RESUMO
Resumo O termo de consentimento livre e esclarecido tem a função de informar o participante de pesquisas clínicas sobre a natureza da pesquisa e seus direitos, formalizando sua decisão de participar. Estudos indicam que esse documento é redigido de modo complexo, comprometendo a autonomia do participante. Para este trabalho, foram redigidos dois termos de consentimento da mesma pesquisa hipotética, com estilos de redação diferentes. Ambos os termos foram analisados pela ferramenta Coh-Metrix Port, que avalia métricas linguísticas e acessibilidade textual. A análise indicou que os textos são complexos e exigem alta escolaridade para serem entendidos. Esses achados reforçam a percepção de que, no Brasil, os termos de consentimento podem ter sua real função comprometida e apontam a importância de modificar sua forma de elaboração.
Abstract The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.
Resumen El formulario de consentimiento informado tiene la finalidad de mostrar la naturaleza de la investigación y sus derechos al participante de la investigación clínica para formalizar su decisión de participar en el estudio. Los estudios indican que la redacción de este documento es compleja, lo que compromete la autonomía del participante. Para este estudio se redactaron dos formularios de consentimiento de una misma investigación hipotética, con diferentes estilos de escritura. Para el análisis de ambos formularios se utilizó la herramienta Coh-Metrix Port, que evalúa las métricas lingüísticas y la accesibilidad textual. Los resultados apuntaron a que los textos son complejos, lo que requiere un alto nivel de educación para su comprensión. Estos hallazgos coinciden que, en Brasil, los formularios de consentimiento pueden tener su finalidad comprometida y señalan la necesidad de modificar su forma de elaboración.
Assuntos
Protocolos Clínicos , Termos de Consentimento/ética , Ética em Pesquisa , Consentimento Livre e Esclarecido , EscolaridadeRESUMO
Introducción: La seguridad del paciente es un asunto preocupante para la salud pública global y, a su vez, resulta relevante por sus efectos en el propio paciente. Objetivo: Determinar la cultura de seguridad del paciente en los hospitales de una subred de Bogotá, Colombia. Métodos: Estudio cuantitativo, descriptivo, transversal. Previo consentimiento informado se aplicó el cuestionario de la Agency for Healthcare Research and Quality en español a 385 miembros del equipo de salud de la subred que tuvieran contacto directo con el paciente. Se excluyeron aquellos con menos de 3 meses de trabajo en la institución. Se analizaron datos según guía de la Agency for Healthcare Research and Quality. Resultados: El aprendizaje organizacional-mejora continua fue la dimensión de la cultura con mayor porcentaje de respuestas positivas (69 por ciento), seguida del trabajo dentro de las unidades (65 por ciento). El menor número de respuestas positivas se obtuvo en las dimensiones de disponibilidad de personal y respuesta no punitiva al error, ambas con 31 por ciento de respuestas positivas. Los porcentajes de eventos reportados por los respondientes en el último año fueron: ninguno el 52 por ciento, de 1 a 2 el 29 por ciento, de 3 a 5 el 13 por ciento, 6 o más el 7 por ciento. Un 52 por ciento consideró el grado de seguridad como excelente o muy bueno, el 40 por ciento como aceptable y el 8 por ciento como pobre o malo. Conclusiones: Hay una cultura de mejora continua que tiende a constituirse en una fortaleza de cultura de seguridad del paciente, así como el trabajo dentro de las unidades. Además, los asuntos de personal y cultura punitiva frente al error requieren de una atención especial(AU)
Introduction: Patient's safety is an important concern for global public health, and at the same time it is relevant due to its effects in the patient. Objective: Determine the patient's safety culture in hospitals of a sub-network in Bogotá, Colombia. Methods: Quantitative, descriptive, cross-sectional study. With previous informed consent, it was applied a questionnaire of the Agency for Healthcare Research and Quality, in Spanish, to 385 members of the health staff if the sub-network whom have direct contact with the patients. Those with less than 3 months of work in the institution were excluded. Data was analyzed according to the guide of the Agency for Healthcare Research and Quality. Results: Organizational learning - continuous improvement was the dimension with a higher percentage of positive answers (69percent), followed by work within the units (65percent). The smallest number of positive answers was obtained in the dimensions called personal availability and no punitive answer to errors, both with 31percent of positive answers. The percentage of events informed by the respondents in the last year were: none (52percent), 1 to 2 (29percent), 3 to 5 (13percent), 6 or more (7percent). 