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PubMed2000

Autopsy consent practice at US teaching hospitals: results of a national survey.

BACKGROUND: Autopsy rates continue to fall despite the enduring benefit of the procedure to families and medical science, yet there are few data about the consent process itself. OBJECTIVE: To evaluate the current practice of obtaining autopsy consent, by assessing the consent forms currently in use, the knowledge and attitudes of chief residents on the procedure, and the expert opinion of pathologists in those institutions. DESIGN: Cross-sectional survey. SETTINGS AND PARTICIPANTS: One hundred twenty-seven US teaching hospitals. RESULTS: Of all autopsy consent forms we surveyed, 84.7% contained 7 of 10 elements recommended by the College of American Pathologists. Only 7.1% of institutions supplied educational materials for the physician, as recommended by the College of American Pathologists. Overall, 50.1% of chief residents reported deficiencies in their knowledge of the autopsy procedure. Correspondingly, greater than 74.5% felt that educational materials would be beneficial for physicians and the family. Finally, 93.3% of chief residents believed that a limited autopsy should be offered to families, while 68 (90%) of 76 pathologists at these institutions believed that limited autopsies are an unsatisfactory alternative to the complete procedure. CONCLUSIONS: Chief residents at US teaching hospitals reported substantial deficiencies in their knowledge about autopsy and desire more training on the consent process. Autopsy consent forms are often lacking information that might help physicians and families in making an educated choice about autopsy. Teaching institutions need to reevaluate the training for the autopsy consent practice.

Autopsy↗
PubMed1994

Interactive method of informing patients of the risks of intravenous contrast media.

PURPOSE: To evaluate interactive computer-based informed consent for use of contrast material versus the same information in a written format. MATERIALS AND METHODS: Patients (n = 160) referred for radiologic examination with intravenous contrast material were block randomized (sex, age, and previous exposure to contrast material) into two groups and were provided either written or computer-based (video) informed consent. RESULTS: The female patients in the video group scored better on the test than those in the group with the written consent form. Male patients attained equivalent scores with both types of consent. The video took an average of 1.6 minutes longer to complete, probably because the majority of patients chose to be informed of every risk of intravenous contrast material. CONCLUSION: This project demonstrates that a video format for informed consent before use of intravenous contrast material offers a good alternative to the written consent form.

Comprehension↗
PubMed2002

Comprehension during informed consent in a less-developed country.

Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrollment. In a study of HIV-1 transmission in Haiti, participants were required to pass an oral examination on the contents of the consent form with a passing score of 12/15 (80%) before enrollment. 15 individuals were given information during a single meeting with a physician, and three (20%) passed. 30 subsequent volunteers were given information by a counsellor during three meetings, and 24 (80%) passed. Formal assessment of research participants' comprehension of the consent form should be considered as a routine step in the informed consent process in less-developed countries.

Adult↗
PubMed2006

The use of an educational video during informed consent in an HIV clinical trial in Haiti.

BACKGROUND: Research volunteers from developing countries who enroll in HIV clinical trials may be illiterate and unfamiliar with the conduct of medical research. Educating volunteers about the contents of the consent form is essential but can be difficult and time consuming. We evaluated the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti. METHODS: HIV-seronegative volunteers were recruited into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, all volunteers received information about the consent form during 2 educational sessions. In the first session, groups of 5 to 10 volunteers viewed an educational video on the essential elements of the consent form. In the second, the volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally by 16 true-false questions and 4 open-ended questions. Volunteers who failed the first evaluation received additional education and had a second evaluation. RESULTS: Two hundred fifty volunteers received education, and 186 (74%) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). Of the 64 who failed, 47 returned for a repeat one-on-one education session and a second evaluation. Among these 47, 39 (83%) passed, and 8 (7%) failed the second evaluation. In total, 225 (90%) of 250 individuals passed either the first or second evaluation and were eligible to enroll in the study. CONCLUSIONS: Informed consent using an educational video ensured good comprehension in most of the volunteers. Additional educational sessions may be necessary for some participants with lower educational level.

Adult↗
PubMed2001

[Patient education before orthopedic elective interventions. "The Lagenthal model of 3-step patient education"].

