FINAL 1

Question 1

A process of information exchange in which participants are provided with understandable information needed to make a participation decision; full disclosure of the risks and benefits, and the assurance that withdrawal is possible at any time without consequences. This process begins with recruitment and ends with a signed agreement document.

Answer 1

Informed consent

Question 2

According to the Belmont Report, the consent process contains 3 components:

Answer 2

• information
• comprehension
• voluntariness

Question 3

This standard requires that the extent and nature of the information provided be sufficient for a reasonable person to decide whether to participate.

Answer 3

“reasonable subject” standard

Question 4

Reporting as much information about research as is known at the time without threatening the validity of the study. This practice allows the subject to make an informed decision as to whether to participate.

Answer 4

Full disclosure

Question 5

A statistical method of aggregating the results of quantitative studies so an overall effect size can be evaluated.

Answer 5

Meta-analysis

Question 6

A methodology that synthesizes quantitative, qualitative, and comparative effectiveness research to provide a comprehensive understanding of the human condition.

Answer 6

Integrative review

Question 7

The development of overarching themes about the meaning of human events based on a synthesis of multiple qualitative studies.

Answer 7

Qualitative meta-synthesis

Question 8

Research-based recommendations for practices that are graded as mandatory, optional, or supplemental and that may be stated as standards of practice, procedures, or decision algorithms.

Answer 8

Practice guidelines

Question 9

Highly structured studies of cause and effect applied to determine the effectiveness of an intervention. The “gold standard” for EBP because they provide convincing support for the value of a treatment.

Answer 9

Experimental design

Question 10

Characteristics of an experimental design:

Answer 10

• the cause must precede the effect in time
• rival explanations for the outcome must be ruled out
• the influence of the cause on the effect must be demonstrated

Question 11

Strengths of experimental designs

Answer 11

• considered the strongest evidence for practice
• these designs are the only ones that allow a definitive conclusion about cause and effect; ideal for testing the effectiveness of interventions
• recognized and valued by other disciplines
• generally understood by the public and patients

Question 12

Limitations of experimental designs

Answer 12

• complex and difficult to carry out
• require substantial resources (time, skill, and access)
• many aspects of healthcare cannot be manipulated
• increasing control = artificial; generalizability of the findings may be limited

Question 13

Studies of cause and effect similar to experimental designs but using convenience samples or existing groups to test interventions.

Answer 13

Quasi-experimental designs

Question 14

Strengths of quasi-experimental designs

Answer 14

• more feasible than true experiments in an applied setting
• true experiments may not be feasible or ethical; it may be impossible to deliver an intervention to some in a group and not others
• introduce a level of control that reduces the effect of extraneous variables
• accessible subjects can be used for the study so that larger samples may be obtained

Question 15

Limitations of quasi-experimental designs

Answer 15

• inappropriate to draw conclusions about cause and effect w/out random assignment to groups
• groups may not be equivalent in characteristics, such that extraneous variables are introduced
• rival explanations for the outcome exist and may weaken confidence in the results

Question 16

The meticulous descriptive exploration of a single unit of study, such as a person, family, group, community, or other entity.

Answer 16

Case study

Question 17

Strengths of a case study design

Answer 17

• can provide in-depth information about the unique nature of individuals
• responses and changes that emerge overtime can be capture and appraised
• new insights can be obtained that can potentially generate additional studies

Question 18

Limitations of a case study design

Answer 18

• no baseline measurement to provide comparison w/intervention outcome
• difficult to determine whether there is an improvement in outcome bc causation cannot be inferred
• researcher objectivity required when drawing conclusions bc interpretation potentially can be biased
• results cannot be generalized to larger populations
• lacks rigor
• lengthy time commitment

Question 19

The board required in research institutions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation criteria, including ethical standards.
*US Department of Health and Human Services developed this regulation under the Code of Federal Regulations.

Answer 19

Institutional Review Board (IRB)

Question 20

Full IRB review must be done under the following conditions:

Answer 20

• studies require direct access to participants
• human subjects are put at more than minimal risk
• protected health information is required
• federal funds are received
• publication is anticipated

Question 21

A review of study proposals that pose no risk to subjects; the full IRB is not required to participate.

Answer 21

Exempt review

Question 22

A review of study proposals that pose minimal risk to subjects; 1-2 members of IRB participate.

Answer 22

Expedited review

Question 23

A review of study proposals that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full IRB committee participates.

Answer 23

Full review

Question 24

Statements of the disparity (gap) between what is known and what needs to be known and addressed by the research.

Answer 24

Problem statements

Question 25

Declarative and objective statements that indicate the general goal of the study and often describe the direction of the inquiry.

Answer 25

Purpose statements

Question 26

PICO (outlines the elements of a good quantitative question)

Answer 26

Population of interest
Intervention under study
Comparison that makes up the control
Outcome of interest