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At least 811 records · Page 45Linked to original sources
PubMed1997

Informed consent--survey of Auckland, N.Z. anaesthetists' practice and attitudes.

Auckland anaesthetists were surveyed. Of these, 68% obtain written informed consent, 67% are familiar with the New Zealand Medical Council's statement on informed consent, and 57% believe that they conform with this statement in their practice. 4% of anaesthetists always warn their patients of the possibility of death, 9% never do. 87% warn of minor complications such as vomiting, 28% warn of possible awareness, 27% of possible paralysis with spinal or epidural. 83% felt that some form of risk-disclosing anaesthetic information leaflet would be of value for elective patients. After perusing a proposed information leaflet, 40% answered "yes" they would be happy for it to be combined with the non-risk-specific anaesthetic information currently given to patients, 23% answered "yes, with reservations", 18% answered "yes, if modified first", 13% "no, only if the patient asks to know more about risks,", and 5% "no, not to any patient".

Anesthesiology↗
PubMed1997

Resist and redirect: physicians respond to breast cancer informed consent legislation.

During the 1980s, former breast cancer patients initiated efforts to introduce Breast Cancer Informed Consent legislation in twenty-two state legislatures. Their general intent in proposing this legislation was to insure that women patients were included in the decision-making process regarding their breast cancer treatment. A qualitative analysis of the reactions of medical professional organizations to these efforts revealed a pattern of change over time. Because professionals were not aware of early efforts for Breast Cancer Informed Consent, these met little or no resistance. Subsequent efforts in the early 1980s were met with organized resistance; physicians' organizations responded to the legislation as if it were a threat to their professional autonomy. By the middle of the decade, professionals had co-opted the efforts, shaping the legislation to their benefit. The challenge to physician authority that former breast cancer patients mounted had mixed results, but ultimately illustrated that professions are quite effective at retaining power.

Attitude of Health Personnel↗
PubMed2005

Increasingly informed consent: discussing distinct aspects of psychotherapy at different points in time.

Psychologists are ethically obligated to obtain informed consent to psychotherapy "as early as is feasible" (American Psychological Association, 2002, p.1072). However, the range of topics to be addressed includes both information that may be immediately and uniformly applicable to most clients via policy or rule, as well as information that is not immediately presentable because it varies widely across clients or emerges over time. In this study, licensed psychologists were surveyed regarding the earliest feasible point at which they could provide information regarding specific aspects of psychotherapy. Results indicate that, although psychologists believe that they are capable of presenting some information, such as payment and confidentiality policies, at the outset, they believe that a discussion of more substantive issues, such as psychotherapy duration, goals, orientation, and activities, can take place only after some therapy has transpired. Implications are discussed regarding the process and event models of informed consent.

Attitude of Health Personnel↗
PubMed1999

Informed consent and general surgeons' attitudes toward the use of pain medication in the acute abdomen.

To determine general surgeons' attitudes about the use of pain medications in the acute abdomen, a questionnaire was mailed to all practicing general surgeons in Iowa. The questionnaire sought to determine the frequency with which pain medications were administered either before informed consent was obtained or before the patient with an acute abdomen was examined, and, in cases when pain medications were withheld, the reasons for withholding. The response rate was 72% (131 of 182). Seven percent of patients with an acute abdomen received pain medications by a general surgeon before being seen and 22% received pain medication by another physician in the emergency department (ED). Fifty-three percent of general surgeons responded that they believe pain medications preclude a patient from signing a valid informed consent; 78% reported that concerns about informed consent enter into their decision to withhold pain medications. Sixty-seven percent agreed that pain medications interfere with diagnostic accuracy, and 82% consider diagnostic accuracy when deciding to withhold pain medication.

Abdomen, Acute↗
PubMed1984

Informed consent in emergency settings.

