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PubMed1993

Reading ability in patients in substance misuse treatment centers.

Adult inpatients in state-supported (public) and private substance misuse treatment settings were tested for reading ability. Patient education materials and consent forms were assessed for readability levels. Public patients' mean reading levels were significantly lower than those of private patients, and were 4 to 5 years below the level needed to read and understand standard treatment materials. More than half of the public and almost one-third of the private patients tested were reading below a 9th grade level. Standard treatment materials were written on 11th to 12th grade reading levels; admission and consent forms were written on 12th to 18th grade levels. Patients in substance misuse settings should be tested for literacy levels upon admission and provided with materials commensurate with their reading ability.

Adolescent↗
PubMed2005

Documentation of acute compartment syndrome at an academic health-care center.

BACKGROUND: Documentation of the clinical course of a compartment syndrome is critical to effective treatment; however, such documentation often is found to be inadequate. METHODS: Notes and consent forms for thirty consecutive patients with adequate follow-up who had undergone fasciotomy for the treatment of compartment syndrome were reviewed for legibility, notation of the time and date, and documentation of the presence of core physical examination and history findings, including pain, paresthesias, tenseness, pain on passive stretch, sensory deficit, motor deficit, pulses, compartment pressures, and diastolic blood pressure. RESULTS: Documentation was inadequate for twenty-one patients (70%): the notes and consent forms were not timed or not dated (or both) for nine patients (30%), and the notes were at least partially illegible for sixteen patients (53%). The documentation was incomplete with regard to the presence of paresthesias in eleven patients, pain on passive stretch in ten, sensory deficit in nine, motor deficit in eight, pulses in seven, pain in five, and tenseness in three. The documentation was incomplete with regard to the blood and compartment pressures for sixteen and six patients, respectively. CONCLUSIONS: The documentation of the core history and physical examination findings was inadequate in this series of patients with compartment syndrome. On the basis of the results of this study, and through an organizational systems approach, we have instituted for our residents, nursing staff, and faculty an educational program on the documentation of compartment syndrome in patients who are at risk for this condition.

Academic Medical Centers↗
PubMed2006

Use of sedation for routine diagnostic upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy Survey of National Endoscopy Society Members.

BACKGROUND/AIMS: Sedation rates may vary among countries, depending on patients' and endoscopists' preferences. The aim of this survey was to investigate the rate of using premedication for routine diagnostic upper gastrointestinal (UGI) endoscopy in endoscopy societies, members of the European Society of Gastrointestinal Endoscopy (ESGE). METHODS: We evaluated a multiple-choice questionnaire which was e-mailed to representatives of national endoscopy societies, which are members of the ESGE. The questionnaire had 14 items referring to endoscopy practices in each country and the representatives' endoscopy units. RESULTS: The response rate was 76% (34/45). In 47% of the countries, less than 25% of patients undergo routine diagnostic UGI endoscopy with conscious sedation. In 62% of the responders' endoscopy units, patients are not asked their preference for sedation and do not sign a consent form (59%). Common sedatives in use are midazolam (82%), diazepam (38%) or propofol (47%). Monitoring equipment is not available 'in most of the endoscopy units' in 46% (13/28) of the countries. Though they were available in 91% of the national representatives' endoscopy units, they are rarely (21%) used to monitor unsedated routine diagnostic UGI endoscopy. CONCLUSIONS: In about 50% of ESGE-related countries, less than 25% of patients are sedated for routine diagnostic UGI endoscopy. Major issues to improve include availability of monitoring equipment and the use of a consent form.

Procedural Sedation↗
PubMed2004

Interventions to improve research participants' understanding in informed consent for research: a systematic review.

