Panel discussion: problems of the specialist's duty to inform the patient (author's transl)

The obligation of the physician to inform the patient--which he has to prove in case of a suit--is based on the patient's right of self-determination. This self-decision information was subject of the panel discussion. Not discussed in detail were the information concerning diagnosis and prognosis, and the instruction of the patient regarding his conduct postoperatively and during medical treatment. Not considered was the so-called malpractice and negligence respectively. Medical liability suits are increasing for various reasons and are frequently directed at a failure to inform the patient becuase the patient is often unable to prove a negligence of the physician ("surrogate liability"). The dimension of the duty of disclosure (complete information--no information at all) is discussed in general and with special regard to the Ear-Nose- and Throat field. Special questions are answered regarding otoplasty, middle ear surgery, transplantations, extension of laryngeal surgery without prior informed consent, paranasal sinus and rhino-basis operations as well as surgery in minors and foreigners. In cases of non-vital indication and particularly in plastic-cosmetic procedures and outsider methods the requirements for informed consent are particularly important. The so-called rate of complications has perhaps a relative, but never an absolute meaning, and even this only in connection with the other circumstances of an individual case. The evidence of an adequate informed consent which must be included in a physician--patient-dialogue is most convincing by means of a written consent and the additional signature of a witness, perhaps also of the patient. The value, the problems and even the risks of an information based only on forms or brochures is discussed in detail. The panel discussion from the four points of view of the organizers should be no means confuse the otorhinolaryngologist. It should inform him about the medicolegal aspects of his activity and protect him from avoidable burdens.     

A monoclonal antibody shows discrete cellular and subcellular localizations of mGluR1 alpha metabotropic glutamate receptors

Informed consent is a process of communication between a health care provider and patient that educates the patient as to the patient's needs and the potential solutions for those needs, and leads to the endorsement of a health care treatment plan. A claim of lack of informed consent may be brought by a patient when there is a perceived failure in the disclosure of adequate information to make a reasoned decision whether to consent to treatment. This article provides the foundation of the informed consent doctrine, delineates the essential elements of a lack of informed consent claim, and identifies the parties and their roles in the informed consent process.     

On call and online: sociohistorical, legal, and ethical implications of e-mail for the patient-physician relationship

Increased use of e-mail by physicians, patients, and other health care organizations and staff has the potential to reshape the current boundaries of relationships in medical practice. By comparing reception of e-mail technology in medical practice with its historical analogue, reception of the telephone, this article suggests that new expectations, practice standards, and potential liabilities emerge with the introduction of this new communication technology. Physicians using e-mail should be aware of these considerations and construct their e-mail communications accordingly, recognizing that e-mail may be included in the patient's medical record. Likewise, physicians should discuss the ramifications of communicating electronically with patients and obtain documented informed consent before using e-mail. Physicians must keep patient information confidential, which will require taking precautions (including encryption to prevent interception) to preserve patient information, trust, and the integrity of the patient-physician relationship.     

Hysterectomy: improving the patient's decision-making process

Increasingly, patients are expecting to be more involved than they traditionally have been in medical and surgical decision making. The unilateral process of informed consent is evolving into one of informed collaborative choice. Hysterectomy is a procedure that is frequently performed when reasonable surgical and nonsurgical alternatives remain. When professional consensus as to the clear recommendation for hysterectomy is not present, patient choice is particularly important. Because more than 80% of health-care decisions, including those in which one of the choices is hysterectomy, are elective, gynecologists and other health care providers increasingly will need to develop more efficient and collaborative methods to integrate patient autonomy and choice into the decision-making process. There is mounting evidence that both clinical and nonclinical outcomes (satisfaction and cost) may be improved when properly informed consumers collaborate in making medical and surgical decisions. Legal liability for adverse outcomes may be decreased by increased patient participation in medical and surgical decision making. The era of managed care has created an agency problem stemming from the fact that consumers (patients) are concerned that necessary procedures and other treatments may be withheld because of cost considerations. Health plans and medical groups likely will be required to provide objective information about the options that consumers (patients) have when faced with choices, including decision making and hysterectomy. By incorporating patient expectations and preferences as part of the process of decision making, an ethically acceptable and effective method of "rationing by patient choice" may be feasible. Figure 3 is a graphic depiction of such a process of informed collaborative choice progressing from effective choices through efficient choices and then to the one providing the best value for an individual patient.     

