Consent for treatment of breast tumor.
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Two views exist about witnessing informed consent for research in acute care settings: nurses witness a signature, and nurses witness the informed consent itself. Nurses are obligated to fulfill legal responsibilities and ethical expectations because of their role in the clinical arena, and to serve as advocates for patients to be informed, willing research participants. This role promotes change in institutional policies to keep up with the changing face of research.
Respect for the wishes of a patient is internationally accepted as standard medical practice. In French law, this principle is enshrined in the Civil Code of 1994 which concerns bioethics. More recently in 2002, we find it included in the Code of Public Health (in the law concerning patient's rights). According to these texts, the patient's wishes must always be respected even when his life is at stake, so long as the patient has been informed of the risk. The refusal by Jehovah's witnesses to receive blood transfusion always poses a problem. When, in full consciousness, a patient refuses a blood transfusion his life depends on, what should the doctor do? In June 1998, the Paris Administrative Court of Appeals ruled on such a case. The judges found that. In October 2001, the State Council decided in this particular case, that given the critical situation and the absence of a therapeutic alternative, the doctor had not committed an error. But it also clearly reiterated that the doctor is required to respect the wishes of the patient and that this obligation does not override the duty of saving a life. Two emergency interim rulings by the Lille Administration Court (25th August, 2002,) and by the State Council (6th August, 2002) confirm the position of the judges. Not respecting the patient's wishes is a great infringement of individual freedom. The doctor will not err only under extreme and precise conditions. Should the doctor go against those wishes? Should the wishes of the patient be respected when their life is at stake? The authors will discuss these two questions.
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The authors investigated the effect of giving written material on information recall from informed consent counselling for cataract surgery. Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre, South Australia, were prospectively enrolled. Systematic counselling for cataract surgery was provided, with a written copy of the content given to a randomly selected group of patients (n = 24). All subjects completed a questionnaire after counselling and again at two weeks after surgery to test their satisfaction with, and recall of, information provided. Patients were found to be satisfied with the amount of information they received and most were able to recall details about the cataract surgery procedure. However, many could not recall success rates or complication rates and only a minority could list any complication. The provision of written information did not significantly alter recall (p>0.05). Recall was significantly better immediately after counselling than two weeks after surgery (p<0.05). Younger patients also had significantly better recall (p<0.05). Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements.
Caudal block with a local anesthetic through the hiatus sacralis has been performed in patients with chronic low back pain, lower limb pain, anal pain, and pelvic pain due to spinal canal stenosis, lumbar disc herniation, lumbar spondylolisthesis, postherpetic neuralgia, peripheral vascular disease, complex regional pain syndrome and so on. We prepar- ed an information and consent sheet on caudal block in The University of Tokyo Hospital. In the information sheet, we included disease, purpose, methods, outcome, accidental complications of caudal block, other treatments, progress on unperformed case, questions and answers, influence of rejection, and doctor's name. We experienced some cases of boring pain, deterioration of low back pain and lower limb pain, headache, nausea, hypertension, hypotension, and tachycardia as accidental complications of caudal block. In describing some accidental complications, we included boring pain, high intracranial pressure, dural puncture, nerve injury, infection, hemorrhage, embolism, allergy, and heart, lung, brain, liver, and kidney failures. Further, we could refer to the accidental complications of epidural block. However, the rate of each accidental complication has not been known in detail. We should survey the outcome and accidental complication of caudal block prospectively in multiple facilities and provide the patients with useful information.
Two hundred Michigan hematologists-oncologists were sent a 34-item questionnaire designed to assess what patients should know at the time of giving consent to bone marrow transplant (BMT). Sixty-three (32%) responded to a single mailing and rated items on a 8-point scale, varying from 0 = no need to know to 7 = appreciation of consequences essential. The mean rating across items was 5.2, indicating that all items were important. Statistically, the items separated into three groups: (1) above average importance - 13 items; (2) average importance - 9 items; (3) below average importance - 12 items. Items of above average importance included the rationale for BMT and the collective risks and benefits of the process, including the patient's well-being post-transplant. Informed consent documents did not include 5/13 items of above average importance, yet 12/21 items of average and below average importance were included. Fourteen demographic variables were correlated with each item and none were significant, indicating that the ratings represent a broad consensus in the referring physician community as to what a patient should understand before consenting to BMT. The vast majority of referring physicians agreed that patients usually have an adequate understanding of BMT at the time of giving informed consent and that a fully informed patient is more likely to adhere to the treatment regimen.
Previous reports have shown consent to be 'short' of informed in many cases. One hundred patients, including a control group, were interviewed between 2 and 7 days after their operations. Those given an information sheet before the operation had a better recall of their operations than the controls, the overall awareness being 97 and 69% respectively. This may have medico-legal implications but further studies are required.
Central to the nature of the physician-patient relationship is how fully patients are informed about their disease and prognosis and how active a role they take in deciding treatment; the "autonomy" and "paternalistic" models represent current poles of physician behavior. While informed consent has become ubiquitous in medical practice, it is not clear to what extent the value of patient autonomy has entered into everyday medical decisions. To evaluate informed consent, we prospectively surveyed 102 outpatients scheduled to undergo a colonoscopy and 16 of their physicians. The colonoscopy examination is straightforward and offers an optimal opportunity for patient participation in decision making. We found that most patients wanted guidance from their physicians and most physicians did not view the patient as autonomous. The more traditional parentalistic model continues to influence the physician-patient relationship, at least for this technical endeavor.
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Clinicians have an obligation to make sure that patients are adequately informed and understand, first, the general risks involved in any elective procedure, and, second, whether there are any features in their medical profiles that pose greater risks or pose the possibility of greater benefits than the average patient. Patients must understand the concepts of general risk, the possibility of unpredictable events happening randomly, and their own personal risk of having this happen. The remainder of the article deals with the information regularly provided to patients who show an interest in dermabrasions or chemical peels.
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