Course: Research in Biomedicine and Health III Seminar 2: Asking a question.
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Transcript of Course: Research in Biomedicine and Health III Seminar 2: Asking a question.
Course: Research in Biomedicine and Health IIISeminar 2: Asking a question
EBM steps◦Step 1: Formulating questions that can be
answered◦Step 2: Finding best evidence◦Step 3: Quick critical assessment of the
evidence◦Step 4: Applying evidence◦Step 5: Assessing effectiveness and
efficiency of the process
“PICOT” model:Patient (For which patient, population or problem you need information?)Intervention/indicator (What is the intervention you are studying?)Comparison/control (Which is the alternative treatment?)Outcome
(What is the effect of the intervention?)Type of study(Which is the optimal study design ?)
Who is treated?
What is given as a treatment?
What is the comparison?
What outcome is of interest to us?
How to ask a clinical question?
What is the study design?
Question type Ideal study design
Therapy RCT
Prevention RCT > Cohort> Case-control
Diagnosis Prospective, blind, randomized trial of comparison with golden standard
Prognosis Cohort> Case-control> Case series/ Case report
Cost and efficiency Economic analysis
Phenomenon Qualitative study
Be precise!
Kew words for database search
PPatient,
problem
Iintervention
CComparison
(not always)
OOutcome
TType of
study
Aim of steps 1. i 2. : find “pearls”
Examples of clinical questions
• What is causing migraine?• How often a 40 year-old women needs to go to
mammography?• What is the efficacy and safety of early and long-term
use of clopidogrel and aspirin compared to aspirin alone in patients with acute coronary syndrome without ST-segment increase?
• In patients with mechanical ventilation longer than 48 hours, is oral decontamination with chlorchexidine (CHX) or CHX + colistine useful in decreasing the risk of pneumonia related to ventilation?
Examples of clinical questions
Ethiology and risk factors
Ethiology and risk factorsWhat is causing the problem?
PrevalencePrevalenceHow common is the problem?
Has this patient a problem? DiagnosisDiagnosis
Who will have a problem? Prognosis and prediction
Prognosis and prediction
InterventionInterventionHow to treat a disease or
condition?
What is the problem? PhenomenonPhenomenon
Interventions cover a wide spectrum of activities - from medications and other clinical therapeutics to change in life habits (exercise, smoking cessation) and social activities (education programmes).
Interventions may include patient care for a single patient but also public health activities.
28 year-old man suffers from furunculosis in the last 8 months. These episodes are treated by drainage and 2 different atibiotics, but the disease relapses. The patient asks if the relapses can be prevented.
Patient with recurring furunculosis
Prophylactic antibiotics
No treatment
Decrease in relapse of furunculosis
Q: In patients with recurring furunculosis, can prophylactic antibiotic therapy in comparison to no treatment decrease the incidence of recurring episodes?
Reading a medical journal, you find an article about imiquimode cream for the treament of basal cell carcinoma. The notion of a cream as cancer therapy sounds surprising, so you wonder about its efficacy, especially in regard to long-term cure rate.
Patient with basal cell carcinoma
Imiquimode cream
Active placebo – standard/gold therapy
Increase in long-term cure rate with the cream
Q: In patients with basal cell carcinoma, can im iquimode cream , in comparison to standad surgical intervention, increase the long-term cure rate in these patients?
Questions about ethiology and risk factors are questions about what causes a disease or health condition.
Harmful outcomes of activities or exposures Common in public health:
◦ Can intake of certain food increase risk of cardiovascular disease?
◦ Can exposure to infrared waves increase risk of cancer?
Jane is expecting her first baby in two months. She read about the benefits and harms of injections of vitamin K to newborns. She is scared by the reports of increased risk of childhood leukemia in babies administered vit. K injections. She asks you if this is true and what the risk is for her baby.
Newborn
Vitamin K injection
No vitamin K injection
Childhood leukemia
Q: In newborns, does the administration of vit. K injection increase the risk of childhood leukemia?
Questions about how many people have a diseases or health condition.
Examples:◦ What is the prevalence of hearing problems in
newborns?◦ What is the prevalence of Alzheimer’s disease in
the population older than 70?
Maria is a 6-month baby coming to her regular check up. She was born prematurely, at the gestational age of 35 months. You want to warn the parents about the odds that Maria may have hearing problems.
Infant
Premature birth
Term birth
Deafness
Q: In preterm infants, in comparison to term babies, what is the prevalence of deafness?
Questions about:◦ How accurate are diagnostic tests in different patient groups. ◦ How accurate are diagnostic tests in comparison to other
tests.
Clara is pregnant for the second time. She had her first baby when she was 30 and had amniocentesis to exclude Down’s syndrome. The test was negative, but she was not satisfied because she got results in the 18th pregnancy week. She is now 35 and asks if there is a test with a quicker answer. Your hospital has biochemical test of serum markers and ultrasound of nuchal folds in the first trimester, but you want the check if the test is sensitive and specific enough in comparison to amniocentesis.
Pregnant women
Serum markers biochemistry +US of nuchal folds
Amniocentesis
Correct diagnosis (specificity and sensitivity) of Down’s syndrome
Q: In pregnant women, is nuchal fold US + serum markers test equaly correct as amniocentesis in diagnosing Down’s syndrome?
What are the odds for an outcome for a population with certain characteristics (risk factors)?
◦ What are the odds that a man who feels atypical chest pain develops heart failure?
◦ What is predicted mortality and morbidity for a person who is diagnosed with colon cancer?
Clonic seizures in childhood are common and disturbing for parents, but the decision to start prophylactic therapy after the first attack is difficult. To help parents make a decision, you have to explain them the risk of new attacks after the first clonic seizure of undetermined cause.
Children
A clonic attack of undetermined cause
No attack
Future attacks
Q: In children with a single clonic attack of undetermined origin, in comparison to children without attacks, what is the risk of future clonic seizures?
• For each type of clinical question there are study designs that provide best evidence for the question.
• These are always study designs that have a maximum decrease in bias .
Question type Ideal study design
Therapy RCT
Prevention RCT > Cohort> Case-control
Diagnosis Prospective, blind, randomized trial of comparison with golden standard
Prognosis Cohort> Case-control> Case series/ Case report
Cost and efficiency Economic analysis
Phenomenon Qualitative study
Observational
Design
Experimental
No control Cohort
Case-control
Non-randomized control
Randomized control
Open
Single blind
Doubleblind
Increasing validity of evidence for conclusions on cause and consequence
Examples of disbalance between surogate and relevant outcomes:
Disease or condition Surogate outcome Relevant outcome
Lidocaine for arrythmia after AMI
Decreases arrythmia Increases mortality
Vitamin E for heart disease
Decreases the level of free radicals
Do not decrease mortality
Clofibrate for hyperlipidemia
Decreases blood lipid levels
Do not decrease mortality
Sodium floride for bone fracture prevention
Increases bone densitiy Do not decrease fracture rate
Hormone replacement therapy
Decreases LDL, increasese HDL
Do not decrease mortality, can increase incidence of cardiovascular events in women over 60