Health care workers with HIV and a patient's right to know

Accidental human immunodeficiency virus (HIV) infection of patients in health care settings raises the question about whether patients have a right to expect disclosure of HIV/AIDS diagnoses by their health workers. Although such a right-and the correlative duty to disclose-might appear justified by reason of standards of informed consent, I argue that such standards should only apply to questions of risks of and barriers to HIV infection involved in a particular medical treatment, not to disclosure of personal diagnoses. Because the degree of risk of HIV infection is low and disclosure would also have damaging consequences for health workers, and because patient protection is available in other ways, it is argued that no such generalized right should be recognized.     

Supporting autonomy to motivate patients with diabetes for glucose control

OBJECTIVE: We applied the self-determination theory of human motivation to examine whether patient perceptions of autonomy supportiveness (i.e., patient centeredness) from their diabetes care providers related to improved glucose control over a 12-month period. RESEARCH DESIGN AND METHODS: We conducted a prospective cohort study of patients with diabetes from a diabetes treatment center at a university-affiliated community hospital. Participants were 128 patients between 18 and 80 years of age who took medication for diabetes, had no other major medical illnesses, and were responsible for monitoring their glucose and taking their medications. The main outcome measure was a change in HbA1c values over the 12 months of the study RESULTS: Patient perception of autonomy support from a health care provider related to a change in HbA1c values at 12 months (P < 0.05). Further analyses showed that perceived autonomy support from the staff related to significant increases in patient autonomous motivation at 12 months (P < 0.05); that increases in autonomous motivation related to significant increases in perceived competence (P < 0.05); and that increases in a patient's perceived competence related to significant reductions in their HbA1c values over 12 months (P < 0.001). CONCLUSIONS: The findings support the prediction of the self-determination theory that patients with diabetes whose health care providers are autonomy supportive will become more motivated to regulate their glucose levels, feel more able to regulate their glucose, and show improvements in their HbA1c values.     

Transformation suppressor activity of C3G is independent of its CDC25-homology domain

Low literacy is a pervasive and underrecognized problem in health care Approximately 21% of American adults are functionally illiterate, and another 27% have marginal literacy skills. Such patients may have difficulty reading and understanding discharge instructions, medication labels, patient education materials, consent forms, or health surveys. Properly assessing the literacy level of individual patients or groups may avoid problems in clinical care and research. This article reviews the use of literacy assessments, discusses their application in a variety of health care settings, and cites issues providers need to consider before testing. The authors describe informal and formal methods of screening for reading and comprehension in English and Spanish including the Rapid Estimate of Adult Literacy in Medicine, the Wide Range Achievement Test-3, the Cloze procedure, the Test of Functional Health Literacy in Adults, and others. Practical implications and recommendations for specific use are made.     

Informed consent: research and the psychotic patient

During the past few decades, western societies seem to have placed a particularly high premium on the individual's personal integrity and right to self-determination. Presently, obtaining a patient's consent is accepted as a prerequisite for the performance of any form of medical treatment, whether diagnostic or therapeutic in nature. A study was undertaken in various centres involved with clinical trials to compare the procedures used for obtaining informed consent from a psychotic patient. Although the study did not investigate the legal aspects related to consent and informed consent, it is necessary that one must be aware of these aspects when doing clinical trials.     

Legal problems in the operating theatre: learning from mistakes

Nurses and other professionals have a legal as well as a professional duty to keep up to date with developments and changes in their clinical field of practice. Healthcare professionals should also be aware of major studies and the complaint and litigation trends in their specialties. This information can inform practice and lead to improvements in the quality of patient care. The information can often be found in the healthcare literature and the general press. This article looks at examples of the reported cases and research on negligence in theatres and discusses the legal and professional duty to keep up to date.     

