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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
Copyright © 2015 Wolters Kluwer • All Rights Reserved
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 ?
Copyright © 2015 Wolters Kluwer • All Rights Reserved
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
Copyright © 2015 Wolters Kluwer • All Rights Reserved
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.
Copyright © 2015 Wolters Kluwer • All Rights Reserved
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.
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Melnyk ppt chapter_22

  • 1. 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
  • 2. 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
  • 3. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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 ?
  • 4. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 5. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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.
  • 6. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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.
  • 7. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 8. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 9. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 10. Copyright © 2015 Wolters Kluwer • All Rights Reserved Differentiating Between Research and 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
  • 11. Copyright © 2015 Wolters Kluwer • All Rights Reserved Differentiating Between Research and 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
  • 12. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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?
  • 13. Copyright © 2015 Wolters Kluwer • All Rights Reserved Differentiating Among Research, EBQI, and Evidence-Based Clinical Practice
  • 14. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 15. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 16. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 17. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 18. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 19. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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.
  • 20. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 21. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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
  • 22. Copyright © 2015 Wolters Kluwer • All Rights Reserved 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.