There is still quite a controverseY when and how an informed consent should be obtained from a patient in the surgical field. As has been stated of the federal court the patient need to be given that information which is understandable to him and which will not cause him undue anxiety. This information has to be sufficient for the decision whether to proceeD or decline a surgical procedure. The federal courts are therefore asking for the optimal patient consent not necessarily the total and complete revelation during the patient information. For this reason the act of obtaining an informed consent was thought to be turned into a scientific question in identifying the base from optimal quality of giving informed consent respecting at the same time the principal of evidence based medicine. The support presents a sample of an oral and written consent-form given in three stages as it is currently being used in the orthopaedic service of the Langenthal hospital. 100 patients were given this type of a consent and were later on asked for their opinion of acceptance. Most of the patients felt to be sufficiently informed on their procedure after having undergone a three times repeated interview as well as having been given a consent form including hand-drawings concerning their particular procedure. The advantages as well as the disadvantage of this type of consent form are being discussed.

Adolescent↗
PubMed2000

Hospital informed consent for procedure forms: facilitating quality patient-physician interaction.

BACKGROUND: Informed consent forms should document and reflect the goals of informed consent and shared decision making. We conducted this study to examine the extent to which informed consent for procedure forms meet accepted informed consent standards, how well state informed consent statutes correlate with these standards, and whether existing forms can enhance the interactions between patients and physicians or other health care providers. HYPOTHESIS: Informed consent forms do not meet accepted standards. A different format may be more useful for patient-physician interactions. DESIGN: A content analysis was conducted of hospital informed consent for procedure forms from a random selection of hospitals in the 1994 American Hospital Association membership directory. Forms were examined for evidence of the basic elements of informed consent (nature of the procedure, risks, benefits, and alternatives) and items that might enhance patient-physician interactions and encourage shared decision making. UNIT OF ANALYSIS: From 157 hospitals nationwide, 540 hospital informed consent for procedure forms were examined. MEASUREMENTS AND MAIN RESULTS: Ninety-six percent of forms indicated the nature of the procedure, but risks, benefits, and alternatives were found less often. Only 26% of forms included all 4 basic elements, 35% included 3 of 4 elements, 23% had 2 of 4 elements, 14% had only 1 element, and 2% had none of the elements. Forms appear to authorize treatment (75%) or protect hospitals and caregivers from liability (59%) rather than clarify information about procedures (40%) or aid patients in decision making (14%). Forms from states with statutes that require that all 4 elements be provided were no more likely than other states to include them (Fisher exact test = 1.000). Fewer than 40% of forms supported models of shared decision making. CONCLUSIONS: The content of most forms did not meet accepted standards of informed consent or patient-physician interactions. We propose a form that more fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical setting.

Ethics, Medical↗
PubMed2003

Improving the process of informed consent in the critically ill.

CONTEXT: Invasive procedures are often performed emergently in the intensive care unit (ICU), and patients or their proxies may not be available to provide informed consent. Little is known about the effectiveness of intensivists in obtaining informed consent. OBJECTIVES: To describe the nature of informed consent in the ICU and to determine if simple interventions could enhance the process. DESIGN, SETTING, AND PATIENTS: Prospective study of 2 cohorts of consecutively admitted patients (N = 270) in a 16-bed ICU at a university hospital. All patients admitted to the ICU during the baseline period from November 1, 2001, to December 31, 2001, and during the intervention period from March 1, 2002, to April 30, 2002, were included. INTERVENTION: A hospital-approved universal consent form for 8 commonly performed procedures (arterial catheter, central venous catheter, pulmonary artery catheter, or peripherally inserted central catheter placement; lumbar puncture; thoracentesis; paracentesis; and intubation/mechanical ventilation) was administered to patients or proxies. Handouts describing each procedure were available in the ICU waiting area. Physicians and nurses were introduced to the universal consent form during orientation to the ICU. MAIN OUTCOME MEASURES: Incidence of informed consent for invasive procedures at baseline and after intervention; whether the patient or proxy provided informed consent; and understanding by the consenter of the procedure as determined by the responses on a questionnaire. RESULTS: Fifty-three percent of procedures (155/292) were performed after consent had been obtained during the baseline period compared with 90% (308/340) during the intervention period (absolute difference, 37.4%; P<.001). During baseline, the majority (71.6%; 111/155) of consents were provided by proxies. This was also the case during the intervention period in which 65.6% (202/308) of consents were provided by proxies (absolute difference, 6.0%; P =.23). Comprehension by consenters of indications for and risks of the procedures was high and not different between the 2 periods (P =.75). CONCLUSIONS: Invasive procedures are frequent in the ICU and consent for them is often obtained by proxy. Providing a universal consent form to patients, proxies, and health care clinicians significantly increased the frequency with which consent was obtained without compromising comprehension of the process by the consenter.