52percent considered the degree of safety as excellent or very well, 40percent as acceptable and 8percent as poor or bad. Conclusions: There is a culture of continuous improvement that tends to represent strength of the patient's safety culture, as well as the work within the units. In addition, the subjects related to personnel and punitive culture facing errors require a special attention(AU)
Assuntos
Humanos , Masculino , Feminino , Inquéritos e Questionários , Termos de Consentimento/ética , Segurança do Paciente , Epidemiologia Descritiva , Estudos Transversais , Colômbia , Estudos de Avaliação como AssuntoRESUMO
OBJECTIVE: To explore the practices of obstetrician-gynecologists (ob-gyns) in the United States surrounding postpartum sterilization when the Medicaid consent form was not valid. METHODS: Using the American College of Obstetricians and Gynecologists' online directory, we conducted a qualitative study where we recruited ob-gyns practicing in 10 geographically diverse U.S. states for a qualitative study using semi-structured interviews conducted by telephone. We analyzed interview transcripts using the constant comparative method and principles of grounded theory. RESULTS: Thirty ob-gyns (63% women, 77% nonsubspecialized, and 53% academic setting) were interviewed. Although most physicians stated that they did not perform sterilizations without a valid Medicaid sterilization form, others noted that they sometimes did due to a sense of ethical obligation toward their patient's health, being in a role with more authority or seniority, interpreting the emergency justification section of the form more broadly, or backdating the form. The physicians who said that they never went ahead without a signed form tended to work at large institutions and were concerned with losing funding and engaging in potentially illegal or fraudulent behavior. CONCLUSION: Physicians' varied behaviors related to providing postpartum sterilization without a valid Medicaid consent form demonstrate that the policy is in need of revision. Unclear terminology and ramifications of the Medicaid sterilization policy need to be addressed to ensure equitable care.
Assuntos
Termos de Consentimento/legislação & jurisprudência , Medicaid/legislação & jurisprudência , Papel do Médico , Período Pós-Parto/ética , Esterilização Reprodutiva/legislação & jurisprudência , Termos de Consentimento/ética , Feminino , Humanos , Entrevistas como Assunto , Medicaid/ética , Gravidez , Esterilização Reprodutiva/ética , Estados UnidosRESUMO
Communicating results from genomic sequencing to family members can play an essential role allowing access to surveillance, prevention, treatment or prophylactic measures. Yet, many patients struggle with communication of these results and it is unclear to what extent this is discussed during the consent process. We conducted an online systematic search and used content analysis to explore how consent forms for genomic sequencing address communication of genetic information to family members. Our search yielded 68 consent forms from 11 countries. Although 57 forms alluded to the familial nature of results, forms varied in their discussion of the potential familial implications of results. Only 11 addressed communication of genetic information with family members, with differences in who would be responsible for this process. Several forms offered patients options regarding communication, even in countries where national guidelines and legislation allow for the disclosure of results in the absence of patient consent. These findings are concerning because they show how forms may potentially mislead patients and health care professionals about whether communication is permissible in cases where the patient does not consent. We suggest that providers and health care professionals reconsider how consent forms address communicating genetic information to family members.
Assuntos
Termos de Consentimento/ética , Revelação , Família/psicologia , Testes Genéticos/ética , Análise de Sequência de DNA/ética , Termos de Consentimento/normas , Aconselhamento Genético/ética , Privacidade Genética/ética , HumanosRESUMO
The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.
