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CTM 101 - Fundamentals of Clinical Trials > Observational Studies > Flashcards

Observational Studies Flashcards

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1
Q

When might an observational study be indicated?

Hint - a scenario where it may not be possible/ethical to randomise patients to a particular exposure

A

Many examples. They include exposure to particular harms e.g. smoking and its relationship to lung cancer. Patients cannot be randomised to smoke.

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2
Q

What is the difference between a descriptive and analytical observational study?

A

Descriptive studies make no comparison between an observed exposure and a comparison group in relation to its effect on the measured outcome. In simple terms. How, what and where but not why.

Analytical studies make a comparison with the observed exposure and a comparison group to assess their effects on the outcome measured. How, what, where and why

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3
Q

List three advantages of cross-sectional studies

A

Cheap
Quick
Simple

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4
Q

What are cross-sectional studies?

A

Studies which collect information from individuals in order to estimate things such as prevalence (not incidence) at a designated point in time

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5
Q

What is the defining criteria of a confounding factor?

A

It must be associated with the exposure and outcome of interest.

It must not be on the causal pathway

It is of greater relevance in observational studies than in randomised trials

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6
Q

Outline the utility of cross-sectional studies

A

Provide important descriptive information on the distribution and burden of exposures/outcomes in a population.

Used as a first step in assessing possible exposure-outcome relationship.

Generally used for hypothesis generation

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7
Q

What is the remit of a case-control study?

A

Investigation of a group of people with an outcome of interest with retrospective assessment of the cases and controls on their past exposure to one or more factors of interest.

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8
Q

Where might the source data come from in a case-control study?

A

Interviews, medical records, analysis of previously stored biological samples.

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9
Q

What is the rationale behind case-control studies?

A

If the cases report a (statistically significantly) greater level of exposure than the controls then this exposure might be a risk factor for the disease

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10
Q

How are controls selected for case-control studies?

A

Selected from a group of individuals who would have been eligible for the case group if they had developed the disease during the study period.

The selection of controls should also be unrelated to the exposure(s) under investigation. i.e. representative of the greater population.

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11
Q

What are cohort studies?

A

Definition of a healthy people by their exposure status. These participants are followed up over time to see which one develops a disease or condition.

More closely resembles an RCT however there is no randomisation.

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12
Q

What effect does loss to follow-up have on observational studies?

A

Introduces bias (more significantly than RCTs as there is no mitigating randomisation in the first place)

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13
Q

What is an ecological study?

A

Examines the association between exposures and outcomes by using grouped data. The average (or other summary statistic) exposure is plotted against the rate of outcome for the population. This is repeated for several populations.

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14
Q

What are the limitations of an ecological study?

A

It is not possible to draw conclusions about exposure on the individual level. Only on a population scale.

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15
Q

What are the benefits of using registry databases for observational studies?

A
  1. Increase external validity (more applicable to wider population)
  2. Not being restricted by limited number of patients and being able to study rare endpoints rather than surrogate markers
  3. Offering insight into rates of adverse outcomes associated w intervention in usual practice
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16
Q

What is the main limitation of using registry databases?

A

They cannot control for selection bias. Interventions are based on clinical judgment not a process of randomisation.

17
Q

What critical questions must be asked if an observational trial indicates an association between an exposure and an outcome?

A
  1. Could the association be due to bias?
  2. Could the observed association be due to confounding?
  3. Random chance?
  4. Is there a causal relationship or not?
18
Q

What is selection bias as it pertains to observational studies?

A

Bias which arises when the study population is not a random selection from the target population for which conclusions are made

19
Q

What is information bias as it pertains to observational studies?

A

This occurs when measurements or classifications of exposures/disease are inaccurate i.e they do not reflect the true values.

E.g. blood samples sitting for a long time before analysis affecting the measured variable

20
Q

How is the role of random chance assessed in observational trials?

A

Significance testing and confidence intervals

21
Q

What are the Bradford-Hall criteria for causality?

A 
Temporal
Plausible
Consistency 
Strength 
Dose-response relationship 
Specificity 
Reversibility 
Coherence
Analogy
22
Q

What are the strengths of cross-sectional studies?

A

Cheap
Quick
Simple

23
Q

What are the limitations of cross-sectional studies?

A

Cannot assess causality

24
Q

What are the benefits of case-control studies?

A

Simple, cheap and quick

Can assess multiple exposures

Good for rare outcomes

Unaffected by loss to follow-up

25
Q

What are the limitations of case-control studies?

A

Subject to many biases including selection and information

Cannot establish causality

Not suitable for rare exposures

Cannot be used to measure prevalence or incidence of disease (only prevalence of the exposure among those with/without the outcome)

26
Q

What are the benefits of cohort studies?

A

Simple (quick and cheap)

Can measure multiple outcomes

Suitable for rare exposures

Can be used to measure incidence of disease in exposed and unexposed groups

27
Q

What are the limitations of cohort studies?

A

Can be expensive and time consuming for prospective studies

Exposure status and diagnostic criteria may change

Ascertainment of outcome might be influenced by the exposure

Loss to follow up introduces serious bias

Less suitable for rare outcomes

28
Q

What are the benefits of an ecological study?

A

Quick , efficient, cheap, easy to interpret

29
Q

What are the limitations of ecological studies?

A

Cannot assess causality

Conclusions are made at the population level (rather than an individual one)

Cannot control confounders

CTM 101 - Fundamentals of Clinical Trials (10 decks)

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