Studies

Question 1

Cross-sectional study: about?

Answer 1

Descriptive and observational.

Measures both exposure and/or outcomes at a single point in time.

Question 2

Cross-sectional study: purpose?

Answer 2

1. Often used in surveys for large populations (e.g. census, survey)
2. Describe and compare prevalence
3. Generate hypotheses
4. Plan (resource allocation)

Question 3

Cross-sectional study: what can it calculate?

Answer 3

Prevalence

Question 4

Cross-sectional study: affected by?

Answer 4

Duration and incidence

Question 5

Cross-sectional study: strengths and limitations

Answer 5

Strengths:
- assess multiple exposures and outcomes
- can be used to calculate prevalence, distribution of prevalence in the population, and hypothesis generation
- inexpensive and quick
- may suit research question

Limitations:
- no temporal sequence (exposure and outcome measured at the same time)
- can’t measure incidence or measures of association
- not good for rare exposures/outcomes
- not good for assessing transient variable exposures/outcomes

Question 6

Ecological study: about?

Answer 6

Descriptive and observational.

Compares exposures and outcomes across GROUPS not individuals.

Question 7

Ecological study: purpose?

Answer 7

1. To compare exposure and disease status across populations
2. Assess population level factors in disease
3. Hypothesis generation

Question 8

Ecological study: strengths and limitations

Answer 8

Strengths:
- assess population level exposures (e.g. UV light, pollution)
- can be used for hypothesis generation
- inexpensive and easy
- may suit research question
- data is often routinely collected

Limitations:
- ecological fallacy (making assumptions about individuals based on data from the group they belong to)
- cannot control for confounding
- cannot show causation

Question 9

Cohort study: about?

Answer 9

Analytic and observational.

Observe people’s exposures and what happens to them.

Question 10

Cohort study: purpose?

Answer 10

1. Identify a source population.
2. Recruit a sample population who don’t have the outcome of interest.
3. Assess their exposure level and categorise participants into appropriate group.
4. Follow up over time and see who develops the outcome.
5. Calculate your measures of association and occurrence.

Question 11

Cohort study: what can it calculate?

Answer 11

O: Incidence proportion and incidence rate.

A: Relative risk and relative difference.

Question 12

Cohort study: considerations?

Answer 12

1. The healthy worker effect.
2. Ensure our sample population doesn’t have the outcome.
3. Ensure our participants have been correctly classified into exposure groups (and haven’t changed exposure groups during the study period).
4. Loss to follow up - did any participants leave the study?
5. Has the outcome been classified correctly?

Question 13

Cohort study: strengths and limitations

Answer 13

Strengths:
- temporal sequence
- can look at multiple outcomes
- can calculate incidence and therefore measures of association
- good for rare exposures

Limitations:
- loss to follow up and its associated bias
- potential for exposure/outcome misclassification
- time consuming
- expensive
- not good for rare outcomes

Question 14

Historical cohort study: about?

Answer 14

Start at the end of the follow-up period.

Question 15

Historical cohort study: purpose?

Answer 15

Splits study individuals by their exposure status - already knowing the outcome.
Existing data used to recreate study how it would’ve gone as if it were a real one.

Question 16

Historical cohort study: strengths and limitations

Answer 16

Strengths:
- good for rare outcomes or outcomes that take a long time to develop
- inexpensive
- quick compared to prospective cohort studies

Limitations:
- could be problems with existing data quality
- selection bias
- incomplete information and may not know about all relevant factors

Question 17

Case-control study: about?

Answer 17

Analytic and observational.

Another example of an analytic and observational study to find an association between exposure and outcome. Looks at outcome status first and the finds out exposures (opposite of cohort studies).

Question 18

Case-control study: purpose?

Answer 18

1. Identify a source population.
2. Identify the cases (people with the outcome) and controls (people without the outcome).
3. Assess their prior exposure level in cases and controls.
4. Calculate your odds ratio (measure of association).

Ideal for rare, slow to develop and transient outcomes.

Question 19

Case-control study: what can it calculate?

Answer 19

No measures of occurrence!

Only odds ratio - a measure of association.
Can treat as RR when reporting.

Question 20

Case-control study: affected by?

Answer 20

If pick more people incidence and prevalence goes up, and vice versa.

Question 21

Case-control study: considerations

Answer 21

1. Index dates.
2. When selecting cases, needs to be clear definition of the outcome and cases should be newly incident.
3. The purpose of having a control group is to estimate the prevalence of exposure in the population from which the cases come from.
4. Controls must be capable of becoming a case, can often have multiple controls for better statistical power.
5. Several ways we can select controls - one is from the hospital. However, this can cause problems as they aren’t necessarily representative of the population which the cases came from (they may have diseases which are also related to the exposure being studied).
6. Need to ensure the exposure is measured before the outcome occurred (so that we have temporal sequencing).

Question 22

Case-control study: strengths and limitations

Answer 22

Strengths:
- good for rare outcomes and transient exposures
- can assess multiple exposures
- temporal sequencing
- quick
- inexpensive

Limitations:
- can only study one outcome
- difficult to select an appropriate control group
- prone to selection and recall bias

Question 23

RCT: about?

Answer 23

Analytic and interventional.

At the top of the hierarchy of evidence, an analytic intervention study.

Question 24

RCT: purpose?

Answer 24

1. Identify a source population.
2. Randomly select the sample population who don’t have the outcome of interest.
3. Randomise the sample to either the intervention or control groups.
4. Follow up over time and see who develops the outcome.
5. Calculate your measures of association and occurrence.

Question 25

RCT: what can it calculate?

Answer 25

O: Incidence proportion and incidence rate. A: Relative risk and relative difference.

Question 26

RCT: important aspects

Answer 26

1. Randomisation (random allocation) = randomly assign to either control or intervention group. NOT the same as random selection. Purpose of this is to control confounding (when another variable like age or sex distorts the relationship between exposure and outcome). Variants of randomisation: 1. Cluster randomisation - where subgroups are randomised instead of individuals. 2. Stratified (block) randomisation - where participants are randomised blocks.

Question 27

How do we protect randomisation and its benefits?

Answer 27

1. Concealment of allocation - meaning the person randomising participants does not know what the next treatment allocation will be (concealed and unpredictable). This also prevents selection bias from the researchers selecting the treatment they want. 2. Intention to treat analysis - analyse as we randomise so we aren't swapping between groups. Gives us a 'real world effect'. 3. Per protocol analysis - analyse participants who fully complied to the study protocol. This can show the efficacy of the treatment, but we lost the benefits of randomisation.

Question 28

Bias in RCT

Answer 28

1. Lack of blinding 2. Loss to follow up 3. Non-adherence (when participants are not good at following instructions - this can lead to bias within the results)

Question 29

RCT: strengths and limitations

Answer 29

Strengths: - gold standard study design to test an intervention and cause effect associations - eliminate confounding and bias (if done well) - calculate incidence and measures of association Limitations: - many exposures cannot be randomised and we need to have clinical equipoise - expensive - sometimes participants aren't representative of the general or source population, therefore are not generalisable - not good for rare outcomes - exposures must be modifiable - often funded by big pharma wanting profit bias