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[Legal questions in radio-oncology. Demands on patient information and documentation of the therapy with examples of current legal cases concerning specialization in radiotherapy/radio-oncology].

BACKGROUND: In recent years, also due to the media, the medical information a physician gives to his patients, the methods of medical treatment and their consequences have increasingly come to the attention of the general public. As a result, to avoid claims for compensation because of faulty treatment or even to evade prosecution, the demands on medical information given before or during treatment are getting greater and greater. Generally, claims for compensation are not based on the accusation of wrong treatment, because this accusation is difficult to prove. As a rule-as a way out of difficulties-these claims for compensation are based on the accusation of mistaken or incomplete information, because if one cannot prove any wrong treatment, faulty information can (nearly) always be proven. METHODS: Methodically, showing the principles that must be followed when giving information on radiotherapy and when documenting it, also taking examples of current legal cases into account. Short survey of the question of liability and the future importance of principles for medical treatment. CONCLUSION: Every attending physician should feel obliged to pay attention to legal questions concerning medical subjects, though judgments on the contents and the extent of the information that must be given to patients are complex and difficult to understand for anybody not experienced in law. Only so the ever-increasing tendency of people to try to make financial profit on information that they consider mistaken or incomplete can be opposed and a lawsuit can be won, if it cannot be avoided.

Consent Forms↗

The impact of disease severity on the informed consent process in clinical research.

PURPOSE: To assess the efficacy of informed consent in subjects differing in disease severity, ranging from those with immediately life-threatening disease to healthy volunteers. SUBJECTS AND METHODS: A total of 127 subjects, enrolled in four types of clinical research protocols, were tested. Subjects completed questionnaires before entry into the protocol, within 24 hours of signing the primary protocol's consent document, and 4 to 6 weeks after entry. RESULTS: Healthy volunteers retained the most information about risks and side effects, and severely ill Phase I subjects retained the least (P <0.0001). Phase I and II subjects had the best long-term retention of information about procedures, whereas Phase III subjects and healthy volunteers retained the least (P <0.001). Information about the scientific purpose and confidentiality of data were retained best by symptom-free, Phase III subjects (P <0.05). Phase I subjects entered the study primarily for treatment purposes, and the consent document was rated less useful by subjects with more advanced disease (P <0.05). CONCLUSIONS: Subjects with differing disease processes and illness severities focused on and retained different aspects of experimental protocols for dissimilar reasons. During the informed consent process, research staff should inquire of potential subjects' personal goals for participating in experimental protocols and develop means for ensuring subjects' understanding of the inherent risks and alternative interventions available.

Adult↗

National efforts to improve the informed consent process.

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.

Breast Neoplasms↗

The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers.

One hundred elderly adults (mean = 71.3 years of age, range = 59-88 years) in four WAIS vocabulary subgroups (less than 40, 40-49, 50-59, greater than or equal to 60) served in an evaluation of the effects of using multiple comprehension test trials to improve informed consent procedures. Participants in Group I were given a single comprehension test and feedback before signing consent documents, while those in Group II were provided with as many as three comprehension trials, if necessary. All participants were tested for memory of the information 2-3 weeks later. Results indicated that both comprehension and memory performance varied directly with vocabulary level. The multi-trial approach improved comprehension scores at all vocabulary levels, but had no effect upon memory.

Aged↗

Informed consent 1980.

The right of a patient, in most cases, to have the final authority to consent to a treatment, operation, or diagnostic procedure is guaranteed by 200 years of legal precedent. The right of that same patient to be adequately informed so that the decision is entirely his or her own seems to be equally well protected. It is unlikely that the medical profession can find a mechanical solution to the problem. That intangible patient-physician relationship must be developed to the point where there is a true interchange of the same information a physician would use to consent to undergo such a procedure or agree to it for a loved one. Finally, the physicians must decide, on the basis of their experience, the literature, personal attorney input, and other sources, the best method of documenting that moment when truly informed consent has been obtained.

Comprehension↗

Consent, dissent, cement.

The patient-doctor relationship has two fundamental components. The first is the application of the skill and knowledge of the doctor in the care of the whole patient and family. The second is the right of the individual to have information about his or her illness or treatment, and to be involved in decision making. This relationship is built on trust and comes sharply into focus in the area of consent to take part in clinical trials. The argument is put forward that the use of written information should be seen as an extension of the communication between the doctor and the patient, and not as a legally restrictive device. The concept of an agreement, both on the part of the doctor and of the patient, to take part in a clinical trial is developed.

Clinical Trials as Topic↗

Informed consent in Malaysia: an overview.

The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

Comprehension↗