Ethical Considerations and EBP/ Is informed consent necessary within EQBI
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No
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Is informed consent necessary within EBQI?
EBP and EBQI should be mandated to have the same regulatory and ethical requirements as a research project within an institution. EBP/EBQI and research both involve human subjects, use the same data collection procedures and the same data analysis methods to process data. To have individuals argue the point that they are very different, and one would require consent and the other does not is unethical. Having research optional for patients and then allowing EBP/EBQI contain all patients involved in an intervention is not giving patients a chance to deny or agree to the care they would be receiving. While we understand that EBP/EBQI is systematic, evidence based activity designed to immediately improve health care delivery in specific settings there is no reason that we cannot offer these patients informed consent. The principles of justice and autonomy are being violated if the patient’s consent is not obtained There is an ethical commitment that health care workers have for their patients, they are to do good (beneficence) and in conjunction do no harm (nonmaleficence) Even though risks with EBQI are usually very low there are still risks involved and patients should be informed. EBP/EBQI focuses implementing evidence in practice so why not step back and take a little extra time to make sure everyone is informed. Informed consent weather for research participation of for treatment, is a foundational component of clinical and research ethics. Research: Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare (3rd Ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Side: Yes
My argument is to support the need for informed consent in some circumstances in which significant risk to the patient may be incurred. There are reasonable and legitimate exceptions. "In emergency settings, for example, it is even considered ethical to include patients in a randomized trial of an experimental treatment without consent, provided that appropriate safeguards are implemented" (Miller & Emanuel, 2008). However, a pillar of research and medicine is patient autonomy. This concept is deeply rooted in American culture if we examine fields outside of medicine such as gun control, democracy, and religion. "Researchers must provide information regarding the risks and benefits of participation and help people understand this information' (Melnyk & Fineout-Overholt, 2015) so each individual can weigh the options and elect based on their knowledge and values.
Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare (3rd Ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Miller, F., & Emanuel, E. (2008). Quality-Improvement Research and Informed Consent. The New England Journal of Medicine, 358(8), 765-767. Side: Yes
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Your argument about EBP and the health care worker having ethical obligations to do right by their patients is noted, but aren't EBP interventions and any subsequent quality initiatives that come from them the right thing to do for them? Technically, when a patient comes to the ED willingly and of their own accord and volition, their actions constitute implied consent. If we are to agree as health care providers that a patient's presence constitutes implied consent, then we should also agree that they consent to us performing needed medical assessments and interventions to keep them safe and to prevent any subsequent harm? Is this not the definition of beneficence and nonmaleficence? Side: No
Hi Sueann, I understand your point of view, but I do believe there needs to be a middle ground with the consent and transparency of policies and procedures. With the changing models of patient-organization, hospitals should take this opportunity to revise and revamp how informed consent is presented to patients. As suggested by Campbell & Parsi (2017), hospitals should try to employ a non-traditional approach to a traditional concept by expanding how information is delivered to patients. For example, while EBP and EBQI may not need to be regulated by informed consent, it should be explained to patients the there are specific practices and procedures that are being implemented into their daily care and can be used later for further improvement. As I had stated, while I do not feel there is a need for informed consent for EBQI, I do feel there is a need for transparency. Campbell, K., & Parsi, K. (2017). A New Age of Patient Transparency: An Organizational Framework for Informed Consent. Journal Of Law, Medicine & Ethics, 45(1), 60-65. doi:10.1177/1073110517703100 Side: No
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Yes. Informed consent should be mandated for EBQI. Individuals have the right to decide what happened to their body and their health under the ethical principle of autonomy. Research is viewed as voluntary therefore, individuals should have the right to decide if they would like to participate once they are provided with if all pertain risks and benefits of participating (Melynk & Fineout-Overholt, 2015). Informed consent for EBQI is utilized “to protect patients, both from harm and from was they might not be respected as persons” (Melynk & Fineout-Overholt, 2015, pg. 526). Informed consent about EBQI is important in addition to informed consent to care for the patients because when a patient seeks medical care they do not think they will be part of a study. This is why it is important to obtain informed consent for EBQI in addition to informed consent for care. Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-Based Practice in Nursing & Healthcare (3rd ed.). Philadelphia, PA: Lippincott, Williams & Wilkins. Side: Yes
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Lindsey, I see your point regarding consent needing to be obtained when the patient is part of a study, but I think I disagree with the assertion that EBQI's are all in the form of research studies that need additional consent. In some instances, EBQI's are obtained through the review of a patient's data from previous care that brings no harm or additional intervention to a patient. In this case, why should informed consent be obtained? Most often, informed consent is obtained when a patient is to undergo a specific intervention or to be included as part of a research study. In these instances, the risks and benefits of receiving or not receiving these interventions are discussed and the patient is given the ability to decide for themselves whether or not they choose to participate. With EBQI's, no additional interventions may be needed, making informed consent unnecessary. Side: No
