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N360: Socialization II > Week 3 - Ethics in Research and EBP > Flashcards

Week 3 - Ethics in Research and EBP Flashcards

1
Q

What is research

A

It is a systematic inquiry that uses orderly methods to answer a question or solve a problem.

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2
Q

What is nursing research

A

It is a systematic inquiry designed to develop knowledge about issues of importance of the nursing profession.

nurses do research to solve issues for the patient and it can encompass many topics

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3
Q

What are the scopes of nursing research

A

scientific approach

applied approach

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4
Q

What are the classifications of nursing research

A

quantitative research

qualitative research

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5
Q

Scientific Approach

A

has to do with building the science of the profession of nursing (starts with something like bench research to clinical trials)

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6
Q

Applied Approach

A

How the information/science is put into practice/populations

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7
Q

What are the 3 interrelated concepts in nursing research which aim to ID, utilize, and apply scientific knowledge from research to clinical practice

A
  1. Research Utilization
  2. Knowledge Translation
  3. EBP
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8
Q

Research utilization

A

Applying the information and applying to populations - started in the 70s and 80s

Use of study findings in a practical application in SPECIFIC clinical areas unrelated to original research

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9
Q

Knowledge Translation

A

acknowledge, take the information, and translate it in a way that is useable (scientific research –> patient care)

Process of synthesizing, disseminating, and using of research knowledge

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10
Q

EBP

A

Evidence based practice

patient care and patient preferences !!!

Integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care

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11
Q

How does Research Utilization flow into Knowledge Translation? How does knowledge translation then flow into EBP

A

Research Utilization: Aims to make an impact on or change in the existing nursing practice –> Knowledge Translation: Bridges the gap in scientific research and its utilization in the delivery of health care services (Stakeholders) –> EBP: Aims to unify research evidence for best decision clinical making

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12
Q

___ causes nursing to move from vocation to profession

A

EBP

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13
Q

Hx of Research Utilization in Nursing Practice

A
  1. Early to Mid 70s: Studies ID’ed Knowledge-Practice Gaps - Nurses were not using research in practice so overall the profession was not using research knowledge
  2. 80s: CURN Project: Sought to bridge the K-P gap and the Conduct and Utilization of Research in Nursing Project created Research Utilization
  3. 90s: EBP began to supercede RU
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14
Q

Archie Cochrane and the Cochrane Collaborative

A

Called for efforts to make research summaries about interventions available to health care providers

These collaborative guidelines aggregate information and studies and rank quality of studies and methods to give overarching guidelines on best available treatment

Part of EBP movement

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15
Q

David Sackett

A

Developed Evidence Based Medicine which brought in the use of best evidence for all health providers

Would lead to EB Nursing Practice

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16
Q

What exactly is EBP

A

a life long problem solving approach to clinical practice integrating best evidence, clinical expertise, preferences of the patients

Its a systematic way to be sure that when we care for a patient we incorporate best evidence and pt preferences

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17
Q

What sets EBP apart from best evidence use

A

PATIENT PREFERENCE incorporation

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18
Q

What things does EBP integrate

A

search, critical appraisal, and synthesis of the most relevant and best research (external evidence/ best evidence)

ones own clinical expertise, which includes internal evidence generated from outcome management or quality improvement projects, patient assessment and evaluation (clinical expertise/internal evidence)

patient preferences and values

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19
Q

Almost all EBP uses ___ research

A

quantitative

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20
Q

Best Evidence of EBP comes from …

A

the findings of quantitative research studies

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21
Q

Clinical Expertise in EBP can include experience and what other things?

A

Expert Panels

Consensus Statements

Practice Groups

Practitioner Experience

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22
Q

Patient Preferences in EBP include what things

A

Satisfaction

QOL

Treatment Burden (Is it worth getting treatment for low QOL?)

Qualitative Studies

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23
Q

While most EBP and best evidence comes from quantitative evidence, what can qualitative evidence do?