CONTEXT: Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. OBJECTIVE: To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. DATA SOURCES AND STUDY SELECTION: A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. DATA EXTRACTION: Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. DATA SYNTHESIS: Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all P<.05), but 5 of 6 trials were of limited quality, casting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P<.05) but were flawed in that they may have mistaken rote memorization for improvement in understanding. Another 5 trials were put into a miscellaneous category and had varying impact on understanding. Some demographic factors, particularly lower education, were associated with less understanding. Satisfaction and willingness to enroll were never significantly diminished by an intervention . CONCLUSIONS: Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants' understanding; however, further research is needed.

Biomedical Research↗
PubMed1994

Reading versus comprehension: implications for patient education and consent in an outpatient oncology clinic.

Written educational materials and consent forms are often given to patients with little regard for their ability to read them. Nationwide sampling and data from the 1990 census suggest that 10% of U.S. adults are functionally illiterate. In this study, 100 adult patients (64 female, 36 male) seen consecutively in an oncology clinic were tested for reading vocabulary (RD-VOCAB) and reading comprehension (RD-COMP) using the Woodcock-Johnson Psychoeducational Battery. The mean grade levels of education (last grade completed), reading vocabulary, and reading comprehension of all participants were 12.5, 11.3, and 10.5, respectively. The discrepancy between the grade level of education and RD-COMP varied by age, the largest discrepancies being found in the 30-39 (three grades) and 60-69 (2 1/2 grades) age groups. After controlling for educational level, it was found that the mean grade level of RD-COMP was statistically lower than educational level. Statistically assuming all subjects to have completed high school, the mean levels of RD-COMP ranged from ninth grade in the 30-39 age group to twelfth grade in the 40-49 age group. This study underscores the fact that the health professional cannot assume that a patient who has completed a certain grade level in school can read at the corresponding level. Consent forms and other health education materials should be written at least three grade levels lower than the average educational level of the target population.

Adolescent↗
PubMed2005

An analysis of U.S. practices of paying research participants.

BACKGROUND: Despite controversy about paying research subjects, little is known about actual practices in the U.S., including what type of studies offer payment, to what type of subjects, and how amounts are determined. OBJECTIVE: To document current U.S. practices regarding payment to research subjects. METHODS: The protocols and consent forms of 467 studies offering payment to research subjects approved by 11 IRBs across the U.S. were reviewed to analyze how they describe and justify payment to subjects. RESULTS: Money was offered in a wide variety of study types, from short term physiologic studies to large clinical trials of therapeutic interventions, to both patient (61%) and healthy (24.4%) subjects or both (14.6%). Dollar amounts varied widely and were infrequently explicitly described as based on time (19%) or procedures (12%). Unexplained variation in dollar amounts occurred in similar studies or in the same (multi-site) study at different sites, and for similar procedures across studies sometimes even within one site. Although the range was wide ($5-$2000), total amounts were usually modest (overall median $155), and almost always described in the consent form (94.4%) and usually as pro-rated (73%). CONCLUSIONS: Both patient and healthy subjects are offered payment in a wide variety of types of research in the U.S. Variation in the dollar amounts offered is largely unexplained.

Choice Behavior↗
PubMed1993

Informed consent and medical ethics.

Informed consent is based on a shared decision between physician and patient, with the physician understanding the relevant values of the patient and the patient understanding the nature of the disease and intervention, including risks and benefits. Informed consent has developed rapidly since it was introduced in the 1950s, reflecting recent changes in the practice of medicine that respect the increase of patient autonomy. The purpose of the written consent form is to document that a process of informed consent has taken place. It is generally agreed that all surgical as well as research procedures require written consent. For certain nonsurgical procedures, the decision regarding obtaining written consent will consider both the risk involved for the patient and the general community standard. Informed consent serves as an important symbol of a physician-patient relationship that adheres to the valued principles of medical ethics.

Consent Forms↗
PubMed1993

A successful system of scientific data audits for clinical trials. A report from the Cancer and Leukemia Group B.