Assuntos
Edição de Genes/ética , Consentimento Livre e Esclarecido/ética , Doadores de Tecidos/ética , Sistemas CRISPR-Cas/genética , Repetições Palindrômicas Curtas Agrupadas e Regularmente Espaçadas/genética , Compensação e Reparação/ética , Termos de Consentimento/ética , Feminino , Edição de Genes/métodos , Genoma Humano/genética , Células Germinativas/metabolismo , Mutação em Linhagem Germinativa/genética , Humanos , Masculino , Doação de Oócitos/ética , Oócitos , EspermatozoidesRESUMO
BACKGROUND: As mobile devices and apps grow in popularity, they are increasingly being used by health care providers to aid clinical care. At our institution, we developed and implemented a point-of-care clinical photography app that also permitted the capture of video recordings; however, the clinical findings it was used to capture and the outcomes that resulted following video recording were unclear. OBJECTIVE: The study aimed to assess the use of a mobile clinical video recording app at our institution and its impact on clinical care. METHODS: A single reviewer retrospectively reviewed video recordings captured between April 2016 and July 2017, associated metadata, and patient records. RESULTS: We identified 362 video recordings that were eligible for inclusion. Most video recordings (54.1%; 190/351) were captured by attending physicians. Specialties recording a high number of video recordings included orthopedic surgery (33.7%; 122/362), neurology (21.3%; 77/362), and ophthalmology (15.2%; 55/362). Consent was clearly documented in the medical record in less than one-third (31.8%; 115/362) of the records. People other than the patient were incidentally captured in 29.6% (107/362) of video recordings. Although video recordings were infrequently referenced in notes corresponding to the clinical encounter (12.2%; 44/362), 7.7% (22/286) of patients were video recorded in subsequent clinical encounters, with 82% (18/22) of these corresponding to the same finding seen in the index video. Store-and-forward telemedicine was documented in clinical notes in only 2 cases (0.5%; 2/362). Videos appeared to be of acceptable quality for clinical purposes. CONCLUSIONS: Video recordings were captured in a variety of clinical settings. Documentation of consent was inconsistent, and other individuals were incidentally included in videos. Although clinical impact was not always clearly evident through retrospective review because of limited documentation, potential uses include documentation for future reference and store-and-forward telemedicine. Repeat video recordings of the same finding provide evidence of use to track the findings over time. Clinical video recordings have the potential to support clinical care; however, documentation of consent requires standardization.
Assuntos
Medicina Clínica/instrumentação , Aplicativos Móveis/normas , Fotografação/ética , Sistemas Automatizados de Assistência Junto ao Leito/organização & administração , Gravação em Vídeo/instrumentação , Adulto , Idoso , Telefone Celular , Termos de Consentimento/ética , Documentação/normas , Feminino , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Neurologia/estatística & dados numéricos , Oftalmologia/estatística & dados numéricos , Ortopedia/estatística & dados numéricos , Fotografação/métodos , Estudos Retrospectivos , Telemedicina/instrumentaçãoRESUMO
BACKGROUND: Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection. METHODS: A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. RESULTS: The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. CONCLUSION: The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts.
Assuntos
Pesquisa Biomédica/ética , Termos de Consentimento/normas , Consentimento Livre e Esclarecido/normas , Doenças Raras/terapia , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Termos de Consentimento/ética , Humanos , Consentimento Livre e Esclarecido/éticaRESUMO
The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus (HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE's genetic experiments. China's guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE's human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist's self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.
