetamol group / Risk in placebo group
- 63/ 18 = 3.42

A participant in the paracetamol group is 3.42 times more likely to experience pain relief than a participant in the placebo group.

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22
Q

risk ratio/relative risk value is the risks in both groups were equal (no benefit)

A

1

  • value of no difference (1:1
  • cannot straddle as unsatisfied of evidence
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23
Q

odds ratio

A

Ratio of odds of pain relief in both groups (usually intervention/control)

Odds of pain relief in paracetamol group = 40 (pain relief)/23 = 1.74

Odds of pain relief in placebo group = 5 (pain relief)/ 22 = 0.23

Odds ratio = 1.74/0.23 = 7.56

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24
Q

odds ratio value were there would be no benefit between the 2 groups

A

1

  • value of no difference (1:1)
  • cannot straddle as unsatisfied of evidence
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25
difference between odds and risk ratio
OR only approximates RR when the outcome is rare - OR tends to overestimate - the RR as in this case
26
confidence intervals
Confidence intervals quantify the level of uncertainty for the population of interest Sampling introduces uncertainty, don’t know how will affect rest of population
27
confidence intervals for risk ratio
A confidence interval tells us the range of values that a true population treatment effect (e.g. RR) is likely to lie (subject to a number of assumptions)
28
what value can a CI not straddle for risk ratio
1 “value of no difference” between treatments indicates that - there is insufficient evidence for a difference between the treatment and control group in the population
29
things to query once read the published study
- Much research is based on weak science - Many results are disseminated too early – trial not fully completed - Is there any science behind the numbers? - How good is the science? - Some research only makes a weak case for the message – be sceptic - Some research makes a strong case Treatments shown to fight diseases in test tubes won’t necessarily translate to humans (bench science in petri dishes, isn’t just a building block to clinical trial which will be benefit to patient) Treatments that work in animals often don’t have the same results in people – Dolly the Sheep – positive benefit in animals may not translate to humans be sceptical about treatments that have only been proven in animal or lab studies
30
observational uncontrolled studies
Researchers watch what happens to a group of people - A group of patients has disease A and is treated with drug X - No control group The researchers observe how many get better - No intervention - Has the treatment caused them to survive or something else attributed?
31
controlled studies
Cohort or case control - Treatment better than control group – shows treatment may be beneficial Researchers observe what happens to people in different situations-without intervening
32
randomised controlled trials
patients randomly split into 2 groups-one gets intervention the other placebo (TAU) splitting into 2 groups randomly – equal chance of being in one group or the other Any differences at follow-up caused by intervention
33
evidence levels
- systematic reviews and meta analysis - randomised controlled trials - cohort studies - case-control studies - cross-sectional surveys - ecological studies - case series and case reports - ideas editorials and opinions higher: experimental interventions lower: observational, non-interventional
34
case report/ case series
A report on a single patient or series of patients with an outcome of interest - No control group is involved
35
case report/case series disadvantages
- Cannot demonstrate valid statistical associations | - Lack of control group
36
cross sectional study
The observation of a defined population at a single point in time (or time interval) snapshot Exposure and outcome are determined at the same time - Can see relationship which may be incorrect as collected at one point e.g. asthma and smoking (cannot determine what came first)
37
cross sectional study used for
- Estimating prevalence of a disease e.g. caries in Scottish schools - Investigate potential risk factors – can’t say actual link as cannot measure prospectively
38
case report/ case series used for
- Identify new disease outcome e.g. when e-cigarettes issue arise, drug for morning sickness in 70s - Hypothesis generation a hunch/feeling of a link, lead onto a trial
39
cross sectional study disadvantages
- Causality - Confounding – measure one thing but other factors contribute e.g. healthy diet, less likely to smoke, more exercise etc - Recall bias - inaccurate
40
case-control study
The study of people with a disease and a suitable control group of people without the disease - Looks back in time at exposure to a particular risk factor in both groups - retrospective is most common, look back at previous exposures See if a higher prevalence between case and control group of risk factor
41
case-control study used for
looking at potential causes of disease
42
case-control study disadvantages
- Confounding - Recall /selection bias - Selection of controls differences between clinicians decisions = Time relationships (did exposure occur before disease? Didn’t can’t have caused it) See if a higher prevalence between case and control group of risk factor - Well conducted is excellent but hard to carry out Rare disease is hard to recruit (need a huge population to identify cases) - Recruit and look back retrospectively
43
cohort study
