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Results for “informed consent”

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PubMedDate not supplied

Video consent: a pilot study of informed consent in laparoscopic urology and its impact on patient satisfaction.

OBJECTIVES: In the current climate of increasing awareness, patients are demanding more knowledge of the operative process. We report a new protocol for consenting patients. In addition to the normal consent process, patients are invited to watch a video of the operation to gain a perspective of what is involved. We applied this novel method of consent and assessed its impact on patient satisfaction. METHODS: As part of postoperative follow-up, prospective data from 43 consecutive laparoscopic patients was obtained in the form of a self-constructed, patient-directed questionnaire regarding the consenting process. Patients were also invited to complete the Client Satisfaction Questionnaire (CSQ-8) 4 weeks after their operation. Laparoscopic workload included nephrectomy (n = 27), deroofing of cysts (n = 2), pyeloplasty (n = 6), exploration for undescended testis (n = 6), lymph node dissection (n = 1), and nephropexy (n = 1). To reduce bias, an individual independent of the team treating the patient conducted these surveys. RESULTS: All study participants read the information leaflet before laparoscopic surgery, and 81% thought we should give patients the option to watch a video before their surgery. The leaflet information was understood by 92% of patients. All patients who opted to watch a video found it helpful to their understanding, and 75% requested a copy of the video of their own operation. The mean patient satisfaction (CSQ-8) score was 29.8 of a possible maximum score of 32. CONCLUSIONS: This novel approach to informed consent has had a positive impact on the patient journey as is evident from high satisfaction scores. Additional randomized, controlled trials need to be conducted to evaluate video consenting methods in laparoscopic urology.

Adult↗
PubMed1996

Critical care research and informed consent.

The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.

Cardiopulmonary Resuscitation↗
PubMed2001

Informed consent: evaluation of the information provided to elderly patients.

The doctor-patient relationship has undergone important changes in recent years. In the new concept of health care, the individual has the right to take decisions and the right to self-determination is only meaningful if the person is appropriately informed, is free to make decisions without coercion and has the ability or "capacity" to make the decision. The aims of this study is to evaluate the information received by the patients and the immediate family's provided by health. A total of 200 randomly chosen patients (109 male and 91 female), were interviewed. The mean age was 74 years (range from 65 to 102 years). In addition, the family member most frequently accompanying the patient was asked their opinion. Our study, found that the information was mainly directed to the family member/companion and that the information offered to the elderly patient was generally scant and insufficient for any consent to be based thereon. We believe that more attention should be paid to the issue of obtaining informed consent in the elderly.

Aged↗
PubMed1999

The nurse's role in the informed consent process.

OBJECTIVES: To review the informed consent process in relation to oncology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies. DATA SOURCES: Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.

Comprehension↗
PubMed2000

[Informed consent of the surgery candidate].

Surgery is a special medical act requiring the patient's prior informed consent. Informed consent necessitates correct comprehensible information which must be documented in case of court claims. Consent must be given freely by the patient who has been properly informed. Consent from patients with impaired cognition raises particular problems as does consent from incarcerated patients. The French Code of deontology does not state how the information must be delivered and how the patient's consent must be recorded nor which party is charged with proof of information. The information delivered must be loyal (true with nothing hidden) and appropriate (adapted) for the health status of the patient and his/her personality and capacity to understand as well as for the proposed care. Information depends on the patient's and the physician's general culture. In addition to the information itself, documentary proof of its delivery is required in case of court claims. Carefully written documents are mandatory. They should meet certain requirements, remaining general enough (example: appendectomy and its risks), updated, and simple and comply with the rules of deontology.

France↗
PubMed2006

Marriage of professional and technical tasks: a strategy to improve obtaining informed consent.

