Antipsychotic treatment for youth in foster care: Perspectives on improving youths' experiences in providing informed consent.
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ABSTRACT:
SUBMITTER: Simmel C
PROVIDER: S-EPMC8404191 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionFrom the first day of residency, residents may be required to consent patients for interventions, procedures, or tests. The ability to perform an informed consent is considered one of the Association of American Medical College's Core Entrustable Professional Activities for entering residency. This case provides learners with the opportunity to obtain informed consent for a lumbar puncture procedure and to receive immediate structured feedback on their performance. This is a formative assessment, which has been used with both senior medical students and first-year residents at our institution.MethodsThe case involves a standardized patient with a history of leukemia who presents to the emergency department with a headache, fever, and lethargy. The learner is charged with the task of compassionately, honestly, and confidently explaining the process of a lumbar puncture in order to appropriately obtain informed consent.ResultsThis case was well received, with the vast majority of learners rating the instructions as clear and the tasks of the station as appropriate for the level of learner. Comments provided by the learners regarding the standardized patients' feedback indicate that this is a useful exercise to assist with the development of the crucial skill of obtaining informed consent.DiscussionOverall, learners are able to perform this task and find it a meaningful exercise. We are able to measure both content and communication skills. In our cohort, learners are able to perform above the targeted passing score. This provides some evidence of competency in terms of both content and communication skills.
| S-EPMC6464558 | biostudies-literature
Project description:BackgroundYouth in protective custody (e.g.. foster care) are at higher risk for poorer physical and mental health outcomes compared with those who are not in custody. These differences may be due in part to the lack of research on the population to create evidence-based recommendations for health care delivery. A potential contributor to this lack of research is difficulties in obtaining informed consent for empirical studies in this population. The objective of this study was to describe the approaches to obtaining informed consent in minimal risk studies of foster youth and provide recommendations for future requirements.MethodsWe conducted a systematic review of the literature to characterize the informed consent approaches in published minimal risk research involving youth in foster care. We searched PubMed, CINAHL, PsychINFO, Embase, ERIC, Scopus, and EBMR. Inclusion criteria were: studies conducted in the United States, included current foster youth, minimal risk, peer reviewed, and published in English. Full text was reviewed, and individuals required to consent and assent were extracted.ResultsForty-nine publications from 33 studies were identified. Studies required 0 to 3 individuals to consent. Individuals required to give consent included case workers (16, 48%), foster caregivers (12, 36%), biological parents (7, 21%), judges (5, 15%), and guardian ad litems (2, 6%). Twenty-nine (88%) studies required the youth's assent. The studies used 14 different combinations of individuals. One (3%) study utilized a waiver of consent.ConclusionsThere is no consistent approach for obtaining informed consent for foster youth to participate in minimal risk research. Consent should ideally involve individuals with legal authority and knowledge of the individual youth's interests and should not be burdensome. Consensus regarding consent requirements may facilitate research involving foster youth.
| S-EPMC8351591 | biostudies-literature
Project description:BackgroundThe development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.MethodsUsing a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants' views and concerns were solicited. Thematic analysis was undertaken using NVivo.ResultsThe majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders' access to an eIC system, and thus, to participants' personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants' understanding before providing their eIC.ConclusionsFollowing a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants' motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.
| S-EPMC9669523 | biostudies-literature
Project description:The authors investigated the extent to which clinical diagnoses of externalizing disorders explain higher rates of antipsychotic use by foster care youths.Medicaid claims data from 44 states for 2009 for youths in foster care (N=301,894) and those not in foster care (N=5,092,574) were analyzed, excluding those with schizophrenia, bipolar disorder, autism, and major depressive disorder. Logistic regressions assessed the relationship between foster care, externalizing disorders, and antipsychotic use.Foster care youths had higher rates of externalizing disorders than the comparison group (attention-deficit hyperactivity disorder, 17.3% versus 6.5%; disruptive behavior disorder, 7.2% versus 2.5%; conduct disorder, 2.3% versus .5%) and greater antipsychotic use (7.4% versus 1.4%). Foster care remained a significant predictor of antipsychotic use after control for demographic and diagnostic covariates, including externalizing disorders (adjusted odds ratio=2.59, 95% confidence interval=2.54-2.63).High rates of externalizing disorder diagnoses only partially explained elevated levels of antipsychotic use in this vulnerable population.
| S-EPMC4489136 | biostudies-literature
Project description:One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences.
| S-EPMC5743761 | biostudies-literature
Project description:Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository.We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important.On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage.The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.
| S-EPMC3250643 | biostudies-literature
Project description:Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking.
The overarching objective of this project is to develop a library of communication tools for the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools will include video clips and written documents that can be readily distributed, modified, and customized. This toolkit will be crafted in collaboration with oncologists and patients living with gastrointestinal cancer and improves upon existing resources in several ways: 1) balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3) use of both written and video format, and 4) inclusion of the patient perspective (e.g. video clips of patients describing their experience). A panel of oncologist and patient stakeholders will evaluate the acceptability of the tools. The investigators will then conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves the quality of informed consent for palliative chemotherapy. If effective, the tools will be amenable to broad dissemination via patient accessible cancer education websites and oncology clinics.
| 2177652 | ecrin-mdr-crc
Project description:There are complex ethical dilemmas inherent to medicine teaching, particularly in clinical practice involving actual patients. Questions must be raised on fulfilling medical students' training needs while still respecting patients' fundamental rights to autonomy and privacy. We aimed to assess patients' perspectives regarding medical students' involvement in their medical care. An observational, cross-sectional study was developed, and a questionnaire was applied randomly to patients waiting for a consultation/admitted to three distinct departments: General Surgery, Obstetrics/Gynaecology, and Infectious Diseases. Of the 77% interviewed patients who reported previous experiences with medical students, only 59% stated that they were asked for consent for their participation, and 28% stated that students had adequately introduced themselves. Patients from Gynaecology/Obstetrics were the ones who reported lower rates of these practices and were also the ones who were most bothered by students' presence, stating that they would be more comfortable without the presence of medical students. Male patients received more explanations than female patients regarding the same matters. Thirty-five percent of patients stated that they would feel more comfortable without the medical students' presence. The study shows a need to pay closer attention to fulfilling patients' fundamental rights.
| S-EPMC9265405 | biostudies-literature
Project description:The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia - a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects.
| S-EPMC4989211 | biostudies-literature
Project description:ObjectiveInformed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers' beliefs and experiences related to principles and practice of informed consent.MethodsQualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a focus group discussion were used to collect data. Participants were 22 clincal officers, nurse-midwives and midwifery students involved in maternity care. Data were analysed to identify themes and construct an analytical framework.ResultsDefinition and purpose of informed consent revolved around providing information, respecting women's autonomy and achieving legal protection. Due to fear of blame and litigation, health workers preferred written consent. Written consent requires active participation by the consenting individual and was perceived to transfer liability to that person. A woman's refusal to provide written informed consent may pose a dilemma for the health worker between doing good and respecting autonomy. To prevent such refusal, health workers said to only partially disclose surgical risks in order to minimize women's anxiety. Commonly perceived barriers to obtain a fully informed consent were labour pains, language barriers, women's lack of education and their dependency on others to make decisions.ConclusionsHealth workers are familiar with the principles around informed consent and aware of its advantages, but fear of blame and litigation, partial disclosure of risks and barriers to communication hamper the process of obtaining informed consent. Findings can be used to develop interventions to improve the informed consent process.
| S-EPMC8008515 | biostudies-literature