Adult↗
PubMed1991

Level of reading difficulty in educational pamphlets and informed consent documents for cancer patients.

Nationwide samplings and data from the 1980 census suggest that a high proportion of patients cared for are functionally illiterate. Since educational materials and consent forms are often given to patients with little regard for their ability to read them, this study was designed to analyze the readability of educational materials and consent forms at the Cancer Center of Southern West Virginia at Charleston Area Medical Center. Results of the survey showed that although the median education of the 127 patients studied was 10th grade, more than 30 percent could not be expected to read at the 10th grade level. Most tested patient education materials required a reading level of 11th to 14th grade, and cooperative group consent forms required a college-level reading comprehension. If patient-directed written material is to serve its purpose, then outpatient populations should be surveyed and the reading level of written material adjusted accordingly.

Adolescent↗
PubMed1996

Shared understandings for informed consent: the relevance of psychological research on the provision of information.

The achievement of informed consent from patients and potential research participants is considered a basic requirement in clinical care and clinical research, but ethicists have paid little attention to the psychological processes and social factors involved in sharing information between individuals. Although many studies on consent have provided useful results, they are rarely informed by basic research in the social sciences. As a result, there are a large number of methodological and conceptual issues which have not been adequately addressed. The purpose of this paper is to illustrate how the work of cognitive and social psychologists can provide insights that are both relevant and valuable to the process of attaining consent. Research in these areas within psychology has indicated that there are important individual differences in how much information people require and that patients' current state of mind can affect estimates of probability, thus making analogue studies misleading. Collaboration between psychologists and ethicists would be of great value in identifying likely areas of mutual interest, particularly the choice of language in consent forms and information sheets, the design of consent forms, the amount of information provided, and the specification of risks and benefits.

Data Display↗
PubMed1997

Informed consent: patients' and junior doctors' perceptions of the consent procedure.

The important task of obtaining informed consent is often left to the most junior member of the surgical team, whose understanding of the surgical procedures involved may be limited. Little is known about patients' and junior doctors' satisfaction with the consent procedure, which was studied with the use of questionnaires. The vast majority of patients (95%) were satisfied with the explanation given to them prior to obtaining consent although 45% thought that the doctor who signed the consent form would be performing the surgery. Thirty-seven per cent of the junior doctors questioned admitted to obtaining consent for procedures of which they had little understanding. The majority of both junior doctors and patients felt that the surgeon performing surgery should sign the consent form. Junior doctors cannot be expected to obtain informed consent for procedures they do not fully understand and patients's; expectations must be taken into consideration if the seemingly inexorable rise in medico-legal litigation is to be halted.

Attitude of Health Personnel↗
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↗
PubMed2002

Physicians attitudes toward DNR of terminally ill cancer patients in Taiwan.

