Responses: Efficacy Vs. Effectiveness

Discussion Post #1
I 100% agree with you that a difference exists between research, QI or quality
improvement, and perhaps you forgot to mention evidence-based practice (EBP). “Research”
entails investigating a subject to gain understanding and knowledge; it involves collecting and
analyzing data and coining research questions and hypotheses or theories, and testing them. QI
focuses on identifying analyzing, and bolstering or improving processes or systems to determine
and enhance their effectiveness and efficiency (Crystal, 2022). EBP is a decision-making process
that uses the best available, objective evidence. Michael’s case is a QI initiative aiming to
establish the efficacy and effectiveness of diabetes medication. Good work!
References
Crystal, G. (2022). Evidence-based practice, quality improvement, and research: A visual model.
Nursing, 52(11), 47-49. doi: 10.1097/01.NURSE.0000889812.89287.45

Discussion Post #2
You are absolutely right that starting a patient on a new medication, especially one whose
efficacy and effectiveness are questionable, such as the diabetes drug Michael is planning to use,
often raises multiple ethical questions, including harm vs. benefit and beneficence vs. autonomy.
The question of autonomy, which is often linked to informed consent, is integral because it
grants patients the right to make “own” decisions about their health (Manti & Licari, 2018).
Therefore, one flaw in Michael’s approach is the failure to seek informed consent from his
patients; he should have communicated earlier the change of plans before emailing them. One

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key takeaway from your discussion is the need for Michael to apply an EBQI to establish the
effectiveness and efficacy of the medications. Great discussion!
References
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2),
145-152. doi: 10.1183/20734735.001918

Discussion Post #3
Your post is exceptional! One thing that stands out though, which everyone else failed to
point out, is differentiating between efficacy and effectiveness, especially why Michael needs the
two before administering the diabetes drug to the patients. Efficacy trials are performed to test
the performance of a new drug or intervention in a controlled or ideal setup, while effectiveness
trials are conducted to test a drug’s performance in the “real world” (Smith, Morrow, & Ross,
2015). You also did pretty well in highlighting the potential ethical issues that might arise: some
patients might not have the knowledge and gadgets/network to access the letter from the mail,
others might be hesitant to use the new drug, and the drug might be expensive, among others.
These are all genuine issues that might influence the new drug’s uptake.
References
Smith, P. G., Morrow, H. R., & Ross, D. A. (2015). Field trials of health interventions: A
toolbox. Oxford University Press.

Discussion Post #4
I honestly feel you have raised critical concerns that can cause serious ethical issues and
adversely impact this project’s implementation. For example, emailing patients about the
program and medication changes is a primary implementational barrier because not everyone has

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access to email, the internet, and smartphones or laptops. Additionally, not everyone has the
knowledge and skills to effectively and meaningfully use the internet or access email. Failure by
other patients to see these medication and program changes can put their health at risk and raise
questions about the patient’s right to accurate information and provide informed consent. As a
DNP-prepared nurse, the nursing practice requires Michael to observe all ethical principles –
beneficence, nonmaleficence, autonomy, and justice – when researching on or implementing QI
and EBP projects involving human subjects (Manti & Licari, 2018). Overall, I like your plan
about the elements Michael could tweak to improve the chances of his QI project succeeding.
Great work!
References
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2),
145-152. doi: 10.1183/20734735.001918