Case Study 3
Investigators conducted a trial to determine whether Coumadin, an anti-coagulant, would reduce future risk of blood clot formation in patients post open sternotomy for aortic valve replacement with a mechanical valve. The investigators used a double-blind, placebo controlled trial design. Participants were randomly assigned to either the experimental group or control group in the study. Participants were evaluated at regularly scheduled intervals for coagulation times, blood clot formation, and risk for blood clot formation based on a detailed questionnaire utilizing a Likert scale for measurement.
Risks of the research study determining if Coumadin is effective in preventing blood clotting in patients with open sternotomy for aortic valve replacement with a mechanical value, can be life threatening. Investigators hopefully are following protocol in regards to whether each individual participant should be taking coumadin post-op sternotomy. Is there a risk for bleeding? However, taking Coumadin and having the right INR level may be necessary for preventing clotting with post-op aortic valve replacement. In the research study it mentions regular scheduled intervals for coagulation times, blood clot formation, and risk for blood clot formation. This is a risk as it seems they are looking for coagulation times and blood clot formation, but what is the care plan for these individuals who do develop clots in the study. What treatment will they get to ensure blood clot dissolves? The double-blind placebo-controlled trial design, allows the clinical research nurses to be unaware of whether they are giving the participant the placebo or the drug coumadin. Participants are unaware as well. The clinical research nurses have to follow the protocol and instructions of the administration of pills as strictly directed for this study to have accurate data. Therefore, the clinical research nurses are unaware of what patients are more at risk of developing clots without knowing who is taking coumadin and who is getting placebo. Every post-op cardiac patient needs to be closely monitored regardless. But, knowing which patients a blood clot risk or a fall risk can be valuable for nurses and participants.
To add to that, the participant who is unaware of whether they are receiving placebo or the actual drug Coumadin could be considered not respecting the participant autonomy. Yes, the participant volunteered, but there is still a unknown factor. Who are the participants, do they have capacity to volunteer? Post-op patients have a tendency to not be at their normal capacity post-op especially cardiac surgery patients. The Belmont Report specifically addresses, participants autonomy, self-determination, and capacity. “In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious” (The Belmont Report 2018). Not to mention, the do no harm principle of the Belmont Report. “Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harm” (The Belmont Report).
Benefits of this research study, can assist gaining the knowledge of how to properly treat post-op cardiac surgery patients, mainly for this study, aortic valve replacement patients. Collecting data from the regularly scheduled intervals of coagulation times, blood clot formation, and risk of blood clot formation will be supportive in knowing more about the effects of coumadin during a length of time. Whatever the length of time of the research study and the collecting of that data.
A full board IRB review is needed in this case study. The medication Coumadin can be dangerous to take in any patient or participant due to the risk of bleeding. And in the case of this study, not taking Coumadin can be a risk due to formation of blood clotting, therefore other health complications. Consequently, a full board IRB review is necessary due to the fact that there in more than minimal risk to the research participant.
References:
The Belmont Report. (2016). Retreived: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
If trial participants are given adequate education regarding the benefits and risks of taking Coumadin as well as not taking Coumadin postoperatively prior to agreeing to participate in the trial I believe the patients’ autonomy is being respected. Patients should be provided with appropriate materials to make an informed decision and consent to participating in the trial. Frequent monitoring and testing would be important not only to determine the effectiveness of Coumadin use but also for early detection of blood clot formation to protect patients participating in the trial. I agree the risks of developing blood clots could lead to devastating consequences which does call for a full board review.
The Belmont Report (Rep.). (1979, April 9). Retrieved https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
In the Belmont report it states “(1) Do not harm, (2) maximize possible benefits and minimize possible harm” (Office of Human Research Protections, 2018). This is a question the Institutional Review Board as well as the investigators must consider with utmost importance. Research does give evidence that demonstrate studies that were “previously proven wrong because of lack of a control group” later was found to be correct (Castro, 2007).
“There are numerous examples in the literature regarding studies that have demonstrated initial findings that were subsequently proven wrong because of a lack of a control group. One such study proven wrong is one using a pacemaker to decrease vasovagal syncopal episodes. A control group was not used in this trial. The initial small unblinded controlled trial found in favor of using a pacemaker to decrease vasovagal syncope. In a subsequent trial using a control group it was found that the pacemaker did “not reduce the risk of recurrent syncope in patients with vasovagal syncope. “Therefore, the use of a control group in this instance was ethically justifiable.” The finding could have been seen in the original trial and would have decreased the number of patients “exposed to risk of complications from inserting a pacemaker” (Castro. 2007).
This is not coumadin of course, but it shows how subsequent studies are needed to confirm what the best therapy is for patients. Assessing the health care needs for every individual needs to be evaluated to achieve best patient outcomes today and in the future. “The Institutional review board’s assessment of risks and potential benefits is central to determining that a research study is ethically acceptable…and what might be gained by the research participant or society” (National Academics of Sciences, 2018). These ethical questions would be assessed prior to a study being initiated that could bring harm to participants. For the IRB to assess a trial a protocol would be submitted which would contain all the required information such as the inclusion exclusion criteria, and consent form.
Resources:
Castro, M. (2007). Placebo versus Best-Available-Therapy Control Group in Clinical Trials for Pharmacologic Therapies: Which Is Better? Proceedings of the American Thoracic Society, 4(7), 570–573. http://doi.org/10.1513/pats.200706-073JK
National Academics of Sciences. (n.d.). (2018). Chapter 4: Assessing risks and potential benefits and evaluating vulnerability (research involving human participants V1). Retrieved on June 23, 2018 from: http://www.onlineethics.org/cms/8033.aspx
Office for Human Research Protections, & OHRP. (2018, January 15). Read the Belmont Report. Retrieved June 23, 2018 from: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Thank you, Jennie and Catherine for your replies.
Jennie, I believe I mentioned the participant who voulunteers. I may have been confusing in my statement. The autonomy of the participants I was referring to them post op. Most these patients don’t have capacity day one or two post op, at least in my experience in CCU and PCU. I guess in my mind it would be like a DNR patient who did not want resuscitation efforts performed but the family decided they wanted them done after patient went into cardiac arrest. Fine line there but efforts would have to be performed after ensuring family understood what their loved one wanted. I have had to do that in the field. Not easy. Two different scenarios I am discussing here by both about patient autonomy.
Catherine, thank you for the resources and input. That is very interesting what you wrote about vasovagal syncope and pacemakers. Plus the lack of the control group in studies. I was not saying a control group does is not needed. But, that the ethics is scary in case study 3 because of the risk. Absolutely the full board would be warranted and all policies and procedures followed to the dot. No half work or nonchalant activities.
Thank you again!