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PubMed2006

Recall from informed consent counselling for cataract surgery.

The authors investigated the effect of giving written material on information recall from informed consent counselling for cataract surgery. Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre, South Australia, were prospectively enrolled. Systematic counselling for cataract surgery was provided, with a written copy of the content given to a randomly selected group of patients (n = 24). All subjects completed a questionnaire after counselling and again at two weeks after surgery to test their satisfaction with, and recall of, information provided. Patients were found to be satisfied with the amount of information they received and most were able to recall details about the cataract surgery procedure. However, many could not recall success rates or complication rates and only a minority could list any complication. The provision of written information did not significantly alter recall (p>0.05). Recall was significantly better immediately after counselling than two weeks after surgery (p<0.05). Younger patients also had significantly better recall (p<0.05). Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements.

Aged↗
PubMed2005

Building informed consent for cholinesterase monitoring among pesticide handlers in Washington State.

BACKGROUND: Pesticide handlers in Washington State are predominantly Mexican and, therefore, require a culturally appropriate process of informed consent. In addition, members of this occupational group are vulnerable to coercion because of poverty, lack of insurance, inability to read, and employment status METHODS: To create a process of culturally competent informed consent for Washington State's cholinesterase monitoring program, we used focus groups to collect data about cultural beliefs, attitudes, knowledge, language, and traditions of Mexican-American pesticide handlers. With this information, we developed a final consent form and evaluated it using a 10-item test-retest questionnaire in a sample of 103 handlers. RESULTS: Using qualitative methods, we created English and Spanish consent forms that incorporated culturally defined risk information. Both the written and audiotape formats significantly improved comprehension; but, for subjects with less than 7 years of schooling, audiotapes in Spanish yielded significantly higher scores (mean comprehension score 7.0 vs. 6.1, t = - 2.2, P = 0.03). CONCLUSIONS: Culturally competent informed consent for particularly vulnerable populations of non-native speakers of English is possible. It requires both knowledge of specific cultural elements and the application of appropriate technology.

Adult↗
PubMed2006

Informed consent and sedation.

The concept of autonomy was not included in the Hippocratic Oath. Nowadays the principle of respect for autonomy is an important right. The basic paradigm of autonomy in health-care, politics and other contexts is expressed as informed consent. In the palliative-care setting, there can be some difficulties in getting informed consent, especially at the end-of-life stage. Can it be good for the patient, always? Could there be some exceptions? At the time of agonizing pain, getting informed consent could become an additional burden for the patient. This present article attempts to shed light on this issue. In our experience, it is not necessary to obtain written consent for a patient who has already expressed his priorities in advance. We believe that this is a good stance for patients as well as doctors.

Advance Directives↗
PubMed1987

Informed consent: a risk management view. Council on Insurance.

In the best of all possible worlds, rules could be established that, if strictly followed, would eliminate litigation. Regrettably, that world does not exist. When dealing with informed consent many issues remain uncertain. Doctors must use their best professional judgment and hope that the jury will support it. Some risk management suggestions would include: Personally discuss the benefits and risks of the proposed treatment with the patient as well as the alternatives, and the consequences of nontreatment. Give the patient an opportunity to ask questions. Get a commitment from the patient to proceed. Use lay terms. Give no guarantees. If in doubt, disclose the risks. Use a signed informed consent form. Keep well-documented records. Consult your attorney about developing informed consent procedures that reflect state laws.

Consent Forms↗
PubMed2006

Chart documentation of informed consent for operative vaginal delivery: is it adequate?

