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PubMed1981

The elderly and informed consent: effects of vocabulary level and corrected feedback.

Eighty-seven elderly adults (57-87 years of age) divided into four WAIS vocabulary subgroups (less than 40, 40-49, 50-59, greater than or equal to 60) participated in a study of comprehension and memory of an informed consent procedure. Ss in Group I read the consent form and, with the information sheet still present, answered multiple choice questions covering the main points of information. Feedback and corrected answers were then provided. Ss in Group II read the consent form but did not receive the comprehension test or feedback. All Ss were tested for memory of the information 2-3 weeks later. Results indicated that losses in performance increased with decreasing levels of vocabulary. Losses associated with low vocabulary levels appeared to be comprehension-related and did not increase in later tests of memory. The use of corrected feedback provided a significant general improvement at all vocabulary levels but did not reduce the effects due to vocabulary levels.

Age Factors↗
PubMed2004

Beyond informed consent: did cancer patients challenge their physicians in the post-World War II era?

Historians have debated the degree to which past patients have provided meaningful consent prior to medical interventions. This article, a chart review of 170 patients treated for cancer between 1945 and 1970, adds to this literature by exploring the years when informed consent was being introduced in medical practice. As would be expected in a largely paternalistic era, physicians controlled most of the clinical encounters, even concealing cancer diagnoses. Yet thirty-one (18 percent) of the patients showed some involvement in decision making, either writing restrictions on their consent forms, asking probing questions, or otherwise challenging physicians' orders. Although the overall number of patients studied was small, minority and other ward patients were as likely as white, private patients to speak up. This study concludes that most patients passively assented to treatment, signing consent forms without making any inquiries. But a small group of patients challenged their physicians, leading them to learn more about proposed treatment options and perhaps make more informed decisions. Although motivated in part by the increasing attention to better consent practices, these patients spoke up for other reasons as well, possibly including their basic personalities, prior negative experiences in hospitals, or apprehensiveness regarding specific types of interventions. Further research should explore the factors--beyond the introduction of informed consent--that have historically promoted better dialogue between physicians and patients.

Female↗
PubMed2004

How much do healthcare professionals know about informed consent? A bristol experience.

BACKGROUND: It is important that healthcare professionals have a thorough knowledge of consent practice. The purpose of this study was to compare understanding against the agreed standards found in consent guidelines and UK case law. METHOD: Twelve 'true or false' questions testing knowledge of the consent process were completed by 118 healthcare professionals from the United Bristol Healthcare NHS Trust. The questions addressed areas of fundamental importance, difficult clinical situations, and common consent dilemmas. The answers were marked against pre-validated answers determined using published guidelines and case law. Results were analysed for differences between pre-determined population sub-groups. RESULTS: A 100% response rate was achieved. Significant areas of weakness were identified including the role of consent forms, Gillick competence and mentally-ill patients. Performance was generally better by medical staff, those in surgical specialties, and more junior doctors. For example, 30.9% of doctors versus 62% of non-doctors (p=0.05) thought, incorrectly, that if an adult is unable to provide consent for an emergency procedure, the patient's next of kin must sign the consent form. Doctors also demonstrated a greater understanding of Gillick case law and scored significantly higher than non-doctors (68% vs. 48.5%, p=0.027). CONCLUSIONS: National guidelines and case law provide the gold standard for ideal consent practice. Many healthcare professionals have either not read these documents or are unable to reliably recall them. Improvements in knowledge and practice could be possible with further education, particularly targeting those most closely involved in the consent process

Clinical Competence↗
PubMed2005

Effects of making emergency contraception available without a physician's prescription: a population-based study.