It is often difficult for emergency physicians to comply with the doctrine of informed consent. Patients suffering true emergencies require immediate treatment, and patients who are unable to give consent, because they are either incompetent or underage, are seen frequently in emergency departments. We examine the legal requirements of informed consent in emergency settings, with specific examples illustrated by Connecticut statutes General guidelines for developing departmental policies are suggested.

Adolescent↗
PubMed2003

[Evaluation of capacity for informed consent in psychiatric and neurological patients--proposal of a stepwise decisional procedure].

Evaluation of capacity for informed consent in psychiatric and neurological patients is assuming increasing importance in clinical practice. After a brief description of legal aspects, a procedural algorithm is presented for evaluation of capacity concerning consent of patients in medical treatment and procedures. This evaluation is based on the investigation and documentation of understanding, voluntariness, and decisional capacity. Relevant deficits of only one of these components in the evaluative procedure exclude capacity for informed consent. The outlined approach is compared with international proposals and discussed with regard to its application in clinical practice.

Decision Making↗
PubMed1985

Informed consent in psychiatric research: preliminary findings from an ongoing investigation.

Preliminary findings from an investigation of informed consent processes in four psychiatric research projects (two being carried out at a university medical center and two at a public psychiatric hospital) are reported. Study methods include the systematic observation of investigator/subject information disclosure sessions using audio and videotape, as well as the use of standardized interaction rating forms and subject understanding interviews. In an attempt to determine if subjects' understanding of research can be improved through increased subject education, several modes of information disclosure are compared. Partial results from the public psychiatric hospital portion of the investigation suggest low subject understanding in many areas with subjects often demonstrating difficulty differentiating between treatment and biomedical research. Subjects' problematic understanding of research purposes and methodology was compounded by investigator disclosures which often emphasized the therapeutic, personalistic and nonresearch-oriented aspects of the project. Nevertheless, even when information disclosures were significantly improved, subject understanding in many cases continued to be low--suggesting that additional factors aside from the quality of investigator disclosure are involved in psychiatric subjects' comprehension and understanding of research. The implication of these findings for informed consent, regulation of biomedical research and the protection of human subjects are discussed.

Antidepressive Agents↗
PubMed2002

Informed consent in functional endoscopic sinus surgery.

OBJECTIVES: Functional endoscopic sinus surgery (FESS) is one of the more common procedures performed by otolaryngologists. Before performing FESS, surgeons are obligated to discuss the procedure and its risks through the process of informed patient consent. The study identifies current practices in informed consent for FESS and formulates guidelines for informed consent for FESS. STUDY DESIGN: Survey. METHODS: Surveys were sent to 1000 American Academy of Otolaryngology-Head and Neck Surgery members in the United States. Surveys inquired about current informed consent practices related to FESS. RESULTS: Three hundred forty-six surveys were returned. Nearly 60% of respondents thought that 1% incidence of a complication warrants a discussion with patients. The percentage of respondents who discuss specific risks were as follows: bleeding, 96.7%; infection, 84.8%; cerebrospinal fluid leak, 99.1%; orbital injury, 96.7%; smell changes, 40.2%; cerebrovascular accident, 17.9%; myocardial infarction, 81%; and death, 28.0%. CONCLUSIONS: The study suggests that there is variability in specific informed consent practices for FESS among otolaryngologists. It also suggests that the incidence or severity of a complication does not necessarily correlate with whether or not it is mentioned during the informed consent process. The authors think that practicing otolaryngologists may be able to use this information to improve their consent practices.

Cross-Sectional Studies↗
PubMed1996

The impact of informed consent on patient interest in prostate-specific antigen screening.

