Introduction to Clinical Research Design Lectures 1/2

Question 1

What is a thoughtful integration of the best available evidence, coupled with clinical experience?

Answer 1

evidence-based practice

Question 2

Kerlinger’s definiton of research?

Answer 2

scientific research is systematic, controlled empirical and critical investigation of natural phenomena guided by theory and hypothesis about presumed relationships is among such phenomena

Question 3

A case study is defined as?

Answer 3

not research, but a scholarly activity

Question 4

What are the 6 levels of evidence (starting with the lowest)?

Answer 4

1. expert opinions
2. cross-sectional studies + case studies
3. uncontrolled longitudinal studies
4. controlled longitudinal studies
5. randomized
6. meta-analysis

Question 5

Where do you have the most bias? least bias?

Answer 5

most bias: at the bottom of the chart (generate hypothesis)

least bias: establish causality

Question 6

Describe the 3 aspects of biomedical research?

Answer 6

I1. hypothesis-driven

2. experimentally-executed
3. leads to further interactions of hypothesis and hypothesis testing

Question 7

What is a proposed explanation for a phenomenon?

Answer 7

a hypothesis

Question 8

For a hypothesis to be put forward as a scientific hypothesis, what is required?

Answer 8

the scientific method requires that one can test is

Question 9

What are research ethics? (2 things)

Answer 9

1. conforming to accepted standards of social behavior or professional behavior
2. adhering to ethical and moral principles

Question 10

What is an example of research misconduct as discussed in class and it’s consequence?

Answer 10

falsification of data… no longer eligible for residency that is federally funded

Question 11

What are the 4 research ethics guidelines to follow?

Answer 11

1. Honesty
2. Accuracy
3. Objectivity
4. Efficiency

Question 12

What are the 3 types of observational studies?

Answer 12

1. Cohort (includes prospective and retrospective)
2. Case-Control
3. Cross-Sectional

Question 13

What is a from of longitudinal study used in medicine?

Answer 13

cohort study

Question 14

EBP allows health care providers to address health care questions with what approach?

Answer 14

evaluative and qualitative

Question 15

What type of study consists of an analysis of risk factors and follows a group of people who do not have the disease?

Answer 15

cohort study

Question 16

EBP allows the practitioner to assess current and past research, clinical guidelines, and other information resources in order to identify what?

Answer 16

relevant literature while differentiating between high and low quality findings

Question 17

Honesty, accuracy, objectivity, and efficiency are considered what things?

Answer 17

research ethic guidelines

Question 18

What study uses correlations to determine the absolute risk of subject contradiction?

Answer 18

cohort studies

Question 19

What are the 5 reasons research is done?

Answer 19

1. evidence based medicine
2. advance practice of medicine
3. legal obligation to test new products
4. intellectual curiosity
5. academic credence

Question 20

DHHS regulations defines research how?

Answer 20

systematic investigation, including research development, test, evaluation, designed to develop or contribute to generalizable knowledge

Question 21

What is an activity that involves a prospective plan that incorporates data collection and data analysis to answer a question?

Answer 21

systematic investigation

Question 22

Surveys/questionnaires are examples of what?

Answer 22

systematic investigation

Question 23

What are 7 things that are considered systematic investigations?

Answer 23

1. surveys/questionnaires
2. interviews/focus groups
3. analyses of existing data or biological specimens
4. epidemiological studies
5. evaluations of social or educational programs
6. cognitive and perceptual experiments
7. medical chart review studies

Question 24

How do cross-sectional studies differ from case-control studies?

Answer 24

cross-sectionaL: aim to provide data on the entire population

case-control: studies only individuals with a specific characteristic

Question 25

Investigations designed to develop or contribute to generalizable knowledge are those designed to do what 3 things?

Answer 25

1. draw general conclusions 2. inform policiy 3. generalize findings beyond a single individual or an internal program

Question 26

Interviews and focus groups are examples of what?

Answer 26

systematic investigation

Question 27

T/F: Research results do not have to be published or presented to qualify the experiment or data gathering as research.

Answer 27

True

Question 28

What makes an experiment or data collection, "research"?

Answer 28

need to have an intent to contribute to "generalizable" scholarly knowledge

Question 29

T/F. Participants in research studies do not deserve protection if the study is not published.

Answer 29

False. THEY DO!

Question 30

Data collected from a defined time involve what type of study?

Answer 30

cross-sectional studies

Question 31

What studies are used to assess the prevalence of acute or chronic conditions?

Answer 31

cross-sectional studies

Question 32

What is a benefit to case-control studies?

Answer 32

relatively inexpensive and can be carried out by a small team or individual researchers

Question 33

Example of the case-control study we learned in class

Answer 33

study between tobacco smoking and lung cancer by Sir Richard Doll

Question 34

People argued that Sir Richard Doll's case study did not show causation, but these people were later proved wrong. Why?

Answer 34

results from cohort studies confirmed a causal link

Question 35

What type of study forms a class of research methods that involve observation of all of a population at a defined time?

Answer 35

cross-sectional study

Question 36

What type of study answers questions about the causes of disease or the reults of medical intervention?

Answer 36

cross-sectional study

Question 37

What studies may involve questions about the past, but often rely on data originally collected for other purposes?

Answer 37

cross-sectional study

Question 38

What type of studies are not suitable for rare diseases?

Answer 38

cross-sectional

Question 39

What study is a form of a clinical trial?

Answer 39

randomized controlled trial

Question 40

What is used in testing the safety and efficacy or effectiveness of healthcare services or technologies?

Answer 40

randomized control studies

Question 41

When are study subjects randomly allocated to receive or another treatment?

Answer 41

after assessment of eligibility and recruitment before the intervention study begins

Question 42

Cost of a cross-sectional study?

Answer 42

moderately expensive

Question 43

What is a study in which both the investigator or the participant are blind to the nature of the treatment the participant is receiving?

Answer 43

double blind

Question 44

What study produces objective results?

Answer 44

double blind

Question 45

What study involves experiments who know the makeup of the test/control groups, but not the subject.

Answer 45

single-blind

Question 46

What is a study when neither experimenter or subjects are blind to the treatments?

Answer 46

non-blind

Question 47

What 3 things reduce bias?

Answer 47

randomization blinding prospective study

Question 48

In clinical practice, what is generally considered the gold standard for research design?

Answer 48

randomized control trial

Question 49

What study is largely about life history of segments of population?

Answer 49

cohort

Question 50

In your own words, what is a cohort study?

Answer 50

a type of study that takes a look at a group of people who do not have a disease, and then try to calculate their risk based on risk factors longitudinal do not have a disease try to find risk factor by looking at history of population segment

Question 51

What are the 2 subdivisions of cohort studies?

Answer 51

prospective and retrospective

Question 52

What type of study has a design in epidemiology?

Answer 52

case-control

Question 53

What is a case-control study in your own words?

Answer 53

comparing healthy people to subjects with the condition to identify factors that may contribute to a medical condition.

Question 54

What study involves measurements on a sample or a series of samples f rom the same population at several times before and after a manipulated event?

Answer 54

nonrandomized trial

Question 55

What is considered a type of quasi-experiment?

Answer 55

nonrandomized

Question 56

What is the phase for exploratory, first-in-human trials conducted in accordance with the FDA?

Answer 56

Phase 0

Question 57

What phase involves microdosing?

Answer 57

phase 0

Question 58

What phase is the first state of testing in human subjects?

Answer 58

Phase 1

Question 59

What phase occurs once the safety of the study drug has been confirmed?

Answer 59

Phase 2

Question 60

How many volunteers are utilized in a Phase 1 study?

Answer 60

20-100

Question 61

When does the development process of a drug usually fail? What stage?

Answer 61

Phase 2 (does not work as planned or has toxic effects)

Question 62

How many volunteers are in a Phase 2 study?

Answer 62

20-300

Question 63

What phase involves trials designed to asses the safety, tolerability, pharmocokinetics, and pharmacodynamics of a drug?

Answer 63

Phase 1

Question 64

What is an example of a Clinical trial of Phase 2 that failed (learned about it in class)

Answer 64

Jesse Gelsinger: ornithine transcarbamylase deficiency; principal investigator has financial ties to the study and eligibility was not respected

Question 65

What are a few reasons the University of Pennsylvania study was unethical?

Answer 65

failure to disclose in the informed-consent documentation that monkeys died when given this treatment; failure to report other side effects etc

Question 66

What study phase involves randomized controlled multicenter trials?

Answer 66

Phase 3

Question 67

How many people are used in a Phase III phase study?

Answer 67

300-3,000

Question 68

What Phase is also know as "post-marketing surveillance trial"?

Answer 68

Phase 4

Question 69

What trial involves the safety surveillance and ongoing technical support of a drug after it receives permission to be sold?

Answer 69

Phase 4

Question 70

What trial aims at being the definitive assessment of how effective the drug is, in comparison with the current, "gold standard" treatment.

Answer 70

Phase 3

Question 71

What Phase involves the comparative effectiveness research and community-based research?

Answer 71

Phase 5

Question 72

What type of study is this: 20 subjects with PF were matched for age and sex to 20 controls.

Answer 72

Case-Control

Question 73

What is the key to success of case-control studies?

Answer 73

matched with a control

Question 74

What Phase is used to signify the integration of a new clinical treatment into widespread public health practice?

Answer 74

Phase 5

Question 75

What study is this: This study examined bone fractures in a cross section of 9th and 10th grade girls at an urban high school. As a whole, 80% of the groups...

Answer 75

cross sectional

Question 76

Can statistical manipulations be used to rescue an intrinsically flawed study?

Answer 76

NO

Question 77

T/F. The best research usually comes from university-affiliated or independent, non profit research institutes (including government based organizations).

Answer 77

True

Question 78

Does it matter who funded the research?

Answer 78

YES!

Question 79

T/F. Journals will not tend to publish single studies unless the discuss how they intend to relate or be used in other studies or why they disagree with others.

Answer 79

T

Question 80

T/F. Observations without controls leaves you wandering the the dark?

Answer 80

T