A

show us patient preferences and patient experience

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24
Q

Models of the EBP Process

A

ARCC Model

Diffusion of Innovations Model

Iowa Model of EBP to Promote Quality Care

Johns Hopkins Nursing EBP Model

PARIHS Model

Stetler Model of RU (still uses RU! despite move to EBP)

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25
Q

What are some resources for EBP in nursing

A

models of the EBP process

preprocessed and pre appraised evidence

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26
Q

What is included under the term pre processed and pre appraised evidence

A

Clinical practice guidelines

Appraisal of Guidelines Research and Evaluation (AGREE and AGREE II)

most evidence is based in guidelines which are mounted on a ton of research

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27
Q

The 5 Major Steps (As) of EBP

A
  1. Ask
  2. Acquire
  3. Appraise
  4. Apply
  5. Assess
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28
Q

What is step 0 of EBP

A

0 - Cultivating the Sense of Inquiry

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29
Q

In Organizational settings, EBP must begin by selecting a problem or topic in one of two ways. What are the 2 possible triggers

A

Knowledge Focused Triggers

Problem Focused Triggers

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30
Q

Knowledge Focused Triggers

A

Begins with an innovation or research finding (eg: might emerge in a journal club) / something that catches your eye and you look into it

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31
Q

Problem Focused Triggers

A

Begins with a perplexing or troubling clinical situation

ex: Why are nurses passing out more than they should

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32
Q

Step 1: Ask

A

Ask: Ask a well-worded clinical question that can be answered with research evidence.

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33
Q

Step 2: Acquire

A

Search for and retrieve the best evidence to answer the clinical question.

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34
Q

Step 3: Appraise

A

Critically appraise the evidence for validity and applicability to the problem and situation.

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35
Q

Step 4: Apply

A

After integrating the evidence with clinical expertise, patient preferences, and local context, apply it to clinical practice.

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36
Q

Step 5: Assess

A

Evaluate the outcome of the practice change.

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37
Q

When doing step 1: Ask of EBP, what framework is used

A

PICO - the framework for asking the question

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38
Q

PICO(T) Question

A

Patient population

Intervention or issue of interest

Comparison intervention or group **

Outcome

Time frame**

** not always specified

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39
Q

What are compared to each other, what is the control, and what is the DV in PICOT

A

I and C are compared

C would be the control

O is the DV

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40
Q

When asking the question regarding qualitative research what components are looked at

A

population

situation (processes, exp, cultures, hx, condition of interest)

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41
Q

Ethno, Grounded, Phenom. Key Words

A

Ethno - Culture

Grounded - Process

Phenom - Experience

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42
Q

Question templates

A

A template of PICOT that can greatly facilitate wording of questions - can reword article titles to make them make more sense too

ex: In (population), what is the effect of (intervention), in comparison to (comparison), on (outcome) in (timeframe)

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43
Q

After Step 1: Ask, what comes next

A

Step 2: Acquire research evidence

Can use PICOT as keywords to search the database

find research

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44
Q

What are some databases for Step 2: Acquire of EBP

A

CINAHL (first line)

MEDLINE

Cochrane Collaboration

Agency for Healthcare Research and Quality**

National Guideline Clearinghouse**

** good place to look for clinical practice guidelines and is directly applicable to clinical practice

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45
Q

Step 3: Appraise the evidence involves what factors

A

Quality

Magnitude

Quantity

Consistency

Applicability

Level of Evidence

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46
Q

Quality (Step 3)

A

to what extent is the evidence valid- how serious is the risk of biases in this research?

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47
Q

Magnitude (Step 3)

A

How large is the effect of the intervention or influence (I) on the outcome (O) in the population of interest (P)? Are the effects clinically significant?

Is it significant enough to change behavior and practice to improve care

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48
Q

Quantity (Step 3)

A

How much evidence is there? How many studies have been conducted, and did those studies involve a large number of participants?

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49
Q

Consistency (Step 3)

A

How consistent are the findings across various studies?

We want to see consistent agreement across studies

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50
Q

Applicability (Step 3)

A

To what extent is the evidence relevant to my clinical situation and patients?

How well can this apply to care bedside, community care, large groups, family care

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51
Q

The key question during Step 3: Appraise is?

A

Applicability of research

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52
Q

Level of Evidence

A

Pyramid of evidence levels that is applicable to research appraisal by seeing where the study falls in regard to what type and level of evidence it is

it looks at the level of study design

7 Levels

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53
Q

Evidence Level 1

A

Systematic Review of RCTs and nonrandomized trials / Reviews of Literature and Studies

Quantitative evidence

Considered the highest level/ best level

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54
Q

Evidence Level 2

A

Experimental Controlled Trials or Quasi Experimental Studies - Quantitative evidence

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55
Q

Evidence Level 3

A

Systematic Reviews of NON experimental studies - still quantitative evidence

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56
Q

Evidence Level 4

A

Individual Correlational Observational Studies

Still quantitative

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57
Q

Evidence Level 5

A

Systematic Review of Qualitative Studies (which is hard to do since they are not made to be reviewed like that)

