Intro to Clinical Research Design Flashcards
What is evidence based practice (EBP)?
integration of evidence with clinical experience
What are the benefits to EBP?
- allows HCP to address healthcare questions with evaluative and qualitative approach
- to differentiate between high-quality and low-quality findings
Why research?
1) evidence based medicine
2) advance practice
3) legal obligation to test new products
4) intellectual curiosity
5) academic credence
According to DHHS regulation, what is research?
systemic investigation that will develop or contribute to generalizable knowledge
What is systemic investigation?
involves a plan that has data collection (quantitative or qualitative) and data analysis to answer a question
What is generalizable knowledge?
It allows you to:
1) draw general conclusions
2) inform policies
3) findings beyond a single individual or an internal program
Do research results have to be published or presented in order for it be considered as research?
No, but if you don’t publish it, it never happened
What is the definition of scientific research?
systematic, controlled, empirical and critical investigation of natural phenomena guided by theory and hypothesis about presumed relationships among such phenomena
According to the federal definition, are case studies consider as research?
no, but it is a scholarly activity
What are the levels of evidence in order of least bias (1) to most bias (6)?
1) meta-analysis/ systematic review (least bias)
2) randomized controlled studies
3) controlled longitudinal studies
4) uncontrolled longitudinal studies
5) cross-sectional studies and case studies
6) expert opinions (most bias)
What is intellectual driving force?
biomed research is hypothesis driven, experimentally-executed and leads to further iterations of hypothesis and hypothesis testing
What is a hypothesis?
- proposed explanation for a phenomenon
- in order for it to be a scientific hypothesis, the scientific method must be used to test it
What is research ethics?
- conforming to accepted standards of social or professional behavior
- adhering to ethical and moral principles
What is research misconduct?
falsifying or manipulating data in published or non-published research
What are the four guidelines to follow for research ethics?
- honesty
- accuracy
- objectivity (avoid bias)
- efficiency
Bottom line: don’t falsify and don’t add to the data
What are the different types of observational study designs?
- cohort (prospective and retrospective)
- case-control
- cross-sectional
What is a cohort study?
- follows a group of people who do not have the disease and uses correlations to determine the absolute risk of subject contraction
- Basically about the life histories of segments of populations
- can be prospective or retrospective
What is a case-control study?
- study design in epidemiology
- compares subjects who have the condition (case) with subjects who do not (control) but otherwise similar
- relatively inexpensive
What’s an example of case-control study that had major impact?
demonstration of the link between tobacco smoking and lung cancer by Sir Richard Doll and others
What is a cross-sectional study?
observes a population or a representative subset at a defined time
How is cross-sectional study different from case-control study?
cross-sectional studies provide data on the entire population under study
case-control studies typically include only individuals with special characteristics
What are treatment studies?
pertains to randomized and non-randomized clinical trials
What are the three different types of randomized controlled trial?
1) double-blind
2) single-blind
3) non-blind
What is a double-blind study?
both the investigator and the participant are blind to the nature of the treatment given (thought to produce objective results)
