Modified informed consent procedure: consent to postponed information.
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ABSTRACT:
SUBMITTER: Boter H
PROVIDER: S-EPMC1126664 | biostudies-literature | 2003 Aug
REPOSITORIES: biostudies-literature
Publications
Modified informed consent procedure: consent to postponed information.
Boter Han H van Delden Johannes J M JJ de Haan Rob J RJ Rinkel Gabriël J E GJ
BMJ (Clinical research ed.) 20030801 7409
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Project description:BACKGROUND:In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant's true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania. METHODS:A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65). RESULTS:In contrast to the pamphlet, attending an information session significantly increased caregivers' knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures). CONCLUSIONS:In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.
| S-EPMC6945786 | biostudies-literature
Project description:BackgroundDespite the 2015 Montgomery Ruling highlighting key requisites for informed consent, little has changed to modernise data-sharing and documentation of the consent process. It can be difficult to gauge patient understanding and address all patient concerns in time-limited appointments. We aimed to assess the feasibility of a digital information-sharing platform to support a move towards a digital informed consent process.MethodsAll adult patients referred to a single centre with symptomatic gallstones were invited to use a digital information-sharing platform to support the informed consent process prior to their first surgical clinic appointment. The platform provided patients with multimedia information on gallstones and available treatment options. It recorded the time spent accessing information, asked patients multiple choice questions (MCQs) to allow a self-test of understanding, documented a summary medical history, and allowed free text for patient questions. This information was summarised into a clinical report to support outpatient clinic consultations.ResultsOf the 349 patients registered to use the digital platform, 203 (58.2%) [165 (81.3%) female, mean age 47.6 years (range 19-84 years)] completed all modules necessary to generate a clinical report. Some 130 patients (64.0%) answered all 10 MCQs correctly and spent a mean of 18.7 min (range 3-88 min) reading the consent information. Most patient-reported medical histories were deemed to be accurate.ConclusionDespite difficulties with access, resulting in drop-outs, patients welcomed the opportunity to receive information digitally, prior to their consultation. Patients described feeling empowered and better informed to be involved in decision-making.
| S-EPMC9734622 | biostudies-literature
Project description:BackgroundA topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important.MethodsTo gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale.ResultsThirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade.ConclusionThe results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.
| S-EPMC1764745 | biostudies-literature
Project description:IntroductionRecent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.MethodsWe downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n = 102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements.ResultsOf the 102 trial records, 76 had identifiable KI sections that were, on average, 10% of the total length of full ICF documents. KI readability grade level was not notably different from other sections of ICFs. Most KI sections were distinguished by section headers and included lists but contained few other formatting elements. Most KI sections included a subset of topics consistent with the basic elements of informed consent specified in the Common Rule.ConclusionMany of the KI sections in the study sample aligned with practices suggested in the preamble to the revised Common Rule. Further, our results suggest that some KI sections were tailored in study-specific ways. Nevertheless, guidelines on how to write concise and comprehensible KI sections would improve the utility and readability of KI sections.
| S-EPMC10514692 | biostudies-literature
Project description:Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence.The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof.Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought.Outcome will be published in a scientific journal.NTR5374; Pre-results.
| S-EPMC4823441 | biostudies-other
Project description:BackgroundLittle is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.ObjectiveTo describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.DesignDescriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).ParticipantsTwo hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives.MeasurementsNumber of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).ResultsParticipants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.ConclusionsLower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.
| S-EPMC1831581 | biostudies-literature
Project description:Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge-including assessment of therapeutic misconception-in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks.This longitudinal study assessed retention of clinical trial-related consent information. Individuals enrolling in 1 of 8 clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not rereviewed at any follow-up visit.Fifty-nine participants were enrolled; analysis included 52 participants with at least 1 follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44 = 3.43, P = .001). Retention of study knowledge was not related to symptoms but had a weak correlation with cognitive capacity (R = 0.28, P = .07). Performance did not differ between participants from research clinics and those from community mental health centers.Clinically stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely reevaluate participants during this type of clinical trial.
| S-EPMC4482016 | biostudies-literature
Project description:Informed consent for living kidney donation is paramount, as donors are healthy individuals undergoing surgery for the benefit of others. The informed consent process for living kidney donors is heterogenous, and the question concerns how well they are actually informed. Knowledge assessments, before and after donor education, can form the basis for a standardized informed consent procedure for live kidney donation. In this prospective, a multicenter national cohort study conducted in all eight kidney transplant centers in The Netherlands, we assessed the current status of the informed consent practice for live donor nephrectomy. All of the potential living kidney donors in the participating centers were invited to participate. They completed a pop quiz during their first outpatient appointment (Cohort A). Living kidney donors completed the same pop quiz upon admission for donor nephrectomy (Cohort B). In total, 656 pop quizzes were completed (417 in Cohort A, and 239 in Cohort B). The average donor knowledge score was 7.0/25.0 (±3.9, range 0-18) in Cohort A, and 10.5/25.0 (±2.8, range 0-17.5) in Cohort B. Cohort B scored significantly higher on overall knowledge, preparedness, and the individual item scores (p < 0.0001), except for the long-term complications (p = 0.91). Donor knowledge generally improves during the live donor workup, but it is still quite disappointing. Long-term complications, especially, deserve more attention during living kidney donor education.
| S-EPMC8837079 | biostudies-literature
Project description:IntroductionDue to a lack of time and staff, informed consent (IC) in clinical practice often lacks clarity, comprehensibility and scope of information. Digital media offer great potential to enhance IC. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC.MethodsIn the randomized, controlled, three-arm DICon (Digital Informed Consent for urological surgery) study 70 patients with an indication for prostate biopsy were randomized 1:1:1 to receive traditional paper-based IC vs. multimedia-supported information before IC vs. multimedia-supported information during IC. Patient satisfaction, anxiety and information gain were measured by validated questionnaires 2 weeks and directly before the procedure and time efficiency was recorded. Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test).ResultsMultimedia information prior to the consultation saved 32.9% time compared to paper-based (5.3 min. vs. 9.5 min; p < 0.05) and 60.4% time compared to shared multimedia information (5.3 min. vs. 13.9 min.; p < 0.001), with no difference in satisfaction (62.6 vs. 62.7 vs. 68.6 of max. 80; p = 0.07), anxiety (8 vs. 8.1 vs. 7 of max. 16; p = 0.35), or information gain (6.5 vs. 5.7 vs. 6.7 of max. 10; p = 0.23). Results on satisfaction (56.6 vs. 62.6 vs. 66; p = 0.06), anxiety (7.2 vs. 7.2 vs. 6.8; p = 0.84), and information gain (7 vs. 6.4 vs. 5.9; p = 0.43) remained stable over time.ConclusionsMultimedia-supported IC prior to consultation provided improved time efficiency (33% gain) compared to traditional paper-based IC, with comparable satisfaction, anxiety and information gain. Multimedia-supported information materials should therefore be used more frequently in patient education.
| S-EPMC11543590 | biostudies-literature
Project description: Not available
| S-EPMC1112854 | biostudies-literature