Establish a group of individuals in population - Measure exposures (through questionnaires, examinations etc) - Follow up over a period of time Identify those that develop disease (outcome of interest) –not know at start what you are going to capture e.g. 1990s baby cohort captured obesity crisis Measure as exposure happening and measure at event so not relying on recall bias – good but time and labour expensive
44
cohort study used for
Estimating incidence of disease – number of new cases of disease over a period of time that has developed Investigating causes of disease – when disease and exposure occurred is recorded Determining prognosis Timing and direction of events – understand when things may have caused disease
45
cohort study disadvantages
- Controls difficult to identify - Confounding - Blinding difficult - For rare diseases- need large samples - Very expensive and time consuming
46
randomised controlled trials
Sometimes referred to as a Clinical Trial RCTs considered the gold standard study design - For effectiveness and efficacy - Provides strongest evidence on effectiveness of treatments Particularly useful for clinical studies – need to see for grounds on changing practice - Measure baseline of groups before trial Small groups as can’t afford large groups and wouldn’t be ethical
47
4 design elements of randomised controlled trials
Specification of participants (inclusion/ exclusion criteria) Control/ Comparison groups – what will be difference between groups Randomisation – allows to separate groups fairly and randomly that can be compared – difference are random, equality across groups so only treatment criteria Blinding/ Masking – administrator, patient and analyser don’t know the different groups
48
inclusion/exclusion criteria
Age – very young or old have slightly different physiological factors so may not be appropriate to include Disease severity/ diagnosis Unambiguous – 100% clear in criteria - Exact definitions How you will know if the results of the trial are relevant to your patients
49
comparison/ control group
Existence of a comparison group - Placebo - Current standard treatment (TAU) Why? - People often get better on their own Need control to compare – what would happen without treatment
50
randomisation
How participants/ subjects/ patients are allocated to treatments. - To minimise Bias Assign participant to one of the two groups - Researcher nor participant has influence over allocation Randomisation should be performed by computer, not up to people as easily manipulated (minimise bias and influence on results) Only systematic difference between the arms of a trial are the treatments themselves
51
why would the researcher not carry out and allocate randomised groups?
because selectively choose to make drug look favourable
52
why would the patient not allocate their randomised group?
because want treatment
53
Random allocation of participant to treatment ensures
Each individual entered into trial has equal chance of being allocated to any treatment arm (paracetamol / placebo)
54
allocation concealment (selection bias)
A technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.
55
what does allocation concealment in RCT prevent?
researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.
56
blinding/MASKING
If the participant or researcher is aware of which treatment is given this may influence the results - look, taste, smell, action be the same – no difference needs to be blind to: - Participant - administrator of treatment - Assessor of outcome - Data analyst
57
advantages of RCTs
Provide strongest and most direct epidemiologic evidence for causality
58
4 disadvantages of RCTs
More difficult to design and conduct than observational studies - ethical issues - feasibility - costs Still some risk of bias and generalisibility often limited Not suitable for all research questions – pregnant women, elderly generally excluded Non-blinded RCTs may overestimate treatment effects e.g. estimates of effect from trials with inadequately concealed allocation have been 40% larger than clinical trials with adequately concealed random allocation
59
summary of cohort study
Participants are recruited to a study and followed up over time Exposures and disease are measured prospectively - No intervention – don’t manipulate end point - Start with anyone and follow
60
summary of RCT
Participants are allocated by chance to different interventions and followed up and outcomes assessed
61
summary of case-series report (case study report)
Description of the medical history of one or more patients
62
summary of cross-sectional study
Observational study that analyses data collected from a population, or a representative subset, at a specific point in time - Survey - No longitudinal aspect - No intervention/trial
63
summary of systematic review and/or meta analysis
All the evidence for RCTs looking at effectiveness of a particular treatment are synthesised
64
summary of case control study
People with a disease (cases) are matched to those without it (control) and earlier exposure to different factors are compared - Start with outcomes – look back at exposures (get association) - Quicker as already have outcomes - Can’t assess prevalence in population
65
how to decide on which study design to use?
variety of study designs may be appropriate for a particular clinical question, need to use the Evidence Levels pyramid / table and question the feasibility of conducting such a study to determine what is most appropriate.
66
4 key study design features of RCTs
inclusion/exclusion criteria comparison/control randomisation blinding