3a. Describe each concept and explain the difference between allocation concealment and blinding.
Allocation concealment refers to the concept of subjects, health care providers and investigators not knowing which group the subject will be a part of before the start of the trial. Simply put, allocation concealment refers to the not knowing the next sequence of the trial. Blinding, on the other hand, refers to the attempt to keep the groups (such as an active group or placebo group) unknown or which is easily discernible by the subjects. Blinding can be for the participants, investigators, healthcare provider, data collectors, or the research assessors (Viera & Bangdiwala, 2007). The simplest difference between allocation concealment and blinding
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While to what extent this bias affects the outcome is not measured, the effect certainly is there. Mainly, there exists a restriction in the generalizability of the finding, especially those trials that relate to alternative medicine (Hróbjartsson et al., 2014). When patients are more aware of their treatment, the way they report their symptoms may vary, adversely even the quality of the doctor-patient relationship is reduced. This also leads to disproportionate rates of attrition and the placebo effect. The rates of attrition of patients are always found to be higher where they are non-blinded (Hróbjartsson et al., 2014). Bias has mainly reported occurring due to a combination of response bias, placebo effect, and attrition. Response bias refers to the methods in which the patient response to the intervention. For example, the patient may be disappointed to know that he is in the control group and hence may become disinterested and more inclined to leave. This leads to attrition of the participants. Further, the patient may experience the “placebo effect” (Sedgwick, 2013). The placebo effect refers to the presumed benefits of the placebo drug, which is not caused by the drug itself, but is due to the patient’s belief in the treatment (Colloca & Benedetti,
Knowledge and lack of knowledge can have a major influence on whether individuals use complementary therapies. For example; people may have heard negative stories about certain therapies such as acupuncture, aromatherapy or massage. This negativity may implement fear of using these therapies. Lack of knowledge may also case negative feelings, for example; individuals may have never heard of certain therapies before that are now available in their local area. Some might know about the therapy, but do not understand the benefits of using it.
The author continues to demonstrate how the placebo effect works by comparing it to the famous biological study by Ivan Pavlov. In Pavlov’s experiment, dogs are conditioned to respond to a specific stimulus and eventually begin to respond to the same stimulus in the same way all the time. Bjerklie explains that, “as far as the placebo effect is concerned, we may as well be those impressionable canines.” What Bjerklie means is that the human mind has the ability to be conditioned to expect certain outcomes. The placebo effect builds on the human minds ability to be conditioned and an individual’s faith in the healthcare providers it choses to visit. Overtime the human mind has come to believe that if given a medication that is suppose to have a positive effect on a specific pathology, it will in fact have an positive effect.
Proponents of placebo-prescribing argue that clinicians “can use non-deceptive means to promote a positive placebo response in their patients” (Brody, 1982, 112). However, some proponents also argue that
The article goes on to say that “some of the misleading reporting observed…was deliberate” (Gary, 2010). It is unethical to try and sway the consumer into using your product with false or misleading information. When someone is sick he or she wants the best care that his or her insurance can provide and he or she are not getting that with this misleading information. The author of the article seems to be concerned with this idea of unethical medical research. According to the author research has proven that misleading research is used often for financial gain. The author does not site one specific person or business, but points the finger at the healthcare and drug markets in general. The author does use one specific source for his research though. He found gaps in the marketing of Pleo-Sanum. He noticed that one of the statements in the article about the product stated that “The investigators reported in the Results section that active treatment produced a significant benefit, whereas placebo did not.” A normal person reading the article would not catch on to the fact that the product had been spun to make the product seem better. Consumers are not dumb, but have no choice but believe what is laid out in front of them. Consumers expect the people who are selling the products to be honest and ethical individuals but research has
The placebo effect has been affecting people for hundreds of years. In the 1940s sugar pills were sold in doctors’ catalogs specifically for the purpose of prescribing them to psychiatric patients. Today, over 60% of doctors admit to prescribing placebos to their patients, although there is an unwritten rule among doctors in the United States that placebos should no longer be given to patients. Some even do it on a regular basis because they believe the effect a fake drug has on the brain is more effective for its price than the real medication or treatment. In the documentary, Placebo: Cracking the Code, viewers see a few different perspective of the placebo effect. They hear from doctors, patients, and researchers to more fully understand the ins and outs of the placebo effect. These different viewpoints serve as an effective way to bring light the producers’ purpose: to show just helpful and sometimes harmful placebo drugs can be.