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I also see your point when you are describing the difference between research and using patient's data for EBQI. However, the issue of not receiving informed consent comes into play with publishing the data that was found. For example "the intent or actual fact of publication in peer-reviewed journals as the major defining characteristics of research, so that any quality improvement activity that included either the intent to publish or actual fact of publication at some later point should be subject to ethics committee review and perhaps requirements for written informed consent by participants" (Nerenz, 2009). So with that being said, wouldn't it be better to just have the informed consent signed prior to collecting the data in case it would be used in some time of publication? Reference: Nerenz, D R. "Ethical issues in using data from quality management programs." European Spine Journal, vol. 18, no. 3, 2009, pp. 321-30, https://www.ncbi.nlm.nih.gov/pmc/ Side: Yes
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Is informed consent necessary for EBQI? No. There is excessive focus on the distinction between research, which has a set of regulatory conventions, and quality improvement (QI), which does not. This misdirection arises because the boundaries between research and QI create confusion, which may grow along with the pragmatic research of “learning health systems” in which every patient encounter offers the opportunity to treat the next patient better. All activity aims to generate reusable knowledge, the important distinction is not whether an activity is research, but whether it risks harming people or their rights. The Institutional Review Board (IRB) has not made a ruling on the inconsistencies of informed consent on EBQI, as the focus of quality improvement is not human testing but evaluating whether or not there was improvement. It is a reassessment of an intervention which is the last step of the nursing process - evaluation. Reference: Asch, D. A., Ziolek, T. A., & Mehta, S. J. (2017). Misdirections in Informed Consent - Impediments to Health Care Innovation. New England Journal Of Medicine, 377(15), 1412-1414. doi:10.1056/NEJMp1707991 Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare (3rd Ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Side: No
I am arguing the fact that there does not need to be informed consent for EBQI projects. EBQI is systematic and guided by data collected through QI activities that are meant to build on patient safety, outcomes, and satisfaction. Patients admitted to the hospital, they give consent for treatment, and I believe this permission covers any QI projects that patients may be involved in during their length of stay. QI projects focus on solving clinical problems, which is beneficial to clinical outcomes. QI is performed by clinicians, collecting data that can improve patient care and is not as invasive as clinical research, where an individual enrolled in a clinical trial (Melnyk & Fineout-Overholt, 2015). When a patient enters into a clinical trial, where there needs to be patient involvement, such as taking new medications or having blood work done, there needs to be informed consent. It is on the contrary with EBQI; it could be unethical to withhold treatments and processes that will be beneficial to patient outcomes. For example, an EBQI project that has been in place in my ICU is the importance of mouth care in ventilated patients. The mouth care kit has a set number of swabs and chlorhexidine mouthwash for a 24hr period to be used to prevent ventilator-assisted pneumonia (VAP). Since implementing this project, there has been a significant decrease in the incidence of VAP. The difference in an EBQI project like this one versus a research project from an ethical standpoint would be the fact that in the EBQI project, there is not a control group and an experimental group. Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare (3rd Ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Side: No
Informed consent is important, and informed consent is only valid if accurate information is given to a patient. If treatments and information are misleadingly this contributes to the risks to our patient population. The study being performed creates the impression that no risks are involved by participating in the study. Then patients are misled in to false beliefs that no harm can be done since there was never an informed consent. A choice cannot be informed if it is based on misinformation. Thus, understanding which risks are properly attributed to treatment and which to research is essential for valid informed consent for either. Misinformation about the relative risks of treatment and research undermine autonomy. Lantos, J. D. (2017). Informed Consent for Comparative Effectiveness Research Should Not Consider the Risks of the Standard Therapies That Are Being Studied as Risks of the Research...22nd Annual Thomas A. Pitts Memorial Lectureship, April 7-8, 2016, Charleston, South Carolina. Journal of Law, Medicine & Ethics, 45(3), 365-374. doi:10.1177/1073110517737537 Side: Yes
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Heather- you mentioned that when a patient comes into the hospital they sign a consent to treatment and that is simply it. I think it is easy for someone in the healthcare field to clump QI under the same umbrella but I do not believe patients have that same understanding. If a patient needs a procedure or a blood transfusion that is not covered under the same consent as the consent they sign for treatment and I do not believe EBQI should be clump under that same consent as well. Patients have a right to know that data will be collected based on their treatment and the only ethical way to complete this is to provided informed consent. Side: Yes
Lindsey, I do not entirely disagree with you on the fact that it is not that simple. I think there needs to be a transparency of what evidence-based practices and QI projects that are being utilized in the care of the patient. There needs to be a revision of the admission consent forms to include these procedures and the possibility that the data could be used in the future to improve patient care. Side: Yes
