Medical Education: Patients' Perspectives on Clinical Training and Informed Consent.
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ABSTRACT:
SUBMITTER: Gil-Santos I
PROVIDER: S-EPMC9265405 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:BACKGROUND:Informed consent is a process of communication between clinician and patient that results in the patient's decision about whether to undergo a specific intervention. However, patients often do not understand the risks, benefits, and alternatives, even after signing a consent form. METHODS:Mixed-methods pilot test of two Agency for Healthcare Research and Quality (AHRQ) informed consent training modules implemented in four hospitals. Methods included staff and patient surveys, interviews, site visits, and pre- and posttests of the modules. RESULTS:A low proportion of clinicians reported using teach-back (40.0%) or high-quality decision aids (55.0%). Patients reported limited use of best practices, including being asked to teach-back (58.4%), having other options described (54.9%), viewing decision aids (37.4%), and finding the form very easy to understand (66.8%). Content of the training modules aligned well with identified deficiencies. Barriers to completing the modules included staff turnover, competing demands, and lack of accountability. Facilitators included committed champions with available time, motivation, and release time for staff to take modules. Knowledge increased for leaders (p <0.05) and staff (p <0.001) who completed the training modules. Hospitals reported the effects of piloting the modules included fostering dialogue and identifying opportunities for improvements, identifying and rectifying policy ambiguity and noncompliance, reinforcing the use of interpreter services, and using modules' strategies and tools to improve informed consent. CONCLUSION:Many opportunities exist for hospitals to improve their informed consent practices. AHRQ's two training modules, have face validity, addressed demonstrated deficiencies in hospitals' informed consent policies and processes, and stimulated improvement activity in motivated hospitals.
| S-EPMC6022821 | biostudies-literature
Project description:PurposeLimited information exists regarding students' routine educational needs in support of ethics and professionalism practices faced in real clinical practice. As such the authors aimed to explore medical students learning needs and preferences for informed consent and relevant ethical issues in the clerkship environments.Materials and methodsA cross-sectional study using a self-administered, printed survey distributed to final year clinical clerks.Results84% completed the survey. Students indicated the need for more attention to all topics related to informed consent (mean = 7.1 on a scale of 0 to 9; ±1.2). Most additional instructional attention was requested for topics raised in discussions with patients concerning the risks, benefits and alternatives to recommended treatments (7.3 ±1.4). The cohort expressed the need for education in the care of vulnerable patients (7.2 ±1.2) with a maximum score for the care of abused children. Women perceived greater need for education concerning informed consent than male respondents (p>0.05). There were significant differences between students who scored high or low on the item "being treated in professional manner" and "endorsement of educational needs for care of adolescents" (p = 0.05).ConclusionThere was heightened perception among final year medical students of the need for greater attention to be paid to informed consent education.
| S-EPMC6169846 | biostudies-literature
Project description:BACKGROUND: Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients' perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient's self decision-making. Different purposes require different processes. METHODS: We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: "meaningless routine", "courtesy gesture" "litigation protection", "take away compensation rights", "inform patient', "make sure patient understand", "document patient's decision", "discover patient's preferences", "have shared decision", and "help patient decide". RESULTS: Respondents' mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ? college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was "meaningless routine" (ranked 1-3 by 2.6% of respondents) and the most reflective statements were "help patient decide", "make sure patient understand", and "inform patient" (ranked 1-3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked "help patient decide" better, whereas females and post-procedure respondents ranked "inform patient" better (p = 0.007 to p < 0.001). Age was associated with better ranking of "help patient decide" and "make sure patient understand" statements (p < 0.001 and p = 0.002, respectively), which were ranked 1-3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). CONCLUSIONS: 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients' self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill's individual autonomy model may be suitable for most patients.
| S-EPMC3897892 | biostudies-other
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
Project description:BackgroundInformed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.ObjectiveWe aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.MethodsWe conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.ResultsA total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies' populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.ConclusionsElectronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979.
| S-EPMC7582148 | biostudies-literature
Project description:The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.
| S-EPMC10609656 | biostudies-literature
Project description:Debates about the ethics of human brain organoids have proceeded without the input of individuals whose brains are being modeled. Interviews with donors of biospecimens for brain organoid research revealed overall enthusiasm for brain organoids as a tool for biomedical discovery, alongside a desire for ongoing engagement with research teams to learn the results of the research, to allow transfer of decision-making authority over time, and to ensure ethical boundaries are not crossed. Future work is needed to determine the most feasible and resource-efficient way to longitudinally engage donors participating in brain organoid research.
| S-EPMC10362497 | biostudies-literature
Project description:As a critical component of medical practice, it is alarming that patient informed consent does not always reflect (1) adequate information provision, (2) comprehension of provided information, and (3) a voluntary decision. Consequences of poor informed consent include low patient satisfaction, compromised treatment adherence, and litigation against medical practitioners. To ensure a well-informed, well-comprehended, and voluntary consent process, the objective and replicable measurement of these domains via psychometrically sound self-report measures is critical. This systematic review aimed to evaluate the adequacy of existing measures in terms of the extent to which they assess the three domains of informed consent, are psychometrically sound and acceptable for use by patients. Extensive searching of multiple databases (PsychINFO, PubMed, Sociological Abstracts, CINAHL, AMED) yielded 10,000 potential studies, with 16 relevant scales identified. No existing scale was found to measure all three consent domains, with most only narrowly assessing aspects of any one domain. Information provision was the most frequently assessed domain, followed by comprehension, and then voluntariness. None of the identified scales were found to have adequate evidence for either high quality psychometric properties or patient user acceptability. No existing scale is fit for purpose in comprehensively assessing all domains of informed consent. In the absence of any existing measure meeting the necessary criteria relating to information, comprehension and voluntariness, there is an urgent need for a new measure of medical consent to be developed that is psychometrically sound, spans all three domains and is acceptable to patients and clinicians alike. These findings provide the impetus and justification for the redesign of the informed consent process, with the aim to provide a robust, reliable and replicable process that will in turn improve the quality of the patient experience and care provided.
| S-EPMC8159027 | biostudies-literature
Project description:IntroductionWhile there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care.MethodsA qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results.ResultsThere were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process.ConclusionOverall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.
| S-EPMC10994281 | biostudies-literature