58
Q

Evidence Level 6

A

Single Qualitative Study - not good evidence to make practice change since it was not meant to be generalized to change practice

Not that its bad quality, just its design isnt for application purposes

59
Q

Evidence Level 7

A

Opinions of Authorities and Expert Committees

Highly susceptible to group think and outside pressure

60
Q

High evidence level does not necessarily mean…

A

high quality research (needs systematic critique)

61
Q

Levels of Evidence is not necessarily synonymous with

A

hierarchy of evidence

62
Q

Grading the strength of a body of evidence addresses what 3 domains

A

quality (individual studies look more to this)

quantity

consistency (lit reviews look more at this)

63
Q

Quality

A

the extent to which a study’s design, conduct, and analysis has minimized selection, measurement, and confounding biases (internal validity)

64
Q

Quantity

A

the number of studies that have evaluated the question, overall sample size across all studies, magnitude of the treatment effect, strength from causality assessment, such as relative risk or odds ratio

65
Q

Consistency

A

whether investigations with both similar and different study designs report similar findings (requires numerous studies)

66
Q

Step 4: Apply the evidence, involves doing what

A

Evidence will be integrated into own clinical expertise and knowledge of the clinical setting - the integration from qualitative research can also provide rich insights into how a pt exp a problem or about barriers to complying with a treatment –> think of the smoking women study story

So its you starting to use it in the practice environment

67
Q

Step 4 is the __ step

A

implementation

68
Q

What things must be considered when doing Step 4: Apply

A

EBP is not just research and published evidence:

Pt hx and circumstances have sig bearing on nurse choice of intervention

Also availability of resources must be considered - feasibility, cost benefit, transferability, cost benefit analysis

View if it will really translate to this particular pt population

69
Q

EBP Model purposes

A

to help implement (step 4) evidence into practice

70
Q

Stetler Model of RU

A

EBP Model

promotes EBP

71
Q

IOWA Model of EBP

A

promotes quality care in practice

72
Q

What do you ask during Step 5: Assess the outcomes of practice change?

A

Did you achieve the desired outcomes and make a change?

If so, were the patients satisfied with the results?

Were there barriers or issues?

73
Q

What is the implicit Step 6 of EBP?

A

Step 6: Disseminate Outcomes of the EBP Decision or Change

74
Q

Why is Step 6: Dissemination so important

A

Often positive outcomes are not shared with others- so communication among areas can help

Numerous strategies exist to do this including personal communication, conference presentation, and peer reviewed article publications

75
Q

What is the problem with Step 6: Dissemination

A

Diffusion of Innovation and Early adapters v Laggards

76
Q

What is the problem with Diffusion of Innovation

A

There is a long gap for people to uptake new information and behavior

Could take almost 20 years for wide adoption of a practice change from the research’s beginning - there is resistance

77
Q

Nursing Research Knowledge to Practice gap is about ___ years

A

17

78
Q

What is another method of quality measurement used in hospitals?

A

HCAHPS and Press Ganey

79
Q

HCAHPS

A

“Hospital Consumer Assessment of Healthcare Providers and Systems”

It is a national survey required by Centers for Medicare and Medicaid services at hospitals accepting those insurances

It requires hospitals to send out pt satisfaction surveys and allow others to view hospitals and their pt satisfaction scores

80
Q

Press Ganey

A

Private for profit organization that polls health care consumers to assess quality of care including HCAHPS in the survey

Not all hospitals can afford them

81
Q

What is the nursing role to improve care for patient populations

A

read widely and critically

attend professional conferences

insist on evidence that a procedure is effective

become involved in a journal club

pursue and participate in EBP projects

ASSUME A STANCE OF SKEPTICISM

82
Q

What are some barriers to EBP

A
  1. Research Related Barriers (ex: Scarcity of published replications)
  2. Nurse Related Barriers (ex: insuff skills in locating and appraising evidence, no love for research)
  3. Organizational Barriers (ex: lack of financial support and staff release time for EBP, or funding)
83
Q

What sort of ways are Nurse Related Barriers to EBP

A

lack of knowledge

information overload

lack of role models

lack of time or money

resistance to change

misperception that you need an advanced degree to read and understand research

disinterest when there is bedside care to be done

84
Q

What are some ways/people that facilitate EBP

A

support from leaders and peers

adequate time to do so

resources

journal clubs and EBP rounds

85
Q

What is often required in order to address barriers and facilitate the implementation of EBP

A

DETERMINED EFFORT

86
Q

The End never justifies

A

the means

87
Q

What are some historical background examples of ethical misconduct

A

jenner and smallpox

nazi medical experiments

Tuskegee syphilis study

willowbrook study

jewish chronic disease hospital study

88
Q

There is no such thing as what for research?

