Informed consent. The possible dangers of too much information conveyed - Research Paper Example

?Introduction Informed consent is an issue that has many facets. While the truism is that informed consent is generally good, there is some research which suggests that there is a limit to how much a patient should be informed. One research study suggests that, if a patient is informed about all risks, no matter how small, this is a disservice, as a patient’s mind tends to conjure up symptoms that do not exist and the more risks are dictated to a patient, the more likely the patient is going to experience that “symptom.” Another study suggests that, with dying patients, it is perhaps better not to inform them of negative statistics, such as how long they might expect to live if they take a certain drug. Moreover, there is an issue with how much comprehension a participant may have of the risks that are dictated in the informed consent protocol. Not surprisingly, the forms must be readable in order for a patient to truly have considered himself “informed,” and the most important part of readability is to put the risks into layman’s terms. Studies have suggested that esoteric forms which are more difficult to read than complicated texts results in considerably less informed consent than forms which are not so. Therefore, it is important to pay attention to the level of language used in the consent forms and keep the audience in mind. If the person drafting these forms keeps in mind this golden rule, then other studies suggest that informed consent is extremely effective. The possible dangers of too much information conveyed Loftus & Fries (2008) theorize that informed consent may do more harm than good, at least when the risks that are presented to the patient consist of all potential risks that might occur, no matter how remote. They argue that the patient might imagine that he or she is experiencing the symptom because of the power of the mind, in that the mind can play tricks on people, and, if the patient knows that a certain risk is possible, then the patient may conjure this risk even though it is only remotely possible that the patient is actually experiencing the symptom. As proof of this, they point to the power of the placebo (Loftus & Fries, 2008, p. 217). To them, a patient is better off just knowing the general level of risk, ie, the symptoms that are likely to occur, and only provide patients the remote risks if the patient specifically asks for it. Therefore, the informed consent carries risks itself, and they “only ask that those whose task it is to formulate informed consent rituals pay some attention to the harm that may be caused by the ritual itself” (Loftus & Fries, 2008, p. 217). Loftus & Fries then cited a study that they performed that was unpublished. It involved patients at the Stanford University Medical School who were diagnosed with scleroderma and were treated with a drug cocktail consisting of propranolol and alpha-methyldopa. The patients were informed about the side effects of the drug cocktail, which included dizziness, headaches, upset stomach and tearfulness. Some patients received a standard informed consent form and some received a standard informed consent form plus a special message which explained the placebo effect, in that the patients who received the special message were informed of the phenomenon of experiencing symptoms simply because the symptoms were mentioned. Loftus & Fries found that all patients experienced “side effects,” even if the patient was given a placebo. They also found that those patients who received the special message experienced fewer side effects than those who did not (Loftus & Fries, 2008, p. 218). Therefore, their point about a patient knowing “too much” was validated. While Loftus & Fries concentrated on the placebo effect as a drawback for informed consent, at least informed consent that lists every possible side-effect, no matter how remote, Audrey et al. (2008) concentrated on the effect informed consent had on patients who want to undergo palliative chemotherapy. The issue that Audrey et al. focuses upon is that patients need to have informed consent, so that they know, if they have incurable cancer, their options and have adequate information of these options. In the case of advanced cancer, the options are either to focus on palliative care, which means that prolonging life is not the focus, but, rather, quality of life is; or palliative chemotherapy, which has at its focus the prolongation of life at the risk of diminishing the quality of the life. Noting that the survival benefits of palliative chemotherapy are measured in months, rather than years, in patients with advanced cancer, Audrey et al. considered how much a patient should know before making the decision between treatments to prolong life and treatments to make the remaining days better. The challenge is that too much information may take away the patient’s hope and will to live; yet the patient must have realistic expectations. These two competing values must be weighed (Audrey et al., 2008, pp. 1-2). The study that Audrey et al. conducted consisted of qualitative research with patients who were diagnosed with either advanced pancreatic cancer, non-small cell lung cancer or colorectal cancer. Each patient was informed by their doctor that their cancer was incurable, and some were given a survival benefit of taking palliative chemotherapy – how much time this drug would buy the