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PubMedDate not supplied

[Readability of informed consent].

A comparative study has been made of the readability of informed consent form of the Navarra Health Service, using the Flesh and SMOG formulas. Signed editorial articles from the local newspapers Diario de Navarra and Diario de Noticias were used as a term of comparison. The results show that the readability of informed consent form is -4 (with a second paragraph of -9), while the editorial articles showed a comprehensibility of 22. The text of the second paragraph of the informed consent form is barely comprehensible, and alternative texts that are more easily comprehensible must be studied.

English Abstract↗
PubMed1992

Informed consent: medical-legal update for the practitioner on recent judicial opinions applying state laws.

Physicians, in general, and surgeons, in particular, need to be aware that there is no universally applicable definition of informed consent. This paper provides a framework for understanding current, commonly accepted legal approaches and trends. State codes, state cases, and federal cases were searched manually and with the Westlaw and Lexis data bases for states with both informed consent statutes and judicial decisions interpreting those laws. Statutory definitions, where present, may be general or detailed. Legal standards for informed consent disclosure are usually either professionally based or objective. Standards for informed consent causation have been either subjective, objective, or modified-objective. Often, a physician must breech both the disclosure and the causation standards to be legally liable. Results of individual cases depend on the legislative and judicial standards adopted. Physicians need to be conversant with the general approaches to informed consent so they may better understand the applicable standards for their own jurisdictions.

Humans↗
PubMed2005

Obtaining written informed consent for the administration of local anesthetic in dentistry.

BACKGROUND: The purpose of this study was to examine the frequency with which dentists obtain written informed consent for the administration of local anesthetic in dentistry. METHODS: The authors administered an informal survey to 252 dentists. RESULTS: Most respondents who practiced a dental specialty or limited their practice to anesthesiology for dentistry obtained written informed consent for the administration of local anesthetic. Most general practitioners did not. CONCLUSIONS: Written informed consent appears to be obtained more often by dental specialists and dentists limiting their practices to anesthesiology for dentistry than by general practitioners. PRACTICE IMPLICATIONS: All dentists may want to consider obtaining written informed consent for the administration of local anesthetic.

Anesthesia, Dental↗
PubMed2006

French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research.

The content of informed consent documents (ICD) is a crucial element in the process of providing information to participants in biomedical research. Clear comprehension of the information, i.e. the ability to understand its meaning and its consequences, is of utmost importance. The objective of this study was to describe the different steps in the French adaptation and preliminary validation of the Qualité de Compréhension des Formulaires d'information et de consentement (QCFic) questionnaire (http://www.lyon.inserm.fr/cic-grenoble) based on the American Quality of Informed Consent (QuIC) questionnaire. Adaptation and preliminary validation of the QuIC for use in France was composed of five principal steps: translation, scientific validation, lexical validation, edition of gold-standard answers and a pilot study. Each stage was conducted by independent groups of experts, under the coordination of the study board. Thirteen questions were added and one was suppressed. Two steps were required for the scientific validation and for lexical validation, 21 modifications were proposed. Relative to gold-standard answers, the three experts gave the same answer for 24 questions and for nine other questions, two of the three gave identical answers, which were validated by the study board. Results of a pilot study showed a global QCFic score of 88.99 (84.13-90.92) and no specific commentary was made about the content of the questions, so no more modification needed to be made. A preliminary validated French questionnaire, the QCFic, is now available to evaluate the quality of an informed consent document in phase I clinical trials. It is quick and easy to use.

Adult↗
PubMed2006

Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.

BACKGROUND: Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. PURPOSE: To identify deficits in comprehension during consent processes in Mali, West Africa. METHODS: After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. RESULTS: Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting. LIMITATIONS: Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself. CONCLUSIONS: This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.

Chi-Square Distribution↗
PubMed1998

Informed consent: an overview.

The patient, as a health care consumer, has a fundamental right to determine what shall be done to his or her own body. The doctrine of informed consent has evolved to protect that right. This article represents a review of the literature regarding the informed consent process in medicine, with an emphasis on consent for anesthesia. A brief history of informed consent is provided, as well as discussion of the controversies surrounding the topic. Several court cases are cited, and the opinions of various authors reflect the wide range of legal and ethical implications associated with informed consent.

Consent Forms↗
PubMed2003

Patient and parent understanding of informed consent in orthodontics.