OBJECTIVE: To report on data collected during on-site audits of source documents in the Cancer and Leukemia Group B (CALGB). DESIGN: A retrospective review of audit reports in four audit cycles. SETTING: A cooperative group of institutions conducting clinical trials in cancer treatment. PARTICIPANTS: Patients taking part in clinical trials at collaborating CALGB institutions, members of the CALGB Data Audit Committee, and group chairmen of CALGB. MAIN OUTCOME MEASURE: The results of 691 institutional audits conducted by the CALGB in 1982 through 1992 with comparisons of main CALGB institutions vs affiliates. RESULTS: In four full reviews of all participating institutions in the CALGB, 3787 patients have had their on-site medical records compared with data submitted to the CALGB Data Management Center. Compliance with federal regulations for oversight by an institutional review board improved from a deficiency rate of 28.0% among the main institutions and 49.6% of the affiliate institutions in the first audit cycle to respective figures of 13.3% and 28.2% in the fourth cycle. Consent form deficiencies also dropped overall from 18.5% in the first cycle to 3.9% in the fourth. Patient eligibility was verified by auditors in 94.5%, and assessment of tumor changes in response to treatment was verified in 96.4% in the fourth cycle; both figures were only slightly lower in the first cycle. Two instances of scientific impropriety were discovered for a rate of only 0.28% of all audits. Both occurred prior to 1984, and none have occurred since. Major protocol deviations in drug dosing have held steady at about 11% over four audit cycles. Over the 11-year period of audits, three main institutions and 96 affiliate institutions have discontinued CALGB membership due solely, or at least partly, to unfavorable audit results. CONCLUSION: Scientific improprieties have occurred very rarely in clinical trials conducted by the CALGB. Protocol compliance in assessing patient eligibility and tumor responses has been high. Attention to administrative matters of consent forms, institutional review board approval, and ancillary data submission has measurably improved in the CALGB, which is at least partly due to the pressure from this on-site peer review of investigator performance.

Clinical Trials as Topic↗
PubMed2005

[How informed is patient consent to interventional cardiology procedures. A quality assurance survey by the nurses].

BACKGROUND: A new patient consent form has recently been adopted in our Institution, with a uniformly written text to be used for all medical procedures and interventions. It is accompanied by a separate information sheet, explaining both the details and the risk/benefit profile for each specific procedure/intervention. It should be given to the patient as early as possible after the procedure/intervention is planned. Testing the effectiveness of this new information policy has been included into the quality assurance goals by our nursing staff. METHODS: From mid April to mid June 2004 a questionnaire was administered to all patients who had undergone an elective cardiac interventional procedure. The timing, manner and perceived completeness of the information received by patients was investigated by 14 yes/no or multiple choice questions. A goal of <5% deviation from a 100% standard was set for all indicators. RESULTS: Two hundred and thirty-eight valid questionnaires were obtained out of 308 consecutive procedures. Seven patients (3%) refused the questionnaire. The response rate was >90% for each question. Seventy-eight patients (33%) had a history of cardiac interventional procedures. The information sheet had been received before the procedure in 93% of cases, and this had happened in the ward in 58% of cases; the procedure had been performed at least 1 hour after receipt of the information sheet in 83% of cases. Twenty-seven patients (13%) stated they had not read the information sheet, in most cases (92%) because they felt they already knew enough. Among patients who had read the information sheet, 99% deemed it could be easily understood. Difficulties in asking questions were reported by 6% of patients. When questions had been asked, the nursing staff was addressed in 42% of cases, and the answers were rated as clear in 98% of cases. The consent form was not read at all by 13% of patients, due to alleged lack of time, and was not read completely by another 15%; 98% of those who had read it, however, found it was fairly understandable. CONCLUSIONS: The effectiveness of our new patient information policy seems to approach our quality goals, and is liable to further improvement. The nursing staff of the cardiac catheterization unit is involved in the patient information process, and has full competence to study this issue.

Adult↗
PubMed2002

The effect of active parental consent on the ability to generalize the results of an alcohol, tobacco, and other drug prevention trial to rural adolescents.