A

implied consent

89
Q

Nazi Medical Experiments

A

German Nazi Physicians tortured under the guise of testing limits of human endurance and tolerance

No attempt to relieve pain, high mortality rates, no informed consent

90
Q

Many guidelines of ethics come from a hindsight view of…

A

what occurred in WWII

91
Q

Tuskegee Syphilis Study

A

30s-70s

USPHS, CDC recruited 400 AA male sharecroppers for a syphilis experiment - one group with and one without

Withheld Penicilin treatment once available, risk outweighed benefits, forced infection, no autonomy respected, coercive rewards, taken advantage of by own gov’t

92
Q

Willowbrook School

A

50s-72

Parents coerced to sign consent for mentally disabled children to be infected with Hep B and study inoculation of IM v PO in order to get them into a state school institution

350 children - some received gamma globulin treatment while others didnt, purposefully infected, unable to give informed consent, coercive

Ripple effect led to institutionalization –> community care in NYS

93
Q

Jewish Chronic Disease Hospital

A

60s

Oncology pts injected with their own cancerous cells while pts and physicians were unaware

Investigator wanted to know rejection response, no informed consent documented and claimed to have verbal consent

no evidence of IRB

Scientific misconduct, fraud, deceit

94
Q

2001 Johns Hopkins Research Problem

A

24 yo healthy female died 1 mo after experimental treatment to induce asthma symptoms

Inadequate Review of Literature occurred - did not review and include how hexamethonium can sometimes cause adverse effects in informed consent sheet

95
Q

19 yo Pre Med Student Problem

A

died within hours of getting bronchoscopy with 4x the amount of lidocaine

received 150$ - coercive reward

96
Q

Why is compensation balance important in research?

A

there needs to be enough to compensate but not enough to be seen as coercive

97
Q

Code of Ethics History

A

Nuremberg Code - Response to Nazi Atrocities

Declaration of Helsinki

1978 - BELMONT REPORT

1995 - ANA Ethical Guide in Nursing Research

2012 - ICN Code of Ethics for Nurses

2015 - ANA Declares Year of Ethics and Revised Code

98
Q

Ethical Dilemma

A

a situation in research in which the rights of study participants are in direct conflict with requirements of a study

99
Q

Examples of Ethical Dilemmas

A

Does a new medication prolong life in pts with AIDS?

Are nurses equally empathetic in their treatment of male and female pts in the ICU?

100
Q

What are the Ethical Principles Outlined in the Belmont Report

A

Beneficence

Respect for Human Dignity

Justice

101
Q

Beneficence

A

Imposes a duty on researchers to minimize harm and maximize benefits

Above all, do no harm

102
Q

Respect for Human Dignity

A

includes the right to self determination and the right to full disclosure

103
Q

Justice

A

Includes participant’s right to fair treatment and their right to privacy

104
Q

Beneficence includes what factors

A
  1. Right to freedom from harm and discomfort / minimize harm; maximize benefits
  2. Right to protection from exploitation - participants should not be at a disadvantage and the special relationship should not be exploited
105
Q

Principle of Respect for Human Dignity includes what factors

A
  1. Right to self determination (absence of coercion)
  2. Right to Full disclosure (absence of deception or concealment)
106
Q

Right to Self Determination

A

you decide voluntarily to participate without risking prejudicial treatment and you have the right to ask questions, refuse to answer questions, and drop out

107
Q

Right to Full Disclosure

A

receiving a description of the study, the persons right to refuse participation, and potential risks and benefits

108
Q

Principle of Justice includes what factors

A
  1. right to fair treatment
  2. right to privacy
109
Q

Right to Fair Treatment

A

Concerns the equitable distribution of benefits and burdens of research

110
Q

Right to Privacy

A

confidentiality and anonymity

ensures that research is not more intrusive than it needs to be and that privacy is maintained

111
Q

Procedures for Protecting Study Participants

A

Risk Benefit Assessments

Informed Consent

Confidentiality Procedures

Debriefings and Referrals

Treatment of Vulnerable Groups - Children, Disabled, Terminally Ill, Institutionalized, Pregnant