In both medical and dental settings, researchers have found that patients do not adequately comprehend the information given during informed consent discussions, especially the less educated, low-income patients. Because of the importance of patient compliance with orthodontic treatment regimens, this study examined patient and parent understanding of the child's Phase I orthodontic treatment in a public dental clinic with ethnically diverse, low-income patients. Interviews were conducted with 29 children (ages 6-12) and their parents or guardians at the orthodontic case presentation appointment. The orthodontist explained the reasons for treatment, the orthodontic procedures to be used, the risks, the alternatives, and patient and parent responsibilities during treatment; the session was audiotaped. Interviews were conducted immediately after this discussion and the results compared with the orthodontists' presentations. In general, both children and parents recalled significantly fewer reasons for treatment (1.10, 1.66, and 2.34 items, respectively), procedures (1.55, 1.59, and 2.45, respectively), risks associated with treatment (0.66, 1.48, and 4.66, respectively), and responsibilities of the child during treatment (2.21, 2.07, and 3.38, respectively) than what the orthodontist had told them. They were also less likely to recall the reasons, procedures, and risks that were most frequently cited by the orthodontist. These findings raise concerns about the effectiveness of current informed consent techniques with public health populations, especially the low recall rates within 30 minutes of the case presentations. Low recall of risks by children and their parents, particularly for critical risks such as relapse, caries, and periodontal problems, raises concerns about treatment compliance, success, and more importantly, the effectiveness of the informed consent process itself. Future research should focus on methods to improve the informed consent process among children undergoing orthodontic treatment in a low-income population.

Child↗
PubMed2006

Informed consent procedures: an experimental test using a virtual character in a dialog systems training application.

Researchers are generally trained to administer informed consent by studying approved guidelines, but still can fail to satisfactorily answer questions from potential participants. An application using a virtual character allowed novice participants to practice administering informed consent. This character was designed to behave as a potential participant for a study and asked many of the questions research participants typically ask, such as queries about the study itself, the sponsor, timing, selection procedures, confidentiality, voluntariness, benefits and risks, and contact information. The user responded to the character's queries as if speaking with a true potential research participant. The application was effective even after only brief usage. In a laboratory experiment, novice participants who practiced with the virtual character were later more effective in conducting informed consent interviews with a human interviewee than those who were trained only with written materials. Thus, simulated learning-by-doing improved informed consent skills. Implications for related health dialog applications are discussed.

Biomedical Research↗
PubMed1993

Informed consent for blood transfusion: a regional hospital survey.

Ninety-two hospitals in a three-state mid-Atlantic region were surveyed to determine their policy toward obtaining written informed consent for transfusion and to examine the content of written consent documents and the process by which consent is obtained. Of 81 hospitals responding, 50 (62%) required written informed consent. Hospitals with fewer than 200 beds were more likely to require written informed consent. The attending physicians had responsibility for obtaining consent in 28 (57%) of 49 institutions, most often on the day or evening before surgery. Twenty-seven of 48 forms mentioned complications: hepatitis in 80 percent, human immunodeficiency virus infection in 46 percent, nonhemolytic reactions in 32 percent, and hemolysis in 25 percent. Alternatives to allogeneic transfusion were mentioned infrequently; eight hospital forms listed autologous transfusion options and only two mentioned designated donation. The reading level required to comprehend 34 consent forms submitted was grade 14.6, which has been attained by only 23 percent of the adult United States population. Although the majority of respondent institutions require written informed consent, those forms, per se, do not document that the fundamental tenets of informed choice have been applied to the decision to transfuse blood.

Blood Banks↗
PubMed2004

The parameters of informed consent.

PURPOSE: To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained. METHODS: Summarization of current law obtained from legal treatises, reports of recent cases, and personal experience as a reviewer and expert. RESULTS: Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research. CONCLUSION: Demonstration of a well-conducted process, not merely of a paper, not only protects the physician from exposure to liability, but increases the patient's autonomy in decisions concerning health and encourages compliance with treatment.

Ethics, Clinical↗
PubMed1998

Informed consent for medical interventions under Turkish law.

Free and informed consent of the patient is the prerequisite of any medical intervention under Turkish law. "Information" comprises the purpose, nature, consequences and risks of intervention. "Intervention" is understood in its widest sense. The patient has the right to withdraw his consent freely at any time. For the patients under age (18 years) or incapacitated persons, informed consent is given by the legal representative (parents or guardian). In emergency situations, including abortion and sterilization, the practitioner may intervene for the benefit of the patient without consent. Furthermore, for purposes of treatment of addicts, and in cases of epidemic diseases medical intervention may be carried out without consent for health reasons and public safety. The right to be informed or not about health and intervention is a patient's personal right. These rights are bound strictly to the personal right of the patient. Disregarding these rights can cause legal liability of the physician. The previous wishes of the patient and the right to refuse treatment of the patient must be respected. Legal representatives of minors or incapacitated patients may not refuse treatment on their behalf. Treatment without consent or without informed consent is a "medical malpractice."