The authors report the effect of active parental consent on sample bias among rural seventh graders participating in a drug abuse prevention trial. Students obtaining active consent from their parents to complete the survey were of higher academic standing, missed fewer days of school, and were less likely to participate in the special education program at their school as compared to students who did not return a parental consent form. However, students with consent were not significantly different from students whose parents actively declined. The sample obtained under active parental consent represents students less at risk for problem behaviors than would have been obtained under passive consent procedures.

Adolescent↗
PubMed1989

Women in labor: some issues about informed consent.

Women wishing hospital admission for childbirth are asked to sign very general pre-admission consent forms. The use of such forms suggests that women in labor are considered incompetent to give informed consent. This paper explores some of the problems with advance directives and general consent, and argues that since women in labor are not generally incompetent, it is not appropriate to require this kind of consent of them.

Advance Directives↗
PubMed1996

Ethics in the doctor-patient relationship.

For historical reasons, much of the attention to the doctor-patient relationship has been based on the concept of informed consent. The concepts of information and consent are both problematic, and as a result, consent forms and advanced directives often undermine the goal that led to the consent doctrine. A better ethic can be derived from stressing the connection between doctor and patient and determining how that connection can be fostered.

Consent Forms↗
PubMed1987

Informed consent: a risk management view. Council on Insurance.

In the best of all possible worlds, rules could be established that, if strictly followed, would eliminate litigation. Regrettably, that world does not exist. When dealing with informed consent many issues remain uncertain. Doctors must use their best professional judgment and hope that the jury will support it. Some risk management suggestions would include: Personally discuss the benefits and risks of the proposed treatment with the patient as well as the alternatives, and the consequences of nontreatment. Give the patient an opportunity to ask questions. Get a commitment from the patient to proceed. Use lay terms. Give no guarantees. If in doubt, disclose the risks. Use a signed informed consent form. Keep well-documented records. Consult your attorney about developing informed consent procedures that reflect state laws.

Consent Forms↗
PubMed1980

Legal and ethical issues in clinical pharmacy research--informed consent, Part II.

Preparation of an effective informed consent document presents significant problems to those investigators not familiar with federal and institutional requirements. This article examines a detailed format for preparation of an informed consent instrument. Prepared by the authors and supplied to potential clinical investigators by a university institutional review committee, the guidelines incorporate Department of Health, Education, and Welfare regulations. An example consent form is provided.

Clinical Trials as Topic↗
PubMed1999

Psychological distress among cancer patients and informed consent.

This study examines the relationships between satisfaction with information provided, understanding of consent procedures, and levels of anxiety/depression in a sample of patients undergoing radiotherapy for cancer. One hundred patients completed a 13-item self-report questionnaire and the Hospital Anxiety and Depression Scale (HADS). Twenty-two percent of patients could not recall signing a consent form and, for those who did recall, the level of understanding for what they had consented to was patchy. One fourth of patients could not recall being told of the side-effects from radiotherapy and were unable to list even common side-effects, such as tiredness, skin irritation, and sickness. No patient had been told about the low risk of second malignancy. Twenty-eight percent of patients were unhappy with the amount of information offered to them. Thirty percent of patients reached caseness for adjustment disorder +/- anxiety/depression. Thirteen percent of patients reached caseness for major depression. There was a significant correlation between patients who scored highly on the HADS and dissatisfaction with the information provided. Clinical implications and possible mechanisms of these findings are discussed.

Adaptation, Psychological↗
PubMed2002

Verteporfin therapy for subfoveal choroidal neovascularization in age-related macular degeneration: three-year results of an open-label extension of 2 randomized clinical trials--TAP Report no. 5.

