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Pharmacoepidemiology: Application I

Teerapon Dhippayom
PharmD, MClinPharm, PhD

Basic Pharmacoepidemiology: Semester 2/2554

Scope
• Application of pharmacoepidemiology • Validity of research finding • Bias and confounding • Issues to be considered in pharmacoepidemiological study

Application of Pharmacoepidemiology

• To promote the rational use of medicine • To investigate the safety of medicine • To investigate the effectiveness of medicine

Validity of research finding
Internal validity • The study measured what it set out to External validity • The ability to generalize from the study to the reader’s patient

Validity of research finding Internal validity Less errors Systematic error Bias Confounding Random error .

Bias Bias in research process • Literature review and variable selection • Sample selection • Intervention or treatment • Exposure and outcome measurement • Data analysis • Results interpretation • Paper publication .

Bias Selection bias • The relation between exposure and outcome is different for those who participate and those who do not participate Information bias • A distortion in measuring exposure or outcome data that results in different quality or frequency of information between comparison groups .

Bias Bias Selection bias Sampling bias Information bias Measurement bias Recall bias Attrition bias Response bias .

Confounding Confounding A situation in which a measure of the effect of an exposure on risk is distorted because of the exposure with other factor(s) that influence the outcome under study .

Confounding Aspirin GI bleeding NSAIDs .

Confounding control Confounding control Study design Restriction Matching Data analysis Stratification Multivariate analysis .

Issues to be considered What to look for in observational studies Is selection bias present? Is information bias present? Is confounding present? If none of the above is presented. could they be the results of chance • If all errors are excluded. the results might be real and worthy of note • • • • .

Issues to be considered Cohort study • Bias and confounding • Measurement and outcome • Follow-up time period .

Issues to be considered Case-control study • Selection bias − Case selection − Control selection − Sources of control group • Measurement and outcome .

Issues to be considered Case selection • Well defined (inclusion criteria) • Represent population at risk • Incident case Control selection • Risk of developing outcome ≈ case • Chance of exposing to risk factor ≈ case .

generalization Hospital based • Convenience and low cost • May not represent the population at risk .Issues to be considered Sources of control group Community based • Reduce referral bias • High cost and low compliance • Ideal.

Issues to be considered Measurement and outcome • Recall bias • Interviewer bias • Case and control group must be assessed for exposure in the same way .

Application: an example .

Abstract .

Background • Several studies suggested the beneficial effects of selected CHF drugs • Older patients were generally not included in HF trials • Older patients may not received appropriate HF drugs like younger patients .

Objectives • Compare outpatient CHF drug utilisation and hospital re-admission patterns in patients 75+yrs with those age <75 yrs • Evaluate the potential benefits of HF medications .

Methods Design • Nested case-control Setting • A French teaching hospital Study period • 12-month period (in 2000) .

Methods Study population • All adults admitted to eight departments • Diagnosed as HF at discharge Data sources • Standardised form? • Claims for reimbursement under French health insurance system .

Methods Outcome measured • CHF drug utilisation patterns • Medication prescribed at discharged • Medication prescribed during follow-up • Hospital re-admission patterns • Re-admission rate • Number of re-admission • Cumulative duration of hospitalisation .

Results Patient characteristics .

Results .

Exercise Odds ratio: calculation Cases Noncases Exposed A B Not exposed C D OR = AD BC .

Exercise Exposure to risk factor Yes No Time Disease conditions Sample with disease (cases) Population at risk Research Sample without disease (controls) Yes No .

Exercise What is case • HF patients age 75+ years What is control • HF patients age 75 years or younger What is exposing factors • HF medications .

Exercise Calculate OR for prescribing of ACE inhibitors > 75 years < 75 years ACE inhibitors 48 63 No ACE inhibitors 102 68 OR = 48 x 68 63 x 102 = 0.51 .

Results .

Results .

The study implication Internal validity Less errors Systematic error Bias Confounding Random error .

Issues considered Study design: Nested case control • Begin with a record of factors interested • Follow-up a group of people (cohort) • Identify case and control from a cohort • Look back for the expose of risk factors in each group .

Issues considered Selection bias • A French teaching hospital • Loss of data during follow-up • Only 50% have their EF measured • Any different among group? • Number and type of concomitant medication • Appropriate dose among group were not measured .

Issues considered Information bias • Appropriateness of diagnosis • Data from 8 different departments • Criteria for discharge diagnosis was unknown • The completeness of the information recorded • It is not cleared if the re-hospitalisation was for HF related .

Issues considered Confounding bias • Confounding variables were adjusted • Other potential confounder were not addressed • Post-MI • Stroke • Cardiac surgery • etc .

but yet not statistically sig. • Other factors may contribute to the longer duration in older patient not prescribed the drug .Issues considered Other issues • Hospitalisation among younger patients appeared not different • The difference between two age group not prescribed HF drugs were obvious.

Conclusion • The descriptive results on utilisation pattern in this study maybe useful • The implication on analytical part is questionable • It is crucial to evaluate the method used before utilising the outcomes of a study .

Questions .