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The issue of informed consent in research-related healthcare practices is one that has spawned debate for decades. Informed consent, as its name implies, refers to the ability of a person to agree or disagree to participate in any activity, based on information given to them regarding the proposed activity. It allows the person, after consideration of all options, including the benefits and risks of all, to decide for his or herself whether they wish to participate in the proposed treatment or not. At the core of informed consent are the concepts of autonomy and self-determination, whereby a patient possesses the right to make decisions for his or herself based on wants and desires. While most research in healthcare requires the consent of a patient to participate, it is difficult to find a reason as to why additional informed consent would be necessary for EBP and EBQI. In most hospitals and care settings, general consent is obtained upfront for routine care and general testing. Additional informed consent is therefore only needed when more invasive testing, administration of blood products, or surgical/medical procedures are deemed necessary. Having to obtain informed consent with all EBP and EBQI initiatives has the potential to delay patient care and needed interventions. Due to the fact that only MD’s can obtain informed consent, time to intervention may be increased if informed consent must be obtained by patients or their families. This, in turn, has the potential to negatively impact patient outcomes. When further considering EBQI’s, the need to obtain additional informed consent is unnecessary, due to the fact that quality improvement initiatives are developed with data and care that the patient has already consented to and received. In addition, if a review of data is being performed in order to develop EBQI’s, informed consent should not be necessary, owing to the fact that there is no direct patient contact or intervention being performed. Miller, F. G., & Emanuel, E. J. (2008). Quality improvement research and informed consent. New England Journal of Medicine, 358, 765-767. Retrieved from: Side: No
Joe, I definitely agree with you on the point of delaying patient care with having to obtain consent for every individual EBP and EBQI initiative. I really feel this additional consent is over the top and unnecessary when EBP is trying to improve patient outcomes with relatively non-invasive techniques. I still stand by my initial response of supporting these initiatives to be covered under the admission consent. Side: Yes
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According to Melykn and Fineout-Overholt(2015), EBQI is systemic, evidence-based activities designed to immediately improve healthcare delivery in specie settings. With this definition it is understood that EBQI is or should be apart of routine clinical practice. Debate over informed consent can be seen as a question of whether patients should expect EBQI to be seen as part of standard healthcare practice. One could argue that much of EBQI is good clinical care including systematic and experimental learning. Individual practitioners are constantly learning by doing and taking steps to improve their own practice. EBQI activities play a role in this, and as such, professionals and organizations have an ethical responsibility to conduct EBQI projects to demonstrate whether or not change improves outcomes. This understanding of EBQI also places a responsibility on patients to participate in such activities.In that case, informed consent would not be necessary. Melnyk, B. M., & Fineout-Overholt, E. (2015). Evidence-based practice in nursing & healthcare (3rd Ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Side: No
When we identify situations in which there is known practice variation, that is, where different practitioners recommend different treatments, patients should be informed of this and, if there is a study to test the different treatments against one another, patients should be told of that as well. Otherwise, their consent is not informed, and their participation in research is not voluntary. They start to resemble other populations who have been exploited in the past because their situation and vulnerability make them convenient for researchers. Shepherd, L. (2017). Informed Consent for Comparative Effectiveness Research Should Include Risks of Standard Care...22nd Annual Thomas A. Pitts Memorial Lectureship, April 7-8, 2016, Charleston, South Carolina. Journal Of Law, Medicine & Ethics, 45(3), 352-364. doi:10.1177/1073110517737535 Side: Yes
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I understand your point that EBQI should be a part of routine clinical practice to improve healthcare delivery. However, if you are using patient's data from their chart, it is only right to let them know. "Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects including; diagnostic, therapeutic, interventional, bioequivalence, social and behavioral studies and for all research conducted..." (Nijhawn et al., 2013). Also, patient's health records are protected under HIPAA and someone who is simply collecting data to improve healthcare delivery would not be assigned to provide care to the patient, therefore, should not be in their medical record. As a patient, I would want to know that someone was looking in my medical record to collect data, wouldn't you? Informed consent is the only ethical way to protect patients in this situation. Reference: Nijawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., & Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of Advanced Pharmaceutical Technology and Research`, 4(3), 134-140. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/ Side: Yes
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I agree that if someone is not providing care for the patient then thy should not be able to have access to the patient's chart but in reality that happens all the time for simply collecting data. For example, at a hospital that I used to work for when patients suddenly die or have a change in mental status and becomes combative, meetings are held with all that where involved in the care to go over the care and see if things could have been done differently. If consent had to be obtained for everyone of those cases it would delay the process and potentially delay improvement to hospital policies. Side: No
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