Week 3 - Ethics in Research and EBP Flashcards
What is research
It is a systematic inquiry that uses orderly methods to answer a question or solve a problem.
What is nursing research
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
What are the scopes of nursing research
scientific approach
applied approach
What are the classifications of nursing research
quantitative research
qualitative research
Scientific Approach
has to do with building the science of the profession of nursing (starts with something like bench research to clinical trials)
Applied Approach
How the information/science is put into practice/populations
What are the 3 interrelated concepts in nursing research which aim to ID, utilize, and apply scientific knowledge from research to clinical practice
- Research Utilization
- Knowledge Translation
- EBP
Research utilization
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
Knowledge Translation
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
EBP
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
How does Research Utilization flow into Knowledge Translation? How does knowledge translation then flow into EBP
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
___ causes nursing to move from vocation to profession
EBP
Hx of Research Utilization in Nursing Practice
- 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
- 80s: CURN Project: Sought to bridge the K-P gap and the Conduct and Utilization of Research in Nursing Project created Research Utilization
- 90s: EBP began to supercede RU
Archie Cochrane and the Cochrane Collaborative
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
David Sackett
Developed Evidence Based Medicine which brought in the use of best evidence for all health providers
Would lead to EB Nursing Practice
What exactly is EBP
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
What sets EBP apart from best evidence use
PATIENT PREFERENCE incorporation
What things does EBP integrate
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
Almost all EBP uses ___ research
quantitative
Best Evidence of EBP comes from …
the findings of quantitative research studies
Clinical Expertise in EBP can include experience and what other things?
Expert Panels
Consensus Statements
Practice Groups
Practitioner Experience
Patient Preferences in EBP include what things
Satisfaction
QOL
Treatment Burden (Is it worth getting treatment for low QOL?)
Qualitative Studies
While most EBP and best evidence comes from quantitative evidence, what can qualitative evidence do?
show us patient preferences and patient experience
Models of the EBP Process
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)
What are some resources for EBP in nursing
models of the EBP process
preprocessed and pre appraised evidence
What is included under the term pre processed and pre appraised evidence
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
The 5 Major Steps (As) of EBP
- Ask
- Acquire
- Appraise
- Apply
- Assess
What is step 0 of EBP
0 - Cultivating the Sense of Inquiry
In Organizational settings, EBP must begin by selecting a problem or topic in one of two ways. What are the 2 possible triggers
Knowledge Focused Triggers
Problem Focused Triggers
Knowledge Focused Triggers
Begins with an innovation or research finding (eg: might emerge in a journal club) / something that catches your eye and you look into it
Problem Focused Triggers
Begins with a perplexing or troubling clinical situation
ex: Why are nurses passing out more than they should
Step 1: Ask
Ask: Ask a well-worded clinical question that can be answered with research evidence.
Step 2: Acquire
Search for and retrieve the best evidence to answer the clinical question.
Step 3: Appraise
Critically appraise the evidence for validity and applicability to the problem and situation.
Step 4: Apply
After integrating the evidence with clinical expertise, patient preferences, and local context, apply it to clinical practice.
Step 5: Assess
Evaluate the outcome of the practice change.
When doing step 1: Ask of EBP, what framework is used
PICO - the framework for asking the question
PICO(T) Question
Patient population
Intervention or issue of interest
Comparison intervention or group **
Outcome
Time frame**
** not always specified
What are compared to each other, what is the control, and what is the DV in PICOT
I and C are compared
C would be the control
O is the DV
When asking the question regarding qualitative research what components are looked at
population
situation (processes, exp, cultures, hx, condition of interest)
Ethno, Grounded, Phenom. Key Words
Ethno - Culture
Grounded - Process
Phenom - Experience
Question templates
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)
After Step 1: Ask, what comes next
Step 2: Acquire research evidence
Can use PICOT as keywords to search the database
find research
What are some databases for Step 2: Acquire of EBP
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
Step 3: Appraise the evidence involves what factors
Quality
Magnitude
Quantity
Consistency
Applicability
Level of Evidence
Quality (Step 3)
to what extent is the evidence valid- how serious is the risk of biases in this research?