OBJECTIVES: To determine the documentation frequency of informed consent for women undergoing a trial of nonemergent instrumental delivery. STUDY DESIGN: A retrospective chart review of instrumented vaginal deliveries from 1992 to 2005 was performed. Cases were identified from a Labor and Delivery database and hospital records were reviewed for documentation of associated risks, general consent for the procedure, indication, and option of cesarean delivery (CD). RESULTS: Three hundred forty six charts were reviewed: 246 were excluded for an emergency delivery (19%), misclassification (25%), or lost notes (27%). In the remaining 100 cases, 61% had a general consent for instrumented vaginal delivery. Documentation of any maternal or neonatal risks was found in 3% and 0%, respectively. The option of a cesarean delivery was documented in 22% of the cases. When comparing 5-year time intervals before and after 2000, there was no increased frequency in documentation of maternal or neonatal risks. CONCLUSIONS: Documentation of informed consent for instrumented vaginal delivery is inconsistent and should be improved.

Consent Forms↗
PubMedDate not supplied

[Readability of informed consent documents used in the hospitals of Asturias].

OBJECTIVE: To evaluate the readability of the informed consent documents (ICD) used in the health centers of Asturias (Spain) with the aim of verifying whether the ICD are understandable and sufficient as a vehicle of information to empower patients to participate in decisions related to their diagnosis and treatment. METHOD: A total of 1114 ICD were gathered from the health centers in Asturias. A representative random sample from each hospital was selected and the following readability indexes were obtained: the Flesch index, the sentence complexity index, and the integrated legibility index. RESULTS: Of the ICD in the sample studied, legibility was acceptable in 77.3% (221 out of 286) according to the integrated legibility index, in 75.2% (215 out of 286) according to the sentence complexity index and in 3.5% (10 out of 286) according to the Flesch index. The mean values of the indexes differed among hospitals (p < 0.001, ANOVA test). CONCLUSIONS: ICD written in Spanish achieved low readability scores in the Flesch index and require corrective measures. Three quarters of the ICD were acceptable due to the use of simple sentences in the text. We believe that readability indexes should be used when drafting or improving informed consent documents.

Comprehension↗
PubMed1998

Abandoning informed consent: an idea whose time has not yet come.

In a recent critique of informed consent, Robert Veatch argues that the practice is in principle unable to attain the goals for which it was developed. We argue that Veatch's focus on the theoretical impossibility of determining patients' best interests is misapplied to the practical discipline of medicine, and that he wrongly assumes that the patient-physician communication fails to provide the knowledge needed to insure the patient's best interests. We further argue that Veatch's suggested alternative, value-based patient-professional pairing, is, on his own terms, impossible to implement. Finally, we reexamine the philosophical and practical justifications for informed consent and conclude that the practice should be retained.

Beneficence↗
PubMedDate not supplied

A randomized trial using videotape to present consent information for colonoscopy.

A randomized controlled trial was conducted to determine if a videotaped presentation by a physician conveys information more effectively than an in-person discussion by the same physician using the identical script. Two hundred one patients undergoing colonoscopy were enrolled in the study. Patients were randomly assigned to one of three groups: video plus discussion, video alone, and discussion alone. A validated, 13-item knowledge test and the State-Trait Anxiety Inventory were administered to all patients. Mean number of correct test answers for video plus discussion was 11.04; for video alone, 10.70; and for discussion alone, 9.61. ANOVA with planned orthogonal comparisons showed that the patients in the two video groups had significantly better scores (p < 0.001) than those in the discussion-only group. No difference was noted between the two video groups (p = 0.32). Anxiety did not increase with increased understanding of the risks and benefits of colonoscopy. This approach may work as well for other invasive medical procedures and could save physician time while laying a foundation for a more personalized discussion.

Adult↗
PubMed2003

The patient's informed consent for pacemakers and ICD implantation: how to write and how to explain it.

Written informed consent for pacemaker and ICD patients should be easy to understand and provided in written form in the patient's language. Comprehensiveness is required. It is essential to address driving and running machines, complication rates, benefits in appropriate hierarchical order and future necessary interventions. Eventually potential risks, e.g., flying, sports, sexual activity should be mentioned. It is important to explain pacemaker systems and ICD devices in details including cardiac resynchronization therapy (CRT) for heart failure. One of the main aspects concerns protection of human subjects participating in clinical studies. Informed consent necessitates a statement that the study involves research. This statement should include explanation of the purposes of the study, expected duration, description of the procedures, identification of experimental procedures, description of foreseeable risks or discomforts, and disclosure of alternative procedures. Further information should be given on psychological concerns, sexual activity, driving and quality of life in pacemaker and ICD patients.

