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Bias. EPIET Introductory Course, 2011 Lazareto, Menorca, Spain. Update: S. Bracebridge Sources: T. Grein , M. Valenciano, A. Bosman. Objective of this session. Define bias Present types of bias How bias influences estimates Identify methods to prevent bias. Epidemiologic Study.
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Bias EPIET Introductory Course, 2011Lazareto, Menorca, Spain Update: S. Bracebridge Sources: T. Grein, M. Valenciano, A. Bosman
Objective of this session • Define bias • Present types of bias • How bias influences estimates • Identify methods to prevent bias
Epidemiologic Study An attempt to obtain an epidemiologic measure • An estimate of the truth
Definition of bias Anysystematic errorin the design or conduct of an epidemiological study resulting in a conclusion which is different from the truth • anincorrect estimateof association between exposure and risk of disease
Main sources of bias • Selection bias • Information bias • [Confounding]
True association? Bias? Chance? Confounding? Should I believe the estimated effect? Mayonnaise Salmonella RR = 4.3
Warning! • Chance and confounding can be evaluated quantitatively • Bias is much more difficult to evaluate • Minimise by design and conduct of study • Increased sample size will not eliminate bias
1. Selection bias • Due to errors in study population selection • Two main reasons: • Selection of study subjects • Factors affecting study participation
Selection bias At inclusion in the study Preferential selection of subjects related to their Exposure status (case control) Disease status (cohort)
Types of selection bias • Sampling bias • Ascertainment bias • surveillance • referral, admission • diagnostic • Participation bias • self-selection (volunteerism) • non-response, refusal • survival
Design Issues Case-control studies
Selection of controls Estimate association of alcohol intake and cirrhosis How representative are hospitalised trauma patients of the population which gave rise to the cases? OR = 6
a b d c Selection of controls Higher proportion of controls drinking alcohol in trauma ward than non-trauma ward OR = 6 OR = 36
Some worked examples • Work in pairs • In 2 minutes: • Identify the reason for bias • How will it effect your study estimate? • Discuss strategies to minimise the bias
a b d c • Overestimation of “a” overestimation of OR • Diagnostic bias Oral contraceptive and uterine cancer You are aware OC use can cause breakthrough bleeding • OC use breakthrough bleeding increased chance of testing & detecting uterine cancer
a b d c • Overestimation of “a” overestimation of OR • Admission bias Asbestos and lung cancer Prof. “Pulmo”, head specialist respiratory referral unit, has 145 publications on asbestos/lung cancer • Lung cancer cases exposed to asbestos not representative of lung cancer cases
Healthy worker effect Association between occupational exposure X and disease Y Source: Rothman, 2002
Healthy worker effect Source: Rothman, 2002
Prospective cohort study- Year 1 lung cancer yes no Smoker 90 910 1000 Non-smoker 10 990 1000
Loss to follow up – Year 2 lung cancer yes no Smoker 45 910 955 Non-smoker 10 990 1000 50% of cases that smokedlost to follow up
Minimising selection bias • Clear definition of study population • Explicit case, control and exposure definitions • Cases and controls from same population • Selection independent of exposure • Selection of exposed and non-exposed without knowing disease status
Sources of bias • Selection bias • Information bias
Information bias During data collection Differences in measurement of exposure data between cases and controls of outcome data between exposed and unexposed
Information bias • 3 main types: • Reporting bias • Recall bias • Prevarication • Observer bias • Interviewer bias • Misclassification
Overestimation of “a” overestimation of OR Recall bias Cases remember exposure differently than controls e.g. risk of malformation • Mothers of children with malformations remember past exposures better than mothers with healthy children
Prevarication bias Exposure reported differently in cases than controls e.g. isolation and heat related death • Relatives of dead elderly may deny isolation • Underestimation “a” underestimation of OR
Overestimation of “a” overestimation of OR Interviewer bias Investigator asks cases and controls differently about exposure e.g: soft cheese and listeriosis • Investigator may probe listeriosis cases about consumption of soft cheese (knows hypothesis) Cases of Controls listeriosis Eats soft cheese a b Does not eat c d soft cheese
Measurement error leads to assigning wrong exposure or outcome category Misclassification Non-differential • Random error • Missclassifcation exposure EQUAL between cases and controls • Missclassification outcome EQUAL between exposed & nonexp. • => Weakens measure of association Differential • Systematic error • Missclassification exposure DIFFERS between cases and controls • Missclassification outcome DIFFERS between exposed & nonexposed • => Measure association distorted in any direction
Minimising information bias • Standardise measurement instruments • questionnaires + train staff • Administer instruments equally to • cases and controls • exposed / unexposed • Use multiple sources of information
Summary: Controls for Bias • Choose study design to minimize the chance for bias • Clear case and exposure definitions • Define clear categories within groups (eg age groups) • Set up strict guidelines for data collection • Train interviewers
Summary: Controls for Bias • Direct measurement • registries • case records • Optimise questionnaire • Minimize loss to follow-up
Questionnaire • Favour closed, precise questions • Seek information on hypothesis through different questions • Field test and refine • Standardise interviewers’ technique through training with questionnaire
The epidemiologist’s role • Reduce error in your study design • Interpret studies with open eyes: • Be aware of sources of study error • Question whether they have been addressed
Bias: the take home message • Should be prevented !!!! • At PROTOCOL stage • Difficult to correct for bias at analysis stage • If bias is present: • Incorrect measure of true association • Should be taken into account in interpretation of results • Magnitude = overestimation? underestimation?
Objective of this session Define bias Present types of bias How bias influences estimates Identify methods to prevent bias
References Rothman KJ; Epidemiology: an introduction. Oxford University Press 2002, 94-101 Hennekens CH, Buring JE; Epidemiology in Medicine. Lippincott-Raven Publishers 1987, 272-285