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2.
Eur J Med Res ; 26(1): 87, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34362461

RESUMO

BACKGROUND: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. METHODS: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. RESULTS: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. CONCLUSION: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Consentimento Livre e Esclarecido/normas , Farmacovigilância , SARS-CoV-2/imunologia , Vacinação/normas , COVID-19/imunologia , COVID-19/virologia , Revelação , Humanos
3.
Med Law Rev ; 29(3): 446-467, 2021 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-34389863

RESUMO

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics.


Assuntos
Pesquisa Biomédica/ética , Pesquisa Biomédica/legislação & jurisprudência , Confidencialidade/legislação & jurisprudência , Confidencialidade/normas , Ética em Pesquisa , Registros Médicos/legislação & jurisprudência , União Europeia , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas
4.
J Postgrad Med ; 67(3): 134-138, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34414930

RESUMO

Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word "COVID-19" and "RCTs" separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.


Assuntos
COVID-19 , Consentimento Livre e Esclarecido , Seleção de Pacientes/ética , Ensaios Clínicos Controlados Aleatórios como Assunto , COVID-19/epidemiologia , COVID-19/prevenção & controle , COVID-19/terapia , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , SARS-CoV-2
6.
Br J Nurs ; 30(13): 824-825, 2021 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-34251858

RESUMO

Richard Griffith, Senior Lecturer in Health Law at Swansea University, considers the impact of errors and omissions in the forms required to lawfully authorise a deprivation of liberty under the Mental Health Act 2005.


Assuntos
Consentimento Livre e Esclarecido , Competência Mental , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Competência Mental/legislação & jurisprudência , Reino Unido
7.
Med Law Rev ; 29(3): 411-445, 2021 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-34270741

RESUMO

In this article, we analyse the legal components of disclosing confidential patient information under the UK's common law duty of confidentiality (CLDoC) and processing personal (health) data under the UK's General Data Protection Regulation (GDPR) and Data Protection Act 2018. We describe the ostensible divide between the CLDoC and data protection law when it comes to the requirements of a valid signal of consent by a patient to use and disclose patient information, obtained by a health professional in the context of direct care, for health care and health research purposes. Ultimately, our analysis suggests that we are saddled, at least in the medium term, with two regimes operating with different standards of a valid consent-while putatively protecting similar interests. There is, however, opportunity for progress. It is possible to improve professional guidance on the interaction between the regimes and to achieve significant normative alignment without aligning the signalling standard for consent; this would promote consistent protection of reasonable expectations of patients across both regimes. Further coherence would require aligning not only the standard, but also the role played by consent under each regime. Here we argue that, in relation to direct care, any such shift should be away from consent as the normal justification. In relation to health research, on the contrary, it should be toward consent as the normal justification for use and disclosure of patient information under both the CLDoC and data protection law.


Assuntos
Confidencialidade/legislação & jurisprudência , Revelação/legislação & jurisprudência , Registros de Saúde Pessoal , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Registros Médicos , Reino Unido
8.
Clin Ter ; 172(4): 253-255, 2021 Jul 05.
Artigo em Inglês | MEDLINE | ID: mdl-34247204

RESUMO

Abstract: Law No 40/2004 regulates in Italy the matter of medically assisted procreation (MAP). Recently, the Tribunal of Capua Vetere expressed its position on the subject of informed consent in a case of MAP. In the specific case, a couple entered the preliminary stages of the PMA procedures, carrying out the fertilization of the ovum and the embryo production. Afterwards, the couple separated and the man denied consent to the continuation of the MAP. The woman, willing to proceed with the implantation, the woman made an urgent judicial appeal, obtaining the judge's permission to transfer the embryo to the uterus. This paper analyses the different bioethical positions on MAP's informed consent. In fact, on the one hand, the paper highlight what is set out in Law 219/2017 which provides for the possibility of the patient to revoke at any time the consent to the treatment given. On the other hand, it should be noted that Law 40/2004, willing to protect the embryo, establishes the irrevocability of the position of parental consent after fertilization. The judgment in question seems to favour this latter position, placing itself in the protection of the cryopreserved embryo and recall-ing the principle of entrustment following the fertilization of the egg. Nevertheless, the matter is controversial a consistent amount of legal developments are expected to arise in the next future.


