The informed consent process in older patients who developed delirium: a clinical epidemiologic study

PURPOSE: Delirium, defined as an acute, fluctuating disorder of attention and cognition, is a serious and increasingly common problem for hospitalized older persons. Delirium poses unique ethical challenges for the informed consent process, notably the preservation of patient autonomy in the face of potentially fluctuating decision-making capacity. To clarify these issues, we examined the informed consent process in a group of hospitalized older patients who developed delirium. PATIENTS: Eighty-four hospitalized patients aged >70 years who developed delirium during hospitalization at a large urban teaching hospital. METHODS: We conducted a clinical epidemiologic investigation of informed consent in 173 medical and surgical procedures performed in 84 patients. Clinical researchers carried out detailed cognitive evaluation of patients on or near the consent date. A separate blinded researcher extracted medical record information on the procedures and informed consent process variables. RESULTS: Of 173 procedures, 33 (19%) had no documentation of any consent, and 34 (20%) used surrogate consent. There were no documented assessments of competency/ decisional capacity; cognitive assessments were done in 7 (4%) cases, and legal consults in 2 (1%) cases. Discussion of potential risks of the procedure with patient or surrogate were documented in 61 (35%) cases. In multivariable analysis, independent predictors for failure to obtain consent were presence of delirium (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI] 1.3, 5.3) and less invasive procedure (OR = 5.0, CI 2.0, 12.8). Although cognitive impairment predicted surrogate use, we found that 47% of cases with substantial impairment did not involve use of a surrogate, whereas surrogates signed for 4% of cases with normal mental status near the time of consent. CONCLUSIONS: Our results highlight the ethical challenges that delirium poses for the informed consent process, including the high rate of no consent, lack of cognitive and decisional capacity assessment, and inconsistent surrogate use.     

Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals

CONTEXT: Pedigree diagrams efficiently communicate family information to genetics investigators; however, the publication of pedigrees poses a risk to the privacy and confidentiality of individuals depicted in the diagrams. Two sets of authoritative guidelines have been published to protect the privacy and confidentiality of subjects, but the influence of these guidelines on publication practices for pedigrees is unknown. OBJECTIVE: To determine the attitudes, practices, and experiences of investigators and journals with respect to privacy and confidentiality concerns in the publication of pedigrees. DESIGN: Investigators who have published pedigrees and editors of 26 biomedical journals were surveyed. Journals were reviewed for content in their "information for authors" sections and for documentation of informed consent in articles containing pedigrees. OUTCOME MEASURES: Practices regarding confidentiality and privacy reported by investigators and editors. RESULTS: Of 226 surveys sent to investigators, 177 were returned (78% response rate). Sixty-one investigators (36%) stated that family members were not informed that their pedigree would be published; 131 (78%) do not obtain informed consent specifically for pedigree publication and only 12 (28%) of the 43 who obtained consent obtained consent from all family members depicted. Thirty-two individuals (19%) reported having altered published pedigrees and 14 (45%) of 31 who had altered pedigrees stated that alterations were not disclosed to journals. Of the 14 journals that responded (54% response rate), only 3 reported written policies for managing potentially identifying information. Two journals reported having asked authors to alter pedigrees and 3 stated they had permitted alterations. A review of 5 genetics journals over a 2-year period revealed no documentation of consent for pedigree publication. CONCLUSIONS: Current practices in the publication of pedigrees do not conform with established recommendations and risk the privacy and confidentiality of subjects, often without informed consent. Attempts to address this problem through the alteration of data are being used, although this practice impairs the integrity of scientific communication.     

Documenting informed consent for treatment with neuroleptics: an alternative to the consent form

Clinicians can comply with Ohio state regulations for documenting patients' informed consent for treatment with neuroleptic medication by checking a box in the medical record stating that a periodic discussion of informed consent has occurred and writing a note about the discussion in the narrative record. The authors discuss clinicians' experience with this alternative to the conventional consent form in a large community support agency. Although the approach has been largely successful, implementation has been hindered by some clinicians' incomplete understanding of the informed consent process. Continued training is needed to bring the ideal of informed consent into clinical practice.     

Medicolegal issues and fine needle aspiration of the breast. What you can do to decrease your risk of being sued

Carcinoma of the breast is the most litigated cancer in women. This article discusses steps that can be taken to reduce the risk of being sued. Topics covered include laboratory practices, patient contact, informed consent, documentation, record keeping, interpretive problems, triple test, diligence, and reporting results as well as what to do if sued.     