BACKGROUND: Timely access to emergency contraception has the potential to reduce the number of unwanted pregnancies and subsequent abortions. A public health policy initiative in British Columbia beginning in December 2000 allowed pharmacists to provide emergency contraceptives (ECs) without a prescription. We sought to determine changes in EC use after the policy was introduced and to analyze EC use with data generated by the policy. METHODS: All Ovral, Preven and Plan B EC prescriptions from Jan. 1, 1996, to Dec. 31, 2003, were identified through the BC PharmaNet and Medical Services Plan administrative databases and the data analyzed to determine changes between 1996 and 2002. Changes over time were determined in the frequency of EC provision, choice of EC agent, frequency of EC use by age group, repeat use and geographic distribution of EC prescription for the pre- and post-policy periods. Anonymized patient-specific data from treatment consent forms were used to describe the reason for EC use, interval between unprotected intercourse and EC prescription, proportion prescribed for immediate or future use, referrals for regular birth control and STD screening and concomitant antiemetic use. Consent data also provided the time in the menstrual cycle that the EC was requested. RESULTS: The number of EC prescriptions increased from a pre-policy mean of 8805 (99% confidence interval 7823-9787) in the years 1996 to 2000 to a post-policy total in 2002 of 17 794. Physicians prescribed the levonorgestrel regimen (Plan B) less frequently than did pharmacists. The frequency of EC use was highest among women aged 20-24 years across all study years, and all age groups demonstrated a post-policy increase in use. On average, 2.1% of the women received an EC 3 or more times a year over the period of the study. More women in urban regions received ECs than women in more rural areas of the province. Analysis of pharmacist treatment consent forms used in 2001 and 2002 showed that 56.2% of women receiving an EC reported using a method of birth control that had failed, 55.7% of pharmacist-provided ECs were obtained within 24 hours after unprotected intercourse, 1.1% of ECs were obtained for future use, antiemetics were provided to 57.7% of women receiving the Yuzpe regimen (Ovral, Preven) and to 20.5% of women receiving levonorgestrel, and women tended to seek ECs when unprotected intercourse occurred at the time of highest risk of pregnancy in their menstrual cycle. Women in greatest financial need obtained ECs more frequently from physicians than from pharmacists. INTERPRETATION: The policy change that granted pharmacists authority to provide ECs to women without a physician's prescription did not simply expand EC availability but was associated with an overall increase in EC use in the province.

Adolescent↗
PubMed2003

[Writing information and consent prior to orthopaedic surgery].

BACKGROUND: In Norway, the Code of Ethics for Doctors and the Patients' Rights Act require informed consent before surgery. Written information and consent may increase the patient's interest in clinical decision making but will also focus on the risks. MATERIAL AND METHODS: This article investigates the attitude of two populations of patient to thorough information about the potential risks of surgery and their attitude to written information and consent. 91 patients accepted for total knee arthroplasty or arthroscopic acromioplasty were offered written information material, a consent form, and a questionnaire. RESULTS: All patients were in favour of that thorough information should be given about the risks of surgery; only three felt that this information caused anxiety. Three patients abstained from the operation after having read the information material; 39 stated that information in writing had improved their ability to decide whether or not to accept the operation. 69 patients stated that giving written consent is a valuable approach. INTERPRETATION: In patients prepared for total knee arthroplasty or arthroscopic acromioplasty, information and consent forms with detailed information about risks could be a valuable supplement to oral information for the purpose of obtaining truly informed consent.

Acromioclavicular Joint↗
PubMed2005

A preliminary study of interactive questioning methods to assess and improve understanding of informed consent among patients with schizophrenia.

Growing recognition of the inadequacy of traditional methods of providing informed consent, especially for individuals vulnerable to impaired decisional capacity, has spurred recent interest in how to assess and improve components of consent-related decision making. In this preliminary study, we aimed to compare different methods of interactive questioning during presentation of research consent information among patients with schizophrenia. Patients were randomized to receive either standard administration (SA) of a consent form or one of two interactive questioning methods: Corrective Feedback (CF), in which the correct answer was provided following the participant's response, or Errorless Learning (EL), in which correct answers were provided just prior to the question. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was used to measure understanding, appreciation, reasoning, and expression of a choice following presentation of the consent form. There was no significant effect of condition (SA vs. EL vs. CF) on any of the components of decisional capacity. Understanding scores measured during the consent process were higher than those measured afterward, but the two scores were highly correlated. Thus, the results of this randomized study suggest that interactive questioning neither helped nor harmed understanding, appreciation, or reasoning among patients with schizophrenia. Other considerations, however, may favor use of such methods in the consenting process.