patient. Audrey et al. found that when patients were informed that the palliative chemotherapy would only buy the patients a few weeks or months, that, whether or not the patient accepted the chemotherapy or turned it down in favor of other palliative care, the patient died within a few weeks or months. On the other hand, two patients who were not given statistics or life expectancy lasted much longer – one patient was alive six months after consultation, while another was alive for eighteen months after consultation. Regardless, Audrey et al. suggested that survival benefit must be discussed so that the patient is adequately informed, but that doctors increase their training on how to do this with a patient. In this way, the doctor can sensitively narrow the gap between expectations and reality (Audrey et al., 2008, p. 9). Adequacy of Informed Consent: Comprehension Audrey et al. and Loftus and Fries demonstrated that there is a limit to informed consent, in that the patient might be able to know too much, although Audrey et al. did not interpret their results in such a manner. Nevertheless, the fact is that the two patients who were not informed about dismal statistics lasted longer than the others, which suggests that perhaps survival benefits should not be discussed with patients if the odds are clearly stacked against the patient. So, their projects showed the limitations of informed consent and the possible need for less information, not more. Park et al. (2009) took a different angle, in that they aimed to discover how much informed consent document improvement helped patient comprehension in the realm of biomedical research. Patient comprehension in such research is especially challenging, as the information is complex and controversial information must be conveyed clearly (Beskow & Dean, 2008, p. 1440). In their research, one hundred and seventy-one patients were given one of three versions of an informed consent form. One document is a standard, unchanged document. The second one is a document which was modified using systematic lexicosyntactic readability improvement, which is important as the lexicosyntatic readability of the standard form was lower than the readability score for difficult reference texts. The third one is a document which was modified by a working group composed of a person qualified in ethics, a clinical research assistant and a user’s representative. They found that none of the improvements aided in comprehension, in that there was not a statistical difference between the patient comprehension using the standard form and the patient comprehension using the improved forms. Either way, only about 10% of patients were able to accurately describe the objective of the study of which they were a part, and 74% did not understand that the treatment they were receiving was not standard (Paris et al., 2009, p. 235). Minnies et al. (2008) also studied the effectiveness of informed consent in the area of research, specifically examining informed consent with regards to participants in a vaccine field trial in a developing country. The objectives of Minnies’ study included finding out how much the participants could recall and understand about the items discussed; whether certain participant and study-related factors were associated with the informed consent quality; and to describe the association between the quality of informed consent and the participant’s knowledge of their health rights. The participants were in the country of South Africa. Minnies et al. found that, after undergoing informed consent procedures that the participants had a median score of 66.7% in recall portion of the study, and 75% in the understanding portion (Minnies et al., 2008, p. 3). Therefore, Minnies et al. seems to find the opposite of Park et al., Minnies found that the informed consent was extremely effective for the research participants, while Park et al. found that informed consent really did not help comprehension, even when more readable consent forms were used. This could have to do with the complexity of the two studies – while Minnies studied a vaccine field trial, Park studied patients who recruited for clinical trial involving stroke, diabetes (both insulin-dependent and non insulin-dependent), and obstructive sleep apnea syndrome. Perhaps Park’s participants had more complex and scientific terms to comprehend than Minnies. Or, more likely, the difference is in the way that the consent forms were composed. The forms studied by Park indicated that the readability was less than the most difficult reference text. This is an indication that the detail in the consent forms was more for the benefit of the researchers than the research participants, which is a major problem with consent forms in general (Gikonyo et al., 2008, p. 709). Gikonyo et al. recognized this to be a problem, as well as the fact that many researchers see informed consent as one-off, rather than as an on-going process; researchers fail to use visual aids and verbal tests; fieldworkers need to be better trained in communication skills and ethics and that assent is only considered on admission and is not on-going (Gikonyo et al., 2008, p. 709). Beskow & Dean (2008) conducted a similar study in assessing the comprehension, after informed consent, of participants in a biorepository, which is where patients contribute tissues for the research process. The participants were recruited by Duke University in Durham, North Carolina, and were informed about