Question 3
Since larger, well-designed studies must be performed before creation of a policy that requires implementation of any therapy, what are some possible limitations to future studies, such as bias or possibly even ethical issues in withholding or assigning a treatment?
posted by Vanessa @ 12:42 PM
11 comments
11 Comments:
There are many biases and ethical considerations to think about when working with real humans and making decisions that can affect their lives forever. I think that many researchers have pre-conceived notions about nutrition support. It seems that if they have had any experience in the medical field with tube-feedings, they are either completely for or completely against certain practices. This could cause them to have a bias one way or the other during studies. I also think there are ethical conflicts when deciding to give one patient a full-strength tube feeding, while withholding essential nutrients from another patient. How do you make the decision? What if, during the experiment, you see that one group is doing remarkably better than the other? Don’t you need stop the study and give them all the same beneficial treatment so that they can have an equal chance at surviving/recuperating. There are many ethical limitations in study designs when it comes to actually withholding medical treatment from human patients.
I think that funding of such a study would create some limitations. Using actual human subjects to test the drug may also provide some significant limitations and ethical considerations. There would need to be several large studies to prevent any bias. I also agree with Karlie when deciding which patients will be withheld from receiving all nutrients and which will be given a full-strength tubefeeding. It would create ethical situations if a group of patients were experiencing less symptoms than others.
Any study dealing with the health and well-being of a patient will present ethical issues. In the case of TPN studies there must be a control group that is not receiving the treatment as well as a group that is. When an experiment is set up in this fashion there is an inevitability that one group will be receiving a better treatment than the other. When this situation arises then ethical conduct questions should show their ugly head as well. Can you really morally and ethically continue to administer a sub-par treatment to one group of patients while a treatment is clear in the other group that allows patients to thrive? Because of this sort of ethical concern many treatments may go untested in experiment form but rather in trial and error whether or not this is the best way to achieve results.
It is very important for more research to be conducted, so that we have a better understanding and are more able to treat our patients. However, there are certainly limitations that may prevent all the necessary research to be conducted. Ethical issues are probably the biggest hurdle. Like Vanessa said, withholding nutrition or providing a diet that is not beneficial for a patient can prevent problems, and further delay their recovery. For example the control group may not receive the nutrition care that is best for them. Every patient is different and the disease states are all different so that may hinder getting the best possible results with any study. Hopefully over time we will be able to pool information from a variety of hospitals and sources to come up with a consensus.
I agree with the others who pointed out that there is ethical concerns that really limit the scope of a study making it nearly impossible to have large scale, randomized controlled trials. I also see that it is difficult sometimes for some to eliminate personal bias that they might have toward the success of TPN as it has often been see as it must be helpful the more the better. However, we also know the concerns of overfeeding and that recent research has really questioned the benefits of TPN in many disease states. Not to mention many patients may not prefer this type of treatment. I believe that the more research the better and even though the perfect conditions may not always present themselves, the combination of many research studies helps put a better view of the whole picture.
When you are doing an experiment, controlled or the treatment groups, there is always going to be a limitation when dealing with human life. If the pt's life quality is worsened because an experiment limited the type and amount of tx the pt could receive, then this brings about many legal issues as well. I think that even if these pts sign waivers to perform experiments, there is possibly a way around it due to the mental stability clause. I do believe that larger studies must be performed to truely find whether nutrition support or not works, but whether these experiments should be allowed in pt with such a compromised health status is ethical, I would have to say no!
Ethically, medical staff do not want to purposely put their pt at any further health risk or with hold medical treatment that will allow the pt to get better. It would be difficult to standardize these studies. Such as specifications: type of disease/problem, stage of disease/problem, length of treatment required (some pt might need longer tx), nutrition status before and during treatment etc. Steph had a good point, eventually hospitals will need to collaborate their data and analyze the results from pt care plan in order to look at the big picture and come to conclusions.
I agree with Annie that some may place a bias in the way of the actual conclusion. Many people develop their own beliefs (bias) relating to the "best treatment available," and because they believe this is the case it may overshadow the actual results. When bias of this nature appear many times results can be read a certain way in order to prove their position rather than looking at the results in an objective fashion. To eliminate this factor many duplications of the same study must be conducted. By doing so, the bias will eventually be disproven.
I completely agree with what Karlie has said about the ethical considerations related to any studies or treatments involving human beings especially those people who are critically ill. Our job is to provide the best care possible so if we notice a treatment is not working we must alter it. Since every person is different no two people will probably enter the hospital and have the same nutrition treatment. So this makes it very difficult to do studies or compare treatments. We must just collect as much information as possible and hope that over time a certain treatment will become the evident better course of action.
I agree with Heather in that hospitals can not withhold treatment or purposely provide treatment that may not be in the best interest of the individual. This can be a sticky situation thus everyone must work together to determine what should be done. I agree that it would also be hard to standardize all the patients, as each patient presents a totally different situation which may not be able to be compared with any other patients.
Most of us have commented and share the same realization that withholding treatment and standardizing the experiment would be extremely hard and unethical. I suppose for now just collecting as much data as possible from the use of TPN, recommendations, etc. is the best we can do right now. Hopefully, upon analyzing the use of treatment a new solution would be discovered. Or perhaps a new system that would indicate which patient would receive which specific treatment based on certain criteria.
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