Adult↗
PubMed1996

Development of a system to evaluate and communicate radiation risk.

Review of research protocols involving positron emission tomography studies on healthy volunteers focused attention on the radiation exposure disclosure statements contained in the informed consent form. Of particular concern was the observation that breast doses from positron emission tomography studies are greater than breast doses from other research uses of radioisotopes, as well as routine nuclear medicine and radiographic procedures. Disclosure of individual organ doses is not normally provided on informed consent forms. A worksheet was developed to aid research investigators in the determination of effective dose equivalents and organ dose equivalents from all sources of radiation to which a volunteer is exposed. Three standardized risk statements are discussed. The final selection and use of these statements are determined by worksheet calculations of effective dose equivalents and organ dose equivalents.

Breast↗
PubMed2001

Variation in institutional review board responses to a standard protocol for a multicenter clinical trial.

UNLABELLED: Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. OBJECTIVE: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. METHODS: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North AMERICA: Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. RESULTS: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40--83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26--62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. CONCLUSIONS: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration.

Androstadienes↗
PubMed2003

Documentation in orthopaedic surgery - do integrated care pathways work?

Integrated care pathways (ICPs) are being widely adopted in orthopaedic surgery. This study compares the quality of medical notation in an ICP with traditional record keeping. During a 3-month period, 53 total hip replacements (ICP notation) and 30 total knee replacements (traditional notation) were performed. The records of each patient were scrutinised using a standardised scoring system, based on The Royal College of Surgeons of England guidelines on medical record keeping. Each set of records (83) was scored for: admission clerking, subsequent entries, consent form, operation note, and discharge letters. The time taken to retrieve this information was recorded. The overall score for traditional records (mean, 70%) was significantly higher (P = 0.001 ) than for the ICP records (mean, 62%). The mean scores for initial clerking, subsequent entries and consent form were higher in the traditional record group. It took 35% longer to retrieve information from the ICP group (P < 0.001). In this study, the quality of record keeping was higher when using the traditional notation than an established ICP. In both groups, the frequency of omissions was high.

Arthroplasty, Replacement, Hip↗
PubMed1992

[Evaluation of the consequences of signing a written consent on physician-patient relations. Apropos of Huriet's legislation].

Whenever an innovative treatment or a research protocol is proposed to a patient, the "loi Huriet" requires a written consent from the patient. This is an important change in the field of the interrelation between the doctor and his patient. To evaluate the impact of this written consent we asked 215 patients who have signed a consent form to answer a questionnaire at the end of their radiation treatment. The signature appears as an important event. The majority of the patients (70%) is not shocked by this procedure. In 97% of cases, in spite of this written relation, the patients keep intact their confidence in their doctor. Sometimes this consent form may improve the information given to the patient and it should not be seen as an obstacle for the development of research trials. There are still many problems to be solved as regards the information of the patient and the application of the "loi Huriet".

Clinical Trials as Topic↗
PubMedDate not supplied

Families' experiences in consenting to eye donation of a recently deceased relative.

OBJECTIVE: To explore the unique experience of families who have consented to eye donation of a recently deceased relative. DESIGN: Exploratory-descriptive. SETTING: A city in western Canada. PARTICIPANTS: Seventeen relatives of 16 eye donors who had died within the previous 3 to 12 months. RESULTS: Families were in psychologic shock after the donor's death, which inhibited their recollection of events. Nurses were found to initiate the possibility of eye donation most often, and the decision to donate was made precipitously. In several cases, it was not stated clearly on the consent form what tissue was to be removed, and whether the family had agreed only to transplantation or transplantation and research. When the tissue was used for research, families had a need to believe this would eventually benefit someone. CONCLUSION: Particular care needs to be taken when reviewing the consent form with families to ensure that it reflects how they or the donor want the tissue to be used. Families can be prepared for the eventuality that the tissue will be used for research rather than transplantation by the reinforcement that the knowledge gained will help many individuals.

