Summary: Clinical Research And Regulations

Read the summary and the most important questions on Clinical research and regulations

• 1 Week 1

• 1.1 EBM

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• Where does empirical research rely on? And not on?

  Relies on observations (via measurements or experiments, qualitative or quantitative) 
  - not on speculations and theories

• Why is empirical research important?

  1. Ensures systematic and structured knowledge
     
  2. Validated knowledge
  3. High quality and reliable research 

• Different steps of the empirical cycle? (5)

  1. Observation (zwangere vrouwen met bloedverlies langer bedlegerig)
     
  2. Induction = broader hypotheses (include a comparison group, en specifieke uitkomst) (meer bloedverlies leidt tot meer vermoeidheid, in vergelijking met minder bloedverlies)
  3. Deduction = specific predictions that can be tested (>1 liter meer dan een week in bed)
  4. Testing = studiedesign (observaties bij zwangere vrouwen)
  5. Evaluation (p value => accept hypothesis)

• What are the three fundaments of EBM?

  1. Clinical experience
     
  2. Patient values
  3. Best research evidence

  
  
  Het zorgvuldig, expliciet, en oordeelkundig gebruik van het huidige beste externe bewijs-materiaal (3) bij het nemen van beslissingen over de zorg voor individuele patienten. Rekening houdend met
  - inzicht beroepsbeoefenaar (ervaring en praktijkkennis) (1)
  - wensen, voorkeuren en verwachtingen van patienten (2)

• What are the 5 steps of EBM?

  Ask: zorgvraag
  Aquire: zoeken naar onderzoeksartikelen, bewijs
  Appraise: beoordelen; is het kwalitatief bewijs, is het geschikt voor mijn patient
  Apply: toepassen in praktijk bij het maken van klinische beslissingen
  Assess: werkt het?

• What did EBM achieve? (5)

  • Cochrane library 400 systematic reviews/year
  • Clinical guidelines (best available evidence on specific topics)
  • Full disclosure of clinical trial data
  • Increased awareness for ‘overdiagnosis’ (focus of campaigns)
  • Development of the medical ethics => Tuskegee study 

• 1.2 Study designs

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• What are the 8 steps to set up a research study?

  Steps in the research process are;
  

  1. Idea: what is the research problem? Make a research proposal 
  2. What is already known: review the literature
  3. Making research questions, objectives, and hypothese => specify
  4. Choose the study design
  5. How many participants? Calculating on the sample size
  6. Collecting data 
  7. Process and analyse the data
  8. Write the research report –Disseminate and utilise results 

• Short description of types of empirical research

  1. Quantitative: identify relationships, hypothesis, generalisations
     
  2. Qualitative: can be unstructured, explore and understand, complex phenonema
  3. Mixed

• What belongs to descriptive designs?

  Ecological studies
  Cross-sectional studies
  Case report or case series

• What is characteristic about an ecological study? Do ecological studies have a follow-up?

  You don't follow people one on one, but in clusters of groups for example on postcode. 
  And yes, can have a follow up