Inquiry into the potential value of an information pamphlet on consent to surgery to improve surgeon-patient communication. (1/1546)

OBJECTIVES: To find out how patients recently undergoing surgery experienced the consenting process and the response of these patients to a pamphlet on consent to surgery. To test the reaction of health professionals to the pamphlet. DESIGN: A pilot pamphlet was produced and a questionnaire was sent to patients inquiring about their consenting experience, and how the pamphlet might have helped them through the consent procedure. A pamphlet and a questionnaire were also sent to a random sample of the health professionals serving these patients. SUBJECTS: Patients and health professionals. RESULTS: 61% of patients returned the questionnaire. Knowledge about the consent procedure was shown to be limited. 49% were unaware that they had the right to insist that the surgeon could only perform the specified operation and nothing more. 83% were unaware that they could add something in writing to the consent form before signing. 28% of health professionals returned their questionnaire, most of whom thought that the pamphlet provided a useful contribution to surgeon-patient communication. CONCLUSION: Evidence shows that patients are not well informed about consenting to surgery and further information would provide much needed guidance on understanding their role in the consent procedure. The low response from the health professional study is perhaps an indication that at present this is an issue which is not seen as a priority.  (+info)

The basis of informed consent for BMT patients. (2/1546)

During recent decades the doctrine of informed consent has become a standard part of medical care as an expression of patients' rights to self-determination. In situations when only one treatment alternative exists for a potential cure, the extent of a patient's self-determination is constrained. Our hypothesis is that for patients considering a life-saving procedure such as bone marrow transplant (BMT), informed consent has little meaning as a basis for their right to self-determination. A longitudinal study of BMT patients was undertaken with four self-administered questionnaires. Questions centered around expectations, knowledge, anxiety and factors contributing to their decision to undergo treatment. Although the informed consent process made patients more knowledgeable about the treatment, their decision to consent was largely based on positive outcome expectations and on trust in the physician. Informed consent relieved their anxieties and increased their hopes for survival. Our conclusion was that the greatest value of the informed consent process lay in meeting the patients' emotional rather than cognitive needs. When their survival is at stake and BMT represents their only option, the patient's vulnerability puts a moral responsibility on the physician to respect the principle of beneficence while not sacrificing the patient's right to self-determination.  (+info)

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. (3/1546)

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.  (+info)

Genetically determined obesity in Prader-Willi syndrome: the ethics and legality of treatment. (4/1546)

A central characteristic of people with Prader-Willi Syndrome (PWS) is an apparent insatiable appetite leading to severe overeating and the potential for marked obesity and associated serious health problems and premature death. This behaviour may be due to the effects of the genetic defect resulting from the chromosome 15 abnormalities associated with the syndrome. We examine the ethical and legal dilemmas that can arise in the care of people with PWS. A tension exists between a genetic deterministic perspective and that of individual choice. We conclude that the determination of the capacity of a person with PWS to make decisions about his/her eating behaviour and to control that behaviour is of particular importance in resolving this dilemma. If the person is found to lack capacity, the common law principles of acting in a person's "best interests" using the "least restrictive alternative" may be helpful. Allowing serious weight gain in the absence of careful consideration of these issues is an abdication of responsibility.  (+info)

Sterilisation of incompetent mentally handicapped persons: a model for decision making. (5/1546)

Doctors are regularly confronted with requests for sterilisation of mentally handicapped people who cannot give consent for themselves. They ought to act in a medical vacuum because there doesn't exist a consensus about a model for decision making on this matter. In this article a model for decision making is proposed, based on a review of the literature and our own research data. We have attempted to select and classify certain factors which could enable us to arrive at an ethically justifiable method of making a medical decision. In doing so we distinguish two major criteria: heredity and parenting competence, and six minor criteria: conception risk, IQ, age, personality, medical aspects and prognosis and finally support and guidance for the mentally handicapped person. The major criteria give rise to a "situation of necessity". In this situation the physician is confronted with a conflict of values and interests. The minor criteria are of an entirely different ethical order. They can only be considered once the major criteria have created a "situation of necessity". Ultimately it comes down to deciding whether the benefits of sterilisation outweigh the drawbacks and whether the means are appropriate to the end, where efficient contraception is the end and irreversible sterilisation is the means.  (+info)

Can the written information to research subjects be improved?--an empirical study. (6/1546)

OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information.  (+info)

The family rule: a framework for obtaining ethical consent for medical interventions from children. (7/1546)

Children's consent to treatment remains a contentious topic, with confusing legal precepts and advice. This paper proposes that informed consent in children should be regarded as shared between children and their families, the balance being determined by implicit, developmentally based negotiations between child and parent--a "family rule" for consent. Consistent, operationalized procedures for ethically obtaining consent can be derived from its application to both routine and contentious situations. Therefore, use of the "family Rule" concept can consistently define negligent procedure in obtaining consent from children, and could be used as a unifying framework in the development of new professional guidelines. A "guideline"-based approach to children's consent to treatment may offer greater individuality than a "rights"-based approach, though careful training and oversight will be needed for it to be effective.  (+info)

Infectious health care workers: should patients be told? (8/1546)

The risk of transmission of HIV or hepatitis B from infectious health care workers to patients is low. However, inadvertent exposure causes great concern amongst patients of an infected health care worker. The patients of a Scottish dentist diagnosed hepatitis B e antigen positive were informed by letter of their exposure. A sample of patients was sent a postal questionnaire. Most (56%) respondents reported feeling anxious on receiving the letter but almost all (93%) thought patients should always be informed following treatment by an infectious health care worker, although the risk was very small. We discuss clinical and ethical factors relating to informing patients following exposure to an infectious health care worker. We suggest that a balance should be struck between patients' wishes to know of risks to which they have been exposed, however small, and the professional view that when risks are negligible, patients need not be informed.  (+info)

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