Eye↗
PubMed1995

Informed consent for research: a study to evaluate readability and processability to effect change.

BACKGROUND: Ninety million Americans are reported to have low literacy skills, and the problems associated with illiteracy permeate all areas of our society, including medical research. The purpose of this study was to determine the readability and comprehensibility of human research informed consent forms using established reading comprehension processes. Further, if comprehension problems were present in the forms, the study sought to identify the exact nature of these difficulties and identify specific areas where the forms could be rewritten to increase readability and understanding. METHODS: All human research informed consents approved by Hartford Hospital in 1993 were evaluated by a Readability and Processability Form (RPF) based on reading research, including the Fry Scale which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital. RESULTS: Seventy-six informed consent forms were evaluated, and neither the Fry score or the RPF score was in the target range. Ninety-six percent of the forms were found to have readability levels higher than the target level (8th grade). The mean readability and processability score was 46, resulting in the classification, Minimally Adequate/Needs Improvement. (The target range was Good, 61-100.) A question by question analysis of each of the 20 checklist items on the RPF identified important aspects of text writing style that were scored as Unacceptable or Poor. CONCLUSIONS: The descriptive data indicates that there were problems with the readability of the informed consent documents studied. The prescriptive portion of this study provides researchers with information on specific areas where their forms need to be studied and rewritten. The comprehension problems found in this study may alert others to similar problems and may provide the basis for other institutional review boards (IRBs) to study their consent forms in order to ensure that the interests of both the patient and the researcher are protected and that the obtained consent is truly informed.

Comprehension↗
PubMed1997

Expectations and experiences of patients with cancer participating in phase I clinical trials.

PURPOSE/OBJECTIVES: To describe the expectations and experiences of patients entering phase I clinical trials. DESIGN: Descriptive, exploratory, prospective. SETTING: A large military medical teaching center. SAMPLE: Thirty-seven adult patients completed the entry and exit interviews. Subjects had a good performance status, were middle aged, and had common tumor types. METHODS: Interviews using structured entry and exit questionnaires. MAIN RESEARCH VARIABLES: Expectations and experiences of patients in phase I clinical trials. FINDINGS: Patients expected slightly increased support from family members and received more support than expected. Patients' expectations for tumor response and increased communication with their physician were not met. Patients expected symptoms such as fatigue, nausea and vomiting, and weight loss to improve during therapy, yet their expectations were not met. CONCLUSIONS: One theme that emerged from the data was hope/optimism. An issue that needs further exploration is the extent to which patients accurately understand information in the consent form. Findings also support the importance of communication between the patient and family members and the healthcare team. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses can mediate the flow of information between physicians and patients. Oncology nurses can and should assess the patient's level of understanding of the clinical trial, the consent form, and potential side effects at the time of entry into the trial and intermittently during the course of therapy. Nurses must allow patients with cancer who are undergoing investigational therapy to maintain a level of hope, while realistically counseling them about their progress during phase I trial participation.

Adult↗
PubMed2003

Truth and consequences: ethics, confidentiality, and disclosure in adolescent longitudinal prevention research.

