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.
I, somewhat, have a problem with this study. If the information provided is all that they are doing during this study, then there are some very big complications with this study that a questionnaire would not suffice as proof whether or not the study is accurate. There needs to be more to this study to assure that it is being correctly conducted. There also is no mention of whether or not the patient was informed of the study and whether consent was obtained and if risk versus benefits were explained.
If the person who is not being provided the Coumadin, but receiving the placebo, there is a chance of getting blood clots, which could further lead to stroke and other medical issues. Not receiving the Coumadin, knowing that it is beneficial to the patient, is just as bad as not treating the patient, in my opinion. That being said, those that are receiving the Coumadin, should be monitored very closely for a number of complications, including bleeding, dark stools, headaches, among other complications. When taking Coumadin it is important to have a regular blood test, called PT/INR. It detects the clotting factors to see if the medication is working properly. Without this regular testing, it can not be determined whether or not the medication is doing what it is supposed to be doing and, therefore, you cannot determine if the study is being done properly.
According to the Belmont Report, there are three major principles that must be followed when conducting studies on human participants, that all have sub-principles within them. They are “boundaries between practice and research”, “basic ethical principles”, and “applications”. These principles must be followed in order to ethically study human subjects and their responses to the study. Without these principles, we will be providing unethical medical care, which can lead to law suits and patient risks. I think that, due to all of the provided information, it is important to provide a full IRB review.
References:
The Belmont Report (Rep.). (1979, April 9). Retrieved https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
Types of IRB Review. (n.d.). Retrieved November 14, 2017, from http://sites.jcu.edu/research/pages/irb/review/review-types/
Fiumara, K., & Goldhaber, S. Z. (2009). A Patients Guide to Taking Coumadin/Warfarin. Circulation, 119(8). doi:10.1161/circulationaha.108.803957
Yes, I agree, it does seem like these patients may be at risk for a serious complications from valvular replacement without anticoagulation that is most often associated with significant morbidity and mortality without their knowledge. I also have questions about the accuracy of the study if the source of their information is from the patients perspective (using a questionnaire) and not from a medical professional interviewing the patient. If the patient’s understanding is lacking, maybe the data isn’t as reliable as it could be with an interview by a medical professional. I also agree that a full review would be needed in this situation as this study poses a greater than minimal risk to the subjects. Minimal risk being defined as the probability and magnitude of the harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
John Carroll University. (2018). John Carroll University. Retrieved from Types of IRB Review: http://sites.jcu.edu/research/pages/irb/review/review-types/
I agree withholding Coumadin in the placebo group could be considered breaching the ethical principle of beneficence. However, if the current standard of care for patients did not include the use of Coumadin for blood clot prevention then I would not see an issue with the placebo group due to the absence of withholding treatment. This trial would need to undergo a full board review to ensure ethical principles and effective measurement of the hypothesis occur. Positive trial results could influence the care of future patients and benefit society by reducing post operative risks. Trials such as this and the ability to provide evidence to support medical treatments allow us to standardize and improve quality of care.
The Belmont Report (Rep.). (1979, April 9). Retrieved https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
What are the considerations needed in using a control group in a clinical trial? Ethical and scientific concepts take a great deal of thought. “Placebo-controlled trials are justifiable when they are supported by sound methodologic consideration and when their use does not expose research participants to excessive risk of harm.” Investigators take into consideration various options for study designs and are targeted toward a specific hypothesis. Considerations do include current best practices for control groups when a new therapy or interventions are being contemplated(Castro, 2007).
“What is the rationale for the use of a control group in clinical research? The guidelines for biomedical research published by the Council for International Organizations of Medical Sciences have established that a clinical trial cannot be justified ethically unless it is capable of producing scientifically reliable results”(Castro, 2007). The goal is to improve care for future patients. This case study does not provide the current standard of care or Institutional Review Board(IRB)information. With the current laws researchers would take into consideration of risks to patients keeping the principles of the Belmont Report.
The World Medical Association (WMA) has developed the Declaration of Helsinki which “is addressed primarily to physicians.” The Declaration of Helsinki is “a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data” (WMA, 2018). The World Medical Association Declaration of Helsinki states specifically on control groups:
“The benefits, risks, burdens, and effectiveness of the new methods should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo or no treatment in studies where no proven prophylactic, or therapeutic methods exist”(Castro, 2007).
With many details not available to be reviewed, it is impossible to actually determine if there is a breach of ethics in this study. As many have already stated, the current lack of information would lead one to believe this study could bring significant harm to a research subject. The date when this study was conducted is not known, this could have been a study before the use of coumadin with valves were known. A full IRB review is needed to determine the safety of subjects and is always needed with any study that is testing drug efficacy.
References:
The World Medical Association (WMA). (n.d)., (2018). WMA Declaration of Helsinki – ethical principles for medical research involving human subjects. Retrieved on June 22, 2018 from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
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. Retrieved on June 22, 2018 from: http://doi.org/10.1513/pats.200706-073JK
Wow! Your comments were very detailed with many great resources! Thank you so much. I think it is easy to say, with the information provided, that a full board review is needed. I think there is too much risk to just jump in and do a trial like this.