Preoperative management of patients with major trauma injuries

Traumatic injuries require rapid, efficient, and precise diagnose and immediate treatment. Patients with major trauma injuries place special demands on emergency department, OR, and intensive care unit health care providers. Cost-effective and time-efficient management of these patients results in improved patient care and optimal outcomes in this era of shrinking health care dollars. Perioperative nurses need to be aware of the many evolving changes in the preoperative management of patients with major trauma injuries to provide quality care to these patients.     

Time for full disclosure with suicidal patients.

Rudd et al. (2009) provide robust data to support their recommendation that mental health providers should include data about frequency of suicide attempts as part of the informed consent process with suicidal clients/patients. Adding information about suicide risks into the informed consent process is an important extension of the patient rights movement begun in the 1970s. Data from research in psychological assessment suggest that feedback about hard-to-hear issues can facilitate therapeutic change when conducted in the context of a collaborative relationship. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of metabolic inhibitors on Na+ transport in isolated perfused rat lungs

A quality assurance system for generic screening of patient care has been developed in a university hospital in The Netherlands. This system is based on the Medical Management Analysis System, developed in the United States. Patient care is systematically screened for adverse patient occurrences (APOs). Screening criteria have been developed and some adjustments have been made to the original system, because of structural differences in health care between the United States and The Netherlands. The results of a study comparing two screening strategies are presented: screening by a medically trained, outside reviewer and screening by the Ear, Nose and Throat specialists themselves. The reviewer screened almost all admissions to the department as opposed to the specialist, who filled in screening forms of only 77.5% of the admissions. Specialists are found to register more APOs in their own domain (42%) as compared to the screener (28%). Issues concerning the nursing process receive less attention by the specialists (14%) than by the screener (22%). Because the personnel delivering direct patient care are more familiar with and informed about this process of care, the importance is stressed of getting specialists as well as nurses involved in the evaluation of the care they deliver to patients.     

Information in the ICU: are we being honest with our patients? The results of a European questionnaire

BACKGROUND: We were interested in determining the current practices and views of European intensive care doctors regarding communication with patients and informed consent for interventions. METHODS: A questionnaire was sent to the 1272 western European doctor members of the European Society of Intensive Care Medicine. All questionnaires were anonymous. Five hundred four completed questionnaires from 16 western European countries were analyzed. RESULTS: Of the respondents, 25 % said they would always give complete information to a patient, although 35 % felt they should. Thirty-two percent would give complete details of an iatrogenic incident, but 70% felt they should. There were significant differences in these attitudes between doctors from different countries, with doctors from the Netherlands more likely to give complete information, and doctors from Greece, Spain and Italy less likely. Fifty percent of the respondents required written consent for surgery, but for insertion of an arterial catheter oral consent was more widely accepted. The Netherlands and Scandinavia generally accepted oral requests for procedures, while Germany and the United Kingdom preferred written requests. Doctors of all countries were generally happy with their current practice concerning informed consent. Seventy-five percent would accept the right of a patient to refuse treatment, but 19% would carry out the procedure against the patient's wishes. CONCLUSIONS: Doctors are often not completely honest with their patients regarding their diagnosis or prognosis, or in the event of an iatrogenic incident. However, most doctors will respect a patient's right to refuse treatment. Informed consent practices vary substantially and are largely determined by locally accepted policy and accepted by doctors working in those areas.     

An emerging cancer risk: organ transplantation

Advancements in surgical techniques, procurement, and immunosuppressant therapy have made organ transplantation a major treatment modality with increasing survival posttransplantation. However, this longevity has placed individuals with transplanted organs at an increased risk for developing cancer. This article examines the following pertinent issues. First, what is the prevalence of malignancies among transplant recipients? Second, are organ recipients told that they may be at risk for developing cancer? Third, is the medical community trading one lethal disease for another? And finally, are oncology nurses properly trained to handle the maintenance of a transplanted organ while caring for a person with cancer? This article looks at several ethical issues, including the ethical principle of autonomy, which examines the respect for a patient's right to choose or refuse treatment. Within this text, autonomy will be the basis for informed consent and the need for cancer risk disclosure. The ethical principle of beneficence is also examined, in regards to the health-care community trading one illness for another. The final ethical principle of nonmaleficence is considered and the need for future oncology nurses to examine their practice to determine if they are ready to care for these posttransplant cancer patients.     