OBJECTIVE: To report vision and safety outcomes from an extension of a 2-year investigation evaluating verteporfin photodynamic therapy in patients with age-related macular degeneration with subfoveal choroidal neovascularization (CNV). DESIGN AND SETTING: Open-label extension of selected patients from 2 multicenter, double-masked, placebo-controlled, randomized clinical trials, the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation, at 22 ophthalmology practices in Europe and North America. PARTICIPANTS: Patients enrolled in the TAP Investigation and followed up for at least 24 months in whom verteporfin therapy to CNV might reduce the risk of further vision loss. METHODS: Before receiving verteporfin therapy in the extension, eligible patients signed a written informed consent form accompanied by an oral consent process approved by local institutional review boards. Methods were similar to those described for 1- and 2-year results, with follow-up examinations beyond 2 years continuing at 3-month intervals with a few exceptions, including that extension patients with fluorescein leakage from CNV were to receive open-label verteporfin therapy irrespective of their original treatment assignment. RESULTS: Of 402 patients in the verteporfin group, 351 (87.3%) completed the month 24 examination; 320 (91.2%) of these enrolled in the extension study. The enrolled participants included 124 (78.0%) of the 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline, of whom 105 (84.7%) completed the month 36 examination. Verteporfin-treated patients with this lesion composition at baseline who participated in the extension study, with or without a month 36 examination, appeared more likely to have a younger age, better level of visual acuity, absence of fluorescein leakage from classic CNV, or no progression of classic CNV beyond the baseline boundaries of the lesion at the month 24 examination compared with those who did not enroll in the extension. For the 105 patients with a predominantly classic baseline lesion composition who completed the month 36 examination, an average of 1.3 treatments were given from the month 24 examination up to, but not including, the month 36 examination. A letter score loss in the study eye of at least 15 from baseline for these patients occurred in 39 (37.5%) at the month 24 examination compared with 44 (41.9%) of these patients at the month 36 examination. Visual acuity changed little from the month 24 examination (mean, -1.9 lines) to the month 36 examination (mean, -2.0 lines) for these eyes. Verteporfin-treated patients had little change in the mean visual acuity lost and few or no additional instances of infusion-related back pain or photosensitivity reactions from month 24 to month 36. Two patients originally assigned to placebo had acute severe vision decrease within 7 days after verteporfin treatment during the extension. One patient originally assigned to verteporfin had acute severe vision decrease after verteporfin treatment of the fellow eye during the extension. CONCLUSIONS: Vision outcomes for verteporfin-treated patients with predominantly classic lesions at baseline remained relatively stable from month 24 to month 36, although only approximately one third of the verteporfin-treated patients originally enrolled with this lesion composition had a month 36 examination. From these results, the TAP Study Group identified no safety concerns to preclude repeating photodynamic therapy with verteporfin. Additional treatment was judged likely to reduce the risk of further vision loss. Caution appears warranted in the absence of comparison with an untreated group during the extension and since not all patients in the TAP Investigation participated in the TAP Extension.

Aged↗
PubMed2006

Healthy participants in phase I clinical trials: the quality of their decision to take part.

AIMS AND OBJECTIVE: This study was set out to test the quality of the decision-making process of healthy volunteers in clinical trials. BACKGROUND: Researchers fear that the decision to volunteer for clinical trials is taken inadequately and that the signature on the consent forms, meant to affirm that consent was 'informed', is actually insubstantial. DESIGN: The study design was quasi-experimental, using a convenience quota sample. METHODS: Over a period of a year, candidates were approached during their screening process for a proposed clinical trial, after concluding the required 'Informed Consent' procedure. In all, 100 participants in phase I trials filled out questionnaires based ultimately on the Janis and Mann model of vigilant information processing, during their stay in the research centre. RESULTS: Only 35% of the participants reached a 'quality decision'. There is a definite correlation between information processing and quality decision-making. However, many of the healthy research volunteers (58%) do not seek out information nor check alternatives before making a decision. CONCLUSIONS: Full disclosure is essential to a valid informed consent procedure but not sufficient; emphasis must be put on having the information understood and assimilated. Research nurses play a central role in achieving this objective.

Attitude to Health↗