The purpose of this study was to survey physicians attitudes toward DNR of terminally ill cancer patients in Taiwan. A total of 7626 structured questionnaires were sent by mail to physicians who were members of the Taiwan Society of Internal Medicine and the Surgical Association of Taiwan, and 1328 valid responses were received. The response rate was 17.6%. The instrument, a structured questionnaire, was composed of one scenario and six questions. A majority (77.6%) of the physicians under investigation would tell a terminally ill cancer patient or his family about the possibility of DNR and ask them to consider signing a consent form. Over one half of the physicians (58.4%) did not know whether the Medical Law in Taiwan permits natural death, and 96.1% of the subjects felt they would need legal protection for agreeing patient s autonomy to decide DNR. Unfortunately, 41.2% of the respondent admitted that they did not have a formal Informed Consent Form that could be used for DNR. Even of those who had such a form, only 27.4% had clear guidelines given by their institutions. Among 623 physicians whose institutions had an formal Informed Consent Form for DNR, 63.7% agreed that it was reasonably used. Surprisingly, 67.9% of the physicians had used Slow Codes. The findings of this study served as a solid base. The investigator and other colleagues used it to convince legislators to pass a Natural Death Act in Taiwan. Since some legislators disliked the term death and the main promotes were people engaged in hospice palliative care, the new law entitled Hospice Palliative Act was passed on May 23, 2000. The DNR order finally gained its legal base for medical practice. The limitation of this study was the low response rate. However, since the subjects, physicians, had a busy work load, this was still an acceptable response rate.

Adult↗
PubMed2005

An audit of informed consent in gastroscopy: investigation of a hospital's informed consent procedure in endoscopy by assessing current practice.

OBJECTIVE: To investigate, by assessing current practice, whether a UK general hospital's informed consent procedure in endoscopy was implemented for all patients, because informed consent is central to the proper conduct of endoscopic procedures. METHODS: A retrospective study of patients' medical notes, in which information written on the UK National Health Service (NHS) consent form and on a departmental leaflet on the gastroscopy procedure completed by the patient was assessed. Sampling began from 9 October 2003 until 100 patients were recorded. For each patient's record, a data collection sheet was completed. RESULTS: Of the 67 patient records assessed (33 were unavailable), all contained the NHS consent form with signatures from the practitioner and patient. The departmental leaflet was present for only 31 patients, and of these, 20 had a signature from the patient and one leaflet had a signature from the practitioner. The multiple choice test was completed for 28 of the 31 departmental leaflets and full marks were awarded for 17 of 28. Although 11 patients answered one or more questions incorrectly, a discussion of the correct answers was only found in two records. CONCLUSION: To achieve improved performance, a training/induction programme should explain the informed consent procedure and its importance. This should be supported by 'booster' training sessions to avoid the emergence of bad practice. These sessions should take advantage of evidence-based medicine via feedback from audits and discussions of litigation cases. Departmental leaflets and NHS consent forms should also be provided in other languages.

England↗
PubMed2006

Improving the informed consent process for surgery.

OBJECTIVE: Obtaining and documenting informed consent is of vital importance to physicians. We developed a procedure-based consent form that facilitates patient discussion and validated this process by surveying the patient regarding elements of the consent process, using an independent evaluator. METHODS: One hundred and twenty consecutive outpatients were evaluated before different neurosurgery procedures. The consent form listed specific diagnoses, procedures, alternatives (eight listed), and risks (22 listed), and each point discussed was checked off by the surgeon. Between 10 and 20 minutes later, each element was questioned by one lay-member of the office staff. A group of patients not at risk for cognitive decline were resurveyed months later. RESULTS: One hundred and twenty (100%) of 120 of patients answered correctly regarding their diagnosis and the planned procedure. Four hundred and twenty-eight alternative treatments were discussed, and 420 (98.1%) of the 428 were recalled correctly. Of 1207 risks that were discussed, 1176 (97.4%) were recalled correctly. When a subset of the patients were reevaluated at a mean of 4.5 months later, all 20 patients correctly recalled their procedure and diagnosis. Of 79 alternatives discussed with patients before surgery, 73 (92.4%) were subsequently recalled. Of 217 risks discussed before surgery, 199 (91.7%) were recalled. Although the immediate or delayed recall rates were high (> 90%), there was a reduction in the recall rate over time (alternatives, P = .007; risks, P < 0.0001). CONCLUSION: A consent process designed for an individual surgeon's practice was validated and showed high rates of patient recall in the postprocedural period. We think that this method to obtain and document informed consent should be considered for use by physicians.

Consent Forms↗
PubMed1999

Effectiveness of a writing improvement intervention program on the readability of the research informed consent document.