BACKGROUND: Education in obtaining informed consent, combined with technical training using a stepwise approach, may improve resident knowledge of, confidence in, and frequency of obtaining consent for bedside procedures. METHODS: Surgical trainees were randomized to receive a lecture on obtaining informed consent. Knowledge of, confidence in, and frequency of obtaining consent were assessed. Subsequent first-year residents received combined technical and consent training using a stepwise approach. Residents listed key steps for procedures before and after training, were observed for consent and technical competency on patients, and were assessed on frequency of obtaining consent by follow-up chart review. RESULTS: Knowledge and confidence improved after lecture instruction, but consent rate (21%) did not. Stepwise training increased resident awareness of obtaining informed consent as a key step (19% to 77%) and increased frequency of obtaining consent (89% for proctored procedures and 79% in follow-up). CONCLUSIONS: Education alone improves knowledge but not practice of obtaining consent. Teaching the consent process concomitantly with technical training may increase awareness and performance of obtaining informed consent for bedside procedures.

Cross-Over Studies↗
PubMed2002

Informed consent to breaking bad news.

Informed consent to breaking (or waiving) bad news is an important yet neglected topic. It is distinct from informed consent to diagnosis and to treatment, and may be logically and ethically sound, provided patients are competent and that no considerable harm may be caused to others by breaking or waiving bad news to patients. This requires a differential assessment procedure in order to balance patient autonomy, benefit and justice towards others, preferably exploring patients' values, expectations and needs with them, so that an acceptable decision can be made on whether to act on their consent to breaking or waiving bad news, or to ignore it and act on informed consent by proxy. Future study should attempt to provide a detailed characterization of procedures for attaining informed consent to breaking or waiving bad news, and to test their success in establishing ethically sound health care.

Ethics, Nursing↗
PubMed1984

Informed consent--the controversy in radiology.

Informed consent is more than a sheet of paper with indications, contraindications, possible side effects, and the physician's and patient's signature. It is a moral and legal Pandora's box. How much information does the patient really need to know? What information is the physician responsible for? What legal implications come into play during an emergency? Is informed consent necessary for IVPs? These topics and a brief history of the doctrine of informed consent should give the radiology administrator some insight into the medico-legal implications of informed consent.

Hospital Departments↗
PubMed1989

[Informed consent in oncology].

Informed consent is not a new principle in the patient--physician relationship. It emphasizes the basic principle of the patient's autonomy and the respect which is due to him/her. In oncology it covers clinical examination, complementary investigations, different treatments and follow-up. Obtaining the necessary information may be complicated by difficulties concerning the patient, the cancers and the physicians. The problematical aspects can be alleviated if the patient's autonomy is acknowledged and respected and if the physician succeeds in establishing a sound personal relationship with the patient.

Humans↗
PubMed2003

Understanding of informed consent by demented individuals.

BACKGROUND: The informed consent process is central to the conduct of research but may be difficult for cognitively impaired participants to understand. The authors developed a brief test addressing the elements of informed consent for a specific minimum-risk nontreatment research protocol. OBJECTIVE: To evaluate and document understanding of informed consent by elderly research participants across a range of dementia severity. METHODS: The elements of informed consent regarding participation in a longitudinal study of healthy aging and dementia were reviewed with both demented (n = 250) and nondemented (n = 165) participants who then completed a short test requiring yes-no responses to assess understanding of these elements. Demented participants had very mild, mild, or moderate dementia as staged by the Clinical Dementia Rating. RESULTS: After adjusting for education, performance on the test varied with dementia severity in mean differences and by correlation. All nondemented and very mildly demented participants and 92% of mildly demented participants provided correct answers for at least 8 of 10 true-false items, whereas only 67% of the moderately demented participants achieved this level of accuracy. CONCLUSIONS: Demented individuals, very mild and mild, understood informed consent information for this nontreatment research study. Understanding notably declined in the moderate stage of dementia. Brief tests may be useful as one method to assess understanding of the consent process for specific studies.

Aged↗
PubMed2004

[On past practices and future directions of informed consent in (radiation) oncology].

