Introduction to Bias in Research

In this session we will consider:

what is meant by bias in the context of research the three main types of bias in epidemiological research
methods to prevent or deal with bias in research

Example
You are concerned about the potential health effect of diesel fumes on miners working underground in several outback communities. You conduct a study and find people working underground are at increased risk of lung cancer. Can you conclude that exposure to the underground environment is hazardous to health?

What is meant by bias in research?

Bias is the term used to describe differences between the study findings and truth Last defines bias as Any effect at any stage of investigation or inference tending to produce results that depart systematically from the true values (to be distinguished from random error)

Classification of bias
There are three broad categories of bias: selection bias confounding measurement bias

Returning to our miners with lung cancer

In an ideal world for our study we would have formed two otherwise identical groups of miners, one group exposed to the underground environment and the other not exposed. Thus each group would contain the same number of smokers and people with other known and unknown causes of lung cancer. Hence any differences in lung cancer rate would be due to exposure to working underground.

Selection bias and confounding

Bias occurs when the exposed and non exposed groups have different risks of developing the outcome of interest for reasons other than being exposed. This can be due to selection bias or confounding eg. more underground workers smoke

Confounding
defined as: a situation in which the measure of effect of exposure on disease is distorted because of the association of the study factor with other factors that influence the outcome. These other factors are called confounders

Confounding variables
A variable is a confounder if: 1. 2. 3. it is an independent risk factor (cause) of disease it is unevenly distributed among the exposed and non-exposed it is not on the causal pathway between exposure and disease

Confounding variables
In our study of miners: 1. 2. .smoking is an independent risk factor (cause) of the disease (lung cancer) .more underground miners smoke ie smoking is unevenly distributed among the exposed and non-exposed .smoking is not on the causal pathway between exposure and disease

3.

Controlling for confounders

At the design phase
(to ensure criterion 2 is not met)

restriction (limit the study to people with stratified allocation within risk strata matching in cohort and RCTs

one level of the potential confounder)

randomisation deals with known and unknown

Controlling for confounders

At the analysis phase
demonstrate comparability (ie not met criterion 2) data analysed in strata of the confounder statistical modelling useful to control for multiple
confounders

Selection bias
A distortion in the measure of frequency or effect that: results from the manner in which subjects are selected from the study population into the group of subjects from which the study data have been obtained. Eg healthy worker effect

Sources of selection bias

inappropriate selection of study subjects from the study population the non-random assignment of exposure status the omission of study subjects from the analysis

Sources of selection bias

1. Inappropriate selection of study subjects from the study population
non-random selection of subjects from the same population selection of subjects from different or ill-defined study populations failure to locate or unwillingness of people to participate loss of persons from the study population because of the health outcome eg selective survival

Sources of selection bias

2. the non-random assignment of exposure

status
non-random allocation methods eg self selection, allocation by clinician regrouping of individuals at analysis by actual exposure status irrespective of initial exposure allocation

3. the omission of study subjects from the analysis

loss to follow up inability to obtain adequate measurements ie missing data

Minimising selection bias

1. Selection of study subjects
clearly define study population in time and place use sampling techniques that result in choosing groups from the same population use methods that result in high recruitment rates

2. Assignment of exposure status

use random allocation (RCTs)

3. Study subjects omitted from analysis

use methods to minimise loss to follow up review non-respondents

Measurement bias
Inaccurate measurement of study variables can lead to bias
Sources of inaccurate measurement: subject error error within the individual for any
reason, eg imperfect recall of past exposures

Instrument error eg equipment not properly

calibrated, wording of question

Observer error error in use of instrument or recording

Types of measurement error

Non-differential error
the inaccuracies of measurement are the same among subgroups of subject Non-differential measurement error in exposure and outcome will always lead to bias towards finding no effect

Differential error
the inaccuracies of measurement are different among subgroups of subject can lead to bias towards or away from no effect

Minimising measurement bias

1. use valid reliable tools to measure all study subjects 2. train staff and monitor their use of research tools 3. regular quality checks of research tools 4. blinding of study subjects and assessors 5. subjects in C-C study unaware of study hypothesis 6. consider sub-study to determine validity and reliability of measurements

In summary
In this session we have discussed:
what is meant by bias in the context of research the three main types of bias in epidemiological research
methods to prevent or deal with bias in research

Exercise
Review the two papers on vitamin K and childhood cancer and answer the following questions:
1. 2. Briefly summarise the main result for each paper For each paper, outline the most important strengths and most important weakness which affect the quality of the paper? (consider study type and biases). Which do you think is the better paper? Using only these two papers what conclusion would you come to?

3.