PURPOSE: To examine data from a natural experiment resulting from a change made in the confidentiality agreement midway through a randomized, longitudinal, controlled trial to prevent or delay adolescent alcohol use. The investigators explored the impact of the change on adolescents' rates of participation and affirmative responses to a question on suicidal thoughts. METHODS: Adolescents 12-17 years old were administered a question on suicidal thoughts as part of a confidential exit interview after a general health examination with their primary care provider. After administration to 263 adolescents, the exit interview was made conditionally confidential with the remaining 181 adolescents. The revised consent form and protocol stipulated that researchers would reveal to appropriate professionals and parents any adolescent indicating suicidal thoughts. Prevalence estimates for the suicidal thoughts question and study participation rates were computed for conditions both before and after the change. RESULTS: Fewer adolescents responded affirmatively to the suicidal thoughts question when they were recruited using the revised (1%) than the original (8%) consent form and protocol (p=.001). The revised confidentiality agreement did not affect participation rates. CONCLUSIONS: Adolescents who assent to participate in research studies may be less likely to disclose personal information regarding suicidal thoughts if they know that their disclosure may result in a break in confidentiality. Specific guidelines are needed for conditional and unconditional confidentiality agreements to study mental health in adolescent longitudinal prevention research.

Adolescent↗
PubMed2002

Literacy in the health care system: a study on open heart surgery patients.

PURPOSE: To determine if patients recovering from open heart surgery were able to read and understand written discharge instructions and further to analyze the level of difficulty of standard discharge instructions and consent forms for open heart surgery. DATA SOURCES: After screening for visual acuity and efficiency, literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine test (REALM) and comprehension was tested by a post-test of five questions based on the discharge instructions. Flesch-Kincaid scores were calculated on four sets of standard written discharge instructions and consent forms. CONCLUSIONS: Results from the study indicated that the REALM test was more accurate than the reported grade level and that reading skills are needed to understand and comprehend information needed for post-operative care. The study further substantiated that health care facilities are not providing written instructional material that is within the reading level of the patient. IMPLICATIONS FOR PRACTICE: Illiteracy can have a major impact in the health care system. Low reading skills can disempower and can prove to be costly for patients who are requiring health care services. Further investigation is needed on the impact of patients' reading skills on the health care system.

Aged↗
PubMed2004

Factors impacting questionnaire response in a Dutch retrospective cohort study.

PURPOSE: To study questionnaire length, type of consent, approach to recruitment, and subject characteristics on participation in epidemiologic studies. METHODS: As part of a health survey among Dutch subjects treated for ear, nose, and throat disorders in childhood, we conducted a pilot study of 200 individuals who were randomly assigned to one of four categories, defined by length of questionnaire (long vs. short) and type of consent form (basic vs. multi-option). In addition, among 8402 subjects eligible to be in the main study (average age 41 years in 1997), we examined the effect of approach to recruitment and subject characteristics on participation rates. RESULTS: The pilot study showed a non-significant 10% increase in participation rate using the shorter questionnaire, but no differences by type of consent form. In the full survey, the participation rate was 49% after the first mailing. Response increased by 15% after a written reminder and by 10% after a telephone survey. The total participation rate was 74%. Attained age, sex, exposure status, age at exposure, and response to an earlier survey were determinants of participation rates. Among male non-participants, outright refusal was less frequent than non-response. The refusal rate, unlike the non-response rate, was positively associated with older age at time of survey. CONCLUSIONS: Health survey participation is influenced by questionnaire length, frequency of contact, and subject characteristics.

Adult↗
PubMed2001

Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?

OBJECTIVE: To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure. DESIGN: A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure. SETTING: Tertiary referral centre. PATIENTS: 31 patients who had given written informed consent for their participation in randomised intervention trials of acute myocardial infarction. RESULTS: The patients interviewed had only fragmentary knowledge about the trial they were involved in. Most considered that reading and signing a consent form was an unwanted or unnecessary procedure. Instead, they would have preferred to have been given concise verbal information about the study. Most were willing to allow a physician to decide for them in the event of their being too ill to be asked about their participation. CONCLUSIONS: Patients who are asked to participate in intervention trials in the early phase of acute myocardial infarction often appear to lack sufficient knowledge to reach an autonomous choice. There were problems and disadvantages associated with the process of obtaining written informed consent in this particular situation, especially regarding the need for the patient to sign a consent form during the acute phase of the disease.

Abciximab↗
PubMed2006

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

OBJECTIVE: To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. METHOD: Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. RESULTS: Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. CONCLUSION: In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Adolescent↗