Melnyk ppt chapter_22

Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
Chapter 22
Ethical Considerations for
Evidence Implementation and
Evidence Generation
Chapter 22
Ethical Considerations for
Evidence Implementation and
Evidence Generation

Copyright © 2015 Wolters Kluwer • All Rights Reserved
Ethical Principles That Guide Healthcare
Practice
•
Beneficence: Captures the importance of doing good for
patients
•
Nonmaleficence: Addresses the importance of not
harming patients
•
Autonomy: Acknowledges that patients have the right to
make decisions about their health, lives, and bodies
•
Justice: Declares that resources should be distributed
fairly among people and without prejudice

Core Ethical Principles as the Foundation
for the IOM’s Core Dimensions of Quality
IOM Quality Dimension Core Ethical Principles
Safety ?
Effectiveness ?
Patient-centeredness ?
Timeliness ?
Equity ?
Efficiency ?

Core Ethical Principles as the Foundation
for the IOM’s Core Dimensions of
Quality—(cont.)
IOM Quality
Dimension
Core Ethical
Principles
Safety Nonmaleficence
Effectiveness Beneficence
Patient-centeredness Autonomy
Timeliness Beneficence
Nonmaleficence
Equity Justice
Efficiency Beneficence
Nonmaleficence

Question
Is the following statement true or false?
There is a lack of agreement regarding the question of
whether ethical principles need to be applied to
evidence-based quality improvement initiatives.

Answer
False
Rationale: It is broadly agreed that ethical principles are an
important consideration in the application of EBP and in
EBQI initiatives. The real debate is whether all of the
requirements that are placed on clinical research also need
to be applied to EBQI initiatives.

Ethical Conflict and Evidence-Based
Quality Improvement (EBQI) Initiatives
Examples of when EBQI initiatives can conflict with ethical
principles:
•
Attempts to improve quality for some patients that
may cause harm for others
•
Strategies intended to improve quality that may turn
out to be ineffective and waste scarce resources
•
Activities declared to be quality improvement that
may be more accurately described as clinical
research

Differentiating Between Research and
EBQI: Definitions
Definitions
•
Clinical research: Activities involving direct interaction
by investigators with human subjects or material of
human origin; generates knowledge on which practice
should be based
•
Evidence-based quality improvement (EBQI)
initiatives: Systematic, evidence-based activities
designed to immediately improve healthcare delivery
in specific settings

EBQI—(cont.)
Similarities
•
Both involve human participants
•
Both may use similar data collection procedures to
evaluate outcomes (e.g., surveys and physiological
measurements)
•
Both may use the same data analysis methods to
manage and process data

EBQI—(cont.)
Differences
Research EBP/EBQI
Patient participation viewed
as an optional activity
All patients receive the same
evidence-based intervention
as part of routine care
Aim is to generalize findings
to a population wider than
the research subjects
Aim is to improve care of
patients in a specific
organization/setting
Aim is to disseminate
findings for use outside of
the organization
Aim is to provide internal
data to practitioners to guide
further practice changes

EBQI—(cont.)
Ethical implications
•
If efforts are not made to improve quality through
EBQI, principles of beneficence and nonmaleficence
may be violated
•
If EBQI does not offer the same treatment strategies
to all patients, then the principle of justice and
autonomy may be violated, especially if patient
consent is not obtained

Current Controversies in Human Subject
Protection Related to EBQI
•
Should EBQIs require the same standards of patient
consent as clinical research?
•
Is it ethical to implement EBP in one setting while
continuing with traditional (and possibly substandard)
practice in another?
•
Should informed consent be obtained from the patients
receiving traditional care?

Differentiating Among Research, EBQI,
and Evidence-Based Clinical Practice

Differentiating Among Research, EBQI,
and Evidence-Based Clinical Practice—
(cont.)
•
Research is not an integral part of routine clinical practice
o
In contrast, EBQI is an integral part of the ongoing
management of clinical care delivery (EBP)
•
Research often carries risks for patients
o
Risks with EBQI activities are usually very low;
sometimes the risks may be greater if the EBQI
activities are not implemented
•
Generally, research is focused on generating evidence for
practice, whereas EBQI is focused on implementing
evidence in practice

Ethical Principles as Applied to Research,
EBP, and EBQI
•
Social or scientific value: For research, EBP, or EBQI to
be ethical, it should be worth doing
•
Scientific validity: Research projects must be
methodologically sound enough to ensure valid and
generalizable findings; poorly designed or implemented
EBP or EBQI projects waste resources and the time of
those involved

EBP, and EBQI—(cont.)
•
Fair subject selection: Inclusion and exclusion criteria for
recruiting study participants should be based on scientific
rationale, not convenience or vulnerability; patients
involved in an EBP or EBQI project should be determined
by the population of patients served by the organization
rather than the ability to generalize outcome findings
•
Favorable risk–benefit ratio: Research, EBP, and EBQI
should be committed to minimizing the risks and
maximizing the gains of all studies and projects

EBP, and EBQI—(cont.)
•
Independent review: Independent review of research is
ethically required because of potential conflicts of interest
and resultant human rights violations
•
Respect for potential and enrolled subjects: The well-
being of the individual research subject takes precedence
over all other interests; refusal of EBP treatment is
always the patient’s right
•
Informed consent: Informed consent, whether for
research participation or for treatment, is a foundational
component of clinical and research ethics

Question
The nurses on a nephrology unit wish to implement an
evidence-based change in the assessment and
management of patients’ arteriovenous fistulas. Which of
the following should perform the first (and possibly only)
review for the ethical considerations of this change?
a.The hospital’s ethics review board
b.The state board of nursing’s ethics committee
c.Expert nurses on the unit
d.The leadership and management of the unit

Answer
d. The leadership and management of the unit
Rationale: The first review should be performed by the unit
management and supervisors to critically examine the
strength of the evidence on which the change is based to
assure the project’s scientific value and validity and to
assure that the risk–benefit ratio is appropriately low. The
review also assures that resources are available and are
fairly distributed.

A Final Dilemma…
•
The ethical commitment to care for and do good for
patients (beneficence), coupled with an avoidance of
harm (nonmaleficence), implies a commitment to
improve clinical practice whenever possible
•
Professionals and organizations have an ethical
responsibility to conduct these types of projects to
demonstrate whether evidence-based changes
demonstrate sustainable improvement in outcomes
•
This commitment places a responsibility on patients to
participate in EBQI initiatives

Question
Controversy about ethical principles as applied to EBQI
versus clinical research is seen most clearly in which of the
following domains of ethics?
a.Scientific validity
b.Social or scientific value
c.Fair subject selection
d.Independent review

Answer
d. Independent review
Rationale: There is significant controversy surrounding the
question of the need for independent ethical review for
EBQI, with many experts citing a different standard for
clinical research than evidence-based practice changes. It
is generally agreed that questions of scientific validity,
social or scientific value, and fair subject selection should
be applied in similar degree to both; however, the need to
have EBP initiatives brought before an ethical review
committee is still equivocal.

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