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Epidemiology > RCT's > Flashcards

RCT's Flashcards

1
Q

What do RCT’s investigate?

A

The effect of any sort of intervention.

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2
Q

What standard of investigation are RCT’s often regarded as?

A

The ‘Gold Standard’.

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3
Q

What three questions are often asked with RCT’s?

A

Superiority, non inferiority, safety effect.

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4
Q

What is the purpose of randomisation?

A

To balance known and unknown covariates between treatment and control groups.

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5
Q

How can you remove allocation bias?

A

Through randomisation.

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6
Q

What value of n is needed for simple randomisation to be a viable form of randomisation?

A

200+

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7
Q

Why is varying block sizes good in blocked randomisation?

A

Stops practitioner bias.

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8
Q

Block sizes are always random in blocked randomisation. True or false?

A

False. They can be preset.

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9
Q

What is the advantage of using larger block sizes in blocked randomisation?

A

Order of events is less predictable.

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10
Q

When would the latin square technique be used with block randomisation?

A

When there are repeated measures of a treatment for a particular individual.

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11
Q

Do you stratify before or after blocking?

A

Before.

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12
Q

Stratification variables should be of _____ significance.

A

Prognositic.

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13
Q

Name four variables you can stratify by.

A

Gender, age, disease status, assessment centre.

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14
Q

What is the goal of minimisation?

A

To maintain balance of stratification variables during allocation.

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15
Q

When is minimisation and effective randomisation technique?

A

Small studies with multiples stratification factors.

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16
Q

When interventions vary between regions (eg vaccine interventions, verbal GP interventions) what sort of randomisation should be used?

A

Cluster randomisation.

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17
Q

What is an advantage of cluster randomisation?

A

It reduces risk of the intervention contaminating the control group.

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18
Q

Why is blinding necessary?

A

As randomisation alone does not prevent differential treatment later on.

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19
Q

Who is blinded in a triple blinded trial?

A

Participants, investigators, assessors.

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20
Q

Why are sham procedures not used anymore?

A

They are unethical.

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21
Q

Do parallel randomised trials require the same amount of people in each arm?

A

No.

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22
Q

What sort of comparisons are made in a parallel studies?

A

Between person comparisons.

23
Q

When are crossover studies used?

A

When you need more statistical power (when the studies are small).

24
Q

What type of conditions are crossover studies good for?

A

Chronic.

25
Q

What determines the order of interventions in a crossover design?

A

Randomisation.

26
Q

Why is variability minimised in a crossover RCT?

A

As each subject is their own control.

27
Q

Factorial designs look at multiple outcomes for one question. True or false?

A

False. They can look at multiple outcomes and multiple questions.

28
Q

What do the treatments in the factorial studies have to be?

A

Independant/ complementary.

29
Q

What sort of effect(s) can be studied with a factorial design?

A

Independant or interacting.

30
Q

What needs to be defined prior to a non-inferiority trial?

A

Need to define what is statistically ‘not different’.

31
Q

What is the general rule of thumb in a non inferiority trial?

A

A quantity must be significantly smaller (1/2 or a 1/3) than the minimal clinical difference that can be used to calculate the required sample size in a superiority trial.

32
Q

What is randomised in cluster randomisation?

A

Groups rather than individuals.

33
Q

What sort of level of interventions do cluster randomisation trials look at?

A

Population level interventions.

34
Q

What happens in a trial that has ‘adaptive design’?

A

Multiple arms get dropped as the trial procedures enriching the study. This means the trial can be modified during study.

35
Q

What is increased in a adaptively designed trial?

A

Time and cost efficacy.

36
Q

What sort of statistics are used in adaptively designed clinical trials?

A

Baysian.

37
Q

Eligibility criteria in RCT’s allow for bias to be minimised. true or false?

A

False. The limited nature of the eligibility criteria introduce bias.

38
Q

Who has the sponsorship of a trial?

A

Those legally responsible for the trial, not those paying for it.

39
Q

What sort of things can be modified as a adaptively designed trial procedures (3 things) ?

A
  1. Sample size.
  2. Dose.
  3. Focus onto a particular group.
40
Q

Name four reasons why an individual may be lost to follow up.

A
  1. Withdrawal.
  2. Discontinuation of treatment.
  3. Unable to locate.
  4. Mortality.
41
Q

What are the two types of analyses that can be used in a RCT.

A
  1. Intention to treat.

2. Per protocol.

42
Q

What is the definition of ‘intention to treat’?

A

All randomised participants are included in the analyses of the group they were allocated to.

43
Q

What is the definition of ‘per protocol’?

A

Only those who were randomised according to the protocol and those who followed the protocol correctly are included in the trial.

44
Q

What must trial results be?

A

Transparent. Everyone must be accounted for.

45
Q

Despite varying methods both ‘intention to treat’ and ‘per protocol’ analysis will give rise to the same results. True or False?

A

False.

46
Q

In both the US and the EU publication of trial results is a legal requirement. True or false?

A

False. It is in the EU.

47
Q

What stage of a clinical trail looks at drug metabolism and bioavailability?

A

1st.

48
Q

What can the 1st stage of a RCT also be called?

A

First in man.

49
Q

What is the main aim of stage 4 in RCT’s?

A

Post marketing surveillance to determine rare side effects and long term effects regarding morbidity and mortality..

50
Q

Who are the HRA and what do they do?

A

Health Research Authority- UK ethics board.

51
Q

What does CONSORT stand for?

A

Consolidated standards of reporting trials.

52
Q

RCT’s allow for greater confidence in what compared to observational studies?

A

Causality.

53
Q

What is reduced in a RCT compared to an observational study?

A

Confounding.

Epidemiology (14 decks)

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