Assuntos
Implantação do Embrião , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Consentimento Livre e Esclarecido/normas , Técnicas de Reprodução Assistida/ética , Técnicas de Reprodução Assistida/legislação & jurisprudência , Técnicas de Reprodução Assistida/normas , Adulto , Divórcio/legislação & jurisprudência , Embrião de Mamíferos , Feminino , Humanos , Itália , Masculino , Pais
9.
Nurs Philos ; 22(3): e12347, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33979474

RESUMO

In this paper we argue that 'informed' consent in Big Data genomic biobanking is frequently less than optimally informative. This is due to the particular features of genomic biobanking research which render it ethically problematic. We discuss these features together with details of consent models aimed to address them. Using insights from consent theory, we provide a detailed analysis of the essential components of informed consent which includes recommendations to improve consent performance. In addition, and using insights from philosophy of mind and language and psycholinguistics we support our analyses by identifying the nature and function of concepts (ideas) operational in human cognition and language together with an implicit coding/decoding model of human communication. We identify this model as the source of patients/participants poor understanding. We suggest an alternative, explicit model of human communication, namely, that of relevance-theoretic inference which obviates the limitations of the code model. We suggest practical strategies to assist health service professionals to ensure that the specific information they provide concerning the proposed treatment or research is used to inform participants' decision to consent. We do not prescribe a standard, formal approach to decision-making where boxes are ticked; rather, we aim to focus attention towards the sorts of considerations and questions that might usefully be borne in mind in any consent situation. We hope that our theorising will be of real practical benefit to nurses and midwives working on the clinical and research front-line of genomic science.


Assuntos
Ciência de Dados/métodos , Genômica/ética , Consentimento Livre e Esclarecido/ética , Ciência de Dados/normas , Genômica/tendências , Humanos , Consentimento Livre e Esclarecido/normas , Participação do Paciente/psicologia
10.
S Afr Med J ; 111(2): 180-183, 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33944731

RESUMO

BACKGROUND: Informed consent forms (ICFs) are used to obtain consent from participants. However the complexity and comprehensiveness of these forms may not be appropriate. Readability can be quantified by formulas in Microsoft (MS) Word, such as the Flesch Reading Ease test. The South African (SA) ethics guidelines suggest that the MS Word Flesch-Kincaid Reading Grade score should be used to assess the complexity of ICFs and should be the equivalent of grade 8 level, or lower. OBJECTIVES: To use readability formulas to determine whether current SA ICFs are appropriate for the general population. METHODS: This was a descriptive study of a sample of English ICFs (solicited from our studies, as well as from local researchers) which received approval from local ethical review boards during the past 5 years, for prospective (≥6 months) drug studies that explored treatment and prevention of HIV, tuberculosis, diabetes or cardiovascular disease. ICFs were evaluated in MS Word for Flesch Reading Ease and Flesch-Kincaid Reading Grade, with the Simple Measure of Gobbledygook (SMOG) index calculated using www.readabilityformulas.com. Recommended targets for easy readability are above 60 for the Flesch Reading Ease score, and less than or equal to a grade 8 reading level for the Flesch-Kincaid Reading Grade and SMOG. RESULTS:   A total of 75 consent forms from 35 individual research studies conducted in SA over the last 5 years were included. The consent forms had been approved by six ethics committees across seven of the SA provinces. The median (interquartile range (IQR)) Flesch Reading Ease score was 55.8 (48.7 - 59.7) and 18 (25.0%) of the ICFs had easy or standard readability, while the median (IQR) Flesch-Kincaid Grade was 10.2 (8.8 - 11.4), with 23 (30.6%) at least a grade 8 level or lower. The median (IQR) SMOG index was 9.8 (9.0 - 11.1) and 4 (5.3%) scored below grade 8 level. CONCLUSIONS: Two-thirds of the ICFs from this study fail to meet the SA readability standard, a result matched by using alternative readability formulas. Readability can be improved with simple techniques and by actively monitoring readability metrics.


