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Results for “informed consent”

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PubMed2005

Informed consent in interventional spine procedures: how much do patients understand?

BACKGROUND: One of the most important issues that interventional physicians address during treatment is informing patients of their treatment options. Prior to beginning treatment, patients are given this information and allowed the opportunity to ask questions. Minimal qualitative information exists as to how much of this material patients retain and understand. OBJECTIVE: To determine the understanding and satisfaction patients have with the information provided through the informed consent process for interventional spine procedures. DESIGN: Prospective qualitative interview study. SETTING: University-based multidisciplinary spine practice. PARTICIPANTS: Twenty-five consecutive patients undergoing spinal procedures who agreed to be interviewed about the informed consent process. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Domains of concern for patients undergoing spinal procedures were determined through a qualitative interview. RESULTS: Primary areas of concern for patients with the informed consent process centered on their desire for more information on the procedure and its risks, expectations of the procedure and benefits, and what treatments patients feel are effective. Patients had difficulty recalling the potential risks and alternatives to the procedure. The majority of patients had tried physical therapy and medications, without benefit. The most common suggestion patients gave for improving the process was to produce a video of the procedure. Common themes encountered during the interview are reviewed, with common phrases presented for each theme. CONCLUSIONS: Despite discussion in the office, handouts, and pre-procedure instructions, patients felt that additional sources of information would be useful to fully understand the procedure and its risks, benefits, and alternatives. Moreover, informing patients' family members may enhance comprehension of all aspects of information provided within the informed consent process about interventional spine procedures.

Journal Article↗
PubMed2002

Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver.

Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.

Bipolar Disorder↗
PubMed2005

A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research.

OBJECTIVE: This study evaluated a brief educational video designed to enhance the informed consent process for people with serious mental and medical illnesses who are considering participating in treatment research. METHOD: Individuals with schizophrenia who were being recruited for ongoing clinical trials, medical patients without self-reported psychiatric comorbidity, and university undergraduates were randomly assigned to view either a highly structured instructional videotape about the consent process in treatment research or a control videotape that presented only general information about bioethical issues in human research. Knowledge about informed consent was measured before and after viewing. RESULTS: Viewing the experimental videotape resulted in larger gains in knowledge about informed consent. Standardized effect sizes were large in all groups. CONCLUSIONS: The videotape was thus an effective teaching tool across diverse populations, ranging from individuals with severe chronic mental illness to university undergraduates.

Adult↗
PubMed1995

Informed consent: its legal history and impact on medicine.

The doctrine of informed consent dictates that a physician has a legal duty to disclose to a patient sufficient information regarding the inherent risks and benefits of a proposed course of treatment, and alternatives to the proposed treatment so the patient can intelligently exercise his or her judgment about whether to undergo that treatment. The development of the law regarding informed consent both nationally and in Hawaii is examined along with the current status of the law and its potential impact on physician behavior and health care delivery in Hawaii.

Delivery of Health Care↗
PubMed1977

Informed consent in California. Latent liability without 'negligence'.

Informed consent is a legal obligation due from a physician to his patient, an obligation which may not be met by the physician's skillful treatment of his patient. It may only be met by the treating physician obtaining from his patient knowing authorization for carrying out the intended medical procedure. The physician is required to disclose whatever would be material to his patient's decision, including the nature and purpose of the procedure, and the risks and alternatives. The disclosures should be made by the physician to his patient, and not through use of consent forms which are not particular to individual patients. To minimize any subsequent claim by the patient that there was a lack of adequate disclosures, the physician should record in the patient's chart the circumstances of the patient's consent, and should not rely on the patient's unreliable ability to recall those circumstances.

California↗
PubMed1999

Informed consent to serum screening for Down syndrome: are women given adequate information?

To assess the information given to women during a maternal serum screening (MSS) programme, we prospectively applied a questionnaire to 504 pregnant women attending for amniocentesis after a screen-positive result. The survey based on 200 usable questionnaires (39.7 per cent of our study population) showed that MSS was imposed as mandatory by 41.5 per cent of providers and done without their patients' agreement by 16 per cent. After release of the test results, 6.5 per cent of women believed that they were carrying a Down syndrome-affected fetus and 21.5 per cent thought the risk was about 50-50. A total of 38.5 per cent of the pregnant women were not informed of the risk of miscarriage after amniocentesis and 67.5 per cent believed that there was no possibility of a false-negative result with MSS. Information given over the telephone was particularly poorly understood compared with information provided during an outcome visit, since women who learned of their test result during such a visit scored significantly higher (69 per cent) when questioned about the risk of carrying a Down syndrome-affected fetus, compared with women informed of their test results by telephone (38.7 per cent) or by letter (47 per cent). We therefore suggest routine consultation with an antenatal care professional before testing to enable pregnant women to give their informed consent to MSS.

Amniocentesis↗