Showing papers on "Informed consent published in 1993"

Factors affecting quality of informed consent.

Abstract: OBJECTIVE--To examine the factors influencing quality of informed consent. DESIGN--Prospective study comprising interviews with patients and patients' completing standard questionnaires. SETTING--Academic surgical unit of large teaching hospital. PATIENTS--265 patients undergoing intrathoracic, intraperitoneal, and vascular surgical procedures. Of these patients, 192 have been followed up for six months. MAIN OUTCOME MEASURES--Patients' recall of information at various points in the study; this score was compared by age, provision of written information, cognitive function, intelligence quotient (IQ), mood state and personality traits, and health locus of control. RESULTS--The patients were best informed immediately after signing the consent form and from then on recall of information deteriorated. A total of 172/250 (69%) patients admitted to not reading the consent form before signing it. Old age adversely affected recall of information at all assessment points. Impaired cognitive function reduced information recall only during the stay in hospital. Patients with above average IQs handled information better than those with a lower IQ except immediately after the signing of consent forms. Patients with an internal locus of health control (that is, those who believed their health to be in their own control) were better informed than those with an external locus of health control. Operation information cards improved recall only on the day of discharge. CONCLUSION--Elderly patients and patients with below average IQ, impaired cognitive functions, and an external locus of control have poor information recall. Written information may be more useful if given before admission to hospital.

Who's afraid of informed consent?

Abstract: OBJECTIVE--To test the assumption that patients will become unduly anxious if they are given detailed information about the risks of surgery in an attempt to obtain fully informed consent. DESIGN--Preoperative anxiety assessed before and after patients were randomly allocated an information sheet containing either simple or detailed descriptions of possible postoperative complications. SETTING--Four surgical wards at two Sheffield hospitals. SUBJECTS--96 men undergoing elective inguinal hernia repair under general anaesthesia. MAIN OUTCOME MEASURE--Change in anxiety level observed after receiving information about potential complications. RESULTS--Detailed information did not increase patient anxiety (mean Spielberger score at baseline 33.7 (95% confidence interval 31.3 to 36.2), after information 34.8 (32.1 to 37.5); p = 0.20, paired t test). A simple explanation of the facts provided a statistically significant degree of reassurance (mean score at baseline 34.6 (31.5 to 37.6), after information 32.3 (29.8 to 34.9); p = 0.012), although this small effect is likely to be clinically important only in those whose baseline anxiety was high (r = 0.27, p = 0.05). CONCLUSIONS--In men undergoing elective inguinal hernia repair a very detailed account of what might go wrong does not increase patient anxiety significantly and has the advantage of allowing patients a fully informed choice before they consent to surgery, thus reducing the potential for subsequent litigation.

Human experimentation and human rights.

Abstract: ion of the research question tends to objectify the person-patient.27 It does so to a significantly greater extent than in therapeutic interactions, even though similar problems of objectification arise in therapeutic settings when doctors attend too much to the disease of the body in the bed and not to the person before them. The readiness with which clinical research continues to be viewed as an extension of clinical practice, both similarly grounded in the millennia-long Hippocratic commitment to the welfare of the individual patient, overlooks the transformation of medical practice since the age of medical science. Throughout most of medical history, research was limited to careful bedside observation of the effects of innovative treatments, with the interests of the individual patient as a polestar. In today's world, on the other hand, the interests of patient-subjects may yield to varying extents to the interests of science. This revolutionary development has not been accompanied by a thoroughgoing re-examination of physicians' ethical obligations in a postHippocratic age. Examples in point are the many cooperative clinical trials, generally randomized clinical trials (RCTs),30 in which institutions throughout the 27. See infra note 66 and accompanying text. 28. In a conversation between a senior physician and a medical intern, the former asked how much the intern knew about "patients as human beings." The question led to a rather nonproductive exchange which the intern ended abruptly with the exasperated comment: "I cannot answer your questions. You're interested in patients. I'm interested in the disease in the body in the bed." RAYMOND S. DUFF & AUGUST B. HOLLINGSHEAD, SICKNESS AND SOCIETY 128 (1968). 29. Medical practice has become transformed in other ways as well which should have led to greater involvement of patients in the medical decision-making process: Medicine's recent ascent from empiricism to science has brought forth spectacular technologic advances in the diagnosis and treatment of disease. Today the numerous options available for the treatment of many diseases allow patients greater choice. Moreover, the introduction into medicine of scientific reasoning, aided by the results of carefully conducted research, permits doctors to be more discriminating between knowledge, ignorance and conjecture in their recommendations for or against a treatment. For the first time in medical history, it is possible, even medically and morally imperative, to give patients a voice in medical decision making; possible, because knowledge and ignorance can be better specified; medically imperative, because a variety of treatments are available, each of which can bestow benefits or inflict harm; morally imperative, because patients, depending on the lifestyle they wish [to lead) after treatment, must be given a choice. Duty and Caring, supra note 20, at 189. 30. The randomized clinical trial (ReT) is generally regarded as the gold standard for the evaluation of therapeutic agents. The ReT has four main elements. 1) It is "controlled," i.e., one part of the subject population receives a therapy that is being tested while another part, as similar as possible ... , receives either another therapy or no therapy.... 2) The significance of its results is established through statistical analysis. . .. 3) When it is feasible, a double-blind