Emergency Medical Services↗
PubMed2000

Informed consent in neurosurgery: patients' recall of preoperative discussion.

OBJECTIVE: Informed consent (IC) is an important principle of modern medicine and the quality of the process is likely to receive increasing attention in future due to complex surgical procedures and a development of social mistrust for medical treatment. Medico-legal action is also becoming an important influence on IC, in particular the extent of warning to be given about the degree of risk. Evaluation of IC, however, encounters various problems. One key element of a knowledgeable decision is an analysis based on the disclosed risks. METHODS: In a prospective study, 104 consecutive patients were asked to write down as many items of the list of risks as possible two hours after consent interview. The sample included adults (mean age: 52 years) without any significant neuropsychological impairment who underwent elective intracranial (52%) or spinal (48%) surgery. Consent interview based on the proposals of the Deutsche Gesellschaft für Neurochirurgie and the Berufsverband Deutscher Neurochirurgen 1998. The average number of disclosed risks was 32 in intracranial and 25 in spinal surgery. According to the results in the literature 6 'typical major risks' of the proposed treatment were selected. RESULTS: The median value of the total of recalled risks was 4 in the spinal group and 5 in the intracranial group. The mean score of general information retention was 18%. 65% of the patients did not recall more than 2 of 6 'typical major risks'. No significant correlation between recall performance and age or education was found. CONCLUSION: The general principles of memory apply and have implications in states of emotional arousal. Whereas education and age, unlike in previous reports, did not appear to influence recall, thus indicating that we had succeeded in tailoring IC to the individual, recall rate was low in most cases. Physicians should highlight the discrepancy and conflict between the requirements for the defence of medical practice in the law courts and the actual interests of patients. They should promote research to establish what really is 'appropriately informed consent'.

Adult↗
PubMed1995

Informed consent forms for clinical and research imaging procedures: how much do patients understand?

OBJECTIVE: Informed consent is often obtained in diagnostic radiology, especially for invasive procedures and research studies. However, how much the average patient actually understands of the information contained in these informed consent forms is uncertain. A cross section of the clinical and research consent forms used in diagnostic radiology was evaluated with respect to their readability, that is, how easy or difficult they were to understand. MATERIALS AND METHODS: The active members of the Association of University Radiologists were solicited to provide copies of their clinical and research informed consent forms. After eliminating duplicates, we digitized the forms and used a computer program to evaluate their readability. Computer readability assessment allows the rapid study of an entire document by a variety of readability formulas (Flesch-Kincaid, Flesch, and Fog). RESULTS: We received 549 different consent forms from 156 institutions; 265 forms were intended primarily for clinical use and 284 were used primarily for research. Although the clinical consent forms were only 41% as long as those for research, a statistical comparison showed them to be harder to understand (p < 0.005). The mean readability score (years of education needed to understand) for all 265 clinical consent forms was 15 versus 12 for the research forms. The most complex clinical consent forms were those written by hospitals for any type of procedure or operation (the generic surgical or procedure consent form). On average, this type of clinical consent form required at least a college education to understand. CONCLUSION: Our results show that most consent forms used in radiology practice are too complex for the average patient to understand. The increased complexity of clinical consent forms, especially the generic surgical or procedure consent forms, as compared with research consent forms, is probably a product of the decreased attention given to the clinical consent forms, the bureaucratic and legal requirements of the clinical forms, and the lack of physician participation in preparing these forms.

Cognition↗
PubMed1977

Informed consent and confidentiality: proposed new approaches in Illinois.

The author examines the basic background and definitions of the issues of consent and, more particularly, informed consent to relinquishing the privacy of mental health records. He sets these issues in the context of some of their specific inherent problems and describes possible solutions suggested by the State of Illinois Governor's Commission To Revise the Mental Health Code.

Confidentiality↗
PubMed1985

Informed consent and the gastrointestinal endoscopist.

The gastrointestinal endoscopist should be familiar with the Doctrine of Informed Consent. Although the concept is difficult to apply clinically, a reasonable approach is presented to the endoscopist. The ultimate goals of informed consent are shared decision making and self-determination, but it is important that the endoscopist also consider the potential legal liability when obtaining informed consent.

Endoscopy↗
PubMed2005

Adolescents, informed consent and confidentiality: a case study.

Issues related to informed consent and confidentiality often arise in the emergency care setting. When the patient is an adolescent further complexities are introduced, especially when the desires of the adolescent are different from those of the parent. Understanding when an adolescent can give informed consent and what the limits of confidentiality are will assist medical personnel in providing the most appropriate care. These concepts are elucidated with a specific case.

Adolescent↗
PubMed1997

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.

Aged↗