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Consumer health information is available in more than 30 languages. Using family members as interpreters raises issues of quality and ethics. Administrative forms the first phase; education will follow.
There are 20 million American adults who cannot read. The demographics of the illiterate population suggest that they represent a significant proportion of patients cared for in a teaching hospital emergency department. This study was designed to assess whether readability of written material given to patients in a university hospital ED matched the literacy level of these patients. Data were gathered from 111 consecutive adult ED patients. Results of the survey showed that although the median education level of ED patients was 10th grade, more than 40% could not be expected to read at the 8th grade level, and at least 20% could be considered functionally illiterate. Readability of ED patient-directed materials was measured using the Fry index. Hospital and commercially generated patients education materials ranged from 8th to 13th grade level; a patient-directed brochure from Virginia ACEP is written at a college reading level. Comprehension of the "leaving against medical advice" (AMA) form or a consent for surgery would require at least an 11th grade education. This study shows that there is an alarming discrepancy between ED patient literacy levels in our sample and the reading skills required to comprehend important written medical and legal information. More than 50% of ED patients in a teaching hospital may read below the level required to understand standard discharge instructions. In addition, understanding the "operative consent" and leaving AMA forms requires a level of education beyond that of the majority of ED patients. If patient-directed written material is to serve its purpose, then ED patient populations should be surveyed and the reading level of written material adjusted accordingly.
Informed consent procedures are commonly employed prior to lumbar puncture. An understanding of the legal and ethical basis of informed consent is important in developing an acceptable approach to consent and in dealing with problems confronted when consent cannot be obtained. I review the current legal concepts in informed consent and their ethical foundation, and make recommendations to clinicians for obtaining consent for this common procedure in the ambulatory pediatric population.
To improve our understanding of physician reluctance to participate in randomized clinical trials, we examined physician responses to the regulation of obtaining written informed consent. Between June 1984 and February 1985 a purposive sample of 170 breast cancer specialists from eight countries completed a self-administered questionnaire and follow-up interview. The sample included 90 medical oncologists, 65 surgeons, and 29 radiotherapists. Responses to individual questions are presented in three global categories: (1) physician role--physicians believed that their view of their professional "self" was not compatible with informed consent regulations; (2) physician autonomy--physicians perceived a loss of individual decision-making power and an increase in professional accountability; and (3) physician-patient relationship--physicians stated that informed consent regulations influenced what they told trial patients and affected the ensuing doctor-patient relationship. Respondents developed complex methods to accommodate the incongruities they perceived between their view of their professional self and the need to obtain informed consent.
Completion of the human genome project is expected to lead to an increase in the number of individuals who participate in genetics research. The current informed consent process-developed prior to widespread genetics research-may not be sufficient to minimize the research risks that these individuals face. The current consent process focuses on informing individuals of the risks of research participation prior to their research enrollment. However, the risks of genetics research often are influenced by what subjects disclose to others after their research participation has ended. To assess whether the current consent process helps subjects remember the risks of future disclosures and, thereby, minimize the risks of genetics research, we interviewed 130 individuals who had previously participated in genetics research. Nineteen percent recalled that their samples would undergo genetic testing; 16% recalled that samples might be used for future research; 15% recalled that release of research records could affect their insurance status. These data suggest that current consent practices may not minimize the risks of genetics research. To address this concern, Institutional Review Boards and investigators should consider implementing supplemental mechanisms to help subjects remember when forgetting aspects of their research participation could place them at increased risk.
Bone marrow transplantation (BMT) is gaining increasing acceptance as a therapeutic treatment modality and is being offered to patients even in the early stages of disease in the presence of minimal debilitating symptoms. Despite this, little is known regarding patients' and physicians' perceptions of the process in which informed consent for this controversial and potentially lethal procedure is obtained. Thirty-nine adult BMT patients and the parents of 61 children undergoing BMT and each of their physicians completed a questionnaire concerning their perceptions of the discussion in which consent for BMT was obtained and their evaluation of the consent document. In addition, the factors influencing patients' and parents' decision to accept BMT and the nature and amount of BMT information retained by patients and parents were assessed. The results indicate that on the whole patients and parents evaluated the BMT consultation and consent document favorably, were motivated by their trust in the physician and their belief in BMT as a cure, retained information regarding major points of informed consent from both the consent document and physician discussion, and had considerable difficulty with recall of the specific toxic side effects associated with BMT. Physicians' perceptions, on the other hand, reflected a less positive view of the extent to which patients and parents were actively involved in the consent process and the readability of the consent document. Perceptions of the informed consent process on the part of oncologist-investigators and patients which could impede the goals of informed consent and implications for facilitating the process are discussed.
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OBJECTIVE: To determine if written preoperative warnings about risks and outcomes of surgery improves patients' recall and recognition of these warnings postoperatively compared to traditional verbal warnings and to determine if the timing of these warnings is significant. DESIGN: Prospective study of patients given written warnings compared to a control group of patients warned in the traditional verbal way. SETTING: Oral and Maxillofacial unit of a District General Hospital. SUBJECTS: Patients undergoing removal of third molars under general anaesthesia. MAIN OUTCOME MEASURES: Patients' recall and recognition of warnings about pain, swelling, trismus and lingual and labial dysaesthesias given before surgery for removal of third molars. RESULTS: Written information significantly improves patients recall and recognition of important warnings such as the risk of dysaesthesia of the tongue (p < 0.001) and lip (p < 0.01) when compared with just verbal warnings. It seems to make no difference if this information is given to the patient a week before on a preadmission clinic or on admission. CONCLUSIONS: Written preoperative information about routine operations would improve the quality of the informed consent process.
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OBJECTIVES: To review theoretical perspectives relating to the communication of informed consent and to describe research efforts and strategies to enhance the informed consent process and document. DATA SOURCES: Research studies review articles, education and communication models, and NCI National Working Group on Informed Consent Recommendations. CONCLUSIONS: Information communicated during the informed consent process is difficult to understand, raising ethical concerns about whether informed decision-making has taken place. Empirical research focuses on the nature of patient-provider interactions and the effectiveness of various delivery systems, a need exists to overcome conceptual and methodologic limitations. IMPLICATIONS FOR NURSING PRACTICE: Nurses must ensure that patients understand informed consent information. Several communication strategies are posited.
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Comprehension of typewritten informed consent information was evaluated for young-old (60-69 years) through old-old (80-89 years) volunteers as a function of years of education (less than 12, 12, and greater than 12), readability of information (low [college level] vs high [7th grade]), and typeface used in the preparation of the materials (Prestige Elite 72, Letter Gothic, and Orator). All volunteers (N = 235) read a typewritten information sheet and retained it for review while answering eight multiple choice questions. Immediate feedback was provided, and a second test was administered if any answers were incorrect. The findings indicated that comprehension varied directly with education and inversely with age. Typeface and age interacted due to age-related differences with the two smaller (Prestige Elite and Letter Gothic), but not with the largest of the typefaces (Orator). These findings suggest that the observed age-related differences may have been due to visual and not cognitive deficits. Readability did not affect performance either by itself or in combination with any other variable.
Dermal fillers are increasingly used for in-office cosmetic treatments. Although complications are rare, they can occur with any dermal filler. Such complications can lead to adverse medical, legal and economic difficulties. This article reviews the various complications most commonly seen with dermal fillers. In addition the appropriate consent prior to filler use and the legal implications of a lack of consent will be described.
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