Module 3-Slides Flashcards

1
Q

Population
(Target Population)

A

ENTIRE group of interest to whom the study findings may be generalized

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2
Q

Accessible Population

A

SUBSETS of the entire / target population who are AVAILABLE for researchers to study

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3
Q

Sample

A

SUB-GROUP of the accessible population; serves as reference group to estimate characteristics of and draw conclusions
*Final Population being studied

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4
Q

Inclusion Criteria for Selection

A

Primary traits of the target and accessible populations that will make someone ELIGIBLE to be a participant (characteristics of interest)

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5
Q

Exclusion Criteria for Selection

A

Factors that would preclude someone from being a subject (INELIGIBLE)
EX: undesirable attributes - confounding factors/variables

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6
Q

Confounding/ Extraneous Variables

A

VARIABLES that may CONFOUND the results or interfere with interpretation of the findings

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7
Q

Probability Samples
(Selecting approach)

A

created via a process of RANDOM sampling or selection; to generate LESS BIASED AND CLOSER REPRESENTATIVE of the population

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8
Q

Random sampling

A

equal chance/probability for all in population to be selected

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9
Q

Nonprobability Samples
(Selecting approach)

A

made by non-random methods; more frequently used in CLINICAL STUDIES

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10
Q

Types of Probability Sampling

A
  1. Simple random
  2. Systematic
  3. Stratified random
  4. Cluster
  5. Disproportional
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11
Q

Types of Nonprobability Sampling

A
  1. Convenience
  2. Purposive
  3. Quota
  4. Snowball
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12
Q

Convenience Sampling

(nonprobability)

A

use of available participants
“accidental sampling”

MOST FREQUENTLY USED SAMPLING METHOD

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13
Q

Purposive Sampling

(nonprobability)

A

used when specific expertise / experience of participants is needed

handpicked /invited bc of known characteristics

used in qualitative studies

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14
Q

Quota Sampling

(nonprobability)

A

incorporate a stratification but lack of a randomization

subjects recruited to represent various levels/classes

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15
Q

Snowball Sampling

(nonprobability)

A

used when it is difficult to find subjects

recruit via communication of “word-of-mouth”

usually when dealing with difficult/sensitive topics

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16
Q

Examples of Convenience Sampling

A

Subjects found in a clinic
Volunteer subjects through ads/flyers

17
Q

Sample Size

A

Direct impact on validity of statistical conclusion; power analysis to determine the adequate sample size

18
Q

LARGER samples tend to be

A

MORE REPRESENTATIVE of the populations than smaller samples

Decrease sampling error

19
Q

Sampling Error

A

difference between an observed STATISTIC from a sample and the population PARAMETER

20
Q

Types of Clinical Trials

A
  1. Therapeutic trials: effect of intervention
  2. Diagnostic trials: accuracy of diagnostic procedures
  3. Preventive trials: evaluation of whether a procedure or agent reduces risk of developing a disease or disorder
21
Q

Randomized Controlled Trials (RCTs)

A

Gold standard for experimental research

Random assignment

Two or more groups (experimental + control groups)

Measurements: Pre- / Post - interventions

22
Q

Assignment of Subjects / Participants

A

Can be done either NONRANDOMLY or RANDOMLY, determined by the purpose and nature of the study

-When COMPARING patients with age- and gender-matched healthy control subjects

23
Q

Balanced group

A

Achieved when there is NO LACK OF RANDOMIZATION

= # subjects/ = distribution of clinical/ + confounding characteristic

24
Q

Random assignment is preferred due to what?

A

validity issues

25
Q

Independent Variable
(IV)

A

Intervention

active variable can be MANIPULATED by researcher and assigned to levels of IV (=# of groups)
Attribute variable cannot be manipulated (age/gender, disease duration/staging)

26
Q

Random Assignment

A

process of assigning subjects to groups (=chance of being assigned to any group)

minimizes BIAS by creating groups that are similar at the start of trial

27
Q

Is random assignment the same as random selection?

A

NO

28
Q

Selection

A

process by which subjects are drawn or selected from the population

RECRUITMENT/ENROLLMENT

29
Q

Assignment (or Allocation)

A

process by which subjects are placed into or allocated to a group within the study

MANAGEMENT

30
Q

Random Assignment Strategies

A
  1. Simple random
  2. Block random
  3. Stratified random
  4. Cluster random
  5. Random consent design
  6. Assignment by patient preference
  7. Run-in period
31
Q

Concealed Allocation (Assignment)

A

ensures group assignment is done w/out knowledge of those involved in the experimental process
minimizes BIAS in group formation

32
Q

Control Groups

A

inactive controls: placebo, sham, attention control group
wait list control: delayed start
active controls: (practical, feasible /ethical reasons)
-standard care or others with known efficacy

33
Q

Blinding (Masking)

A

minimizes observation BIAS by ensuring those involved in the study are unaware of a subject’s group assignment
-participant/subject/pt

34
Q

Double Blind

A

at least 2 of the 3 parties are unaware of group assignment

35
Q

Single Blind

A

at least 1 of the 3 parties is unaware of group assignment

36
Q

Explanatory Trial
(RCT, aka True experimental)

A

ideal situations to control for confounding
-strict and broad exclusion criteria
-standardized treatment protocol

37
Q

Pragmatic Trial
(RCT)

A

more reflective of practice situations
-diverse pt populations w/fewer or min exclusion criteria
-active controls (standard/other common care)
-Tx reflects practice + less standardized

38
Q

Phases of Clinical Trials /
New drug, surgical procedure

A

Phase I: Is the Tx safe?
Phase II: Does the Tx work?
Phase III: How does this Tx compare w/ standard care?
Phase IV: What else do we need to know?