Assuntos
Edição de Genes/ética , Sistemas CRISPR-Cas , China , Termos de Consentimento/ética , Ética Médica , Feminino , Edição de Genes/legislação & jurisprudência , Técnicas de Inativação de Genes/ética , Infecções por HIV/genética , Infecções por HIV/imunologia , Infecções por HIV/prevenção & controle , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Humanos , Recém-Nascido , Gravidez , Má Conduta Profissional/ética , Receptores CCR5/deficiência , Receptores CCR5/genéticaRESUMO
PURPOSE: Little is known about how health-care professionals communicate with patients about consenting to genome sequencing. We therefore examined what topics health-care professionals covered and what questions patients asked during consent conversations. METHODS: Twenty-one genome sequencing consent appointments were audio recorded and analyzed. Participants were 35 individuals being invited to participate in the 100,000 Genomes Project (14 participants with rare diseases, 21 relatives), and 10 health-care professionals ("consenters"). RESULTS: Two-thirds of participants' questions were substantive (e.g., genetics and inheritance); one-third administrative (e.g., filling in the consent form). Consenters usually (19/21) emphasized participant choice about secondary findings, but less often (13/21) emphasized the uncertainty about associated disease risks. Consenters primarily used passive statements and closed-ended, rather than open-ended, questions to invite participants' questions and concerns. In two appointments, one parent expressed negative or uncertain views about secondary findings, but after discussion with the other parent opted to receive them. CONCLUSION: Health-care professionals need to be prepared to answer patients' questions about genetics to facilitate genome sequencing consent. Health-care professionals' education also needs to address how to effectively listen and elicit each patient's questions and views, and how to discuss uncertainty around the disease risks associated with secondary findings.
Assuntos
Consentimento Livre e Esclarecido/ética , Sequenciamento Completo do Genoma/ética , Adulto , Idoso , Comunicação , Termos de Consentimento/ética , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Pessoal de Saúde , Humanos , Consentimento Livre e Esclarecido/normas , Masculino , Pessoa de Meia-Idade , Pais , Pacientes , Sequenciamento Completo do Genoma/métodosRESUMO
There are ethical aspects to each of the three phases of cerebrovascular disease: hyperacute management, acute prognostication and management of early complications, and long-term recovery and reintegration with the community. This article addresses ethical concerns pertinent to each phase. First, we discuss ethical issues regarding consent for thrombolysis and endovascular treatment for acute ischemic stroke, including a review of considerations regarding the provision of acute stroke treatment advice over the telephone. Next, we discuss capacity for consent and prognostication after ischemic stroke and intracranial hemorrhage, with a focus on the problems of the self-fulfilling prophecy. Finally, we discuss residual disability and patients' return to driving. Consideration of these ethical dimensions of cerebrovascular disease will assist neurologists in caring for patients and families suffering from this complex condition.
Assuntos
Termos de Consentimento/ética , Fibrinolíticos/uso terapêutico , Neurologia/ética , Acidente Vascular Cerebral/terapia , Terapia Trombolítica/ética , Humanos , Médicos/éticaRESUMO
BACKGROUND: The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. METHODS: This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). RESULTS: Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively). CONCLUSIONS: Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.
Assuntos
Termos de Consentimento/ética , Necessidades e Demandas de Serviços de Saúde/ética , Sujeitos da Pesquisa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Tomada de Decisões , Ética em Pesquisa , Feminino , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Sujeitos da Pesquisa/estatística & dados numéricos , Inquéritos e Questionários , Adulto JovemAssuntos
Anestesiologia/ética , Tomada de Decisões/ética , Parto/psicologia , Autonomia Pessoal , Termos de Consentimento/ética , Cultura , Parto Obstétrico , Feminino , Humanos , Consentimento Livre e Esclarecido/ética , Troca Materno-Fetal , Parto/etnologia , Educação de Pacientes como Assunto/ética , GravidezRESUMO
There is great power and promise for mobile health (mHealth) technology in the realms of clinical practice and research. By offering the opportunity to reshape the interaction between clinician and patient or researcher and subject, the introduction of this technology allows clinicians and researchers access to larger quantities of more timely and reliable data. The potential developments are significant, and they are ethically relevant. With all technological developments, however, come new sets of ethical risks. In this paper, I assess the ethics of mHealth. I argue that while we have an ethical obligation to advance this work in order to further the quality and scope of care, the use of mHealth technology also presents challenges that must be addressed before and during the use of this technology. After describing the ethical landscape, I offer a pragmatic approach to meeting some of these challenges and minimizing ethical risk by switching from a privacy-centered frame to a consent-centered frame.
