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ERROR AND BIAS IN OBSERVATION

Lilik Zuhriyah
20 April 2012

Sub Topics

1 2 3

Sources of error and bias Practical issues in reducing bias and error Assessment the consistency of information Effects of misclassification on study results

Introduction
Assessing error and bias is the first step in

the critical appraisal of a study

Error (Non-differential error) = inaccuracy

which is similar in the different groups of subjects being compared

Ex : bleeding, volume of breastmilk
Bias = inaccuracy which is different in size

or direction in one of the groups under study than in the others

Types of Error
Random Error Systematic Error = Bias

any systematic error in the design, conduct or analysis of study that results in a mistaken estimate of an exposures effect on the risk of disease (Gordis, 1996) If the result of study close to the correct value, it has little error.

Sources of Error and of Bias

True value of factor

1. Random variation 2. Biological variation

True value of factor at the point of measurement

3. Performance of the instrument used to measure the factor : bias due to the influence of the subjects being assessed or bias due to the influence of the observers

4. Recording of the results

5. Computation of the results

Value of the variable used in the study

VALIDITY RELIABILITY RELATIONSHIP

Valid Reliabel A : Robin Hood scenario: Your measure is both reliable and valid C : Seldom hit the center of the target but, on average, you are getting the right answer for the group (but not very well for individuals. In this case, you get a valid group estimate, but you are inconsistent Tidak Valid B : Consistent but wrong

Tidak Reliabel

D : Your hits spread across the target and you are consistently missing the center. In this case, your measure neither reliable nor valid

Matriks sasaran tembak (Bulls eye) (Murti, 2003 p 181 & Greenberg, 1996 p. 134)

VALIDITY RELIABILITY RELATIONSHIP

Validity and reliability are separate ideas, in fact, theyre

related to each other If the spots are less scattered, it show less variability and more precision (Confidence Intervals) Confidence intervals are a numeric measure of the range within which such variation is likely to occur. The 95% confidence intervals represent the range within which we are likely to find the underlying true treatment effect. The greater the precision the narrower the confidence intervals. The greater precision results from larger sample sizes and consequent larger number of events. C versus A show increased random error (error) B & D versus A & C show systematic error (bias)

Relation of Systematic Error & Random Error to Study Size

Systematic Error E r r o r Random Error Study Size

Sources of Bias

Selection Bias The way the subjects have been selected

Sources of bias
Information Bias The way the study variables are measured Confounding Some confounding factor that is not completely controlled

Selection Bias
When the association between exposure and

disease differs for those who participate and those who do not participate in the study
Example :

New Screening Test to detect colon Cancer

Volunteer Vs Non Volunteer Surveillance bias Disease maybe better in the monitored population than in the general population

Information Bias
Bias may be introduced in the way information
is abstracted from medical, employment or other records or from the manner in which interviewers ask questions. Ex : case control study of pancreatic cancer. The respondent is a family member

Non response are generally not a

representative group.

Evaluation of Bias

The evaluation of bias is subjective : Presence of bias Its direction and potential magnitude of effects on the results : Positive (OR target pop > OR source
pop) or negative (OR target pop < OR source pop) Towards (underestimate) or away from (overestimate) null hypothesis

Bias in Case Control Studies

Ensuring that cases and controls are assessed by

the same observer or group of observers, and by the same methods used under the same circumstances Need additional observation (recording) : the length of time taken for examination/ interviews the interviewers assessment of the cooperation of the subject and the degree of difficulty experienced with some of the key questions Asking the subjects / interviewer whether they aware of any relationship

Practical Issues in Reducing Bias and Error

The main approach to minimize error and bias : The definition of the item to be recorded The choice of methods of measurement The standardization of procedures Quality control of all aspects of data gathering and processing

Example of Bias :
Reporting Bias in A Case-Control Study
Patients with Controls RA (A) Arthritis in parents neither one both (B) Arthritis in parents neither one 11 23 20 17 1,0 (Referent) 2,5 3 10 6 19 111 74 16 201 1,0 (Referent) 5 13,9 Odds Ratio

Both

6
40

3
40

3,6

A = unaffected control; B = unaffected sibling RA = Rheumatoid arthritis

Assessment of bias and error

ASSESSMENT OF OBSERVATION BIAS AND ERROR
What is the definition of the factor being Is it the same for each group ? assessed ? Is it appropriate to the hypothesis ? What is the same method of assessment ? Instrument used Observer making the assessment Circumstances of use Subjects circumstances Subjects knowledge and cooperation When is the observation made ? In calendar time In relation to the hypothesis How are the data handled ? Recording and coding computation Are the methods of assessment similar for each group ? Are the subjects, or the observers, aware of the groping of the subjects when the assessment is made? How accurate and reliable is the method of assessment? Is it the same for each group

Are the methods the same for each group ?

Bias, and Methods to control bias

The most important source of bias are

variation in the subjects response to the method of assessment, and variation in the observers response. to ensure that the methods used are applied in the same manner and with the same care to all subjects

The general principle for minimizing bias is

Double blind (possible in clinical trial, but no

possible in prospective design) is to reduce error

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lilikz.fk@ub.ac.id