Legal and ethical considerations of informed consent

The law of informed consent remains ineffective at resolving patient comprehension issues primarily because differing interpretations exist regarding who is responsible for the duty to inform. Court cases continue to set precedents for practicing physicians and other health care providers; however, other measures can be applied for effectual patient advocacy. Health care personnel should rewrite typical consent forms in simpler terms, use larger print, and create duplicate copies. If patients are given copies of the permits they sign, the can reread the forms at home when they are more comfortable. For true autonomy to exist in informed consent for surgical procedures, consent forms should contain patients' primary languages whenever possible, or an adequate interpreter should be made available. Surgeons, nurses, and other health care providers must become aware of their responsibilities related to informed consent for treatment. It is necessary for health care personnel to develop and use effective communication techniques and remember that although some patients are more visually attuned to new information, other patients may benefit more from listening or reading. The cases in this article show that a patient's autonomy is part of the informed consent process and the duty to inform the patient lies with the person performing the procedure. A more important issue, however, involves the patient's comprehension of the information given, because without it, the patient cannot achieve true autonomy in making decisions. Ensuring that all elements of informed consent are met to obtain informed consent will result in fewer malpractice claims, greater patient satisfaction, and an improved professional image. Nevertheless, nurses should make themselves aware of the state laws in which they practice, including their nurse practice acts. They then should advocate for patient rights by encompassing all elements of informed consent.     

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.     

A guide to understanding informed consent

Anesthesia providers are expected to provide information to the patient during the preanesthesia interview that enables the patient to make informed choices. Adequate disclosure during the informed consent process ensures the equalization of the practitioner/patient relationship and the decision-making rights of the patient. Both certified registered nurse anesthetists (CRNAs) and anesthesiologists are not only legally required to provide information that will allow a patient to make an informed judgment about how to proceed with various anesthetic modalities but are also obligated by their standards of practice. This article informs the CRNA about the principles of informed consent so that they can better understand their role in the informed consent process.     

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.     

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.     

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.     

Experimental study on TNF-alpha linked percutaneous isolated hepatic chemoperfusion (PIHP)]

BACKGROUND: This study aimed to establish perceptions of informed consent in patients undergoing surgery for acute abdominal conditions. METHODS: A prospective observational study was carried out using a structured questionnaire-based interview technique in patients undergoing surgery for acute abdominal conditions. Main outcome measures were to establish the effects of pain and preoperative analgesia on informed consent, patient comprehension of planned surgery and the degree of discussion of potential side-effects and complications. RESULTS: Thirty-one of 49 patients perceived that pain did not interfere with their ability to give informed consent. Forty of 48 stated that preoperative analgesia did not impair their ability to give informed consent. Forty-two understood why an operation was being planned but 28 patients stated that there had been no preoperative discussion of any potential side-effects or complications of surgery. CONCLUSION: In this study the majority of patients perceived that they retained the ability to give informed consent despite the effects of pain and analgesia. Although the majority of patients understood why an operation was being planned there is a clear need for improved discussion of potential side-effects and complications.     

Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients

BACKGROUND: The process by which patients are informed and their consent is obtained in phase I trials has thus far been only marginally studied. Since 1986 we have followed an oral procedure, consisting of three consecutive conversations in which the investigator responsible for phase I studies, the research nurse and the patients' relatives and/or friends also participate, followed by the patients signing of a written consent form. It is required that six items of information considered essential by our staff be conveyed to patients by the responsible investigator. Meerwein's model, which defines three main dimensions of the informing process (the information itself, the emotional and interactive aspects), has been studied to ascertain whether it can be applied to evaluate the quality of the information proffered. METHODS: Thirty-two conversations were taped, transcribed and evaluated by one psychiatrist and one psychologist. A quantitative analysis of information was performed by calculating the number of patients to whom the essential items of information had been conveyed. The qualitative analysis was performed by rating on a five-point scoring system, from 1 (very bad) to 5 (excellent), the three dimensions of the informing process for each patient and by calculating for each dimension the mean score of the constituent items. RESULTS: Complete information about the characteristics of the phase I drug and the modalities of the treatment and follow up was given to almost 80% of the patients. All but one of the items of the information dimension scored 3.5 or higher, with the one related to the assessment by the doctor of the patient's understanding at the end of the consultation scoring less than 3 in 53% of the patients. All items of the emotional dimension scored higher than 3.5. Greater difficulty was encountered by the physician with the interactive dimension, the lowest mean scores being reported on the items related to the doctor's awareness of the indirectly expressed anxieties of the patients. In 71% of the consultations the three dimensions of information scored more than 3 and balanced one another, indicating a successful consultation by the Meerwein model. CONCLUSIONS: The informed consent procedure applied was satisfactory from a quantitative point of view, and the main items of information were acceptable to the patients. Meerweins's model proved to be applicable and useful for identifying pitfalls in communication. Greater attention should be paid to the indirect messages and implied criticisms of the patients to improve their participation in decision making. Physicians should become more skillful in providing adequate information and improve their methods of communication.     