Assuntos
Compreensão , Termos de Consentimento/normas , Letramento em Saúde/normas , Consentimento Livre e Esclarecido/normas , Sujeitos da Pesquisa/estatística & dados numéricos , Humanos , Estudos Prospectivos , África do Sul , Inquéritos e Questionários
11.
CMAJ Open ; 9(2): E358-E363, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33849985

RESUMO

BACKGROUND: Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD. METHODS: This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus. RESULTS: The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only "yes" or "no" as an answer. INTERPRETATION: The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.


Assuntos
Tomada de Decisão Clínica , Eutanásia Ativa Voluntária , Consentimento Livre e Esclarecido/normas , Competência Mental , Prática Profissional/estatística & dados numéricos , Controle Social Formal/métodos , Suicídio Assistido , Atitude do Pessoal de Saúde , Canadá , Tomada de Decisão Clínica/ética , Tomada de Decisão Clínica/métodos , Códigos de Ética , Eutanásia Ativa Voluntária/ética , Eutanásia Ativa Voluntária/legislação & jurisprudência , Eutanásia Ativa Voluntária/psicologia , Guias como Assunto , Humanos , Enfermeiras e Enfermeiros , Médicos , Padrões de Prática Médica/ética , Padrões de Prática Médica/normas , Pesquisa Qualitativa , Direito a Morrer/ética , Direito a Morrer/legislação & jurisprudência , Suicídio Assistido/ética , Suicídio Assistido/legislação & jurisprudência , Suicídio Assistido/psicologia
14.
Eur J Cancer ; 148: 405-410, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33784533

RESUMO

The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring of clinical management to the genetic characteristics of tumours. While the primary aim of mainstream genomic sequencing of cancer patients is therapy-focussed, genomic testing may yield three types of results beyond the answer to the clinical question: suspected germline mutations, variants of uncertain significance (VUS), and unsolicited findings pertaining to other conditions. Ideally, patients should be prepared beforehand for the clinical and psychosocial consequences of such findings, for themselves and for their family members, and be given the opportunity to autonomously decide whether or not to receive such unsolicited genomic information. When genomic tests are mainstreamed into cancer care, so should accompanying informed consent practices. This paper outlines what mainstream oncologists may learn from the ethical tradition of informed consent for genomic sequencing, as developed within clinical genetics. It argues that mainstream informed consent practices should focus on preparing patients for three types of unsolicited outcomes, briefly and effectively. Also, it argues that when the chance of unsolicited findings is very low, opt-out options need not be actively offered. The use of a layered approach - integrated in information systems - should render informed consent feasible for non-geneticist clinicians in mainstream settings. (Inter) national guidelines for mainstreaming informed consent for genomic sequencing must be developed.


Assuntos
Tomada de Decisões , Testes Genéticos/normas , Genômica/métodos , Mutação em Linhagem Germinativa , Consentimento Livre e Esclarecido/normas , Neoplasias/genética , Medicina de Precisão , Família , Testes Genéticos/ética , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Humanos , Achados Incidentais , Consentimento Livre e Esclarecido/ética , Neoplasias/epidemiologia , Neoplasias/psicologia
15.
J Clin Epidemiol ; 137: 14-22, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33652081

RESUMO

OBJECTIVE: To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study. STUDY DESIGN: International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting. RESULTS: The literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition. CONCLUSION: The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an randomized controlled trial. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders. REGISTRATION: COMET database - http://www.comet-initiative.org/Studies/Details/595.


Assuntos
Consentimento Livre e Esclarecido/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Humanos , Cooperação Internacional , Resultado do Tratamento
16.
Med Leg J ; 89(2): 102-105, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33691511

RESUMO

Recent reports suggest that the use of an outpatient-based procedure (pneumatic retinopexy, PR) for retinal detachment repair should be encouraged within the UK, especially in light of Covid-19 and possible restrictions/competing demands on access to operating theatres. It is therefore essential that patients receive comprehensive information about the risks and benefits of this approach compared with a formal surgical repair either by pars plana vitrectomy (PPV) and/or scleral buckling (SB). We report a retrospective case series of retinal detachments (RD) satisfying the strict selection criteria for PR but who were managed with formal surgery. Single-operation success rate for PPV/SB at six months follow-up was 93.8% in our study, higher than published primary success rates for PR (60-80%). When counselling patients for possible PR, the ease, speed and potentially reduced co-morbidity of an outpatient-based procedure needs to be balanced against its significantly higher failure rate in comparison with primary PPV/SB.