BACKGROUND AND PURPOSE: Informed consent, especially in oncology, is predominantly seen from a legal point of view. Such a limited perspective runs the risk of reducing informed consent to some tiresome formalism. The present article highlights how the relationship between patient and physician might be enriched by a comprehensive historicocultural understanding of informed consent. The authors show in which future directions the practice of informed consent might develop. MATERIAL AND METHODS: Analysis of historical and forensic literature regarding informed consent. RESULTS: With the terms "information" and "consent" the last 2500 years of medical history can schematically be divided in three epochs: the first epoch started around 500 years BC, lasted until the 19th century AC and was dominated by the principle of "salus aegroti suprema lex". The patient's benefit was exclusively defined by the treating physician. Formal consent was not required in those times. The era of enlightment brought new ideas to Europe, especially the principle of individual autonomy. In 1894, the Supreme Court of the German Reich decided that any medical intervention without the patient's consent was regarded as physical injury and was thus illegal. Systematic requirements regarding patient information on planned medical interventions were not known. The beginning of the third epoch is marked by the introduction of the term "informed consent" in modern medicine in 1957. Since then, a comprehensive information of the patient is seen as a prerequisite for consent. The patient's right of self-determination is attributed a higher legal and moral value than the physician's concept of the proposed treatment. Nowadays, the debate regarding informed consent is dominated by the continuing differentiation of modern medicine, the development of medical practice as part of the service sector, and the changing ways how patients see themselves. CONCLUSIONS: Social and legal developments have strongly influenced medical practice in the past. The importance of informed consent will continue to rise in the future, while the emphasis of the physician's task will shift from information to counseling. Informed consent will be increasingly established as independent service.

History, 17th Century↗
PubMed1997

[Informed consent in neurology].

Informed consent has remained in the medical tradition but the scale of values and human rights have changed. Today the emphasis is on a human being's right to autonomy, his personality and power to make decisions. At the same time, the doctor-patient relationship has undergone considerable changes. It has evolved from one of paternalism based on the old idea of charity, to one in which the principle of freedom is prevalent whereby it is the patient who has the right to decide the type of medical procedures to be used on him. This idea is recognized as such in the General Health Act of 1986. It has therefore become obligatory for the medical profession to abide by this Act. To do so the patient must be given sufficient information regarding the medical procedures to be applied in his case in particular, including all the risks and advantages as well as any possible alternatives, so that the patient is able to play a part in choosing the most suitable treatment. By law this information must be written down. This is essential to create protocols or medical guide-lines to orientate both the patient and the judge in the event of a demand action as to whether the medical procedure was in accordance with the lex artis or not in each case (lex artis ad hoc). We wish to encourage our colleagues to create a model such as we present, indicating what we consider to be essential points to be included in guide-lines in order to achieve uniform criteria throughout the country thereby facilitating the work of medical assessors and judges. We encourage the scientific societies involved and the corresponding medical departments to form a working party to draw up these medical guide-lines in order to achieve the maximum agreement possible.

Humans↗
PubMed1993

Informed consent. The whole truth for patients?

Two misconceptions about informed consent concern the difference between the legal and moral justification for it, and the rationale for more rigorous consent for research than for "standard" therapy. Legally, informed consent for therapy is a risk-management tool that functions essentially as a release of liability. If the patient is informed of all expected or potential side-effects or toxicities of a treatment, he cannot sue because those side effects occur. The moral doctrine of informed consent is derived from a respect for the patient's autonomy as well as the patient's vulnerability. The physician's goal is not to minimize liability, but to help the patient make the best decision. These two goals are not necessarily incompatible, but they often lead to different attitudes toward informed consent and different decisions about what information needs to be shared with patients. If the goal is risk-management, then informed consent forms should be encyclopedic, providing the "whole truth" to patients. This would, however, not meet the moral goals of shared decision-making, because few patients could make sense of such data. Informed consent for research often leads to a different paradox. If a new therapy becomes available and a physician thinks it may benefit a patient, the physician may use it in an uncontrolled manner. This does not require the approval of an institutional review board and does not need the more rigorous approach to informed consent generally associated with research. In contrast, if the physician wants to evaluate the effectiveness of the same therapy carefully and intends to gather data to do so, he will need to describe his protocol, defend it before an institutional review board, and provide a more carefully written and closely scrutinized informed consent form. The paradox derives from the fact that the patient in the first, uncontrolled situation is inevitably at higher risk of harm than the patient in the second situation. The distinction between informed consent for treatment and informed consent for research is based on a distinction that is growing ever more cloudy and ever less relevant to the moral goals that informed consent seeks to achieve. Current standards for informed consent for research are, in many ways, counterintuitive and probably counter-productive.