Confidential Health Services for Adolescents

Abstract: DURING the past 20 years rates of suicide,1illicit drug use,2sexually transmissible diseases (STDs),3and births to single mothers4have increased dramatically among adolescents. The changing nature of adolescent morbidity and mortality makes it critical that they receive medical care on a timely basis, and that barriers to care are removed.5One such barrier for many adolescents is their concern about whether sensitive information shared in private with their physician will remain confidential. See also p 1404. This report reviews adolescents' need for confidential health services and support by physicians and organized medicine for confidential care. Examined are two major barriers to confidential medical care: the prerogative to provide informed consent for medical treatment and payment for health services. The report describes how physicians can balance parental involvement and adolescents' needs for privacy in health care decisions and strategies to allay parental concerns and

Parental knowledge and attitudes toward discussing the risk of death from anesthesia

Abstract: There is considerable debate as to the extent of disclosure of risks when obtaining informed consent for anesthesia, especially when discussing with parents the rare risk of death of healthy children about to undergo elective, outpatient surgery. In Part I, we attempted to determine parents' knowled

Informed consent. The whole truth for patients

Abstract: Two misconceptions about informed consent concern the difference between the legal and moral justification for it, and the rationale for more rigorous consent for research than for "standard" therapy. Legally, informed consent for therapy is a risk-management tool that functions essentially as a release of liability. If the patient is informed of all expected or potential side-effects or toxicities of a treatment, he cannot sue because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability, but to help the patient make the best decision. These two goals are not necessarily incompatible, but they often lead to different attitudes toward informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management, then informed consent forms should be encyclopedic, providing the "whole truth" to patients. This would, however, not meet the moral goals of shared decision-making, because few patients could make sense of such data. Informed consent for research often leads to a different paradox. If a new therapy becomes available and a physician thinks it may benefit a patient, the physician may use it in an uncontrolled manner. This does not require the approval of an institutional review board and does not need the more rigorous approach to informed consent generally associated with research. In contrast, if the physician wants to evaluate the effectiveness of the same therapy carefully and intends to gather data to do so, he will need to describe his protocol, defend it before an institutional review board, and provide a more carefully written and closely scrutinized informed consent form. The paradox derives from the fact that the patient in the first, uncontrolled situation is inevitably at higher risk of harm than the patient in the second situation. The distinction between informed consent for treatment and informed consent for research is based on a distinction that is growing ever more cloudy and ever less relevant to the moral goals that informed consent seeks to achieve. Current standards for informed consent for research are, in many ways, counterintuitive and probably counter-productive.

Determining the capability of individuals with mental retardation to give informed consent.

Abstract: Interviews were conducted for individuals without mental retardation and with mild or moderate mental retardation in order to determine their capability to provide informed consent to hypothetical treatment vignettes. Protocols were developed to permit structured interviews, and standardized scoring procedures were devised to provide reliable determinations. Use of these procedures resulted in highly reliable ratings across different clinicians, and the likelihood of being determined capable to provide consent was positively related to level of intellectual functioning. Results point to the need to educate individuals with mental retardation about treatment situations and to balance protection from harm with self-determination.

Can children withhold consent to treatment

Abstract: A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.

Minors' assent, consent, or dissent to medical research.

Abstract: features of youths' thinking also need to be considered when determining whether to seek assent and in pursuing it. The young person from whom assent is requested must be able to recognize and express fulfillment of his or her rights concerning participation in or withdrawing from the research. Other questions of voluntariness also occur when seeking assent. For example, should minors' conformity or nonconformity to the influence of authority figures be relevant to assent? Another issue is that

Do Clinical and Formal Assessments of the Capacity of Patients in the Intensive Care Unit to Make Decisions Agree

Abstract: 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 κs 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. (Arch Intern Med. 1993;153:2481-2485)

The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation

Abstract: The Nazi Doctors and the Nuremberg Code , an excellent and well-organized reader edited by George Annas and Michael Grodin, is about the "Doctors' Trial," convened to examine the gross abuses in human experimentation in Nazi Germany. From this trial emerged the Nuremberg Code, intended to establish the boundaries of research ethics and to set the agenda for future discussions of the ethical and legal issues involved in the conduct of human experimentation. The essays in this volume, by historians, philosophers, lawyers, and medical researchers, address the meaning of the Code and its impact—on American and international law, on current medical research practices and policies, and on ethical perspectives. The authors vary in their interpretations, reflecting continued disagreement over the actual influence of this Code, the meaning of such principles as informed consent, and the relevance of its guidelines in the context of current medical research and the urgency of problems

The request for assistance in dying. The need for psychiatric consultation.