Assuntos
Consentimento Livre e Esclarecido/normas , Retina/cirurgia , Descolamento Retiniano/cirurgia , Recurvamento da Esclera/normas , Vitrectomia/normas , Idoso , COVID-19/prevenção & controle , COVID-19/transmissão , Feminino , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Masculino , Pessoa de Meia-Idade , Retina/fisiopatologia , Estudos Retrospectivos , Recurvamento da Esclera/estatística & dados numéricos , Vitrectomia/estatística & dados numéricos
17.
Stroke ; 52(4): 1527-1531, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33588599

RESUMO

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.


Assuntos
COVID-19 , Consentimento Livre e Esclarecido/normas , Pandemias , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/terapia , Idoso , COVID-19/epidemiologia , Humanos , Masculino , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo
18.
Allergol. immunopatol ; 49(1): 32-39, ene.-feb. 2021. tab
Artigo em Inglês | IBECS | ID: ibc-199223

RESUMO

BACKGROUND: Asthma control is the goal of asthma management. A nationwide study on this aspect was launched by the Italian Society of Paediatric Allergy and Immunology (ControL'Asma study). OBJECTIVE: To define variables associated with different asthma control grades in a nationwide population of asthmatic children and adolescents. METHODS: This cross-sectional real-world study included 480 asthmatic children and adoles­cents (333 males, median age 11.2 years) consecutively enrolled in 10 third level pediatric allergy clinics. According to the Global Initiative for Asthma (GINA) document, history, med­ication use, perception of asthma symptoms assessed by visual analog scale (VAS), clinical examination, lung function, childhood asthma control test (cACT)/asthma control test (ACT), and asthma control level were evaluated. RESULTS: Considering GINA criteria, asthma was well controlled in 55% of patients, partly con­trolled in 32.4%, and uncontrolled in 12.6%. Regarding cACT/ACT, asthma was uncontrolled in 23.2%. Patients with uncontrolled asthma had the lowest lung function parameters and VAS scores, more frequent bronchial obstruction and reversibility, and used more oral and inhaled corticosteroids (CS). CONCLUSIONS: The ControL'Asma study, performed in a real-world setting, showed that asthma in Italian children and adolescents was usually more frequent in males. Asthmatic patients had an early onset and allergic phenotype with very frequent rhinitis comorbidity. Uncontrolled and partly controlled asthma affected about half of the subjects, and the assessment of asthma symptom perception by VAS could be a reliable tool in asthma management


No disponible


Assuntos
Humanos , Masculino , Feminino , Criança , Adolescente , Asma/epidemiologia , Asma/prevenção & controle , Infecções Respiratórias/epidemiologia , Infecções Respiratórias/prevenção & controle , Escala Visual Analógica , Sociedades Médicas/normas , Estudos Transversais , Consentimento Livre e Esclarecido/normas , Inquéritos e Questionários , Rinite/epidemiologia , Guias de Prática Clínica como Assunto
19.
Trials ; 22(1): 90, 2021 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-33494785

RESUMO

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.


Assuntos
Aspirina/administração & dosagem , Aterosclerose/prevenção & controle , Comitês de Ética em Pesquisa/normas , Projetos de Pesquisa/normas , Prevenção Secundária/métodos , Adulto , Aspirina/efeitos adversos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Humanos , Consentimento Livre e Esclarecido/normas , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto/ética , Estudos Multicêntricos como Assunto/normas , Participação do Paciente , Ensaios Clínicos Pragmáticos como Assunto/ética , Ensaios Clínicos Pragmáticos como Assunto/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medição de Risco/normas , Resultado do Tratamento
20.
J Cancer Res Clin Oncol ; 147(7): 2117-2126, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33420813

RESUMO

PURPOSE: Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients' individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients' comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation. METHODS: Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician-patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire. RESULTS: In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients. CONCLUSIONS: To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.


Assuntos
Institutos de Câncer/organização & administração , Comunicação , Consentimento Livre e Esclarecido/normas , Neoplasias/terapia , Relações Médico-Paciente , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Compreensão , Estudos Transversais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Retrospectivos , Inquéritos e Questionários , Adulto Jovem
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