External reviews and the protection of human rights

Ethical issues in using animals in research

112
Q

Informed Consetn

A

means participants have adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily

113
Q

With informed consent participants…

A
  1. have adequate info about the research
  2. can comprehend the info
  3. have free choice to participate in or withdraw from the study
114
Q

Researchers usually document informed consent via a …

A

signed consent form

115
Q

Implied Consent

A

e.g. consent form for self administered questionnaires

116
Q

Process Consent

A

Renegotiated over time - used in qualitative studies

117
Q

Confidentiality Procedures involve what things

A

Anonymity

Confidentiality in the Absence of Anonymity

Certificate of Confidentiality (NIH)

118
Q

Anonymity

A

researchers cannot link participants to their data

119
Q

Confidentiality in the Absence of Anonymity

A

other confidentiality procedures will need to be implemented - taking steps to ensure breach of confidentiality does no occur

120
Q

Certificate of Confidentiality (NIH)

A

a certificate obtained to prevent forced disclosure of confidential information to authorities

121
Q

How do Debriefings and Referrals work for Research

A

Debriefings can be held following data collection so participants can ask questions or share concerns

Researchers can demonstrate interest in participants by offering to share study findings with them after data is analyzed

Also, researchers may assist participants by making referrals to appropriate health, social, or psychological services

122
Q

Vulnerable Subjects

A

study participants that require special protections since they may be incapable of giving fully informed consent, may be high risk for unintended side effects, or are children who cannot make a truly informed decision about voluntary participation

123
Q

Ethical aspects of a study are increasingly likely to have what happen before a study can be conducted

A

they will need to be reviewed and given permission by an external review for protection of human rights

ex: human subjects committees, IRBs, research ethics boards

124
Q

Tell whether the following statement is True or False.

The Nuremberg Code was one of the first established sets of ethical standards.

A

True

Rationale: One of the first international efforts to establish ethical standards was the Nuremberg Code. These ethical standards were developed in 1949 in response to the Nazi atrocities.

125
Q

The principle of justice ensures a research subject’s right to:

A - Self-determination
B - Full disclosure
C - Protection from harm
D - Privacy

A

D -Privacy

Rationale: The principle of justice ensures a research subject’s right to privacy and fair treatment. The right to self-determination and the right to full disclosure are ensured by the principle of respect for human dignity. The right to protection from harm is ensured by the principle of beneficence.

126
Q

Tell whether the following statement is True or False.

Children require special protection when they are involved in a research study.

A

True

Rationale: Children, because of their inability to make a truly informed decision about voluntary participation in a research study, are considered vulnerable and thus require special protection.

127
Q

Belmont Report created what and why was it created?

A

It was created due to the national research act of 1964

it made the 3 principles of ethical conduct - Justice, beneficence, and Autonomy

128
Q

Ethical Dilemma

A

When rights of participants are in dilemma with the requirements of the study

129
Q

What is one key factor between caring for patients medically and conducting research?

A

It is implied consent in medicine - we care assuming they want care unless otherwise told

Research needs consent

130
Q

Respect for Human Dignity

A

Autonomy

131
Q

Above all, Do no harm

A

Beneficence

132
Q

Minimal Risk

A

Idea and Concept that people won’t be exposed to more risk than what they are exposed to over their daily lives

133
Q

Random Sampling allows for the principle of ____

A

justice

134
Q

Informed Consent can be ___ if an ADR occurs and is made known

A

updated

135
Q

If you treat a vulnerable population, the research as a whole must…

A

provide benefit for that group (like if its children, benefit the children or that group of children)

136
Q

For participants, how should information be provided for informed consent

A

no longer than 2 syllable words and at a 5th grade reading level

137
Q

___ does not require people continue to participate

A

signature (in informed consent)

138
Q

Implied Consent

A

if no ID information is gained, they may have no blatant informed consent signing

139
Q

Process Consent

A

consent changing over time - updating based on things

UNIQUE TO QUALITATIVE RESEARCH

Renegotiate to have them maybe join another study after (qual)

140
Q

A good way to keep anonymity?

A

do not gather identifiable information that can link back to the person

Not possble in all cases of research

141
Q

Can only bacouot in of informed consent when…

A

Can use if the person is at hihg risk plsu we ca ll hteen

N360: Socialization II (13 decks)

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