Abstract: Background. Public initiatives and legislative proposals have increased the likelihood that some states will legalize euthanasia and assisted suicide as a means of ending the suffering of patients with terminal illness. However, suggested safeguards that would guide physicians in such cases have not properly addressed the need to evaluate psychosocial factors that could motivate patients' requests for premature death. Methods. Four cases of patients with cancer who expressed a wish to end their lives prematurely are described. These cases were evaluated with regard to mental and emotional functioning. Results. Pain and suffering, organic mental disease, depression, and personality issues play significant roles in patients' requests for assistance in dying. Conclusion. Comprehensive psychosocial assessment is needed when evaluating requests for assistance in dying. This assessment may reveal hidden problems or conflicts that affect rational decision making, a prerequisite to informed consent for any procedure or intervention. Cancer 1993; 722786-91.

Informed consent: using a structured interview changes patients' attitudes towards informed consent.

Abstract: Patients want to know more about their condition and its proposed treatment. Gaining patients' confidence before treatment reduces the changes of their seeking legal redress for an unexpected outcome. As part of a prospective study of informed consent for surgery we have assessed the attitudes of patients towards informed consent when different types of consent interview are used. We found that most patients are happy to do as their doctor advises but think the informal consent interview is important because it gives them information; they also want to know about most, but not all, complications of the procedure. One quarter worried about the anaesthetic, about one eighth worried about 'not waking up' and similar proportions worried about complications and other things such as pain and nausea. Most patients think that the consent form is a legal document. In addition patients who had an informal interview felt obliged to sign the consent form and thought it had medicolegal implications. In contrast those who had a structured interview felt less obliged to sign the consent form and more involved in the decision to operate.

Psychological factors in cosmetic plastic surgery: recent developments in patient care.

Abstract: The goal of cosmetic surgery is to facilitate improvement in the patient's psychological functioning primarily by modifying the patient's body image. This article updates the professional literature on recent developments in the study of the psychology of cosmetic plastic surgery.

Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers.

Abstract: In this paper some of the general issues surrounding recently published guidelines for the practice of research ethics committees are outlined, concentrating in particular on the difficulties raised by research with psychiatric patients. Research is distinguished from ordinary clinical practice by the intention to advance knowledge. So defined, research with psychiatric patients should be governed by the same four principles as research with any other group--knowledge, necessity, benefit and consent. In applying these principles, however, particularly the principle of consent, many acute difficulties are raised by psychiatric patients. A number of proposals for addressing these difficulties are discussed. It is suggested that, notwithstanding the value of published guidelines, and the help that may be available from research ethics committees, the primary responsibility for maintaining high standards of practice in research rests with research workers themselves.

Screening and informed consent.

Abstract: Before they participate in a screening program, patients must give informed consent. To do so, they need to understand the risk of a false positive result and the invasive procedures that may follow it. Rather than merely transmit expert recommendations, physicians should match the appropriate level of screening with each patient's unique attitude toward the risks of disease and the risks associated with the screening procedures. But to inform patients, physicians themselves must be informed. Stange et al. recently discovered that family physicians are more interventionist in their screening than the U.S. Preventive Services Task Force recommends1. The study . . .

Innovations in surgery. A proposal for phased clinical trials

Abstract: There is an urgent need for the staged, controlled, introduction of new technology and new procedures to surgery. A classification system in four stages is proposed, which would allow for prospective assessment of new devices or methods before they are released for use by the surgical community. The proposal recognises the unique nature of a surgical operation and its learning curve. The issues of randomisation and of informed consent are discussed, and are shown not to be barriers to clinical trials, but necessary adjuncts to orderly testing. The importance of continued surveillance of innovations is emphasised.

Maturity of children to consent to medical research: the babysitter test.

Abstract: The age of maturity of children to consent for medical research is under debate, as different authorities regard the capacity of young teenagers as either satisfactory or not to grant consent without parental participation in the process. The present paper contrasts the generally accepted guideline for ethics in paediatric research in Canada with what the same children are allowed and expected to be able to do as babysitters. This comparison reveals deep incongruences in the way the maturity of the same children is appreciated for two different tasks.

Postmortem procedures in the emergency department: using the recently dead to practise and teach.