Secondly, priori power calculation showed a sample size of 52 was needed to reach a power of 0.8 with a large effect size. However, only 42 participants were successfully recruited, which reduced the power of the current study. However, previous studies with similar sample sizes (Pincus et al., 1996) found evidence of cognitive biases in chronic pain patients. On the other hand, we assumed a large effect size based on
They deceived them for 40 years by making them think they were receiving treatments for “bad blood” when in fact they were withholding treatment. However, in present day, researchers must comply with guidelines and undergo a review panel to be approved. Participants must be informed of the study and its risks as well as the right to decline participation at any given time. The subjects must also be competent and be able to understand what is happening in the experiment as well as its
Ignoring these considerations or downplaying their effects has a history of countering the positive effects of evidence-based practice (Hajjaj, Salek, Basra, & Finlay,
Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal
To start out, it is important to differentiate between practice and research, especially in this discussion of therapeutic research trials. Practice is meant to treat an individual in order to improve upon their quality of life. The practice of medicine generally yields good outcomes and is not inherently risky, with some exceptions. However, research on the other hand includes subjects or participants to learn something about people or a topic as a whole. While it seems that the differences are clear, there are many times when the lines between the two may blur. One of the ways that the differences are more ambiguous is in the case of
An example of overtreatment in the film Escape fire: The fight to rescue American healthcare was the segment about the patient, Yvonne Osborn, who kept receiving surgery for her heart problems instead of getting to the root of the problem. Her doctor was never concerned with really help her, only temporary treating her. Her doctor was able to make more money with treating her this way. In an article about the overuse of medical interventions, they did a study on what patients thought about the subject of the matter. “Our findings highlight the complexity of addressing the overuse of testing and screening. While patients are skeptical about pharmaceuticals, this perspective cannot necessarily be extended to testing and screening. Pharmaceuticals can give patients quick negative feedback in the form of side-effects, whereas the side effects of testing and screening are not necessarily immediately apparent” (Schleifer &
In my research, I’ve learned that subjects extending the truth about their therapeutic histories keeping in mind the end goal to get into profitable studies. That is by all accounts genuinely basic; not realizing what sort of effect it has on the outcomes; however it shouldn't be appallingly stunning. We have a wellbeing testing system where subjects don't have any stake in the aftereffects of the study, where they don't generally believe the examination supports, and where they don't trust they are going to become acquainted with the medications which are created by the studies. I believe if destitute individuals are being approached to test medications for the profit of rich individuals, then we shouldn't be amazed if the needy are not generally effortlessly
Unfortunately, a human can be biased on incorrect without any knowledge of it. Data-backed treatments help to eliminate error on the part of the clinician.
This is the part of biopsychology that leans more towards the physiology of our body’s physical and mental state. There were a lot of fundamental problems of psychology observe and report it was limited by the bias of the observers or those who were in charge of the tests. As well if the observed knew they were being observed or not. A Halo effect you may have a vested interest in proving an idea and may not realize your own cognitive bias. Even with blind double blind and random studies it also depends on a subjective interpretation of the data.
I completely agree with you, ignorance is one thing, but to commit evil deeds willingly is a whole different level of low for people like those who are involved with all of these unethical trials. I am glad that you pay attention to the details in your patient charts and it is reassuring that the clinical trials that you are involved with will continue to be fraudulent-free (at least from obvious fraud). All that can be done is to ensure that those who are in charge of monitoring such trials are capable and that they pay close attention to ensure trials like the one in your discussion post do not happen in the future. Thank you for your