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Yr 5 - Social & Population Health & Research Methods > Study Design > Flashcards

Study Design Flashcards

1
Q

What happens in a randomised controlled trial?

A

Participants randomly allocated to intervention or control group (e.g. standard treatment or placebo).

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2
Q

What may limit the use of a randomised controlled trial?

A

Practical or ethical problems

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3
Q

What happens in a cohort study?

A

Observational and prospective.

Two (or more) are selected according to their exposure to a particular agent (e.g. medicine, toxin) and followed up to see how many develop a disease or other outcome.

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4
Q

What is the usual outcome measure in a cohort study?

A

Relative risk

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5
Q

What are participants selected according to in a cohort study?

A

Their exposure to a particular agent

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6
Q

What happens in a case-control study?

A

Observational and retrospective.

Patients with a particular condition (cases) are identified and matched with controls.

Data is then collected on past exposure to a possible causal agent for the condition.

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7
Q

What is the usual outcome measure in a case-control study?

A

The odds ratio

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8
Q

Benefits of a case-control study?

A

1) Inexpensive, produce quick results

2) Useful for studying rare conditions

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9
Q

Key disadvantage of a case-control study?

A

Prone to confounding

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10
Q

What is confounding?

A

when a third variable (a confounder), distorts the relationship between an exposure and an outcome

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11
Q

What happens in a cross-sectional survey?

A

Provide a ‘snapshot’, sometimes called prevalence studies

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12
Q

Disadvantage of a cross-sectional survey?

A

Provide weak evidence of cause and effect

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13
Q

What are 3 common causes of confounding?

A

Age, sex and social class

Confounding occurs when there is a non random distribution of risk factors in the populations

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14
Q

In the design stage of an experiment, what can confounding be controlled by?

A

Randomisation –> aims to produce an even amount of potential risk factors in two populations.

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15
Q

In the analysis stage of an experiment, what can confounding be controlled for by?

A

Stratification

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16
Q

Clinical trials are commonly classified into how many phases?

A

4 - (0, I, II, III, IV)

17
Q

What is the goal of phase 0 of a clinical trial?

A

Exploratory studies

18
Q

What happens in phase 0 of a clinical trial?

A

Involves a very small number of participants and aim to assess how a drug behaves in the human body.

Used to assess pharmacokinetics and pharmacodynamics.

Phase 0 trials help in determining whether it is FEASIBLE to move on to further phases.

19
Q

What is the goal of phase I of a clinical trial?

A

Safety assessment

20
Q

What happens in phase I?

A

Determines side-effects prior to larger studies.

Conducted on healthy volunteers

21
Q

What is the goal of phase II of a clinical trial?

A

Assess efficacy

22
Q

What happens in phase II of a clinical trial?

A

Involves small number of patients affected by particular disease

May be subdivided into:
- IIa - assesses optimal dosing
- IIb - assesses efficacy

23
Q

What is the goal of phase III of a clinical trial?

A

Assess effectiveness

24
Q

What happens in phase III of a clinical trial?

A

Typically involves 100-1000’s of people, often as part of a randomised controlled trial, comparing new treatment with established treatments

25
Q

What is the goal of phase IV of a clinical trial?

A

Postmarketing surveillance

26
Q

What happens in phase IV?

A

Monitors for long-term effectiveness and side-effects

27
Q

Which type of study follows a group of people over time to determine how many develop a specific health outcome (prospective)?

A

Cohort

28
Q

What type of study compares two groups of people to determine if an exposure is a risk factor for a health outcome (retrospective)?

A

Case control

29
Q

Efficacy vs effectiveness?

A

Efficacy is how well an intervention performs under controlled conditions, while effectiveness is how well it performs in the real world.

30
Q
A

Yr 5 - Social & Population Health & Research Methods (4 decks)

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