Ethics, Medical↗
PubMed2005

Teaching pediatrics residents how to obtain informed consent.

BACKGROUND: Few physicians view informed consent as a critical component of the physician-patient relationship or as a way to improve individual and population health. We hypothesized that formal education about informed consent would affect first-year pediatrics residents' knowledge and attitudes. METHOD: Twenty-seven first-year pediatrics residents participated in a randomized controlled trial with a wait-list control group. The one-hour interactive intervention consisted of a lecture, video, and small-group discussion. Outcomes were measured after randomization at baseline and after the intervention group received the intervention. Data were analyzed using multivariate analysis and between and within group t tests. Qualitative data were obtained after the wait-list control group's exposure to the intervention. RESULTS: The quantitative analyses demonstrated that the intervention yielded statistically significant improvements in the measured outcomes. The qualitative analyses confirm the quantitative findings. CONCLUSION: A formal session on informed consent in the pediatrics residency educational program positively affects residents' knowledge and attitudes about informed consent.

Adult↗
PubMed2005

The medical-legal aspects of informed consent in orthopaedic surgery.

BACKGROUND: Orthopaedic surgeons routinely obtain informed consent prior to surgery. Legally adequate informed consent requires a thorough discussion of treatment options and risks and proper documentation; however, there is little data to guide orthopaedic surgeons regarding effective methods of obtaining informed consent. METHODS: We performed a closed claims analysis on malpractice claims involving an allegation of inadequate informed consent brought during a twenty-four-year period with two malpractice insurers. Relevant malpractice claims were reviewed, and data were abstracted. We then performed statistical analyses to identify factors that positively correlated with a successful defense. RESULTS: We identified twenty-eight lawsuits that included a claim of inadequate informed consent. All of the cases involved elective orthopaedic surgical procedures; there were no emergent cases. Three cases involved a disputed surgical site; all three cases involved foot and ankle surgery and resulted in an indemnity payment. Documentation of appropriate informed consent in the office notes of the surgeon was associated with a decreased indemnity risk (p < 0.005). Obtaining the informed consent on the hospital ward or in the preoperative holding area was associated with an increased indemnity risk (p < 0.004). When informed consent was obtained in the office by the operating surgeon, the risk of malpractice payment was significantly decreased (p < 0.004). CONCLUSIONS: Surgeons may be able to decrease the risk of a malpractice claim by obtaining informed consent in their offices, rather than in the preoperative holding area, and by documenting the informed consent discussion within their dictated office or operative notes.

Adult↗
PubMed2003

The era of valid informed consent.

The concept of informed consent in clinical trials is well understood, although when viewed from the perspective of legal consent and valid consent, problems arise. Legal consent can be as simple as the signing of a document of informed consent. Valid consent, however, implies that the participant in the clinical trial is aware of the risks involved in being exposed to a new medical drug, including the risk of possible severe adverse drug reactions. Since most pre-clinical data is based largely on animal experiments, and animal data cannot be extrapolated to human beings with any degree of confidence, valid consent cannot be provided by the participant. It is therefore suggested that animal experiments be replaced with human-based methodologies, which rely on modern methods of molecular biology and human genetics.

Animals↗