Magnitude (Step 3)
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
Quantity (Step 3)
How much evidence is there? How many studies have been conducted, and did those studies involve a large number of participants?
Consistency (Step 3)
How consistent are the findings across various studies?
We want to see consistent agreement across studies
Applicability (Step 3)
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
The key question during Step 3: Appraise is?
Applicability of research
Level of Evidence
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
Evidence Level 1
Systematic Review of RCTs and nonrandomized trials / Reviews of Literature and Studies
Quantitative evidence
Considered the highest level/ best level
Evidence Level 2
Experimental Controlled Trials or Quasi Experimental Studies - Quantitative evidence
Evidence Level 3
Systematic Reviews of NON experimental studies - still quantitative evidence
Evidence Level 4
Individual Correlational Observational Studies
Still quantitative
Evidence Level 5
Systematic Review of Qualitative Studies (which is hard to do since they are not made to be reviewed like that)
Evidence Level 6
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
Evidence Level 7
Opinions of Authorities and Expert Committees
Highly susceptible to group think and outside pressure
High evidence level does not necessarily mean…
high quality research (needs systematic critique)
Levels of Evidence is not necessarily synonymous with
hierarchy of evidence
Grading the strength of a body of evidence addresses what 3 domains
quality (individual studies look more to this)
quantity
consistency (lit reviews look more at this)
Quality
the extent to which a study’s design, conduct, and analysis has minimized selection, measurement, and confounding biases (internal validity)
Quantity
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
Consistency
whether investigations with both similar and different study designs report similar findings (requires numerous studies)
Step 4: Apply the evidence, involves doing what
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
Step 4 is the __ step
implementation
What things must be considered when doing Step 4: Apply
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
EBP Model purposes
to help implement (step 4) evidence into practice
Stetler Model of RU
EBP Model
promotes EBP
IOWA Model of EBP
promotes quality care in practice
What do you ask during Step 5: Assess the outcomes of practice change?
Did you achieve the desired outcomes and make a change?
If so, were the patients satisfied with the results?
Were there barriers or issues?
What is the implicit Step 6 of EBP?
Step 6: Disseminate Outcomes of the EBP Decision or Change
Why is Step 6: Dissemination so important
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
What is the problem with Step 6: Dissemination
Diffusion of Innovation and Early adapters v Laggards
What is the problem with Diffusion of Innovation
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
Nursing Research Knowledge to Practice gap is about ___ years
17
What is another method of quality measurement used in hospitals?
HCAHPS and Press Ganey
HCAHPS
“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
Press Ganey
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
What is the nursing role to improve care for patient populations
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
What are some barriers to EBP
- Research Related Barriers (ex: Scarcity of published replications)
- Nurse Related Barriers (ex: insuff skills in locating and appraising evidence, no love for research)
- Organizational Barriers (ex: lack of financial support and staff release time for EBP, or funding)
What sort of ways are Nurse Related Barriers to EBP
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
What are some ways/people that facilitate EBP
support from leaders and peers
adequate time to do so
resources
journal clubs and EBP rounds
What is often required in order to address barriers and facilitate the implementation of EBP
DETERMINED EFFORT
The End never justifies
the means
What are some historical background examples of ethical misconduct
jenner and smallpox
nazi medical experiments
Tuskegee syphilis study
willowbrook study
jewish chronic disease hospital study
There is no such thing as what for research?
implied consent
Nazi Medical Experiments
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
Many guidelines of ethics come from a hindsight view of…
what occurred in WWII
Tuskegee Syphilis Study
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
Willowbrook School
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
Jewish Chronic Disease Hospital
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
2001 Johns Hopkins Research Problem
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
19 yo Pre Med Student Problem
died within hours of getting bronchoscopy with 4x the amount of lidocaine
received 150$ - coercive reward
Why is compensation balance important in research?
there needs to be enough to compensate but not enough to be seen as coercive
Code of Ethics History
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
Ethical Dilemma
a situation in research in which the rights of study participants are in direct conflict with requirements of a study
Examples of Ethical Dilemmas
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?