Assuntos
Registros Eletrônicos de Saúde/ética , Registros Eletrônicos de Saúde/tendências , Informática Médica/ética , Informática Médica/tendências , Telemedicina/ética , Telemedicina/tendências , Segurança Computacional/ética , Segurança Computacional/tendências , Termos de Consentimento/ética , Termos de Consentimento/tendências , Humanos , Informática Médica/métodos , Propriedade/ética , Pacientes , Privacidade , Pesquisadores/ética , Telemedicina/métodosRESUMO
The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.
Assuntos
Técnicas de Cultura de Células/normas , Terapia Baseada em Transplante de Células e Tecidos/normas , Guias de Prática Clínica como Assunto , Controle de Qualidade , Automação Laboratorial/normas , Termos de Consentimento/ética , Regulamentação Governamental , Humanos , Federação Russa , Doadores de Tecidos/éticaRESUMO
BACKGROUND: For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their addressees can improve their understandability. In this study we aimed at further developing a method for testing and improving informed consent documents with regard to readability and test-readers' understanding and reactions. METHODS: We tested, revised, and retested template informed consent documents for biobank research by means of 11 focus group interviews with members from the documents' target population. For the analysis of focus group excerpts we used qualitative content analysis. Revisions were made based on focus group feedback in an iterative process. RESULTS: Focus group participants gave substantial feedback on the original and on the revised version of the tested documents. Revisions included adding and clarifying explanations, including an info-box summarizing the main points of the text and an illustrative graphic. CONCLUSION: Our results indicate positive effects on the tested and revised informed consent documents in regard to general readability and test-readers' understanding and reactions. Participatory methods for improving informed consent should be more often applied and further evaluated for both, medical interventions and clinical research. Particular conceptual and methodological challenges need to be addressed in the future.
Assuntos
Bancos de Espécimes Biológicos/ética , Comportamento de Escolha/ética , Termos de Consentimento/ética , Consentimento Livre e Esclarecido/ética , Seleção de Pacientes/ética , Sujeitos da Pesquisa , Adulto , Idoso , Idoso de 80 Anos ou mais , Medicina Baseada em Evidências , Feminino , Grupos Focais , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Sujeitos da Pesquisa/psicologia , Adulto JovemRESUMO
BACKGROUND: The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. METHODS: In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. RESULTS: The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. CONCLUSIONS: In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.
Assuntos
Compreensão , Termos de Consentimento , Consentimento Livre e Esclarecido , Seleção de Pacientes , Sujeitos da Pesquisa/psicologia , Termos de Consentimento/ética , Humanos , Seleção de Pacientes/ética , Leitura , Terminologia como Assunto , RedaçãoRESUMO
Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.
Assuntos
Compreensão/ética , Termos de Consentimento , Consentimento Livre e Esclarecido/normas , Procedimentos Ortopédicos/legislação & jurisprudência , Termos de Consentimento/classificação , Termos de Consentimento/ética , Termos de Consentimento/normas , Humanos , Consentimento Livre e Esclarecido/ética , AlfabetizaçãoRESUMO
OBJECTIVE: Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers. METHODS: A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required. RESULTS: Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P < .001). For hospitals that did provide treatment, there was a difference between the percentages of hospitals requiring consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P < .001). Within both treatment windows, 98% accepted a health-care proxy or surrogate in lieu of the patient. Of the hospitals with less than 500 beds, 11 of 81 (14%) did not require consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P < .05). Beyond the 3-hour treatment window, hospitals with more than 500 beds required written consent-2-fold increase "compared to less than 3 hour window" (P < .05). Fifty-five percent of the hospitals were academic, whereas 45% were nonacademic. Academic status was not related to the type of consent in either window. CONCLUSIONS: Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers.