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Biostats > Exam 1 - Julia's Quizlets > Flashcards

Exam 1 - Julia's Quizlets Flashcards

1
Q

What are the types of research

A

Basic (biological)
Applied
Clinical
Translational
Patient-centered
Epidemiological
Behavioral
Pharmacy practice and policy
Comparative effectiveness

(Please ACCEPT Blind Boys)

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2
Q

What is basic (biological) research comprised of

A

Biochemistry
Genetics
Biology

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2
Q

What is applied research comprised of

A

Pharmaceutics
Medicinal chemistry
Pharmacology
Pharmacotherapy

(PMPP)

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3
Q

What is clinical research comprised of

A
  • includes research involving human participants; either specimens from them or the humans themselves (eg behavioral studies)
  • research clinical trials are required for FDA approval
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4
Q

What is translational research

A

Utilizes technology and innovation along with new practices

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5
Q

What is biomedical research

A

Involves biological and medical sciences to understand and improve the health of patients and populations

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6
Q

Types of biomedical research

A

Basic research
Applied research

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7
Q

Basic research (biomedical)

A
  • systematic study directed toward fuller knowledge/understanding of phenomena and observable facts without specific applications towards processes/products in mind
  • usually conducted in labs to provide knowledge of natural phenomenon
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8
Q

What are the areas of inquiry of basic research

A

Biology
Genetics
Physiology
Biochemistry

(Babes Get Pointy Boobs)

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9
Q

Why is basic research imperative for applied research

A

Knowledge must exist before it can be applied

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9
Q

Applied research

A
  • systematic study to gain knowledge/understanding necessary to determine how a recognized and specific need may be met
  • utilized to develop a product/application like new meds, drug regimens, services
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10
Q

How is applied research conducted

A

In animals and other living systems to solve a problem/create a product

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11
Q

What are the areas of inquiry for applied research

A

Pharmacology
Medicinal chemistry
Pharmaceutics

(Pretty Mia Pino)

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12
Q

Describe the development component of drug development

A

Systematic application of knowledge/understanding, directed toward production of useful materials/devices/systems/methods

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13
Q

Define research and development

A

Creative work undertaken on a systematic basis to increase stock of knowledge including:

  • knowledge of man
  • culture and society
  • use of stock knowledge to devise new applications
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13
Q

Limitations of research and development

A
  • time consuming
  • very expensive
  • takes ~15 years for new product to enter market
  • average cost = ~$2B
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14
Q

What is clinical research

A

Defined by NIH as:

Research that either 1. Directly involves a particular person/group of people or 2. Uses materials from humans (ex behavior, samples of tissue)

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15
Q

What does clinical research help us understand

A

application of knowledge for products or processes in the:

  • prevention
  • diagnosis
  • prognosis
  • treatment
  • cure

Of diseases in humans

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16
Q

What type of research does clinical research encompass

A

Patient oriented research
Epidemiological
Health services research

(HEP)

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17
Q

Patient oriented research (clinical)

A

Examines in humans:

  • mechanisms of disease
  • effects of drug therapies & interventions
  • utilization of tech & devices in humans
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18
Q

Epidemiological (clinical)

A

Also includes behavioral research which evaluates distribution and factors associated with:

  • diseases
  • health behavior
  • health in general
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19
Q

Health services research (clinical)

A

Evaluates effectiveness and efficiency of:

  • treatment interventions
  • services in real world practice
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20
Q

What is pharmaceutical practice and policy research a component of

A

Health services research

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21
Q

Define pharmaceutical practice and policy research

A

Multidisciplinary field of scientific investigation that examines cost/access/quality of pharmaceutical care from these perspectives:

  • clinical
  • socio-behavioral
  • economic
  • organizational
  • technological
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22
Q

Which areas of pharmacy are within the scope of pharmaceutical practice and policy research

A

Pharmaceutical
Pharmacist services
Pharmacy systems

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23
Q

What is the goal of pharmaceutical practice and policy research

A

Increase knowledge of pharmaceuticals, pharmacist services, and pharmacy systems for individuals/populations

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24
Q

What are some new areas of pharmaceutical practice and policy research

A
  • pharmacoepidemiology
  • pharmacoeconomics
  • pharmaceutical outcome research
  • pharmacy practice based research
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25
Q

Comparative effectiveness research

A

Aims to generate and synthesize evidence that compares the benefits/harms of alternative methods

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26
Q

What is the goal of comparative effectiveness research

A

Provide info to decision makers at individual and population levels

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26
Q

What are the findings of comparative effectiveness research used for

A

Prevent/diagnose/treat/monitor a clinical condition or to improve delivery of care

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27
Q

Translational research

A
  • transferring knowledge across the research and practiced continuum
  • applying discoveries in labs & preclinical studies to the development of trials and studies in humans
  • aims to enhance adoption of best practices in the community
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28
Q

Empiricism

A
  • collection of info based on human experience
  • info derived from sensory experience
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28
Q

Which disease states could translational research be essential for

A

Ex. Cancer & AIDS

Diseases that are in need for products to cure

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29
Q

Patient centered outcomes research (PCOR)

A

Helps patient communicate and make informed healthcare decisions

Allows the pt’s voice to be heard in assessing value of healthcare options

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30
Q

Research topics funded by PCORI

A
  • assessment of prevention, diagnosis, and treatment options
  • improving access and care in healthcare systems
  • communication and dissemination research for shared decision making
  • addressing disparities in prevention, diagnosis, or treatment effectiveness
  • accelerating pt centered outcomes research and methodology research
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30
Q

What was created to fund research in order to generate evidence for pt centered care outcomes

A

Patient centered outcomes institute (PCORI)

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31
Q

4 determinants of scientific methodology

A

Theory
Objectivity
Empiricism
Ethics

(TOEE)

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32
Q

Objectivity

A

NO bias in any aspect of research including:

  • definition
  • measurement
  • design
  • analysis
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33
Q

Theory

A
  • provides understanding/explanation of natural phenomena
  • provides rationale & logic for research question and hypothesis
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34
Q

Steps in scientific research process

A
  • develop research questions & hypothesis
  • develop & implement research plan
  • perform data collection & analysis
  • prepare research report
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35
Q

Sources used to develop research question

A

Policy
Current issue
Theory
Literature
Clinical practice

(Point Cassie Towards Loser Central)

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36
Q

Desirable characteristics of a research question

A

Feasible
Interesting
Novel
Ethical
Relevant

(FINER)

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37
Q

Considerations when formulation a research question

A

Environment
Resource availability
Access to pt data

(in your research question ERA)

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38
Q

PICOTS framework for development of a clinical question

A

Patient/population
Intervention
Comparator
Outcomes
Timeline
Setting

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39
Q

ECHO framework used in pharmaceutical practice and policy research

A

Economical
Clinical
Humanistic
Outcomes

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39
Q

Descriptive research

A

Describes/explores population characteristics

Ex. Prevalence of a disease

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40
Q

How is research typically classified

A

Descriptive
Analytical

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41
Q

Analytical research

A

Evaluations relationship between 2+ variables for the purpose of explanation/prediction

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42
Q

Hypothesis

A
  • typically developed in clinical research
  • specifies expected/proposed relationship being evaluated between intervention and outcome
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43
Q

Research design classifications

A

Experimental
Observational

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44
Q

Experimental research design

A

Strongest design to test a research hypothesis

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44
Q

Research design

A

Overall plan allowing researchers to gather answers to study questions and test study hypotheses

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45
Q

Research methodology

A

Provides details on data collection and measurement techniques

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45
Q

How is research methodology grouped

A

Primary methods
Secondary methods

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45
Q

Observational research design

A

Provide evidence of associations/relationships

Ex. Cohort studies, cross-sectional studies

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46
Q

Primary methods

A

Specific data collection using self-reported observations, biological assessments

(Ex. Surveys, lab tests)

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47
Q

Statistical analysis

A
  • quantitative answers to research questions
  • organizes, summarizes, and analyzes data
  • includes descriptive measures such as mean, median, mode
  • includes inferential statistics such as t-test and analysis of variances (used to make inferences on population)
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47
Q

Which sections are included in a research report

A

Introduction
Methods
Results
Discussion

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48
Q

Evidence based medicine steps

A
  1. Asking an appropriate and answerable question
  2. Finding evidence
  3. Appraising evidence
  4. Applying evidence to practice
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48
Q

Secondary methods

A

Use of previously collected data for purposes such as pt care or reimbursement

Ex. Medical charts/claims

48
Q

What types of research communication tools are useful for presentations

A

Abstracts
Posters
Papers

(APP)

49
Q

What are the aims of EBM

A

Ensure delivery of highest quality pt care

50
Q

Under the umbrella of EBM, according to the institute of medicine, what should quality healthcare be

A

Safe - avoid pt harm

Effective - care should benefit pt

Patient centered - care should be individualized based on pt preferences/values

Timely - ensure timely, needed care and avoid delay

Efficient - maximizes use of healthcare

Equitable - does not vary due to personal beliefs/practices

(STEEEP)

51
Q

What does the accreditation council for pharmacy education (ACPE) require of pharmacist training

A
  • principles of research design and methodology
  • regulatory and ethical principles of research
  • data management and statistical analyses
  • principles of drug literature evaluation
  • practice implication of research

(Pretty Dumb People R Pharmacists)

52
Q

What are the aims of the clinical and translational science award (CTSA) program

A
  • develop academic infrastructure for translating biomedical research to treatments
  • involve community practitioners and industry in translational research
  • train the next generation of clinical and translational researchers
53
Q

Practice bases research

A
  • can be instrumental in clinical and translational research
  • the practice based research network (PBRN) consists of clinicians, dentists, nurses, pharmacies
54
Q

How can the PBRN be instrumental

A
  • ID problems in pt care
  • test effectiveness of treatments in real world settings
  • evaluate patients who can benefit from treatments
55
Q

Drug development process

A
  • preclinical
  • phases 1-4
  • randomized controlled trials are gold standard
  • INDA and NDA submissions
  • post marketing research

(PRIPP)

56
Q

Phase I clinical trial characteristics: primary interest

A

Toxicity/tolerability

57
Q

Phase I clinical trial characteristics: Target population

A

Healthy volunteers OR subjects w/ the disease in question

58
Q

Phase I clinical trial characteristics: Study design

A
  • dose escalation in cohort of patients
  • often uncontrolled
  • generally unblinded
59
Q

Phase I clinical trial characteristics: Duration

A

~ 1 month to > 1 yr

60
Q

Phase II clinical trial characteristics: primary interest

A

Preliminary efficacy and safety

61
Q

Phase I clinical trial characteristics: Volunteers enrolled

A

~50

62
Q

Phase II clinical trial characteristics: Target population

A

Subjects w/ disease in question

63
Q

Phase II clinical trial characteristics: Study design

A

Can be:

Randomized
Double blind
Placebo
Controlled

64
Q

Phase II clinical trial characteristics: Duration

A

Months, up to 2 years

65
Q

Phase II clinical trial characteristics: Volunteers enrolled

A

~ 100

66
Q

Phase III clinical trial characteristics: primary interest

A

Efficacy and safety

67
Q

Phase III clinical trial characteristics: Target population

A

Subjects w/ disease in question

68
Q

Phase III clinical trial characteristics: Study design

A

Can be:

Randomized
Double blind
Placebo
Active controlled

69
Q

Phase III clinical trial characteristics: Duration

A

1-2 years, up to several years

70
Q

Phase III clinical trial characteristics: Volunteers enrolled

A

100s to 1000s

71
Q

Phase IV clinical trial characteristics: primary interest

A

Long term data

72
Q

Phase IV clinical trial characteristics: Target population

A

Could include subjects w/ other diseases

73
Q

Phase IV clinical trial characteristics: Study design

A

Various depending on intent

Experimental/observational designs

74
Q

Phase IV clinical trial characteristics: Duration

A

Variable

75
Q

Phase IV clinical trial characteristics: Volunteers enrolled

A

Varies

75
Q

Consent issues as they relate to ethics and respect for persons

A

Autonomy/self-determination
Voluntariness
Confidential/privacy
Elements of consent
Informed consent form
Consent process

(A Very Cold ICE)

76
Q

Who are considered vulnerable subjects

A

Children
Decisionally impaired persons

77
Q

Beneficence

A
  • risk/benefit analysis issues
  • data & safety monitoring plans/boards
  • special populations such as limiting risks in children
78
Q

Justice

A
  • fairness in the distribution of burdens and benefits
  • issues
  • recruitment practices
79
Q

Regulatory framework for clinical research

A

Codes/reports

US federal regulations (FA, OHRP, HIPAA)

ICH/GCP

Definitions of human subjects research

IRB systems of review

Role of IRB and IRB membership

IRB approval considerations

Continuing review

Amendments

Human Research Protection Programs (HRPPs)

SAE reporting unanticipated problems involving risk to subjects and others

(I HID At CIRCUS)

80
Q

Ethical challenges in clinical research

A
  • Placebo ethics
  • Ethical issues w/ Phase I trials
  • Conflicts of interest
  • QI vs research
  • Ethical issues w/ tissue & data banking
  • Privacy/confidentiality issues
  • Public registries of clinical trials
  • Genetic testing in clinical research
  • Globalization of clinical research

(Good Girl PEEP, Cat Princess)

81
Q

How can a good research design impact research findings

A

Increases the validity of research findings

82
Q

What are the ramifications of a flawed research design

A

Could raise questions about the credibility of research findings

83
Q

Purpose of clinical studies

A

Well designed

Provide valuable evidence to assist practitioners in making decisions that best suit patient needs

83
Q

Which factors are essential to evaluate and apply research evidence

A

Understanding of research designs and methodology

84
Q

What are the issues w/ poorly designed research studies

A
  • limited scientific value
  • can be useless/wasteful/harmful to patients when incorporated into evidence based practice
84
Q

What is the decision to use a particular study design dependent on

A

The ability of that design to provide valid results

84
Q

How do clinicians practice EMB

A

Integrate their own clinical experience w/ the best available clinically relevant research

84
Q

What does validity reflect

A

Accuracy of study results

84
Q

What does the development of research design allow researchers to do

A

Gather answers to study questions and test study hypotheses

84
Q

Which two types of validity exist

A

Internal validity
External validity

85
Q

Internal validity

A

Extent to which the dependent variable (clinical outcome of interest) in a study is caused by the independent variable (treatment)

85
Q

Causation

A

AKA causality

One of the most commonly used terms in scientific literature

Represents a cause and effect relationship

85
Q

External validity

A

Refers to the extent to which the results of a study can be generalized to other settings

85
Q

When does causality exist

A

When there is a causal relationship between the treatment (cause) and the clinical outcome (effect)

86
Q

9 criteria for causation

A

Analogy
Coherence
Consistency
Experiment
Plausibility
Temporality
Specificity
Strength
Biological gradient

(ACCEPTS Some Bitches)

86
Q

Two broad categories of research designs

A

Observational
Experimental

86
Q

Which type of criteria can be used to classify research designs

A

Study purpose
Time orientation
Investigator orientation
Clinical/experimental setting

(STIC)

87
Q

Observational designs

A
  • researcher observes interplay of independent variables w/ dependent variable
  • variations in exposure and outcomes are observed to evaluate their relationship or association
87
Q

Experimental designs

A
  • researcher controls treatment (independent variable) that is likely to have an effect on clinical outcome (dependent variable)
  • criteria such as temporality, strength, biological gradient can be easily achieved to prove causality
88
Q

Investigator orientation criteria

A

Interventional
Quasi-experimental

88
Q

Time orientation criteria

A

Prospective
Retrospective

88
Q

Study purpose criteria

A

Descriptive

89
Q

Experimental setting criteria

A

Randomized controlled trials
Observational

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Biostats (17 decks)

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