What are the Ethical Principles Outlined in the Belmont Report
Beneficence
Respect for Human Dignity
Justice
Beneficence
Imposes a duty on researchers to minimize harm and maximize benefits
Above all, do no harm
Respect for Human Dignity
includes the right to self determination and the right to full disclosure
Justice
Includes participant’s right to fair treatment and their right to privacy
Beneficence includes what factors
- Right to freedom from harm and discomfort / minimize harm; maximize benefits
- Right to protection from exploitation - participants should not be at a disadvantage and the special relationship should not be exploited
Principle of Respect for Human Dignity includes what factors
- Right to self determination (absence of coercion)
2. Right to Full disclosure (absence of deception or concealment)
Right to Self Determination
you decide voluntarily to participate without risking prejudicial treatment and you have the right to ask questions, refuse to answer questions, and drop out
Right to Full Disclosure
receiving a description of the study, the persons right to refuse participation, and potential risks and benefits
Principle of Justice includes what factors
- right to fair treatment
2. right to privacy
Right to Fair Treatment
Concerns the equitable distribution of benefits and burdens of research
Right to Privacy
confidentiality and anonymity
ensures that research is not more intrusive than it needs to be and that privacy is maintained
Procedures for Protecting Study Participants
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
Informed Consetn
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
With informed consent participants…
- have adequate info about the research
- can comprehend the info
- have free choice to participate in or withdraw from the study
Researchers usually document informed consent via a …
signed consent form
Implied Consent
e.g. consent form for self administered questionnaires
Process Consent
Renegotiated over time - used in qualitative studies
Confidentiality Procedures involve what things
Anonymity
Confidentiality in the Absence of Anonymity
Certificate of Confidentiality (NIH)
Anonymity
researchers cannot link participants to their data
Confidentiality in the Absence of Anonymity
other confidentiality procedures will need to be implemented - taking steps to ensure breach of confidentiality does no occur
Certificate of Confidentiality (NIH)
a certificate obtained to prevent forced disclosure of confidential information to authorities
How do Debriefings and Referrals work for Research
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
Vulnerable Subjects
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
Ethical aspects of a study are increasingly likely to have what happen before a study can be conducted
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
Tell whether the following statement is True or False.
The Nuremberg Code was one of the first established sets of ethical standards.
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.
The principle of justice ensures a research subject’s right to:
A - Self-determination
B - Full disclosure
C - Protection from harm
D - Privacy
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.
Tell whether the following statement is True or False.
Children require special protection when they are involved in a research study.
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.
Belmont Report created what and why was it created?
It was created due to the national research act of 1964
it made the 3 principles of ethical conduct - Justice, beneficence, and Autonomy
Ethical Dilemma
When rights of participants are in dilemma with the requirements of the study
What is one key factor between caring for patients medically and conducting research?
It is implied consent in medicine - we care assuming they want care unless otherwise told
Research needs consent
Respect for Human Dignity
Autonomy
Above all, Do no harm
Beneficence
Minimal Risk
Idea and Concept that people won’t be exposed to more risk than what they are exposed to over their daily lives
Random Sampling allows for the principle of ____
justice
Informed Consent can be ___ if an ADR occurs and is made known
updated
If you treat a vulnerable population, the research as a whole must…
provide benefit for that group (like if its children, benefit the children or that group of children)
For participants, how should information be provided for informed consent
no longer than 2 syllable words and at a 5th grade reading level
___ does not require people continue to participate
signature (in informed consent)
Implied Consent
if no ID information is gained, they may have no blatant informed consent signing
Process Consent
consent changing over time - updating based on things
UNIQUE TO QUALITATIVE RESEARCH
Renegotiate to have them maybe join another study after (qual)
A good way to keep anonymity?
do not gather identifiable information that can link back to the person
Not possble in all cases of research
Can only bacouot in of informed consent when…
Can use if the person is at hihg risk plsu we ca ll hteen
