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PubMed1984

The elderly patient and informed consent. Empirical findings.

Informed consent with the elderly patient and the competency of this patient population have been neglected issues in medicine and law. Particularly, the competency of the elderly patient has received little empirical investigation. The present study examines the capacity of geriatric patients to consent to research participation. Competency is investigated through the use of hypothetical consent information on three dimensions: comprehension of consent material, quality of reasoning about the decision to participate or not participate in research, and reasonable choice regarding participation. The results indicate that elderly patients' choices about those projects in which participation is "reasonable" do not differ, by and large, from younger patients. However, the elderly show significantly poorer comprehension of consent information. Thus, screening for competency and providing special instructions may become an important part of the research process when the elderly are participants.

Adult↗
PubMed2004

EPO or not-EPO? An evidence based informed consent.

BACKGROUND: Informed consent is crucial in therapeutic choices; however, the forms presented to patients are often locally developed and information may not be homogeneous. OBJECTIVE: To prepare an evidence-based model for informed consent, applied in the case of erythropoietin therapy (EPO) as a teaching tool for medical students. METHODS: Methodological tools of Evidence-Based Medicine (EBM) were developed within the EBM Course in the Medical School of Torino, Italy, as problem solving and patient information tools (5th year students work in small groups under the supervision of statisticians, epidemiologists and experts of internal medicine--nephrology in this case). RESULTS: Methodological and ethical problems were identified: in the pre-dialysis field, evidence from randomized clinical trials (RCT) is scant; how to use evidence gathered in dialysis? How to deal with implementation? How with the mass media? Do we need to discuss the drug choice with the patients? How to deal with rare and severe side effects?). The "evidence" was searched for on Medline/Embase, by using key-words and free terms. About 680 papers were retrieved and screened. Forms available on the Internet were retrieved and a general scheme was drawn: it included 5 areas: title, aim and targets (patients and family physicians); search strategies and updating; pros and cons of therapy; alternative options; open questions. CONCLUSIONS: EBM may offer valuable tools for systematically approaching patient information; the inclusion of this kind of exercise in the Medical School EBM courses may help enhance the awareness of future physicians of the correct communication with patients.

Aged↗
PubMedDate not supplied

Verbal expressions of probability in informed consent litigation.

Informed consent litigation provides a forum in which probabilistic evidence is elicited from physicians as parties or as expert witnesses. The authors reviewed over 450 medical informed consent opinions reported by both trial and appellate courts in all 50 states over 40 years to determine 1) the extent to which verbal expressions of probability were used by testifying physicians to characterize the risks of medical procedures; 2) when such expressions were used, whether consistent numeric interpretations of the terms were being applied by the physicians; 3) whether the choice of expression was influenced by the severity of the consequences associated with the particular risk; and 4) whether the use of such terms was correlated with trial outcomes, inasmuch as the duty to disclose a risk is said to increase with the magnitude of the risk and probability is one measure of such magnitude. It was found that subjective verbal expressions of probability are used in the litigation setting, and that such expressions represent broad ranges of numeric probabilities. There was some correlation between the expression and the represented numeric probabilities. In general, expressions such as "extremely low" and "low" corresponded to probabilities lower than those represented by terms such as "high" and "very high." Further, verbal expressions appeared to be influenced by the severity of the consequences associated with the risks, but whether this increases or decreases the ambiguity of verbal expressions in the communication process warrants further research. The authors suggest a syntax of verbal expressions of probability as a means to reduce the numeric ambiguity of these terms.

Choice Behavior↗
PubMed1991

A randomized controlled trial comparing quantitative informed consent formats.

Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.

Behavioral Research↗
PubMed1995

[Informed consent].

The informed consent, in which the physician informs about procedures to be performed and requests approval, puts into practice the communication between physicians and patients. The consent will always be verbal and will only put writing in complex or risky situations. This doctrine, that promotes the recognition of patients autonomy, is employed since the end of World War II. Its main features are mental competence to know and elect, adequate and comprehensible information and voluntary acceptance or denial. In the situations of requested paternalism, therapeutic privilege and placebo use, information is not given and the consent is not requested. In all research protocols, a written informed consent must be requested. The consent is a form of communication that tries to defend patients rights as something close and alive, and should not become a ritual.

Humans↗
PubMed1994

Informed consent--recall of risk information following epidural analgesia in labour.

