melnyk ppt chapter_22

Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins

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 PrinciplesSafety ? 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 NonmaleficenceEffectiveness BeneficencePatient-centeredness AutonomyTimeliness Beneficence

NonmaleficenceEquity JusticeEfficiency 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 toevidence-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


Differentiating Between Research and 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



DifferencesResearch 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



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 patientso 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


Ethical Principles as Applied to Research, 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


Ethical Principles as Applied to Research, 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 boardb.The state board of nursing’s ethics committeec.Expert nurses on the unitd.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 validityb.Social or scientific valuec.Fair subject selectiond.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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