their rights and the procedures using the Duke Biorepository consent template. The biorepository carried risks with it, such as the risk that the information stored about the participant would compromise the person’s privacy, as well as other controversial aspects, such as the fact that the blood and tissue may be kept indefinitely, that commercial products may be developed with the person’s blood and tissue and the person would not see any person any personal benefit and that the people might be contacted in the future for additional research. Beskow and Dean discovered that the informed consent was effective, as most of the participants understood the risks and why they were doing what they were doing (Beskow & Dean, 2008, pp. 1442-1443). Similarly to Beskow & Dean, Mascalzoni et al. (2008) indicated that such issues as who has the right to information, who handles the information, is the information being handled properly and what security measures are in place are of high concern in the area of bioethics, and specifically, for Mascalzoni, genomics, as genomics implicates concerns that the information obtained might fall into the wrong hands and be used against the participant to deny insurance, employment and may lead to other methods of discrimination. Therefore, the participant must be acutely aware of these risks. To that end, they recommend that informed consent includes explanation of terms without ambiguity; explaining opt-in and opt-out procedures for further genetic testing; and respecting the right to know verses the right not to know (Mascalzoni et al., 2008, p. 1304). Conclusion The research regarding informed consent has focused on two major issues – whether informed consent is effective, and, to be effective, it must be comprehensible; and whether informed consent should be limited. The studies regarding whether or not informed consent should be limited would seem to point to affirmative on that point, as it seems that there really is such a thing as too much information. In the case of the oncologists informing their patients about the survival rates regarding their cancer, and the proposed treatment, it seems that no news is better news, as the patients who were not offered depressing statistics lived considerably longer than those who did. This suggests that patients might do better if they are not offered these statistics when they are offered the chance for chemotherapy to prolong life. On the other hand, this still seems unethical, as patients need to have this piece of information in order to decide between life prolonging chemotherapy and simple palliative treatment that is not designed to prolong life. Therefore, it seems that the compromise offered by the researchers in this study is a reasonable one, although it is tempting to see what would happen if oncologists did not supply this information at all. As for the studies that studied how effective informed consent was, one thing was clear – informed consent forms must be readable. Most of the studies indicate that informed consent was effective, in that the participants in studies understood much of what was going on. The exception was the study by Park et al., and it was clear that the problem with this study was that the forms were simply not readable. The readability of these forms was less than complex texts, and there does not seem to be an excuse for this. While an example of the forms in the Park studied were not made available, one could imagine that the sentences were long and complex, with many words that are not necessarily known by the average citizen. Because of this, there was low comprehensibility in the participants in that study, even when there was an attempt to improve the forms. Low comprehensibility necessarily means that informed consent is not meaningful, as the participants need to understand what is going on in order to truly consent. So, the lesson learned here is that the forms must be in language that is readable. If that is accomplished, then informed consent forms are comprehended, and informed consent is effective. If not, it is the opposite. Bibliography Audrey, S. (2008) What oncologists tell patients about survival benefits of palliative chemotherapy and implications for informed consent: Qualitative study. British Medical Journal [on-line] Available at: http://www.bmj.com/content/337/bmj.a752.abstract Beskow, L. & Dean, E. (2010) Informed consent for biorepositories: Assessing prospective participants’ understanding and opinions. Cancer Epidemiol Biomarkers Prevention 17.5: 1339-1451. Gikonyo, C., Bejon, P., Marsh, V. & Molyneux, S. (2008) Taking social relationships seriously: Lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Social Science & Medicine 67.5: 708-720. Loftus, E. & Fries, J. (2008) The potential perils of informed consent. MJM 11.2: 217-218. Mescalzoni, D., Hicks, A., Pramstaller, P. & Wjst, M. (2008) Informed consent in the genomics era. PLOS Medicine 5.9: 1302-1305. Minnies, D., Hawkridge, T., Hanekom, W., Ehrlich, R., London, L. & Hussey, G. (2008) Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics 9.15: 1-9. Molyneux, C. & Bogaert, P. (Nov. 2010) The need for informed consent in off-label use in the EU. Informa UK Ltd. , pp. 13-16. Parks, A., Brandt, C., Comu, C., Malson, P., Thalamas, C. & Cracowski, J. (2010) Informed consent document improvement does not increase patients’ comprehension in biomedical research. British Journal of Clinical Pharmacology 69.3: 231-237. Read More