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Summary

Summary Clinical Research in Practice (CRIP)

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Summary statistics for the exam for the Master of Biomedical Sciences in Leiden. Includes all effects of colleges of Statistics, Epidemiology, Data management and Molecular Epidemiology. It has taken a lot of time to make this summary as complete as possible, but I have taken on the basis of this summary, the examination with a 9. So hope you can help as well!

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December 14, 2016
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2016/2017
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© M.Dalenberg




CRiP Epidemiology
26 september CRiP introduction
Myocardial infarction and clinical research ~ Jan Willem Borleffs
Research in 4 simple steps:
1. Know the problem
o Magnitude of the problem ~ worldwide is coronary artery disease most
frequent cause of death
o 10 missed heart beats = loss of consciousness
The heart = muscle  needs oxygen.
 No oxygen = myocardial infarction. Myocardial cell death due to a blocked coronary
artery.
 Plaque formation  atherosclerosis. Results in occlusion (block) of the artery!
Treatment ~
o Medication ~ anticoagulation
o Percutaneous coronary intervention (PCI) ~ dotteren
2. Know research thus fur
o Phase 1 ~ bedrest, relaxation, alcohol
o Phase 2 ~ intensive cardiac monitoring, rhythm monitoring with alarm, trained
personnel for defibrillation. Mortality from 30% to 15%.
o Phase 3 ~ Reperfusion  early medication, early resolving of thrombus,
percutaneous intervention. From 15% mortality to 3,5% .
3. Evaluate your idea
o Research for every step in the whole process.
4. Nobel price

-------------------

CAREMA study ~ Cardiovascular Registry Maastricht
Data collection:
 Questionnaires
 Type 2 diabetes
 Behavior (smoking, drinking, physical activity)
 Family history (parental age at diagnosis: premature MI: <60 (men) <65 (women)
have increased risk)
 Medical examinations (BMI, non-fasted blood)
 Lab assays: traditional risk factors (TRF)




© M.Dalenberg

,© M.Dalenberg



Other cardiovascular risk profiles ~ find better/different markers.
o Genome (DNA), transcriptome (RNA), proteome (proteins), metabolome
(sugars, nucleotide, AA, lipids)  phenotype/function
o Metabolomics is important field ~ >4000 metabolites can be measure by
different platforms in blood.

Aims of CAREMA substudy ~ to what extent can traditional risk factors predict future
coronary heart disease (CHD) risk in a population based prospective study. (Case-control
study).

----------------

Clinical research in practise (CRiP) ~ Anske van der Bom
Epidemiology ~ methods of research, how to answer research questions, how to design.

Clinical research in practise:
1. Designing the research question
2. Choosing the methods
3. Data collection
4. Statistical analysis
5. Interpretation of findings

REWARD alliance ~ reduce research waste and reward diligence. Estimated that 85% of
research is wasted, because it asks the wrong questions, badly designed, not published or
poorly reported.
Research waste: most findings are false due to:
o Publishing pressure, time, journals and thinking after doing.
o Spend a lot of time to think about what the problem is!




© M.Dalenberg

, © M.Dalenberg



When is a research question not a research question?
3 types of clinical research question
1. Diagnosis ~ what is wrong with this patient? Ask for symptoms, do tests
o Added value of a new diagnostic test in addition of an already existing test.
o Cross-sectional ~ observational study that analysis data collected from a
population at a specific point in time.
i. cross-sectional studies differ from case-control studies in that they aim
to provide data on the entire population under study, whereas case-
control studies typically include only individuals with a specific
characteristic
2. Prognosis/Intervention ~ What is going to happen in the future? Is he going to die?
o Prediction about the future
o Randomised trial ~ effect of intervention compared to another invention
i. de te testen behandeling wordt uitgevoerd bij een interventiegroep en
vergeleken met een controlegroep.
ii. Een controlegroep is een vergelijkbare groep proefpersonen of
proefdieren met dezelfde klacht of hetzelfde probleem, maar die met
een placebo of met een ander middel wordt behandeld.
iii. RCT ~ randomize patients. In both groups characteristics are the same.
o Cohort ~ get knowledge about prediction.
i. Een populatie gedurende een bepaalde tijd volgen
ii. A cohort is a group of people who share a common characteristic or
experience within a defined period (e.g., are currently living, are
exposed to a drug or vaccine or pollutant, or undergo a certain medical
procedure)
3. Etiology ~ why did this patient get this disease? (smoking, drinking etc.)
o Case control study ~ history of certain exposure, did this contribute to the
disease development? Compared to control group.
i. Personen met een ziekte vergelijken met een groep zonder de ziekte
maar wel gelijksoortig (geslacht, leeftijd etc.)
ii. Provide less evidence for causal interference than a randomized
controlled trial!
Example: Young cannabis smokers run risk of lower IQ ~
o What type of research question? Start with: what do I want to know?
o Etiology
o If I use cannabis, will my IQ be lower?




© M.Dalenberg

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