BACKGROUND: Problems with the comprehensibility of human research informed consent have been documented since the 1970s, and efforts aimed at rewriting consents have not been successful in consistently producing more readable consents. This study employed researched principles of reading comprehension research to create writing intervention program designed to help the research writer produce more comprehensible informed consent documents. The purpose of this study was to determine if this intervention program was effective. METHOD: The key component of the writing improvement intervention packet was a newly formatted consent form that contained annotated instructions for researchers on how to write each section for optimum comprehension. The resulting consent forms were evaluated using a Readability and Processability Form (RPF). The RPF is based on reading research and includes the Fry Scale, which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of comprehension analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital institutional review board. RESULTS: We evaluated 66 post-intervention informed consents. The mean readability and processability score was 62, resulting in the RPF classification of "good." The established readability and processability target range was good to excellent or 61-100 points; 66% of the forms scored in this range. In our 1995 pre-intervention study, the corresponding score was 12%. The target range for grade reading level was 8th grade: 53% scored in that range as compared with 4% in 1995. A question-by-question analysis of each of the 20 checklist items on the RPF identified important aspects of the consent writing that improved and others that were still weak and needed improvement. CONCLUSIONS: The Hartford Hospital writing improvement intervention program was associated with the production of more comprehensible informed consent documents. Using the intervention materials, investigators from a variety of departments could function independently to produce readable consent forms. This program may help others who wish to assist their research departments in creating consents that are written for optimal reading comprehension.

Cognition↗
PubMed1979

Patient recall of informed consent.

The protection of human subjects in research is a shared responsibility. The informed consent procedure was introduced to implement protection of the subjects. The contents of consent forms have been in dispute, and the impact of the procedure on the human subject has caused concern. It was demonstrated that patients with cancer have poor recall of the contents of a signed consent form.

Consent Forms↗
PubMed1994

[Informed consent, what information is left after a therapeutic trial?].

In order to evaluate the outcome of information given to patients included in a therapeutic trial after having signed a consent form, 77 patients (68 men, 9 women with an average age of 57.9 years) included in the IMPACT study (multicenter, randomised, double-blind protocol, the main objective of which was to assess the antiarrhythmic effect of oral administration of delayed action mexiletine in patients with a recent myocardial infarction), answered a questionnaire of 85 items. The quantity and degree of comprehension of the recalled information at the end of the trial were appreciated from the replies to 13 questions based on the definition or understanding of the most important details of the consent form and on a comprehension score with a maximum value of 14 points. The global quantity of information recalled after an interval ranging from 5 to 21 months was estimated at 60% of the information provided but the recall was not uniform according to the different elements of the consent form: the aim of the study, the concept of placebo, the nature of the active treatment, the randomisation and possible side effects were only correctly apprehended by 40 to 50% of patients: the type of patient included, the duration of the trial, the content of the gelules, the division between treatment/placebo and the concept of double-blind were known to 50 to 75% of participants: the sites of the test centres, the possibility of unmasking the "blind" are of withdrawing from the trial were correctly understood in 75 to 90% of cases. The global average comprehension score was 8.7.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2001

Perceptions of informed consent by participants in a prostate cancer prevention study.

This study examined perceptions of the informed consent process in healthy men participating in a cancer prevention clinical trial. Specifically, we examined influence of the consent form on participation and understanding, adequacy of the consent process in preparing participants for trial experiences, and perceived needs for additional follow-up strategies. Participants (n = 69) enrolled in the Prostate Cancer Prevention Trial at our institution completed mailed questionnaires approximately 2 years after joining the study. Results indicated that many participants had no remembrance of the consent process, and only a minority reported that the consent process had helped in decision-making about study participation. Eleven men (16%) reported experiencing unexpected study side effects, most related to sexual functioning. Most men (78%) did not feel that they currently needed more information about the study, although virtually all of the respondents wanted to learn the study results. Almost one-third wished to interact with other Prostate Cancer Prevention Trial participants. Results indicate that a signed consent form and initial counseling for a prevention study does not ensure that participants feel they are adequately informed about the study or the side effects. Providing and reinforcing information on a regular and continuous basis is especially important in studies where compliance is required over a period of years.

Aged↗