BACKGROUND: Because of the many uncertainties surrounding screening for prostate cancer, authorities recommend that patients be involved in the screening decision. OBJECTIVE: To determine the impact of informed consent on patient interest in undergoing prostate-specific antigen (PSA) screening. METHODS: Men 50 years or older with no prior PSA testing and no history of prostate cancer presenting to 1 of 4 university-affiliated primary care practices were eligible for enrollment. Patients were randomized to receive either a scripted informational intervention simulating an informed consent presentation (intervention group, n = 103) or a single sentence about the PSA (control group, n = 102). The main outcome measure was patient interest in undergoing PSA screening measured on a 5-point Likert scale. RESULTS: Patients who received the informational intervention were significantly less interested in undergoing PSA screening than controls (mean difference in interest, 0.8 on 5-point scale, P < .001). Informed patients were much less likely to indicate high interest in screening (odds ratio, 0.34; 95% confidence interval, 0.19-0.60; P < .001). In a multivariate model, family history of prostate cancer was associated with increased interest and advancing age with decreased interest in PSA screening, but the informational intervention remained the strongest predictor of interest. CONCLUSIONS: Among primary care patients of predominantly lower socioeconomic status, those who received informed consent were significantly less interested in PSA screening than those who did not. For physicians who offer the PSA as a screening test, this finding highlights the importance of apprising patients of the associated benefits, burdens, and uncertainties and allowing them to participate in the screening decision.

Aged↗
PubMed1993

Informed consent in demented patients: a question of hours.

Dementia, and especially Alzheimer's disease is today the subject of endless research, most of it including some kind of prolonged physical treatment. When considering such treatment, one first has to deal with the quality and validity of the consent of the demented patient suspected of impaired judgment. The term 'informed consent' involves at least two types of decisions: one regarding short-term intervention like a surgical procedure; the other concerns long-term intervention, like treatment by a new kind of drug intended to improve memory. In the latter case, the informed consent attributed to the patient raises both clinical and legal questions regarding validity of the continuing authorization given to the physician--a question which should also be examined in terms of time in fluctuating conditions, like dementia. What are the tests required to determine competency? What determines the grade of competency required in different types of research with different benefit-risk ratios? Do the changes in the cognitive function of the patient during the research demand constant assessment of competency. Where is the 'cut-off' point that dictates reassessment of the patient's consent and who is legally and practically responsible to identify this condition and decide whether to proceed? Finally, what are the alternative procedures that might simplify the decision-making process in fluctuating conditions without affecting the rights and autonomy of the patient? This article proposes several possible solutions to these legal and ethical dilemmas.

Aged↗
PubMed1998

Informed consent for clinical trials: in search of the "best" method.

OBJECTIVE: To review the literature on comparisons between different methods of obtaining informed consent for clinical trials. DESIGN: Eight hundred and twelve articles were traced, in the process of conducting a systematic review of the ethics of clinical trials, by searching a number of sources: bibliographic databases (Medline, Psychlit and BIDS science and social science indices), hand searches, personal contacts, an original collection and a systematic follow-up of reference lists. Fourteen research reports were found which provided comparative data on different methods of obtaining informed consent. Eleven of these used a randomised design. Studies were classified according to three outcome measures (anxiety, consent rate and understanding). RESULTS: The results of the various studies suggest that giving people more information and more time to reflect tends to be associated with a lower consent rate. There seems to be an optimal level of information about side-effects such that patients are not overburdened by detail, while grasping the most important risks. More information in general is associated with greater awareness of the research nature of the trial, voluntariness of participation, right to withdraw and (available) alternative treatments. This result does not, however, extend to explanations of the concept of randomisation on which the literature is contradictory--sometimes more information is associated with increased understanding of the concept and sometimes it is not. Although divulging less information seems to be associated with less anxiety, there is evidence of an interaction with knowledge--high levels of knowledge are significantly associated with less anxiety, irrespective of consent method. The more that patients know before they are invited to participate in a trial, the better equipped they are to cope with the informed consent procedure. CONCLUSION: There is some evidence to suggest that there is an optimal amount of information which enhances patient understanding and which might, in turn, reduce anxiety. However. the studies were not altogether conclusive. More work needs to be carried out, especially on public understanding of science and on how different ways of explaining scientific concepts affect that understanding.

Clinical Trials as Topic↗
PubMed1992

Informed consent in oral and maxillofacial surgery: a study of its efficacy.