Adult↗
PubMed2004

Informed consent in acute myocardial infarction research.

Acute myocardial infarction (AMI) is a common disease in the Western world and has been the topic of much research. Conducting clinical trials with patients in the acute phase of a myocardial infarction, however, poses an ethical challenge. As patients are often under extreme stress and require urgent medical attention, the process of informed consent is severely constrained. Furthermore. the very procedure of informed consent, which is supposed to protect eligible patients, may be a cause of harm in itself due to the delay in the provision of therapy which it causes. This paper describes how physicians have dealt with the informed consent process in various AMI trials and summarizes the results from empirical studies of the consent process of such trials. Finally, the ethical issues and their implications for future trials involving this particular group of patients are discussed.

Clinical Trials as Topic↗
PubMed1987

Regulatory overview: protection of human subjects--IRBS and informed consent.

The Food and Drug Administration (FDA) regulations on Institutional Review Boards (IRBs) and Informed Consent (IC) were published on January 27, 1981 and became operational on July 27, 1981. The historical development of these regulations began in August 1978 when the FDA proposed standards for IRBs. During the comment period, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report and recommendations on IRBs and informed consent. In its report, the National Commission recommended revision of the Department of Health and Human Services (DHHS) regulations and one uniform standard for IRBs. On August 14, 1979, the FDA withdrew the 1978 proposal and published a revised proposal that it had developed in conjunction with the DHHS in response to the recommendations made by the National Commission. Following consideration of the comments received on the 1979 proposal, the new regulations were published as final. I would like to discuss how these regulations relate to the FDA's mandate and regulatory responsibilities, to the work of IRBs, and to the protection of human subjects involved in the FDA-regulated research. I will also mention the FDA's internal organization to deal with IRB issues and, finally, what we may look forward to in the future.

Drug Evaluation↗
PubMed2006

[Prior informed consent is also a requirement of 'no-risk' scientific research].

The right to decide for oneself about participation in medical research is the foundation of informed consent. If the requirement of informed consent is dropped for research that is considered free of risk to the individual participant, then participation becomes involuntary. The absence of risk is an insufficient argument to ignore an individual's right to free choice.

Ethics, Research↗
PubMed1999

Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research?

OBJECTIVE: Because of stress and illness, conscious emergency medicine (EM) patients may be temporarily cognitively impaired and thus incapable of participating in the informed consent process for acute care research. This pilot study sought to assess the mental capacity of ED patients during their evaluation and treatment for acute myocardial infarction (AMI). METHODS: A prospective observational design at a university tertiary referral center. EM patients with AMI from November 1996 to February 1997 were enrolled. While usual care was delivered, patients were administered three subtests of the Wechsler Adult Intelligence Scale-Revised (WAIS-R) test. Subtest scaled scores range from 1 to 19, with abnormal being less than 5. Demographic, historical, and environmental parameters were recorded. Patients assessed how serious they perceived their conditions; and rated their degrees of pain, nausea, breathlessness, and anxiety on 10-cm visual analog scales (VASs). Testing was repeated prior to hospital discharge. RESULTS: Twenty-five patients were enrolled. Of these, two (8%) were suspected by their emergency physicians to have insufficient capacity to give informed consent. However, five (20%) scored less than 5 on all of the WAIS-R subtests (kappa = 0.5) and eight (32%) scored less than 5 on at least one of the subtests (kappa = 0.3). The initial median Digit Span, Comprehension, and Similarities subtest scores were 7, 5, and 6. By discharge, these improved to 8, 7, and 8, respectively. CONCLUSIONS: This pilot study suggests that some patients with AMI may have difficulty processing information necessary to give informed consent for acute care research. Routine clinical evaluation may not detect this cognitive defect.

Acute Disease↗