Abstract: In generations past, it was common practice for doctors to learn lifesaving technical skills on patients who had recently died. But this practice has lately been criticised on religious, legal, and ethical grounds, and has fallen into disuse in many hospitals and emergency departments. This paper uses four questions to resolve whether doctors in emergency departments should practise and teach non-invasive and minimally invasive procedures on the newly dead: Is it ethically and legally permissible to practise and teach non-invasive and minimally invasive procedures on the newly dead emergency-department patient? What are the alternatives or possible consequences of not practising non-invasive and minimally invasive procedures on newly dead patients? Is consent from relatives required? Should doctors in emergency departments allow or even encourage this use of newly dead patients?

Ethical and social issues in presymptomatic testing for Huntington's disease: A European Community collaborative study

Abstract: An analysis of social and ethical aspects of presymptomatic testing for Huntington's disease has been carried out, based on data on linked DNA markers, from four major testing centres in different European Community countries (Belgium, Italy, Netherlands, and United Kingdom). Information was available on 603 applicants, with 213 final results given, of which 32% gave an increased risk. A series of specific issues and problems were documented systematically for all applicants, results being given on frequency of occurrence and illustrated by individual case histories. The principal issues could be grouped as problems of inappropriate referral, problems involving relatives, and problems relating to disclosure of results. At least one important problem was encountered in 46% of applicants, emphasising the importance of expert counselling, preparation, and support of applicants, and of close liaison between clinical, counselling, and laboratory staff. The extensive and detailed information available for Huntington's disease from this and other studies will be of considerable value in relation to genetic testing for other late onset genetic disorders and will be even more relevant to Huntington's disease now that specific mutation analysis is possible for this disorder.

Informed consent: a case for more education of the surgical team.

Abstract: A questionnaire was given to 37 members of staff of the Department of Surgery, Addenbrooke's Hospital, Cambridge, in order to determine whether their knowledge was adequate to give accurate information to patients regarding operations and thus to obtain properly informed consent for that operation. Each participant was asked to estimate the 24-h and 30-day mortality for five common elective operations. A wide range of answers was given for operations by all groups. Estimates of 24-h mortality after unilateral inguinal herniorrhaphy differed between staff grades by a factor of 3, but estimates of 24-h mortality after thyroidectomy differed by a factor of 100 between consultant surgeons and staff nurses. Our findings suggest that some members of the surgical team have insufficient knowledge about common operations to obtain properly informed consent from patients.

Biomedical and Behavioral Research in Nursing Homes: Guidelines for Ethical Investigations

Abstract: As nursing homes become increasingly important sites for biomedical and behavioral research, researchers must address the ethical problems of increased vulnerability and the high prevalence of mental and physical disorders in the nursing home population. Obtaining valid informed consent is but one of the many difficult issues that confronts the investigator in the nursing home. Efforts should be made to involve nursing home residents, as well as family and staff members, in the review of research. The benefits and burdens of research protocols should be equitably distributed, and potential conflicts of interest for staff members and physicians should be minimized or their potential adverse impact ameliorated. Appropriate attention to these ethical concerns may facilitate nursing home research while still safeguarding vulnerable residents. We offer proposed guidelines for the ethical conduct of research in nursing homes in an effort to stimulate discussion among investigators, nursing home staff and residents, residents' families, and ethicists.

Readability of informed consent forms for use with iodinated contrast media.

Abstract: Informed consent forms used before intravenous administration of contrast media by both private practice (Pennsylvania Blue Shield) and academic (Association of University Radiologists) physician groups were analyzed to evaluate for readability and content. Most of the 160 consent forms required at least a high school education to be understood; 10 (6%) required a college education. Consent forms from academic institutions tended to be longer and contain more problems with sentence structure than those from private practice. Consent forms from both groups tended to have a weak, wordy writing style. Although most of the consent forms discussed at least some of the potential adverse reactions from intravenous contrast media, 37 (23%) made no mention of any potential adverse reaction. Indeed, 25 (16%) made no mention of contrast media at all. Only 12 (8%) consent forms included a discussion of nonionic contrast media. The authors provide sample consent forms that cover the common risks of ionic and nonionic ...

The ethics of experimental heroin maintenance.

Abstract: In response to widespread concern about illegal drug use and the associated risk of the spread of HIV/AIDS, a study was undertaken to examine whether it was, in principle, feasible to conduct a trial providing heroin to dependent users in a controlled manner. Such a trial involves real ethical issues which are examined in this paper. The general issues examined are: should a trial be an experiment or an exercise in public policy?; acts and omissions; countermobilization; termination of a trial, and payment for drugs and for a trial. The specific issues examined are: selection of trial participants; privacy; issues for staff working on a trial; coupling the trial with other treatment, and issues for researchers. A number of alternative approaches to the various ethical issues are presented and discussed.