Recall of information pertaining to informed consent for epidural insertion in 40 primiparous labouring women was assessed. The recall of informed consent was compared between those patients who had attended antenatal epidural education classes, and those who had not. Overall recall of information was poor. Recall of information was significantly better in patients who had attended antenatal epidural education classes. We recommend that informed consent for epidural analgesia in labour be obtained antenatally whenever possible, and that details of the consent be recorded in the patient's notes.

Adolescent↗
PubMed2005

Evaluating the quality of informed consent.

CONTEXT: Although informed consent is a critical means of protecting the rights and interests of participants in clinical research, effective and efficient means of evaluating the quality of consent are needed. Having such means will be important to monitoring consent and testing potential improvements in the consent process. OBJECTIVE: To develop and test a practical and general means of evaluating the quality of informed consent for clinical research. Methods We developed and tested the Brief Informed Consent Evaluation Protocol (BICEP), a short telephone-based assessment of informed consent. As soon as patient-participants completed the informed consent process for a participating VA Cooperative Studies Program clinical trial they called an interviewer who administered the BICEP. RESULTS: 632 participants completed BICEP, representing eight ongoing studies from 14 VA and one non-VA medical centers across the country. Site coordinators reported little to no difficulty implementing BICEP. The average duration of BICEP was 8.8 minutes (SD 3.6). Overall, patient-participants evaluated the informed consent process positively. A reliable coding system was then developed to analyze the verbatim responses of the final 191 participants. An Informed Consent Aggregate Score (ICAS) had a mean score of 8.23 (SD 1.17) with a range of 0-10, with 10 a perfect score; and a Therapeutic Misconception Aggregate Score (TMAS) had a mean of 1.62 (SD 0.93) with a range of 0-5, with 5 a perfect score. CONCLUSIONS: The BICEP is an efficient means of evaluating informed consent that is acceptable to research participants and research personnel. While participants tend to be satisfied with the informed consent process, the BICEP indicates there is room for improvement in the informed consent process for research.

Consent Forms↗
PubMed2005

[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].

Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.

Adolescent↗
PubMed2001

Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process.

OBJECTIVE: Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period. METHODS: This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined. RESULTS: The population had a mean age (+/-SD) of 39.4 +/- 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (+/-2.0), range 2-12 (maximum 12). The MF score was 10.6 (+/-1.4) vs the IF score of 8.6 (+/-2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = -6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%). CONCLUSIONS: Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.

Adolescent↗
PubMed1999

Understanding informed consent.

Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to document the informed consent discussion. The place of informed consent in leading international codes of research ethics is reviewed. Some prominent examples of past violations of informed consent are discussed. Even when properly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information must be given to research subjects, and how much is too much; and how to ensure the full voluntariness of subjects' consent, especially when the researcher is also the patient's physician. An ongoing problem is the 'therapeutic misconception'--the belief that proposed research is a promising treatment intended to benefit the subjects. The complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied.

Communication↗
PubMed2001

Informed consent for acupuncture--an information leaflet developed by consensus.

Patients have the right to be fully informed about the likely benefits and risks of any proposed examination or treatment, and practitioners are obliged to obtain informed consent beforehand. Accurate information about the risks of acupuncture is available following publication of the results of two prospective surveys. At a joint meeting on the safety of acupuncture, members of the three largest UK professional bodies expressed a need to establish what information on risks patients should be given. A standard Information Leaflet was developed by consensus between thesc organisations, and is intended to be used as a stimulus for discussion of standard risks as well as any particular risks that might apply to individual patients. Additionally, it may be used as a form for written consent when this is required. To provide the context for using the Leaflet, the legal and ethical bases of informed consent for medical procedures are discussed.

Acupuncture↗
PubMed2004

Informed consent in the (mis)information age.

Recent studies suggest that large numbers of health-care consumers are turning to the Internet as a source of health information. This article considers the potential impact of on-line health information on women's health-care decisions, and the role of physicians relating to their patients' use of the Internet as an information source. In particular, the article examines the effect of on-line health information on the informed consent process. Physicians' disclosure obligations (their legal duty to provide information to patients) and the law of informed consent are briefly described. The article then considers the Internet as a source of health information, and instances and types of misinformation. Finally, the article suggests steps physicians may take to help their patients benefit from Internet health information and to become critical consumers who do not fall victim to inaccurate or misleading information. The article concludes by suggesting that physicians make a practice of asking their patients about alternate sources of information they may have accessed, in order to help ensure that patients' health-care decisions are based on current, accurate, and complete information.

Canada↗