Getting meaningful informed consent from older adults: a structured literature review of empirical research

OBJECTIVES: To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. DESIGN: Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. MEASUREMENTS: Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. RESULTS: A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). CONCLUSIONS: A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.     

Do clinical and formal assessments of the capacity of patients in the intensive care unit to make decisions agree?

BACKGROUND: The complex environment and technology of intensive care unit (ICU) care may impair the ability of patients to participate in medical decision making or give informed consent. We studied the agreement of the intuitive assessments of residents and nurses of ICU patients' cognition, judgment, and decision-making capacity, and whether those assessments agreed with abbreviated formal mental status testing. METHODS: Using a prospective survey case study, we assessed 200 English-speaking patients within 24 hours of their ICU admission. Formal assessment of cognition, judgment, and insight was performed by a research assistant. We obtained independent intuitive ratings by nurses and residents of patient cognition, judgment, and ability to participate in medical decision making or give informed consent. RESULTS: Residents' and nurses' assessment of cognition and judgment showed a high degree of agreement with weighted ks of greater than 0.76. Assessments of cognition by residents and nurses agreed with Folstein Mini-Mental State Examination in 70% and 73.6% of cases, respectively. Forty percent of the population had an unimpaired Mini-Mental State Examination score of greater than 23, and an additional 12% of the subjects were mildly impaired with scores of 20 to 23. When asked whether they would approach patient or family for consent for an invasive procedure, nurses and physicians said they would request informed consent from 66% and 62% of the patients, respectively. CONCLUSIONS: Residents and nurses caring for patients newly admitted to the ICU agree in their assessment of cognition, judgment, and capacity to participate in medical decision making, and are not unduly influenced by ventilator status. Their assessments correlate highly with abbreviated formal mental status testing.     

Clinical trial enrollers vs. nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project

The Recruitment and Enrollment Assessment in Clinical Trials (REACT) was a National Heart, Lung, and Blood Institute (NHLBI)-sponsored substudy to the Cardiac Arrhythmia Suppression Trial (CAST). Two-hundred-sixty (260) patients who enrolled in CAST and 140 partially or fully eligible patients who did not enroll were compared across several parameters, including demographic variables, disease severity, psychosocial functioning, health beliefs, recruitment experience, and understanding of informed consent procedures used in CAST. Significant predictors of enrollment included several demographic variables (e.g., being male, not having medical insurance), episodes of ventricular tachycardia, and health beliefs (e.g., extra beats are harmful, a higher degree of general health concern). Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients. In the multivariate model, the key variables that emerged were the patient's reading of the informed consent form and the patient's lack of medical insurance. These results suggest that (1) the clinical trial staff's interaction with the patient and the time when recruitment is initiated contribute significantly to the decision to enroll; and (2) it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage. Some of the significant variables are modifiable, suggesting interventions that may increase enrollment rates in future trials.     

Burnout as a clinical entity--its importance in health care workers

Burnout, viewed as the exhaustion of physical or emotional strength as a result of prolonged stress or frustration, was added to the mental health lexicon in the 1970s, and has been detected in a wide variety of health care providers. A study of 600 American workers indicated that burnout resulted in lowered production, and increases in absenteeism, health care costs, and personnel turnover. Many employees are vulnerable, particularly as the American job scene changes through industrial downsizing, corporate buyouts and mergers, and lengthened work time. Burnout produces both physical and behavioural changes, in some instances leading to chemical abuse. The health professionals at risk include physicians, nurses, social workers, dentists, care providers in oncology and AIDS-patient care personnel, emergency service staff members, mental health workers, and speech and language pathologists, among others. Early identification of this emotional slippage is needed to prevent the depersonalization of the provider-patient relationship. Prevention and treatment are essentially parallel efforts, including greater job control by the individual worker, group meetings, better up-and-down communication, more recognition of individual worth, job redesign, flexible work hours, full orientation to job requirements, available employee assistance programmes, and adjuvant activity. Burnout is a health care professional's occupational disease which must be recognized early and treated.