This paper explains the legal principle of informed consent in surgery and presents the results of a study of the efficacy of verbal information as part of the informed consent process in oral and maxillofacial surgery, using third molar surgery as a model. The results showed that patients were most likely to recall being warned about pain and swelling and less likely to recall being warned about trismus, dysaesthesia of the lip and dysaesthesia of the tongue. The last two are complications with important medicolegal implications. It appeared to make no difference to their recall if they were given this information on a preadmission clinic or on admission. The implications of these findings are discussed.

Adult↗
PubMed1983

Obtaining informed consent for research with psychiatric patients. The controversy continues.

Over the past decade the subject of informed consent has become increasingly important for general and forensic psychiatry. Viewed by many as the preeminent means by which psychiatric and other medical patients can secure their rights to full participation in treatment decision-making in therapeutic settings, informed consent has also gained general acceptance as an ethical and legal requirement for enrolling patients in human experimentation. The authors explore the many facets of this controversial issue.

Child↗
PubMedDate not supplied

Using continuous improvement to obtain and document informed consent.

This article describes a continuous improvement team's activities to improve the process of obtaining and documenting informed consent and to decrease the incidence of communication errors during the surgical scheduling process. Integrating surgeons' informed consent process at their office sites with hospital records was the key to success.

Appointments and Schedules↗
PubMedDate not supplied

Residents seeking informed consent: Are they adequately knowledgeable?

PURPOSE: The purpose of this study was to determine the extent to which first-year surgical residents are prepared to obtain informed consent from patients. The study was designed to answer the following research questions: 1) Are first-year residents who are asked to obtain informed consent sufficiently knowledgeable about the risks, benefits, and alternatives of the procedures? 2) Can first-year residents accurately answer the questions patients may pose about these procedures? METHODS: First-year residents (n = 18) were asked to list the risks, benefits, and alternatives for open inguinal hernia repair, laparoscopic cholecystectomy, total thyroidectomy, esophagogastrectomy, and abdominal aortic aneurysm repair, assuming the procedures were elective on otherwise healthy individuals. Residents were also asked to answer questions that patients may pose about each of the procedures. The basic minimum risks, benefits, and alternatives to be listed and answers to the questions were validated by asking faculty representing general (n = 6) and vascular (n = 3) surgery to complete the questionnaires. RESULTS: Few residents were able to correctly list all risks, benefits, and alternatives of any of the procedures. Less than one-half of the questions that patients may ask about the procedures were correctly answered. CONCLUSIONS: Even though first-year residents are commonly obtaining consent for surgical procedures, many are unable to provide patients with the correct descriptions of the risks, benefits, and alternatives. Nor were they able to correctly answer common questions. Surgical faculty must take more time to educate first-year residents on the appropriate issues in informed consent for the procedures being performed.

Journal Article↗
PubMed1989

The ethics of informed consent: an overview.

For the past twenty years patient consent to medical intervention has, increasingly, been required to be informed. For consent to be fully informed, the physician has to address five areas: 1) the nature; 2) purpose; 3) risks; 4) benefits of; and, 5) availability of alternatives to the proposed procedure. There are four exceptions to these requirements: 1) emergency; 2) waiver; 3) incompetence; and, 4) therapeutic privilege. There are ethical issues related to each of these nine dimensions of informed consent. Additionally, three issues pertinent to the discussion have been neglected in the literature: confidentiality, the cost of care and consent under duress. All these issues need to be considered in the context of the discrepency between the current theory and the current practice of informed consent.

Confidentiality↗
PubMed1996

Informed consent in human experimentation before the Nuremberg code.

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

Codes of Ethics↗
PubMed1985

Informed consent in dentistry.

This article discusses the doctrine of informed consent and its impact on the practice of dentistry. It summarizes relevant case and statutes, and stresses the uncertainty that prevails in this area of the law. A procedure is set forth for dentists to follow on an everyday basis that will assist them in the event that they become involved in litigation based on allegations of uninformed consent.

Consent Forms↗