Informed consent in capital sentencing evaluations: Targets and content.

Far-reaching implications are associated with psychological evaluation procedures in capital cases. The gravity and complexity of evaluations in a death penalty context call for an expanded perspective on informed consent disclosures from psychologists who perform capital sentencing assessments. A rationale is presented for making defense counsel the primary target for these expanded informed consent procedures. Informed consent obligations of prosecution-retained psychologists primarily involve issues of notice, with a proposal for proactive acknowledgement of limitations in the evaluation procedures. Issues for informed consent discussion between defense-contacted psychologists and defense counsel include attitudes, theoretical perspectives, and professional history of the psychologist; logistics of the evaluation; and parameters and procedures of the evaluation. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Computer-based multimedia in plastic surgery education

Computer animation complements text explanation, image documentation, and graphic analysis techniques. It is compatible with the development of interactive multimedia science. Computer animation may emerge as a critical tool to assist in the efficient processing and analysis of greater volumes of educational data in plastic surgery training. At St. Louis University, we have continuously developed multimedia plastic surgery teaching materials with full-fidelity digital sound, three-dimensional computer graphics, and "picture-in-picture" video capabilities since 1987. We have used these materials, many of which are illustrated in this paper, for patient informed consent and the education of medical students and residents.     

Whither informed consent to psychotherapy?

Suggests that, although T. A. Widiger and L. G. Rorer (see record 1984-29794-001) presented an excellent discussion of the ethical dilemmas that arise for responsible psychotherapists, they may have been overly critical of the informed consent process. It is argued that if the ethical guidelines for obtaining informed consent are left to individual therapists, the perception of the profession by consumers and by members of the legal profession (who are already wary of the field's ethical fortitude) will be negatively affected. (4 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Information and consent]

Informed consent is applied more and more in routine medical practice. It is the consequence of a long history during which patients' rights have been progressively better recognised. This process begins by the right to be informed about one's health or disease and about consecutive treatment. After this information is given the patient is free to give opinion, consent or refusal with regard to what the physician proposes to improve his/her health or to treat the disease, according to present medical knowledge. Medical science has a power which must not constrain excessively patients, who may refuse some medical intervention, particularly if they have received adequate information and if they have their faculties. The physician is responsible for affording consistent information and for respecting patient's right to self-determination.     

Serum growth hormone-binding protein is decreased in prepubertal children with idiopathic short stature

Every activity of a medical practitioner may be subjected to court control. This creates not only uncertainty gut also anger amongst most physicians. However, it is clear that no court judgement against a physician will be made without the competent support of independent medical experts. On the basis of the relevant legal literature and judgments, the present article is an attempt to consider medical errors in the administration of contrast media, to describe the required medical informed consent before such measures, and to discuss the ever increasing importance of adequate documentation in the light of malpractice proceedings. importance of adequate documentation in the light of malpractice proceedings. This is followed by a discussion of the very important medical necessity to inform the patient about recommended behaviour after injections of such contrast media, the responsibility question in both civil and criminal terms in case of an incident, and various tips for steps to be taken in the case of a liability action.     

Responsibilities in providing psychological test feedback to clients.

This introduction to a series of articles of test feedback highlights 10 fundamental aspects of the feedback process: (1) feedback as process; (2) clarification of tasks and roles; (3) responding effectively to a crisis; (4) informed consent and informed refusal; (5) framing the feedback; (6) acknowledging fallibility; (7) countertransference and the misuse of feedback; (8) records, documentation, and follow-up; (9) looking toward the future; and (10) assessing and understanding important reactions. (PsycINFO Database Record (c) 2010 APA, all rights reserved)